Institutional Sustainability and Innovation

This bill updates Pennsylvania's emergency medical services laws to clarify rules for patient transport and insurance coverage. It defines "receiving facilities" as places where patients need further medical assessment after an ambulance response and requires protocols for handling behavioral health and substance use crises before transport. The legislation also mandates that health insurers cover emergency service payments when patients are treated and transported to these designated facilities, while simultaneously removing an outdated regulation regarding covered services.

HB 2162 amends Pennsylvania's Wholesale Prescription Drug Distributors License Act to clarify definitions and license application requirements. It specifically defines "virtual manufacturer" as a business that doesn't physically handle drugs in Pennsylvania but has FDA approval processes underway, including submitting or planning to submit FDA applications within 12 months. The bill adds new application requirements: manufacturers of unapproved drugs must state they've applied to or plan to apply to the FDA within 12 months, and virtual manufacturers must provide similar documentation. Crucially, it states the state department cannot require FDA approval as a condition for licensure. This directly affects drug distributors operating under the "virtual manufacturer" model and unapproved drug manufacturers seeking state licenses.

HB 1460, the Health System Protection Act, requires health care entities (like hospitals and clinics) and certain investors (such as private equity firms) to obtain pre-approval from Pennsylvania's Department of Health and Attorney General before completing major transactions. This applies to sales of assets worth $10 million or more, ownership changes, or large financial distributions that could affect competition, costs, or access to care. The law prohibits transactions deemed "against the public interest," such as those reducing competition, raising prices, or limiting services in rural or low-income areas. Health care entities must either file a notification with a waiting period or get written approval before proceeding.

Senate Bill 1360, titled the "So Every BODY Can Move Act," requires health insurance policies in Pennsylvania to cover prostheses and custom orthotics for enrollees. The bill mandates that insurers provide these devices in a nondiscriminatory manner and allows patients to choose their own licensed providers for determination and prescription. Additionally, the legislation assigns duties to the Insurance Department and the Department of Human Services to oversee financial requirements, issue necessary notices, and enforce compliance with the new coverage rules.

This bill creates the Biobonds Innovation Fund to provide low-interest loans and loan guarantees for companies and research institutions conducting clinical trials for drugs or medical devices in Pennsylvania. The program requires recipients to maintain a physical presence in the state and conduct the majority of their research there while receiving financial support. Money for the fund will come from state appropriations, bond proceeds, loan repayments, and interest earnings, with the Department of Community and Economic Development managing the application and oversight process.