The purpose is to repeal outdated sections, update language to be consistent with statute and address requirements of the AIDS Drug Assistance Program (ADAP).

 

DEPARTMENT OF HEALTH

Division of Disease Control

RULE NOS.:RULE TITLES:

64D-4.001Purpose

64D-4.002Definitions

64D-4.003Eligibility and Documentation Requirements

64D-4.004Determined Eligible or Ineligible

64D-4.005Re-Determination and Continued Eligibility

64D-4.006Rights and Responsibilities

64D-4.007AIDS Drug Assistance Program (ADAP)

PURPOSE AND EFFECT: The purpose is to repeal outdated sections, update language to be consistent with statute and address requirements of the AIDS Drug Assistance Program (ADAP).

SUMMARY: This rule describes the client eligibility requirements and adopts required forms for enrollment into HIV/AIDS patient care programs.

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: This rule defines the requirements for clients seeking assistance from HIV/AIDS patient care programs. Therefore, this rulemaking will not have an adverse impact or regulatory costs in excess of $1 million within five years as established in Section 120.541(2)(a), F.S.

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: 381.0011(2), 381.003(2) FS.

LAW IMPLEMENTED: 381.001, 381.0011, 381.003(1)(b) FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Joe May, HIV/AIDS Section, Florida Department of Health, Bin #A09, 4052 Bald Cypress Way, Tallahassee, FL 32399-1715, telephone number [phone]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64D-4.001 Purpose.

Rulemaking Authority 381.0011(2), (3), 381.003 FS. Law Implemented 381.001, 381.003(1) FS. History–New 1-23-07, Repealed________.

 

64D-4.002 Definitions.

For the purpose of this rule chapter, the words and phrases listed below are defined as follows in the following manner:

(1) “AIDS Drug Assistance Program (ADAP)” – The Ryan White HIV Program codified by Title XXVI of the Public Health Services Act, as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009. ADAP provides HIV/AIDS medications to persons in need by either providing the medications directly, providing access through pharmacies, or providing health insurance continuation support for policies that include coverage for HIV/AIDS drugs.

(2) “ADAP Premium Plus Insurance Program (APPIP)” – a component of ADAP designed to assist eligible clients who have insurance and need assistance with premiums, copays, and/or deductibles.

(1) “Allowable Services” mean the HIV/AIDS patient care services listed in the current federal Glossary of Services as referenced by the Health Resources and Services Administration in the Ryan White CARE Act Title II Manual (2002); the eligible activities as governed by 24 CFR Part 574.300 (b)(1) and (6) by the U. S. Department of Federal Housing and Urban Development (HUD), (effective April 11, 1994); and, the list of HIV/AIDS patient care services administered by the Department of Health, Bureau of HIV/AIDS, all of which are incorporated by reference and available upon request from the Department of Health, Bureau of HIV/AIDS at 4052 Bald Cypress Way, Bin A09, Tallahassee, FL 32399-1715. Allowable Services are based on availability, accessibility and funding of the service.

(2) “Application” means the application, instructions and information in the brochure titled the Application and Eligibility Requirements (#DH 150-884, effective 1-23-07), which is incorporated by reference. The Application and Eligibility Requirements brochure can be obtained at any Florida county health department.

(3) “Applicant” means an individual who has submitted or is in process of preparing and submitting the application.

(4) “Bureau” means the Department of Health, Bureau of HIV/AIDS.

(5) “Client” means an applicant who has been determined eligible.

(6) “Department” means the Florida Department of Health.

(7) “Eligible” means approved by the Department to receive allowable services.

(8) “Eligibility Staff” means personnel authorized by the Department to determine eligibility.

(3)(9) “Federal Poverty Level” – (FPL) means the poverty income guidelines levels (effective January 2014 2009) as published by the U.S. Department of Health and Human Services (HHS), Federal Office of Management and Budget (OMB), which is incorporated by reference and available at_______. The federal poverty guidelines are located on the Department of Health, Bureau of HIV/AIDS website at: http://www.doh.state.fl.us/disease_ctrl/aids/care/EligibilityAdRule.html and the U.S. Department of Health and Human Services website at: http://aspe.hhs.gov/poverty/09poverty.shtml or can be obtained at any Florida county health department.

(4)(10) “Household Income” – means income from all sources received by the applicant, the applicant’s spouse (if married), and other adult persons living in the home, if they are included in the household size as defined in subsection (5) below 64D-4.002(11), F.A.C.

(5)(11) “Household Size” – means the number of persons in an applicant’s household whose income is counted for purposes of determining the Federal Poverty Level defined in subsection 64D-4.002(9), F.A.C. The number counted in household size includes the applicant, the applicant’s spouse (if married), and any adults such as parents, adult siblings, adult children, significant others and partners who live with the applicant and meet one or more of the following:

(a) Claims the applicant as a dependent on a tax return, or.

(b) Claims the applicant on a health insurance policy. This does not apply to life insurance when the applicant is claimed as the beneficiary.

(b)(c) Have Has legal custody or other legal arrangement or guardianship of the applicant.

(d) Has commingled funds with the applicant, such as banking accounts, savings accounts, business, mortgage agreement or other personal finances.

(6)(12) “HIV/AIDS Patient Care Programs” means the:

(a) Ryan White Part B Title II Consortia Program,.

(b) Ryan White Part B Title II AIDS Drug Assistance Program,.

(c) ADAP Premium Plus Insurance Program, Ryan White Title II AIDS Insurance Continuation Program.

(d) State Housing Opportunities for Persons with AIDS (HOPWA) Program, and

(e) HIV/AIDS pPatient cCare pPrograms provided by the patient care networks and county health departments as administered by the Florida Department of Health, Bureau of Communicable Diseases HIV/AIDS.

(7)(13) “Low Income” – modified adjusted means a gross household income at or below 400 percent % of the Federal Poverty Level. For HOPWA, low income means 80 percent of a county’s medium income, which can be found at http://www.huduser.org/portal/datasets/il/il14/index_il2014.html. FPL in accordance with subsection 64D-4.002(9), F.A.C.

(14) “Program Qualifications” are program specific requirements to qualify for enrollment in the following single service programs, after eligibility has been approved:

(a) Ryan White Title II AIDS Drug Assistance Program.

(b) Ryan White Title II AIDS Insurance Continuation Program.

(c) State Housing Opportunities for Persons with AIDS.

(15) “Verification” means to confirm the accuracy of information through sources other than a self-declaratory statement of the individual originally supplying the information.

Rulemaking Authority 381.0011(2), (3), 381.003(2) FS. Law Implemented 381.001, 381.0011, 381.003(1)(b) FS. History–New 1-23-07, Amended 8-31-07, 3-21-08, 10-27-08, 3-30-09,_________.

 

64D-4.003 Eligibility and Documentation Requirements.

Only an individual seeking assistance, or their court-appointed representative, legal representative, or legal guardian seeking assistance on their behalf, may apply for services.

An applicant for HIV/AIDS patient care programs is eligible to be linked to services based on a preliminary positive HIV test result from a test approved by the Food and Drug Administration to determine the presence of HIV infection. For this rule, linkage to service is defined as referring the applicant to eligibility determination and counseling services and the scheduling of medical appointments. To receive services from an HIV/AIDS patient care program an applicant. The applicant eligibility and documentation requirements to receive allowable services from the HIV/AIDS Patient Care Programs include the following:

(1) Must have a positive test result from a test approved by the Food and Drug Administration to determine the presence of HIV infection. documentation of a medical diagnosis of HIV disease with a laboratory test documenting confirmed HIV infection from one of the following:

(a) A confirmed positive HIV antibody test result (Reactive EIA/ELISA screening test confirmed by Western Blot or Immunofluorescense Assay (IFA) or Nucleic Acid Testing (Aptima) by blood, oral fluid or urine.

(b) A positive HIV direct viral test such as PCR or P24 antigen.

(c) A positive viral culture result.

(d) A detectable HIV-viral load or viral resistance test result.

(2) Must be living in Florida.

(3) Cannot be receiving the same services or be eligible to participate in local, state, or federal programs where the same type service is provided or available. This requirement does not preclude an individual from receiving allowable services not provided or available by other local, state or federal programs, or pending a determination of eligibility from other local, state or federal programs.

(4) Must have low-income.

(5) Must submit a completed and signed Application to Receive Allowable Services for HIV/AIDS Patient Care Programs, DH 150-884 (08/2014), which is incorporated by reference and available at __________, be willing to cooperate with eligibility staff during the eligibility process, and sign and comply with the Rights and Responsibilities stated established in the application.

(6) Must not be currently institutionalized in a prison, jail, nursing home, hospital, or other entity that is legally required to provide medical care and prescription medications submit a completed application in accordance with the application instructions.

(7) Must have their eligibility recertified every six month or at shorter intervals if the client’s income or other factors change before the six month period. The client must report any changes in his/her situation which impacts his/her eligibility status to the eligibility staff no later than 10 days after it is known include all requested information and documentation with the application or during the eligibility process. Failure to provide the requested information may delay or prevent a determination of eligibility.

Rulemaking Authority 381.0011(2), (3), 381.003(2) FS. Law Implemented 381.001, 381.0011, 381.003(1)(b) FS. History–New 1-23-07, Amended 10-27-08,_________.

 

64D-4.004 Determined Eligible or Ineligible.

Rulemaking Authority 381.0011(2), (3), 381.003 FS. Law Implemented 381.001, 381.003(1) FS. History–New 1-23-07, Repealed_________.

 

64D-4.005 Re-Determination and Continued Eligibility.

Rulemaking Authority 381.0011(2), (3), 381.003 FS. Law Implemented 381.001, 381.003(1) FS. History–New 1-23-07, Repealed_________.

 

64D-4.006 Rights and Responsibilities.

Rulemaking Authority 381.0011(2), (3), 381.003 FS. Law Implemented 381.001, 381.003(1) FS. History–New 1-23-07, Repealed_________.

 

64D-4.007 AIDS Drug Assistance Program (ADAP).

(1) The program requirements for the AIDS Drug Assistance Program are:

(a) Must have a current Notice of Eligibility, DH8000-PHSPM-08/2014, which is incorporated by reference and available at ________.

(b) Must have a prescription for at least one antiretroviral on the ADAP Formulary.

(c) Must have CD4 and HIV viral load laboratory results that are less than six months old at the time of enrollment or recertification.

(2) In addition to the requirements listed in subsection (1) above, the following requirements apply to the ADAP Premium Plus Insurance Program:

(a) Must be enrolled in an ADAP approved plan which includes pharmaceutical benefits equivalent to the ADAP formulary.

(b) Must use the ADAP contracted pharmacy(ies) to receive premium assistance, medications co-payment and/or deductible.

(c) Must need prescription coverage to the extent that payment cannot be made, or cannot reasonably be expected to be made, by a primary payer.

Rulemaking Authority 381.0011(2), 381.003(2) FS. Law Implemented 381.001, 381.0011, 381.003(1)(b) FS. History–New________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Joe May

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: John H. Armstrong, MD, FACS, State Surgeon General

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 22, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: January 28, 2014