An Act To Expand Access to Clinical Trials
Maine Legislature, Session 125, LD 0712
Committee: Insurance and Financial Services
Sponsors: STRANG BURGESS, SAVIELLO, BEAUDOIN, BEAULIEU, DILL, FOSSEL, PETERSON, RICHARDSON, SANBORN, SULLIVAN
Amends: 24-A MRSA §4310

Legislative Document 
No. 712 
H.P. 543 
House of Representatives, February 23, 2011 
An Act To Expand Access to Clinical Trials 
Received by the Clerk of the House on February 18, 2011.  Referred to the Committee on 
Insurance and Financial Services pursuant to Joint Rule 308.2 and ordered printed pursuant to 
Joint Rule 401. 
HEATHER J.R. PRIEST 
Clerk 
Presented by Representative STRANG BURGESS of Cumberland. 
Cosponsored by Senator SAVIELLO of Franklin and 
Representatives: BEAUDOIN of Biddeford, BEAULIEU of Auburn, DILL of Cape Elizabeth, 
FOSSEL of Alna, PETERSON of Rumford, RICHARDSON of Warren, SANBORN of 
Gorham, Senator: SULLIVAN of York. 
Be it enacted by the People of the State of Maine as follows: 
Sec. 1.  24-A MRSA §4310, as amended by PL 2003, c. 517, Pt. B, §31, is further 
amended to read: 
§4310.  Access to clinical trials 
1.  Qualified enrollee.  An enrollee is eligible for coverage for participation in an 
approved clinical trial if the enrollee meets the following conditions: 
A.  The enrollee has a life-threatening illness for which no standard treatment is 
effective medical condition for which an approved clinical trial that is approved by an 
institutional review board is available; 
B.  The enrollee is eligible to participate according to the clinical trial protocol with 
respect to treatment of such illness; and 
C.  The enrollee's participation in the trial offers meaningful potential for significant 
clinical benefit to the enrollee; and 
D.  The enrollee's referring physician has concluded that the enrollee's participation 
in such a trial would be appropriate based upon the satisfaction of the conditions in 
paragraphs A, and B and C. 
2.  Coverage.  A carrier may not deny a qualified enrollee participation in an 
approved clinical trial or deny, limit or impose additional conditions on the coverage of 
routine patient costs for items and services furnished in connection with participation in 
the clinical trial. For the purposes of this section, "routine patient costs" does not include 
the costs of the tests or measurements conducted primarily exclusively for the purpose of 
the clinical trial involved. 
3.  Payment.  A carrier shall provide payment for routine patient costs but is not 
required to pay for costs of items and services that are reasonably expected to be paid for 
by the sponsors of an approved clinical trial. In the case of covered items and services, 
the carrier shall pay participating providers at the agreed upon rate and pay 
nonparticipating providers at the same rate the carrier would pay for comparable services 
performed by participating providers. 
4.  Approved clinical trial.  For the purposes of this section, "approved clinical trial" 
means a clinical research study or clinical investigation  approved and funded by the 
federal Department of Health and Human Services, National Institutes of Health or a 
cooperative group or, center of the National Institutes of Health or a pharmaceutical 
manufacturer.  It includes all phases of clinical trials, including translational trials and 
Phase I, Phase II and Phase III trials. 
5.  Application.  The requirements of this section apply to all individual and group 
policies, contracts and certificates executed, delivered, issued for delivery, continued or 
renewed in this State. For purposes of this section, all contracts are deemed to be renewed 
no later than the next yearly anniversary of the contract date. 
SUMMARY 
This bill amends the Maine Insurance Code to include those with medical conditions 
for whom an approved clinical trial is available.  It requires health insurance coverage of 
clinical trials by pharmaceutical manufacturers.  It also clarifies that the law covers all 
phases of clinical trials, including translational trials as well as Phase I, Phase II and 
Phase III trials.