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

Under Medicare rules, 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. For a drug to be approved by the Food and Drug Administration, the manufacturer of the drug must file a New Drug Application or Abbreviated New Drug Application with the Food and Drug Administrations Center for Drug Evaluation and Research. Current Food and Drug Administration law requires a manufacturer to prove that its drug is both safe and effective. Some drugs currently on the market were Food and Drug Administration approved for safety only. These drugs were approved prior to the passing of current Food and Drug Administration law. The Food and Drug Administration reviews these drugs to determine which are less than effective for their labeled indications. This review process is known as the Drug Efficacy Study Implementation program. This program has resulted in the Food and Drug Administration classifying some of these drugs as less than effective Drug Efficacy Study Implementation program drugs. Medicare Part D does not pay for prescription drug products classified by the Food and Drug Administrations Drug Efficacy Study Implementation program as less than effective for their labeled indications. Medicare Part D also does not pay for prescription drug products that are identical, related or similar to drugs that are classified as less than effective drugs. [Sections 1860D2(e)(1) and 1927(k)(2) of the Social Security Act; the Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual Chapter 6, Sections 10.1 and 10.9]
Appeal type: unknown
Decision: unknown

An at-risk determination is a decision made under a plan sponsors drug management program under the rules at 42 Code of Federal Regulations Section 423.153(f) that involves: 1) Identification of an individual as an at-risk enrollee for prescription drug abuse; 2) A limitation, or the continuation of a limitation, on access to coverage for frequently abused drugs [i.e., an enrollee specific point-of-sale edit or the selection of a prescriber and/or pharmacy for purposes of lock-in]; or 3) Information sharing for subsequent Part D plan enrollments. [Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance, Section 40.3]
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 4, Section 20.2, and Appendix C]
Appeal type: unknown
Decision: unknown

Under Medicare rules, 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 annual deductible requirements. For 2006, $250; or for years subsequent to 2006, the amount specified in this paragraph for the previous year, increased by the annual percentage increase, and rounded to the nearest multiple of $5. The annual percentage increase for each year is equal to the annual percentage increase in average per capita aggregate expenditures for Part D drugs in the United States for Part D eligible individuals and is based on data for the 12-month period ending in July of the previous year. [42 Code of Federal Regulations Section 423.104]
Appeal type: unknown
Decision: unknown

The Medicare Coverage Gap Discount Program Agreement (or Discount Program Agreement) between the manufacturer and the Centers for Medicare & Medicaid Services must contain the provisions specified in paragraph (b) of this section, and may contain such other provisions as are established in a model agreement consistent with section 1860D-14A (a)(1) of the Act. [42 Code of Federal Regulations, Section 423.2315]
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; or (iv) Spans the coverage gap from the initial coverage period and exceeds the annual out-of-pocket threshold. [Medicare Prescription Drug Benefit Manual, Chapter 5, Section 10.2]
Appeal type: unknown
Decision: unknown

Under Medicare rules, 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 protection against high out-of-pocket expenditures. After an enrollee's incurred costs exceed the annual out-of-pocket threshold described in paragraph (d)(5)(iii) of this Section, the cost-sharing amount is equal to the greater of: 1) In 2006, $2 for a generic drug or preferred drug that is a multiple source drug and $5 for any other drug; and 2) For subsequent years, the copayment amounts specified in this paragraph for the previous year increased by the annual percentage increase and rounded to the nearest multiple of five cents; or for coinsurance, it is five percent of actual cost. A Part D plan may substitute for cost-sharing an amount that is actuarially equivalent to expected cost-sharing. [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

The Part D plan sponsor grants 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: 1) Would not be as effective for the enrollee as the requested drug; 2) Would have adverse effects for the enrollee; or 3) Both.If the physician or other prescriber provides an oral supporting statement, the Part D plan sponsor may require the physician or other prescriber to subsequently provide a written supporting statement. The Part D plan sponsor may require the prescribing physician or other prescriber to provide additional supporting medical documentation as part of the written follow-up. [42 Code of Federal Regulations Section 423.578(a)(4)-(5)]
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 in the coverage gap for applicable beneficiaries. Coinsurance in the coverage gap for costs for covered Part D drugs that are not applicable drugs under the Medicare coverage gap discount program that is: A) Equal to the generic gap coinsurance percentage; or B) Actuarially equivalent to an average expected coinsurance for covered Part D drugs that are not applicable drugs under the Medicare coverage gap discount program. The generic gap coinsurance percentage is equal to: A) For 2011, 93 percent; B) For years 2012 through 2019, the amount specified in this paragraph for the previous year, decreased by seven percentage points; or C) For 2020 and each subsequent year, 25 percent. The applicable gap coinsurance percentage is equal to: 1) For 2013 and 2014, 97.5 percent; 2) For 2015 and 2016, 95 percent; 3) For 2017, 90 percent; 4) For 2018, 85 percent; 5) For 2019, 80 percent; or 6) For 2020 and subsequent years, 75 percent. [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

A covered Part D drug means a Part D drug that is included in a Part D plans formulary, or treated as being included in a Part D plans formulary as a result of a coverage determination or appeal, and obtained at a network pharmacy or an out-of-network pharmacy. [Title 42 Code of Federal Regulations Section 423.100]The term drugs and the term biologicals, include only such drugs (including contrast agents) and biologicals, respectively, as are included (or approved for inclusion) in the United States Pharmacopoeia, the National Formulary, or the United States Homeopathic Pharmacopoeia, or in New Drugs or Accepted Dental Remedies (except for any drugs and biologicals unfavorably evaluated therein), or as are approved by the pharmacy and drug therapeutics committee (or equivalent committee) of the medical staff of the hospital furnishing such drugs and biologicals for use in such hospital. For purposes of paragraph, the term drugs also includes any drugs or biologicals used in an anticancer chemotherapeutic regimen for a medically accepted indication.The term medically accepted indication, with respect to the use of a drug, includes any use which has been approved by the Food and Drug Administration for the drug, and includes another use of the drug if: 1) The drug has been approved by the Food and Drug Administration; and 2) Such use is supported by one or more citations which are included (or approved for inclusion) in one or more of the following compendia: the American Hospital Formulary Service-Drug Information, the American Medical Association Drug Evaluations, the United States Pharmacopoeia-Drug Information, and other authoritative compendia as identified by the Secretary, unless the Secretary has determined that the use is not medically appropriate or the use is identified as not indicated in one or more such compendia, or 3) The carrier involved determines, based upon guidance provided by the Secretary to carriers for determining accepted uses of drugs, that such use is medically accepted based on supportive clinical evidence in peer reviewed medical literature appearing in publications which have been identified for purposes of this subclause by the Secretary. [Section 1861(t) of the Social Security Act]
Appeal type: unknown
Decision: unknown

The issue of applicability of Part D coverage has also arisen in the context of inpatients in acute care hospital settings (including long-term care) hospitals, which are certified as acute care hospitals) who have exhausted their Part A inpatient stay benefit, but who require and continue to receive a level of care that qualifies them for a Part A inpatient stay. Drugs provided in an inpatient setting to an individual who has exhausted his or her lifetime inpatient hospital benefit under Part A are not drugs that could be covered under Part A for that individual. Unlike a beneficiary who, for example, chooses not to buy into Part B, there is no way for an individual who has exhausted his or her Part A inpatient stay benefit to obtain coverage under Part A for his or her drugs; therefore, Part D coverage may be available to a Part D enrollee who has exhausted his or her Part A inpatient stay benefit and who remains in that inpatient setting (provided the drug would otherwise be covered under Part D). See Medicare Prescription Drug Benefit Manual, Chapter 5, Section 50.5.4, regarding sponsor contracting requirements when a beneficiary has exhausted inpatient Part A benefit days. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 20.2.1]
Appeal type: unknown
Decision: unknown

Potential at-risk beneficiaries and at-risk beneficiaries are identified by the Centers for Medicare & Medicaid Services or a Part D sponsor using clinical guidelines that: 1) Are developed with stakeholder consultation; 2) Are based on the acquisition of frequently abused drugs from multiple prescribers, multiple pharmacies, the level of frequently abused drugs used, or any combination of this factors; 3) Are derived from expert opinion and an analysis of Medicare data; and 4) Include a program size estimate. [42 Code of Federal Regulations Section 423.153(f)(16)]
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

A sponsor may not limit the access of an at-risk beneficiary to coverage for frequently abused drugs unless the sponsor has done all of the following: A) Conducted case management and updated it, if necessary; B) Except in the case of a pharmacy limitation imposed, obtained the agreement of at least one prescriber of frequently abused drugs for the beneficiary that the specific limitation is appropriate; and C) Provided the notices to the beneficiary in compliance with the rules set forth in the Code of Federal Regulations. Except when involving a prescriber limitation, if the sponsor has complied with the requirements involving attempts to reach prescribers, and the prescribers were not responsive after three attempts by the sponsor to contact them within 10 business days, then the sponsor has met the requirement for eliciting information from the prescribers. The sponsor may not implement a prescriber limitation if no prescriber was responsive. [42 Code of Federal Regulations Section 423.153(f)(4)]
Appeal type: unknown
Decision: unknown

Clinical trials that meet the qualifying criteria will receive Medicare coverage of routine costs after the trial's lead principal investigator certifies that the trial meets the criteria. This process will require the principal investigator to enroll the trial in a Medicare clinical trials registry, currently under development. Some clinical trials are automatically qualified to receive Medicare coverage of their routine costs because they have been deemed by Agency for Healthcare Research and Quality (AHRQ), in consultation with the other agencies represented on the multi-agency panel to be highly likely to have the above listed seven desirable characteristics of clinical trials. The principal investigators of these automatically qualified trials do not need to certify that the trials meet the qualifying criteria, but must enroll the trials in the Medicare clinical trials registry for administrative purposes, once the registry is established.  Effective September 19, 2000, clinical trials that are deemed to be automatically qualified are: 1) Trials funded by National Institutes of Health, Centers for Disease Control and Prevention, AHRQ, the Centers for Medicare & Medicaid Services, Department of Defense, and the Department of Veterans Affairs; 2) Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD and VA; 3)Trials conducted under an investigational new drug application (IND) reviewed by the Food and Drug Administration; and 4) Drug trials that are exempt from having an IND under 21 Code of Federal Regulations Section 312.2(b)(1) will be deemed automatically qualified until the qualifying criteria are developed and the certification process is in place. At that time the principal investigators of these trials must certify that the trials meet the qualifying criteria in order to maintain Medicare coverage of routine costs. This certification process will only affect the future status of the trial and will not be used to retroactively change the earlier deemed status. [Section 1142 of the Social Security Act; 21 Code of Federal Regulations Section 312.2(b)(1)]
Appeal type: unknown
Decision: unknown

The Centers for Medicare & Medicaid Services is aware that it may be difficult for Part D sponsors to distinguish between new prescriptions for non-formulary Part D drugs and refills for ongoing drug therapy involving non-formulary Part D drugs. The Centers for Medicare & Medicaid Services believes a minimum of a 108-day look-back (consistent with other reviews) is typically needed to adequately document ongoing drug therapy. Although Part D sponsors may be able to access prior drug claims history for an enrollee of an affiliated plan, or may attempt to follow up with prescribing physicians and pharmacies to ascertain the status of a prescription presented during the transition period, the Centers for Medicare & Medicaid Services clarifies that if a sponsor is unable to make this distinction at the point of sale, the sponsor is required to provide the enrollee with a transition fill. In other words, for transition purposes, a brand-new prescription for a non-formulary drug will not be treated any differently than an ongoing prescription for a non-formulary drug when a distinction cannot be made at the point of sale. Generally, a sponsor may apply any Centers for Medicare & Medicaid Services approved prior authorization or step therapy after the transition fill has been satisfied if the sponsor determines that the transition fill was the first fill. However, for protected class drugs that are subject to prior authorization or step therapy on new starts only, in accordance with the Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.2.5, if a sponsor allows an initial fill because it cannot determine at the point of sale that an enrollee is not currently taking the protected class drug (during transition or otherwise), the sponsor shall treat such enrollees as currently taking the drug. Therefore, any protected class PA or ST requirements for new starts are no longer applicable after the first fill has been provided. [The Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-18, Medicare Prescription Drug Benefit Manual, Chapter 6, Section 30.4.3]