Illinois Enacts New Healthcare Legislation on 340B, Billing, and Privacy
Key Takeaways
- Illinois passed the Patient Access to Pharmacy Protection Act and sent it to the governor, which would prohibit pharmaceutical manufacturers from interfering with 340B drug acquisition by covered entities and contract pharmacies. The legislature also passed legislation requiring a comprehensive study of how the 340B program operates in Illinois, including financial data and manufacturer participation
- The legislature passed several new insurance coverage mandates for prescription hormone therapy, menopausal treatments, topical eye medication, and seizure detection devices. Illinois also passed the Transparency in Downcoding Act, which would prohibit fully automated downcoding and place limitations on the practice.
- Illinois lawmakers passed healthcare market oversight measures that would extend pre-transaction notice requirements to parent entities like private equity companies and update Certificate of Need processes. The legislature also approved patient billing protections that would prohibit hospital liens on primary residences for unpaid medical debt and establish a uniform financial assistance application.
- The legislature passed privacy protections for abortion medication that would exempt mifepristone and misoprostol from Prescription Monitoring Program reporting requirements. The bills would also require electronic health networks to prevent disclosure of abortion-related health information to out-of-state entities.
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Overview of Illinois General Assembly Healthcare Actions
The Illinois General Assembly closed out its regular session at the end of May, advancing several notable healthcare measures to Governor JB Pritzker (D), who will have 60 days after they are formally presented to sign or veto the bills.
What Changes Did Illinois Make to the 340B Drug Program?
The legislature passed some of the most significant 340B legislation this session.
Patient Access to Pharmacy Protection Act Provisions
The Patient Access to Pharmacy Protection Act (HB 2371) contains provisions to prohibit pharmaceutical manufacturers from interfering with the acquisition or delivery of 340B drugs by covered entities or contract pharmacies, while also establishing reporting requirements for 340B entities.
340B Program Study and Reporting Requirements
Lawmakers also enrolled HB 4327, which would require the Department of Insurance to conduct a comprehensive study of how 340B covered entities and pharmaceutical manufacturers participate in the 340B program, including financial and reimbursement data, use of savings, manufacturer participation, and the program's effects on patients, communities, and state health programs. The bill would also authorize the Department to request information from covered entities and pharmaceutical manufacturers for the study.
340B Drug Pricing Program
The 340B program is a federal drug pricing program that requires pharmaceutical manufacturers to provide outpatient drugs at significantly reduced prices to eligible healthcare organizations (called "covered entities") that serve low-income and uninsured patients. These covered entities can then use the savings to expand services to their communities.
Contract Pharmacies
Contract pharmacies are retail or specialty pharmacies that have agreements with 340B covered entities to dispense discounted 340B drugs on their behalf. This arrangement allows covered entities to serve patients who may not have access to an in-house pharmacy.
Downcoding
Downcoding is the practice by insurance companies of changing a healthcare provider's billing code to a lower-level service code, which results in reduced reimbursement. This can occur when insurers believe the original code doesn't match the service provided or documentation submitted.
Certificate of Need (CON)
Certificate of Need is a regulatory process that requires healthcare facilities to obtain state approval before making major capital expenditures, expanding services, or acquiring expensive medical equipment. The goal is to prevent unnecessary duplication of healthcare services and control costs.
New Insurance Mandates and Coverage Requirements in Illinois
Expanded Coverage for Prescription and Medical Treatments
Illinois lawmakers also enrolled several insurance mandates to establish coverage requirements for prescription hormone therapy, treatments related to menopausal and perimenopausal symptoms or conditions, topical eye medication, rehabilitative services for the treatment of stuttering, and seizure detection devices, as well as bills to update existing mandates for cancer screenings and mammograms.
Regulation of Insurer Practices and Downcoding
The legislature also targeted certain insurer practices, including downcoding, with the Transparency in Downcoding Act (SB 3114), which would prohibit fully automated downcoding and impose several other limitations on the practice.
Healthcare Market Oversight and Patient Financial Protections
Oversight of Healthcare Transactions and Certificate of Need Changes
The legislature also advanced several healthcare market oversight measures, including HB 5000, which would extend pre-transaction notice requirements to parent entities, including private equity companies, and HB 4757, which would make changes to Certificate of Need processes.
Patient Billing and Financial Assistance Reforms
Lawmakers also approved patient billing and financial assistance measures with HB 4461, HB 5390, and HB 4698, which would prohibit hospital liens on primary residences for unpaid medical debt, establish a uniform financial assistance application, and require fee-splitting disclosure notices, respectively.
How Is Illinois Protecting Patient and Provider Privacy for Abortion Medication?
In addition, Illinois enrolled legislation (HB 4834 & HB 5295) seeking to protect patient and provider privacy related to abortion medication. The bills would exempt mifepristone and misoprostol, among other drugs, from the reporting requirements of the Prescription Monitoring Program, and require electronic health networks to prevent the disclosure of a patient's coded private health care information, including information related to abortion and abortion medication services, to entities located outside the state.
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What does Illinois HB 2371 do for 340B covered entities and contract pharmacies?
Illinois HB 2371, the Patient Access to Pharmacy Protection Act, prohibits pharmaceutical manufacturers from interfering with the acquisition or delivery of 340B drugs by covered entities or contract pharmacies. The bill also establishes reporting requirements for 340B entities and was passed by the Illinois General Assembly in May 2024.
Does Illinois require a study of the 340B drug pricing program?
Yes, Illinois HB 4327 would require the Department of Insurance to conduct a comprehensive study of how 340B covered entities and pharmaceutical manufacturers participate in the 340B program. The study would include financial and reimbursement data, use of savings, manufacturer participation, and the program's effects on patients, communities, and state health programs.
What is the Illinois Transparency in Downcoding Act and what does it prohibit?
The Transparency in Downcoding Act (Illinois SB 3114) would prohibit fully automated downcoding by insurers and impose several other limitations on the practice. The bill was passed by the Illinois legislature during the May 2024 session.
Does Illinois HB 5000 apply to private equity companies in healthcare transactions?
Yes, Illinois HB 5000 would extend pre-transaction notice requirements to parent entities, including private equity companies. The bill was advanced by the Illinois legislature as part of several healthcare market oversight measures during the May 2024 session.
What protections does Illinois legislation provide for abortion medication privacy?
Illinois passed legislation (HB 4834 and HB 5295) that would exempt mifepristone and misoprostol from Prescription Monitoring Program reporting requirements. The bills would also require electronic health networks to prevent disclosure of patients' coded private health care information related to abortion and abortion medication services to entities located outside the state.