Question Posted by Reader of Let's Talk Sleep Blog Re: CMS Review on Home Testing

Hello All,

Someone wrote in and asked underneath this posting from yesterday: "CMS Reviewing Issue Surrounding Home Sleep Testing; 30-Day Public Comment Period Now Open"

The reader did not sign their name, but I thought I would post their question and my answer here on the blog.

The letter requesting the CMS review by the American Academy of Otolaryngology lists studies in the letter. Readers can view that letter by clicking here.

Show Original Post


Anonymous said...
This issue is being reviewed again already! Who's behind this push? The recent CMS review of this same issue resulted in the determination that the technology was not yet reliable enough for home use. The AASM formal study of portable testing has just been initiated. Is there a new, large quantity of data available to effect the first CMS determination?
Mar 15, 2007 1:16:00 PM

Let's Talk Sleep! said...
The CMS received the request from the American Academy of Otolaryngology-Head and Neck SurgeryYou can read the request letter at: https://www.cms.hhs.gov/DeterminationProcess/downloads/id204.pdf
Mar 15, 2007 1:22:00 PM
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Many of the questions readers have been asking me today can be answered by listening to a podcast related to this topic

The podcast is now posted at www.letstalksleep that features Lena Kauffman, editor for Sleep Review who recently conducted interviews with five members of the Sleep Community for the Sleep Review Home Testing Podcast Series. Kauffman’s guests included Dr. William C. Dement, Dr. Barbara Phillips, Dr. Michael J. Breus, Dr. Dominic A. Munafo, and Dr. David White. The Kauffman podcast will be available to listeners through Let’s Talk Sleep or iTunes by no-cost, direct download.



Be well,
Theresa

CMS Reviewing Issue Surrounding Home Sleep Testing; 30-Day Public Comment Period Now Open

A formal request was accepted and a review initiated today by the U.S. Department of Health & Human Services Centers for Medicare & Medicaid Services (CMS) regarding its national coverage determination (NCD) on the diagnosis of patients with obstruct obstructive sleep apnea (OSA) requiring CPAP therapy. Current national coverage policy specifies that only polysomnography done in a facility-based sleep study laboratory can be used to identify patients with OSA requiring CPAP (see section 240.4 of CAG-00093R2).

A 30-day public comment period for reconsideration of this issue was opened today by CMS and runs now through April 13th. The proposed decision memo due date is September 14, 2007.

To read more about CMS review and instructions for submitting pubic commentary, click here.

Updated Sleep Symposia Calendar- Send your meeting notices

To have your meeting listed, send information to sleepsymposia@yahoo.com

Royal Infirmary of Edinburgh Sleep Medicine Course, Mar. 26-30, 2007
AAST Spring Review 2007, Louisville, KY, USA, Apr. 16-17
British Sleep Society 2007 Meeting, Loughborough University, Leicestershire, UK, Apr. 16-18
FOCUS 2007, Nashville, TN, USA, April 19-20
SESW RAPT 2007, Virginia Beach, VA, USA, May 3-7
ATS 2007, San Francisco, CA, USA, May 20-22
KSS 2007, Bowling Green, KY, USA, May 31-June 1
Movement Disorders Society 2007 Congress, Istanbul, Turkey, June 3-7
Sleep 2007 (APSS), Minneapolis, MN, USA, Jun 9-14
Current Concepts in Sleep 2007, Tampa, FL, USA, Aug. 31-Sept. 1
worldsleep07, Carins, QLD, Australia, Sept. 2-6
Montana Regional Sleep Seminar 2007 at St. Vincent Healthcare, Billings, MT, USA, Sept. 6-8
2007 BSS 19th Annual Scientific Meeting, Cambridge, UK, Sep. 23-25
XII Congreso Panamerricano de Neurologia 2007, Santo Domingo, Domincan Republic, Oct. 7-11
Narcolepsy Association UK (UKAN) 2007 Annual Conference, Altrincham, Cheshire, UK, Oct. 13
ESRS 2008, Glasgow, Scotland, Sep. 9-13

FDA Requests Label Change for All Sleep Disorder Drug Products

FDA News- FOR IMMEDIATE RELEASE

March 14, 2007

FDA Requests Label Change for All Sleep Disorder Drug Products

The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.

"There are a number of prescription sleep aids available that are well-tolerated and effective for many people," said Steven Galson, M.D., MPH, director of FDA’s Center for Drug Evaluation and Research. "However, after reviewing the available post-marketing adverse event information for these products, FDA concluded that labeling changes are necessary to inform health care providers and consumers about risks."

In December 2006, FDA sent letters to manufacturers of products approved for the treatment of sleep disorders requesting that the whole class of drugs revise product labeling to include warnings about the following potential adverse events:

• Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
  


• Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).
  

FDA has been working with the product manufacturers over the past three months to update labeling, notify health care providers and inform consumers of these risks.
Along with the labeling revisions, FDA has requested that each product manufacturer send letters to health care providers to notify them about the new warnings. Manufacturers will begin sending these letters to providers starting this week.

In addition, FDA has requested that manufacturers of sedative-hypnotic products develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken. Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information such as proper use and the recommendation to avoid ingesting alcohol and/or other central nervous system depressants. When these Medication Guides are available, patients being treated with sleep medications should read the information before taking the product and talk to their doctors if they have questions or concerns. Patients should not discontinue the use of these medications without first consulting their health care provider.
Although all sedative-hypnotic products have these risks, there may be differences among products in how often they occur. For this reason, FDA has recommended that the drug manufacturers conduct clinical studies to investigate the frequency with which sleep-driving and other complex behaviors occur in association with individual drug products.

The medications that are the focus of the revised labeling include the following 13 products:
Ambien/Ambien CR (Sanofi Aventis) Butisol Sodium (Medpointe Pharm HLC) Carbrital (Parke-Davis) Dalmane (Valeant Pharm)Doral (Questcor Pharms) Halcion (Pharmacia & Upjohn)Lunesta (Sepracor) Placidyl (Abbott) Prosom (Abbott) Restoril (Tyco Healthcare) Rozerem (Takeda) Seconal (Lilly) Sonata (King Pharmaceuticals)

For more information on the sedative hypnotic products and sleep disorders, visit

http://www.fda.gov/cder/drug/infopage/sedative_hypnotics/default.htm; www.fda.gov/womens/getthefacts/sleep.html and www.nhlbi.nih.gov/health/dci/Diseases/inso/inso_whatis.html.
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March 15th Let’s Talk Sleep Podcast Guest: Lena Kauffman, Sleep Review Editor

My guest on a new podcast that will air March 15th on Let’s Talk Sleep will be Lena Kauffman, editor for Sleep Review who recently conducted interviews with five members of the Sleep Community for the Sleep Review Home Testing Podcast Series. Kauffman’s guests included Dr. William C. Dement, Dr. Barbara Phillips, Dr. Michael J. Breus, Dr. Dominic A. Munafo, and Dr. David White. The Kauffman podcast will be available to listeners through Let’s Talk Sleep or iTunes by no-cost, direct download.

Kauffman has been the editor of Sleep Review, The Journal for Sleep Specialists since 2005. She is a graduate of the Medill School of Journalism at Northwestern University, and, as a medical science reporter and editor, has covered such diverse fields as home health care and diagnostic imaging.

Due to the issue being laden with controversy, no matter what is said about home sleep monitoring -- either for or against the issue – it appears that someone is distressed. The mainstream media had an overwhelming response to the recent study in the journal Annals of Internal Medicine that found home testing for sleep apnea to be as effective as in-laboratory polysomnography in terms of patient outcomes. The study title is Diagnosis and Initial Management of Obstructive Sleep Apnea without Polysomnography: A Randomized Validation Study. There have been a number of posts about the topic on the sleep forums at binarysleep.com.

Having dialogue is a positive in that it is the responsibility of the Sleep Community to talk about these issues and concerns now and come up with solutions, guidelines and standards. Once the door is opened to home monitoring, those administering testing at home may not come from sleep backgrounds, thus potentially placing quality patient care at risk.

One of the most visible mainstream media reports on home testing came from FOX News Channel's resident medical expert Dr. Isadore Rosenfeld on Sunday Housecall who recently gave his opinion that there was no longer the need to go to sleep centers for testing he termed “a whole big deal” that may not always be necessary, and that people should look to home testing for a simpler approach. After the Annals of Internal Medicine study was released, there were numerous articles that appeared in the mainstream media, but were not comprehensive enough.

“The important thing about the mainstream media giving short headlines and sound bites on research studies is that patients and physicians read only this one little thing, and not be aware of the more complex issues,” Kauffman said. “By creating forums where experts can debate these issues, even if they are more devisive for a field, helps bring out more information in response to the studies.”

In the Sleep Review Podcast Series on Home Testing, guest opinions ranged from support for home testing to home testing being "a tempest in a teapot" and unnecessary. Kauffman gives a media expert opinion and overview of the messages relayed through the Sleep Review podcasts and covers educating insurers about home testing, existing reimbursement issues, the Veteran Administration’s current utilization of home sleep testing exclusively for its patients, and the fact that some private insurers are paying for home testing through contractual agreements with home testing companies.

I feel certain that many of you will be following the issue on home testing closely. I feel that as media members, Kauffman and Sleep Review represent an integral arm of the Sleep Community and that they chose to bring forth this very important issue using responsible journalism by informing readers and raising awareness. Kauffman invites listeners and readers to contact her with their ideas about home testing at lkauffman@ascendmedia.com

Be well, Sleep well,
Theresa

A facial, a pedicure, and a sleep study? Should we look closer at this headline: “Sleep Disorders Fuel Hot New Spa Trend in 2007” ? ?

I just saw this issue resurface on the newswire in the form of a new market report, and as it captures my attention again, I continue to wonder if this trend will be thought of by sleep medicine and technology professionals as a "watering-down of the science of sleep.” Recommending patients learn relaxation techniques is one thing, but if I was prescribing treatment for sleep disorders, I know I would want to know what a spa or resort program consists of before sending a patient there.

Due to the March 12 Millennium Research Group analysis report and press release that spurred the newswire headline, “Sleep Spas Will Help Expand the US Respiratory and Sleep Management Market to over $2.4 Billion by 2011, According to Millennium Research Group,” such news may also fuel the Sleep Community to examine this issue a bit closer.

Looking at the concept from a 10,000-foot view, it concerns me to think that someone with a parasomnia, or some other sleep disorders besides insomnia, would seek help from a spa rather than from a qualified sleep specialist. Certainly a lot of factors impact such issues.


What do you think? Do you believe that we as a community should examine this issue closer. With stakes as high as $2.4 Billion, and the mainstream media likely being all over this headline today, I believe spas will certainly have the time to pay attention...


Sleep well, Be Well,
Theresa