CMS Issues 2016/2017 Final Rule and Issuers Letter for QHPs in Federally Facilitated Marketplaces
On Friday, Feb. 20, 2015, CMS issued its Final Rule Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2016 and Final 2016 Letter to Issuers in the Federally Facilitated Marketplaces. The following is a summary of important prescription drug coverage and formulary provisions for qualified health plans (QHPs):
Formulary publication. Beginning in 2016, plans must publish accurate, updated formularies on a publicly available website. Formulary information must include a current list of formulary medications required pursuant to the essential health benefits (EHB) requirements. All medications must be listed by name and any coverage restrictions, including prior authorization, step therapy, quantity limits, and any restrictions on accessing medications at a retail pharmacy.
Maintains United State Pharmacopeia (USP) requirements for class and category drug count. Despite seeking input in last year on alternatives, CMS maintained the USP requirement. Therefore, plans must continue to use the requirement to cover the greater of one drug per USP category and class or the same number of drugs in each USP category and class as the state’s EHB benchmark. Beginning in 2017, CMS will rely on the most updated USP category and class requirements.
Pharmacy & therapeutics (P&T) committees should be primarily responsible for developing formularies. CMS finds that plans should rely upon P&T committees in addition to USP category and class drug counts as the means to develop formularies. P&T committee membership should consist of experts in chronic disease and individuals with disabilities and practicing professionals, including physicians, pharmacists, and other health care professionals. CMS finds part-time practice acceptable. No more than 20% of P&T committee should have a conflict with pharmaceutical company. CMS may provide further guidance regarding P&T committee management, oversight, operations, and management of conflicts of interest in the future.
CMS has adopted a modified version of Medicare Part D’s standards for P&T committees in the marketplaces to do the following:
- Document decisions regarding formulary development, revision, and utilization management activities.
- Be transparent about operation and function.
- Base clinical decisions on the strength of scientific evidenced and standards of practice.
- Assess peer-reviewed medical literature, pharmacoeconomic studies, outcomes research data, and other information deemed appropriate
- Review policies that guide exceptions and other utilization management process, including drug utilization review, quantity limits, and therapeutic interchange.
- Review all new FDA approved drugs and new use for existing drugs within 90 days of release or new use and make a final determination within 180 days.
Formulary decisions must be based on scientific evidence and may also be based on pharmacoeconomic considerations that achieve safe, appropriate, and cost-effective drug therapy.
Formulary exceptions process. In 2016, plan issuer must notify the enrollee or the enrollee’s designee and the prescriber of coverage determinations no more than 72 hours following the receipt of a standard exceptions request. Plan issuers must also have a system for independent reviews of denials of exceptions. Medications granted exceptions will be included as an EHB and count toward the plans’ annual limitation on cost sharing. Exceptions will count for the duration of coverage the prescription, including refills.
Transition fills encouraged but not required. CMS encourages plans to provide a temporary fill of non-formulary items, including medications covered by step therapy when an individual is transitioning to a new plan.
Mid-year plan changes. CMS remains concerned about mid-year plan formulary changes and is considering whether to develop new standards.
Formulary outlier review and prescription drug coverage. CMS will conduct a review of each QHP’s formulary to ensure non-discrimination. CMS will identify outliers based on large numbers of prior authorization or step therapy in participate USP category and class.
CMS will also review prescription drug coverage to ensure the availability of covered drugs recommended by nationally-recognized clinical guidelines in the following medication conditions: bipolar disorder, diabetes, rheumatoid arthritis, and schizophrenia. CMS will analyze whether plan offer a sufficient number and type of drugs to treat conditions and do not restrict coverage or access to first line therapies through inappropriate use of utilization management techniques or non-coverage.
Access to medications at retail and via mail-order. The final rule requires plans to offer individuals a retail and a mail-order option beginning in 2017. Plans may charge differential co-payments in retail and mail-order. However, any differential on EHB required medications must count toward the annual limit on cost sharing and accounted for in the actuarial value of the plan.
Access to medications from specialty pharmacies. Plans may require the use of specialty pharmacies for drugs that have restricted distribution requirements by the Food and drug Administration (ex, drugs subject to a Risk Evaluation and Mitigation Strategy) or appropriate dispensing requires special handling, provider coordination, or patient education that cannot be met by a retail pharmacy.