Ohio Adm.Code 4729:11 | Ohio Administrative Code 4729:11 — State Board of Pharmacy | Home Medical Equipment Service Providers

Chapter 4729:11-1 Definitions

Ohio Adm.Code 4729:11-1-01 Definitions - home medical equipment.

As used in this division:

(A) "24/7 coverage" means that facilities that provide HME services must have a telephone number that is operational twenty-four hours a day, seven days a week that clients can call to seek assistance. The telephone line may be an answering service that is monitored on a regular basis by the HME provider and should also alert clients to contact 911 in an emergency.

(B) "Abandoned application" means an application submitted for licensure or registration where an applicant fails to complete all application requirements within thirty days after being notified of the incomplete application by the board. An applicant forfeits all fees associated with an abandoned application. The board shall not be required to act on any abandoned application and the application may be destroyed by board staff. If an application is abandoned, the applicant shall be required to reapply for licensure or registration, submit the required fee and comply with the licensure or registration requirements in effect at the time of reapplication.

An application shall not be deemed abandoned if the application is subject to any of the following:

(1) An administrative proceeding; or

(2) If there is discipline pending against the applicant.

(D) "Addicted to or abusing alcohol or drugs" means the chronic and habitual use of alcohol or the use of a drug of abuse as defined in section 3719.011 of the Revised Code by an individual to the extent that the individual no longer can control the individual's use of alcohol or drugs, the individual is physically or psychologically dependent on alcohol or drugs, or the individual's use or abuse of alcohol or drugs endangers the health, safety, or welfare of the individual or others.

(E) "Board" means the state board of pharmacy.

(F) "Business day" means any day other than Saturday, Sunday or a holiday recognized by the state of Ohio on which the offices of the board of pharmacy are not open for business.

(G) "Certificate of registration" or "registration" means a person holding a valid certificate of registration issued under Chapter 4752. of the Revised Code.

(H) "Client" or "patient" means a person who receives HME services from a HME services provider.

(I) "CMS" means the centers for medicare and medicaid services.

(J) "Contact hour" means a period of sixty minutes with a minimum of fifty minutes of instruction. For credit hours earned on an academic quarter system, one credit hour is equivalent to ten contact hours. For credit hours earned on an academic trimester system, one credit hour is equivalent to twelve contact hours. For credit hours earned on an academic semester system, one credit hour is equivalent to fifteen contact hours.

(K) "Disciplinary action" means any of the following by a federal agency or licensing agency of any state or jurisdiction, regardless of whether the action occurred by formal proceeding, consent, settlement, or other agreement:

(1) An action to revoke, suspend, restrict, limit, or refuse to grant or renew a license, registration or certification;

(2) A summary or emergency suspension of a license, registration or certification, of any length, and any subsequent revision to the action;

(3) An administrative fine or monetary penalty, taken as a result of a formal proceeding, to include any fine or money penalty connected to the delivery of health care services or taken in conjunction with other adverse licensure, registration or certification actions, such as revocation, suspension, censure, reprimand, or probation;

(4) An action to reprimand or place the license, registration, or certification holder on probation;

(5) The issuance of a corrective action plan only if such issuance is in conjunction with other adverse licensure, registration or certification actions, such as revocation, suspension, reprimand, probation, or surrender;

(6) The withdrawal of a renewal application for licensure, registration or certification while under investigation;

(7) The non-renewal of a license, registration or certification while under investigation or to avoid an investigation;

(8) The surrender of a license or other relinquishment, registration or certification in lieu of a formal sanction against a person's license, registration or certificate, whether permanent or temporary;

(9) In lieu of an adverse licensure, registration or certification action, a licensing agency issues a consent order in which a person agrees not to re-apply for a license in the future.

(10) An enforceable agreement not to practice or to be placed into inactive or other equivalent status while under investigation or in exchange for not conducting an investigation.

(L) "Disqualifying offense" has the same meaning as defined in rule 4729-3-01 of the Administrative Code.

(M) "Expired certificate of registration" means the holder of a certificate of registration under Chapter 4752. of the Revised Code has failed to fulfill all requirements of certificate renewal and has failed to request that the board place the certificate into inactive status.

(N) "Expired license" means the holder of a license under Chapter 4752. of the Revised Code has failed to fulfill all requirements of licensure renewal and has failed to request that the board place the license into inactive status.

(O) "Home medical equipment" or "HME" has the same meaning as defined in section 4752.01 of the Revised Code. Pursuant to division (B)(3) of that section, HME shall also include the following equipment:

(1) Hospital grade pulse oximeters pursuant to a prescription issued by a prescriber;

(2) Home photo therapy (bili lights or blankets);

(3) Individually sized or customized accessories that are an integral part of equipment defined in this paragraph and paragraphs (U) and (EE) of this rule;

(4) Transcutaneous electronic nerve stimulators (TENS), excluding devices labeled by the federal food and drug administration for over-the-counter use and are identified with the federal food and drug administration product code "NUH.OTC TENS";

(5) Drop foot stimulators;

(6) Bone growth stimulators;

(7) Vision restoration therapy devices;

(8) In-home patient lifts;

(9) Life-sustaining equipment as defined in paragraph (U) of this rule; and

(10) Technologically sophisticated medical equipment as defined in paragraph (EE) of this rule.

(P) "Home medical equipment services" or "HME services" has the same meaning as defined in section 4752.01 of the Revised Code.

(Q) "Home medical equipment services provider" or "HME services provider" has the same meaning as defined in section 4752.01 of the Revised Code.

(R) "Inactive status" means the status of a license or registration issued under Chapter 4752. of the Revised Code of a facility that has made a request, in a manner determined by the board, that the board place the license or registration into inactive status. A facility with an inactive license does not hold a current, valid license or certificate of registration under Chapter 4752. of the Revised Code.

(S) "In-service education" means that a continuing education program is offered by a HME service provider organization and not an approved peer review organization.

(T) "Joint commission on accreditation of healthcare organizations," as used in section 4752.12 of the Revised Code, means "the joint commission" or its predecessor organization.

(U) "Life sustaining equipment" has the same meaning as defined in section 4752.01 of the Revised Code and includes the following:

(1) Ventilators;

(2) Oxygen concentrators;

(3) Oxygen liquid systems;

(4) Oxygen compressed gas systems;

(5) Non-invasive ventilator system (e.g. bi-level, iron lungs, rocking beds, diaphragmatic pacers, etc.);

(6) Any other life sustaining equipment as determined by the board.

(V) "Person" includes any individual, partnership, association, limited liability company, or corporation, the state, any political subdivision of the state, and any district, department, or agency of the state or its political subdivisions. It also includes any individual member, regardless of the percentage of ownership, of any partnership, association, limited liability company, or corporation.

(W) "Place on probation" means to take action against a license or registration for a period of time determined by the board which imposes conditions or other requirements, or suspends or otherwise restricts some or all of the activities in which the licensee or registrant may engage.

(X) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer or inspector of the board.

(Y) "Refuse to grant or renew" means to deny original or continued licensure or registration for a period of at least twenty-four months. After twenty-four months, or such period of time as the individual board order may require, a person licensed or registered by the board or a person seeking to attain such status by licensure or registration, and whose license or registration the state board of pharmacy has refused to grant or renew, may make application to the board for issuance of a new license. A person that seeks to attain such status by licensure or registration, whose license the state board of pharmacy has refused to grant or renew must meet all requirements established by the board in rule and as may be set forth in the person's board order.

(Z) "Registered" and "licensed" mean that a person has met the initial qualifications for a certificate of registration (registered) or license (licensed) with the state board of pharmacy under Chapter 4752. of the Revised Code and rules adopted thereunder and have complied with renewal procedures, including payment of applicable fees.

(AA) "Revoke" means to take action against a license or registration rendering such license or registration void and such license or registration shall not be reissued. Revoke is an action that is permanent against the licensee or registrant.

(BB) "Staff" means employees or their representatives of a licensee or registrant.

(CC) "Suspend" means to take action against a license or certificate of registration rendering such license or registration without force and effect for a period of time as determined by the state board of pharmacy.

(DD) "Summary suspension" means to take immediate action against a license or registration without a prior hearing rendering such license or registration without force and effect for a period of time as indicated in section 4752.09 of the Revised Code. The board may suspend a license or registration issued pursuant to Chapter 4752. of the Revised Code by utilizing a telephone conference call to review the allegations and take a vote.

(EE) "Technologically sophisticated medical equipment" has the same meaning as defined in section 4752.01 of the Revised Code and includes the following:

(1) Oxygen conservation devices;

(2) CPAP (continuous positive airway pressure) devices;

(3) High frequency chest wall oscillators (vests);

(4) Intrapulmonary percussive ventilation (IPV) devices;

(5) Intermittent positive pressure breathing (IPPB) devices;

(6) Cough-assist mechanical in-exsuffaltor;

(7) Apnea monitors;

(8) Percussors for chest physiotherapy;

(9) Suction machines;

(10) Feeding pumps;

(11) Infusion pumps;

(12) Continuous passive motion (CPM) devices;

(13) Custom seating or positioning systems;

(14) Custom rehab equipment (e.g. standers and gait trainers);

(15) Vacuum assisted wound closure devices;

(16) Electric wheelchairs and custom scooters;

(17) Auto-titrating airway devices; and

(18) Any other technologically sophisticated medical equipment as determined by the board.

Last updated March 4, 2026 at 1:33 PM

History

Effective: June 30, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:11-2-04

(A) The board recognizes the joint commission as a national body that accredits HME services providers.

(B) The board, at its discretion, may recognize other national accrediting bodies if an agency submits a written request to the board for recognition. The board shall consider the following criteria in determining whether to recognize an agency:

(1) The agency is recognized by CMS or other nationally recognized independent quality review organization;

(2) The agency operates under the control of a multi-disciplinary governing body or board;

(3) The agency operates within the continental United States;

(4) The agency currently accredits and maintains accreditation of at least fifty HME, respiratory, or rehab organizations;

(5) The agency has a measurable process with outcome standards for determining whether to accredit a HME services provider;

(6) The agency performs on site evaluations of organizations using quantitative performance criteria;

(7) The agency awards accreditation for a finite period of time;

(8) The agency develops and publishes surveyor/site visitor qualifications and competencies;

(9) The agency provides written reports of survey visits, observations, violations, citations, and requirements for improvement; and

(10) The agency signs a cooperative agreement with the board, for mutual reporting of legal or accrediting violations.

(D) National accrediting bodies recognized by the former respiratory care board prior to January 21, 2018 shall be deemed recognized by the state board of pharmacy.

(E) If the board determines that the agency applying to be recognized does not meet the requirements of paragraph (B) of this rule, the board may deny recognition of the agency. An agency denied by the board may not resubmit a request for recognition for twenty-four months from the date of denial.

Last updated March 6, 2025 at 12:58 PM

History

Effective: December 15, 2019
Promulgated Under: 119.03

Chapter 4729:11-2 Licensure and Registration

Ohio Adm.Code 4729:11-2-01 Licensure, registration and renewal.

(A) An applicant applying for licensure as a HME services provider shall:

(1) File an application with the board pursuant to rule 4729:11-2-03 of the Administrative Code; and

(2) Submit the required fee as established in paragraph (F) of this rule.

(3) To be licensed as a HME services provider, the applicant shall comply with the following:

(a) The applicant shall be physically located in Ohio. A HME services provider located outside the boundaries of the state of Ohio may only apply for a certificate of registration pursuant to paragraph (B) of this rule.

(b) Meet the minimum standards set forth in rule 4729:11-3-01 of the Administrative Code.

(d) Submit to an on-site inspection pursuant to rule 4729:11-3-03 of the Administrative Code.

(B) An applicant applying for a certificate of registration as a HME services provider shall:

(1) File an application with the board pursuant to rule 4729:11-2-03 of the Administrative Code.

(2) Submit the required fee as established in paragraph (F) of this rule.

(3) The applicant shall be accredited by the joint commission on accreditation of healthcare organizations or another national accrediting body recognized by the board in accordance with rule 4729:11-2-04 of the Administrative Code. Part of the registration process shall be an inquiry to the accrediting agency with which the entity is accredited. This information will be used as a part of the consideration in granting a registration.

(C) The persons listed in paragraphs (A) and (B) of this rule shall be a natural person that owns and/or operates the business entity applying for licensure or registration. In the event the applicant is not owned by a natural person, each business entity with an ownership interest in the applicant must be disclosed on the application up to and through the entity that is owned by a natural person.

(D) A license or registration expires at the end of the period for which it is issued and may be renewed. For purposes of issuing and renewing licenses, the board shall use a biennial licensing period that begins on the first day of July of each even-numbered year and ends on the thirtieth day of June of the next succeeding even-numbered year.

(E) A person who seeks to renew a license or registration shall submit an application for renewal, containing information as required by the board, and pay the required fee in accordance with paragraph (F) of this rule on or before the thirtieth day of June each even-numbered year.

(F) The board establishes the following non-refundable fees:

(1) Applications for an initial certificate of registration shall include a fee of one hundred fifty dollars.

(2) Applications for an initial license shall include a fee of three hundred dollars.

(3) Applications for biennial renewal of a certificate of registration shall include a fee of three hundred dollars.

(4) Applications for biennial renewal of a license shall include a fee of four hundred dollars.

(5) If an application for renewal of a license or certificate of registration is filed with the board after the renewal date, the applicant will be charged an additional late fee of two hundred dollars.

(6) If a complete application for renewal has not been submitted by the sixty-first day after the renewal date specified in this rule, the license or certificate of registration is considered void and cannot be renewed, but the holder may reinstate the licensure or registration in accordance with procedures specified by the board.

(G) A person that fails to renew a license or certificate or registration in accordance with this rule is prohibited from engaging in the provision of HME services.

(H) A HME services provider located outside the boundaries of the state of Ohio currently licensed under Chapter 4752. of the Revised Code shall obtain a registration as a HME services provider.

(I) Except as provided in division (B) of section 4752.02 of the Revised Code, no person shall provide home medical equipment services or claim to the public to be a HME services provider unless either of the following is the case:

(1) The person holds a valid license issued under this division of the Administrative Code;

(2) The person holds a valid certificate of registration issued under this division of the Administrative Code.

Last updated June 30, 2025 at 8:12 AM

History

Effective: June 30, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:11-2-03

(A) The following information shall be required on a form supplied by the state board of pharmacy from each person making an application for a HME services provider license or certificate of registration:

(1) The name, full physical business address (not a post office box), and telephone number of the applicant.

(2) All trade, fictitious, or business names used by the applicant (e.g. "doing business as" or "formerly known as").

(3) Addresses, telephone numbers, and the full names of contact persons for all facilities used by the applicant for the storage, handling, and distribution of HME.

(4) The type of ownership or operation (i.e., sole proprietorship, partnership, limited liability company, corporation, government agency, or nonprofit organization).

(5) The following information for the owner(s) and/or operators(s) of the applicant:

(a) For a partnership:

(i) The full name, business address, social security number, and date of birth of each partner. If the partner is not a natural person, each business entity that is a partner having an ownership interest must be disclosed on the application up to and through the entity that is owned by a natural person.

(ii) The name of the partnership.

(iii) The partnership's federal employer identification number.

(b) For a sole proprietorship: the full name, business address, social security number, and date of birth of the sole proprietor.

(c) For a limited liability company: the full name, business address, social security number, and date of birth of each member. If the member(s) is not a natural person, each business entity that is a member having an ownership interest must be disclosed on the application up to and through the entity that is owned by a natural person.

(d) For a corporation:

(i) The full name, business address, social security number, and date of birth of the corporation's president, vice-president, secretary, treasurer, and chief executive officer, or any equivalent position.

(ii) The name or names of the coporation.

(iii) The state of incorporation.

(iv) The corporation's federal employer identification number.

(v) The name of the parent company, if applicable.

(vi) If the corporation is not publicly traded on a major stock exchange, the full name, business address, and social security number of each shareholder owning ten percent or more of the voting stock of the corporation.

(e) For a government agency: the full name, business address, social security number, and date of birth of the agency director.

(f) For a nonprofit organization: the full name, business address, social security number, and date of birth of the executive director or any equivalent position.

(6) If the person making application for a certificate of registration, information necessary to verify accreditation authorized pursuant to rule 4729:11-2-04 of the Administrative Code.

(7) If applicable, the Ohio medicaid number, federal medicare number, and federal tax identification number for the applicant.

(8) A copy of the applicant's certificate of product and professional liability insurance from an insurer showing a minimum one million dollars per occurrence, three million dollars aggregate of coverage.

(9) A list of the HME to be stored, repaired, leased, or sold by the applicant.

(10) A brief description of the HME services provided, including square footage of the facility.

(11) A list of the personnel currently employed by the applicant who are engaged in the delivery of HME services, including job titles.

(12) List of other licenses, registrations, or certifications held by the applicant.

(13) Any additional information required on the application as determined by the board.

(14) Any follow-up information as deemed necessary upon the receipt of the application materials.

Last updated June 30, 2025 at 8:12 AM

History

Effective: June 30, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:11-3-01

(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 and standards of care or guidelines for providing HME services from nationally recognized organizations.

(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;

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

(E) Only employees and authorized contractors of a HME services provider shall be permitted to have unsupervised access to client records and HME maintained by the provider. When no HME employees are on-site to provide supervision, all patient records and HME equipment shall be secured by either:

(1) A physical barrier with suitable locks to prevent unauthorized access; or

(2) An alarm system that is monitored by a central station for control and can detect unauthorized access. The alarm system shall be tested on a biannual basis. The HME services provider or the entity that manages security for the provider shall maintain testing records for three years from the date of testing and shall make such records readily retrievable.

(F) 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.

(G) 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 investigation (BCI) and shall consist of a BCI criminal records check.

(d) Orientation and training records.

(e) Verification of competence.

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

(H) 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.

Last updated June 30, 2025 at 8:13 AM

History

Effective: June 30, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:11-3-02

(A) A licensed or registered 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.

Last updated June 30, 2025 at 8:13 AM

History

Effective: June 30, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:11-3-03

(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 employee 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 employee's credentials, the employee 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.

Last updated June 30, 2025 at 8:14 AM

History

Effective: June 30, 2025
Promulgated Under: 119.03