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

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.Medicare law 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.Coverage determinations include a plan sponsor's decision on an enrollee's exceptions request. Enrollees may request an exception to a plan's tiered cost-sharing structure, or formulary. Once an exception is granted, the plan sponsor is prohibited from requiring the enrollee to request approval for a refill or new prescription to continue using the Part D prescription drug approved under the exceptions process for the remainder of the plan year, so long as the enrollee remains enrolled in the plan, the physician continues to prescribe the drug and it continues to be safe for treating the enrollee's condition. A plan sponsor may choose not to require an enrollee to resubmit an exceptions request at the beginning of a new plan year. For example, if a plan sponsor grants an exception request near the end of a plan year, it may choose not to require the enrollee to request a new exception when the new plan year begins. Medicare Prescription Drug Benefit Manual, Chapter 18, Section 30.2.The Part D Plan can only cover drugs prescribed for a medically accepted indication. Please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will find abbreviated as 42 CFR with the corresponding section numbers, i.e., 42 CFR Sections 423.578, 423.100.A Part D plan is permitted to use a number of different tools to manage its formulary. One of these tools is known as prior authorization. This process requires an enrollee to obtain coverage approval for a drug before the drug is dispensed and covered by the plan. 70 Federal Register No. 18, issued January 28, 2005 (Preamble to Final Rule).Coverage determinations include a plan sponsor's decision on an enrollee's exceptions request. Enrollees may request an exception to a plan's tiered cost-sharing structure, or formulary. Once an exception is granted, the plan sponsor is prohibited from requiring the enrollee to request approval for a refill or new prescription to continue using the Part D prescription drug approved under the exceptions process for the remainder of the plan year, so long as the enrollee remains enrolled in the plan, the physician continues to prescribe the drug and it continues to be safe for treating the enrollee's condition. A plan sponsor may choose not to require an enrollee to resubmit an exceptions request at the beginning of a new plan year. For example, if a plan sponsor grants an exception request near the end of a plan year, it may choose not to require the enrollee to request a new exception when the new plan year begins. Medicare Prescription Drug Benefit Manual, Chapter 18, Section 30.2.The Part D Plan can only cover drugs prescribed for a medically accepted indication. The Plan requires prior approval (also called prior authorization) before covering some prescription drugs. If prior approval is not obtained, the Plan may not cover the drug. Please refer to the Plan's Evidence of Coverage (EOC).
Appeal type: unknown
Decision: unknown

Citations used in this letter come from Section 42 of the Code of Federal Regulations which you will 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 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).Coverage determinations include a plan sponsor's decision on an enrollee's exceptions request. Enrollees may request an exception to a plan's tiered cost-sharing structure, or formulary. Once an exception is granted, the plan sponsor is prohibited from requiring the enrollee to request approval for a refill or new prescription to continue using the Part D prescription drug approved under the exceptions process for the remainder of the plan year, so long as the enrollee remains enrolled in the plan, the physician continues to prescribe the drug and it continues to be safe for treating the enrollee's condition. A plan sponsor may choose not to require an enrollee to resubmit an exceptions request at the beginning of a new plan year. For example, if a plan sponsor grants an exception request near the end of a plan year, it may choose not to require the enrollee to request a new exception when the new plan year begins. Medicare Prescription Drug Benefit Manual, Chapter 18, Section 30.2.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).
Appeal type: unknown
Decision: unknown

A Part D plan sponsor must grant an exception whenever it determines that the drug is medically necessary, consistent with the physician's or other prescriber's statement, and that the drug would be covered but for the fact that it is an off-formulary drug. A prescribing physician or other prescriber must provide an oral or written supporting statement that the requested prescription drug is medically necessary to treat the enrollee's disease or medical condition. The statement must support that all of the covered Part D drugs on any tier of a plan's formulary for treatment for the same condition would not be as effective for the enrollee as the non-formulary drug, and/or there would have adverse effects for the enrollee. [42 Code of Federal Regulations Section 423.578(b)]Medicare rules define drugs or biological products that may be covered under the Part D prescription drug benefit. One of the requirements for coverage is that the prescription drug or biological product must be prescribed for a use that is a 'medically accepted indication.' The term medically accepted indication means any use that is approved by the Federal Food, Drug, and Cosmetic Act, or which is supported by one or more citations included (or approved for inclusion) in one the following drug compendia: the American Hospital Formulary Service Drug Information] and the DRUGDEX Information System. [Sections 1860D-2(e)(1) and 1927(k)(6) of the Social Security Act; 42 Code of Federal Regulations Section 423.100; the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 4, Section 10.6]
Appeal type: unknown
Decision: unknown

Medicare law defines those drugs or biological products that are eligible to be covered under the prescription drug benefit. A drug prescribed for a Part D eligible individual cannot be considered a covered Part D drug if payment for the drug is available under Medicare Part A or B for that individual (as prescribed and dispensed or administered for the individual). The Centers for Medicare & Medicaid Services interprets this to mean that if payment could be available under Part A (e.g., hospital inpatient, hospice benefit) 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) 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. [Section 1860D-2(e)(2)(B) of the Social Security Act; the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 4, Section 20.2 and Appendix C] Medicare Part B pays for durable medical equipment, and supplies necessary for the effective use of durable medical equipment, if the equipment is used in the patient's home or in an institution that is used as a home. Supplies that may be covered, if determined to be medically necessary, include drugs and biologicals that are put directly into the equipment. [42 Code of Federal Regulations Section 410.38(a); the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-02, Medicare Prescription Drug Benefit Manual, Chapter 15, Section 110.3]
Appeal type: unknown
Decision: unknown

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. 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.Under Medicare rules, each Part D plan sponsor that provides prescription drug benefits for Part D drugs, and manages the benefit through the use of a tiered formulary, must establish and maintain reasonable and complete exceptions procedures. These procedures must permit enrollees to obtain a covered non-preferred drug in a higher cost-sharing tier at the more favorable cost-sharing terms applicable to alternative drugs in a lower cost-sharing tier. A Part D plan sponsor is required to grant an exception whenever it determines that the requested non-preferred drug for treatment of the enrollee's condition is medically necessary, consistent with the physician's or other prescriber's statement. A prescribing physician or other prescriber must provide an oral or written supporting statement that the preferred drug(s) for the treatment of the enrollee's condition would not be as effective for the enrollee as the requested drug and/or would have adverse effects for the enrollee. Moreover, there are additional limitations permitted under the Medicare rules. Plans cannot be required to offer tiering exceptions for brand name drugs or biological products at the cost-sharing level of alternative drugs, where the alternatives include only generic or authorized generic drugs. Plans that maintain a specialty tier in which they place very high cost drugs and biological products may design its exception process so that Part D drugs placed on the specialty tier are not eligible for a tiering exception. [42 Code of Federal Regulations Section 423.578; Parts C & D Grievances, Organization/Coverage Determinations, and Appeals Guidance Manual, Section 40.5.1, Tiering Exceptions; the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Manual, Chapter 4, Section 30.2.4]
Appeal type: unknown
Decision: unknown

When a plan processes a coverage request that involves a prior authorization or other utilization management requirement, such as step therapy for Part B drugs, the plans determination on whether to grant approval of a service or a drug for an enrollee constitutes an initial determination and is subject to appeal. In addition, if a plan denies coverage of a service or a drug because the enrollee failed to seek prior authorization or failed to comply with similar limits on coverage, the denial also constitutes an initial determination and is subject to appeal. Thus, the adjudication timeframe, notice, and other requirements applicable to coverage determinations or organization determinations under 42 Code of Federal Regulations Parts 422 and 423, Subpart M apply to requests that involve a prior authorization or other utilization management requirement in the same manner that they apply to all coverage requests. If an enrollee requests coverage of a service, item, or drug that involves prior authorization, the plan must accept and process the request as a coverage determination or organization determination and should contact the physician or prescriber for information needed to satisfy the prior authorization, in accordance with the outreach guidance at Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance, Section 10.6.
Appeal type: unknown
Decision: unknown

Effective January 1, 1994, oral self administered versions of covered injectable cancer drugs furnished may be paid by Medicare Part B if other coverage requirements are met. To be covered the drug must have had the same active ingredient as the injectable drug. Effective January 1, 1999, this coverage was expanded to include Food and Drug Administration approved Prodrugs used as anti-cancer drugs. A Prodrug may have a different chemical composition than the injectable drug but body metabolizing of the Prodrug results in the same chemical composition in the body. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-04, Medicare Claims Processing Manual, Chapter 17, Section 80.1]Medicare law defines those drugs or biological products that are eligible to be covered under the prescription drug benefit. A drug prescribed for a Part D eligible individual cannot be considered a covered Part D drug if payment for the drug is available under Medicare Part A or B for that individual (as prescribed and dispensed or administered for the individual). The Centers for Medicare & Medicaid Services interprets this to mean that if payment could be available under Part A (e.g., hospital inpatient, hospice benefit) 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) 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. [Section 1860D-2(e)(2)(B) of the Social Security Act; the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 4, Section 20.2 and Appendix C]
Appeal type: unknown
Decision: unknown

Part D sponsors are required to coordinate with State Pharmaceutical Assistance Programs and 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 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 expenditures; and 5) Other processes that the Center for Medicare & Medicaid Services determines. When a Medicare Part D enrollee has other prescription drug coverage, Coordination of Benefits allows the plans that provide coverage for this same beneficiary to determine each of their payment responsibilities. This process is necessary in order to avoid duplication of payment and to prevent Medicare from paying primary when it is the secondary payer. The Coordination of Benefits within Part D provides the mechanism for support of the tracking and calculating of beneficiaries true out-of-pocket expenditures, or incurred costs as defined in the Medicare Modernization Act and the Centers for Medicare & Medicaid Services implementing regulations. Costs for covered Part D drugs are treated as incurred only if they were paid by the individual (or by another person, such as a family member, on behalf of the individual), paid by the Centers for Medicare & Medicaid Services on behalf of a low-income subsidy-eligible individual, or paid under a qualified entity such as State Pharmaceutical Assistance Programs, acquired immune deficiency syndrome Drug Assistance Programs, or a bona fide charity as defined in the Centers for Medicare & Medicaid Services regulations. Costs do not count as incurred when: 1) No benefits are provided because of the application of either a formulary or the Medicare Secondary Payer laws, or 2) When costs are reimbursed through insurance or otherwise, a group health plan, or other coverage. Therefore, only certain costs not paid for by the Part D sponsor count toward true out-of-pocket expenditures. [42 Code of Federal Regulations Section 423.464(f); the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 14, Section 20 and Appendix E]
Appeal type: unknown
Decision: unknown

The Centers for Medicare & Medicaid Services considers it best practice for Part D sponsors to consider the proper listing of a drug product with the Food and Drug Administration as a prerequisite for making a Part D drug coverage determination. The Food and Drug Administration is unable to provide regulatory status determinations through their regular processes if a drug product is not properly listed. Therefore, Part D sponsors should begin the drug coverage determination process by confirming that a prescription drug product national drug code is properly listed with the Food and Drug Administration. The Food and Drug Administrations Comprehensive national drug code Structured Product Labeling Data Elements file is used as a source of national drug code information for Medicare Part D Formulary Reference File and prescription drug event editing. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.1]
Appeal type: unknown
Decision: unknown

In the case of a drug that would incur a copayment, the Part D sponsor must apply cost-sharing as calculated by multiplying the applicable daily cost-sharing rate by the days' supply actually dispensed when the beneficiary receives less than the approved month's supply. In the case of a drug that would incur a coinsurance percentage, the Part D sponsor must apply the coinsurance percentage for the drug to the days' supply actually dispensed. [42 Code of Federal Regulations Section 423.153(b)(4)(iii)]
Appeal type: unknown
Decision: unknown

Under Medicare rules, Part D sponsors must exclude Part D drugs from qualified prescription drug coverage if they are not sold in the United States. In addition, Part D sponsors may only pay for drugs that satisfy the definition of Part D drug. In general, such definition requires Food and Drug Administration approval for sale in the United States. Therefore, even if the manufacturer has Food and Drug Administration approval for a drug, the version produced for foreign markets usually does not meet all of the requirements of the United States approval, and thus it is considered to be unapproved. In the event of a drug shortage, in order to ensure access to critically needed drugs in conjunction with the actions taken by the Food and Drug Administration, the Center for Medicare & Medicaid Services will accept prescription drug event submissions with national drug codes for foreign versions of Part D drugs, imported under the Food and Drug Administrations exercise of its enforcement discretion. Prescription drug event allowances will be limited to the specific drug product(s), conditions, and the duration of the shortage as specified by the Food and Drug Administration. Such products cannot be discounted under the Medicare Coverage Gap Discount Program. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.7]
Appeal type: unknown
Decision: unknown

Under Medicare rules, there must be out-of-network access to covered Part D drugs at out-of-network pharmacies for when the enrollee cannot reasonably be expected to obtain such drugs at a network pharmacy, and does not have access to covered Part D drugs at an out-of-network pharmacy on a routine basis. A plan is required to establish reasonable rules to appropriately limit out-of-network access to covered prescription drugs. [42 Code of Federal Regulations Sections 423.120(a) and 423.124; the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 5, Section 60.1]