Prohibit Restrictions on 340B Drugs

Under the federal 340B drug pricing program (340B program), a covered entity, including certain hospitals, programs, and federally qualified health centers (covered entity), that serves patients with low income receives discounted outpatient drugs (340B drugs) from manufacturers that participate in the federal medicaid and medicare programs. Unless the receipt of 340B drugs is prohibited by the federal department of health and human services, the act prohibits a manufacturer, third-party logistics provider, or repackager in this state, or an agent, contractor, or affiliate of those entities, including an entity that collects or processes health information, from directly or indirectly denying, restricting, prohibiting, discriminating against, or otherwise limiting the acquisition of a 340B drug by, or delivery of a 340B drug to, a covered entity, a pharmacy contracted with a covered entity, or a location otherwise authorized by a covered entity to receive and dispense 340B drugs.

The act also prohibits a manufacturer from directly or indirectly requiring a covered entity, a pharmacy contracted with a covered entity, or any other location authorized to receive 340B drugs by a covered entity to submit any health information, claims or utilization data, or other specified data that does not relate to a claim submitted to certain federal health care programs, unless the data is voluntarily furnished or required to be furnished under federal law.

The act defines "340B savings" as the difference between the aggregated market rate costs and the aggregated acquisition costs for 340 B drugs. Certain hospital covered entities are prohibited from using 340B savings for certain purposes.

A violation of the prohibitions in the act is an unfair or deceptive trade practice under the "Colorado Consumer Protection Act" (protection act), and the violator is subject to the enforcement provisions and penalties contained in the protection act. In addition, a person regulated by the state board of pharmacy (pharmacy board) that violates the provisions of the protection act may be subject to discipline by the pharmacy board against the person's license, certification, or registration, as well as other penalties.

The act requires certain hospital covered entities to annually report to the department of health care policy and financing certain information concerning 340B savings and costs relating to providing charity care.

(Note: This summary applies to this bill as enacted.)