AN ACT Relating to reducing prescription drug costs by eliminating barriers impeding access to biosimilar medicines;
Bill Description
Increasing access to biosimilar medicines.
What this bill does Powered by Legitron
This bill amends existing Washington insurance and health plan statutes to change prescription drug utilization management and qualified health plan contracting. It modifies RCW 48.43.420 to require health carriers and prescription drug utilization management entities, for plans delivered, issued, or renewed on or after January 1, 2021, to post a clear exception request process and disclose criteria to providers, to approve exceptions when submitted evidence meets listed clinical criteria, to authorize coverage when an exception is granted, and to meet strict timelines (nonurgent: notice and decision within three business days after sufficient information; urgent: within one business day). Exception requests are deemed granted if the carrier does not respond in time; carriers must allow emergency supply fills and permit stabilized patients to remain on their drug during the process; denials must cite clinical review criteria, explain appeals, and administrative denials must state what additional information is needed and deadlines. The changes preserve a carrier’s ability to require trial of AB‑rated generics, interchangeable biological products, or biosimilars before covering a branded drug and to deny coverage for drugs removed by the FDA for safety reasons. The chunk references biosimilars per 42 U.S.C. §262(i)(2).
The bill also amends RCW 41.05.410 and related sections to require the unnamed authority, in consultation with the Washington health benefit exchange, to contract with one or more carriers to offer standardized qualified health plans on the exchange for plan years beginning in 2021, with requirements including offering bronze/silver/gold options, procurement goals for county coverage, certification and rate approval before contracting, incorporation of certain collaborative and health technology assessment recommendations, participation requirements (population health, primary care, care coordination, high‑value care, health equity), utilization review focused on high‑variation/high‑cost/low‑evidence care, and aggregate non‑pharmacy reimbursement limits not to exceed 160% of Medicare statewide aggregate reimbursement. For rural hospitals certified as critical access or sole community hospitals, rates may not be less than 101% of Medicare allowable costs. The authority may require qualified plans to supply cost and quality data for monitoring; that data is exempt from public disclosure under RCW 42.56.650. A provision sets a floor that reimbursement for primary care physicians in family medicine, general internal medicine, or pediatrics may not be less than 135% of what Medicare would pay for the same or similar services.
The bill amends pharmacy substitution rules (amending RCW 69.41.120 and 69.41.125) to allow pharmacists to select a biosimilar or interchangeable biological product unless the prescriber personally indicates “do not substitute” (a checked box must be personally initialed), to require the substitute to cost the patient less than the prescribed product, to require communication of the dispensed product name on the label, to require noting the manufacturer on the prescription file, and to retain prescription records per RCW 18.64.245. Cost‑saving intent is emphasized and the person selecting the dispensed drug assumes responsibility for selection; prescribers are not liable for a pharmacist’s selection.
The provided text is incomplete in places: the RCW 41.05.410 amendment in the extract cuts off mid‑sentence, the bill header references amendments and a new section to RCW 69.41.120 and 69.41.125 and creation of a new section that are not fully included here, and key definitions (for example, the statutory identity of “the authority” and the specific definition of “primary care services”) are not present in these chunks.
Why it matters Powered by Legitron
If enacted, health insurers would have to run a clearly posted, fast exception process that lets a prescriber keep a patient on a requested drug when specific clinical reasons exist, with nonurgent decisions in three business days and urgent ones in one day, emergency fills to keep patients stable while requests are processed, and automatic approval if the carrier misses the deadline. This will shift operational burdens onto carriers and utilization management entities to staff and document rapid reviews, give providers and patients more certainty during switches, and reduce sudden forced changes for stabilized patients; carriers still can require trials of generics or biosimilars first and can deny drugs removed by the FDA.
The bill would also raise payment floors and limits that change money flows: primary care doctors in family medicine, internal medicine, and pediatrics must be paid at least 135% of Medicare rates, qualified plans’ nonpharmacy aggregate payments are capped around 160% of Medicare statewide rates, and rural critical access or sole community hospitals must receive at least 101% of allowable Medicare costs. Pharmacists could substitute lower‑cost biosimilars or interchangeable biologics unless a prescriber personally initials a “do not substitute,” shifting drug cost savings toward patients and plans but adding pharmacy recordkeeping duties; plans must provide cost and quality data to the state authority. Key details are missing here (the bill text cuts off in places and does not define the named authority or include earlier amendments referenced), so the exact scope and some implementation responsibilities remain unclear.