Part D Benefits & Clinical Research Trials: What's Covered
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1 Part D Benefits & Clinical Research Trials: What's Covered Presented by: Ryan Meade, JD Meade & Roach, LLP RMeade@MeadeRoach.com Health Care Compliance Association December 12, 2005 Baltimore, Maryland (c) Meade & Roach, LLP 1
2 When is there an impact? Clinical trial is studying the off-label use of a prescription drug Prescription drug may not be the investigational item but may be part of the required items/services of a clinical trial prescription drug utilized in the course of a clinical trial (c) Meade & Roach, LLP 2
3 Issues Raised Part D covers prescription drugs for medically accepted uses How is an off-label use of a drug considered medically accepted prior to re-labeling by the FDA? Clinical trials Medical literature support (c) Meade & Roach, LLP 3
4 Take away points from the presentation 1. What are PDPs and pharmacies doing to know whether a prescription drug is part of a clinical trial? 2. PDPs and pharmacies will need to determine what prescription drugs are not covered during a clinical trial 3. Assumption that the National Coverage Determination on Clinical Trials provides the coverage rules for prescription drugs during clinical trials (language of Clinical Trials NCD says it applies to all benefit categories) (c) Meade & Roach, LLP 4
5 Overview Medicare covers the routine costs of qualifying clinical trials under the National Coverage Decision on Clinical Trials ( Clinical Trials NCD ). Does the Clinical Trials NCD apply to covered Part D drugs? If it does apply, then what is the impact of the Clinical Trials NCD s on prescription drug coverage? (c) Meade & Roach, LLP 5
6 Structural Considerations: Part D interaction with other Medicare Rules The role of NCDs Medicare payment is contingent upon a determination that a service meets a benefit category, is not specifically excluded from coverage, and the item or services is reasonable and necessary. 68 FR (September 26, 2003) In general, an NCD is a national policy statement granting, limiting or excluding Medicare coverage for a specific medical item or service. Id. (c) Meade & Roach, LLP 6
7 Structural Considerations: Part D interaction with other Medicare Rules The role of NCDs NCDs tend to focus on specific services or indications within a specific benefit category; there are few that apply a coverage rule across all benefit categories. A benefit category is the congressional authority that authorizes reimbursement. CMS Internet Document, Requesting an NCD Based on this understanding of a benefit category, coverage Part D drugs is a benefit category and susceptible to NCDs. There are approximately 300 NCDs listed on the CMS website the Clinical Trials NCD is one of the few NCDs (and possibly the only NCD) that applies a rule across all benefit categories. (c) Meade & Roach, LLP 7
8 How the Clinical Trials NCD fits into the Part D rules In defining what items and services are considered covered in qualifying clinical trials, the Clinical Trials NCD identifies routine costs as covered. Routine costs are partly defined within the Clinical Trials NCD as follows: Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national noncoverage decision). (emphasis added) Unless the Clinical Trials NCD is revised in light of the new Part D benefit rules, it appears to apply to covered Part D drugs. (c) Meade & Roach, LLP 8
9 What the Clinical Trials NCD covers: Routine costs in qualifying clinical trials A qualifying clinical trial is a research study that: Meets 3 necessary requirements:» Must study an item or service that is a benefit category» Must enroll patients with diagnosed diseases» Must have therapeutic intent and not designed solely to study the safety or toxicity of the investigational item or service And meets 7 desirable characteristics (currently only for certain studies deemed to meet the 7 desirable characteristics) Routine costs include conventional care items and services as well as items and services to detect, prevent or treat complications Routine costs does not include the investigational item or service or services that are paid for by the sponsor Policy Point: The Clinical Trials NCD allows coverage for items and services that would be covered under the same conditions outside a clinical trial. (c) Meade & Roach, LLP 9
10 2 phases in thinking through the Clinical Trials NCD The Clinical Trials NCD is a rule that applies to all items and services provided during a clinical trial. The Clinical Trials NCD needs to be thought of in two phases: First, the trial must be a qualifying clinical trial and the items and services must meet the definition of routine costs but a routine cost only gives the potential to bill, it does not guarantee reimbursement. Second, all other Medicare rules must be applied to routine costs to determine whether the items or services are reimbursable. (c) Meade & Roach, LLP 10
11 2 phases in thinking through the Clinical Trials NCD Consequently for prescription drugs, prescription drugs during qualifying clinical trials must first be determined to be routine costs and then the Part D rules must applied to determine whether the prescription drugs are reimbursable during a clinical trial. (c) Meade & Roach, LLP 11
12 Scenarios involving prescription drugs in clinical trials Prescription drug is the investigational item: How would this be? A prescription drug could be the investigational item of the study if the clinical trial is studying the off-label use of the prescription drug. Is off-label use of drugs considered covered a covered benefit under Part D? Off-label use of prescription drugs is covered if the off-label use is medically accepted by specific drug compendia. Indications are not "medically accepted" if they are supported in peerreviewed medical literature, but not yet included or approved for inclusion in one of the compendia." CMS Internet Document, Comparing Part B with Part D for Drug Coverage (c) Meade & Roach, LLP 12
13 Scenarios involving prescription drugs in clinical trials Prescription drug is the investigational item (continued): If the trial is studying off-label use of a prescription drug and the off-label use meets the Part D rules on being medically accepted, then the drug is covered. If the trial is studying off-label use of a prescription drug and the off-label use is not medically accepted by one of the compendia, then the drug is not covered even if medical literature supports the off-label use of the drug. (c) Meade & Roach, LLP 13
14 Scenarios involving prescription drugs in clinical trials Prescription drug is an item required under the protocol: Is the drug a routine cost? Is the drug being used as conventional care? Is the drug being used to detect, prevent or treat complications? If the drug is a routine cost, is the drug a covered Part D drug? Is the drug being used for its approved purpose? Is the drug being used off-label? (c) Meade & Roach, LLP 14
15 Scenarios involving prescription drugs in clinical trials A host of questions with no easy answers: What obligation does the patient have to inform the pharmacy that the drug is being prescribed as part of a clinical trial? What obligation does the physician have to inform the pharmacy that he/she is prescribing a drug as part of a clinical trial? What obligation does the pharmacy have to inquire whether a drug is being prescribed as part of a clinical trial? What obligation does the PDP sponsor have to develop audits and reviews for prescription drug use in clinical trials? (c) Meade & Roach, LLP 15
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