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Home Medical Equipment Regulation

In 2005, the 125th General Assembly passed H.B. 105, establishing a licensing and certification requirement for home medical equipment facilities under Chapter 4752 of the Ohio Revised Code. The Ohio Respiratory Care Board's regulatory authority was changed to include Home Medical Equipment (HME) facility regulation. Chapter 4752 requires licensing or registration for any facility that provides life-sustaining equipment, technologically sophisticated medical equipment, or other equipment identified by the Board in rule.

(1) Life-sustaining HME is defined as equipment that medically sustains, restores, or supplants a vital bodily function, such as breathing.  This HME equipment must be prescibed by an authorized healthcare professional. Click HERE for definition of authorized health care professional.

(2) Technologically sophisticated medical HME is defined as equipment that requires individualized adjustment or regular maintenance by an HME service provider to maintain a patient's health care condition or the effectiveness of the equipment. This HME equipment must be prescibed by an authorized healthcare professional.

(3) Other HME equipment is HME defined by the Board in rule. 

The Board has amplified in rule the three classification of HME listed above by identifying specific HME equpment types that fall within each classification.  OAC rule 4761:1-3-02 should be reviewed prior to completing an application for a license or certificate of registration. 

Certificate of Registration Applicants - to qualify for a certificate of registation an applicant must be accredited by an organization approved by the Board.  Click HERE to see a full list of recognized organization.

License Applicants - to qualify for a license an HME provider must meet Ohio's standards of practice and operational requirements for an HME provider.  To see the full standards of practice and operational requirements click HERE.  In addition, a license applicant must hold professional and product liability insurance coverage.  Click HERE to see requirements.

News and Events
HME forms amended - Thursday, June 19, 2014

the Board adopted new versions of the following forms:

HME Facility License Application (Non-accredited facilities)

HME Facility Certificate of Registration Application (Accredited facilities)

Facility Self Evaluation for Ohio HME Regulation

Affidavit of Exception

Prior versions of these forms are obsolete and will not be accepted.

 
Rule 4761:1-3-02 amended effective June 4, 2014 - TENS Devices re-defined - Thursday, June 19, 2014

Specific amendments to Rule 4761:1-3-02 will go into effect on June 4, 2014.  Among the amendments, the definition of Transcutaneous Electronic Stimulators (TENS) devices has been changed.  The new definition excludes TENS devices labeled by the food and drug administration (FDA) for over-the-counter use and are identified with the FDA product code "NUH.OTC.TENS."  

This change does not remove TENS devices from the list of defined home medical equipment, but refines the definition of TENS devices.  A copy of the rules effective on June 4, 2014, click - HERE.

 
Rules Filed to amend examination requirements for licensure - Friday, March 15, 2013

The Ohio Respiratory Care Board final filed five proposed rules on March 14, 2013.  

One rule will rescind current rule OAC 4761-5-01 effective April 24, 2013.  A new OAC rule 4761-5-01 will take its place on the same day.  Three other amended rules were final filed:  OAC 4761-5-04, eff. April 24, 2013, OAC 4761-8-01, eff. April 24, 2013, and OAC 4761:1-10-03 eff. March 29, 2013.

For more information on these rules, click here.

 

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The sale and rental of TENs Units by Health Care Providers - Wednesday, March 06, 2013

The sale and rental of TENs units, or other HME devices defined under OAC 4761:1-3-02, by health care providers is not permitted, unless the provider obtains an license or certificate of registration issued by the Ohio Respiratory Care Board.  ORC 4752.01(B) of the Revised Code defines home medical equipment.  This definition is expanded under OAC rule 4761:1-3-02, which lists TENs units among the HME items defined by the Board.  ORC 4752.02(B)(1) exempts "health care practitioners" from requiring a license or certificate of registration as long as the practitioner does not sell or rent HME.

To obtain a license to sell or rent home medical equipment requires that the applicant meet specific standards promulgated by the Board.  The Board, soon after issuance of the license, will inspect each facility to verify compliance with the HME standards.  For a copy of these standards, click on this link:  HME Standards .  The Board recommends that these standards be carefully reviewed and verified by the applicant prior to filing an application for an HME license.  Filing fees are non-refundable.

 
HME - Transfer of Authorization to new facility, cessation of business, or new ownership - Tuesday, June 24, 2008

OAC 4761:1-15-03 requires: 

1. HME Licenses or Certificates of Registration are valid only for the facility location listed in the original application.  If a facility moves to a new address, the HME License or Certification of Registration is no longer valid.  An HME facility that does not obtain a new License or Certificate of Registration is not in compliance with Ohio laws and rules regulating the provision of HME services.

2. If an HME facility ceases to be engage in HME services, the facility must provide written notification to the Board.  Upon receipt, the Board will cancel the applicable HME license or certificate of registration.

3. If an HME facility changes ownership, the new owner shall immediately notify the Board in writing of the ownership.  For licensed HME facilities, the new owner is responsible for scheduling an inspection within sixty days of the change in ownership.  Specifics are addressed in rule.  

4. An HME facility that changes its name shall request an updated license or certificate of registration identification card.  

To see a full copy of the rule, click HERE.

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Contact
Contact the Board:
 
Ohio Respiratory Care Board
77 S. High Street, 16th Floor • Columbus, Ohio 43215
Tel: (614) 752-9218 •
Fax: (614) 728-8691