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National Coverage Determination for Obstructive Sleep Apnea

Posted Sep 14 2008 12:19am

This is an excerpt from a letter written by the President of SleepQuest to the Director of Coverage and Analysis Group Centers for Medicare and Medicaid Services

My name is Robert Koenigsberg and I am the CEO and Founder of SleepQuest, Inc. In 1996, we began providing in-home sleep testing and treatment exclusively, and currently have three field offices which continue to serve the needs of the local communities. Demand for our sleep testing and therapy continues to expand in each of the areas we serve. I started SleepQuest because my father had such a horrible experience during his in-lab test that he handed me a Polaroid picture that was taken the following morning after the in-lab test and said “son, do something about this as I just experienced the worst night of sleep of my life”. The past eleven years have been my and my company’s quest to fulfill his desire that all patients would have the ability to be tested and treated in their own home.

I learned early on that patients were caught in a game of pickle between the sleep center and the generalized home care company. The home care company was committed to providing 1500 diverse products for various disease states and didn’t have the specialization to properly educate OSA patients in all of the problems that patients encounter once beginning use of nasal PAP equipment. By taking accountability for the patient, we have now successfully diagnosed over 10,000 patients in their own home, provided in home titrations for those who required them and provided our unique sleep care specialization to insure patients are compliant with their treatment.

I understand why CMS currently doesn’t allow the provider who does the testing to also provide the treatment. I have redefined the delivery model for sleep care by placing the management of the sleep related breathing disorder (i.e. OSA) in the hands of the primary care physician who is currently caring for diabetics and asthmatics and can easily be informed on how to properly evaluate a sleep questionnaire as well as what to look for in their clinical assessment of the patient. Since we are not taking on the care of the patient but acting as an extension of his/her practice by providing a needed service, we don’t run into the same self-referral situation that a lab encounters. The referring physician and patient have a choice as to who they want to provide the service. By the way, this is the way other developed countries throughout the world practice sleep medicine.

Since OSA is more prevalent than either diabetes or asthma, it makes sense that the lower cost and competent PCP should be entrusted with the care of the patients sleep apnea condition. We work complementary with local sleep labs as we believe that roughly 10% of patients have sleep disorders that cannot be properly tested in the home setting. (Not including Insomnia or Restless Legs Syndrome) The PCP is empowered to make this determination by evaluating the questionnaire and doing a clinical assessment of the patient. By providing a continuum of care, the patient benefits from a disease management approach to their breathing disorder. We track outcomes and have successfully provided compliance for 93% of our patients.

In 1999 we began working with the father of sleep medicine, Dr. William Dement who became a believer in our unique approach after speaking to several patients who had become compliant with nasal PAP. In an effort to validate our pathway we undertook a research study to determine if our clinical model could improve the patient’s Quality of Life (QOL) while providing comparable results to previously published studies using traditional in-laboratory management. Quality of life as measured by SF-36 improved significantly for physical health, general health, vitality, social functioning, emotional and mental health subscales. Physical function trended towards improvement. Epworth scores improved from 13.21 (S.D.4.08) to 5.57 (S.D. 3.78) after treatment.

I am concerned that not providing initial diagnostic studies on patients suspected to have OSA, will not produce the outcomes desired. Although a patient with moderate to severe OSA can be properly assessed by a competent physician, the in-home titration is important in determining the type of device to be suggested as well as the type of mask or interface. If patients are placed on treatment without this analysis of their condition I fear that compliance will be less than optimal.

In 2004, we became certified as an Independent Diagnostic Testing Facility by CMS. An investigator came to our offices to perform an inspection prior to our receiving the IDTF status from CMS. During that short window of opportunity, we successfully performed sleep studies for Medicare patients, and received high satisfaction from these patients, again validating our pathway of providing in-home testing.

I would be willing to once again testify at a CMS hearing that may commence prior to the final NCD. Thank you for giving the public an opportunity to voice our opinions and share their experiences and clinical research findings.

Best regards,

Robert Koenigsberg

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