(a) If there is more than one drug that is clinically appropriate for the treatment of a medical condition, a health care service plan that provides coverage for prescription drugs may require step therapy. (b) A health care service plan shall expeditiously grant a request for a step therapy exception within the applicable time limit required by Section 1367.241 if a prescribing provider submits necessary justification and supporting clinical documentation supporting the providerâs determination that the required prescription drug is inconsistent with good professional practice for provision of medically necessary covered services to the enrollee, taking into consideration the enrolleeâs needs and medical history, along with the professional judgment of the enrolleeâs provider. The basis of the providerâs determination may include, but is not limited to, any of the following criteria: (1) The required prescription drug is contraindicated or is likely, or expected, to cause an adverse reaction or physical or mental harm to the enrollee in comparison to the requested prescription drug, based on the known clinical characteristics of the enrollee and the known characteristics and history of the enrolleeâs prescription drug regimen. (2) The required prescription drug is expected to be ineffective based on the known clinical characteristics of the enrollee and the known characteristics and history of the enrolleeâs prescription drug regimen. (3) The enrollee has tried the required prescription drug while covered by their current or previous health coverage or Medicaid, and that prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse reaction. The health care service plan may require the submission of documentation demonstrating that the enrollee tried the required prescription drug before it was discontinued. (4) The required prescription drug is not clinically appropriate for the enrollee because the required drug is expected to do any of the following, as determined by the enrolleeâs prescribing provider: (A) Worsen a comorbid condition. (B) Decrease the capacity to maintain a reasonable functional ability in performing daily activities. (C) Pose a significant barrier to adherence to, or compliance with, the enrolleeâs drug regimen or plan of care. (5) The enrollee is stable on a prescription drug selected by the enrolleeâs prescribing provider for the medical condition under consideration while covered by their current or previous health coverage or Medicaid. (c) A health care provider or prescribing provider may appeal a denial of an exception request for coverage of a nonformulary drug, prior authorization request, or step therapy exception request consistent with the health care service planâs current utilization management processes. (d) An enrollee or the enrolleeâs designee or guardian may appeal a denial of an exception request for coverage of a nonformulary drug, prior authorization request, or step therapy exception request by filing a grievance under Section 1368. (e) (1) This section does not prohibit a health care provider from prescribing a prescription drug that is clinically appropriate. (2) This section does not prohibit a health care service plan or utilization review organization from requiring an enrollee to try an AB-rated generic equivalent, biosimilar, as defined in Section 262(i)(2) of Title 42 of the United States Code, or interchangeable biological product, as defined in Section 262(i)(3) of Title 42 of the United States Code, before providing coverage for the equivalent branded prescription drug. (3) Paragraph (2) does not prohibit or supersede a step therapy exception request as described in subdivision (b). (f) This section does not require or authorize a health care service plan that contracts with the State Department of Health Care Services to provide services to Medi-Cal beneficiaries to provide coverage for prescription dr
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