ALL of the following

• The plan shall not deny a qualified enrollee's participation in an approved clinical trial (CA HSC §1370.6(a)(1)).
• The plan shall not deny, limit, or impose additional conditions on coverage of routine patient care costs for services furnished in connection with participation in an approved clinical trial (CA HSC §1370.6(a)(2)).
• The plan shall not discriminate against an enrollee based on participation in an approved clinical trial (CA HSC §1370.6(a)(3)).

• Applicability

  • Applies when the qualified enrollee participates in an approved clinical trial conducted by a participating provider (CA HSC §1370.6(b)(1)(A)).
  • Applies when the qualified enrollee participates in an approved clinical trial conducted by a nonparticipating provider if the trial is not offered or available through a participating provider (CA HSC §1370.6(b)(1)(B)).

• Provider and location rules

  • If one or more participating providers is conducting the approved clinical trial, the plan may require the qualified enrollee to participate through a participating provider if that provider accepts the enrollee as a clinical trial participant (CA HSC §1370.6(b)(2)).
  • The plan may restrict coverage to an approved clinical trial in-state unless the clinical trial is not offered or available through a participating provider in this state (CA HSC §1370.6(b)(3)).

• Payment rate and cost sharing for nonparticipating providers

  • Payment rate for routine patient care costs provided by a nonparticipating provider shall be the negotiated rate the plan would otherwise pay a participating provider for the same services, less applicable cost sharing (CA HSC §1370.6(c)(1)).
  • Cost sharing for routine patient care costs shall be the same as that applied to the same services not delivered in a clinical trial, except that in‑network cost sharing and the in‑network out‑of‑pocket maximum shall apply if the clinical trial is not offered or available through a participating provider (CA HSC §1370.6(c)(2)).

• Definition — routine patient care costs

  • Includes drugs, items, devices, and services typically covered absent a clinical trial; items required solely for provision of the investigational intervention; clinically appropriate monitoring of the investigational intervention; prevention of complications arising from the investigational intervention; and reasonable and necessary care arising from the investigational intervention, including diagnosis and treatment of complications (CA HSC §1370.6 related provisions).
  • Excludes the investigational drug/item/device itself; items provided solely to satisfy data collection/analysis needs not used in direct clinical management; items specifically excluded from the contract (unless required by law); and items customarily provided free of charge to a clinical trial participant by the research sponsor (CA HSC §1370.6 related provisions).
• This section does not limit other coverage provided by the plan and provision of services required by this section does not, in itself, give rise to liability for the plan (CA HSC §1370.6(e) and (f)).