Prescription Drug Transparency and Affordability

Summary#

This bill would change three federal laws to increase oversight of companies that manage pharmacy benefits (often called pharmacy benefit managers or PBMs). It requires that, for plan years starting 30 months after the law is passed, contracts entered into or renewed must allow PBMs and other relevant entities to share data needed for reporting. PBMs must give group health plans regular reports (at least every 6 months, or quarterly if requested) in plain language and machine-readable form. Reports must include detailed, drug-level and therapeutic-class information such as contracted compensation paid to PBMs and pharmacies, the difference between amounts paid, drug identifiers, dispensing channel, brand or generic status and listed costs, counts of claims and dosage units, net price after rebates and discounts, total out-of-pocket spending by participants, amounts received by plans and PBMs in rebates or fees, and, to the extent feasible, copayment assistance amounts. Plans must be able to provide summary documents to participants and, on request, specific claims-level information for that participant. The bill includes privacy limits requiring consistency with HIPAA rules and that reports contain only summary health information. The Secretary (of Health and Human Services, with enforcement authority described) must set a standard report format and issue necessary regulations within 18 months. Failure to comply can trigger civil monetary penalties ($10,000 per day for non-disclosure and up to $100,000 for knowingly providing false information). The bill also allows plans sponsored by large employers to opt in to receive more-detailed reports and directs the Secretary to define limited-report forms to prevent anti-competitive behavior when plans are affiliated with drug supply entities.

What it means for you#

• If you manage or sponsor a group health plan or are a health insurer, your contracts must allow PBMs and related entities to share information needed for the required reports. You must give yearly written notice to participants about the reporting requirement. You must provide a summary document to participants on request and claims-level information for a participant's own claim on request. You may request quarterly reports from PBMs under the same terms as semiannual reports.
• If you are a PBM or an entity that provides pharmacy benefit services, you must prepare and deliver detailed reports to the group health plans you serve, in the required formats, while following HIPAA and other privacy rules.
• If you are a plan participant or beneficiary, you can request the participant-facing summary document and, on request, claims-level information for your own prescriptions.
• All parties must protect privacy: reports are limited to summary health information and must follow HIPAA and other applicable privacy laws.
• The Secretary will have access to reports and authority to enforce the law.

Expenses#

No publicly available information on estimated federal budget costs or private-sector compliance costs in the bill text or metadata. The bill does specify administrative requirements and penalties that could affect costs: reports must be delivered at least every 6 months (quarterly if requested); the Secretary must issue a standard reporting format and additional regulations within 18 months; the effective date for reporting and contract rules is 30 months after enactment. Civil monetary penalties in the text are $10,000 per day for failures to provide required information and up to $100,000 for each item of knowingly false information. The bill does not include numeric estimates of implementation or enforcement costs.

Proponents' View#

No publicly available information.

Opponents' View#

No publicly available information.