HB 21 (2019-136, L.O.F.) repealed provisions of Chapter 408 Part II, relating to certificate of need applications for general hospitals. The Agency proposes to amend Rule 59C-1.008 and application forms incorporated into ....

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Certificate of Need

RULE NO.:RULE TITLE:

59C-1.008Certificate of Need Application Procedures

PURPOSE AND EFFECT: HB 21 (2019-136, L.O.F.) repealed provisions of Chapter 408 Part II, relating to certificate of need applications for general hospitals. The Agency proposes to amend Rule 59C-1.008 and application forms incorporated into the rule to remove references to Rule Chapter 59A-3 (Hospital Licensure) and hospital providers. In addition, the proposed amendments will include clarification for reporting mathematical or data input errors made by the Agency in its calculation of the Fixed Need Pool numbers.

SUMMARY: The Agency is proposing to amend Rule 59C-1.008 to remove references to Rule Chapter 59A-3 Hospital Licensure and to remove references of the term’s hospitals and general hospitals. The Agency further proposes to revise incorporated forms AHCA Form 3150-0001 and AHCA Form 3150-0003.

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 SERC has not been prepared by the agency. For rules listed where no SERC was prepared, the Agency prepared a checklist for each rule to determine the necessity for a SERC. Based on this information at the time of the analysis and pursuant to section 120.541, Florida Statutes, 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: 408.034(3), 408.15(8), FS.

LAW IMPLEMENTED: 408.033, 408.034, 408.035, 408.036, 408.037, 408.038, 408.039, 408.040, 408.042, F.S.

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

DATE AND TIME: November 9, 2021, from 2:00pm – 3:00pm

PLACE: No public face-to-face meeting. This hearing will be conducted via teleconference. Participate by dialing the Open Voice conference line, 1(888)585-9008, then enter the conference room number followed by the pound sign, 476-211-242#. The agenda and related materials can also be found on the web at:

https://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Rulemaking.shtml.

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 3 days before the workshop/meeting by contacting: James McLemore, Bureau of Health Facility Regulation, 2727 Mahan Drive, MS 28, Tallahassee, Florida, 32308, [phone], Email: [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: James McLemore, [phone], email: [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59C-1.008 Certificate of Need Application Procedures.

(1) Letters of Intent and applications subject to comparative review shall be accepted in two batching cycles annually each for hospital facilities and hospice programs and freestanding inpatient hospice facilities and for nursing homes and intermediate care facilities for the developmentally disabled (ICF/DD), as specified in paragraph (g) of this subsection. The category “hospital facilities and hospice” includes proposals for new Class II, III or IV hospital facilities pursuant to subsection 59A-3.252(1), F.A.C., replacement Class II, III or IV hospital facilities if being replaced more than a mile away, hospice programs and hospice inpatient facilities. The category “nursing homes and ICF/DDs intermediate care facilities for the developmentally disabled” includes proposals for community nursing home projects unless the project meets criteria in Section 408.036(2) or Section 408.036(3), F.S., and intermediate care facilities for the developmentally disabled.

(a) Letter of Intent. A letter of intent shall state with specificity the type of project proposed with sufficient clarity to notify the public of the intention to file a Certificate of Need application. A separate letter of intent is required for each type of project and for each type of bed, program or facility service having a separate need methodology, proposed to be located in a different planning area as defined for each program under this chapter, or licensing category, even if the projects are within the same facility. At least 30 days prior to the applicable batching cycle application due date, an applicant shall file a letter of intent respecting the development of a proposal in the following manner:

1. The letter of intent must be actually received by the Agency by 5:00 p.m. (local time). The original of the letter of intent must be submitted to the Agency at the address in paragraph 59C-1.008(1)(f), F.A.C.

2. A letter of intent is for a specific project within a specific geographic planning area as defined by rule or statute for an established planning horizon. When no planning area is defined, the District should be specified.

3. A prospective applicant submitting a letter of intent is solely responsible for its conformity with any and all statutory and rule criteria.

4. If an application is not filed on or before the earliest subsequent due date for filing applications of the same type as that specified in the letter of intent, the letter of intent will be considered invalid and a new letter of intent must be timely filed in a subsequent batching cycle before an application may be filed.

(b) No change

(c) As to content, the letter of intent shall describe the proposal with specificity by indicating clearly and unequivocally the following information:

1. Identification of the applicant means the legal name, mailing address, and telephone number of the applicant.

a. If an existing health care facility seeks to undertake a project subject to a comparative review, then the legal name of the license holder must be stated and the license holder must be the applicant except when the applicant has a pending application to become the new licensee of the existing health care facility filed with the applicable licensure unit within the Agency’s Bureau of Health Facility Regulation. In addition, the license number and date of expiration must be stated. It is the responsibility of the person issued a license to keep licensure information current. If Agency records indicate information different from that presented in the letter of intent with respect to the identification of the holder of the license and the licensure status, then the Agency records create a rebuttable presumption as to the correctness of those records and therefore the letter of intent is not valid.

b. If the proposal is for a project which will result in licensure of a new health care facility, the applicant seeking the Certificate of Need must be in existence at the time the letter of intent is submitted. If the applicant is a corporation, Limited Partnership, or otherwise organized, it must have filed an application with the Florida Department of State authorizing the applicant to conduct business in Florida.

2. The letter of intent must identify the type of project proposed and shall contain only one project type as described in Section 408.036(1), F.S.

3. The number of beds sought is indicated by the numerical representation of how many beds of a specific type will compose the proposed project.

4. Services is the type of health care service sought and shall be indicated by describing the specific service requested.

4.5. Location refers to the health planning subdistricts adopted in Chapter 59C-2, F.A.C., for nursing home projects in each program rule under this chapter, or the service areas adopted in Rule 59C-1.0355, F.A.C., for hospice projects districts. The applicant must indicate the subdistrict or service area by name or number. Applicants must also give the name of the county where the proposed project will be located, as provided in Chapter 59C-2, F.A.C.

(d) Letter of Intent Deadline Extension. In order to provide for a mechanism by which applications may be filed to compete with the proposals described in filed letters of intent the following provisions apply:

1. In cases where a letter of intent for a specific type of project has been received by the Agency 30 calendar days or more prior to the appropriate application filing due date as set forth in paragraph 59C-1.008(1)(g), F.A.C., and been initially accepted by the Agency, a grace period shall be established.

2. The grace period provides an opportunity for applicants applying for beds, programs or facilities services having the same Certificate of Need need methodology or health care facility service licensing category proposed in the initially accepted letter of intent in the same applicable subdistrict or district to file a proposed competing letter of intent. Under this grace period, a competing letter of intent must be filed not later than 16 days after the letter of intent deadline promulgated under paragraph 59C-1.008(1)(g), F.A.C.

3. It shall be the sole responsibility of the Agency to determine if a letter of intent is competing with any other letter of intent.

4. The application filing due date shall not be extended for any applicant filing a letter of intent under the requirements of this paragraph unless specified under the provisions of subparagraph 59C-1.008(1)(g)1., F.A.C.

5. The Agency shall publish notices of filing of letters of intent in the Florida Administrative Register in accordance with Section 408.039(2)(d), F.S.

(e) No change

(f) Certificate of Need Application Submission.

An application for a Certificate of Need shall be submitted on AHCA Forms 3150-0001, August 2021 2020 Application For A Certificate of Need, which includes a Cover Page, Schedules A, B, C, D, D-1, 1, 2, 3, 4, 5, 6, 6A, 7, 7A, 7B, 8, 8A, 9, 10 and 11, which are incorporated by reference herein http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. An application for a transfer of a Certificate of Need shall be submitted on AHCA Form 3150-0003, August 2021 2020 Transfer Of A Certificate of Need which includes Schedules 1(TRN), 10(TRN), 11(TRN), 12(TRN), B(TRN), D(TRN), D-1(TRN), in addition to a Cover (TRN) Page, which are incorporated by reference herein http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX. Paper copies or copies on electronic media of AHCA Form 3150-0001, August 2021 2020 Application For A Certificate of Need, or AHCA Form 3150-0003, August 2021 2020 Transfer of A Certificate of Need, and the Schedules may be obtained from:

Agency for Health Care Administration

Certificate of Need

2727 Mahan Drive, Mail Stop #28

Tallahassee, FL 32308

Electronic versions of AHCA Forms 3150-0001 and 3150-0003 and the Schedules are also available at http://ahca.myflorida.com/MCHQ/CON_FA/Application/index.shtml.

1. The application must be actually received by the Agency by 5:00 p.m. (local time) on or before the application due date.

2. Applications for projects which exceed the proposed number of beds contained in the letter of intent shall not be deemed complete for review by the Agency and shall be withdrawn from further review.

3. Applications may propose a lesser number of beds than that contained in the letter of intent.

(g) Applications Subject to Comparative Review – Batching Cycles. In order that applications pertaining to similar types of programs services or facilities affecting the same service area, district or subdistrict may be considered in relation to each other for purposes of comparative review, letters of intent and applications shall be received by the agency no later than dates prescribed in the following schedule, unless the date is a designated state holiday then it shall be received by the agency the next business day:

Hospital Facilities and Hospice 1st Batching Cycle
Summary Need Projections Published in the F.A.R.	First Friday in February
Letter of Intent Deadline	Fourth Monday in February
Application Deadline	Last Wednesday in March
Completeness Review Deadline	First Wednesday in April
Application Omissions Deadline	Fourth Wednesday in April
Agency Initial Decision Deadline	Third Friday in June

 

Hospital Facilities and Hospice 2nd Batching Cycle
Summary Need Projections Published in the F.A.R.	First Friday in August
Letter of Intent Deadline	Fourth Monday in August
Application Deadline	Last Wednesday in September
Completeness Review Deadline	First Wednesday in October
Application Omissions Deadline	Fourth Wednesday in October
Agency Initial Decision Deadline	Third Friday in December

 

Nursing Homes and ICF/DDs 1st Batching Cycle
Summary Need Projections Published in the F.A.R.	First Friday in April
Letter of Intent Deadline	Third Monday in April
Application Deadline	Third Wednesday in May
Completeness Review Deadline	Fourth Wednesday in May
Application Omissions Deadline	Third Wednesday in June
Agency Initial Decision Deadline	Second Friday in August

 

Nursing Homes and ICF/DDs 2nd Batching Cycle
Summary Need Projections Published in the F.A.R.	First Friday in October
Letter of Intent Deadline	Third Monday in October
Application Deadline	Third Wednesday in November
Completeness Review Deadline	Fourth Wednesday in November
Application Omissions Deadline	Third Wednesday in December
Agency Initial Decision Deadline	Second Friday in February

1. Section 408.039 (2)(a), F.S. prevails in cases of conflict. In months when the application deadline is less than thirty days from the letter of intent deadline, the application deadline, the completeness review deadline, and the application omissions deadline will be extended by one week. The Agency initial decision deadline will remain the same.

2. Paragraph 59C-1.008 (1)(d), F.A.C., prevails in cases of conflict and summary need projections published in the Florida Administrative Register (F.A.R.) shall be published one week earlier than identified above with all other dates in the batching cycle remaining unchanged.

3. All dates shall be posted by January 1 of each calendar year on the Agency website at http://ahca.myflorida.com/MCHQ/CON_FA/Batching/index.shtml.

(h) through (i) no change

(2) Fixed Need Pools.

(a) Publication of Fixed Need Pools.

1. The Agency shall publish in the Florida Administrative Register at least 15 days prior to the letter of intent deadline for a particular batching cycle the Fixed Need Pools for the applicable planning horizon specified for each bed or program service in applicable Agency rules contained in Rules 59C-1.0355 and 59C-1.036 59C-1.034-.041, F.A.C. In cases of conflict with paragraph 59C-1.008 (1)(g), F.A.C., subparagraph 59C-1.008(2)(a)1., F.A.C., prevails, and the summary need projections published in the F.A.R. shall be published one week earlier with all other dates in the batching cycle remaining as noticed in paragraph 59C-1.008(1)(g), F.A.C.

2. Any person who identifies a mathematical or data input an error made by the Agency in its calculation of in the Fixed Need Pool numbers must advise the Agency of the error within 10 days of the date the Fixed Need Pool was published in the Florida Administrative Register. As used in this section, the term “error” does not include inaccuracies in reports which provide the underlying data required to calculate the Fixed Need Pool numbers if such reports were not produced by the Agency unless the Agency is notified of such inaccuracy at least fifteen days prior to the initial publication of the Fixed Need Pool numbers. If the Agency concurs in the error, the Fixed Need Pool number will be adjusted and re-published in the first available edition of the Florida Administrative Register. Failure to notify the Agency of the error during this time period will result in no adjustment to the Fixed Need Pool number for that batching cycle.

3. Except as provided in subparagraph 2. above, the batching cycle specific Fixed Need Pools shall not be changed or adjusted in the future regardless of any future changes in need methodologies, population estimates, bed inventories, or other factors which would lead to different projections of need, if retroactively applied.

(b) Counting Beds and Programs Services. For the purpose of establishing a Fixed Need Pool, all existing and approved beds at the time the Fixed Need Pool is computed will be included in the beds or program services inventory. If a specific substantive rule addresses the date upon which existing and approved beds and programs services will be counted, those rules will take precedence over this rule. In all other cases:

1. Beds and programs services will be counted as approved on the date a Certificate of Need is issued or a written decision of intent to award a Certificate of Need is made, whichever occurs first.

2. Beds or programs services initially denied by the Agency and subsequently granted in Administrative Hearing or by stipulated agreement will be counted as approved when the final order granting them is rendered. No beds or programs services previously denied will be included in the inventory based on a recommended order.

(c) Deleting Beds or Programs Services. Beds or programs services will be included in the inventory as long as there is a valid intent to grant or a valid Certificate of Need outstanding. Beds or programs services will not be deleted from the inventory until an intent to grant is overturned in a final order or judicial review of the final order. Beds or programs services will not be deleted from the inventory until a Certificate of Need is rescinded, revoked, modified, voided, or voluntarily surrendered by an applicant. Licensed beds and programs services will be deleted when the license is no longer in effect. The effective date for the deletion will be the date the license was voluntarily surrendered by the license holder, the date of final Agency action in the case of a final order or the date of a court order if a final order is appealed.

(d) The Agency will follow these procedures when awarding beds or programs services identified in a Fixed Need Pool:

1. Beds or programs services will be awarded based on the availability of a qualified applicant and proposed project which meets statutory review criteria.

2. In the absence of a qualified applicant and a project which meets statutory review criteria, the Agency may elect not to approve any applications for beds or services.

3. If a qualified applicant exists but the proposed project exceeds the beds or programs services identified in the Fixed Need Pool, the Agency may award beds or programs services in excess of the pool when warranted by special circumstances as defined in the applicable section of Chapter 59C-1, F.A.C., for the particular type of bed or program service.

(e) Comparative Review. Applications submitted to the Agency in the same batching cycle for the same program service or beds having the same Certificate of Need methodology in the same district or subdistrict, as defined in applicable rules, shall be comparatively reviewed through final Agency action against the same Fixed Need Pools in existence at the initial review. The Fixed Need Pools and other relevant planning information shall be used by the Agency to review the application against all applicable statutory review criteria contained in Section 408.035, F.S., and applicable rules, and policies. If an Agency need methodology does not exist for the proposed project:

1. The Agency will provide to the applicant, if one exists, any policy upon which to determine need for the proposed beds or  program service. The applicant is not precluded from using other methodologies to compare and contrast with the Agency policy.

2. If no Agency policy exists, the applicant will be responsible for demonstrating need through a needs assessment methodology which must include, at a minimum, consideration of the following topics, except where they are inconsistent with the applicable statutory or rule criteria:

a. Population demographics and dynamics;

b. Availability, utilization and quality of like services in the district, subdistrict or both;

c. Medical treatment trends; and,

d. Market conditions.

3. Regardless of need methodology, the existence of unmet need will not be based solely on the absence of a service, health care facility, or beds in the district or subdistrict.

(3) through (6) no change

Rulemaking Authority 408.034(3), (8), 408.15(8) FS. Law Implemented 408.033, 408.034, 408.035, 408.036, 408.037, 408.038, 408.039, 408.040, 408.042 FS. History–New 1-1-77, Amended 11-1-77, 9-1-78, 6-5-79, 2-1-81, 4-1-82, 7-29-82, 9-6-84, Formerly 10-5.08, Amended 11-24-86, 3-2-87, 6-11-87, 11-17-87, 3-23-88, 5-30-90, 12-20-90, 1-31-91, 9-9-91, 5-12-92, 7-1-92, 8-9-92, Formerly 10-5.008, Amended 4-19-93, 6-23-94, 10-12-94, 10-18-95, 2-12-96, 7-18-96, 9-16-96, 11-4-97, 7-21-98, 12-12-00, 4-2-01, 1-10-02, 6-26-03, 12-13-04, 9-28-05, 10-9-07, 4-21-10, 2-13-12, 8-15-13, 10-29-15, 10-17-19, 12-30-20,         .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: James McLemore

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 06, 2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 08/18/2021