The purpose of the amendment to Rule 59G-4.251, Florida Administrative Code (F.A.C.), is to update methodology factors contained in the rule, and include definitions.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Medicaid

RULE NO.: RULE TITLE:

59G-4.251: Prescribed Drugs Reimbursement Methodology

PURPOSE AND EFFECT: The purpose of the amendment to Rule 59G-4.251, Florida Administrative Code (F.A.C.), is to update methodology factors contained in the rule, and include definitions.

SUMMARY: The amendment specifies changes to the reimbursement calculation for physician administered drugs, removes obsolete or duplicative language, and adds the definition of a new term referenced in the rule.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: A checklist was prepared by the Agency to determine the need for a SERC. Based on this information at the time of the analysis and pursuant to section 120.541, Florida Statutes, (F.S.) the rule will not require legislative ratification.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 409.919 FS.

LAW IMPLEMENTED: 409.906, 409.908, 409.912 FS.

A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: October 28, 2021 from 2:30 p.m. to 3:00 p.m.

PLACE: The Agency is offering both a remote and an in-person option to attend the hearing at the Agency for Health Care Administration, 2727 Mahan Drive, Tallahassee, Florida 32308-5407. Remote Listeners: Attendees may register for the hearing at: https://attendee.gotowebinar.com/register/8178491161800782864. After registering, a confirmation email will be received containing information about joining the webinar, and opportunities to offer comments and questions will be available.

Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 7 days before the workshop/meeting by contacting: [e-mail]. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: [e-mail].

Please note that a preliminary draft of the reference material, if available, will be posted prior to the hearing at http://ahca.myflorida.com/Medicaid/review/index.shtml. Official comments to be entered into the rule record will be received until 5:00 p.m. on October 29, 2021 and may be e-mailed to [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

59G-4.251 Prescribed Drugs Reimbursement Methodology.

(1) This rule applies to all prescribed drug service providers enrolled in the Florida Medicaid program

that provide services under the fee-for-service delivery system in accordance with Rrule 59G-4.250, Florida Administrative Code, (F.A.C.).

(2) Definitions.

(a) Actual Acquisition Cost for Prescribed Drugs – (AAC) – The National Average Drug Acquisition Cost (NADAC) will be used for the AAC, when available. If the NADAC is unavailable, the AAC will be equal to the wholesaler acquisition cost.

(b) Average Sales Price – (ASP) – The average sales price as reported by prescribed drug manufacturers to the Centers for Medicare and Medicaid Services (CMS).

(c)(b) State Maximum Allowable Cost – (SMAC) – The maximum allowable unit cost established by the state; SMAC may be manually set.

(d)(c) Usual and Customary Charge ‒ (U&C Charge) ‒ The average charge to all other customers in any quarter for the same drug, quantity, and strength.

(e)(d) Wholesaler Acquisition Cost ‒ (WAC) – The cost wholesalers pay for a prescribed drug.

(3) Reimbursement Methodology.

(a) Florida Medicaid reimburses for drugs dispensed by an approved Florida Medicaid pharmacy provider, or a provider enrolled as a dispensing practitioner, in an amount not to exceed the lesser of:

1. The AAC plus a professional dispensing fee (PDF) of $10.24.

2. The WAC plus a PDF of $10.24.

3. The SMAC plus a PDF of $10.24.

4. The provider’s U&C Charge.

(b) The above reimbursement methodology applies to all of the following:

1. Covered outpatient drugs dispensed by a retail community pharmacy.

2. Specialty drugs dispensed primarily through the mail.

3. Drugs not purchased pursuant to the 340B program by a covered entity, as defined in section 340B(a)(4) of the federal Public Health Service Act.

4. Drugs acquired at a nominal price, except for drugs purchased through the 340B program or the Federal Supply Schedule (FSS).

4 5. Drugs dispensed in an institutional or long-term care pharmacy, when not included as part of the floor stock contained in the institution’s cost report.

(4) Florida Medicaid utilizes the actual purchased drug price plus a PDF in the reimbursement methodology for drugs acquired via the Federal Supply ScheduleFSS.

(5) Florida Medicaid utilizes the actual purchased drug price plus a PDF in the reimbursement methodology for drugs acquired via nominal price.

(6) Florida Medicaid reimburses for drugs purchased under the 340B program at the actual purchased drug price, which cannot exceed the 340B ceiling price, plus a dispensing fee of $10.24. This provision only applies to covered entities, Indian Health Services, tribal organizations, urban Indian pharmacies, and federally qualified health centers that dispense drugs purchased at prices authorized under section 340B of the Public Health Services Act.

(7) Florida Medicaid reimburses for clotting factor to the vendor(s) awarded the state’s hemophilia contract(s) at the negotiated price.

(8) Florida Medicaid reimburses for prescribed drugs administered by a licensed practitioner in an office setting at 106 percent of ASP, as provided by CMS quarterly in the format of drug pricing files, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/

index.html; or, when no ASP rate is available, at WAC.

(9) Florida Medicaid reimburses for prescribed drugs administered in an outpatient facility at WAC.

(9)(10) Florida Medicaid reimburses for prescribed drugs purchased under the 340B program administered in an outpatient facility at an amount not to exceed the 340B ceiling price.

(10)(11) Florida Medicaid does not reimburse for investigational or experimental drugs.

(11) The rule is in effect for five years from its effective date.

Rulemaking Authority 409.919 FS. Law Implemented 409.906, 409.908, 409.912 FS. History–New 1-28-09, Amended 8-23-09, 5-20-12, 6-2-16, 3-29-18,________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Kelly Rubin

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Simone Marstiller

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: September 21, 2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 4, 2021