A recent study helps to develop a model nebulizer compliance program for patients receiving mail-order medications.

The prevalence of chronic obstructive pulmonary disease (COPD) including emphysema, bronchitis, and asthma continues to increase nationwide. Recent data show that, in the age 65-plus Medicare group alone, more than 4.5 million people have been diagnosed with COPD.1,2 Statistics are lacking, but a significant number of these people require home bronchodilator therapy delivered via either metered dose inhaler (MDI) or air compressor-driven nebulizer.

In the Medicare population, since MDI medication is not a reimbursable item, recipients have turned to modalities of delivering inhaled medications that are reimbursed by Medicare intermediaries. This has created a significant market for mail-order pharmacies to provide medications for inhalation that can be administered through a durable medical equipment (DME) compressor/nebulizer system. One example is the increased advertising in professional and trade journals soliciting respiratory therapists who will market the services of a mail-order pharmacy to physicians, discharge planners, and other respiratory therapists they may know in order to gain patient referrals for the pharmacy.3

A mail-order nebulizer medication program has the potential to be a win-win scenario for the patient, the mail-order pharmacy, and the Medicare reimbursement program. When medical necessity is established for inhaled medications, a mail-order delivery program is convenient for the patient, profitable for the mail-order pharmacy, and cost efficient to the Medicare program when the regimen reduces the incidence of hospital admissions, as well as nonscheduled visits to hospital emergency departments and walk-in medical clinics.

Once patients are admitted into a mail-order pharmacy medication program, then the monthly reordering of the medications becomes important. The clinical goal is to have the patient self-administer the nebulizer treatments, as prescribed, thereby reducing unscheduled visits to health care providers. The business goal is to ship nebulizer medications monthly in order to generate income for the company. Another business goal is to continue to attract and admit new patients into the respiratory medication mail-order program. These clinical and business goals together can be accomplished with the assistance of a functional patient compliance program led by a licensed respiratory therapist.

Clinical compliance can be defined as a patient self-administering nebulizer treatments according to the physician’s prescription. In a mail-order pharmacy, compliance with the prescription can be inferred by noting the number of monthly medication reorders authorized by the patient.

The following elements are important in establishing and conducting a patient compliance program:

  • Define the goals of the nebulizer medication mail-order program.
  • Define the requirements that must be met before a patient can be accepted into the nebulizer medication mail-order program.
  • Provide clinical management for those patients accepted into the program.
  • Provide a mechanism to communicate with the prescribing physician on a regular basis.
  • Enforce the patient requirements for continued participation in the mail-order nebulizer medication program.

Patient selection is an important part of a successful compliance program. We do not want to accept every patient who inquires about our program for the sole purpose of sending medications for the first month or two only to find they are using their nebulizer on an occasional basis. The company’s philosophy is rather to provide unparalleled service to those patients who require compressor-driven nebulizer treatments on a daily basis. Those who do not satisfy this requirement are not the type of patients our program is designed to serve. When a patient is accepted into a mail-order service, it is emphasized that treatment is required at least once a day. If patients do not meet this requirement, they are not accepted into our mail-order nebulizer medication program. Instead, they are directed to a local pharmacy. Occasionally, an exemption is granted from the daily treatment requirement (homebound with no readily available assistance to obtain nebulizer medications from a local pharmacy).

At the heart of a compliance program is active clinical management. When the patient is accepted into the program and the required medical documentation has been received, the patients are advised when their nebulizer medication and supplies will be shipped and that a respiratory therapist will contact them with further instructions. The first shipment consists of the ordered nebulizer medications, a high-quality permanent reusable nebulizer, and, when required, a high-quality air compressor. Also included in the first shipment are written procedures for the operation, use, and care of the air compressor and nebulizer as well as a copy of a booklet published by the American Lung Association called “Help Yourself to Better Breathing.”4 Shortly after the patient receives the first shipment, a respiratory therapist phones and performs the following tasks:

1. Assessment of patient’s pulmonary history and current respiratory status.

  1. If done properly, this telephone call can also help establish a relationship between the patient, respiratory therapist, and mail-order company. When this relationship is developed, patients may be more inclined to follow the clinical recommendations offered by the respiratory therapist to manage their pulmonary condition within the physician’s prescription.
  2. The assessment may also uncover opportunities to provide other appropriate services for patients.

2. Describe or review clinical goals and objectives of the treatment program.

3. Describe or review action and potential side effects of ordered medication.

4. Provide instruction on operation and maintenance of air compressors.

5. Provide instruction on operation and maintenance of permanent reusable nebulizers.

6. Provide instruction on infection control protocols including hand washing, assembly/disassembly of nebulizers, and sterilization or disinfection techniques.

7. The name and toll-free telephone number of the consulting respiratory therapist is provided and patients are encouraged to call regarding any problems or concerns, or for a review of any information provided.

8. Advise patients that the respiratory therapist will complete additional follow-up assessments every 90 days.

Every 90 days, the respiratory therapist follows up with a telephone assessment of the patient’s status and progress. This report is sent to the ordering physician and is one of several communication links between the company and the patient’s doctor. A copy of the report is sent to the patient and another copy is retained in their medical records. The goal of this assessment is to provide:

1. A subjective assessment by the patient of how his breathing has been in the recent past.

2. The patient’s level of compliance with the physician’s prescription.

  1. Any variance is an opportunity to consult with the patient to provide support, encouragement, and further instructional reinforcement.
  2. A variance is also an opportunity for the company’s pharmacist to consult with the prescribing physician to update any change in the prescription and to educate the physician regarding the pharmacy’s capabilities to serve this patient and others.

3. The patient’s subjective evaluation of how he has been responding to the nebulizer treatments. This will provide useful information on whether the patient is following the treatment protocol and whether he is experiencing any adverse side effects.

4. Is the patient following the recommended infection control protocol? If not, an opportunity exists for instructional reinforcement.

5. Recommendations are made to the patient that can be reviewed by the physician and the patient.

To achieve the goals of the compliance program, a system needs to be in place to identify noncompliant patients who require respiratory therapist intervention or to delete those patients who do not satisfy the basic requirements of the program. Our program addresses this issue by identifying any patient who skips two consecutive monthly shipments. A compliance letter is sent to this patient drawing his attention to the fact that he has not authorized two consecutive monthly shipments, reminding him of the goals of our program, and asking him to ascertain whether our program is appropriate to his needs. A copy of this letter is also sent to the prescribing physician. Many times a patient will offer a reasonable explanation for skipped shipments (inpatient hospitalization, inpatient rehabilitation facility admission, or short-term nursing home admission). If the patient continues to skip monthly shipments and accumulates 3 consecutive months without a nebulizer medication reorder authorization, he is contacted by a respiratory therapist to determine either of the following:

1. Whether the nebulizer treatments have been discontinued by the physician.

2. Whether the patient has reduced treatment frequency or stopped treating every day, regardless of physician orders.

If the physician has discontinued the nebulizer treatments or the patient states they will no longer take the nebulizer treatments on a daily basis, they are advised that they no longer qualify for our program and will be deleted. We recommend they acquire nebulizer medications, as needed, from a local pharmacy. We emphasize that if his condition deteriorates to the point that he requires nebulizer treatments at least once daily, then we will be pleased to reinstate him. If patients have only decreased treatment frequency, then we work with them to adjust the quantity of monthly medication they will require to continue to ship on a monthly basis. It is important to note that Medicare rules require a pharmacy to supply the patient with only the amount of medication he is actually using each month, not what the physician prescription or Certificate of Medical Necessity indicates.5

Our mail-order nebulizer medication supply program was initiated and patients were grouped in weekly shipping queues as they were admitted into the program. Upon the patient’s written or verbal approval, they were mailed a 30-day supply of nebulizer medications each month. A compliance program was designed and put into place. With 2 years’ experience in providing mail-order nebulizer medications to patients, the data from this small study satisfactorily justify the expense of a respiratory therapist to lead the patient compliance program.

Philip A. Porter, RRT, is a clinical home care respiratory therapist for Lincare Inc, Clearwater, Fla.

1. American Lung Association. Trends in Asthma Morbidity and Mortality, January 2001. Available at: www.lungusa.org. Accessed August 3, 2001.
2. American Lung Association. Trends in Chronic Bronchitis and Emphysema Morbidity and Mortality, 1998. Available at: http://www.lungusa.org. Accessed August 3, 2001.
3. Classified Advertising. RC job opportunities. AARC Times. 2001;25:85.
4. Help Yourself to Better Breathing. New York: American Lung Association; September 1996.
5. Medicare Region C. DMERC DMEPOS Supplier Manual. Durable Medical Equipment, Prosthetics, Orthotics and Supplies. 2001;20:5.