Carve Out & Contract Standardization

Hemophilia and Bleeding Disorders Toolkit

Benefit Plan Design: Carve Out & Contract Standardization

Gold-standard guidelines for treatment of members with hemophilia recommend the use of an integrated medical and pharmacy care model that includes clinical care from a multidisciplinary team. Employers should consider contracting with Hemophilia Treatment Centers (HTCs) as in-network providers of clinical and pharmacy services. This will help to ensure that an integrated model is being used, members receive optimal care and experience improved outcomes, and employers can manage related ancillary health care services and costs. Carving out different elements of care, e.g. specialty pharmacy, physical therapy, dental care, is not optimal and can lead to fragmented, fractured care.

If services are carved out to HTCs, it is important to make sure they are in-network for both medical/clinical care and specialty pharmacy services. The network should consist of at least one specialty pharmacy and one HTC specialty pharmacy option to create competition, drive down unit pricing and improve customer service. Including HTC specialty pharmacy programs in all payer networks either directly or as an allowable option is also recommended.

Contracting for Hemophilia-Related Services

In specialty pharmacy contracts, employers can be specific about how vendors/partners are required to manage and report on hemophilia drugs. There is an opportunity to provide clarity in both health plan and PBM contracts for these drugs, so hemophilia-related claims can be targeted appropriately and be cost effective. The key is to hold vendors accountable for managing use and spend. One way to accomplish this is by requiring quarterly reports that include agreed upon standard data and metrics, including:

  • Dispensed clotting factor dose compared to prescribed clotting factor dose (typically measured as a percentage)
  • Unit and total cost of clotting factor medication (to ensure the cost is competitive)

During PBM contract negotiations, it is important to get clarification about the cost drivers for hemophilia treatment and their practices for ongoing clinical management of bleeding disorders. It is also important to build a strategy with vendor partners that includes the right contract language, ongoing reporting requirements and whether HTCs are to be included.

If an employer is under an exclusive specialty pharmacy contract, allowing another pharmacy to dispense would likely violate the contract. However, if you find equitable rates through an HTC, you could consider entering into a single case Letter of Agreement (LOA). This allows the HTC to serve the patient under the medical benefit versus a pharmacy adjudication and avoids violation of the specialty pharmacy contract. When the current specialty pharmacy exclusivity contract expires, consider requiring that HTC's be included in the specialty pharmacy network.

Traditional v. Value-Based Contracting

Traditional contracting for clotting factor medication is straightforward. The pharmacy that dispenses the clotting factor is typically reimbursed either a fixed per unit rate or a percentage discount off Average Wholesale Price (AWP) as determined in the contract.

Value-based contracting is more complex and involves outcomes measures. For example, if the clotting factor was 100% effective (zero bleeds during a given timeframe), the manufacturer is not required to provide a refund to the payer. If the clotting factor was less effective (bleeds occurred during a given timeframe), the manufacturer provides a refund to the payer.

Today, hemophilia clotting factor medication is reimbursed under the more traditional contracting model. However, as gene therapy becomes more readily available to treat hemophilia, it is likely that more value-based contracting will be implemented.

MASAC Guidelines

The National Hemophilia Foundation’s Medical and Scientific Advisory Council developed MASAC 188: Recommendation Regarding Standards of Service for Pharmacy Providers of Clotting Factor Concentrates for Home Use to Patients with Bleeding Disorders, to set the following minimum standards that all specialty pharmacies should adhere to:

  • Have staff knowledgeable about clotting factor concentrates, necessary ancillary supplies and the proper handling of both
  • Provide the full range of available, FDA-approved clotting factor concentrates, ancillaries and supportive services (either directly or through a third party)
  • Process prescription orders in a timely manner (48-hours or less) and fill prescriptions within a certain, acceptable range (e.g. +/-5%)
  • Be available to patients within normal business hours, have 24-hour emergency services, provide access to multi-lingual customer service representatives, and maintain necessary contact with the treating physicians
  • Have appropriate, safe, federally compliant delivery services to ensure timely delivery, a faster process in emergent need cases (less than 12 hours; goal of three hours), and a back-up plan for natural disasters
  • Maintain accurate, up-to-date records meeting all federal and state requirements, be HIPAA compliant and:
    • Provide patients with accurate information about factor costs per unit and their out-of-pocket responsibilities under their insurance
    • Maintain an accurate process to track all shipments
    • Participate in the National Patient Notification System for clotting factor concentrate recalls to ensure patient safety

The guidelines should be incorporated into employer/pharmacy provider contracts to ensure that all specialty pharmacy providers meet certain minimum standards when working with people with hemophilia and other bleeding disorders.

Innovative contracting

Innovative contracting with hemophilia medication is in the introductory phase. As gene therapy evolves and becomes available, innovative contracting will become more prevalent. Following are examples:

  • Outcomes-based contracts that reimburse based on the performance of the drug treating the condition; if the outcome is positive, reimbursement occurs at the agreed upon rate/amount
  • Contracts with refunds provided if the patient stays on a drug for a sufficient/agreed upon duration (usually at least six months)
  • Limits on plan liability; i.e. if costs exceed expected amounts, place a cap or maximum on the amount that will be paid