Okla. Stat. tit. 63, § 63-7330

protocol — Circumstances requiring an exception.

A. "Health benefit plan" means a plan as defined pursuant to

Section 6060.4 of Title 36 of the Oklahoma Statutes, that provides

coverage for invasive or noninvasive mechanical ventilation to treat

chronic respiratory failure consequent to chronic obstructive

pulmonary disease (CRF-COPD), requiring a step therapy protocol.

B. "Treatment step therapy protocol" means a treatment

utilization management protocol or program under which a group

health plan or health insurance issuer offering group health

insurance coverage of respiratory care treatments requires a

participant or beneficiary to try an alternative, plan-preferred

treatment and fail on this treatment before the plan or health

insurance issuer approves coverage for the non-preferred therapy

prescribed by the beneficiary's medical provider.

C. A health benefit plan shall:

1. Implement a clear and transparent process for a participant

or beneficiary, or the prescribing health care provider on behalf of

the participant or beneficiary, with CRF-COPD to request an

exception to such a step therapy protocol, pursuant to subsection B

of this section; and

2. Where the participant or beneficiary or prescribing health

care provider's request for an exception to the treatment step

therapy protocols satisfies the criteria and requirements of

subsection D of this section, cover the requested treatment in

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accordance with the terms established by the health plan or coverage

for patient cost-sharing rates or amounts at the time of the

participant's or beneficiary's enrollment in the health plan or

health insurance coverage.

D. The circumstances requiring an exception to a treatment step

therapy protocol, pursuant to a request under subsection C of this

section, are any of the following:

1. Any treatments otherwise required under the protocol have

not been shown to be as effective as other available options in the

treatment of the disease or condition or the participant or

beneficiary, when prescribed consistent with clinical indications,

clinical guidelines, or other peer-reviewed evidence;

2. Delay of proven effective treatment would lead to severe or

irreversible consequences, and the treatment initially required

under the protocol is reasonably expected to be less effective

based upon the documented physical or mental characteristics of the

participant or beneficiary and the known characteristics of such

treatment;

3. Any treatments otherwise required under the protocol are

contraindicated for the participant or beneficiary or have caused,

or are likely to cause, based on clinical, peer-reviewed evidence,

an adverse reaction or other physical harm to the participant or

beneficiary;

4. Any treatment otherwise required under the protocol has

prevented, will prevent, or is likely to prevent a participant or

beneficiary from achieving or maintaining reasonable and safe

functional ability in performing occupational responsibilities or

activities of daily living; or

5. The patient's disease state is classified as life

threatening.

E. The process required by subsection C of this section shall:

1. Provide the prescribing health care provider or beneficiary

or designated third-party advocate an opportunity to present such

provider's clinical rationale and relevant medical information for

the group health plan or health insurance issuer to evaluate such

request for exception;

2. Clearly set forth all required information and the specific

criteria that will be used to determine whether an exception is

warranted, which may require disclosure of the medical history or

other health records of the participant or beneficiary demonstrating

that the participant or beneficiary seeking an exception:

a. has tried other qualifying treatments without success,

or

b. has received the requested treatment for a clinically
n and the specific

criteria that will be used to determine whether an exception is

warranted, which may require disclosure of the medical history or

other health records of the participant or beneficiary demonstrating

that the participant or beneficiary seeking an exception:

a. has tried other qualifying treatments without success,

or

b. has received the requested treatment for a clinically

appropriate amount of time to establish stability, in

relation to the condition being treated and guidelines

given by the prescribing physician.

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Other clinical information that may be relevant to conducting

the exception review may require disclosure.

3. Not require the submission of any information or supporting

documentation beyond what is strictly necessary to determine whether

any of the circumstances listed in subsection B of this section

exist.

F. The health benefit plan shall make information regarding the

process required under subsection C of this section readily

available on the Internet website of the group health plan or health

insurance issuer. Such information shall include:

1. The requirements for requesting an exception to a treatment

step therapy protocol pursuant to this section; and

2. Any forms, supporting information, and contact information,

as appropriate.

G. The process required under paragraph 1 of subsection C of

this section shall provide for the disposition of requests received

under such paragraph in accordance with the following:

1. Subject to paragraph 2 of this subsection, not later than

seventy-two (72) hours after receiving an initial exception request,

the plan or issuer shall respond to the requesting prescriber with

either a determination of exception eligibility or a request for

additional required information, strictly necessary to make a

determination of whether the conditions specified in subsection D of

this section are met. The plan or issuer shall respond to the

requesting provider with a determination of exception eligibility no

later than seventy-two (72) hours after receipt of the additional

required information; or

2. In the case of a request under circumstances in which the

applicable equipment step therapy protocol may seriously jeopardize

the life or health of the participant or beneficiary, the plan or

issuer shall conduct a review of the request and respond to the

requesting prescriber with either a determination or exception

eligibility or a request for additional required information

strictly necessary to make a determination of whether the conditions

specified in subsection D of this section are met, in accordance

with the following:

a. if the plan or issuer can make a determination of

exception eligibility without additional information,

such determination shall be made on an expedited basis

and no later than one (1) business day after receipt

of such request, or

b. if the plan or issuer requires additional information

before making a determination of exception

eligibility, the plan or issuer shall respond to the

requesting provider with a request for such

information within one (1) business day of the request

for a determination, and shall respond with a

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determination of exception eligibility as quickly as

the condition or disease requires and no later than

one (1) business day after receipt of the additional

required information.

H. This act shall apply with respect to any licensed provider

in the State of Oklahoma that provides coverage of a treatment

pursuant to a policy that meets the definition of treatment step

therapy protocol in subsection B of this section, regardless of

whether such policy is described by such group health plan or health

insurance coverage as a step therapy protocol.