22-264m Apply New Processes for Prescription Prior Authorization and Step Therapy, and Ensure PrEP Coverage
Date: 03/28/22
This information applies to Participating Physician Groups (PPGs).
AB 347 clarifies step therapy processes; Bulletin 2021-10 reviews PrEP coverage
Per California State Assembly Bill (AB) 347, participating physician groups (PPGs) that are delegated and financially responsible for self-injectable drugs must implement new processes in their prescription prior authorization (PA) and step therapy programs.
How AB 347 affects you
For PPGs delegated as financially responsible through capitation or other financial arrangement, or for which medical management (medical necessity review) is done by other than the health plan, the utilization review organization must comply with the specified provisions of AB 347 relating to self-injectable medications and self-injectable step therapy exception determinations and procedures.
What the bill requires
- AB 347 revises and adds to existing statutory language that was introduced in 2014. The 2014 bill included the 72-hour/24-hour (calendar hours) prescription drug PA and step therapy exception review timeframes. AB 347 adds language that allows the provider to appeal a denial of an exception request for coverage of a nonformulary drug, prior authorization request or step therapy exception request consistent with the plan’s current utilization management processes. It requires the provider to submit justification and supporting clinical documentation supporting the provider’s determination that the required prescription drug is inconsistent with good professional practice for provision of medically necessary covered services.
- PPGs that do their own utilization review on behalf of the plan, or between the plan and another contracted entity, are required to comply with the specified provisions of AB 347 relating to step therapy determinations and procedures. Denial of step therapy exception requests require a notification to the prescribing provider and member on the external appeal process through the plan (independent medical review) or request additional or clinical documentation to make a coverage determination. In addition, notification of an incomplete or missing clinical documentation step therapy exception request requires notification to the prescribing provider.
PPGs must ensure that they have this process in place.
As a result, a financially responsible PPG cannot deny, as standard practice:
- PA for a nonformulary drug only because the member has not tried and failed with a formulary drug, and
- PA for a step therapy exception only because the member has not tried and failed with a preferred drug in the step therapy process.
- Denial or approval must be based on the medically necessary documentation provided with the PA.
Commercial plan coverage for PrEP
The insurance commissioner’s Bulletin 2021-10, released December 29, 2021, pertains to preventive services coverage for HIV pre-exposure prophylaxis (PrEP) with provider-administered antiretroviral drug therapy.
How Bulletin 2021-10 affects you
Health plans and delegated PPGs must cover the drugs for PrEP, its administration and other integral services that are necessary to initiate therapy and provide ongoing follow-up, as preventive care without cost sharing and as set forth in a 2021 update to the Centers for Disease Control and Prevention’s PrEP guidelines. This includes injectable drugs for PrEP administered in a physician’s office.
The bulletin is a reminder that health insurance policies, including student health insurance policies1, must cover HIV PrEP consistent with the USPSTF recommendation and federal regulations and guidance on coverage of preventive health services under Public Health Service Act section 2713. Pursuant to these authorities, preventive health services coverage for HIV PrEP on non-grandfathered health insurance policies must be provided without cost sharing, including deductible, copayment and coinsurance, in accordance with the following:
- Provide coverage for persons, including adolescents, who are at high risk of HIV infection, as determined by a person’s attending health care provider.2
- Cover prescription drugs approved by the U.S. Food and Drug Administration for HIV PrEP and recommended for HIV PrEP by the CDC.
- Coverage is for the generic, if available. Coverage is for both oral and injectable drugs listed in the formulary as a preventive drug with zero copay.
- Drugs for PrEP include:
- Tenofovir disoproxil fumarate/emtricitabine (oral generic Truvada® – pharmacy benefit)
- Descovy® (oral – pharmacy benefit)
- Apretude® (injectable – medical benefit)
The above coverage must also be provided to grandfathered health insurance policies, and can include cost sharing, including deductible, copayment and coinsurance.
1 Under federal law, student health insurance is considered individual coverage and must comply with Section 2713 of the Public Health Service Act (42 USC § 300gg-13), including by covering “A” and “B” grade recommendations of the USPSTF without cost sharing. See 45 CFR §§ 147.130, 147.145.
2 Insurance Commissioner Ricardo Lara, Notice Re: Preventive Health Services Coverage for HIV Preexposure Prophylaxis (PrEP) (June 10, 2020).
Additional information
Relevant sections of Health Net’s provider operations manuals have been revised to reflect the information contained in this update as applicable. Provider operations manuals are available electronically in the Provider Library after logging in to Health Net’s provider website > Provider Library under Quick Links, or go directly to the Provider Library.
If you have questions regarding the information contained in this update, contact the applicable Health Net Provider Services Center within 60 days at:
Line of business | Phone number | Email address |
|---|---|---|
EnhancedCare PPO (IFP & SBG) | 844-463-8188 | |
Health Net Employer Group HMO, POS, HSP, PPO, & EPO | 800-641-7761 | |
IFP (CommunityCare HMO, PPO, PureCare HSP, & PureCare One EPO) | 888-926-2164 |