The purpose of the proposed rule amendments is to update statutory references, forms, fees, websites; to make grammatical changes and corrections; to update provisions based on statutory changes; and to amend and delete language currently in Ch. 408,...

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NOS.:RULE TITLES:

59A-25.001Definitions

59A-25.002Licensure Requirements

59A-25.005Compliance

PURPOSE AND EFFECT: The purpose of the proposed rule amendments is to update statutory references, forms, fees, websites; to make grammatical changes and corrections; to update provisions based on statutory changes; and to amend and delete language currently in Chapter 408, F.S. and Chapter 59A-35, F.A.C. for conformity.

SUMMARY: The purpose of the proposed rule amendments is to update statutory references, forms, fees, websites; to make grammatical changes and corrections; to update provisions based on statutory changes; and to delete language currently in Chapter 408, F.S. and Chapter 59A-35, F.A.C. for conformity. Rule 59A-25.001, F.A.C, is amended to update the definition in paragraph (2) “Central Service Center” to clarify that a central service center and its distribution centers must be wholly owned and operated by the same entity or individual; the definitions for classes of deficiencies are removed since they are defined in Section 408.813(2), F.S. Rule 59A-25.002, F.A.C. is amended as follows: wording was added to paragraph (1) to make it clear that the rule only pertains to the provision of equipment to consumers in Florida; the license fee amount is corrected in paragraph (3)(a) to show the Consumer Price Index increase implemented pursuant to Section 408.805(2), F.S.; language relating to licensing procedures and background screening that are now in Chapter 59A-35, F.A.C. and Chapter 408 Part II, F.S. is removed; paragraph (5) is amended to remove language provided in Chapter 408, F.S. and provisions for submission of a surety bond no longer provided for in statute. Rule 59A-25.005, F.A.C., is amended to revise or delete language relating to classification of violations, fines and survey requirements already found in Chapter 408, F.S and Chapter 59A-35, F.A.C.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will 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 been prepared by the Agency.

A statement of estimated regulatory costs has been prepared for proposed rule revisions in Rule 59A-25.002, F.A.C., and is available from the person listed below. The following is a summary of the SERC:

For proposed rule subsection 59A-25.002(3), F.A.C., license fees are increased by the Consumer Price Index pursuant to Section 408.805(2), F.S. The biennial license fee will increase by $4.50. Based on the number of currently licensed facilities and projected growth, the total regulatory impact for a 5 year period is $10,980.00.

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 been prepared by the agency for Rule 59A-25.002, F.A.C. 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: 400.935 FS.

LAW IMPLEMENTED: 400.92, 400.925, 400.93, 400.931, 400.932, 400.933, 400.934, 400.935, 400.94, 400.945, 400.953, 400.957, 408.803, 408.804, 408.805, 408.806, 408.8065, 408.807, 408.809, 408.810, 408.811, 408.812, 408.813 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 (IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):

DATE AND TIME: January 6, 2015, 2:00 p.m. – 3:00 p.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: Noël Cronin Lawrence via e-mail: [e-mail] or by phone: [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: Noël Cronin Lawrence via e-mail: [e-mail] or by phone: [phone]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59A-25.001 Definitions.

In addition to definitions contained in Chapter 400, Part VII and Chapter 408, Part II, F.S., the following terms shall apply:

(1) “AHCA” means Agency for Health Care Administration.

(2) “Central Service Center” means the licensed premises that are in charge of taking consumer orders, dispatching the orders to licensed their distribution centers owned and operated by the same licensee that provide home medical equipment services, and maintaining consumer and personnel records. The central service center is responsible for the operation of its designated distribution centers.

(3) Class I deficiency is any act, omission, or practice that results in a consumer’s death, disability, or permanent injury, or places a consumer at imminent risk of death, disability, or permanent injury. Upon finding a class I deficiency, the agency shall impose an administrative fine in the amount of $5,000 for each occurrence and each day that the deficiency exists. In addition, the agency shall immediately revoke the license, deny the renewal of a license or impose a moratorium on accepting new consumers until the factors causing the deficiency have been corrected.

(4) Class II deficiency is any act, omission, or practice that has a direct adverse effect on the health, safety, or security of a consumer. Upon finding a class II deficiency, the agency shall impose an administrative fine in the amount of $1,000 for each occurrence and each day that the deficiency exists. In addition, the agency shall revoke the license, deny the renewal of a license or impose a moratorium on accepting new consumers, until the deficiency has been corrected.

(5) Class III deficiency is any act, omission, or practice that has an indirect, adverse effect on the health, safety, or security of a consumer. Upon finding an uncorrected or repeated class III deficiency, the agency shall impose an administrative fine not to exceed $500 for each occurrence and each day that the uncorrected or repeated deficiency exists.

(6) Class IV deficiency is any act, omission, or practice related to required reports, forms, or documents which does not have the potential of negatively affecting consumers. These violations are of a type that the agency determines do not threaten the health, safety, or security of patients. Upon finding an uncorrected or repeated class IV deficiency, the agency shall impose an administrative fine not to exceed $200 for each occurrence and each day that the uncorrected or repeated deficiency exists.

(3)(7) “Distribution centers” means those licensed premises that are not located at the address of the central service center but are owned and operated by the same licensee, receive orders from the central service center and are utilized to provide home medical equipment services.

(4)(8) “HME” means home medical equipment.

Rulemaking Specific Authority 400.935 FS. Law Implemented Part VII of Chapter 400, 400.92-.957, 408.804 FS. History–New 6-4-00, Amended 10-6-02, 3-13-07,_________.

 

59A-25.002 Licensure Requirements.

(1) Home medical equipment locations requiring a license are any locations that sell, rent, or distribute, or offer to sell or rent to or for a consumer any home medical equipment that requires services. These locations can be identified as follows:

(a) Any location providing or distributing home medical equipment requiring services to consumers in Florida;

(b) Any location where an intake person takes calls from consumers in Florida and offers to sell or rent home medical equipment requiring services;

(c) Any location where a consumer in Florida may call in response to a provider advertising to sell or rent home medical equipment requiring services,; e.g., television advertisements, toll-free telephone 800 numbers, phone books, newspapers, flyers or any other forms of public advertisement;.

(d) Any location out of state that offers to sell or rent home medical equipment requiring services to consumers in Florida;

(e) Any location in state or out of state, with sales representatives working in Florida, that offers to sell or rent home medical equipment requiring services to consumers in Florida, i.e., the sales representatives themselves do not need to be licensed; and

(f) Any buildings, that are not located at the licensed central service center address, called shops, warehouses, distribution centers, or called by any other name, are required to have a license if that site location provides selection (via telephone, showroom or sales representative), delivery, set up, consumer instruction or maintenance of equipment to consumers in Florida.

1.(g) A cCentral service centers must provide the names and locations of all of its their designated distribution centers on the licensure application.

2.(h) A dDistribution centers must submit a separate licensure application and must specify the name of its their central service center on the application.

3.(i) Each licensed distribution center is required to meet all standards for licensure but may be determined to meet the standards through the activities of its designated central service center as referenced in paragraph 59A-25.005(1)(b), F.A.C.

(2) Home medical equipment locations that do not require a license: Diabetic monitors and disposable supplies, e.g., diabetic, ostomy, urological and wound care supplies have been identified as equipment and supplies that do not require services as defined in Section 400.925(9)(11), F.S.; therefore, locations that supply these items only will not require a HME license.

(3) Licensing application and fees:

(a) An application for initial, change of ownership and renewal licensure must be made on the Health Care Licensing Application, Home Medical Equipment Provider, AHCA Form 3110-1005, October 2014, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX, and the Health Care Licensing Application Addendum prescribed in subsection 59A-35.060(1), F.A.C. These forms are available online at http://ahca.myflorida.com/HQAlicensureforms. An application Fees for initial, change of ownership licensure application and renewal licensure must be accompanied by will be a non-refundable $304.50 biennial 300 licensing fee and, if required, a $400 inspection fee for a two-year license per location. Businesses with a central service center having distribution centers sites are required to submit an application and a $304.50 biennial 300 licensing fee for each location, but shall submit only one $400 inspection fee with the application of the central service center.

(b) When a change is reported which requires the issuance of another license, a fee must be assessed by AHCA as referenced in Sections 408.805 400.931(13) and (14), F.S. The following fees have been established:

1. Change of ownership: a $300 license fee and a $400 inspection fee unless exempt from inspection;

2. Change of address: a $15 license fee;

3. Name change: a $15 license fee;

4. Duplicate license: a $5 license fee;

(c) The fee for an application package with rules, law, forms and an instruction package is based on AHCA’s actual cost of postage plus the copying fee per page as authorized in Section 119.07, F.S. The costs are rounded up to the next whole dollar. The documents and forms in the application package can be printed with no fee from the AHCA website at http://ahca.myflorida.com under ‘Licensing and Certification’, ‘Home Medical Equipment Providers’.

(4) Initial licensure application: An application for initial licensure must be made on forms prescribed by AHCA. The application package contains the following forms that are incorporated by reference as part of this rule:

(a) Health Care Licensing Application, Home Medical Equipment Provider AHCA Form 3110-1005, Revised December, 2006;

(b) Affidavit of Compliance with Screening Requirements, AHCA Form 3110-1006, Revised December 2006;

(c) Home Medical Equipment Provider Bond, AHCA Form 3110-1018, Revised August 2006.

These forms may be obtained through the AHCA Licensed Home Health Programs Unit, 2727 Mahan Drive, Mail Stop 34, Tallahassee, Florida 32308-5407. In addition to the application, the following information must be submitted.

(4)(d) Initial and change of ownership applicants must submit proof of demonstrate financial ability to operate pursuant to as referenced in Sections 400.931(3) 408.8065(1) and 408.810(8), F.S., and Rule 59A-35.062, F.A.C. by submitting proof of a current $50,000 surety bond for each location to be licensed or submission of Home Medical Equipment Provider, Proof of Financial Ability to Operate, AHCA Form 3110-1021, December 2006 with evidence of sufficient assets to cover projected expenses. If a bond is submitted, submission of a copy of a current Medicaid bond will satisfy as proof of financial ability to operate. Corporations that own multiple licensed HME locations will not be required to resubmit proof of financial ability to operate when applying for a license for an additional provider location.

(e) Background screening:

1. The general manager as defined in Section 400.925(7), F.S., and the financial officer must submit level 2 screening directly to AHCA as referenced in Section 408.809, F.S.

2. The general manager must coordinate the submission of level 1 screening for all personnel who enter a consumer’s home, including contractors, hired on or after 7/1/99 Level 1 screening consists of the submission of the criminal history check either to the AHCA Background Screening Unit, 2727 Mahan Drive, Mail Stop 40, Tallahassee, FL 32308-5407 or to the Florida Department of Law Enforcement. The cost of processing screening must be paid by the provider or by the employee that is screened. New employees may work on probationary status, once they have submitted their screening documents as permitted in Chapter 435, F.S. The general manager must submit a signed affidavit with each initial and renewal application affirming that direct and contract personnel who enter the home in the capacity of their employment, have been screened for good moral character.

(5)(f) Each licensed HME provider location must obtain and maintain professional and commercial liability insurance of not less than $250,000 per claim as referenced in Sections 400.931(3)(6) and 408.810(7), F.S. In case of contracted services, the contractor must maintain liability insurance of not less than $250,000 per claim. A corporation can provide a blanket policy, which indicates that each of its licensed locations is insured under one policy, verifying not less than $250,000 per claim for each location.

(6)(g) Initial aApplicants and providers requesting to change the address of record must provide proof of compliance with meet the local zoning requirements. Physical location cannot be a post office box. The licensee must have all county licenses and permits that are applicable.

(5) Renewal application:

(a) An application for renewal of licensure, with its forms and attachments, is required per Sections 400.931 and 408.806, F.S., and these rules. AHCA Form 3110-1005, December 2006, incorporated by reference must be submitted and can be obtained as stated in subsection (4) above.

(b) If AHCA has reason to believe a provider is financially unstable, the applicant must demonstrate financial ability to operate by submitting proof of a current $50,000 surety bond as referenced in Section 400.931(3), F.S., or by submitting AHCA Form 3110-1021, December 2006, with evidence of sufficient assets to cover projected expenses before the license is renewed. In addition, the applicant must document its correction of the financial instability, to include evidence of the payment in full of any bad checks, delinquent bills or liens, and all associated fees, costs and charges related to the instability. If payment in full cannot be or is not made, evidence must be submitted of partial payment along with a plan for payment in full with satisfaction of any liens or delinquent bills. If the lien is with a government agency or repayment is ordered by a federal, state, or district court, an accepted plan of repayment must be provided. Failure to pay any outstanding fines, unless the fine is being appealed, is an indicator of financial instability and AHCA will ask the provider to demonstrate financial ability to operate by submission of proof of a bond unless the provider pays the fine.

(6) If an HME provider has shown signs of financial instability at any time, pursuant to Sections 408.810(8) and (9), F.S., the HME provider must submit proof of financial ability to operate, including financial schedules that show anticipated provider revenue and expenses and the basis for financing the anticipated cash flow requirements of the licensee on AHCA Form 3110-1021, December 2006, and documentation of correction of the financial instability, to include evidence of payment made and proof of receipt of payment by the respective creditor, vendor or lienor of any bad checks, delinquent bills or liens, and all associated fees, costs and charges relating to the instability. Verifiable copies of satisfactions of liens, copies of cancelled checks, certified mail (courier) return receipts with copies of checks, receipts for payments, paid invoices and authorized letters of estoppel will suffice as proof of payment, if in the full and correct amounts. If payment in full cannot be or is not made, evidence must be submitted of partial payment along with a plan for payment in full of any liens or delinquent bills. If the lien is with a government agency or repayment is ordered by a federal, state, or district court, an accepted plan of repayment must be provided.

(7) If a change of ownership is to occur, an application for a change of ownership, AHCA Form 3110-1005, December 2006, incorporated by reference, must be submitted per the requirements in Section 408.807, F.S., and these rules.

(7)(8) If a change of name and/or address of record is to occur, the provider must submit Home Medical Equipment Provider, Request to Amend License for Notification of Change of Name and/or Address, AHCA Form 3110-1020, October 2014 December 2006, https://www.flrules.org/ Gateway/reference.asp?No=Ref-XXXX, incorporated by reference and available online at http://ahca.myflorida.com/HQAlicensureforms, according to the timeframes as required in subsection 59A-35.040(2), F.A.C. and accompanied by a fee as required in subsection 59A-35.050(4), F.A.C. not less than 24 hours prior to the actual move. The applicant must comply with local zoning requirements and obtain all applicable local county licenses and permits for the new location.

Rulemaking Specific Authority 400.935, 408.810(8) FS. Law Implemented Part VII of Chapter 400, 400.92-.957, 408.803, 408.805, 408.806, 408.8065, 408.807, 408.809, 408.810, 408.810(8), 408.815 FS. History–New 6-4-00, Amended 10-6-02, 4-13-03, 3-13-07, Amended__________.

 

59A-25.005 Compliance.

(1) The survey or inspection:

(a) All providers must be in compliance with and each separately licensed location, except as described in paragraph (b), shall be surveyed in accordance with Part VII of Chapter 400, F.S., Part II of Chapter 408, F.S., Chapter 59A-35, F.A.C. and these rules. A provider shall be surveyed on an unannounced basis as required in Section 408.811, F.S. Area offices may do follow-up surveys to check on correction of deficiencies at any time on an unannounced basis.

(b) If a provider is operating with a central service center that has one or more distribution centers, the central service center shall be the premises where the survey will be initiated. A surveyor will inspect at least one of the distribution centers associated with the central service center. The distribution center will be held accountable for equipment and services provided but will not be responsible for maintaining patient or personnel records.

(c) All providers must have available, at the time of survey, at least one category of equipment that is provided directly, filling orders from its own inventory as referenced in Section 400.934(2), F.S. Failure to have, at the time of survey, at least one category of equipment that is provided directly will result in the provider’s application being denied or the provider’s license being revoked. A licensed central service center may be determined to meet this standard through the inventory available at its designated distribution center.

(d) Once the AHCA surveyor has finished conducting an inspection, an exit conference is conducted with the general manager or designee to discuss the results of the inspection and any deficiencies that may have been found.

(e) The survey findings will be written and if any deficiencies were cited during the survey, a statement of deficiencies will be sent to the provider.

(f) Except for situations as described in paragraphs (c), (g) and (h), if any deficiencies were cited during the survey, the provider will be given ten working days to submit a plan of correction to the area office. A follow up visit or a desk review will then be made by the area office to determine if the plan of correction is acceptable and has been implemented. The plan of correction is subject to approval by the agency.

(g) If a provider is cited regarding serious patient harm or a threat of clear and present danger to the public’s health and safety, AHCA has the authority to request an injunction to halt operations through an emergency order or moratorium. Also, AHCA has the authority to deny, revoke or suspend a license when survey findings present a threat or clear and present danger to the public’s health and safety as permitted in Section 400.932, F.S.

(h) If the provider fails to meet the minimum standards in Section 400.934, F.S., or this rule, the area office shall recommend denial, revocation or suspension of the provider’s license or impose an administrative fine as authorized in Section 400.932, F.S.

(i) An acceptable plan of correction must:

1. Include specific information on how the deficiency was or will be corrected;

2. Include reasonable time frames based on the dates discussed during the exit conference;

3. Address the problem and be aimed at correction in a systematic sense, as opposed to correcting an example or an isolated problem;

4. Identify the position that will be monitoring the corrective action to preclude its reoccurrence.

(j) All licensed providers must make records available on the premises during the course of the survey.

(2) Complaint investigations:

(a) AHCA will conduct investigations of complaints regarding violations of licensure requirements. Complaint investigations will be unannounced. An entrance conference will be conducted to inform the general manager of the nature of the complaint. An exit conference will be conducted to report the findings and to receive additional information or clarification concerning the investigation. Distribution centers will be allowed forty-eight hours to obtain patient or personnel records from its their central service center and to submit the records to the area office when related to a complaint investigation.

(b) A statement of any deficiencies found will be sent to the provider after the investigation. If the complaint was confirmed or any incidental deficiencies were cited as a result of the complaint investigation, the provider must submit a plan of correction to the area office.

(3) Adverse action: Denial, Suspension, Revocation, and Administrative Fines. Fine amounts are not to exceed $5,000 per violation, per day as stated in Section 400.932(1), F.S.

(a) AHCA shall deny, suspend or revoke an application for license, or impose a fine for the reasons in Section 400.932, F.S., Part II of Chapter 408, F.S., Chapter 59A-35, F.A.C. and for the following reasons:

(a)1. If the provider fails to submit an application for a change of ownership within the time frames specified in Sections 408.806 and 408.807, F.S., a $50 fine per day, not to exceed 50 percent of the licensure fee, $150 shall be levied. If the application is received after the required filing date and, exhibits a hand-canceled postmark from a United States Post Office dated on or before the required filing date, no fine will be levied;

2. If the provider fails to notify AHCA of a change of address within the timeframes specified in subsection 59A-25.002(8), F.A.C., a minimum of a $500 fine shall be levied;

3. If the applicant fails to screen all employees including contracted employees, or is unable to show screening clearance for any contracted employees who enter a consumer’s home, as required in Section 400.93, F.S., or employs persons who are disqualified from employment based on a criminal record check, a $1,000 fine shall be levied;

(b)4. If the provider is cited for a class I violation as defined in Section 408.813(2)(a), F.S. deficiency that is any act, omission or practice that results in a consumer’s death, disability, or permanent injury, or places a consumer at imminent risk of death, disability, or permanent injury, the agency shall impose an administrative fine in the amount of $5,000 for each occurrence and each day that the deficiency exists. In addition, the agency shall immediately revoke the license, deny the renewal of a license or impose a moratorium on accepting new consumers until the factors causing the deficiency have been corrected;

(c)5. If the provider is cited for a class II violation as defined in Section 408.813(2)(b), F.S. deficiency that is any act, omission or practice that has a direct adverse effect on the health, safety or security of a consumer, the agency shall impose an administrative fine in the amount of $1,000 for each occurrence and each day that the deficiency exists. In addition the agency shall revoke the license, deny the renewal of a license or impose a moratorium of new consumers until the deficiency has been corrected;

(d)6. If the provider is cited for a class III violation as defined in Section 408.813(2)(c), F.S. deficiency that is any act, omission or practice that has an indirect, adverse effect on health, safety, or security of a consumer, the agency shall impose an administrative fine not to exceed $500 for each occurrence and each day that the uncorrected or repeated deficiency exists;

(e)7. If the provider is cited for a class IV violation as defined in Section 408.813(2)(d), F.S. deficiency that is uncorrected or repeated acts or omissions or practices related to required reports, forms or documents which do not have the potential of negatively affecting consumers, the agency shall impose an administrative fine not to exceed $200 for each occurrence and each day that the uncorrected or repeated deficiency exists;

(f)8. If the provider is not available for inspection during the office hours indicated on its licensure application, AHCA shall deny an initial, renewal or change of ownership application or impose a $500 fine upon a licensed provider applying to renew a license.

(g)9. If the central service center’s license is revoked, the revocation includes the licenses of all distribution centers.

10. If the provider fails to submit a plan of correction to the area office within 10 days of the receipt of the deficiency statement, AHCA shall deny an initial, a change of ownership or a renewal application or revoke the license of a licensed provider.

(h)11. Failure of a provider to provide records to AHCA during an inspection shall result in a $500 fine.

(i)12. Failure of a distribution center to provide records to AHCA within forty-eight hours shall result in a $500 fine.

(b) The action taken by AHCA regarding the above shall be based on the following:

1. The gravity of the violation, including the probability that death or serious physical or emotional harm to a patient will result or has resulted, and the severity of the actual or potential harm;

2. The actions taken by the HME provider to correct violations, and

3. Any previous violations.

(4) Providers must report unlicensed home medical equipment providers to the AHCA Consumer Complaint, Publication and Information Call Center toll free number of 1(888) 419-3456 or the local number of [phone].

Rulemaking Specific Authority 400.935 FS. Law Implemented Part VII of Chapter 400, 400.92-.957, 408.806, 408.807, 408.811, 408.812, 408.813 FS. History–New 6-4-00, Amended 10-6-02, 3-13-07,___________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Noël Cronin Lawrence

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 21, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 21, 2013