Accreditation Considerations for Alternative Delivery Models in HME
Structuring programs to meet standards
by Randy Hughes

Changing reimbursement environments, tightening regulatory requirements and managed care are forcing HME providers to develop alternative delivery models for equipment and services. Some of the concepts have existed for a while; some were tried, abandoned, then redesigned and reactivated; and some are brand new. The goal of each has been to provide service more efficiently and effectively and to decrease labor costs.

An important consideration with all models is, “Who owns the patient?” That is, who is responsible for providing the product to the patient in the appropriate manner? In almost all instances, the answer is driven by who bills—and who gets reimbursed—for the equipment or services provided. This must be a guiding consideration when any alternative model is developed. It is incumbent upon the owner of the patient to ensure that goods and services are delivered in a manner that meets all accreditation requirements.

Below are some examples of alternative models currently in use and an overview of some of the accreditation implications.

Direct Shipping

Direct or drop shipping has been present since the birth of the industry. What has changed are the types of products being shipped. Prior to the advent of competitive bidding, few imagined that patients would receive oxygen concentrators and bi-level therapy equipment through the mail, but this model has become prevalent and cost-effective. Equipment manufacturers have become providers, shipping equipment directly to the patient. Some have developed a model that successfully meets accreditation requirements, allowing them to obtain a PTAN number.

Accreditation considerations with this model center around documentation of the actual shipping and receipt of the product, and especially on patient education, evaluation of safety-related issues and the provision-of-care process (Plan of Care or Plan of Service). The requirement to obtain a patient’s acknowledgment of receiving patient rights and responsibilities, HIPAA notice, AOB, etc., can be a challenge and is usually addressed by providing the patient with a self-addressed, stamped envelope. If the products being shipped require backup equipment or supplies, such as oxygen, the model must include provision of a backup supply of oxygen that meets the guidelines of the state in which the patient resides. Additionally, before reshipping supply items, the shipper must verify the patient had been using the supplies and has utilized enough of the product/service to justify another shipment.

Group Patient Teaching

Recognizing the value of instructing multiple patients during one encounter has led some organizations to hold new patient classes, providing patient education and equipment fitting in a group setting. This model is gaining popularity for new and reinstruction CPAP patients and group compressor/nebulizer instructions. In some cases the equipment is sent to a patient’s home before the class begins. This model offers multiple advantages including increased staff productivity and better interaction between patient and instructor and between patients, and has even resulted in the formation of patient-hosted support teams that encourage patient compliance and sharing of experiences. Not all patients are comfortable in a group setting, and experience has demonstrated that a pre-screening tool to identify such individuals facilitates group participation.

The most prevalent accreditation obstacles have been HIPAA implications and patient confidentiality. Organizations that have sought counsel have addressed this by developing a waiver that grants permission for group discussions and sharing of information. Additional considerations are adherence to infection control protocol and practices, assurance that each patient’s documentation is completed thoroughly and accurately, and individualizing each patient plan of care as patient-specific issues are identified.

Subcontracted Delivery Services

In an attempt to control costs, some organizations have implemented sub-contracted patient delivery services. In this model, the billing entity provides the equipment and supplies while the subcontractor delivers the products. The most common model delivers resupply items to patients, including reusable and disposable items and oxygen cylinders, for which new patient teaching and instruction are not required. If the subcontractor is providing patient education, fitting, etc., they must also be accredited.

Models such as this require a well-defined description of expectations from the subcontractor and a clear description of the services to be provided, documentation requirements, staff training, orientation, competency and others. A written contract detailing the responsibilities of each party is required. It is also necessary to develop a performance indicator that monitors the services provided by the contracted organization. This performance indicator should be included as part of the organization’s performance improvement monitoring program.

Nontraditional Oxygen Model

The goal of this model is to eliminate or minimize resupply visits to a patient’s home after the initial delivery of an oxygen delivery device, usually an oxygen concentrator. The most prevalent examples of this model are the various home oxygen cylinder filling units and the use of portable oxygen concentrators (POC). The use of home-filling units is well established but has not become widespread, in part due to higher capital costs. The same can be said for POCs. POCs have historically had limitations including reliability issues, low flow capability and short battery life. However, advances in technology are overcoming most of these obstacles and reliable, 3 to 4 LPM continuous flow capability, improved battery life and 24-hour continuous use capability are positioning this technology to perhaps replace the traditional oxygen concentrator/cylinder with one unit that can do it all.

Another advantage of POC technology is that there are no special accreditation considerations. Patient education is key; as long as the equipment is utilized and maintained as required by the manufacturer, the same accreditation standards that apply to a traditional oxygen concentrator apply to POCs.

Non-Clinical Ventilator Services

Just as the reimbursement models have changed, so has the technology associated with providing mechanical ventilation equipment to intubated patients. Today’s ventilators incorporate sophisticated technology to provide multiple modes of ventilation, humidification and alarm systems in one compact unit. Additionally, the explosion of noninvasive ventilation as an adjunct to or in place of invasive ventilation raises questions as to the need for these patients to receive clinical respiratory services (CRS). Providers who offer ventilator services as non-clinical are considered accredited for equipment management.

If an organization chooses to continue to provide ventilators as a clinical service, attention must be paid to the most common areas of deficiency. These include obtaining and maintaining up-to-date physician orders, medication profiles, care plans and thorough documentation from the clinicians performing the home visits.

Impact of Technology

Remember when a pulse oximeter cost more than $1,000? Today you can buy one at a chain pharmacy—without a doctor’s prescription—for $20. Remember a POC at well over $2,500? We will soon see an affordable device that is both a POC and oximeter in one unit. It will include a modem similar to today’s CPAP units that will not only transmit compliance data but will include an active interface that will facilitate remote troubleshooting, repair and maintenance. Instead of having to visit a patient’s home to change and reinstruct liter flow, it can be done remotely. Instead of a physician ordering oxygen at 2 LPM, a patient will be able to self-titrate to maintain SaO2, as ordered by the physician. An evolution of this concept involves an integrated device that will automatically monitor the patient’s saturation levels and adjust the flow rate to meet the patient’s oxygen demands to maintain adequate saturation levels.

As we move through this continuum, many new questions will be posed from an accreditation perspective including:

  • What kind of doctor’s order will I need for this new application?—An order from the physician to, “Maintain O2 saturations above x percent,” will likely suffice.
  • What about equipment maintenance documentation?—As with all equipment, manufacturers will provide maintenance guidelines. As long as an organization can demonstrate that these guidelines are being adhered to, there will be no accreditation implications.
  • What competency is required for a tech to remotely access a patient’s concentrator for troubleshooting?—With clear manufacturer guidance, this is simply a process of documenting the employee’s ability to follow the manufacturer’s recommendations. If guidance is not provided, an organization will be expected to develop performance expectations, train employees, then monitor and document employees’ ability to implement and follow the process.
  • Is a respiratory therapist (RT) required to teach a patient to self-titrate?—This is subject to the RT Practice Act in various states. Continuing to follow policies and procedures that organizations currently utilize to perform self-titration education should be sufficient.

These and other matters will challenge providers and accrediting organizations (AO) to develop revised expectations of how a particular model must be structured to meet the standards. Proactive communication with your AO about the models you are exploring and what impact they have from a standards interpretation perspective will help facilitate this transition.