‘‘(C) The study or investigation is a drug trial that is exempt from having such an investigational new drug application. ‘‘(2) C ONDITIONS FOR DEPARTMENTS .—The conditions described in this paragraph, for a study or investigation con- ducted by a Department, are that the study or investigation has been reviewed and approved through a system of peer review that the Secretary determines— ‘‘(A) to be comparable to the system of peer review of studies and investigations used by the National Institutes of Health, and ‘‘(B) assures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review. ‘‘(e) L IFE - THREATENING C ONDITION D EFINED .—In this section, the term ‘life-threatening condition’ means any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted. ‘‘(f) C ONSTRUCTION .—Nothing in this section shall be construed to limit a plan’s or issuer’s coverage with respect to clinical trials.
H. R. 3590—777 ‘‘(g) A PPLICATION TO FEHBP.—Notwithstanding any provision of chapter 89 of title 5, United States Code, this section shall apply to health plans offered under the program under such chapter. ‘‘(h) P REEMPTION .—Notwithstanding any other provision of this Act, nothing in this section shall preempt State laws that require a clinical trials policy for State regulated health insurance plans that is in addition to the policy required under this section.’’. (d) Section 1251(a) of this Act is amended— (1) in paragraph (2), by striking ‘‘With’’ and inserting ‘‘Except as provided in paragraph (3), with’’; and (2) by adding at the end the following: ‘‘(3) A PPLICATION OF CERTAIN PROVISIONS .—The provisions of sections 2715 and 2718 of the Public Health Service Act (as added by subtitle A) shall apply to grandfathered health plans for plan years beginning on or after the date of enactment of this Act.’’. (e) Section 1253 of this Act is amended insert before the period the following: ‘‘, except that— ‘‘(1) section 1251 shall take effect on the date of enactment of this Act; and ‘‘(2) the provisions of section 2704 of the Public Health Service Act (as amended by section 1201), as they apply to enrollees who are under 19 years of age, shall become effective for plan years beginning on or after the date that is 6 months after the date of enactment of this Act.’’. (f) Subtitle C of title I of this Act is amended— (1) by redesignating section 1253 as section 1255; and (2) by inserting after section 1252, the following: ‘‘SEC. 1253. ANNUAL REPORT ON SELF-INSURED PLANS. ‘‘Not later than 1 year after the date of enactment of this Act, and annually thereafter, the Secretary of Labor shall prepare an aggregate annual report, using data collected from the Annual Return/Report of Employee Benefit Plan (Department of Labor Form 5500), that shall include general information on self-insured group
- Spring '09
- Health Care Law, Sec.