The Agency is proposing to amend Rules 59C-1.004, 1.005 and 1.036, F.A.C., due to statutory changes.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Certificate of Need

RULE NOS.:RULE TITLES:

59C-1.004Projects Subject to Review

59C-1.005Certificate of Need Exemption Procedure

59C-1.036Nursing Facility Beds

PURPOSE AND EFFECT: The Agency is proposing to amend Rules 59C-1.004, 1.005 and 1.036, F.A.C., due to statutory changes.

SUMMARY: The proposed amendments to Rules 59C-1.004, 1.005 and 1.036, F.A.C., include statutory changes to amend the occupancy rate from 94 to 92 percent, adding projects subject to expedited review, as well as amending projects subject to exemption.

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.

Based on the fact that the updates to the proposed rule are solely updating materials incorporated and removal of language, the Agency has determined that no SERC is required.

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: Based on the fact that the updates to the proposed rule are solely updating materials incorporated and removal of language, the Agency has determined that no legislative ratification pursuant to subsection 120.541 (3), F.S. is required.

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), (5) and (8), 408.15(8) FS.

LAW IMPLEMENTED: 400.071, 408.034(4), (6) and (7), 408.035, 408.036(1)(a)-(d), (3) and (4), 408.0361(2) and 408.043(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 (IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):

DATE AND TIME: November 13, 2015, 8:30 a.m. ‒ 10:30 a.m.

PLACE: Agency for Health Care Administration, Building Three, Conference Room C, 2727 Mahan Drive, Tallahassee, Florida 32308

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 1 days before the workshop/meeting by contacting: Marisol Fitch, [e-mail] or 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).

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Marisol Fitch, [e-mail] or at [phone]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59C-1.004 Projects Subject to Review.

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

(c) Replacement of a nursing home within the same district, if the proposed project site is located within a geographic area that contains at least 65% percent of the facility’s current residents and is within a 30-mile radius of the replaced nursing home. If the proposed project site is outside the subdistrict where the replaced nursing home is located, the prior six-month occupancy rate for licensed community nursing homes in the proposed subdistrict must be at least 85 percent in accordance with the Agency’s most recently published inventory.

1. In the case of a nursing home with an inactive license, the facility shall address the 65% percent requirement through an identification of where its former residents resided.

2. The nursing home license holder is the only entity that may submit the application to replace the nursing home, pursuant to paragraph 59C-1.008(1)(h), F.A.C.

(d) Replacement of a nursing home within the same district, if the proposed project site is outside a 30-mile radius of the replaced nursing home but within the same subdistrict or a geographically contiguous subdistrict within the district.

1. In the case that a proposed project site is in a geographically continguous subdistrict within the district, the prior six-month occupancy rate for licensed community nursing homes for that subdistrict must be at least 85 percent in accordance with the Agency’s most recently published inventory.

(e)(d) Relocation of a portion of the nursing home’s licensed beds to a licensed facility or to establish a new facility within the same district, or a geographically contiguous district if the relocation is within a 30-mile radius of the existing facility and the total number of nursing home beds in the state district does not increase increase as a result of this project.

1. Applications submitted under this paragraph must be submitted by the licensed nursing home proposing to add the beds or by the applicant proposing to establish a new facility. Notarized letter from the facility from which the beds are being relocated must be submitted certifying that beds will be delicensed should the CON be awarded to the applicant.

2. The relocation of beds under this paragraph shall be limited to a portion of beds such that the occupancy rate of the remaining licensed beds of the facility from which beds are being relocated does not exceed 92% 94% percent.

(f) New construction of a community nursing home in a retirement community pursuant to the provisions in 408.036 (2) (e), F.S.

Rulemaking Authority 408.034(6), 408.15(8) FS. Law Implemented 408.033, 408.035, 408.036(1), (2), 408.037, 408.038, 408.039 FS. History–New 1-1-77, Amended 11-1-77, 9-1-78, 6-5-79, 4-25-80, 2-1-81, Formerly 10-5.04, Amended 11-24-86, 11-17-87, 1-31-91, 1-1-92, Formerly 10-5.004, Amended 9-10-92, 1-9-95, 11-4-97, 12-12-00, 11-12-01, 8-1-05,_____.

 

59C-1.005 Certificate of Need Exemption Procedure.

(1) through (6)(e) No change.

(6)(f) Addition of nursing home beds licensed under chapter 400 for a replacement nursing home not to exceed 30 total beds or 25 percent of the number of licensed and approved beds in the facility being replaced according to the provisions in 408.036 (2) (b), (2) (c) or (3) (p), whichever is less. A request for exemption of a proposed expansion of authorized nursing home beds must specify:

1. The licensed bed capacity of the nursing home proposed to be expanded.

2. The exact number of beds proposed to be added.

3. The subdistrict location of the facility as defined in Rule 59C-2.200, F.A.C.

Provision of adult inpatient diagnostic cardiac catheterization services.

1. A request for exemption of a proposed adult inpatient diagnostic cardiac catheterization program shall include certification by the applicant that:

a. The applicant will not provide therapeutic cardiac catheterization pursuant to the grant of the exemption;

b. The applicant will meet and continuously maintain the minimum licensure requirements specified in subsection 59A-3.2085(13), F.A.C.; and,

c. At least 2% percent of the applicant’s annual Adult Diagnostic Cardiac Catheterization Admissions will be charity and Medicaid patients.

2. An exemption granted for provision of Adult Inpatient Diagnostic Catheterization Services remains in effect while the requirements specified in Section 408.036(3)(i), F.S. and subsection 59A-3.2085(13), F.A.C., are met.

3. Annual reports of compliance with standards for minimum program volume and minimum services to charity and Medicaid patients, as specified in paragraphs 59A-3.2085(13)(d) and (i), F.A.C., shall be forwarded to the Agency’s Certificate of Need Office. The total volume reported shall include both Inpatient and Outpatient Admissions to the Adult Diagnostic Cardiac Catheterization Program. A single admission is equal to one patient visit to the cardiac catheterization program. The first annual report for the exempted program shall be forwarded within 30 days of the end of the first 12 month period completed subsequent to the 18th month of operation. Annual reports thereafter shall be forwarded within 30 days after the anniversary of the first annual report. The reports should be submitted to the address shown in subsection (1) of this rule.

4. The Agency shall provide written notification to the exempted hospital of a determination of non-compliance with the annual compliance requirements of subparagraph (h)3. of this rule. Action upon a finding of non-compliance shall be consistent with the provisions of Section 408.036(3)(i)3.b., F.S.

(6)(g) Establishment of a Level II neonatal intensive care unit (NICU) within a licensed acute care facility if the facility can document that it has had a minimum of 1,500 births during the 12 months preceding the month the Certificate of Need exemption request was submitted and agrees to establish at least 10 Level II NICU beds. The request for exemption should specify:

1. The total licensed bed capacity of the hospital.

2. The total licensed bed capacity if the Certificate of Need exemption request is granted.

3. Applicants for exemption under this paragraph must certify that the NICU unit will provide a level of charity care or Medicaid patient days equal to or greater than the district average. The district average will be determined by averaging all Medicaid, Medicaid HMO, and charity care reported to the Florida State Center for Health Information and Policy Analysis Statistics for the most recent 12-month period in which data has been certified cleared by the Florida State Center for Health Information and Policy Analysis Statistics.

a. Applicants seeking exemption under this paragraph will verify the district average with the Florida State Center for Health Information and Policy Analysis Statistics and certify to provide a certain percentage of patient days to either Medicaid, including Medicaid HMO, or charity care patients or a combination of Medicaid, including Medicaid HMO, and charity care patients.

b. Applicants granted exemption under this paragraph shall report annually, pursuant to Section 408.040, F.S. and Rule 59C-1.013, F.A.C.

4. Applicants for exemption under this paragraph shall demonstrate that it meets the requirements for quality of care, nurse staffing, physician staffing, physical plant, equipment, emergency transportation, and data reporting found in Rule 59C-1.042, F.A.C.

a. Documentation of staffing patterns shall be submitted in a clearly organized format and certified to be correct by the applicant or its authorized representative.

b. Physical plant requirements shall be presented in a clearly organized format and certified to be correct by the applicant or its authorized representative and must indicate the establishment of at least a 10-bed unit.

c. A listing of equipment and equipment specifications should be presented and the applicant or its authorized representative must certify that listed equipment will be purchased.

d. Documentation from authorized emergency transportation providers must be presented attesting to the availability of such transportation to the applicant and certifying that it will provide emergency transportation to the applicant’s NICU patients.

(h) Establishment of a Level III Neonatal Intensive Care Unit (NICU) with at least 15 beds within a licensed acute care facility if the facility has at least a 10-bed Level II NICU and can document that it has had a minimum of 3,500 births during the 12 months preceding the month the Certificate of Need exemption request was submitted and the establishment of agrees to establish at least 5 15 Level III NICU beds. in an applicant hospital that is a verified trauma center pursuant to s. 395.4001(14), and has a Level II neonatal intensive care unit.  A request for exemption should specify.

1. The total licensed bed capacity of the hospital.

2. The total licensed bed capacity if the Certificate of Need exemption request is granted.

3. Applicants for exemption under this paragraph must certify that the NICU unit will provide a level of charity care or Medicaid patient days equal to or greater than the district average. The district average will be determined by averaging all Medicaid, Medicaid HMO, and charity care reported to the Florida State Center for Health Information and Policy Analysis Statistics for the most recent 12-month period in which data has been certified cleared by the Florida State Center for Health Information and Policy Analysis Statistics.

a. Applicants seeking exemption under this paragraph will verify the district average with the S Florida State Center for Health Information and Policy Analysis Statistics and certify to provide a certain percentage of patient days to either Medicaid, including Medicaid HMO, or charity care patients or a combination of Medicaid, including Medicaid HMO, and charity care patients.

b. Applicants granted exemption under this paragraph shall report annually, pursuant to Section 408.040, F.S. and Rule 59C-1.013, F.A.C.

4. Applicants for exemption under this paragraph shall demonstrate that it meets the requirements for quality of care, nurse staffing, physician staffing, physical plant, equipment, emergency transportation, and data reporting found in Rule 59C-1.042, F.A.C.

a. Documentation of staffing patterns shall be submitted in a clearly organized format and certified to be correct by the applicant or its authorized representative.

b. Physical plant requirements shall be presented in a clearly organized format and certified to be correct by the applicant or its authorized representative and must indicate the establishment of the at least a 15-bed unit.

c. A listing of equipment and equipment specifications should be presented and the applicant or its authorized representative must certify that listed equipment will be purchased.

d. Documentation from authorized emergency transportation providers must be presented attesting to the availability of such transportation to the applicant and certifying that it will provide emergency transportation to the applicant’s NICU patients.

(6)(i) No change.

(6)(j) The consolidation or combination of licensed nursing homes or transfer of beds between licensed nursing homes within the same planning subdistrict, by providers that operate multiple nursing homes within that same planning subdistrict, if there is no increase in the planning subdistrict total number of nursing home beds as a result of this project and the site of the relocation is not more than 30 miles from the original location. A request for exemption under this paragraph shall specify:

1. For transfer requests:

a. The name and licensed bed capacity of nursing home from which beds will be transferred.

b. The name and licensed beds capacity of the nursing home to which beds will be transferred.

c. The exact number of beds proposed to be added.

d. The total number of licensed beds at each facility should this exemption be granted.

e. The subdistrict location of each facility as defined in Rule 59C-2.200, F.A.C.

f. The physical location of each facility.

2. For consolidation or combination requests:

a. The name and licensed bed capacity of each nursing home to be consolidated.

b. The name of the resulting consolidated nursing home.

c. The total number of licensed beds at the consolidated facility should this exemption be granted.

3. Verification that the providers have shared controlled interest in operate operate the nursing homes from which beds will either be transferred, consolidated, or combined. Certificate of Need exemption requests under this provision shall require verification that providers operate the nursing facilities in question under a common ownership or control. Verification may include copies of nursing home licenses showing common ownership or appropriate documentation that establishes the subject nursing homes are affiliates through a shared common ownership or controlling interest as defined in Section 408.803(7), F.S. If Agency records indicate information inconsistent with that presented by the requesting parties, then Agency records create a rebuttable presumption as to the correctness of those records and the request for exemption will be denied.

(k) The reestablishment of a health care facility or service.  A request for exemption under this paragraph shall specify:

1. Documentation that the exemption applicant was previously licensed within the past 21 days as a health care facility or provider pursuant to Section 408.036 (1), F.S.

2. The request shall certify that the exemption applicant failed to submit a renewal application.

3. The request shall certify that the exemption applicant does not have a license denial or revocation action pending with the Agency.

4. The service type, district, service area and site for the reestablished health care facility or service.

5. If applicable, the number and type of beds for the reestablished health care facility.

6. If applicable, identify the conditions that were previously imposed on the certificate of need or exemption related to the exemption applicant’s previously licensed health care facility or service.

7. The request shall certify that the exemption applicant agrees to the conditions that were previously imposed on the certificate of need or exemption related to the exemption applicant’s previously licensed health care facility or service.

8. An exemption granted under this paragraph will expire on the 22nd day following the Agency’s approval if the exemption applicant does not apply for an initial license as required under Section 408.806, F.S.

Rulemaking Authority 408.034(8), 408.15(8) FS. Law Implemented 400.071, 408.036(3), (4), 408.0361(2) FS. History–New 1-1-77, Amended 6-5-79, 2-1-81, Formerly 10-5.05, Amended 11-17-87, 3-23-88, 1-31-91, Formerly 10-5.005, Amended 7-13-98, 4-2-01, 11-12-01, 8-18-05,_____.

 

59C-1.036 Nursing Facility Beds.

(1) through (3)(d) No change.

(3)(e) Geographically Continguous Subdistricts within a District. If nursing home need is determined by the bed need formula contained in this rule in continguous subdistricts within a District, the applicant may aggregate the subdistricts’s need for a new community nursing home pursuant to Section 408.034 (6), F.S.

1. If need is aggregated from two subdistricts, the proposed nursing home site must be located in the subdistrict with the greatest published need as determined by the bed need formula contained in this rule.

2. If need is aggregated from more than two subdistricts, the location of the proposed nursing home site must provide reasonable geographic access for residents in the aggregated subdistricts given the relative bed need in each subdistrict.

(f)(e) Geographically Underserved Areas. In a competitive Certificate of Need review within the nursing facility subdistrict as defined in Rule 59C-2.200, F.A.C., the Agency shall award a Certificate of Need if the applicant meets all applicable criteria for a geographically underserved area as specified in Section 408.032(15), F.S., and if the applicant meets applicable statutory Certificate of Need review criteria specified in Section 408.035, F.S., including bed need according to the relevant bed need formula contained in this rule. If an applicant is awarded a Certificate of Need based on the provisions of this paragraph, the applicant shall agree that the nursing facility will be located in a county without a nursing facility, or in the center of an area within the subdistrict with a radius of at least 20 miles which meets the definition of a geographically underserved area. The center of the geographically underserved area shall be the proposed nursing facility location in the application.

(4) through (4)(a) no changes.

(4)(b) Summary of Need Formula. The need formula for nursing facility beds seeking licensure under Chapter 400, F.S., links the projected subdistrict need to a projected increase in the district need for beds licensed under Chapter 400, F.S. The District increase is based on the expected increase in the district population age 65 to 74 and age 75 and over, with the age group 75 and over given 6 times more weight in projecting the population increase. The projected district bed need total is then allocated to its subdistricts consistent with the current subdistrict distribution of the total. The result for a given subdistrict is adjusted to reflect the current subdistrict occupancy of beds licensed under Chapter 400, F.S., and a desired standard of 92 94 percent occupancy. This subdistrict total of allocated beds is then reduced by the current number of Chapter 400, F.S., beds in the subDistrict that are licensed or approved, resulting in the net need for additional nursing facility beds to be licensed under Chapter 400, F.S. The rule also provides that if current occupancy of beds licensed under Chapter 400, F.S., is less than 85 percent, the net need in the subdistrict is zero regardless of whether the formula otherwise would show a net need.

(c) Need Formula. The formula for determining the net need in a subdistrict for nursing facility beds licensed under Chapter 400, F.S., is as follows:

1. A = (POPA × BA) + (POPB × BB)

where:

A is the projected age-adjusted total number of nursing facility beds to be licensed under Chapter 400, F.S., at the planning horizon for the district in which the subdistrict is located.

POPA is the projected population age 65-74 years in the district.

POPB is the projected population age 75 years and older in the district.

BA is the estimated current bed rate for facilities licensed under Chapter 400, F.S., for the population age 65-74 years in the district.

BB is the estimated current bed rate for facilities licensed under Chapter 400, F.S., for the population age 75 years and over in the district.

2. BA = LB / (POPC + (6 × POPD))

where:

LB is the number of nursing facility beds licensed under Chapter 400, F.S., in the district as of January 1, for fixed bed need pools published between January 1 and June 30, or as of July 1 for fixed bed need pools published between July 1 and December 31.

POPC is the current population age 65-74 years in the district.

POPD is the current population age 75 years and over in the district.

3. BB = 6 × BA

4. SA = A × (LBD/LB) × (OR/.92.94)

where:

SA is the subdistrict allocation of community nursing facility beds to be licensed under Chapter 400, F.S., at the planning horizon.

LBD is the number of nursing facility beds licensed under Chapter 400, F.S., in the subdistrict as of January 1, for fixed bed need pools published between January 1 and June 30, or as of July 1 for fixed bed need pools published between July 1 and December 31.

OR is the average 6 month occupancy rate for nursing facility beds licensed in the subdistrict under Chapter 400, F.S. For fixed bed need pools published between January 1 and June 30, occupancy rates shall be based upon patient days in nursing facilities licensed under Chapter 400, F.S., for the 6 month period from July 1 through December 31 of the previous year; for fixed bed need pools published between July 1 and December 31, occupancy rates shall be based upon patient days in nursing facilities licensed under Chapter 400, F.S., for the 6 month period from January 1 through June 30 of the year the fixed bed need pool is published.

.92 94 equals the desired average 6 month occupancy rate for nursing facility beds licensed under Chapter 400, F.S., in the subdistrict.

5. The net bed need allocation for a subdistrict at the planning horizon is determined by subtracting the total number of licensed and approved beds for facilities licensed under Chapter 400, F.S., in the subdistrict from the bed allocation determined under subparagraphs (c)1. through (c)4. unless, as defined in subparagraph (c)4. is less than 85% percent, in which case the net bed need allocation is zero. The number of licensed beds that is subtracted from the bed need allocation shall be the number licensed under Chapter 400, F.S., as of the most recent published deadline for Agency initial decisions prior to publication of the Fixed Bed Need Pool. The number of approved beds that is subtracted shall be the number for which the Agency has issued a Certificate of Need, a letter stating the Agency’s intent to issue a Certificate of Need, a signed stipulated agreement, or a final order granting a Certificate of Need, as of the most recent published deadline for Agency initial decisions prior to publication of the Fixed Bed Need Pool.

(4)(d) through (4)(f) No change.

(g) Other Factors to be Considered in the Review of Certificate of Need Applications for nursing facility beds. An applicant who agrees to voluntarily relinquish licensed community nursing home beds in one or more subdistricts where there is no calculated need, may be recognized as a postitive application factor when applying for nursing facility beds in a subdistrict with published need.  The applicant must demonstrate that it operates or has a controlled interest as defined in Rule 59C-1.005(6)(j) 3., F.A.C., or has an agreement with another licensed community nursing home to ensure that beds are voluntarily relinquished if the application is approved.  The nursing home from which the beds are being relinquished must submit a notarized letter certifying that the identified number of beds at its facilty will be delicensed no later than initial licensure of the proposed facility should the CON be awarded to the applicant.  The relocation of beds under this paragraph must be limited to a portion of beds such that the occupancy rate of the remaining licensed beds of the facility from which the beds are being relinquished does not exceed 92 percent.

(5) No changes.

Rulemaking Authority 408.034(3), (5) and (8), 408.15(8) FS. Law Implemented 408.034(4)(3), (6)(5),(7), 408.036(1)(a), (b), (c) 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)(k), Amended 8-9-92, Formerly 10-5.036, Amended 10-6-92, 8-24-93, 6-11-98, 4-7-02, 8-1-05,_______.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Marisol Fitch

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Elizabeth Dudek

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: September 14, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: December 17, 2014