75th OREGON LEGISLATIVE ASSEMBLY--2009 Regular Session
 
SA to SB 316
 
LC 216/SB 316-2
 
                      SENATE AMENDMENTS TO
                         SENATE BILL 316
 
        By COMMITTEE ON HEALTH CARE AND VETERANS' AFFAIRS
 
                            April 15
 
  On page 1 of the printed bill, line 6, after 'patients ' insert
'enrolled in and'.
  Delete lines 8 through 31.
  On page 2, delete lines 1 through 13 and insert:
  ' (a) Means medically necessary conventional care, items or
services covered by the health benefit plan if typically provided
absent a clinical trial.
  ' (b) Does not include:
  ' (A) The drug, device or service being tested in the clinical
trial unless the drug, device or service would be covered for
that indication by the health benefit plan if provided outside of
a clinical trial;
  ' (B) Items or services required solely for the provision of
the drug device
 or service being tested in the clinical trial;
  ' (C) Items or services required solely for the clinically
appropriate monitoring of the drug, device or service being
tested in the clinical trial;
  ' (D) Items or services required solely for the prevention,
diagnosis or treatment of complications arising from the
provision of the drug, device or service being tested in the
clinical trial;
  ' (E) Items or 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;
  ' (F) Items or services customarily provided by a clinical
trial sponsor free of charge to any participant in the clinical
trial; or
  ' (G) Items or services that are not covered by the health plan
if provided outside of the clinical trial.
  ' (3) As used in subsection (1) of this section, 'qualifying
clinical trial' means a clinical trial that is:
  ' (a) Funded by the National Institutes of Health, the Centers
for Disease Control and Prevention, the Agency for Healthcare
Research and Quality, the Centers for Medicare and Medicaid
Services, the United States Department of Defense or the United
States Department of Veterans Affairs;
  ' (b) Supported by a center or cooperative group that is funded
by the National Institutes of Health, the Centers for Disease
Control and Prevention, the Agency for Healthcare Research and
Quality, the Centers for Medicare and Medicaid Services, the
United States Department of Defense or the United States
Department of Veterans Affairs;
  ' (c) Conducted as an investigational new drug application, an
investigational device exemption or a biologics license
application subject to approval by the United States Food and
Drug Administration; or
  ' (d) Exempt by federal law from the requirement to submit an
investigational new drug application to the United States Food
and Drug Administration.
  ' (4) The coverage required by this section may be subject to
provisions of the health benefit plan that apply to other
benefits within the same category, including but not limited to
copayments, deductibles and coinsurance.
  ' (5) An insurer that provides coverage required by this
section is not, based upon that coverage, liable for any adverse
effects of the clinical trial.'.
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