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

A Part D sponsor must provide enrollees with standard prescription drug coverage. The benefits may be provided directly by the Part D sponsor or through arrangements with other entities. Standard prescription drug coverage includes access to negotiated prices, provides coverage of Part D drugs, and includes cost-sharing under the initial coverage limit. Subject to cost-sharing in the coverage gap for applicable beneficiaries, coinsurance for actual costs for covered Part D drugs covered under the Part D plan above the annual deductible, and up to the initial coverage limit, that is: A) Equal to 25 percent of actual cost; or B) Actuarially equivalent to an average expected coinsurance of no more than 25 percent of actual cost, as determined through processes and methods established under 42 Code of Federal Regulations Section 423.265(c) and (d). A Part D plan providing actuarially equivalent standard coverage may apply tiered copayments, provided that any tiered copayments are consistent with Medicare rules and are approved as described in 42 Code of Federal Regulations Section 423.272(b)(2). Tiered cost sharing may not exceed levels annually determined by the Centers for Medicare & Medicaid Services to be discriminatory. [42 Code of Federal Regulations Section 423.104]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

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 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 Code of Federal Regulations Sections 423.771 through 423.782] A subsidy eligible individual is a Part D eligible individual residing in a state who is enrolled in, or seeking to enroll in a Part D plan and meets the following requirements: 1) Has income below 150 percent of the federal poverty line applicable to the individual's family size; 2) Has resources at or below the resource thresholds for full subsidy or low-income subsidy as described below.Low income subsidy individuals are subsidy eligible individuals who have income less than 150 percent of the federal poverty line applicable to the individual's family size and have resources that do not exceed: 1) For 2006, $10,000 if single or $20,000 if married (including the assets or resources of the individual's spouse); 2) For subsequent years, the resource amount allowable for the previous year, increased by the annual percentage increase in the consumer price index (all items, United States city average) as of September of the previous year, rounded to the nearest multiple of $10. The nearest multiple will be rounded up if it is equal to or greater than $5 and down if it is less than $5.For an individual deemed eligible between January 1 and June 30 of a calendar year, the individual is deemed eligible for a full subsidy for the remainder of the calendar year. For an individual deemed eligible between July 1 and December 31 of a calendar year, the individual is deemed eligible for the remainder of the calendar year and the following calendar year. [42 Code of Federal Regulations Section 423.773]
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 Enrollee 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 the Centers for Medicare and Medicaid Services, Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance, 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 6, 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 Enrollee 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 6, Section 30.2.4]
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 6, 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 6, Section 20.2 and Appendix C]
Appeal type: unknown
Decision: unknown

Medicare rules state that an applicable beneficiary is defined as an individual who, on the date of dispensing a covered Part D drug: 1) Is enrolled in a prescription drug plan or an MA-PD plan; 2) Is not enrolled in a qualified retiree prescription drug plan; 3) Is not entitled to an income-related subsidy under section 1860D-14(a) of the Social Security Act; 4) Has reached or exceeded the initial coverage limit under section 1860D-2(b)(3) of the Act during the year; 5) Has not incurred costs for covered Part D drugs in the year equal to the annual out-of-pocket threshold specified in section 1860D-2(b)(4)(B) of the Social Security Act; and 6) Has a claim that- (i) Is within the coverage gap; (ii) Straddles the initial coverage period and the coverage gap; (iii) Straddles the coverage gap and the annual out-of-pocket threshold. [the Centers for Medicare and Medicaid Services Internet-Only Manual (IOM), Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 5, Section 10.2]
Appeal type: unknown
Decision: unknown

In order 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: 1) It requires a prescription for dispensing; 2) It is approved by the Food and Drug Administration for safety and effectiveness; 3) It is prescribed for a medically accepted indication; and 4) It is not otherwise excluded from coverage under Part D law and rules. Medical supplies directly associated with delivering insulin to the body, 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, can satisfy the definition of a Part D drug. However, test strips, lancets and needle disposal systems are not considered medical supplies directly associated with the delivery of insulin for purposes of coverage under Part D. Insulin syringes equipped with a safe needle device, in their entirety (syringe and device), are also Part D drugs and should be managed like any other Part D drug the sponsor places on its formulary. Part D sponsors must make safety enabled insulin syringes available on their formularies for all of their institutionalized beneficiaries. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 10.5]Medicare defines those drugs or biological products that are eligible for coverage 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 6, Section 20.2, and Appendix C]
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 Enrollee 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 6, Section 30.2.4]