16 Del. Admin. Code § 3350-2.0

Current through Register Vol. 28, No. 3, September 1, 2024

Section 3350-2.0 - Licensing Requirements and Procedures

2.1 General Requirements

2.1.1 No person shall establish, conduct or maintain in this State any home health agency without first obtaining a license from the Department.

2.1.2 A separate license shall be required for each office maintained by a home health agency.

2.1.3 The home health agency shall advise the Department in writing at least thirty (30) calendar days prior to any change in office location.

2.1.4 Any agency that undergoes a modification of ownership and control is required to re-apply as a new agency.

2.1.5 A license is not transferable from person to person or from entity to entity.

2.1.6 The license shall be posted in a conspicuous place on the licensed premises.

2.1.7 The agency shall only provide services in the service area. The agency may provide services to a patient during the patient's time-limited travel outside the service area.

2.2 Application Process

2.2.1 All persons or entities applying for a license shall submit a written statement of intent to the Department describing the services to be offered by the agency and requesting a licensure application from the Department.

2.2.1.1 The issuance of an application form is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Department.

2.2.1.2 No person or entity shall hold themselves out to the public as being a home health agency until a license has been issued by the Department.

2.2.2 In addition to a completed application for licensure, applicants shall submit to the Department the following information:

2.2.2.1 The names, addresses and types of agencies owned or managed by the applicant;

2.2.2.2 A copy of the applicant's policies and procedures manual as requested by the Department;

2.2.2.3 Identity of:

2.2.2.3.1 Each officer and director of the corporation if the entity is organized as a corporation;

2.2.2.3.2 Each general partner or managing member if the entity is organized as an unincorporated entity;

2.2.2.3.3 The governing body;

2.2.2.3.4 Any officers/directors, partners, managing members or members of a governing body who have a financial interest of five percent (5%) or more in a licensee's operation or related businesses;

2.2.2.4 Disclosure of any officer, director, partner, employee, managing member or member of the governing body with a felony criminal record;

2.2.2.5 Name of the individual (director) who is responsible for the management of the home health agency;

2.2.2.6 A list of management personnel, including credentials;

2.2.2.7 A plan for providing continuing education and training for agency personnel or contractors during the first year of operation; and

2.2.2.8 Any other information required by the Department.

2.3 Issuance of Licenses

2.3.1 Initial license

2.3.1.1 An initial license shall be granted for a period of ninety (90) calendar days to every agency that completes the application process consistent with these regulations and whose policies and procedures demonstrate compliance with the rules and regulations pertaining to skilled home health agency licensure.

2.3.1.2 All home health agencies shall have an on-site survey during the first ninety (90) calendar days of operation.

2.3.1.3 A home health agency, at the time of an initial on-site survey, must meet the definition of a home health agency as contained within these regulations and must be in operation and caring for patients. Agencies that, at the time of an on-site survey, do not meet the definition of a home health agency or that are not in substantial compliance with these regulations will not be granted a license.

2.3.1.4 An initial license will permit an agency to hire or contract with personnel and establish a patient caseload.

2.3.1.5 An initial license may not be renewed.

2.3.2 Provisional license

2.3.2.1 A provisional license may be granted for a period of less than one year to all home health agencies that:

2.3.2.1.1 Are not in substantial compliance with these rules and regulations; or

2.3.2.1.2 Fail to renew a license within the timeframe prescribed by these regulations.

2.3.2.2 The Department shall designate the conditions and the time period under which a provisional license is issued.

2.3.2.3 A provisional license may not be renewed unless a plan of correction for coming into substantial compliance with these rules and regulations has been approved by the Department and implemented by the home health agency.

2.3.2.4 A license will not be granted after the provisional licensure period to any agency that is not in substantial compliance with these rules and regulations.

2.3.3 Annual License

2.3.3.1 An annual license shall be granted for a period of one year (12 months) to all home health agencies which are in substantial compliance with these rules and regulations at the time of application.

2.3.3.2 An annual license shall be effective for a twelve-month period following date of issue and shall expire one year following the issue date, unless it is: modified to a provisional, suspended or revoked, or surrendered prior to the expiration date.

2.3.3.3 Existing home health agencies must apply for renewal of licensure at least thirty (30) calendar days prior to the expiration date of the license.

2.3.3.4 A license may not be issued to a home health agency:

2.3.3.4.1 Which does not meet the definition of a home health agency as contained within these regulations;

2.3.3.4.2 Which is not in substantial compliance with these regulations; or

2.3.3.4.3 Whose deficient practices present an immediate threat to the health and safety of its patients.

2.4 Disciplinary proceedings

2.4.1 The Department may impose sanctions (subsection 2.4.2 of this regulation) singly or in combination when it finds a licensee or former licensee has:

2.4.1.1 Violated any of these regulations;

2.4.1.2 Failed to submit a reasonable timetable for correction of deficiencies;

2.4.1.3 Exhibited a pattern of cyclical deficiencies which extends over a period of two or more years;

2.4.1.4 Failed to correct deficiencies in accordance with a timetable submitted by the applicant and agreed upon by the Department;

2.4.1.5 Engaged in any conduct or practices detrimental to the welfare of the patients;

2.4.1.6 Exhibited incompetence, negligence or misconduct in operating the home health agency or in providing services to individuals;

2.4.1.7 Mistreated or abused individuals cared for by the home health agency;

2.4.1.8 Violated any statutes relating to Medical Assistance or Medicare reimbursement for those agencies who participate in those programs; or

2.4.1.9 Refused to allow the Department access to the agency or records for the purpose of conducting inspections/surveys/investigations as deemed necessary by the Department.

2.4.2 Disciplinary sanctions may include:

2.4.2.1 Permanently revoke a license.

2.4.2.2 Suspend a license.

2.4.2.3 Issue a letter of reprimand.

2.4.2.4 Place a licensee on provisional status and require the licensee to:

2.4.2.4.1 Report regularly to the Department upon the matters which are the basis of the provisional status;

2.4.2.4.2 Limit practice to those areas prescribed by the Department; and

2.4.2.4.3 Suspend new intakes and admissions.

2.4.2.5 Refuse a license.

2.4.2.6 Refuse to renew a license.

2.4.2.7 The Department may request the Superior Court to impose a civil penalty of not more than $10,000 for a violation of these regulations. Each day a violation continues constitutes a separate violation.

2.4.2.7.1 In lieu of seeking a civil penalty, the Department, in its discretion, may impose an administrative penalty of not more than $10,000 for a violation of these regulations. Each day a violation continues constitutes a separate violation.

2.4.2.7.2 In determining the amount of any civil or administrative penalty imposed, the Court or the Department shall consider the following factors:

2.4.2.7.2.1 The seriousness of the violation, including the nature, circumstances, extent and gravity of the violation and the threat or potential threat to the health or safety of any patient;

2.4.2.7.2.2 The history of violations committed by the person or the person's affiliate(s), agents, employee(s) or controlling person(s);

2.4.2.7.2.3 The efforts made by the agency to correct the violation(s);

2.4.2.7.2.4 Any misrepresentation made to the Department; and

2.4.2.7.2.5 Any other matter that affects the health, safety or welfare of a patient(s).

2.4.2.8 Otherwise discipline.

2.4.3 Imposition of Disciplinary Action

2.4.3.1 Before any disciplinary action is taken (except as authorized by subsection 2.4.4):

2.4.3.1.1 The Department shall give twenty (20) calendar days written notice to the holder of the license, setting forth the reasons for the determination.

2.4.3.1.2 The disciplinary action shall become final twenty (20) calendar days after the mailing of the notice unless the licensee, within such twenty (20) calendar day period, shall give written notice of the agency's desire for a hearing.

2.4.3.1.3 If the licensee gives such notice, the agency shall be given a hearing before the Secretary of the Department or her/his designee and may present such evidence as may be proper.

2.4.3.1.4 The Secretary of the Department or her/his designee shall make a determination based upon the evidence presented.

2.4.3.1.5 A written copy of the determination and the reasons upon which it is based shall be sent to the agency.

2.4.3.1.6 The decision shall become final twenty (20) calendar days after the mailing of the determination letter unless the licensee, within the twenty (20) calendar day period, appeals the decision to the appropriate court of the State.

2.4.4 Order to immediately suspend a license

2.4.4.1 In the event the Department identifies activities which the Department determines present an immediate jeopardy or imminent danger to the public health, welfare and safety requiring emergency action, the Department may issue an order temporarily suspending the licensee's license, pending a final hearing on the complaint. No order temporarily suspending a license shall be issued by the Department, with less than 24 hours prior written or oral notice to the licensee or the licensee's attorney so that the licensee may be heard in opposition to the proposed suspension. An order of temporary suspension under this section shall remain in effect for a period not longer than 60 calendar days from the date of the issuance of said order, unless the suspended licensee requests a continuance of the date for the final hearing before the Department. If a continuance is requested, the order of temporary suspension shall remain in effect until the Department has rendered a decision after the final hearing.

2.4.4.2 The licensee, whose license has been temporarily suspended, shall be notified forthwith in writing. Notification shall consist of a copy of the deficiency report and the order of temporary suspension pending a hearing and shall be personally served upon the licensee or sent by mail, return receipt requested, to the licensee's last known address.

2.4.4.3 A licensee whose license has been temporarily suspended pursuant to this section may request an expedited hearing. The Department shall schedule the hearing on an expedited basis provided that the Department receives the licensee's written request for an expedited hearing within 5 calendar days from the date on which the licensee received notification of the Department's decision to temporarily suspend the licensee's license.

2.4.4.4 As soon as possible, but in no event later than 60 calendar days after the issuance of the order of temporary suspension, the Department shall convene for a hearing on the reasons for suspension. In the event that a licensee, in a timely manner, requests an expedited hearing, the Department shall convene within 15 calendar days of the receipt by the Department of such a request and shall render a decision within 30 calendar days.

2.4.4.5 In no event shall an order of temporary suspension remain in effect for longer than 60 calendar days unless the suspended licensee requests an extension of the order of temporary suspension pending a final decision of the Department. Upon a final decision of the Department, the order of temporary suspension may be vacated in favor of the disciplinary action ordered by the Department.

2.4.5 Termination of license

2.4.5.1 Termination of a license to provide services as a home health agency occurs secondary to:

2.4.5.1.1 Revocation of a license or the voluntary surrender of a license in avoidance of revocation action.

2.4.5.2 Termination of rights to provide services extends to:

2.4.5.2.1 Agency;

2.4.5.2.2 Owner(s);

2.4.5.2.3 Officers/Directors, partners, managing members or members of a governing body who have a financial interest of five percent (5%) or more in the home health agency; and

2.4.5.2.4 Corporation officers.

2.5 Modification of Ownership and Control (MOC)

2.5.1 Any proposed MOC must be reported to the Department a minimum of thirty (30) calendar days prior to the change.

2.5.2 A MOC voids the current license in possession of the agency.

2.5.3 A MOC may include but is not limited to:

2.5.3.1 Transfer of full ownership rights;

2.5.3.2 Transfer of the majority interest;

2.5.3.3 Transfer of ownership interests that result in the owner with the majority interest becoming a minority interest owner;

2.5.3.4 Transfer or re-organization that results in an additional majority interest that is equal in ownership rights; or

2.5.3.5 Transfer resulting in a measurable impact upon the operational control of the agency.

2.6 Fees

2.6.1 Fees shall be in accordance with 16 Del.C. § 122(3)o.

2.7 Inspection. A representative of the Department shall periodically inspect every home health agency for which a license has been issued under this chapter. Inspections by authorized representatives of the Department may occur at any time and may be scheduled or unannounced.

2.8 Notice to Patients. The home health agency shall notify each patient or the patient's authorized representative, the patient's attending physician or allowable provider (as appropriate), and any third-party payers at least thirty (30) calendar days before the voluntary surrender of its license, or as directed under an order of denial, revocation or suspension of license issued by the Department.

2.9 Exclusions from Licensure. The following persons, associations or organizations are not required to obtain a home health agency license:

2.9.1 Those individuals who contract directly with a patient to provide services for that patient, where the patient pays the individual for services rendered and neither the patient nor the individual pays an agency on a periodic basis.

2.9.2 Those agencies that provide only durable medical equipment and supplies for in-home use.

2.9.3 Those agencies that provide staff to licensed home health agencies, such as temporary employment/staffing agencies, provided that:

2.9.3.1 Temporary employment/staffing agencies may not provide services under direct agreements with patients.

2.9.3.2 Temporary employment/staffing agencies must be contractually bound to perform services under the contracting providers' direction and supervision.

2.9.3.3 Temporary staff working for a licensed provider must meet the requirements of these regulations.

2.9.4 Any visiting nurse service or home health services conducted by and for those who rely upon spiritual means through prayer alone for healing in accordance with the tenets and practices of a registered church or religious denomination.

2.9.5 An agency which solely provides services as defined in 16 Del.C. Ch. 94, the Community Based Attendant Services Act.

2.9.6 A Personal Assistance Services Agency which solely provides services defined in 16 Del.C. § 122(3) x.

16 Del. Admin. Code § 3350-2.0

12 DE Reg. 1217 (03/01/09)
19 DE Reg. 849(3/1/2016)
25 DE Reg. 527( 11/1/2021) (Final)