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This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

Chapter 4729:11-3 | Standards for HME Service Providers

 
 
 
Rule
Rule 4729:11-3-01 | Minimum standards for licensees.
 

(A) This rule sets forth the minimum acceptable standards for licensure as a HME services provider under Chapter 4752. of the Revised Code.

(B) A licensee shall maintain knowledge of the duties and responsibilities of a HME services provider and shall practice in accordance with the following:

(1) Chapter 4752. of the Revised Code;

(2) Division 4729:11 of the Administrative Code;

(3) Any other applicable federal and state laws, rules and regulations; and

(4) Position statements, standards of care or guidelines for providing HME services from nationally recognized organizations, including medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier standards, joint commission, or other accrediting bodies recognized by the board pursuant to rule 4729:11-2-04 of the Administrative Code.

(C) A licensee and the licensee's staff shall demonstrate competence and accountability in all areas of HME services in which they are engaged, including, but not limited to, the following:

(1) HME storage, leasing, sales, delivery, billing services, maintenance, cleaning, infection control, and repair;

(2) Appropriate recognition, referral, or consultation and intervention when a complication arises in conjunction with the function of HME or when a change in patient or client compliance occurs; and

(3) Referral to another HME services provider if the client's needs are beyond the scope of the license holder.

(D) A licensee is responsible for maintaining a facility that meets all the following requirements:

(1) The facility must have appropriate physical space to safely store, maintain and service on site equipment;

(2) The facility must have separation of business office, patient records, equipment cleaning, maintenance, and storage functions, as applicable;

(3) The facility must be able to demonstrate appropriate equipment flows through various stages to ensure that the equipment is properly disinfected, repaired, stored, and maintained;

(4) The facility must maintain inventory on site or by arrangement with a supplier to meet the needs of the licensee's current client base; and

(5) The facility must meet all federal, state and local laws, rules, and regulations, including those pertaining to the storage, maintenance, and sale of upholstery or bedding, if applicable.

(E) In maintaining equipment, a licensee shall:

(1) Maintain and document equipment in accordance with the manufacturer's guidelines;

(2) Clean, disinfect, repair, store, segregate and identify all equipment in a manner that ensures the equipment is safe for use by the public;

(3) Ensure that all equipment is used within the manufacturer's recommended guidelines and expirations dates, if applicable.

(F) A licensed HME services provider shall:

(1) Maintain appropriate staffing to handle the scope of equipment sold, rented and maintained and to appropriately meet the demands of the business.

(2) Ensure that all staff members are trained and supervised by qualified persons.

(3) Maintain personnel records for each employee, which shall include all of the following:

(a) Job description for the position held by the employee.

(b) Application qualifications.

(c) For any employee that provides HME services, supervises an employee who provides HME services, or has access to records maintained in accordance with rule 4729:11-3-02 of the Administrative Code who is working within the state of Ohio, a criminal background check shall be performed only upon initial hire by the Ohio bureau of criminal identification and investigation (BCI&I) and shall consist of both a BCI&I and FBI criminal records check.

(d) Orientation and training records.

(e) Verification of competence.

(f) Performance plan to be completed annually by the licensee.

(G) A licensed HME services provider shall possess product and professional liability insurance coverage in the amount of one million dollars per occurrence, three million dollars aggregate. The certificate of insurance must show that the product and professional liability insurance coverage is contained in the total aggregate amount.

Supplemental Information

Authorized By: 4752.17
Amplifies: 4752.17
Five Year Review Date: 12/15/2024
Rule 4729:11-3-02 | Record keeping.
 

(A) A HME services provider shall maintain records for each client that has been sold or leased equipment.

(1) All records maintained in accordance with this rule shall be uniformly maintained and readily retrievable for inspection and copying by properly identified agents, inspectors or employees of the state board of pharmacy.

(2) All client records must contain a prescriber order, if required, and documentation of settings and other data relevant to the equipment that has been sold or leased, and other documentation regarding service checks of the equipment sold or rented to the client.

(3) All client records must be maintained for three years from the date of sale or in the case of a minor client, records must be maintained for seven years after the client turns eighteen years of age.

(B) A HME services provider located in this state intending to maintain records at a location other than the location licensed or registered by the state board of pharmacy shall notify the board in a manner determined by the board. Any such alternate location shall be secured and accessible only to authorized representatives or contractors of the licensee or registrant.

(C) A HME services provider maintaining records at location other than the location licensed or registered by the state board of pharmacy or via a computerized record keeping system shall maintain an executed agreement with the company possessing or storing the records authorizing an agent of the board access to the records maintained in accordance with this rule within three business days.

Supplemental Information

Authorized By: 4752.17
Amplifies: 4752.17
Five Year Review Date: 12/15/2024
Rule 4729:11-3-03 | Inspections and corrective actions.
 

(A) An entity licensed or registered by the state board of pharmacy pursuant to Chapter 4752. of the Revised Code is subject to an on-site inspection by the board. An authorized board agent may, without notice, carry out an on-site inspection or investigation of an entity licensed or registered by the board. Upon verification of the board agent's credentials, the agent shall be permitted to enter the licensed or registered entity.

(B) Submission of an application for a license or registration as a HME services provider with the state board of pharmacy constitutes permission for entry and on-site inspection by an authorized board agent.

(C) If an agent of the state board of pharmacy identifies a violation specified in paragraph (D) of this rule, the agent may provide written notice, in a manner determined by the board, of the nature of the observed violations to the designated representative on the license, registration or application. The licensee, registrant or applicant may also be subject to disciplinary actions pursuant to Chapter 4752. of the Revised Code and this division of the Administrative Code.

(D) Violations may include any of the following:

(1) Violating any rule of the board;

(2) Violating any provision of Chapter 4752. of the Revised Code;

(3) Violating any federal, state and local law, rule, or regulation regarding the provision of HME services.

(E) The licensee, registrant or applicant shall submit to the board within thirty days of a written notice provided in accordance with paragraph (C) of this rule, in a manner determined by the board, either of the following:

(1) The action(s) the licensee, registrant or applicant has taken to correct the violation(s) and the date of implementation of the corrective action(s); or

(2) An explanation disputing the observed violations.

(F) The designated representative of a HME services provider shall comply with investigations and inspections conducted by the board or accrediting body recognized in accordance with rule 4729:11-2-04 of the Administrative Code and shall instruct their staff members to comply with all requests made by the board or accrediting body.

Supplemental Information

Authorized By: 4752.17
Amplifies: 4752.17
Five Year Review Date: 12/15/2024
Rule 4729:11-3-04 | Continuing education.
 

(A) Licensed HME services providers shall provide ten contact hours of continuing education per renewal cycle for staff rendering home medical equipment services.

(B) Of the number of continuing education contact hours required, one contact hour shall include subject content on infection control, equipment cleaning standards and cleaning agents, rotation of inventory, or equipment separation requirements. The remaining contact hours must be relevant to the HME services rendered. The following are acceptable sources of continuing education:

(1) In-service education developed and taught by the licensed HME services provider.

(2) In-service education developed and taught by a HME manufacturer.

(3) Continuing education approved by any organization recognized by the board that offers continuing education relevant to HME services rendered.

(C) Any organization that provides HME continuing education may apply to the board to be recognized as an authorized continuing education provider. Request for recognition must be made in writing to the board and must include an overview of the organization and an outline of the continuing education courses provided by the organization, including course content.

(D) Documentation of all completed continuing education courses taken by each staff member must be maintained in the employee's personnel file for three years from the date of completion and shall made readily retrievable.

In-service continuing education credits shall be documented for employed staff involved in HME service delivery to the public. Records of attendance and completion shall include any of the following:

(1) Sign in logs;

(2) Agendas and training manuals;

(3) Certificates of completion; or

(4) Online completion logs/rosters.

Supplemental Information

Authorized By: 4752.17
Amplifies: 4752.02
Five Year Review Date: 12/15/2024
Rule 4729:11-3-05 | Advertising and solicitation.
 

(A) No HME services provider shall advertise or solicit for patronage in connection with the licensee or registrant's business if any communication contained therein is false, fraudulent, deceptive, or misleading.

(B) Excluding a free consultation, any advertisement or solicitation which offers HME services on a gratuitous basis shall include a disclaimer. If the advertisement is visual, the disclaimer shall be contained therein. If the advertisement is audio-based, the disclaimer shall be read. A written copy of the disclaimer shall be provided to every patient who responds to an offer, prior to the rendering of patient care.

(1) The disclaimer shall clearly and conspicuously state the following:

(a) Any exclusions, prohibitions, restrictions, limitations, conditions, or eligibility requirements which apply to the offer; and

(b) Any additional services, which are associated with the offer, that are rendered on the same day but are not provided free of charge.

(C) All advertisements and solicitations shall include therein the name of the licensee or registration holder pursuant to Chapter 4752. of the Revised Code who has reviewed and approved the content of the advertisement or solicitation.

(D) Any trade or fictitious names utilized in connection with HME services or sales shall be duly registered with the Ohio secretary of state.

(E) Each of the following shall constitute an abusive telemarketing act and shall be considered a violation of this rule:

(1) Use of threats, intimidation, or profane or obscene language.

(2) Calling a person repeatedly or continuously with intent to annoy, abuse or harass any person at the number called.

(3) Calling a person when that person has previously stated that they do not wish to receive an outbound telephone call made by or on behalf of the seller whose goods or services are being offered or a person who is listed on federal government's national do not call registry. Every seller of goods or services shall maintain a "do not call" list.

(4) Calling a person's residence at any time other than between eight a.m. and eight p.m. local time at the persons location.

(5) Requiring an immediate response from the prospect to any offer made during the solicitation.

(6) Failure to disclose within the first sixty seconds of the telephone call the solicitors identity and the practice on whose behalf the solicitation is being made; the purpose of the telephone call; a statement of the goods or services being sold; and that no purchase or payment is necessary to participate in a promotion if a promotion is offered.

(7) The solicitors are prohibited from misrepresenting their affiliation with, or endorsement by, any government or third-party organization.

(8) Communicating with prospective patients in a way that invades privacy of the prospect, or interferes with an existing prescriber/patient relationship.

(F) A licensee or registrant may utilize testimonials in advertising if the patient giving the testimonial has given written consent as to the exact wording and proposed use of the testimonial. A copy of such consent and testimonial shall be retained by the HME service provider for two years from the last date of publication. Testimonials shall be true and shall not be false, fraudulent, deceptive or misleading.

(G) A HME services provider may not utilize signs which include any false, fraudulent, deceptive or misleading information.

Supplemental Information

Authorized By: 4752.17
Amplifies: 4752.17
Five Year Review Date: 12/15/2024