Frequently Asked Questions

Our clients frequently ask us reimbursement questions that are general in nature, so we thought we’d share some of our answers in hopes that you will find what you are looking for. Below are some of the most common questions.

  • Is there an ideal time to start working on launch plans prior to a drug getting FDA approval?

    In general, there is never too much lead time in putting together a launch strategy, and it’s ideal to begin work at least twelve months prior to anticipated FDA-approval. Some key questions that impact effective launch strategies include:

    • Is the manufacturer a new company, and what specific actions are required to prepare for access across all payers?
    • What is the current payer landscape for the new molecule, and how do payers approach decision-making related to drug coverage, prior authorization, formulary placement, and specialty pharmacy requirements?
    • How do Oncology Benefit Managers, clinical pathway organizations, and internal physician pathways impact the availability of new products?
    • How are compendia positioning potential competitor products, and what level of data will be required for a new product coming into this disease state?
  • What kinds of services does DK Pierce offer a manufacturer preparing to launch a new product?

    At DK Pierce, we like to customize our services to meet the business needs of each of our clients and the new product coming to market. A few of our services include the following:

    • Business immersion strategy session
    • Compendia implications analysis
    • Companion diagnostics payer assessment
    • Payer analysis of competitor products
    • Patient cost share assessment
    • Patient assistance and copay program design
    • CMS strategy
    • Organizational staffing and workload development tool
    • Sales training – for sales representatives and market access teams
    • Communications strategy to announce FDA approval
  • What reimbursement issues should be considered when a clinical trial is being developed?

    Reimbursement implications are influenced by many variables, including:

    • Formulation (e.g., oral, self-administered injection, physician-administered injection)
    • Disease state (e.g., cancer, arthritis, congestive heart failure)
    • Setting of care (e.g., hospital inpatient, hospital outpatient, physician office, retail pharmacy access, home care)
    • Clinical trial phase

    DKP has created a clinical development resource to help the clinical team understand what important reimbursement questions should be answered during the development process. Additionally, we provide comprehensive milestone reimbursement analyses. These analyses include qualitative market research and are intent on assessing how the pipeline product’s planned strategic clinical development and commercialization direction will be affected by current and trending reimbursement mechanisms.

  • Are there existing codes that describe our product or will we need a new code?

    Having a complete understanding of codes is essential to the success of a new product or procedure. Inappropriate coding can cause delays in claims processing or lead to inappropriate payments and ultimately may limit patient access.

    DKP can conduct a thorough coding analysis of current coding systems such as Healthcare Common Procedural Coding System (HCPCS) and Current Procedural Terminology (CPT) drug administration codes. Additionally, we assess the application of International Classification of Diseases (ICD-9) diagnosis and procedure codes and outline the action items necessary to ensure successful coding of the product or procedure, including strategies to mitigate issues with miscellaneous coding.

  • What is happening with oncology clinical pathways?

    In the recent past a positive coverage policy was sufficient to ensure provider and patient access. With the advent of clinical pathways, both physicians and payers are now managing which drugs are prescribed, covered, and reimbursed for their patients and members. Providers and payers are selecting clinical pathway program packages from vendors, tailoring vendor programs to meet their needs, or developing internal programs when vendor programs do not fit. Payers have adopted pathways as a way to control cost, while providers are looking for a way to document evidence-based treatment decisions. Our senior consultants keep a watchful eye on the evolution of clinical pathways and other utilization management trends, and our DKP PayerScope® team keeps our monitoring clients informed via DKP e-Alerts®.

  • Which payers do not cover NCCN 2B level of evidence?

    If you have an oncology drug, you know that NCCN© is integral to payer policy decisions. However, many payers stipulate the level of evidence that is acceptable for coverage. For example, Tufts Health Plan may authorize coverage for off-label uses in other cancer diagnoses provided the use is recognized as a “Medically Accepted Indication” according to the National Comprehensive Cancer Network Drugs & Biologics Compendium (NCCN Compendium®), as indicated by a Category 1 or 2A. In cases where the requested off-label use for the diagnosis is not recognized by the NCCN Compendium, Tufts Health Plan will accept clinical documentation referenced in one of the other CMS-recognized compendia or when supported by specific peer-reviewed medical literature.

    DKP tracks the influence of clinical drug compendia ratings on oncology policy in Medicare (Parts B and D), Medicaid, and top commercial payers, facilitating our client’s awareness of coverage advantages or disadvantages pertaining to their products and their competitors’ products.

  • What patient cost share trends would affect our product(s)?

    In the not-so-distant past, physician-administered drugs were strictly a medical benefit managed by the medical department, with few specific drug policies. With the proliferation of expensive biologics and orphan drugs, payers are more closely scrutinizing ways to control escalating cost in this sector. By applying pharmacy utilization management oversight and tools, many payers are now managing physician administered drugs with specialized injectable formulary tiers subject to significant coinsurance.

    DKP can provide an analysis of the trends affecting a particular disease state and provide specific recommendations to help your company understand the implications of these trends to your product.

  • What claims documentation is conventionally required for Medicare claims of new FDA-approved drugs?

    In the real estate market the colloquial response for the three most desirable home characteristics is “location, location, location.” For Medicare claims it is “documentation, documentation, documentation!”

    New drugs are always described by not otherwise classified codes (NOC), so additional detail is required on claims as they will be manually reviewed. In general, in order to expedite the review as well as assure proper payment, all claims should include the new drug name, dosage, mode of administration, NDC number, and description in the appropriate field of the claim form (CMS 1500 or CMS1450/UB-04).

  • How will the implementation of the ICD-10 system affect billing and coding for our product?

    CMS will convert from the ICD-9-CM system to the ICD-10-CM system on October 1, 2015. The new coding system would incorporate much greater specificity and clinical information, which results in:

    • Improved ability to measure health care services
    • Increased sensitivity when refining grouping and reimbursement methodologies
    • Enhanced ability to conduct public health surveillance
    • Decreased need to include supporting documentation with claims

    The ICD-10 codes are more granular than the ICD-9 codes, and the codes will likely change for products that are on the market before the implementation date of October 2015. DKP can highlight the new ICD-10 codes for a particular product and make recommendations for the transition to minimize errors related to the coding of products.


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A few areas of our expertise
  • Product Launch
  • Competitive Reimbursement Analysis
  • Payer Relations, Notifications, and New Drug Applications
  • National/Local Payer Strategies
  • Reimbursement Planning and Training
  • Qualitative Stakeholder Research and Analysis
  • Strategic Market Monitoring
  • Payer Policy Monitoring
  • Compendia Services
  • Advisory Boards
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