§5-16B-6a. Coverage for patient cost of clinical trials


Published: 2015

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WVC 5 - 16 B- 6 A

§5-16B-6a. Coverage for patient cost of clinical trials.

(a) The provisions of this section and section six-b of this

article apply to the health plans regulated by this article.

(b) This section does not apply to a policy, plan or contract

paid for under Title XVIII of the Social Security Act.

(c) A policy, plan or contract subject to this section shall

provide coverage for patient cost to a member in a clinical trial,

as a result of:

(1) Treatment provided for a life-threatening condition; or

(2) Prevention of, early detection of or treatment studies on

cancer.

(d) The coverage under subsection (c) of this section is

required if:

(1)(A) The treatment is being provided or the studies are

being conducted in a Phase II, Phase III or Phase IV clinical trial

for cancer and has therapeutic intent; or

(B) The treatment is being provided in a Phase II, Phase III

or Phase IV clinical trial for any other life-threatening condition

and has therapeutic intent;

(2) The treatment is being provided in a clinical trial

approved by:

(A) One of the national institutes of health;

(B) An NIH cooperative group or an NIH center;

(C) The FDA in the form of an investigational new drug

application or investigational device exemption;

(D) The federal department of veterans affairs; or

(E) An institutional review board of an institution in the

state which has a multiple project assurance contract approved by

the office of protection from research risks of the national

institutes of health;

(3) The facility and personnel providing the treatment are

capable of doing so by virtue of their experience, training and

volume of patients treated to maintain expertise;

(4) There is no clearly superior, noninvestigational treatment

alternative;

(5) The available clinical or preclinical data provide a

reasonable expectation that the treatment will be more effective

than the noninvestigational treatment alternative;

(6) The treatment is provided in this state: Provided, That,

if the treatment is provided outside of this state, the treatment

must be approved by the payor designated in subsection (a) of this

section;

(7) Reimbursement for treatment is subject to all coinsurance,

copayment and deductibles and is otherwise subject to all

restrictions and obligations of the health plan; and

(8) Reimbursement for treatment by an out of network or

noncontracting provider shall be reimbursed at a rate which is no

greater than that provided by an in network or contracting

provider. Coverage shall not be required if the out of network or

noncontracting provider will not accept this level of reimbursement.

(e) Payment for patient costs for a clinical trial is not

required by the provisions of this section, if:

(1) The purpose of the clinical trial is designed to extend

the patent of any existing drug, to gain approval or coverage of a

metabolite of an existing drug, or to gain approval or coverage

relating to additional clinical indications for an existing drug;

or

(2) The purpose of the clinical trial is designed to keep a

generic version of a drug from becoming available on the market; or

(3) The purpose of the clinical trial is to gain approval of

or coverage for a reformulated or repackaged version of an existing

drug.

(f) Any provider billing a third party payor for services or

products provided to a patient in a clinical trial shall provide

written notice to the payor that specifically identifies the

services as part of a clinical trial.

(g) Notwithstanding any provision in this section to the

contrary, coverage is not required for Phase I of any clinical

trial.





Note: WV Code updated with legislation passed through the 2015 Regular Session

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