The Department of Health proposed to amend regulations under FAC 64D-3 to add the coronavirus (COVID-19) to the list of reportable diseases and conditions. Comments and hearing requests are due July 21. 

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

An emergency rule of the Department of Health adopts regulations under FAC 64DER21-9 to require all health care practitioners and other enrolled coronavirus (COVID-19) vaccine providers to report to the online immunization information system within 72 hours the administration of any COVID-19 vaccine with an emergency use authorization from the FDA. The rule replaces a March 17, 2021, emergency rule on the same topic. The rule is effective June 11, 2021 and expires September 9, 2021.

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

The Board of Pharmacy issued a Final rule to repeal regulations under FAC 64B16-28 to remove outdated requirements for automated pharmacy systems in community pharmacies. The rule is effective June 24, 2021.  

Also in Florida, the Board of Pharmacy issued a Final rule to amend regulations under FAC 64B16-28 to increase to 120 days the maximum beyond-use date requirement for labels of customized patient medication packages. The rule also requires pharmacies using customized patient medication packages to have policies and procedures addressing patient medication regimens. The rule is effective June 24, 2021.

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

Effective October 1, 2021, any fee-for-service (FFS) claim submitted with a National Provider Identifier (NPI) for a provider not enrolled with Florida Medicaid will be denied, and the provider will not receive reimbursement for services. This includes claims that list a Referring, Ordering, Prescribing, or Attending (ROPA) provider. ROPA providers must be enrolled with Florida Medicaid following Title 42, Code of Federal Regulations, Section 455.410(b).  Starting October 1, 2021, claims will not be paid for any practitioner, group practice, facility, or pharmacy providing services to Florida Medicaid recipients based on a ROPA provider’s referral, order, prescription, or attending services, unless the ROPA provider identified by NPI on the FFS claim is actively enrolled with Florida Medicaid.

Florida Medicaid features a quick and easy, automated ROPA provider enrollment application on the Florida Medicaid Web Portal Enrollment Application Wizard page. Please visit the ROPA Provider Enrollment page of the Web Portal for updated information, including the recently created Unenrolled ROPA Provider List, ROPA Providers Frequently Asked Questions, and Quick Reference Guides on ROPA provider enrollment and claims billing.  Providers may call the Provider Services Contact Center at 1-800-289-7799, option 7, for billing assistance and option 4 for enrollment assistance.

Also in Florida, the Department of Business and Professional Regulation has proposed the below rules.

• Proposed rule of the Department of Business and Professional Regulation would amend regulations under FAC 61N-1 regarding drug and device labeling requirements to revise the references to federal regulations incorporated by reference. Comments and hearing requests are due June 28, 2021.
• Proposed rule of the Department of Business and Professional Regulation would amend regulations under FAC 61N-1 to update the application forms incorporated by reference for permits to be a diethyl ether manufacturer, distributor, dealer, or purchaser. Comments and hearing requests are due June 28, 2021.

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

The Florida Board of Pharmacy issued a proposed rule that would amend regulations under FAC 64B16-31 to update references to the incorporated application forms for pharmacy interns, consultant pharmacists, nuclear pharmacists, and pharmacy technicians. Comments and hearing requests are due June 14, 2021.

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

The Board of Pharmacy published a final rule to amend regulations under FAC 64B16-31 to update “smoking cessation” with “nicotine dependence” on the list of chronic health conditions for which a certified pharmacist may provide patient care services. The rule is effective April 29, 2021.

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

Florida Medicaid will continue to align with the Medicare vaccine administration rates. These rates were updated by the Centers for Medicare and Medicaid Services effective March 15, 2021. COVID-19 vaccines administered with a date of service on or after March 15, 2021, must be paid at the new rates. All guidance applies to both the fee-for-service and Statewide Medicaid Managed Care delivery systems unless otherwise stated.

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.

The Department of Business and Professional Regulation issued a notice to announce its intentions to amend regulations under FAC 61N-1 regarding drug and device labeling requirements to make technical revisions to conform to statutes. The Department will be accepting comments but no due date has been specified.

Also in Florida,  the Department of Health issued an emergency rule to adopt regulations under FAC 64DER21-4 to require all health care practitioners and other enrolled COVID-19 vaccine providers to report to the online immunization information system within 24 hours the administration of any COVID-19 vaccine with an emergency use authorization from the FDA. The rule replaces a December 15 rule on the same topic. The rule is effective March 15 and expires June 13, 2021.

Lastly, in Florida, the Department of Health issued an emergency rule to adopt regulations under FAC 64DER21-5 to authorize redistribution of the COVID vaccine between vaccine providers within the state. The rule requires providers to receive approval from the Florida Vaccines for Children and Adults Program and requires tracking of vaccine redistribution between enrolled providers. The rule is a readoption of a December 21 emergency rule. The rule is effective March 17 and expires June 15, 2021.

For more information, contact NACDS’ Leigh Knotts at 803-243-7207.