Page:United States Statutes at Large Volume 124.djvu/919

 124 STAT. 893 PUBLIC LAW 111–148—MAR. 23, 2010 ‘‘(A) may not deny the individual participation in the clinical trial referred to in subsection (b)(2); ‘‘(B) subject to subsection (c), may not deny (or limit or impose additional conditions on) the coverage of routine patient costs for items and services furnished in connection with participation in the trial; and ‘‘(C) may not discriminate against the individual on the basis of the individual’s participation in such trial. ‘‘(2) ROUTINE PATIENT COSTS.— ‘‘(A) INCLUSION.—For purposes of paragraph (1)(B), subject to subparagraph (B), routine patient costs include all items and services consistent with the coverage provided in the plan (or coverage) that is typically covered for a qualified individual who is not enrolled in a clinical trial. ‘‘(B) EXCLUSION.—For purposes of paragraph (1)(B), routine patient costs does not include— ‘‘(i) the investigational item, device, or service, itself; ‘‘(ii) items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient; or ‘‘(iii) a service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis. ‘‘(3) USE OF IN-NETWORK PROVIDERS.—If one or more partici- pating providers is participating in a clinical trial, nothing in paragraph (1) shall be construed as preventing a plan or issuer from requiring that a qualified individual participate in the trial through such a participating provider if the provider will accept the individual as a participant in the trial. ‘‘(4) USE OF OUT-OF-NETWORK.—Notwithstanding paragraph (3), paragraph (1) shall apply to a qualified individual partici- pating in an approved clinical trial that is conducted outside the State in which the qualified individual resides. ‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For purposes of sub- section (a), the term ‘qualified individual’ means an individual who is a participant or beneficiary in a health plan or with coverage described in subsection (a)(1) and who meets the following condi- tions: ‘‘(1) The individual is eligible to participate in an approved clinical trial according to the trial protocol with respect to treatment of cancer or other life-threatening disease or condi- tion. ‘‘(2) Either— ‘‘(A) the referring health care professional is a partici- pating health care provider and has concluded that the individual’s participation in such trial would be appropriate based upon the individual meeting the conditions described in paragraph (1); or ‘‘(B) the participant or beneficiary provides medical and scientific information establishing that the individual’s participation in such trial would be appropriate based upon the individual meeting the conditions described in para- graph (1). ‘‘(c) LIMITATIONS ON COVERAGE.—This section shall not be con- strued to require a group health plan, or a health insurance issuer Applicability.