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. The amendment specifies changes to the reimbursement ....

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Medicaid

RULE NO.:RULE TITLE:

59G-4.251Prescribed 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. 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.

SUBJECT AREA TO BE ADDRESSED: Prescribed Drugs Payment Methodology.

An additional area to be addressed during the workshop will be the potential regulatory impact Rule 59G-4.251, F.A.C., will have as provided for under sections 120.54 and 120.541, Florida Statutes.

RULEMAKING AUTHORITY: 409.919 FS.

LAW IMPLEMENTED: 409.906, 409.908, 409.912 FS.

A RULE DEVELOPMENT WORKSHOP WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: August 18, 2021, 10:30-11:00 a.m.

PLACE: The Agency is offering both a remote and an in-person option to attend the workshop at the Agency for Health Care Administration, 2727 Mahan Drive, Tallahassee, Florida 32308-5407.

Remote Listeners: Attendees may register for the workshop at: https://attendee.gotowebinar.com/register/3757434070049420812. 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 DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: [e-mail]. Please note that a preliminary draft of the reference material, if available, will be posted prior to the workshop at http://ahca.myflorida.com/medicaid/review/fee_schedules.shtml. Official comments to be entered into the rule record will be received until 5:00 p.m., August 19, 2021. Comments may be e-mailed to [e-mail]. For general inquiries and questions about the rule, please contact [e-mail].

 

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT 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).

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

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

(ed) 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).

45. 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.

(910) 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.

(1011) 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,________.