This is a second public hearing on proposed Rules 59C-1.008, 59C-1.010, 59C-1.012, 59C-1.013 and 59C-1.030, F.A.C., related to General Hospital Applications for Certificate of Need. The proposed rules are updated to reflect statutory changes to the ...

 

AGENCY FOR HEALTH CARE ADMINISTRATION
Certificate of Need

RULE NO: RULE TITLE
59C-1.008: Certificate of Need Application Procedures
59C-1.010: Certificate of Need Application Review Procedures
59C-1.012: Administrative Hearing Procedures
59C-1.013: Monitoring Procedures
59C-1.030: Criteria Used in Evaluation of Applications
PURPOSE AND EFFECT: This is a second public hearing on proposed Rules 59C-1.008, 59C-1.010, 59C-1.012, 59C-1.013 and 59C-1.030, F.A.C., related to General Hospital Applications for Certificate of Need. The proposed rules are updated to reflect statutory changes to the hospital application procedures currently defined in the listed rules in Chapter 59C-1, F.A.C.
SUMMARY: This hearing will consider changes to punctuation and grammar in subsections 59C-1.008(1) and (4), and paragraph 59C-1.010(2)(a), F.A.C.; the deletion of paragraph 59C-1.010(5)(e), F.A.C., the addition of the Batching Calendar cycles for 2010, 2011 and deletion of the Batching Calendar cycles for 2007, 2008 and the first two cycles of 2009; also consider the notices of change submitted since the December 2008 hearing.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
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.
SPECIFIC AUTHORITY: 408.034(3), (6), 408.15(8) FS.
LAW IMPLEMENTED: 408.033, 408.035, 408.036, 408.037, 408.038, 408.039, 408.040(1), (2) FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:
DATE AND TIME: November 16, 2009, 1:00 p.m.
PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building 3, Conference Room B, Tallahassee, Florida
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 5 days before the workshop/meeting by contacting: Calvin J Vice, Sr., PhD at [phone]. 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). 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: Calvin J Vice, Sr., PhD at [phone]

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 beds and facilities and for other beds and programs, as specified in paragraph (g) of this subsection. The category “hospital beds and facilities” includes proposals for new hospital facilities, replacement hospital facilities if being replaced more than a mile away, acute care beds pursuant to section 408.036(1)(g), F.S., the establishment of new neonatal level II and level III programs unless otherwise exempt pursuant to section 408.036(3)(l)(k), F.S., and comprehensive medical rehabilitation beds unless otherwise exempt pursuant to section 408.036(3)(j)(i), F.S., and except as provided in Section 408.037(2), F.S., for a general hospital. Unless otherwise directed by 408.037(2), F.S., general hospital applications shall conform to the schedules in this rule and will use all the application and schedules described in paragraph (1)(f). The category “other beds and programs” includes proposals for pediatric open heart surgery, pediatric cardiac catheterization, specialty burn units, organ transplantation, community nursing home projects, hospice programs, hospice inpatient facilities, and intermediate care facilities for the developmentally disabled.

(a) No change.

(b) The contents of the letter of intent shall be consistent with paragraph 408.039(2)(c), F.S., and must be a written communication with an original signature. The applicant is solely responsible for the content and clarity of the letter of intent. The agency shall not assume any facts not clearly stated. Applications should be submitted with one bound copy and one unbound print copy.

(c)1. through 4. No change.

5. Location refers to the health planning subdistricts adopted in Chapter 59C-2, F.A.C., in each program rule under this chapter, or the service districts. The applicant must indicate the subdistrict by name or number. Nursing home Aapplicants 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) through (e) No change.

(f) Certificate of Need Application Submission. An application for a certificate of need shall be submitted on AHCA Forms 3150-0001, March 2009 Application for a Certificate of Need, or 3150-0003, March 2009 Transfer of a Certificate of Need, CON-1, July 2000, which includes a Cover Page, Cover Page-TRN Schedules A or A-Trn, B or B-TRN, C, D, D-1, 1 or 1-TRN, 2, 3, 4, 5, 6, 6A, 7, 7A, 7B, 8, 8A, 9, 10 or 10-TRN, 11-Trn, and 12-TRN, which are incorporated by reference herein. An application for a general hospital shall be submitted on AHCA Form 3150-0002, March 2009 Application for a General Hospital Certificate of Need which includes Schedules 11, A(H), B(H), C, D(H) in addition to a Cover (H) Page, which are incorporated by reference herein. Paper copies or copies on electronic media A copy of AHCA Forms 3150-0001, March 2009 Application for a Certificate of Need; AHCA Form 3150-0002, March 2009 Application for a General Hospital Certificate of Need; or AHCA Form 3150-0003, March 2009 Transfer of a Certificate of Need, CON-1 and the Schedules may be obtained from:

Agency for Health Care Administration,

Certificate of Need

2727 Mahan Drive, Building 1, Mail Stop 28

Tallahassee, FL 32308.

An Eelectronic versions of AHCA Forms 3150-0001, 3150-0002 and 3150-0003 CON-1 and the Schedules are also available at http://ahca.myflorida.com/MCHQ/CON_FA/Application/index.shtml. www.fdhc.state.fl.us

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 services or facilities affecting the same service 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:

 

Hospital Beds and Facilities

1st Batching Cycle – 2007

Summary Need Projections Published in F.A.W.1-26-07

Letter of Intent Deadline2-12-07

Application Deadline3-14-07

Completeness Review Deadline3-21-07

Application Omissions Deadline4-18-07

Agency Initial Decision Deadline6-15-07

 

Hospital Beds and Facilities

2nd Batching Cycle – 2007

Summary Need Projections Published in F.A.W.7-27-07

Letter of Intent Deadline8-13-07

Application Deadline9-12-07

Completeness Review Deadline9-19-07

Application Omissions Deadline10-17-07

Agency Initial Decision Deadline12-14-07

 

Hospital Beds and Facilities

1st Batching Cycle – 2008

Summary Need Projections Published in F.A.W.1-25-08

Letter of Intent Deadline2-11-08

Application Deadline3-12-08

Completeness Review Deadline3-19-08

Application Omissions Deadline4-16-08

Agency Initial Decision Deadline6-13-08

 

Hospital Beds and Facilities

2nd Batching Cycle – 2008

Summary Need Projections Published in F.A.W.7-25-08

Letter of Intent Deadline8-11-08

Application Deadline9 10-08

Completeness Review Deadline9-17-08

Application Omissions Deadline10-15-08

Agency Initial Decision Deadline12-12-08

 

Hospital Beds and Facilities

1st Batching Cycle – 2009

Summary Need Projections Published in F.A.W.1-23-00

Letter of Intent Deadline2-09-09

Application Deadline3-11-09

Completeness Review Deadline3-18-09

Application Omissions Deadline4-15-09

Agency Initial Decision Deadline6-12-09

 

Hospital Beds and Facilities

2nd Batching Cycle – 2009

Summary Need Projections Published in F.A.W.7-24-09

Letter of Intent Deadline8-10-09

Application Deadline9-09-09

Completeness Review Deadline9-16-09

Application Omissions Deadline10-14-09

Agency Initial Decision Deadline12-110-09

 

Hospital Beds and Facilities

1st Batching Cycle – 2010

Summary Need Projections Published in F.A.W.1-22-10

Letter of Intent Deadline2-08-10

Application Deadline3-10-10

Completeness Review Deadline3-17-10

Application Omissions Deadline4-14-10

Agency Initial Decision Deadline6-11-10

 

Hospital Beds and Facilities

2nd Batching Cycle – 2010

Summary Need Projections Published in F.A.W.7-23-10

Letter of Intent Deadline8-09-10

Application Deadline9-08-10

Completeness Review Deadline9-15-10

Application Omissions Deadline10-13-10

Agency Initial Decision Deadline12-10-10

 

Hospital Beds and Facilities

1st Batching Cycle – 2011

Summary Need Projections Published in F.A.W.1-21-11

Letter of Intent Deadline2-07-11

Application Deadline3-09-11

Completeness Review Deadline3-16-11

Application Omissions Deadline4-13-11

Agency Initial Decision Deadline6-10-11

 

Hospital Beds and Facilities

2nd Batching Cycle – 2011

Summary Need Projections Published in F.A.W.7-22-11

Letter of Intent Deadline8-08-11

Application Deadline9-07-11

Completeness Review Deadline9-14-11

Application Omissions Deadline10-12-11

Agency Initial Decision Deadline12-09-11

 

Other Beds and Programs

1st Batching Cycle – 2007

Summary Need Projections Published in F.A.W.4-06-07

Letter of Intent Deadline4-23-07

Application Deadline5-23-07

Completeness Review Deadline5-30-07

Application Omissions Deadline6-27-07

Agency Initial Decision Deadline8-24-07

 

Other Beds and Programs

1st Batching Cycle – 2007

Summary Need Projections Published in F.A.W.4-06-07

Letter of Intent Deadline4-23-07

Application Deadline5-23-07

Completeness Review Deadline5-30-07

Application Omissions Deadline6-27-07

Agency Initial Decision Deadline8-24-07

 

Other Beds and Programs

2nd Batching Cycle – 2007

Summary Need Projections Published in F.A.W.10-05-07

Letter of Intent Deadline10-22-07

Application Deadline11-21-07

Completeness Review Deadline11-28-07

Application Omissions Deadline12-26-07

Agency Initial Decision Deadline2-22-08

 

Other Beds and Programs

1st Batching Cycle – 2008

Summary Need Projections Published in F.A.W.4-04-08

Letter of Intent Deadline4-21-08

Application Deadline5-21-08

Completeness Review Deadline5-28-08

Applicant Omissions Deadline6-25-08

Agency Initial Decision Deadline8-22-08

 

Other Beds and Programs

2nd Batching Cycle – 2008

Summary Need Projections Published in F.A.W.10-03-08

Letter of Intent Deadline10-20-08

Application Deadline11-19-08

Completeness Review Deadline11-26-08

Applicant Omissions Deadline12-24-08

Agency Initial Decision Deadline2-20-09

 

Other Beds and Programs

1st Batching Cycle – 2009

Summary Need Projections Published in F.A.W.4-03-09

Letter of Intent Deadline4-20-09

Application Deadline5-20-09

Completeness Review Deadline5-27-09

Application Omissions Deadline6-24-09

Agency Initial Decision Deadline8-21-09

 

Other Beds and Programs

2nd Batching Cycle – 2009

Summary Need Projections Published in F.A.W.10-02-09

Letter of Intent Deadline10-19-09

Application Deadline11-18-09

Completeness Review Deadline11-25-09

Application Omissions Deadline12-23-09

Agency Initial Decision Deadline2-19-10

 

Other Beds and Programs

1st Batching Cycle – 2010

Summary Need Projections Published in F.A.W.4-02-10

Letter of Intent Deadline4-19-10

Application Deadline5-19-10

Completeness Review Deadline5-26-10

Application Omissions Deadline6-23-10

Agency Initial Decision Deadline8-20-10

 

Other Beds and Programs

2nd Batching Cycle – 2010

Summary Need Projections Published in F.A.W.10-01-10

Letter of Intent Deadline10-18-10

Application Deadline11-17-10

Completeness Review Deadline11-24-10

Application Omissions Deadline12-22-10

Agency Initial Decision Deadline2-18-11

 

Other Beds and Programs

1st Batching Cycle – 2011

Summary Need Projections Published in F.A.W.4-01-11

Letter of Intent Deadline4-18-11

Application Deadline5-18-11

Completeness Review Deadline5-25-11

Application Omissions Deadline6-22-11

Agency Initial Decision Deadline8-19-11

 

Other Beds and Programs

2nd Batching Cycle – 2011

Summary Need Projections Published in F.A.W.9-30-11

Letter of Intent Deadline10-17-11

Application Deadline11-16-11

Completeness Review Deadline11-23-11

Application Omissions Deadline12-21-11

Agency Initial Decision Deadline2-17-12

 

(h) through (j) No change.

(2) through (3) No change.

(4) Certificate of Need Application Contents. An application for a certificate of need shall contain the following items:

(a) All requirements set forth in sections 408.037(1), (2) and (3), (2) F.S.;

(b) The correct application fee;

(c) With respect to paragraph 408.037(1)(c), F.S., which requires an audited financial statement of the applicant the following provisions apply:

1. The audited financial statement of the applicant must be for the most current fiscal year. If the most recent fiscal year ended within 120 days prior to the application filing deadline and the audited financial statements are not yet available, then the prior fiscal year will be considered the most recent.

2. Existing health care facilities must provide audited financial statements for the two most recent consecutive fiscal years in accordance with subparagraph 1. above.

3. Only audited financial statements of the applicant will be accepted. Audited financial statements of any part of the applicant, including but not limited to subsidiaries, divisions, specific facilities or cost centers, will not qualify as an audit of the applicant. Nor shall the audited financial statements of the applicant’s parent corporation qualify as an audit of the applicant.

(d) To comply with Section 408.037(1)(b)1., F.S., which requires a listing of all capital projects, the applicant shall provide the total approximate amount of anticipated expenditures for capital projects which meet the definition in subsection 59C-1.002(7), F.A.C., at the time of initial application submission, or state that there are none. An itemized list or grouping of capital projects is not required, although an applicant may choose to itemize or group its capital projects. The applicant shall also indicate the actual or proposed financial commitment to those projects, and include an assessment of the impact of those projects on the applicant’s ability to provide the proposed project; and

(e) Responses to applicable questions contained in the application forms.

(5) No change.

Rulemaking Specific Authority 408.034(6), 408.15(8) FS. Law Implemented 408.033, 408.037, 408.038, 408.039 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, 8-10-92, 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,________.

 

59C-1.010 Certificate of Need Application Review Procedures

(1) No change.

(2) General Provisions.

(a) Applications subject to comparative or expedited review shall be submitted to the agency on AHCA Form 3150-0001, March 2009 Application for a Certificate of Need; or 3150-0003, March 2009 Transfer of a Certificate of Need; or 3150-0002, March 2009 Application for a General Hospital Certificate of Need, CON-1, as referenced in paragraph 59C-1.008(1)(f), F.A.C.

(b) through (c) No change.

(d) An application for a general hospital must meet the requirements of Sections 408.035(2) and 408.037 (2), F.S.

(3) through (7) No change.

Rulemaking Specific Authority 408.034(6)(5), 408.15(8) FS. Law Implemented 408.033(1), 408.035(2), 408.036(2), 408.037(2), 408.039(3), (4), (5) FS. History–New 1-1-77, Amended 11-1-77, 9-1-78, 6‑5‑79, 4‑25‑80, 2‑1‑81, 3‑31‑82, 12‑23-82, Formerly 10-5.10, Amended 11‑24‑86, 11‑17‑87, 3-23-88, 8-28-88, 1-31-91, 7-1-92, 7-14-92, Formerly 10-5.010, Amended 10-8-97, 12-12-00, 4-2-01, 6-23-05,________.

 

59C-1.012 Administrative Hearing Procedures.

(1) through (2)(d) No change.

(e) The party appealing a final order that grants a general hospital certificate of need shall post a $1 million bond as directed in Section 408.039(6)(d), Florida Statutes. The bond must be made payable to the appellee or appellees and must reference the appealing party, the CON number being appealed, and the Division of Administrative Hearings (DOAH) case number. The bond needs to be sent to:

Agency for Health Care Administration

Attention: Agency Clerk

2727 Mahan Drive, MS #3

Tallahassee, Florida 32308

Rulemaking Specific Authority 408.034 (6), 408.15(8) FS. Law Implemented 408.039(5), 408.039(6) 120.57, 120.59 FS. History– New 1-1-77, Amended 9-1-78, 6-5-79, 10-23-79, 4-25-80, Formerly 10-5.12, Amended 11-24-86, 11-17-87, Formerly 10-5.012, Amended 12-14-92,_______.

 

59C-1.013 Monitoring Procedures.

(1) through (2) No change.

(3) Documentation. The following is a listing of all reports required for monitoring compliance with this rule and Rule 59C-1.018, F.A.C.

(a) Final Cost Report. The certificate of need holder shall file a Final Cost Report AHCA Form CON-3, Revised July 1997, incorporated by reference herein. A copy of Form CON-3 may be obtained from: Agency for Health Care Administration, Certificate of Need Office, Fort Knox Executive Center, 2727 Mahan Drive, Building 3, Tallahassee, FL 32308. The Final Cost Report must be received by the agency within 90 calendar days of submission of the Architect’s Certificate of Final Payment, or upon commencement of the health services, whichever is applicable.

(b) Architect’s Certificate of Final Payment. The certificate of need holder shall provide the agency, in writing, a completed and fully executed architect’s certification of final payment, AIA Documents G702 and G703, May 83 incorporated by reference herein, or a suitable substitute. A substitute is suitable if it contains the following items:

1. A certification by the contractor or the architect of final payment which contains the original construction cost, any cost for change orders, and the total expenditures made or requested;

2. A certification by the architect that the project is complete and final payment has been made; and

3. An itemized sheet for direct construction costs which breaks down the expenditures by description of work.

The report must be received by the agency no later than 30 calendar days following the completion of construction as defined in the owner and contractor agreement, and final approval of the project by the agency.

(3)(4) Reporting Requirements Subsequent to Licensure or Commencement of Services. All holders of a certificate of need that was issued predicated upon conditions expressed on the face of the certificate of need shall provide annual compliance reports to the agency. The reporting period shall be January 1 through December 31 of each year. The holder of a certificate of need who began operation after January 1 will report from the date operation began through December 31. The compliance report shall be submitted no later than April 1 of the subsequent year.

(a) The compliance report will contain information necessary for an assessment of compliance with conditions on the certificate of need, utilizing measures, such as a percentage of patient days, that are consistent with the stated condition. The following information shall be provided in the holder’s annual compliance report:

1. The time period covered by the measures;

2. The measure for assessing compliance with each of the conditions identified and described on the face of the certificate of need;

3. The way in which the conditions were evaluated by applying the measures;

4. The data sources used to generate information about the conditions that were measured;

5. The person and position responsible for supplying the compliance report;

6. Any other information necessary for the agency to determine compliance with conditions; and,

7. If applicable, the reason or reasons, with supporting data, why the certificate of need holder was unable to meet the conditions set forth on the face of the certificate of need.

(b) A change in the licensee for a facility or service does not affect the obligation for that facility or service to continue to meet conditions imposed on a certificate of need and to provide annual condition compliance reports.

(c) Conditions imposed on a certificate of need may be modified consistent with Rule 59C-1.019, F.A.C.

(4)(5) Violation of Certificate of Need Conditions. Health care providers found by the agency to be in noncompliance with conditions set forth in their certificate of need shall be fined as defined in Rule 59C-1.021, F.A.C.

Rulemaking Specific Authority 408.034(6)(5), 408.15(8) FS. Law Implemented 408.040(1), (2), (3) FS. History–New 1-1-77, Amended 11-1-77, 9-1-78, 6-5-79, 2-1-81, 3-31-82, Formerly 10-5.13. Amended 11-24-86, 7-25-89, Formerly 10-5.013, Amended 10-18-95, 11-4-97, 12-12-00,________.

 

59C-1.030 Criteria Used in the Evaluation of Applications.

In addition to criteria set forth in 408.035, F.S., the following criteria are used in the review of an application.

(1) For a new general hospital as defined in Section 395.002, F.S. and subparagraph 59A-3.252(1)(a)1. and 3., F.A.C. the criteria for evaluation are those found in Sections 408.035(2) and 408.037(2), F.S. General Provisions (Reserved)

(2) No change.

Rulemaking Specific Authority 408.15(8), 408.034(3), (6)(5) FS. Law Implemented 408.035, 408.037 FS. History–New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81, 4-1-82, 11‑9-82, 2-14-83, 4-7-83, 6-9-83, 6‑10-83, 12-12-83, 3-5-84, 5-14-84, 7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended 6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88, 4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly 10-5.011(1)(a), (b), Formerly 10-5.030, Amended_________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Calvin J. Vice, Sr., PhD

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Holly Benson

DATE PROPOSED RULE APPROVED BY AGENCY HEAD:

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: September 26, 2008