The agency is proposing to update the materials incorporated by reference and removes a regulation.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Certificate of Need

RULE NO.:RULE TITLE:

59C-1.0355Hospice Programs

PURPOSE AND EFFECT: The agency is proposing to update the materials incorporated by reference and removes a regulation.

SUBJECT AREA TO BE ADDRESSED: The proposed rule is being updated to include the 2012 Department of Health Office of Vital Statistics Florida Vital Statistics Annual Report, deaths, and the 2012 Office of the Governor Florida Population Estimates and Projections by AHCA District 2010 to 2025 reports. This amendment also removes “a change in licensed bed capacity of a freestanding inpatient hospice facility” from this rule’s regulation.

RULEMAKING AUTHORITY: 408.15(8), 408.034(3), (6) FS.

LAW IMPLEMENTED: 408.034(3), 408.035, 408.036(1)(d), 408.043(2), 400.606(3), (4) FS.

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

DATE AND TIME: July 18, 2013, 8:30 a.m. – 9:30 a.m.

PLACE: Agency for Health Care Administration, 2727 Mahan Drive, Building #3, Conference Room D, 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, Florida Center for Health Information and Policy Analysis, 2727 Mahan Drive, Mail Stop 28, Building 1, Tallahassee, Florida or call [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 DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT IS: Marisol Fitch, Florida Center for Health Information and Policy Analysis, 2727 Mahan Drive, Mail Stop 28, Building 1, Tallahassee, Florida or call [phone]

 

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

 

59C-1.0355 Hospice Programs.

(1) Agency Intent. This rule implements the provisions of Sections 408.034(3), 408.036(1)(d), and 408.043(2), 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, 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.

(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(19), 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 58A-2, 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, 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. 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 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 × P1) + (65C × P2) + (U65NC × P3) + (65NC × 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)	×	PT
65C	=	(65c/CT)	×	PT
U65NC	=	(u65nc/CT)	×	PT
65NC	=	(65nc/CT)	×	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 following materials are incorporated by reference within this rule; Department of Health Office of Vital Statistics Florida Vital Statistics Annual Report 2012 2010, Deaths, and the Office of the Governor Florida Population Estimates and Projections by AHCA District 2010 2000 To 2025 2020, released February, 2012 September, 2010. These publications are available on the Agency website at http://ahca.myflorida.com/MCHQ/CON_FA/Publications/index.shtml and http://www.flrules.org/Gateway/reference.asp?No=Ref-01677.

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.

3. That there are persons referred to hospice programs who are not being admitted within 48 hours. The applicant shall indicate the number of such persons.

(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 AHCA Form 5000-3545, incorporated by reference within this rule and available on the Agency website at http://ahca.myflorida.com/MCHQ/CON_FA/Forms/index.shtml. 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 AHCA Form 5000-3546, incorporated by reference within this rule and available on the Agency website at http://ahca.myflorida.com/MCHQ/CON_FA/Forms/index.shtml. 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), (6), 408.15(8) FS. Law Implemented 408.034(3), 408.035, 408.036(1)(d), 408.043(2), 400.606(3), (4) FS. History–New 4-17-95, Amended 7-30-95, 7-21-09, 5-3-10, 10-14-12,_________.