Lawriter - OAC - 4729:11-1-01. Definitions - home medical equipment

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.
(C) "Accrediting body" means an agency recognized by the board under rule 4729:11-2-04 of the Administrative Code.
(D) "Act of moral turpitude" means an act or behavior that gravely violates moral sentiment or accepted moral standards of the community and is a morally culpable quality held to be present in some criminal offenses as distinguished from others.
(E) "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.
(F) "Board" means the state board of pharmacy.
(G) "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.
(H) "Certificate of registration" or "registration" means a person holding a valid certificate of registration issued under Chapter 4752. of the Revised Code.
(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) "Expired certificate of registration" means the holder of a certificate of a 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.
(M) "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 who has failed to request that the board place the certificate on inactive status.
(N) "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 (T) and (DD) 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 (T) of this rule; and
(10) Technologically sophisticated medical equipment as defined in paragraph (DD) of this rule.
(O) "Home medical equipment services" or "HME services" has the same meaning as defined in section 4752.01 of the Revised Code.
(P) "Home medical equipment services provider" or "HME services provider" has the same meaning as defined in section 4752.01 of the Revised Code.
(Q) "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.
(R) "In-service education" means that a continuing education program is offered by a HME service provider organization and not an approved peer review organization.
(S) "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.
(T) "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.
(U) "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.
(V) "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.
(W) "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.
(X) "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.
(Y) "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.
(Z) "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.
(AA) "Staff" means employees or their representatives of a licensee or registrant.
(BB) "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.
(CC) "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.
(DD) "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 & 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.

Replaces: 4761:1-3-01, 4761:1-3-02


Cite as Ohio Admin. Code 4729:11-1-01

History. Effective: 12/15/2019
Five Year Review (FYR) Dates: 12/15/2024
Promulgated Under: 119.03
Statutory Authority: 4752.17
Rule Amplifies: 4752.17
Prior Effective Dates: 05/23/2005, 05/24/2006, 10/26/2009, 08/09/2010, 06/04/2014