Organizations are sometimes surprised to find out that surveyors look at various state and federal laws along with accreditation standards during the survey. The fact of the matter is that law and regulation overlaps accreditation standards in many ways and in many places. In fact, many accreditation standards have their basis in law and regulation. Standard ORG 2 states that an organization willdemonstrate compliance with “all required federal, state, and local licenses, permits, certifications, and registration requirements”. It also references compliance with Medicare enrollment standards, meaning that you must comply with the Quality Standards, which were the basis for all accreditation standards. Essentially, what ORG 2 says is that you must follow all applicable law and regulation.
This standard represents hundreds of laws and regulations. Complicating the standard is the fact that these laws and regulations vary from state to state; and among providers depending on the type of equipment and services you offer. In some states, oxygen providers are required to have a pharmacy license. This makes sense; after all, oxygen is a drug. In other states, a pharmacy license is NOT required, but a home medical equipment provider license requirement is in place. Finally, in other states, there is no requirement for either pharmacy or HME license.
These discrepancies and differences can be confusing to providers, particularly providers that have locations in multiples states or who provide care in multiple states from one location. Just because you don’t have a license requirement in your home state doesn’t mean that you are “legal” to provide care across the state line.
Accrediting agencies are all tasked with ensuring that your business is properly licensed, registered, and certified to operate. Some federal and state agencies who’s rules and regulations are commonly validated during survey include:
- FDA—The Food & Drug Association. This national agency sets forth rules for companies providing legend items (medical equipment and supplies that require a physician prescription to dispense) including oxygen. They have a set of rules regarding providing oxygen in the so-called “FRESH AIR” document.
- OSHA—The Occupational Safety & Health Administration. This national agency establishes rules regarding workplace safety. This includes training requirements for staff performing certain physical tasks as well as a requirement for companies to provide vaccinations for staff that works in healthcare settings (presumably because of the risk of exposure to diseases).
- State HME Licenses. Currently, approximately 25-30 states require HME licenses; depending on the categories of medical equipment/supplies your business is providing. Regulations relating to these licenses vary greatly from state to state.
- State Board of Pharmacy Licenses. Currently, about 10-15 states require state pharmacy license for businesses dispensing medical equipment. Most commonly, providing oxygen is the trigger for requirement of this license.
- State Respiratory Care Practitioner (RCP) Licensing. These are the professional licenses of respiratory therapists, who commonly work for HME organizations providing oxygen, ventilators, and other respiratory equipment.
- DOT—Department of Transportation. This agency establishes rules regarding delivery vehicles and the delivery process ranging from standards that address the actual delivery vehicle (placarding for oxygen delivery, for instance) to standards for commercial drivers’ licenses and hazardous material endorsements for delivery personnel (in certain kind of delivery vehicles only).
- Bedding Licenses. Some states have rules regarding the need for licenses for any company providing or sanitizing and re-using upholstered items and mattresses. These items can include hospital beds, mattresses, and even wheelchairs because of the upholstery.
The surveyors who visit your company will have been trained on state and federal requirements. Prior to the survey, as part of their preparation, they will have reviewed the need for licensure, registration, and certification at your company. To perform this preparation, the surveyor will review your company’s equipment list and your application for accreditation to review the types and categories of equipment and services you offer. They will then cross reference that against the rules and regulations in your home state, any state where you have locations/branches, and any state you dispense equipment or services to. Thus, if you are a national company providing care in all 50 states, they will review requirements in all 50 states!
Does that sound like a lot of research and/or a lot of information to carry around? It is, indeed. Many surveyors use a helpful Medicare tool to check these state requirements. The concept of this tool is that anyone can punch in their state (or any state where they are wanting to do business) and they can learn what the requirements are based on type of equipment provided. The website is:
Keep in mind that state regulations often change. They are somewhat subject to interpretation as well. In fact, many companies report that they’ve called a state agency multiple times and asked questions about licensing, only to get different answers each time.
It is generally advisable to document these conversations and save the documentation. That way, if your company is challenged for NOT having a license or questioned about how you comply with a given rule or regulation; you have a “paper trail” to document that you sought information out regarding the rule. Try to “get it in writing”. Absent getting it in writing, be sure to document the date and who you talked to. It is also advisable to check back from time to time and make sure the rules haven’t changed.
Most companies truly want to comply with all rules and regulation and strive for that compliance on a daily basis. Besides this tool and the information you glean from your surveyor, state HME trade associations are also excellent resources. Because they have a limited number of state rules to keep track of, they quickly become experts at the law and regulation within their state(s).
