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 and 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 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 are required to manage and report on hemophilia medications. There is an opportunity to provide clarity in both carrier and PBM contracts for these medications, so hemophilia-related claims can be targeted appropriately and be cost effective. The key is to hold vendor partners 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 vendors that includes the right contract language, ongoing reporting requirements and whether HTCs are to be included.

Integrating HTCs into Your Exclusive Specialty Pharmacy Contract
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.

Employer Example: Preauthorization Language

Consider adding preauthorization language to your medical and/or pharmacy contract: services and treatments are covered if a Hemophilia Treatment Center is utilized (as available).

Traditional v. Value-Based Contracting

Traditional contracting for clotting factor is straightforward. The pharmacy that dispenses 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 clotting factor was 100% effective (zero bleeds during a given timeframe), the manufacturer is not required to provide a refund to the payer. If clotting factor was less effective (bleeds occurred during a given timeframe), the manufacturer provides a refund to the payer.

Today, hemophilia medications are mostly 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 (refer to MASAC 188 for the complete list):

  • 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. +/- 5-10%).
  • 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 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.

These guidelines should be incorporated into vendor partner 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 medication 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 medication for a sufficient/agreed upon duration (usually at least six months)
  • Limits on plan liability; e.g. if costs exceed expected amounts, place a cap or maximum on the amount that will be paid


Employer Example:
Integrating Performance Guarantees into PBM Contract

  • Worked with PBM and specialty pharmacy to deliver a better patient experience for people with hemophilia. Drove accountability with PBM for cost:
    • Tracked medical and pharmacy claims for people with hemophilia who have a history of ER visits to capture precursors to care.
    • Tracked trends year over year for ER visits (percent of decrease and if minimum threshold of visits were exceeded) and hospital length of stay to determine impacts, achieve more effective clinical management and reduce occurrences.
  • Drove accountability with PBM for care:
    • Required performance guarantees be subject to downside financial risk based on patient experience.
  • Provided education and information to medical care team(s); shared available hemophilia prescription coverage to assist with appropriate counseling.