The agency intends to amend the rule used in certificate of need (CON) review of proposals to establish hospice programs. The proposed rule amendments amends projects subject to review, the definitions used in the current rule, the rule name, the ...

Certificate of Need

RULE NO.: RULE TITLE:

59C-1.0355 Hospice Programs

PURPOSE AND EFFECT: The agency intends to amend the rule used in certificate of need (CON) review of proposals to establish hospice programs. The proposed rule amendments amends projects subject to review, the definitions used in the current rule, the rule name, the hospice service areas, the review criteria, and the hospice utilization reporting requirements. A preliminary draft of the rule is included in this Notice.

SUBJECT AREA TO BE ADDRESSED: Definitions used in the hospice rule, the review criteria, and hospice utilization reporting.

SPECIFIC AUTHORITY: 408.15(8) FS., 408.034(6), FS.

LAW IMPLEMENTED: 408.034(3) FS., 408.036(1)(b)(d)(e) FS., 408.043(2), FS.

A RULE DEVELOPMENT WORKSHOP WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: April 25, 2006, 2:00 p.m. (EST)

PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building 3, Conference Room C, Tallahassee, Florida

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

 

59C-1.0355 Hospice Programs.

(1) Agency Intent. This rule implements the provisions of subsection 408.034(3), paragraphs 408.036(1)(d) and (e), and subsection 408.043(2), Florida Statutes. It is the intent of the agency to ensure the availability of hospice services 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, and a change in licensed bed capacity of a freestanding inpatient hospice facility. A separate certificate of need application shall be submitted for each service area defined in this rule. Projects for a new hospice program will not be comparatively reviewed with projects for free standing inpatient hospice facilities.

Definitions.

(2)(a) through (c)No change.

(d) “Fixed Need Pool.” The fixed need pool defined in Rule subsection 59C-1.002(20), Florida Administrative Code. 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.” A corporation eligible for licensure as a hospice consistent with the provisions in Chapter 400, Part VI, Florida Statutes. A hospice may not provide hospice services in the state without a license as described in Chapter 400, Part VI, Florida Statutes. Hospices are licensed to serve a specified county or group of counties, and may provide hospice services in one or more of the service areas defined in this rule. A hospice licensed to serve any county in a service area may serve all other counties in that area without further certificate of need approval.

(g)(f) “Hospice Program.” A program that provides hospice services as provided in Section 400.609, Florida Statutes, in one of the 27 service areas defined under this rule. described in subsections 400.601(2), 400.602(5), 400.609, and 400.6095(1), Florida Statutes, 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.

(h) “Hospice Services.” As provided in Section 400.609, Florida Statutes, hospice services include a continuum of palliative and supportive care for the terminally ill patient and their 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 within the service area, and available without regard to age, gender, national origin, sexual orientation, disability, diagnosis, cost of therapy, ability to pay, or life circumstances.

(i)(g) “Inpatient Bed.” Inpatient beds located in a freestanding inpatient hospice facility, a hospital, or a nursing home and available for hospice inpatient care. Inpatient beds located in a freestanding inpatient hospice facility are licensed to the hospice. Inpatient hospice beds in a hospital are licensed to the hospital, and remain licensed as acute care beds; inpatient hospice beds in a nursing home are licensed to the nursing home, and remain licensed as skilled nursing beds.

(h) “Local Health Council.” The council referenced in section 408.033(1), Florida Statutes.

(j)(i) No change.

(k)(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 s. 400.601(5)(4), 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.

(l)(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, and 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 3F consists of Alachua, Bradford, Dixie, Gilchrist, Lafayette, Levy, and Union Counties.

10. Service Area 3G consists of Putnam County.

11. through 27. renumbered 13. through 29. No change.

(m)(l) “Terminally Ill.” As defined in subsection 400.601(10)(9), Florida Statutes, 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. Hospices programs shall comply with the standards for program licensure described in Chapter 400, Part VI, Florida Statutes, and Chapter 59A-2, Florida Administrative Code. 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, or change in licensed bed capacity 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(2), F.S., and the standards and need determination criteria set forth in this rule. Notification to the agency of a change in licensed bed capacity of a freestanding inpatient hospice facility is required under section 480.036(5),F.S. 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(2), 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 in a service area 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 services 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’s and Rehabilitative Services’ 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’s and Rehabilitative Services’ 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 published by 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 (9) 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)(9) of this rule.

350 is the targeted minimum 12-month total of patients admitted to a hospice program.

(b) through (d) No change.

(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 4.5.:

1. Preference shall be given to an applicant who demonstrates has a commitment to serve populations with unmet needs.

2. Preference shall be given to an applicant who proposes to provide services beyond the required core services listed in 42 CFR part 418, subpart D. 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. through 4. No change.

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. The applicant shall provided evidence of its ability to obtain contractual arrangements for inpatient services in acute care hospitals and skilled nursing facilities in the service area.

(6)(a) through (i) No change.

(j) Provisions for serving persons without primary caregivers at home and the homeless.

(k) though (m) No change.

(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 applicant must be in conformance with applicable physical plant requirements for a freestanding inpatient hospice facility. In addition to demonstrating that the project is more cost-efficient than contracting for inpatient beds in a hospital or nursing home, tThe 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) A listing and description of eExisting contractual arrangements for inpatient care at hospitals and nursing homes including availability of such beds and evidence of the willingness of area providers to contract for inpatient hospice services; 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.

(d) If the freestanding hospice will be located within another separately licensed healthcare facility such as a hospital or skilled nursing facility, the applicant must include evidence of compliance with Rule 58A-2.025, Florida Administrative Code, Physical Plant Requirement for an Inpatient Facility along with a copy of the proposed lease agreement.

(e) When an existing hospice program seeks to establish multiple freestanding hospice facilities that will be licensed to that hospice:

1. Evidence that services are not duplicative.

2. Evidence that inpatient beds can expect a reasonable occupancy of at least 80 percent by the second year of operation.

3. Evidence that the local community supports the establishment of the additional facility.

4. Evidence that the additional facility is not located within a 15 mile radius of an existing freestanding inpatient hospice operated by the same hospice program.

(8) Change in Licensed Bed Capacity of a Freestanding Inpatient Hospice Facility. A hospice program proposing to change the licensed bed capacity of its freestanding inpatient hospice facility shall indicate in its application:

(a) The annual occupancy rate for the freestanding inpatient hospice facility beds for the most recent 12-month period preceding the application submission.

(b) The extent to which the number of contracted beds in hospitals and nursing homes will be modified as a result of the change in licensed capacity of the freestanding inpatient hospice facility.

(8)(9) 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 indicate the number of new patients admitted during the 6-month period by zip code location 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 indicate the number of new patients admitted during the 6-month period by zip code location 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. Each hospice program shall submit a report for a single hospice planning area. A hospice program serving more than one planning area may not submit a report containing combined data. The following detail shall also be provided.

(a) through (b) No change.

(9)(10) 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.

Specific Authority 408.15(8) FS., 408.034(6)(3), (5) FS. Law Implemented 408.034(3) FS., 408.035 FS., 408.036(1)(c), (e), (f) FS.,408.043(2) FS., 400.606(4), (5) FS. History–New 4-17-95, Amended 7-30-95, ________.