Current through Reg. 50, No. 187; September 24, 2024
(1) Agency
Intent. This rule implements the provisions of Sections
408.034(3),
408.036(1)(d)
and 408.043(1),
F.S. It is the intent of the Agency to ensure the availability of Hospice
programs as defined in this rule to all persons requesting and eligible for
Hospice services, regardless of ability to pay. This rule regulates the
establishment of new Hospice programs and the construction of freestanding
inpatient Hospice facilities as defined in this rule. A separate Certificate of
Need application shall be submitted for each service area defined in this
rule.
(2) Definitions.
(a) "Agency." The Agency for Health Care
Administration.
(b) "Approved
Hospice Program." A Hospice program for which the Agency has issued an intent
to grant a Certificate of Need, or has issued a Certificate of Need, and that
is not yet licensed as of 3 weeks prior to publication of the Fixed Need
Pool.
(c) "Contractual
Arrangement." An arrangement for contractual services, as described in Section
400.6085, F.S.
(d) "Fixed Need Pool." The Fixed Need Pool
defined in subsection
59C-1.002(16),
F.A.C. The Agency shall publish a Fixed Need Pool for Hospice programs twice a
year.
(e) "Freestanding Inpatient
Hospice Facility." For purposes of this rule, a facility that houses inpatient
beds licensed exclusively to the Hospice program but does not house any
inpatient beds licensed to a hospital or nursing home.
(f) "Hospice Program." A program described in
Sections 400.601(3),
400.602(1),
400.609 and
400.6095(1),
F.S., that provides a continuum of palliative and supportive care for the
terminally ill patient and his family. Hospice services must be available 24
hours a day, 7 days a week, and must be available to all terminally ill persons
and their families without regard to age, gender, national origin, sexual
orientation, disability, diagnosis, cost of therapy, ability to pay, or life
circumstances.
(g) "Inpatient Bed."
Inpatient beds located in a freestanding inpatient Hospice facility, a
hospital, or a nursing home and available for Hospice inpatient care.
(h) "Local Health Council." The council
referenced in Section
408.033(1),
F.S.
(i) "Planning Horizon." The
date by which a proposed new Hospice program is expected to be licensed. For
purposes of this rule, the planning horizon for applications submitted between
January 1 and June 30 is July 1 of the year 1 year subsequent to the year the
application is submitted; the planning horizon for applications submitted
between July 1 and December 31 is January 1 of the year 2 years subsequent to
the year the application is submitted.
(j) "Residential Facility." For purposes of
this rule, a facility operated by a licensed Hospice program to provide a
residence for Hospice patients, as defined in Section
400.601(5),
F.S. A residential facility is not subject to regulation under this rule.
Provided, however, that a proposal to convert such a residence to a
freestanding inpatient Hospice facility is subject to regulation under this
rule.
(k) "Service Area." The
geographic area consisting of a specified county or counties, as follows:
1. Service Area 1 consists of Escambia,
Okaloosa, Santa Rosa, and Walton Counties.
2. Service Area 2A consists of Bay, Calhoun,
Gulf, Holmes, Jackson, and Washington Counties.
3. Service Area 2B consists of Franklin,
Gadsden, Jefferson, Leon, Liberty, Madison, Taylor, and Wakulla
Counties.
4. Service Area 3A
consists of Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette,
Levy, Putnam, Suwannee, and Union Counties.
5. Service Area 3B consists of Marion
County.
6. Service Area 3C consists
of Citrus County.
7. Service Area
3D consists of Hernando County.
8.
Service Area 3E consists of Lake and Sumter Counties.
9. Service Area 4A consists of Baker, Clay,
Duval, Nassau, and St. Johns Counties.
10. Service Area 4B consists of Flagler and
Volusia Counties.
11. Service Area
5A consists of Pasco County.
12.
Service Area 5B consists of Pinellas County.
13. Service Area 6A consists of Hillsborough
County.
14. Service Area 6B
consists of Hardee, Highlands, and Polk Counties.
15. Service Area 6C consists of Manatee
County.
16. Service Area 7A
consists of Brevard County.
17.
Service Area 7B consists of Orange and Osceola Counties.
18. Service Area 7C consists of Seminole
County.
19. Service Area 8A
consists of Charlotte and DeSoto Counties.
20. Service Area 8B consists of Collier
County.
21. Service Area 8C
consists of Glades, Hendry and Lee Counties.
22. Service Area 8D consists of Sarasota
County.
23. Service Area 9A
consists of Indian River County.
24. Service Area 9B consists of Martin,
Okeechobee, and St. Lucie Counties.
25. Service Area 9C consists of Palm Beach
County.
26. Service Area 10
consists of Broward County.
27.
Service Area 11 consists of Dade and Monroe Counties.
(l) "Terminally Ill." As defined in section
400.601(10),
F.S., terminally ill refers to a medical prognosis that a patient's life
expectancy is 1 year or less if the illness runs its normal
course.
(3) General
Provisions.
(a) Quality of Care. Hospice
programs shall comply with the standards for program licensure described in
Chapter 400, Part IV, F.S. and Chapter 59A-38, F.A.C. Applicants proposing to
establish a new Hospice program shall demonstrate how they will meet the
standards.
(b) Conformance with
Statutory Review Criteria. A Certificate of Need for the establishment of a new
Hospice program or construction of a freestanding inpatient Hospice facility
shall not be approved unless the applicant meets the applicable review criteria
in Sections 408.035 and
408.043(1),
F.S., and the standards and need determination criteria set forth in this rule.
Applications to establish a new Hospice program shall not be approved in the
absence of a numeric need indicated by the formula in paragraph (4)(a) of this
rule, unless other criteria in this rule and in Sections
408.035 and
408.043(1),
F.S., outweigh the lack of a numeric need.
(4) Criteria for Determination of Need for a
New Hospice Program.
(a) Numeric Need for a
New Hospice Program. Numeric need for an additional Hospice program is
demonstrated if the projected number of unserved patients who would elect a
Hospice program is 350 or greater. The net need for a new Hospice program in a
service area is calculated as follows:
(HPH) - (HP) > 350
where:
(HPH) is the projected number of patients electing a Hospice
program in the service area during the 12 month period beginning at the
planning horizon. (HPH) is the sum of (U65C x P1) + (65C x P2) + (U65NC x P3) +
(65NC x P4)
where:
U65C is the projected number of service area resident cancer
deaths under age 65, and P1 is the projected proportion of U65C electing a
Hospice program.
65C is the projected number of service area resident cancer
deaths age 65 and over, and P2 is the projected proportion of 65C electing a
Hospice program.
U65NC is the projected number of service area resident deaths
under age 65 from all causes except cancer, and P3 is the projected proportion
of U65NC electing a Hospice program.
65NC is the projected number of service area resident deaths
age 65 and over from all causes except cancer, and P4 is the projected
proportion of 65NC electing a Hospice program.
The projections of U65C, 65C, U65NC, and 65NC for a service
area are calculated as follows:
|
U65C
|
=
|
(u65c/CT)
|
x
|
PT
|
|
65C
|
=
|
(65c/CT)
|
x
|
PT
|
|
U65NC
|
=
|
(u65nc/CT)
|
x
|
PT
|
|
65NC
|
=
|
(65nc/CT)
|
x
|
PT
|
where:
u65c, 65c, u65nc, and 65nc are the service area's current
number of resident cancer deaths under age 65, cancer deaths age 65 and over,
deaths under age 65 from all causes except cancer, and deaths age 65 and over
from all causes except cancer.
CT is the service area's current total of resident deaths,
excluding deaths with age unknown, and is the sum of u65c, 65c, u65nc, and
65nc.
PT is the service area's projected total of resident deaths
for the 12-month period beginning at the planning horizon.
"Current" deaths means the number of deaths during the most
recent calendar year for which data are available from the Department of
Health, Office of Vital Statistics at least 3 months prior to publication of
the Fixed Need Pool.
"Projected" deaths means the number derived by first
calculating a 3-year average resident death rate, which is the sum of the
service area resident deaths for the three most recent calendar years available
from the Department of Health, Office of Vital Statistics at least 3 months
prior to publication of the Fixed Need Pool, divided by the sum of the July 1
estimates of the service area population for the same 3 years. The resulting
average death rate is then multiplied by the projected total population for the
service area at the mid-point of the 12-month period which begins with the
applicable planning horizon. Population estimates for each year will be the
most recent population estimates from the Office of the Governor at least 3
months prior to publication of the Fixed Need Pool.
The projected values of P1, P2, P3, and P4 are equal to
current statewide proportions calculated as follows:
P1 = (Hu65c/Tu65c)
P2 = (H65c/T65c)
P3 = (Hu65nc/Tu65nc)
P4 = (H65nc/T65nc)
where:
Hu65c, H65c, Hu65nc, and H65nc are the current 12-month
statewide total admissions of Hospice cancer patients under age 65, Hospice
cancer patients age 65 and over, Hospice patients under age 65 admitted with
all other diagnoses, and Hospice patients age 65 and over admitted with all
other diagnoses. The current totals are derived from reports submitted under
subsection (8) of this rule.
Tu65c, T65c, Tu65nc, and T65nc are the current 12-month
statewide total resident deaths for the four categories used above.
(HP) is the number of patients admitted to Hospice programs
serving an area during the most recent 12-month period ending on June 30 or
December 31. The number is derived from reports submitted under subsection (8)
of this rule.
350 is the targeted minimum 12-month total of patients
admitted to a Hospice program.
(b) Licensed Hospice Programs. Regardless of
numeric need shown under the formula in paragraph (4)(a), the Agency shall not
normally approve a new Hospice program for a service area unless each Hospice
program serving that area has been licensed and operational for at least 2
years as of 3 weeks prior to publication of the Fixed Need Pool.
(c) Approved Hospice Programs. Regardless of
numeric need shown under the formula in paragraph (4)(a), the Agency shall not
normally approve another Hospice program for any service area that has an
approved Hospice program that is not yet licensed.
(d) Approval Under Special Circumstances. In
the absence of numeric need identified in paragraph (4)(a), the applicant must
demonstrate that circumstances exist to justify the approval of a new Hospice.
Evidence submitted by the applicant must document one or more of the following:
1. That a specific terminally ill population
is not being served.
2. That a
county or counties within the service area of a licensed Hospice program are
not being served.
(e)
Preferences for a New Hospice Program. The Agency shall give preference to an
applicant meeting one or more of the criteria specified in subparagraphs 1.
through 5.:
1. Preference shall be given to
an applicant who has a commitment to serve populations with unmet
needs.
2. Preference shall be given
to an applicant who proposes to provide the inpatient care component of the
Hospice program through contractual arrangements with existing health care
facilities, unless the applicant demonstrates a more cost-efficient
alternative.
3. Preference shall be
given to an applicant who has a commitment to serve patients who do not have
primary caregivers at home; the homeless; and patients with AIDS.
4. In the case of proposals for a Hospice
service area comprised of three or more counties, preference shall be given to
an applicant who has a commitment to establish a physical presence in an
underserved county or counties.
5.
Preference shall be given to an applicant who proposes to provide services that
are not specifically covered by private insurance, Medicaid, or
Medicare.
(5)
Consistency with Plans. An applicant for a new Hospice program shall provide
evidence in the application that the proposal is consistent with the needs of
the community and other criteria contained in local health council plans and
the State Health Plan. The application for a new Hospice program shall include
letters from health organizations, social services organizations, and other
entities within the proposed service area that endorse the applicant's
development of a Hospice program.
(6) Required Program Description. An
applicant for a new Hospice program shall provide a detailed program
description in its Certificate of Need application, including:
(a) Proposed staffing, including use of
volunteers.
(b) Expected sources of
patient referrals.
(c) Projected
number of admissions, by payer type, including Medicare, Medicaid, private
insurance, self-pay, and indigent care patients for the first 2 years of
operation.
(d) Projected number of
admissions, by type of terminal illness, for the first 2 years of
operation.
(e) Projected number of
admissions by two age groups, under 65 and 65 or older, for the first 2 years
of operation.
(f) Identification of
the services that will be provided directly by Hospice staff and volunteers and
those that will be provided through contractual arrangements.
(g) Proposed arrangements for providing
inpatient care (e.g., construction of a freestanding inpatient Hospice
facility; contractual arrangements for dedicated or renovated space in
hospitals or nursing homes).
(h)
Proposed number of inpatient beds that will be located in a freestanding
inpatient Hospice facility, in hospitals, and in nursing homes.
(i) Circumstances under which a patient would
be admitted to an inpatient bed.
(j) Provisions for serving persons without
primary caregivers at home.
(k)
Arrangements for the provision of bereavement services.
(l) Proposed community education activities
concerning Hospice programs.
(m)
Fundraising activities.
(7) Construction of a Freestanding Inpatient
Hospice Facility. The Agency will not normally approve a proposal for
construction of a freestanding inpatient Hospice facility unless the applicant
demonstrates that the freestanding facility will be more cost-efficient than
contractual arrangements with existing hospitals or nursing homes in the
service area. The application shall include the following:
(a) A description of any advantages that the
Hospice program will achieve by constructing and operating its own inpatient
beds.
(b) Existing contractual
arrangements for inpatient care at hospitals and nursing homes; or, in the case
of a proposed new Hospice program, contacts made with hospitals and nursing
homes regarding contractual arrangements for inpatient care.
(c) Anticipated sources of funds for the
construction.
(8)
Semi-Annual Utilization Reports. Each Hospice program shall report utilization
information to the Agency or its designee on or before July 20 of each year and
January 20 of the following year. The July report shall use the Semi-Annual
Report of Hospice Utilization (July), AHCA Form 5000-3545 (created June 2013),
incorporated by reference within this rule and available on the Agency website
at http://ahca.myflorida.com/MCHQ/CON_FA/Forms/index.shtml
and https://www.flrules.org/Gateway/reference.asp?No=Ref-03949.
The July report shall indicate the number of new patients admitted during the
6-month period composed of the first and second quarters of the current year,
the census on the first day of each month included in the report, and the
number of patient days of care provided during the reporting period. The
January report shall use the Semi-Annual Report of Hospice Utilization
(January) AHCA Form 5000-3546 (created June 2013), incorporated by reference
within this rule and available on the Agency website at
http://ahca.myflorida.com/MCHQ/CON_FA/Forms/index.shtml
and https://www.flrules.org/Gateway/reference.asp?No=Ref-03948.
The January report shall indicate the number of new patients admitted during
the 6-month period composed of the third and fourth quarters of the prior year,
the census on the first day of each month included in the report, and the
number of patient days of care provided during the reporting period. The
following detail shall also be provided.
(a)
For the number of new patients admitted:
1.
The 6-month total of admissions under age 65 and age 65 and over by type of
diagnosis (e.g., cancer; AIDS).
2.
The number of admissions during each of the 6 months covered by the report, by
service area of residence.
(b) For the patient census on January 1 or
July 1, as applicable, the number of patients receiving Hospice care in:
1. A private home.
2. An assisted living facility.
3. A Hospice residential unit.
4. A nursing home.
5. A hospital.
(9) Grandfathering Provisions. A Hospice
program licensed as of the effective date of this rule is authorized to
continue to serve all counties in the service area where its principal place of
business is located. A Hospice program whose Certificate of Need or current
license permits Hospice services in a county or counties in an adjacent service
area may continue to serve those adjacent counties. Any expansion to provide
service to other counties in an adjacent service area is subject to regulation
under this rule.
Rulemaking Authority 408.034(3), (8), 408.15(8) FS. Law
Implemented 408.035, 408.036(1)(d), 408.043(1)
FS.
New 4-17-95, Amended 7-30-95, 7-21-09, 5-3-10, 10-14-12,
4-14-14, 9-10-15.
