Florida Legislature Passes HB 19 Authorizing Importation of Prescription Drugs

Morgan Lewis
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Morgan Lewis

A handful of bills that comprised a healthcare reform package championed by Florida House Republicans are on their way to the governor’s desk where they’ll likely be signed into law. The result of an ambitious effort by lawmakers to overhaul how Florida regulates healthcare, the bills represent a striking departure from the current regulatory environment. Passed during the last week of the legislative session with a July 1, 2019, general effective date, providers will want to begin reviewing their policies in anticipation of the coming change.

Bills That Passed

A high priority bill (HB 19) passed by the legislature authorizing importation of prescription drugs calls for establishing three programs: (1) the Canadian Prescription Drug Importation Program (CPDP) within the Agency for Health Care Administration that will serve the state’s Medicaid program and Department of Corrections; (2) the International Prescription Drug Importation Program (IPDIP) within the Department of Business and Professional Regulation (DBPR) that allows for importation of prescription drugs from other countries and will serve all residents; and (3) a pilot program operated by the DBPR and the Florida Department of Health that is thin on detail. Both the CPDP and IPDIP programs will require federal approval prior to implementation.

Taking a cue from a 2018 US Department of Health and Human Services report that argues Certificate of Need (CON) programs closely correlate with escalating state healthcare costs, Florida passed legislation to overturn its CON program. Specifically, HB 21 will eliminate CON regulation of new general hospitals and tertiary healthcare services but not nursing homes, hospice, and intermediate care facilities for the developmentally disabled.

Legislation rounding out the reform package approved by lawmakers this week include measures to expand telehealth services and allow for registration of out-of-state telehealth providers to deliver services in the state (HB 23). Another bill (HB 843) addressing a number of healthcare issues notably allows for ambulatory surgical centers to admit and discharge patients within 24 hours (as opposed to the same working day under current law). Lastly, legislation encouraging “direct primary care” agreements (HB 7) and allowing such arrangements with dentists passed both Houses on May 2 with little time to spare.

One Notable Bill That Did Not Pass

Florida’s HB 1243 proposed to regulate hospital or physician practice’s acquisitions of another hospital or physician practice that results in a “material change” to the acquired hospital or practice through notification and reporting requirements to the state’s attorney general. It would have also imposed a $500,000 civil penalty for noncompliance. Although unanimously passed by the House on April 11, 2019, it died in the Senate with less than two weeks to go before the end of the session. Had it been enacted, HB 1243 would have provided a mechanism for the state’s Attorney General to determine whether a proposed transaction has antitrust implications and if warranted, “pursue action to prevent coercive monopolies from forming in the healthcare market.” Given this year’s momentum behind HB 1243 in the House, the legislation could be resurrected in a future session and/or generate a number of lookalike bills in other states.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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