Pennsylvania bill would set payment and access rules for 340B drugs

The bill would set minimum payments for certain 340B drugs and require a specific way to identify them in Medicaid claims. The payment rule covers drug benefit managers, insurers, and their agents when they pay participating providers or their contract pharmacies for 340B drugs. Payments would be based on national average drug acquisition cost when available, or wholesale acquisition cost when it is not. A covered entity could voluntarily waive the payment protection, but no one could pressure it to do so. For Medicaid drug payments, the claims method would identify 340B drugs and keep their use data out of specified reports and rebate requests. The bill would take effect immediately if enacted.

The bill would limit how Medicaid managed care plans handle 340B drugs and require the department to maintain outpatient drug coverage through those plans. These rules cover Medicaid managed care organizations, which include entities managing prescription drug benefits for them. Plans could not block lawful dispensing or claims, refuse payment for a drug already dispensed, set distance limits, or demand program data except as needed to comply with federal law. The department's coverage duty would last as long as a Medicaid managed care organization delivers any medical assistance service.

The department would provide federal grant money to certain sexually transmitted disease clinics for testing and treatment. Clinics must receive department support under a participating provider agreement funded through the federal sexually transmitted disease program. The bill specifies grants of at least $500 from federal funding for the named disease prevention program. The first grants would be due within 90 days after this requirement takes effect. Each new or renewed clinic award would also include a grant.

The bill would limit when drug makers and delivery companies can interfere with access to 340B drugs. The restrictions cover manufacturers, their agents or affiliates, and third-party delivery providers, and protect participating providers and their contract pharmacies. The restrictions would not apply when federal law prohibits the provider or pharmacy from acquiring or receiving the drug. Drug makers could require claims or use data only when federal law requires it. The bill would take effect immediately if enacted.

The bill would allow state agencies to investigate violations and impose penalties, and providers or contract pharmacies could ask a court to stop violations. The Insurance Department would enforce payment and Medicaid managed care rules; the Attorney General and Human Services Department would enforce drug maker access rules. Drug makers or their agents could face a $50,000 penalty for each violation, with total penalties capped at $10 million per year; each affected package counts separately. For certain payment or plan violations, penalties would be $1,000 per wrongly handled claim or, for distance limits, $1,000 per day for each excluded contract pharmacy. A business that does not correct a violation within 30 days after written notice could be suspended from operating in Pennsylvania. For covered violations, a business that fails to correct the problem within 30 days after written notice could be suspended from doing business in Pennsylvania.