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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 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 amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. During the deductible stage, the enrollee is responsible for the full cost of the drugs. The enrollee remains in the deductible stage until drug payments total $435. Once the enrollee has met the deductible amount of $435, the enrollee moves into the initial coverage stage. Elmiron 100 mg is on Tier 5 of the Plan's 2020 formulary with a 25% coinsurance amount for up to a 30 day supply when purchased from an in-network retail pharmacy. Once total drug costs reach $4,020, the enrollee enters the coverage gap stage. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.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.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 step therapy to manage its formulary. This is the process of beginning drug therapy for a medical condition with preferred (or more cost-effective) non-formulary drug alternative(s) and progressing to other drug therapies only as necessary. A plan must grant an exception to its step therapy rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. The statement must show that the step therapy drug(s): has been ineffective in the treatment of the enrollee's disease or medical condition or, based on both sound clinical evidence and medical and scientific evidence and the known relevant physical or mental characteristics of the enrollee and known characteristics of the drug regimen, is likely to be ineffective or adversely affect the drug's effectiveness or patient compliance; or has caused or based on sound clinical evidence and medical and scientific evidence, is likely to cause an adverse reaction or other harm to the enrollee. 42 CFR Section 423.578(b)(5)(ii).The Plan requires certain drugs be tried first before it will cover the requested drug. This is called step therapy. However, the Part D Plan contract allows an enrollee to request an exception. The Plan will cover the requested drug without requiring step therapy if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 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 amount of the copayment or coinsurance will vary depending on the drug's tier and place of purchase. During the deductible stage, the enrollee is responsible for the full cost of the drugs. The enrollee remains in the deductible stage until drug payments total the deductible amount specific to your coverage. Once the enrollee has met the deductible amount, the enrollee moves into the initial coverage stage. Drugs that are not on the Plan's Formulary but coverage is approved as a formulary exception are covered at the Tier 7 copayment or coinsurance level. Victoza is not on the Plan's 2020 Formulary, but the Plan agreed to provide coverage as a formulary exception. Tier 7 drugs require a 50% coinsurance amount for up to a 90 day supply when purchased from a preferred mail order pharmacy. Once total drug costs reach the Initial Coverage Limit total specific to your coverage, the enrollee enters the coverage gap stage. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Enrollee 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.The Part D Plan contract allows an enrollee to request an exception to the Plan's cost-sharing tier to pay less for a drug. The prescriber must provide medical reasons to support an exception to the Plan's cost-sharing rules.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 $4,020. Once total drug costs reach this amount, the enrollee enters the coverage gap stage. During the coverage gap stage, the enrollee pays 25%. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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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.Compounded prescription drug products can contain (1) all Part D drug product components; (2) some Part D drug product components; or (3) no Part D drug product components. Only costs associated with those components that satisfy the definition of a Part D drug are allowable costs under Part D because the compounded products as a whole do not satisfy the definition of a Part D drug. The labor costs associated with mixing a compounded product that contains at least one Part D drug component can be included in the dispensing fee (as defined in 423.100). Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.. 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); 42 CFR Section 423.100; and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10. The definition of a Part D drug includes only those prescription drugs that are approved by the FDA for safety and effectiveness. For a drug to be approved by the FDA, the manufacturer of the drug must file a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) with the FDA's Center for Drug Evaluation and Research (CDER). Medicare Part D does not pay for drugs that are not FDA approved prescription drugs. See Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(2)(A)(i)-(iii). 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), 1927(k) and 1927(d)(4)(C); and 42 CFR Section 423.100. A Part D drug must be used for a medically accepted indication that facilitates the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (except for Part D vaccines). Consequently, if a drug works on medical equipment or devices and is not used for a medically accepted indication of therapeutic value on the body, it cannot satisfy the definition of a Part D drug. For example, a Heparin flush is not used to treat a patient for a medically accepted indication, but rather to dissolve possible blood clots around an infusion line. Therefore, Heparin's use in this instance is not therapeutic but is, instead, necessary to make durable medical equipment work. It would therefore not be a Part D drug when used in a Heparin flush. Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.6.The 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Plan may exclude from qualified prescription drug coverage any covered part D drug--(A) for which payment would not be made if section 1862(a) applied to this part; or (B) which is not prescribed in accordance with the plan or this part. Such exclusions are determinations subject to reconsideration and appeal pursuant to subsections (g) and (h), respectively, of Section 1860D-4. Social Security Act, Section 1860D-2(e)(3). Notwithstanding any other provision of this title, no payment may be made under part A or part B for any expenses incurred for items or services--(1)(A) which, except for items and services described in a succeeding subparagraph, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,... Social Security Act, Section 1862(a)(1)(A). The following actions by a Part D Plan are coverage determinations: (1) A decision not to provide or pay for a Part D drug (including a decision not to pay because the drug is not on the Plan's formulary, because the drug is determined not to be medically necessary, because the drug is furnished by an out-of-network pharmacy, or because the Part D Plan sponsor determines that the drug is otherwise excludable under section 1862(a) of the Act if applied to Medicare Part D) that the enrollee believes may be covered by the Plan. 42 CFR Section 423.566(b)(1).Each Part D Plan must have established, for covered Part D drugs furnished through a Part D Plan, a drug utilization management program, quality assurance measures and systems, and an Medication Therapy Management Program (MTMP). 42 CFR Section 423.153(a). A Part D Plan must have established a reasonable and appropriate drug utilization management program that addresses the following: incentives to reduce costs when medically appropriate; policies and systems to assist in preventing over-utilization and under-utilization of prescribed medications; providing CMS with information concerning the procedures and performance of its drug utilization management program, according to guidelines specified by CMS. 42 CFR Section 423.153(b). A Part D Plan must have established quality assurance measures and systems to reduce medication errors and adverse drug interactions and improve medication use that include all of the following--(1) Representation that network providers are required to comply with minimum standards for pharmacy practice as established by the States. (2) Concurrent drug utilization review systems, policies, and procedures designed to ensure that a review of the prescribed drug therapy is performed before each prescription is dispensed to an enrollee in a sponsor's Part D Plan, typically at the point-of-sale or point of distribution. The review must include, but not be limited to: Screening for potential drug therapy problems due to therapeutic duplication; Age/gender-related contraindications; Over-utilization and under-utilization; Drug-drug interactions; Incorrect drug dosage or duration of drug therapy; Drug-allergy contraindications; Clinical abuse/misuse. 42 CFR Section 423.153(c).A Part D sponsor must have established a MTMP that--(i) Is designed to ensure that covered Part D drugs prescribed to targeted beneficiaries described in paragraph (d)(2) of this section are appropriately used to optimize therapeutic outcomes through improved medication use. (ii) Is designed to reduce the risk of adverse events, including adverse drug interactions, for targeted beneficiaries described in paragraph (d)(2) of this section. (iii) May be furnished by a pharmacist or other qualified provider. (iv) May distinguish between services in ambulatory and institutional settings. (v) Must enroll targeted beneficiaries using an opt-out method of enrollment only. (vi) Must target beneficiaries for enrollment in the MTMP at least quarterly during each Plan year. (vii) Must offer a minimum level of medication therapy management services for each beneficiary enrolled in the MTMP... 42 CFR Section 423.153(d).In accordance with section 1860D-2(e)(3) of the Act, a Part D Plan may exclude from qualified prescription drug coverage any Part D drug: 1) For which payment would not be made if items and services are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (except for Part D vaccines); or 2) Which is not prescribed in accordance with the Part D Plan. Such exclusions are coverage determinations or redeterminations pursuant to chapter 18 of this manual, and are subject to appeal. Medicare Prescription Drug Benefit Manual, Chapter 6, Section 20.4.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)(5)(ii).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).The Plan conducts drug use reviews for enrollees to help make sure that they are getting safe and appropriate care. These reviews are especially important for enrollees who have more than one provider who prescribes their drugs. The Plan does a review each time an enrollee fills a prescription. During these reviews, the Plan looks for potential problems such as possible medication errors, drugs that may not be necessary because the enrollee is taking another drug to treat the same medical condition, drugs that may not be safe or appropriate due to the enrollee's age or gender, certain combinations of drugs that could harm the enrollee if taken at the same time, prescriptions written for drugs that have ingredients the enrollee is allergic to, or possible errors in the amount (dosage) of a drug the enrollee is taking. Please refer to Chapter 3 of the Plan's Evidence of Coverage. 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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, Section 1860D-2(e)(2)(B). Medicare Part B pays for the rental or purchase of 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; Medicare Benefit Policy Manual, Chapter 15, Section 110.3. Medicare Part B covers an external infusion pump for the administration of other drugs if either of the following sets of criteria (1) or (2) are met:Criteria set 1:- Parenteral administration of the drug in the home is reasonable and necessary. - An infusion pump is necessary to safely administer the drug - The drug is administered by a prolonged infusion of at least 8 hours because of proven improved clinical efficacy - The therapeutic regimen is proven or generally accepted to have significant advantages over intermittent bolus administration regimens or infusions lasting less than 8 hoursCriteria set 2:- Parenteral administration of the drug in the home is reasonable and necessary - An infusion pump is necessary to safely administer the drug - The drug is administered by intermittent infusion (each episode of infusion lasting less than 8 hours) which does not require the beneficiary to return to the physician's office prior to the beginning of each infusion - Systemic toxicity or adverse effects of the drug are unavoidable without infusing it at a strictly controlled rate as indicated in the Physicians Desk Reference, or the U.S. Pharmacopeia Drug Information Administration of parenteral inotropic therapy using the drugs dobutamine (J1250), milrinone (J2260) ordopamine (J1265) for beneficiaries with American College of Cardiology Foundation/American Heart Association (ACCF/AHA) Stage D heart failure (HF) or New York Heart Association (NYHA) Class IV HF, if a beneficiary meets all of the following criteria:1. Remains symptomatic despite optimal guideline directed medical therapy (GDMT) as defined below; and,2. As Bridge therapy for patients eligible for and awaiting mechanical circulatory support (MCS)/cardiac transplantation, or as palliative care for patients not eligible for either MCS/cardiac transplantation; and,3. Prescribed following an evaluation by a cardiologist with training in the management of advanced heart failure; and,4. There has been a documented improvement in beneficiary symptoms of heart failure while on theselected inotropic drug at the time of discharge from an inpatient or skilled nursing care facility; and,5. An evaluation every three months by the prescribing provider or a heart failure team with oversight by a cardiologist with training in the management of advanced heart failure, which documents the beneficiary's cardiac symptoms and the continuing response and need for therapy. The heart failure team or physician.Medicare National Coverage Determinations Manual (CMS Pub. 100-03), Chapter 1, ?280.14. CGS or Noridian Local Coverage Determination (LCD) for External Infusion Pumps (L33794).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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 $275, 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 is 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.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. A Part D Plan must exclude Part D drugs from coverage if they are not used and sold in the United States. Social Security Act, Sections 1860D-2(e)(1), 1927(k); Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.7.The Part D Plan cannot cover a drug purchased outside the United States and its territories, even for a medical emergency. Please refer to the Plan's Evidence of Coverage (EOC).Medicare Part D does not cover a (1) drug used for anorexia, weight loss or weight gain; (2) drug used to promote fertility; (3) drug used for cosmetic purposes or to promote hair growth; (4) drug used for the symptomatic relief of coughs and colds; (5) prescription vitamin and mineral product; (6) non-prescription or over-the-counter drug; (7) drug subject to manufacturer tying arrangements; and (8) drug used to treat sexual or erectile dysfunction or (9) sexual or erectile dysfunction drug used to treat a condition other than sexual 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 Plan does not offer supplemental (additional) coverage for it. If you purchase drugs that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).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 must grant an exception for a drug that is not on its formulary whenever it determines that the drug is medically necessary, consistent with the prescriber's statement, and that the drug would be covered but for the fact that it is not on the formulary. The statement must show that all of the covered drugs on any tier of the plan's formulary for treatment of the enrollee's condition would not be as effective as the non-formulary drug or would have adverse effects for the enrollee. 42 CFR Sections 423.578(b) and 423.578(b)(5)(i).If a drug is not on the formulary (drug list), an enrollee can ask the Plan to make an exception and cover the drug. The Plan will make an exception for coverage if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).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.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. 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.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 bone marrow transplant, II) the transplant met Medicare coverage criteria in effect with respect to the facility being approved for bone marrow 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. Medicare rules state that the definition of a Part D drug includes medical supplies directly associated with the injection of insulin, including syringes, needles, alcohol swabs, gauze, and insulin injection delivery devices not otherwise covered under Medicare Part B, such as insulin pens, pen supplies, and needle-free syringes. Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.5.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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. Access to covered drugs from an out-of-network pharmacy is required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacy and (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required to establish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42 CFR Sections 423.120(a) and 423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, Section 60.1. For a drug to be covered under Medicare Part D, it must meet the definition of a Part D drug. The Social Security Act generally defines a Part D drug as a drug product that meets the following requirements: -It requires a prescription for dispensing; and -It is approved by the Food and Drug Administration (FDA) for safety and effectiveness; and -It is prescribed for a medically accepted indication; and -It is not otherwise excluded from coverage under Part D law and rules. See Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(2)(A)(i)-(iii); and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.1. The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA?s Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, 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. Prescriptions filled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. The Plan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for a medical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonable driving distance or when the prescription is for a drug that is out of stock at an accessible network pharmacy. 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 liver transplant, II) the transplant met Medicare coverage criteria in effect with respect to the facility being approved for liver 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. 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. 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 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 Enrollee 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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Enrollee 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). The Medicare Part D law states that an enrollee is not allowed to request a tiering exception for a drug being covered under the non-formulary exception rules. 42 CFR Section 423.578(c)(4)(iii). The Part D Plan contract states that the Plan does not provide tiering exceptions for off-formulary drugs which it has approved coverage for through a formulary exception. Please refer to the Plan?s Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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). 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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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). 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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.Part D specifies that a drug prescribed to a Part D eligible individual cannot be considered a covered Part D drug if payment for such drug ...is available (or would be available but for the application of a deductible) under part A or B for that individual. CMS interprets this to mean that if payment could be available under Part A or Part B to the individual for such drug, then it will not be covered under Part D. Consequently, drugs covered under Parts A and B are considered available (and excluded from Part D) even if a beneficiary chooses not to pay premiums or if a beneficiary has enrolled in Part B but that coverage has not yet taken effect. Medicare Prescription Drug Benefit Manual, Chapter 6, Section 20.2.Medicare Part B local policy states that prescription drugs used in immunosuppressive therapy are covered if I) they are prescribed following a heart transplant, II) the transplant met Medicare coverage criteria in effect with respect to the facility being approved for heart 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Enrollee 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.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 110.3Medicare Part B local policy states that a small volume nebulizer and related compressor are considered for coverage when medically necessary to administer albuterol, arformoterol (Brovana), budesonide, cromolyn, formoterol, ipratropium, levalbuterol, metaproterenol or revefenacin for the management of obstructive pulmonary disease (Refer to Group 8 Codes in the LCD-related Policy Article for applicable diagnoses). You can find this rule at Noridian Healthcare Solutions, 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 Part A or Part B. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. 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. 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)(5)(ii). 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. The Part D Plan may cover limited quantities of some drugs. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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). 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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA?s Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.10 and Chapter 7, Section 60.2. The definition of a Part D drug includes only those prescription drugs that are approved by the FDA for safety and effectiveness. For a drug to be approved by the FDA, the manufacturer of the drug must file a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) with the FDA?s Center for Drug Evaluation and Research (CDER). Medicare Part D does not pay for drugs that are not FDA approved prescription drugs. See Social Security Act, Sections 1860D-2(e)(1), 1927(k)(2), and 1927(b)(3). The Plan does not cover drugs/items excluded from Medicare Part D coverage. If you purchase drugs/items that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. Access to covered drugs from an out-of-network pharmacy is required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacy and (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required to establish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42 CFR Sections 423.120(a) and 423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, Section 60.1. A Part D plan must have enough contracted retail pharmacies in its network to ensure that enrollees have adequate access to covered prescription drugs. Access to covered drugs from an out-of-network pharmacy is required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacy and (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required to establish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42 CFR Sections 423.120(a) and 423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, Section 60.1. Vaccines administered in a physician's office or by other non-network providers may be covered under the out-of-network access rules. A Part D enrollee may self-pay for the vaccine cost and its administration and submit a paper claim for reimbursement to his or her Part D sponsor. 42 CFR Section 423.124; Prescription Drug Benefit Manual, Chapter 5, Section 60.3.4. For a drug to be covered under Medicare Part D, it must meet the definition of a Part D drug. The Social Security Act generally defines a Part D drug as a drug product that meets the following requirements: -It requires a prescription for dispensing; and -It is approved by the Food and Drug Administration (FDA) for safety and effectiveness; and -It is prescribed for a medically accepted indication; and -It is not otherwise excluded from coverage under Part D law and rules. See Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(2)(A)(i)-(iii); and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.1. The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA?s Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, 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. Prescriptions filled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. The Plan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for a medical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonable driving distance or when the prescription is for a drug that is out of stock at an accessible network pharmacy. Please refer to the Plan?s Evidence of Coverage (EOC). 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. 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 and who administers the vaccine. Note that in some cases, an enrollee may receive a vaccine outside of the Plan?s pharmacy network, and may have to pay for the entire cost of the vaccine and its administration. The enrollee can then ask the Plan to pay its share of the vaccine costs. For detailed information on how vaccines are reimbursed, please refer to the Plan?s Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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), and2. 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, and3. 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, and4. 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).Part D specifies that a drug prescribed to a Part D eligible individual cannot be considered a covered Part D drug if payment for such drug ...is available (or would be available but for the application of a deductible) under part A or B for that individual. CMS interprets this to mean that if payment could be available under Part A or Part B to the individual for such drug, then it will not be covered under Part D. Consequently, drugs covered under Parts A and B are considered available (and excluded from Part D) even if a beneficiary chooses not to pay premiums or if a beneficiary has enrolled in Part B but that coverage has not yet taken effect. Medicare Prescription Drug Benefit Manual, Chapter 6, Section 20.2.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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.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.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.The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 provides coverage of intravenous immune globulin (IVIG) for the treatment of primary immune 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 diagnosed primary immune deficiency disease, it is administered in the home of a patient with a diagnosed primary immune deficiency disease, and the physician determines that administration of the derivative in the patient's home is medically appropriate. Medicare Benefit Policy Manual, Chapter 15, Section 50.6; Cigna Government Services Article for Intravenous Immune Globulin (A52509). National Government Services Article for Intravenous Immune Globulin (A52509). Noridian Administrative Services Article for Intravenous Immune Globulin (A52509).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).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.The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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/pancreas transplant, II) the transplant met Medicare coverage criteria in effect with respect to the facility being approved for kidney/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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. 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 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 $4,020. Once total drug costs reach this amount, the enrollee enters the coverage gap stage. During the coverage gap stage, the enrollee pays 25% plus a portion of the dispensing fee for brand name drugs or 25% for generic drugs. Once total out-of-pocket costs reach $6,350, the enrollee will qualify for catastrophic coverage. Please refer to the Plan?s Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Enrollee 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 Plan does not provide tiering exceptions for brand or biologic drugs if the lower cost-sharing tier or tiers contain only generic drugs approved for treating the same condition. Please refer to the Plan's Evidence of Coverage (EOC). The Medicare Part D law states that an enrollee is not allowed to request a tiering exception for a drug being covered under the non-formulary exception rules. 42 CFR Section 423.578(c)(4)(iii). The Part D Plan contract states that the Plan does not provide tiering exceptions for off-formulary drugs which it has approved coverage for through a formulary exception. Please refer to the Plan?s Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 $435, 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 received at Walgreen's Pharmacy on August 24, 2020 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.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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). 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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100. Medicare law defines those drugs that may be covered under Part D. A covered prescription drug must be used for a ?medically accepted indication.? A ?medically accepted indication? means a use that is approved by the Food and Drug Administration (FDA), or a use supported by one or more citations in the drug compendia approved by Medicare. Medically accepted indications do not include uses in research or uses described in peer-reviewed medical literature. Please refer to Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(6); and 42 CFR Section 423.100. A Part D drug must be used for a medically accepted indication that facilitates the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member (except for Part D vaccines). Consequently, if a drug works on medical equipment or devices and is not used for a medically accepted indication of therapeutic value on the body, it cannot satisfy the definition of a Part D drug. For example, Sterile Water is not used to treat a patient for a medically accepted indication, but rather to dilute the components of a compound. Therefore, Sterile Water in this instance is not therapeutic. Manual, Chapter 6, Section 10.6. The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to the Plan?s Evidence of Coverage (EOC). For a drug to be covered under Medicare Part D, it must meet the definition of a Part D drug. The Social Security Act generally defines a Part D drug as a drug product that meets the following requirements: -It requires a prescription for dispensing; and -It is approved by the Food and Drug Administration (FDA) for safety and effectiveness; and -It is prescribed for a medically accepted indication; and -It is not otherwise excluded from coverage under Part D law and rules. See Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(2)(A)(i)-(iii); and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.1. The definition of a Part D drug includes only those prescription drugs that are approved by the FDA for safety and effectiveness. For a drug to be approved by the FDA, the manufacturer of the drug must file a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) with the FDA?s Center for Drug Evaluation and Research (CDER). Medicare Part D does not pay for drugs that are not FDA approved prescription drugs. See Social Security Act, Sections 1860D-2(e)(1), 1927(k)(2), and 1927(b)(3). The Plan does not cover drugs/items excluded from Medicare Part D coverage. If you purchase drugs/items that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Enrollee 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Part D does not cover a (1) drug used for anorexia, weight loss or weight gain; (2) drug used to promote fertility; (3) drug used for cosmetic purposes or to promote hair growth; (4) drug used for the symptomatic relief of coughs and colds; (5) prescription vitamin and mineral product; (6) non-prescription or over-the-counter drug; (7) drug subject to manufacturer tying arrangements; and (8) drug used to treat sexual or erectile dysfunction or (9) sexual or erectile dysfunction drug used to treat a condition other than sexual 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 Plan does not offer supplemental (additional) coverage for it. If you purchase drugs that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 GuidanceManual, 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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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). 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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 coveragerequests 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 forthe 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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 provides coverage of intravenous immune globulin (IVIG) for the treatment of primary immune 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 diagnosed primary immune deficiency disease, it is administered in the home of a patient with a diagnosed primary immune deficiency disease, and the physician determines that administration of the derivative in the patient's home is medically appropriate. Medicare Benefit Policy Manual, Chapter 15, Section 50.6; Cigna Government Services Article for Intravenous Immune Globulin (A52509). National Government Services Article for Intravenous Immune Globulin (A52509). Noridian Administrative Services Article for Intravenous Immune Globulin (A52509). 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer tothe Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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(EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 a small volume nebulizer and related compressor are considered for coverage when medically necessary to administer tobramycin to a beneficiary with cystic fibrosis or bronchiectasis (Refer to Group 10 Codes in the LCD-related Policy Article for applicable diagnoses). You can find this rule at Noridian Healthcare Solutions, 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 Part A or Part B. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 Enrollee 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.The Part D Plan contract allows an enrollee to request an exception to the Plan's cost-sharing tier to pay less for a drug. The prescriber must provide medical reasons to support an exception to the Plan's cost-sharing rules. 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 $4,020. Once total drug costs reach this amount, the enrollee enters the coverage gap stage. During the coverage gap stage, the enrollee pays 25% coinsurance. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).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. The Part D Plan may cover limited quantities of some drugs. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, 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/items that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.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. Butalbital-Acetaminophen-Caffeine 50-325-40 mg is on Tier 2 of the Plan's 2020 Formulary. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. The definition of a Part D drug includes only those prescription drugs that are approved by the FDA for safety and effectiveness. For a drug to be approved by the FDA, the manufacturer of the drug must file a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) with the FDA's Center for Drug Evaluation and Research (CDER). Medicare Part D does not pay for drugs that are not FDA approved prescription drugs. See Social Security Act, Sections 1860D-2(e)(1), 1927(k)(2), and 1927(b)(3).The Plan does not cover drugs/items excluded from Medicare Part D coverage. If you purchase drugs/items that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, 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/items that are excluded, you must pay for them yourself. 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. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.10 and Chapter 7, Section 60.2.Medicare Part D does not cover a (1) drug used for anorexia, weight loss or weight gain; (2) drug used to promote fertility; (3) drug used for cosmetic purposes or to promote hair growth; (4) drug used for the symptomatic relief of coughs and colds; (5) prescription vitamin and mineral product; (6) non-prescription or over-the-counter drug; (7) drug subject to manufacturer tying arrangements; and (8) drug used to treat sexual or erectile dysfunction or (9) sexual or erectile dysfunction drug used to treat a condition other than sexual 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 Plan does not offer supplemental (additional) coverage for it. If you purchase drugs that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).A Part D plan must have enough contracted retail pharmacies in its network to ensure that enrollees have adequate access to covered prescription drugs. Access to covered drugs from an out-of-network pharmacy is required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacy and (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required to establish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42 CFR Sections 423.120(a) and 423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, Section 60.1.The Plan will generally cover prescriptions only if they are filled at a Plan network pharmacy. Prescriptions filled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. The Plan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for a medical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonable driving distance or when the prescription is for a drug that is out of stock at an accessible network pharmacy. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to the Plan's Evidence of Coverage (EOC).For a drug to be covered under Medicare Part D, it must meet the definition of a Part D drug. The Social Security Act generally defines a Part D drug as a drug product that meets the following requirements:-It requires a prescription for dispensing; and -It is approved by the Food and Drug Administration (FDA) for safety and effectiveness; and -It is prescribed for a medically accepted indication; and -It is not otherwise excluded from coverage under Part D law and rules. See Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(2)(A)(i)-(iii); and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.1.The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, 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/items that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 a small volume nebulizer and related compressor are considered for coverage when medically necessary to administer acetylcysteine (J7608) for persistent thick or tenacious pulmonary secretions. (Refer to Group 7 Codes in the LCD-related Policy Article for applicable diagnoses). You can find this rule at Noridian Healthcare Solutions, 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 Part A or Part B. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 provides coverage of intravenous immune globulin (IVIG) for the treatment of primary immune 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 diagnosed primary immune deficiency disease, it is administered in the home of a patient with a diagnosed primary immune deficiency disease, and the physician determines that administration of the derivative in the patient's home is medically appropriate. Medicare Benefit Policy Manual, Chapter 15, Section 50.6; Cigna Government Services Article for Intravenous Immune Globulin (A52509). National Government Services Article for Intravenous Immune Globulin (A52509). Noridian Administrative Services Article for Intravenous Immune Globulin (A52509).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).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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 step therapy to manage its formulary. This is the process of beginning drug therapy for a medical condition with preferred (or more cost-effective) non-formulary drug alternative(s) and progressing to other drug therapies only as necessary. A plan must grant an exception to its step therapy rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. The statement must show that the step therapy drug(s): has been ineffective in the treatment of the enrollee's disease or medical condition or, based on both sound clinical evidence and medical and scientific evidence and the known relevant physical or mental characteristics of the enrollee and known characteristics of the drug regimen, is likely to be ineffective or adversely affect the drug's effectiveness or patient compliance; or has caused or based on sound clinical evidence and medical and scientific evidence, is likely to cause an adverse reaction or other harm to the enrollee. 42 CFR Section 423.578(b)(5)(ii). The Plan requires certain drugs be tried first before it will cover the requested drug. This is called step therapy. However, the Part D Plan contract allows an enrollee to request an exception. The Plan will cover the requested drug without requiring step therapy if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. Access to covered drugs from an out-of-network pharmacy is required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacy and (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required to establish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42 CFR Sections 423.120(a) and 423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, Section 60.1. The Plan will generally cover prescriptions only if they are filled at a Plan network pharmacy. Prescriptions filled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. The Plan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for a medical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonable driving distance or when the prescription is for a drug that is out of stock at an accessible network pharmacy. Please refer to the Plan's Evidence of Coverage.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. 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. 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. When the enrollee has additional coverage, how the Plan will coordinate depends on the situation. Sometimes, a group health plan must provide health benefits to the enrollee before the Part D Plan will provide benefits. Please refer to the Plan's Evidence of Coverage.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. 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 ??423.578, 423.100. 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 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.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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). 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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. 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. Please refer to the Plan?s Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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, 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 $4,020. 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 plus a portion of the dispensing fee or 25% for generic drugs. Once total out-of-pocket costs reach $6,350, the enrollee will qualify for catastrophic coverage. While in the coverage stage, the Plan will pay most of the cost of drugs for the rest of the calendar year (through December 31, 2020). Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. Access to covered drugs from an out-of-network pharmacy is required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacy and (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required to establish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42 CFR Sections 423.120(a) and 423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, Section 60.1. 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 Plan will generally cover prescriptions only if they are filled at a Plan network pharmacy. Prescriptions filled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. The Plan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for a medical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonable driving distance or when the prescription is for a drug that is out of stock at an accessible network pharmacy. Please refer to the Plan's Evidence of Coverage (EOC).For a drug to be covered under Medicare Part D, it must meet the definition of a Part D drug. The Social Security Act generally defines a Part D drug as a drug product that meets the following requirements: -It requires a prescription for dispensing; and -It is approved by the Food and Drug Administration (FDA) for safety and effectiveness; and -It is prescribed for a medically accepted indication; and -It is not otherwise excluded from coverage under Part D law and rules. See Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(2)(A)(i)-(iii); and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.1.The definition of a Part D drug includes only those prescription drugs that are approved by the FDA for safety and effectiveness. For a drug to be approved by the FDA, the manufacturer of the drug must file a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) with the FDA's Center for Drug Evaluation and Research (CDER). Medicare Part D does not pay for drugs that are not FDA approved prescription drugs. See Social Security Act, Sections 1860D-2(e)(1), 1927(k)(2), and 1927(b)(3).The Plan does not cover drugs/items excluded from Medicare Part D coverage. If you purchase drugs/items that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. Access to covered drugs from an out-of-network pharmacy is required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacy and (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required to establish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42 CFR Sections 423.120(a) and 423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, Section 60.1. For a drug to be covered under Medicare Part D, it must meet the definition of a Part D drug. The Social Security Act generally defines a Part D drug as a drug product that meets the following requirements: -It requires a prescription for dispensing; and -It is approved by the Food and Drug Administration (FDA) for safety and effectiveness; and -It is prescribed for a medically accepted indication; and -It is not otherwise excluded from coverage under Part D law and rules. See Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(2)(A)(i)-(iii); and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.1. The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, 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. Prescriptions filled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. The Plan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for a medical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonable driving distance or when the prescription is for a drug that is out of stock at an accessible network pharmacy. 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. Access to covered drugs from an out-of-network pharmacy is required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacy and (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required to establish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42 CFR Sections 423.120(a) and 423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, Section 60.1. For a drug to be covered under Medicare Part D, it must meet the definition of a Part D drug. The Social Security Act generally defines a Part D drug as a drug product that meets the following requirements: -It requires a prescription for dispensing; and -It is approved by the Food and Drug Administration (FDA) for safety and effectiveness; and -It is prescribed for a medically accepted indication; and -It is not otherwise excluded from coverage under Part D law and rules. See Social Security Act, Sections 1860D-2(e)(1) and 1927(k)(2)(A)(i)-(iii); and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.1. The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.10 and Chapter 7, Section 60.2.The definition of a Part D drug includes only those prescription drugs that are approved by the FDA for safety and effectiveness. For a drug to be approved by the FDA, the manufacturer of the drug must file a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) with the FDA's Center for Drug Evaluation and Research (CDER). Medicare Part D does not pay for drugs that are not FDA approved prescription drugs. See Social Security Act, Sections 1860D-2(e)(1), 1927(k)(2), and 1927(b)(3).The Plan will generally cover prescriptions only if they are filled at a Plan network pharmacy. Prescriptions filled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. The Plan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for a medical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonable driving distance or when the prescription is for a drug that is out of stock at an accessible network pharmacy. 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. The definition of a Part D drug includes only those prescription drugs that are approved by the FDA for safety and effectiveness. For a drug to be approved by the FDA, the manufacturer of the drug must file a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) with the FDA's Center for Drug Evaluation and Research (CDER). Medicare Part D does not pay for drugs that are not FDA approved prescription drugs. See Social Security Act, Sections 1860D-2(e)(1), 1927(k)(2), and 1927(b)(3).The Plan does not cover drugs/items excluded from Medicare Part D coverage. If you purchase drugs/items that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. Please refer to the Plan's Evidence of Coverage (EOC). A Part D plan must have enough contracted retail pharmacies in its network to ensure that enrollees have adequate access to covered prescription drugs. Access to covered drugs from an out-of-network pharmacy is required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacy and (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required to establish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42 CFR Sections 423.120(a) and 423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, Section 60.1. The Plan will generally cover prescriptions only if they are filled at a Plan network pharmacy. Prescriptions filled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. The Plan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for a medical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonable driving distance or when the prescription is for a drug that is out of stock at an accessible network pharmacy. Please refer to the Plan's Evidence of Coverage.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.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.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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 must grant an exception for a drug that is not on its formulary whenever it determines that the drug is medically necessary, consistent with the prescriber's statement, and that the drug would be covered but for the fact that it is not on the formulary. The statement must show that all of the covered drugs on any tier of the plan's formulary for treatment of the enrollee's condition would not be as effective as the non-formulary drug or would have adverse effects for the enrollee. 42 CFR Sections 423.578(b) and 423.578(b)(5)(i).If a drug is not on the formulary (drug list), an enrollee can ask the Plan to make an exception and cover the drug. The Plan will make an exception for coverage if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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). A Part D plan must have enough contracted retail pharmacies in its network to ensure that enrollees have adequate access to covered prescription drugs. Access to covered drugs from an out-of-network pharmacy is required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacy and (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required to establish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42 CFR Sections 423.120(a) and 423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, Section 60.1. The Plan will generally cover prescriptions only if they are filled at a Plan network pharmacy. Prescriptions filled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. The Plan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for a medical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonable driving distance or when the prescription is for a drug that is out of stock at an accessible network pharmacy. Please refer to the Plan?s Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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.The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to the Plan's Evidence of Coverage (EOC).d indication. Please refer to the Plan?s Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. Access to covered drugs from an out-of-network pharmacy is required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacy and (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required to establish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42 CFR ?423.120 and ?423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, ?60.1. The Part D Plan contract The Plan will generally cover prescriptions only if they are filled at a Plan network pharmacy. Prescriptions filled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. The Plan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for a medical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonable driving distance or when the prescription is for a drug that is out of stock at an accessible network pharmacy. Please refer to the Plan?s Evidence of Coverage.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. The Part D Plan limits coverage to drugs covered under Medicare Part D.

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.10 and Chapter 7, Section 60.2.Medicare Part D does not cover a (1) drug used for anorexia, weight loss or weight gain; (2) drug used to promote fertility; (3) drug used for cosmetic purposes or to promote hair growth; (4) drug used for the symptomatic relief of coughs and colds; (5) prescription vitamin and mineral product; (6) non-prescription or over-the-counter drug; (7) drug subject to manufacturer tying arrangements; and (8) drug used to treat sexual or erectile dysfunction or (9) sexual or erectile dysfunction drug used to treat a condition other than sexual 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 Plan does not offer supplemental (additional) coverage for it. If you purchase drugs that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).A Part D plan must have enough contracted retail pharmacies in its network to ensure that enrollees have adequate access to covered prescription drugs. Access to covered drugs from an out-of-network pharmacy is required when enrollees: (1) cannot reasonably be expected to obtain such drugs at a network pharmacy and (2) do not access covered drugs at out-of-network pharmacies on a routine basis. A plan is required to establish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. 42 CFR Sections 423.120(a) and 423.124; Medicare Prescription Drug Benefit Manual, Chapter 5, Section 60.1.The Plan will generally cover prescriptions only if they are filled at a Plan network pharmacy. Prescriptions filled at an out-of-network pharmacy may only be covered when a network pharmacy is not available. The Plan will typically cover prescriptions filled at an out-of-network pharmacy when the prescription is for a medical emergency or urgent care, when there are no 24-hour network pharmacies within a reasonable driving distance or when the prescription is for a drug that is out of stock at an accessible network pharmacy. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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). 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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, 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/items that are excluded, you must pay for them yourself. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

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. The definition of a Part D drug does not include over-the-counter (OTC) products. OTC drug products are those drugs that are available to consumers without a prescription. The FDA's Center for Drug Evaluation and Research (CDER) is the entity that oversees the designation and marketing of OTC drugs. Medicare Part D does not pay for OTC drug products. See rules noted above; and Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.10 and Chapter 7, Section 60.2.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 August 1, 2020 through December 31, 2020. For copay level 2, an enrollee is required to pay $1.30 and $3.90 copayments in 2020.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.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. 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. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

unknown

unknown

CCitations 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).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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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 provides coverage of intravenous immune globulin (IVIG) for the treatment of primary immune 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 diagnosed primary immune deficiency disease, it is administered in the home of a patient with a diagnosed primary immune deficiency disease, and the physician determines that administration of the derivative in the patient's home is medically appropriate. Medicare Benefit Policy Manual, Chapter 15, Section 50.6; Cigna Government Services Article for Intravenous Immune Globulin (A52509). National Government Services Article for Intravenous Immune Globulin (A52509). Noridian Administrative Services Article for Intravenous Immune Globulin (A52509).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).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.The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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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, Section 1860D-2(e)(2)(B).Medicare Part B pays for the rental or purchase of 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; Medicare Benefit Policy Manual, Chapter 15, Section 110.3.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 (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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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 provide its enrollees with coverage of prescription drug benefits as per the Medicare rules and as approved by CMS. The prescription drug benefit offered by the Plan must meet certain requirements. The requirements that must be met pertain 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.During the initial coverage phase of your benefit, you pay a $0 copayment for a 30 day supply of Tier 3 drugs obtained through standard retail pharmacy. Once your total drug costs reach $5,000, you will reach your initial coverage limit. Your initial coverage limit is calculated by adding payments made by the Plan and you. After your total drug costs reach the initial coverage limit, you, or others on your behalf, will pay 25% coinsurance for your drugs until your total out-of-pocket costs reach $6,350, and you qualify for catastrophic coverage. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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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. The definition of a Part D drug includes only those prescription drugs that are approved by the FDA for safety and effectiveness. For a drug to be approved by the FDA, the manufacturer of the drug must file a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) with the FDA's Center for Drug Evaluation and Research (CDER). Medicare Part D does not pay for drugs that are not FDA approved prescription drugs. See Social Security Act, Sections 1860D-2(e)(1), 1927(k)(2), and 1927(b)(3).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.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. The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to the Plan's Evidence of Coverage (EOC).

2024-02-03

https://qic.cms.gov/api/1/datastore/query/8152455d-179d-4455-9d09-e5dfc516be10/0/download?redirect=false&ACA=fgCeroIxj9&format=csv

44124e33664f775b7b0985f6ae206368

./data/processed/medicare_qic/part_d.jsonl

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