Rule 59A-33 will undergo rule development to update the application form reference; update the financial forms incorporated by reference and remove the surety bond option as an alternative to financials; remove outdated language and language found ...

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NOS.:RULE TITLES:

59A-33.002Licensure, Application Process, General Requirements

59A-33.006Certificates of Exemption and Exempt Status

59A-33.007AHCA Forms Availability, Information and Website

59A-33.008Medical or Clinic Director

59A-33.012Survey Requirements and Process

PURPOSE AND EFFECT: Chapter 59A-33, F.A.C. will undergo rule development to update the application form reference; update the financial forms incorporated by reference and remove the surety bond option as an alternative to financials; remove outdated language and language found in uniform licensing Chapter 59A-35, F.A.C.; amend rule to implement assessment fee and new accreditation requirements; add provisions for licensees whose accreditation no longer meets the statutory requirements.

SUMMARY: Chapter 59A-33, F.A.C., is amended to update the Rule Chapter Title to remove “Index to Proposed Rules”. Chapter 59A-33.002, F.A.C., is amended to update the application form reference, update the financial forms incorporated by reference and removing the surety bond option as an alternative to financials; Removing outdated language and language found in uniform licensing rule; Amend rule to implement new accreditation requirements; add provisions for licensees whose accreditation no longer meets the statutory requirements. Rule 59A-33.006, F.A.C., is amended to update the application form reference. Rule 59A-33.007, F.A.C., is amended to update phone information. Rule 59A-33.008, F.A.C., is amended to update statutory reference to correct statute numbers and removing outdated language and language found in uniform licensing rule. Rule 59A-33.012, F.A.C. is amended to update statutory references to correct statute numbers.

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.

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: 400.991(1), 400.991(7)(d), 400.995(3), 400.9925, 408.809, 408.810(8), 408.819 FS.

LAW IMPLEMENTED: 120.54, 120.60(6), 400.9905(5), 400.9915(3), 400.991(1)(a), (4), (7)(d), 400.9925, 400.993(6), 400.9935(1)(a)-(g), (3), 400.995(1), (6), (8), 408.809, 408.810(8), 408.819, 435.04 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:

DATE AND TIME: October 27, 2014, 10:00 a.m. – 11:00 a.m.

PLACE: Agency for Health Care Administration, Ft. Knox Bldg. 3, Conference Room C, 2727 Mahan Drive, Tallahassee, FL 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 7 days before the workshop/meeting by contacting: Tom Jones, 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: Tom Jones, [phone], email: [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

INDEX TO PROPOSED RULES FOR HEALTH CARE CLINIC LICENSURE

 

59A-33.002 Licensure, Application Process, General Requirements.

(1) The applicant or licensee or prospective licensee shall make application for an initial, change of ownership, or renewal license to operate a health care clinic and shall provide all of the information required by this rule and Chapter 400, Part X, F.S., on the Health Care Licensing Application, Health Care Clinics, AHCA Form 3110-0013, July 2014, Application for Health Care Clinic Licensure July 2006,which is incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX and available from the Agency for Health Care Administration website at: http://ahca.myflorida.com/HQAlicensureforms.

The following shall be included with the application:

(a) License Fee. A nonrefundable $2,000 application fee payable to AHCA; and

(b) Fictitious Name. When an applicant intends to operate under a fictitious name, a copy of an Affidavit of Compliance with Fictitious Name pursuant to Section 865.09, F.S., or a copy of a registration form from the Division of Corporations, Secretary of State, showing registration of the applicant’s fictitious name; and

(c) Evidence of Incorporation. When an applicant is a corporation or other entity, a copy of the registration of the applicant entity on file with the Division of Corporations, Secretary of State, State of Florida; and

(d) Financial Projections. Proof of financial ability to operate for the first year of licensure. Proof of financial ability to operate must be demonstrated for initial licensure and change of ownership applications as required in Section 408.810(8), F.S. and Rule 59A-35.062, F.A.C. This proof shall include evidence that the applicant has sufficient assets, credit, and projected revenues to cover liabilities and expenses. The applicant must submit a projected income and expense statement and projected balance sheet that have been prepared according to generally accepted accounting principals and signed by a certified public accountant. As a convenience, the applicant may submit the required information on AHCA Form 3110-0013, July 2006, Schedule 2, Projected Income and Expense, and Schedule 3, Projected Balance Sheet, which form is incorporated by reference. As an alternative, and not in addition to providing a projected income and expense statement and projected balance sheet, the applicant may submit a surety bond in the amount of $500,000 payable to the Agency for Health Care Administration. For a Surety Bond the applicant must submit AHCA Form 3110-0013, Health Care Clinic surety bond, July 2006, which is incorporated by reference; and

(e) Accreditation. Each clinic engaged in magnetic resonance imaging (“MRI”) services shall provide documentation that it is accredited by a national accrediting organization that is approved by the Centers for Medicare and Medicaid Services for magnetic resonance imaging and advanced diagnostic imaging services within 1 year after licensure or one year after beginning MRI services to patients or placing a new magnet for an existing MRI. This period may be extended in accordance with Section 400.9935(7)(a), F.S. Clinics that are accredited by the Accreditation Association for Ambulatory Health Care prior to July 1, 2013, shall be accredited by an approved accreditating organization on or before July 1, 2014; and

(f)(e) Background Screening. Applicants must submit evidence of compliance with level 2 background screening requirements as required in Section 400.991, F.S. and Section 408.809, F.S. All information required by this paragraph (e) to enable the Agency to evaluate and determine compliance with the Act regarding background screening. This information must include the identification of all individuals who must be the subject of Level 2 background screening under standards established in Chapter 435, F.S., and in Section 400.991(7)(d), F.S., as required on AHCA Form 3110-0013, July 2006, Application for Health Care Clinic Licensure, adopted by reference.

1. Individuals required to meet background screening requirements include individuals owning or controlling, directly or indirectly, 5% or more of an ownership interest in the health care clinic; the medical or clinic director, or similarly titled person responsible for the day to day operation of the health care clinic; the financial officer or similarly titled individual responsible for the financial operation of the health care clinic, and all licensed health care practitioners employed by or under contract to the health care clinic that have been issued a license, registration or certification by the Florida Department of Health.

2. For each individual not previously screened within the last 5 years who passed background screening in accordance with the Act in such previous background screening, the applicant for licensure shall submit an original completed applicant (meaning that individual) fingerprint card (blue and white card) from any authorized agency or law enforcement office in the United States plus the applicable processing fee established by the Florida Department of Law Enforcement (FDLE); provided however, an individual who owns an interest in a health care clinic, where such ownership interest is less than a 10% interest, shall not be required to submit a fingerprint card. This latter proviso shall not preclude the Agency from determining through means other than through the examination of fingerprints, whether any such individual has a criminal record that precludes issuance of a health care clinic license to the applicant for licensure.

3. Within thirty (30) days of receipt by the Agency of the results of background screening by FDLE and by the Federal Bureau of Investigation (FBI), the Agency will notify the applicant in writing if the determination is other than compliant (“HCC-OK”). Within twenty-one (21) days of such notice by the Agency to the licensure applicant, with the Agency’s accompanying request for additional information, the applicant shall provide the additional information to the Agency to enable the Agency to make a final determination regarding whether a disqualifying criminal record exists for any such individual that would preclude issuance of the license to the applicant. The Agency will notify the applicant for the license in writing of a final disqualifying criminal record and the right to formally contest the determination.

4. Any applicant that fails to provide requested criminal or other necessary information within twenty-one (21) days after the notice to the applicant of the need for such information regarding any particular individual, or that otherwise fails to respond to the notice in a manner that resolves the problem in determining the disqualifying nature of the criminal record of a particular individual, shall be subject to having the applicant’s pending license application withdrawn or an existing license revoked for such failure.

5. Individuals directly or indirectly owning or controlling 5% or more of an interest in a health care clinic means the natural persons owning or controlling stock, directly or indirectly, in the applicant entity or owning or controlling 5% or more interest in a company or companies directly or indirectly related to the applicant entity through inter-company ownership or control. For example: When a parent company or companies own 100% of the outstanding stock or controls the applicant entity, any individual owning or controlling a 5% or more interest in the parent company is required to undergo background screening in accordance with the Act.

6. No license will be issued to any health care clinic until all of the required background screening responses from FDLE and from the FBI have been received by the Agency and the individuals screened have been determined cleared in accordance with the Act and with this rule. Documentation that resolves background screening issues is required documentation pursuant to Section 400.991(4), F.S. A license that is granted, notwithstanding the existence of a pending criminal charge against an individual whose criminal case will not be resolved within the time specified in this rule, and which criminal charge may result in the establishment of a criminal record that would have precluded licensure if established prior to issuance of the license, shall be subject to periodic review by the Agency specifically as to the disposition of that individual’s criminal charge. The licensee shall promptly notify the Agency of such disposition upon learning of it.

(g) Medical/Clinic Director Attestation, AHCA Form 3110-1028 (Sept 2014), incorporated herein by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX and available from the Agency for Health Care Administration website at: http://ahca.myflorida.com/HQAlicensureforms.

(2) All forms and these rules may be obtained by contacting the Agency as shown in Rule 59A-33.007, F.A.C.

Rulemaking Specific Authority 400.991(1), 400.991(7)(d), 400.995(3), 400.9925, 408.809, 408.810(8) FS. Law Implemented 400.9925, 400.991(1)(a), (4), (7)(d), 408.809, 408.810(8), 435.04 FS. History–New 8-28-06, Amended________.

 

59A-33.006 Certificates of Exemption and Exempt Status.

(1) Facilities and entities exempt from health care clinic license requirements are set forth in Section 400.9905(4), F.S. A facility is not required to have, but may voluntarily apply for a certificate of exemption.

(2) Facilities that claim an exemption, either by filing an application for a certificate of exemption with the Agency and receiving a certificate of exemption, or self-determining, must maintain an exempt status at all times the facility is in operation.

(3) When a change to the exempt status occurs to an exempt facility or entity that causes it to no longer qualify for an exemption, any exempt status claimed or reflected in a certificate of exemption ceases on the date the facility or entity no longer qualifies for a certificate of exemption. In such case, the health care clinic must file with the Agency a license application under the Act within 5 days of becoming a health care clinic and shall be subject to all provisions of the Act applicable to unlicensed health care clinics. Failure to timely file an application for licensure within 5 days of becoming a health care clinic will render the health care clinic unlicensed and subject the owners, medical or clinic directors and the health care clinic to sanctions under the Act.

(4) A facility becomes a “clinic” as defined in Section 400.9905 (4), F.S., when it does not qualify for an exemption, provides health care services to individuals and bills third party payers for those services.

(5) Change of Exempt Status. When exempt status changes are discovered, the Agency will notify a facility or entity applying for, obtaining or self-determining exempt status, that the exempt status is no longer valid, giving the grounds therefore, the date of the change, when known, and the statutory and rule provisions applicable. The Agency shall give the facility or entity notice of unlawful health care clinic operation, the statutory and rule requirements of becoming a health care clinic and sanctions for operating without a valid license for the owners, medical or clinic directors and the location. The Agency shall also provide information to the facility or entity believed to be operating without exempt status of the licensing procedures and the Agency filings necessary to meet licensure requirements.

(6) The applicant for a certificate of exemption must affirm, without reservation, the exemption sought pursuant to Section 400.9905(4), F.S., and the qualifying requirements for obtaining and maintaining an exempt status; the current existence of applicable exemption-qualifying health care practitioner licenses; qualified ownership, qualified certifications or registration of the facility or owners; federal employer identification number; services provided; proof of legal existence and fictitious name, when the entity and name are required to be filed with the Division of Corporations, Department of State; plus other satisfactory proof required by form adopted by this rule.

(7) The fee for issuance of a certificate of exemption shall be $100 and submitted to the Agency with the application.

(8) Within 30 calendar days after application receipt, the Agency shall determine whether the application is complete. If the application is deemed incomplete, the Agency shall request in writing from the applicant specific information necessary for the application to be deemed complete. Only one such request will be made by the Agency. If the applicant does not provide the specific additional information required by the statute and rule in writing to the Agency within 21 calendar days of receipt of the Agency’s request, the application will be deemed incomplete and the certificate of exemption shall be withdrawn from further consideration. The applicant’s response must be received by the Agency no later than 5:00 p.m., E.S.T., on the omissions due date. An application for a certificate of exemption from health care clinic licensure shall be granted or denied by the Agency within 90 days of receipt of a fully completed application on the Application for Exemption from Licensure as a Health Care Clinic, AHCA Form 3110-0014, July 2014 July 2006, which is incorporated by reference and may be obtained at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX and available from the Agency for Health Care Administration web address at: http://ahca.myflorida.com/HQAlicensureforms in accordance with Rule 59A-33.007, F.A.C.

(9) The Agency shall rely upon the address given on the application as the official address to which correspondence may be sent. It is the duty of the applicant to notify the Agency in writing at least 10 days in advance of any change of the current mailing address by contacting the Agency according to Rule 59A-33.007, F.A.C.

(10) Certificates of exemption are not moveable or transferable, directly or indirectly. They are valid only for the applicant, qualifying owners, licenses, registrations, certifications and services provided under specific statutory exemptions and are valid only to the specific exemption claimed and granted. In order for a certificate of exemption to be valid the applicant must apply for and receive a new certificate of exemption for changes of location and any qualifying statutory or rule requirement of an exemption.

Rulemaking Authority 400.9925 FS. Law Implemented 400.9905(4), 400.9935(2), (9) FS. History–New 8-28-06, Amended________..

 

59A-33.007 AHCA Forms Availability, Information and Website.

All forms and corresponding instructions, copies of these rules, the Health Care Clinic Act and other information necessary for licensure and exemption that are incorporated by reference into this chapter, may be obtained from the Health Care Clinic Unit website: http://www.fdhc.state.fl.us/MCHQ/Health_Facility_Regulation/HealthCareClinic/index.shtml or may be obtained by written request addressed to: AHCA, Health Care Clinic Unit, 2727 Mahan Drive, MS #53, Tallahassee, FL 32308 or by telephone at [phone] 488-1365 for mailing or inquiry.

Rulemaking Specific Authority 400.9925 FS. Law Implemented 120.54 FS. History–New 8-28-06, Amended________.

 

59A-33.008 Medical or Clinic Director.

(1) A licensed health care clinic may not operate or be maintained without the day-to-day supervision of a single medical or clinic director as defined in Section 400.9905(5), F.S. The health care clinic responsibilities under Sections 400.9935(1)(a)-(i)(g), F.S., cannot be met without an active, appointed medical or clinic director. Failure of an appointed medical or clinic director to substantially comply with health care clinic responsibilities under Rule 59A-33.012, F.A.C., and Sections 400.9935(1)(a)-(i)(g), F.S., shall be grounds for the revocation or suspension of the license and assessment of a fine pursuant to Section 400.995(1), F.S.

(2) By statutory definition in Section 400.9905(5), F.S., a medical director is a health care practitioner that holds an active and unencumbered Florida physician’s license in accordance with Chapters 458 (medical physician), 459 (osteopathic physician), 460 (chiropractic physician) or 461 (podiatric physician), F.S. A suspended or non-renewed license is considered an encumbered license, as is a license that restricts the license holder from performing health care services in a manner or under supervision different from a license holder without board or Department of Health restrictions.

(3) The Agency shall issue an emergency order suspending the license of any health care clinic operated or maintained without a medical or clinic director as required by the Act and this rule for such period of time as the health care clinic is without a medical or clinic director. The Agency shall assess a civil fine of up to $5,000 for operating or maintaining a health care clinic without a medical or clinic director. Each day of operation following receipt of Agency notice is considered a separate offense. Operation and maintenance of a health care clinic without a medical or clinic director shall be grounds for revocation of the license in addition to the assessment of fines pursuant to Section 400.995 (1), F.S.

(4) Unless otherwise exempted by law, an application for a change in the medical or clinic director shall be accompanied by a fingerprint card of the new medical or clinic director together with the required processing fee for background screening of that individual.

Rulemaking Authority 400.9925(1), (2) FS. Law Implemented 120.542, 120.60(6), 400.9905(5), 400.9915(3), 400.993, 400.9935(1) (a)-(g), 400.9935(3), 400.995(1), (6) FS. History–New 8-28-06, Amended________.

 

59A-33.012 Inspection Survey Requirements and Process.

(1) An applicant for health care clinic licensure must demonstrate compliance with the requirements in Ch. 400, Part X, Florida Statutes (F.S.), Ch. 408, Part II, F.S., Chapters 59A-35 and 59A-33, Florida Administrative Code (F.A.C.) during an inspection as required in Sections 408.806 and 408.811, F.S. The survey process is an onsite inspection and review of the health care clinic facility or administrative office, by authorized Agency employees to determine the health care clinic’s compliance with the minimum standards established by the Act, its statutory references and rules regulating the operation and licensure of health care clinics. Inspections Surveys will be conducted as part of the review process for initial, renewal, change of ownership and complaint investigations and may be unannounced. The purpose of the survey is to verify information provided on an application as well as inspect, review, interview, document and determine that the minimum health care delivery system attributes for a health care clinic, as required by the Act and these rules are in place and operational or will be operational after commencing business.

(2) A survey will be conducted for:

(a) Initial applications for licensure; and

(b) Applications for renewal licenses; and

(c) Applications for a change of ownership;

(d) Complaints filed with the Agency.

(2)(3) The surveyor will request the health care clinic to demonstrate how it is meeting or will meet the minimum requirements for licensure. The medical or clinic director must attend the survey entrance conference and be available when the survey is conducted for the surveyor to determine compliance with minimum standards and requirements for licensure. Other key personnel required include the financial director, a representative of management or ownership and persons responsible for patient records and billing.

(4) At the entrance conference, each surveyor will identify himself or herself and will discuss the survey process and what is expected of the health care clinic during the survey. At the exit conference, surveyors will inform health care clinic representatives of the findings of the survey. When deficiencies are found, the surveyor will discuss them with the persons then in attendance and discuss the criteria for determining the level of sanctions in accordance with Sections 400.995(1)(a)-(d), F.S. The field office shall inform the health care clinic in writing of its recommendations and shall require a plan of correction to be prepared and delivered to the field office within 10 days of receipt to correct deficiencies when minimum health care delivery system requirements have not been met. Implementation and Agency verification of a successful plan of correction does not prohibit the field office from recommending sanctions. Sanctions shall include the assessment of fines, suspension, moratorium, emergency order of suspension and revocation.

(3)(5) To facilitate a licensure survey, the health care clinic shall have the following materials readily available for review at the time of the survey:

(a) The professional license or facsimile of the license for the medical or clinic director.

(b) Copy of medical or clinic director’s written agreement with the health care clinic assuming the responsibilities for the statutory activities in Sections 400.9935(1)(a)-(i)(g), F.S. If the medical or clinic director signs the Medical/Clinic Director Attestation, AHCA Form 3110-1028 (Sept 2014), referenced in Rule 59A-33.002, F.A.C. application or change of medical or clinic director form, acknowledging these responsibilities as specified in Section 400.9935, F.S., this requirement is met.

(c) Written policies, protocols, guidelines and procedures used or to be used by the facility staff in day-to-day operations. This includes, but is not limited to protocols for physician assistants and advanced registered nurse practitioners plus a copy of the supervision form submitted to the Department of Health by the physician supervisor.

(d) Any policies, procedures, guidelines, checklists and/or means that are used in the systematic creation and maintenance of the health care clinic’s medical record system.

(e) Any policies, procedures, guidelines, checklists that demonstrate compliance with the medical records retention, disposition, reproduction, and disclosure requirements of the medical or clinic director’s practice act.

(f) Any policies, procedures, guidelines, checklists that demonstrate compliance with the office surgery requirements of the practice acts for services performed at the facility.

(g) Any policies, procedures, guidelines, checklists that demonstrate compliance with adverse incident reporting requirements and injury disclosure.

(h) Personnel files.

(i) Logs, charts or notes demonstrating day-to-day oversight of health care clinic activities by the medical or clinic director.

(j) Copies of professional licenses issued by the respective boards and the Department of Health under the several practice acts.

(k) Any patient referral contracts or agreements of the health care clinic that are in writing and a disclosure to the surveyor of any such agreements that are not in writing including the names of the parties to the agreement, the date and the essential terms of agreement.

(l) For health care clinics that are in operation at the time of the survey, the surveyor will select a sample of at least five (5) patient medical records from the previous 6 months of operation with at least one Medicaid file, if certified as a Medicaid provider, plus the five (5) billing records that correspond with the five patient records.

(m) Description of means by which the health care clinic conducts a systematic review of billings that ensures billings are not fraudulent or unlawful. A sample must be reviewed by the medical director or clinic director at least once every 30 days and a record maintained by the health care clinic for at least three years identifying the records reviewed and when and what action was taken to correct fraudulent or unlawful billings. A log of systematic reviews shall be kept and maintained in a discrete file at the health care clinic for review on request of the Agency during the retention period.

(n) List of services provided or a general descriptor of scope, level and complexity of care for services provided.

(o) Current diagnostic and treatment equipment records showing equipment certification when such equipment must have regulatory certification. This requirement is met with presentation of a current maintenance agreement.

(p) An organizational flow chart with lines of authority and names of key individuals and positions.

(q) An all-inclusive and up to date listing of original signatures and initials of all persons entering information on billing and patient records, the printed name and medical designation, if any, such as PA, RN, MD, etc. The log shall be kept and concurrently maintained at the health care clinic. Information required by this rule shall be stored and maintained by the health care clinic for a period of 5 years.

(r) Log of all natural persons required and who have been screened under Level 2 criteria of Chapter 435 and Section 400.991, F.S.

(s) Documentation for the past two years or from the date of licensure, whichever is earlier, demonstrating in writing compliance, when, and what action was taken by the medical or clinic director to perform the functions, duties and clinic responsibilities under Sections 400.9935(1)(a)-(i)(g), F.S. Such documentation shall be made available to authorized agency personnel upon request.

Rulemaking Specific Authority 400.9925, 408.806, 408.811 FS. Law Implemented 120.542, 120.60(6), 400.9905(5), 400.9915(3), 400.993(6), 400.9935(1)(a)-(i)(g), 400.9935(3), 400.995(1), (6), (8), 408.806, 408.811 FS. History–New 8-28-06, Amended________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Tom Jones

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: September 15, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 22, 2014