| AI Summary |
Senate Bill 25-071, known as the "Prohibit Restrictions on 340B Drugs," was introduced in the Colorado General Assembly to safeguard the federal 340B Drug Pricing Program within the state. This program enables covered entities, such as certain hospitals and federally qualified health centers, to acquire discounted outpatient medications, thereby enhancing healthcare access for low-income patients.
Key provisions of the bill include:
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Prohibition of Restrictions: The bill forbids manufacturers, wholesalers, third-party logistics providers, repackagers, and their affiliates from denying, restricting, or limiting the acquisition or delivery of 340B drugs to covered entities or their contracted pharmacies.
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Data Submission Limitations: Manufacturers are prohibited from requiring covered entities or their pharmacies to submit health information or claims data unrelated to federal healthcare program claims, unless mandated by federal law.
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Enforcement and Penalties: Violations are classified as unfair or deceptive trade practices under the Colorado Consumer Protection Act, subjecting offenders to enforcement actions and penalties. The Attorney General and affected businesses are empowered to investigate and enforce these provisions.
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Transparency Requirements: Hospitals participating as covered entities must annually disclose on their public websites the estimated financial benefits received from the 340B program and detail how these savings are utilized.
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| Summary |
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 bill prohibits a
manufacturer, wholesaler, 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 bill 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.
A violation of the prohibitions in the bill is an unfair or deceptive
trade practice under the Colorado Consumer Protection Act (act), and
the violator is subject to the enforcement provisions and penalties
contained in that act. The attorney general may investigate and enforce
the provisions of the bill, as well as a business harmed by a violation of
the provisions of the bill. In addition, a person regulated by the state
board of pharmacy (pharmacy board) that violates the provisions of the
bill may be subject to discipline by the pharmacy board against the
person's license, certification, or registration, as well as other penalties.
The bill requires a covered entity that is a hospital to annually post
on its public-facing website information concerning the annual, estimated,
aggregate financial benefit to the hospital covered entity resulting from
its ability to acquire pharmaceuticals at a discount through the 340B
program and a description of how the hospital covered entity uses savings
from participation in the 340B program.
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