ISSUE: Are different procedures necessary when a pharmacist substitutes a biologic/biosimilar medicine in the place of a brand name biologic medicine.

DISCUSSION: With the enactment of the Affordable Care Act in March 2010, federal law was updated to allow for the U.S. Food and Drug Administration (FDA) to oversee an abbreviated pathway for the approval of biologics that are biosimilar to products that are already approved by the FDA. This has prompted the FDA to begin a complex process to establish guidelines for the approval of biosimilar and interchangeable biosimilar medicines in the U.S. The ability to substitute biosimilar medicines will result in substantial savings to individual patients, as well as to reduce the overall cost of health care in the State of Florida.

POSITION: The Florida Retail Federation is supportive of any legislation that will make the substitution of biosimilar medicines by a dispensing pharmacist as simple as the current procedures for substituting generic chemical drugs for brand name drugs.

RELATED BILLS:

HB 365 - Hudson
SB 732 - Grimsley

Recent Developments

(5/3/2013) HB 365 passed, allowing the substitution of approved biosimilar medications, and removing the notification requirement in the bill that was originally filed.


ISSUE: Should Florida increase the pharmacy technician ratio.

DISCUSSION: Pharmacy technicians are trained individuals who assist pharmacists in dispensing medications by doing routine pharmacy tasks such as taking customer phone calls, creating labels, and taking payment for prescriptions. Pharmacy technicians must be registered with the Florida Board of Pharmacy and complete a board approved training program. Additionally, in order to renew their registration, pharmacy technicians must complete twenty hours of continuing education biennially. The use of pharmacy technicians allows pharmacists to delegate simple tasks in order to focus more of their time on patient care.

Seventeen states do not place restrictions on the number of pharmacy technicians that can be supervised by a pharmacist. These states recognize that pharmacy technicians are trained professionals who are an integral part of the pharmacy workforce. Currently, much of a pharmacists’ time is spent performing non-judgmental functions that can be safely performed by pharmacy technicians. Studies have shown that when a pharmacist’s time is freed up to perform judgmental tasks such as reviewing prescriptions, assessing drug therapies, resolving clinical conflicts, contacting physicians and counseling patients, patient care is significantly improved and errors reduced.

POSITION: The Florida Retail Federation supports expanding the number of registered pharmacy technicians a pharmacist can supervise.

RELATED BILLS:

HB 671 - Hutson
SB 818 - Garcia

Recent Developments:

(4/19/2013) HB 671, increases the pharmacy tech ratio to 6:1. The bill passed the House floor this week.


ISSUE: Should Medicaid providers be given proper notification in advance of changes made to the Medicaid Provider Handbook.

DISCUSSION: Chapter 409, Florida Statutes, governs the way the state handles Medicaid. It allows for the Agency for Health Care Administration to set forth the methodologies by which it will reimburse Medicaid providers. Those methodologies, which include reimbursement methods and fee schedules, are published in the agency’s Florida Medicaid Provider General Handbook, Coverage and Limitations Handbooks, and Reimbursement Handbooks. The authority granted to the agency to implement provider reimbursement methodologies is so broad that it has allowed for a system to develop in which the provider community has little or no input. The agency is not required to hold public workshops on changes to the handbooks, and they may apply changes retroactively, applying retroactive changes even to reimbursement rates. Such measures create confusion and instability in the industry that cares for Medicaid recipients.

POSITION: The Florida Retail Federation supports giving Medicaid providers advance notice of changes to claims submissions and rate reductions, as well as giving providers adequate opportunity for input prior to rule changes.


ISSUE: Should local governments regulate the operation and practice of pharmacies.

DISCUSSION: In the past several years, Florida has struggled with the growing problem of prescription drug abuse and trafficking. In the 2011 Legislative Session, a sweeping reform bill was passed bringing stricter regulation to the entire prescription drug industry. From manufacturers to distributors to community pharmacies, controlled substances will be tracked and reported into the Prescription Drug Monitoring Program. Additionally, physicians will no longer be able to dispense controlled substances. With all of the reforms that were implemented at the state level, Florida will begin to see a drastic drop in the illicit pill mill industry. During the time that the Legislature was struggling with exactly how to address the problem, local governments were becoming desperate to control this very real threat to their communities. They began to pass strict local ordinances in an effort to mitigate the problem. However, now that there is very strict regulation from the state, these local ordinances may not only be unnecessary, they may be in conflict with the state regulation. Because the practice of healthcare already operates in a highly regulated environment, streamlining is crucial to ensuring compliance. There should be one ultimate authority responsible for the regulation of pharmacies and pharmacists.

POSITION: The Florida Retail Federation supports restricting the regulation of the Practice of Pharmacy to the state level. The Florida Board of Pharmacy, which operates under the Department of Health, is best equipped to oversee regulatory issues related to the practice of pharmacy.

RELATED BILLS:

SB 1192 - Grimsley
SB 966 - Bean

Recent Developments:

(4/19/2013) SB 966 includes language that establishes a preemption to the state for the regulation of pharmacies and pharmacist. This bill passed the Senate Appropriations Committee this week.

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Florida Healthcare Affordability Summit

Legislative Update 5-3-13

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