Provider accreditation

The cost and the complexity of administering some cell and gene therapies (CGTs) is leading payers and developers to accredit or certify which providers may offer the products. For example, both Gilead/Kite and Novartis have limited access to their CAR-T therapies to company-certified treatment centers. Beyond core medical competence, some stakeholders suggest providers should meet additional quality procedure standards and/or reporting requirements. Insurers may want assurances that providers have sufficient expertise and that the laboratory and other sources needed by patients for these treatments are readily available. Therapy-specific certification programs may be an avenue to define standards for providers who wish to provide these more complex treatments and services. Certification will require provider organizations to expend time and resources.

Centers of Excellence

As the cost and the complexity of administering some CGTs leads payers and manufacturers to certify which providers may offer the products, we may also see movement toward Centers of Excellence (COEs). Current COEs exist at academic medical centers and specialty hospitals. A patient seeking treatment for a rare condition often travels to these types of hospitals for treatment. In the future, we expect to see further COE development.

Establishing COEs as part of a specialty network typically includes defining:

• Selection criteria
• Volume/outcome reporting requirements
• Quality improvement plans
• Designation/de-designation processes
• Clarity in how members can identify designated centers
• Care coordination
• Benefit language
• (Maybe) contracting strategies

Ideally, COE networks will help to ensure a consistent quality of patient care and encourage better clinical outcomes, while creating incentives for cost-effective care with disincentives for waste. Challenges will include implementation of consistent but minimally burdensome reporting and quality standards, and broad access to patients regardless of geography, clinical need, and socioeconomic background. Additional detail may be found in the FoCUS research brief Role of Centers of Excellence (COE) Networks in the Delivery of Curative Cellular Therapies in Oncology.