The Agency proposes to update rule 59A-38.004 pursuant to changes in section 400.60501(1), F.S. Proposed amendments remove references to the Department of Elder Affairs reporting requirements, timeframes, and outdated forms. ....

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NO.:RULE TITLE:

59A-38.004Administration of the Hospice

PURPOSE AND EFFECT: The Agency proposes to update rule 59A-38.004 pursuant to changes in section 400.60501(1), F.S. Proposed amendments remove references to the Department of Elder Affairs reporting requirements, timeframes, and outdated forms. New language specifies hospice providers must comply with the national hospice outcome measures adopted by the Centers for Medicare and Medicaid Services.

SUMMARY: The Agency proposes to update rule 59A-38.004 pursuant to changes in section 400.60501(1), F.S., to align hospice outcome measures and survey data with federal regulations adopted by the Centers for Medicare and Medicaid Services (CMS).

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.

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: A SERC has not been prepared by the agency. For rules listed where no SERC was prepared, the Agency prepared a checklist for each rule to determine the necessity for a SERC. Based on this information at the time of the analysis and pursuant to section 120.541, Florida Statutes, the rule will not require legislative ratification.

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: 400.605, 400.60501, FS.

LAW IMPLEMENTED: 400.605(1)(c), 400.60501, 400.610, FS.

A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: June 8, 2021, 2:00 p.m. to 3:00 p.m.

PLACE: No public face-to-face meeting. This hearing will be conducted via teleconference. Participate by dialing the Open Voice conference line, 1(888)585-9008, then enter the conference room number followed by the pound sign, 476-211-242#. The agenda and related materials can also be found on the web at: https://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Rulemaking.shtml.

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 3 days before the workshop/meeting by contacting: Leigh Meadows, Bureau of Health Facility Regulation, 2727 Mahan Drive, Tallahassee, Florida, [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: Leigh Meadows at [phone] or email at:[e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59A-38.004 Administration of the Hospice

(1) Governing Body. The hospice provider must establish established written bylaws for a governing body with autonomous authority for the conduct of the hospice program. The governing body must satisfy the following requirements:

(a) Members must reside or work in the hospice provider’s hospice’s service area as defined in paragraph 59C-1.0355(2)(k), F.A.C.

(b) No person shall be denied membership on the governing body by reason of race, creed, color, age or sex.

(c) Duties of the governing body must include:

1. Adoption in writing of the following documents which must be in compliance with provisions of Chapter 400, Part IV, F.S., and these rules, with updates as necessary:

a. Criteria defining eligibility for hospice services;

b. A program for building and coordinating relationships with other community organizations in order to provide hospice patients assistance with meals, utility payments, legal services, home repair and equipment, and other needs as identified on an individual basis;

c. Standards of hospice care which will ensure compliance with these rules and chapter 400, part IV, F.S., and which will promote and maintain a quality of life for each patient and family that reflects the patient’s needs and values;

d. A comprehensive emergency management plan for all administrative, residential, free-standing inpatient facilities, and hospice services designed to protect the safety of patients and their families and hospice staff; and,

e. An annual operating and strategic plan and budget.

2. Promulgation of rules and bylaws which include at least the following:

a. The purpose of the hospice;

b. Annual review of the rules and bylaws which shall be dated and signed by the chairman of the governing body;

c. The powers and duties of the officers and committees of the governing body;

d. The qualifications, method of selection and terms of office of members and chairpersons of the governing body and committees; and,

e. A mechanism for the administrator’s appointment of the medical director and other professional and ancillary personnel.

(2) Administrative Officer. The hospice provider must employ an administrator whose duties must be outlined in a written job description, including job qualifications. The administrator must be approved by the governing body. The job description must be kept in an administrative file.

(a) The administrator shall be responsible for day-to-day operations and the quality of services delivered by the hospice provider.

(b) The administrator must be responsible for maintaining an administrative office for the purpose of the operations of the hospice provider.

(3) Administrative Policies and Practices.

(a) The administrator must be responsible for developing, documenting and implementing administrative policies and practices which are consistent with these rules, the bylaws, and the plans and decisions adopted by the governing body. These policies and practices must ensure the most efficient operation of the hospice program and the safe and adequate care of the patient and family units. These policies and practices must include:

1. Policies governing admission to the hospice program and discontinuation of care.

2. Personnel policies applicable to all full-time and part-time paid employees and volunteers, including job descriptions, job qualifications and duties, which shall be kept in an administrative file.

3. A plan for orientation and training of all staff, including volunteers, which must ensure that staff receive training prior to the delivery of services. This plan must describe the method of assessing training needs and designing training to meet those needs, and must include a curriculum outline with specific objectives.

4. Financial policies and practices that include:

a. An annual budget for approval by the governing body;

b. An annual audited financial statement for approval by the governing body;

c. An ongoing bookkeeping and financial management system that is developed and implemented according to sound business practice;

d. An ongoing payroll system that is developed and implemented according to sound business practice;

e. Procedures for accepting and accounting for gifts and donations; and,

f. A fee schedule for hospice care.

5. Policies for administering drugs and biologicals in the home which must include:

a. All orders for medications shall be dated and signed by a physician licensed in the State of Florida pursuant to chapter 458 or 459, F.S.

b. All orders for medications shall contain the name of the drug, dosage, frequency and route.

c. All verbal orders for medication or treatments, or changes in medication or treatment must be taken by a licensed health professional and recorded in the patient’s record. Verbal orders must be signed by the physician within thirty (30) calendar days from the date of the order.

d. Experimental drugs shall not be administered without the written consent of the patient or the patient’s legal representative, surrogate or proxy. The program administering such drugs must fully inform the patient or the patient’s legal representative, surrogate or proxy of any risks, and be prepared to invoke remedial action should an adverse reaction occur. A copy of the signed consent must be kept in the patient’s record.

6. Policies and procedures for the administration and provision of pharmaceutical services in inpatient and residential settings that are consistent with the drug therapy needs of the patient as determined by the medical director or the patient’s attending physician(s). The pharmaceutical services shall be directed by a pharmacist registered in the State of Florida.

7. Policies and procedures approved by the medical director and governing body pertaining to the hospice provider’s drug control system in the hospice including specific policies and procedures for disposal of Class II drugs upon the death of a patient.

8. Procedures which ensure the hospice provider can provide patients with medications on a twenty-four (24) hours a day, seven (7) days a week basis.

9. Policies and procedures for maintenance, confidentiality, and retention of clinical records for a minimum five-year period following the patient’s death.

10. Procedures for inpatient visitation by family and friends.

11. Procedures for maintaining a record of requests for services. The record shall indicate the action taken regarding each request for hospice services and whether or not the patient has the ability to pay for the services. In no case shall a hospice provider refuse or discontinue hospice services based on the inability of the patient to pay for such services.

12. Notice to the public that the hospice provider renders provides services regardless of ability to pay.

13. Notice to the public of all services provided by the hospice program, the geographic area in which the services are available, and admission criteria.

14. Policies for educating the community to enhance public awareness of hospice services.

15. Policies and procedures for completion, retention, and submission of reports and records as required by the department, agency, and other authorized agencies.

16. Policies and procedures for implementing universal precautions as established by the Centers for Disease Control and Prevention.

(b) Equipment and personnel, under medical supervision, must be provided for diagnostic procedures to meet the needs of the hospice inpatient, residential and home-care programs. This must include the services of a clinical laboratory and radiological services, which must meet all standards of the State of Florida. There must be written agreements or contracts for such services unless provided on the premises of the hospice. The hospice program must ensure that services are available twenty-four (24) hours a day, seven (7) days a week, either through contractual agreement, written agreement, or direct service provision by the hospice provider.

(c) Each hospice provider shall develop an infection control program which specifies procedures and responsibilities for inpatient, residential care and home-care programs. Procedures regulating the structure and function of this program shall be approved by the medical director and the governing body, and shall comply with federal and state laws regarding blood-borne pathogens, infection control and biohazardous waste.

(4) Outcome Measures. Each hospice provider must comply with the national hospice outcome measures as adopted by the Centers for Medicare and Medicaid Services (CMS) pursuant to 42 Code of Federal Regulations (CFR) Part 418, as a tool to set benchmarks for measuring quality of hospice care in the state.

(a) Effective with the report due by March 31, 2009, hospices must annually report the outcome measures outlined in this subsection on DOEA Form H-002, State of Florida Department of Elder Affairs Hospice Demographic and Outcome Measures Report, August 11, 2008.

1. The form is hereby incorporated by reference and may be obtained from the following address: Department of Elder Affairs, Planning and Evaluation Unit, 4040 Esplanade Way, Tallahassee, Florida 32399-7000. The form may also be obtained from the department’s Web site at: http://elderaffairs.state.fl.us/doea/hospice/DOEAformH002.xls.

2. The reporting time frame is January 1 through December 31, with the exception of the 2008 report, which only needs to include outcome measure data from the rule effective date through December 31, 2008.

3. The report must be submitted to the following email address no later than March 31 of the following year: [e-mail]. The report may alternately be submitted to the following address: Department of Elder Affairs, Planning and Evaluation Unit, 4040 Esplanade Way, Tallahassee, FL 32399-7000.

(b) In addition to the outcome measure regarding pain management pursuant to section 400.60501, F.S., each hospice must conduct the National Hospice and Palliative Care Organization (NHPCO) Patient/Family Satisfaction Survey, or a similar survey, with its patients and families.

1. Each hospice must report results from survey questions that inquire about the following areas of concern

a. Did the patient receive the right amount of medicine for his or her pain?

b. Based on the care the patient received, would the patient and/or family member/caregiver/legal representative/surrogate/proxy recommend hospice services to others?

2. The acceptable standard for this measure must be an affirmative response on at least fifty (50) percent of the survey responses received by the hospice.

(5) National Initiatives.

(a) In accordance with Section 400.60501, F.S., and as referenced in subsection (4) of this rule, the department Agency adopts the national initiative of utilizing patient/family surveys as a tool to set benchmarks for measuring quality of hospice care in the State of Florida.

(b) The department has also considered the national initiatives that are under evaluation and development by the Centers for Medicare and Medicaid Services (CMS) located at 70 Fed. Reg., 30840-30893, dated May 27, 2005. Hospices are encouraged to utilize these guidelines, along with the initiatives developed by the National Hospice and Palliative Care Organization available at http://www.nhpco.org, in developing their own comprehensive data collection and performance measurement process for these initiatives.

(c)(b) Hospice providers Hospices must maintain documentary evidence of their compliance with these national outcome measures and demonstrate their operations to the department or the Aagency during the survey process.

(6) This rule is in effect for five years from its effective date.

Rulemaking Authority 400.605, 400.60501 FS. Law Implemented 400.605(1)(c), 400.60501, 400.610 FS. History–New 5-6-82, Formerly 10A-12. 045(1) FS. Law Implemented 400.6045(1) FS. History–New 1-1-04, Amended           .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Leigh Meadows

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Simone Marstiller

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 3/26/2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 09/19/2019