Washington law bars drug makers from blocking many 340B drug deliveries and requires certain health centers and hospitals to report yearly program finances.
Drug makers and their agents may not block covered providers from getting discounted 340B medicines through contracted pharmacies or authorized locations, unless federal law prohibits receipt.
Washington federally qualified health centers and certain hospitals must report yearly 340B finances and how they use savings. After written notice, they have 30 days to fix a missed report before a fine may be issued.
The health care authority may charge yearly fees to manufacturers and covered providers that report 340B data. Provider fees are based on revenue and cannot cover more than 25 percent of reporting costs.
Covered providers may sue drug makers or their agents for violations, and the attorney general may bring an enforcement action. A court may order the violation to stop and impose civil penalties.
Drug makers and their agents may not block or limit covered providers from getting 340B drugs through contracted pharmacies or authorized locations. It covers 340B providers, pharmacies contracted to receive and dispense their drugs, and locations those providers authorize. The rule does not apply when federal law prohibits receipt of the drug. The rule applies to acquiring or delivering a 340B drug.
Certain covered providers must report yearly information about their 340B programs to the health care authority. The duty applies to Washington federally qualified health centers and hospitals that meet the listed federal definitions. Reports cover finances, use of savings, payments to pharmacies and other service providers, and patients served using sliding fees. The authority may fine a provider $1,000 per day for a late report, but must first give written notice and allow 30 days to correct it. Reports are due by April 1 after the provider's fiscal year and cover the previous fiscal year.
The health care authority may charge yearly fees to manufacturers and covered providers that report 340B data. Fees apply to manufacturers and covered providers required to report 340B data. Fees must cover the authority's data collection and reporting costs. Provider fees are tiered by gross operating revenue and cannot be set to cover more than 25 percent of those costs. Fee money may be spent only after an appropriation and only on collecting and reporting 340B data. Fees are paid annually in the form and manner set by the authority; spending from the fee account requires an appropriation.
Covered providers may sue drug makers, and the attorney general may bring enforcement actions. A covered entity may sue a manufacturer or its agent; the attorney general may sue in the state's name or for state residents. A court may order a violation to stop and award up to $5,000 per day for each violation, plus reasonable legal fees and costs. Each package of 340B drugs involved in a prohibited act counts as a separate violation. Federal law controls if it conflicts with these rules.
No hearings or votes scheduled.