Do Sleeping Pills Kill?

A recent study published in BMJ Open found that the prescription of sleeping pills (hypnotics) was associated with a greater than threefold increase in the risk of death. The abstract and full article are available (free) here:

http://bmjopen.bmj.com/content/2/1/e000850.full

There are a number of problems with this study, as mentioned by Dr. Nancy Collop, President of the American Academy of Sleep Medicine:

"Although the study found that the use of hypnotic medication, or sleeping pills, was associated with an increased risk of mortality, a cause-and-effect relationship could not be established because the study only analyzed an insurance database... it was impossible for them to control for psychiatric conditions and anxiety, which is an area of significant concern to this study population..." http://www.medscape.com/viewarticle/759336?src=mpnews&spon=17

The major problem that I have with the study is that, as I far as I can see looking at the full article, the presence of insomnia was not controlled for (most of the comparison group did not have insomnia). Insomnia itself is associated with increased mortality (in some but not all studies) and morbidity (illness). To further illustrate why this is a problem, consider a hypothetical study in which the use of insulin was associated with an increased death rate. It is well known that dibetes itself increases the risk of death. If the comparison group in this hypothetical study did not have diabetes, I don't think much if anything could be learned from the study.

This new sleeping pill study doesn't add much new information to the field of sleep medicine, although it does add to the literature suggesting that insomnia is a serious problem. I did find this earlier editorial by Dr. Kripke (primary author of the current study) which sums up the problem with this current study:
"Numerous previous studies have shown an association of hypnotic use to mortality, which can become confounded with insomnia. Was mortality controlled for hypnotic usage in examining the association with insomnia?" http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3079930/?tool=pubmed
To fully apply to the current study, that last statement can be changed to: Was mortality controlled for insomnia in examining the association with hypnotic usage?

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Edit: The association between insomnia and death is a complex issue. It is clearly associated with illness/morbidity. This abstract sums up the issues: http://www.ncbi.nlm.nih.gov/pubmed/15600216

Some studies have found that while a subjective complaint of insomnia is not associated with an increased risk of death, short sleep time is.

CDC Issues Warning About Nasal Washes

Nasal rinses can be very helpful for allergies, but can also be deadly:

http://denver.cbslocal.com/2012/02/28/cdc-issues-warning-about-nasal-washes/

" It’s because of a brain-eating amoeba called Naegleria fowleri" that can be present in tap water.

Many patients with sleep apnea use nasal rinses.... these are safe as long as boiled or distilled water are used. Similarly, tap water should not be used in CPAP humidifiers (distilled water is recommended).

Reggie White Medical Enterprises.....New Commercial

Heavy NFL players are at increased risk of Death

"The heaviest athletes are more than twice as likely to die before their 50th birthday than their teammates, according to a Scripps Howard News Service study of 3,850 professional-football players who have died in the last century."

http://www.sleepdt.com/heavy-nfl-players-twice-as-likely-to-die-before-50/

Many of these athletes likely had untreated or inadequately treated obstructive sleep apnea (OSA). The heavier NFL players tend to have large necks. Increased neck size (greater than 16 inches in men) is a risk factor for OSA, whether the increased neck size is due to fat or muscle. Obstructive sleep apnea increases the risk of various types of heart disease, including coronary artery disease, heart attack, and congestive heart failure.

An earlier 1994 study found that "offensive and defensive linemen had a 52 percent greater risk of dying from heart disease than the general population."

Sleep Disorders are High in the South

A recent study found that "Oklahoma, Arkansas, Mississippi, Alabama and West Virginia had the highest rates of sleep disturbance and daytime fatigue"

I suspect that the high rate of sleep disturbance and fatigue in the south is due to obesity, a major risk factor for obstructive sleep apnea

Read more: http://www.foxnews.com/health/2012/02/24/southerners-sleepiest-in-us-study-says/#ixzz1nOmzb4lX

I will try to post a link to the actual research study later. As a southern sleep doctor (currently licensed in Mississippi and Alabama, formerly licensed in West Virginia), this topic is of concern to me.

Compensation for Sleep Physicians

An experienced sleep technician recently asked me about compensation for sleep physician services at a sleep disorders center (IDTF) he is starting. Below is what I told him (disclaimer: this is based on my experiences over the last several years talking to numerous sleep professionals, and not on my own salary/compensation) -

1. There are 2 basic options for compensating the sleep physician for interpreting sleep studies. One is for the physician to bill for the professional component (-26) of the study, and the IDTF for the technical component (-TC). The other option is for the IDTF to bill for the studies on a global basis and pay the physician a fee for each interpretation. This fee typically ranges from $75 to $175 ($100-125 is average).
Although I am unsure if you can legally take it into account, the physician is going to probably expect to receive somewhere in the higher range if he is generating many of the referrals to the sleep center or providing outpt follow up to the patients. In this case, I would recommend letting the physician just bill for the professional component.

2. Medical director fees: Although some sleep centers try to bundle this in with interpretations, it is best from a legal standpoint to pay a separate fee for medical director duties (such as supervision of technicians, developing policies and procedures, administration, etc). There are 2 basic options. First, the medical director can keep a log of his administrative hours and be compensated on an hourly basis (typically $100-$150 per hour). The other option is to pay the medical director a fixed monthly fee- this is usually based on number of beds. $500-1000 for a 4 bed lab and $750-$1500 for a 6 bed lab are typical salaries.

One of the reasons that I don't recommend bundling sleep study interpretation fees with medical director fees is that it makes things "messy" if a 2nd sleep physician (other than the medical director) starts interpreting studies.

There are a lot of legal pitfalls in setting physician compensation, and I recommend consulting with an experienced healthcare attorney familiar with both federal regulations and the laws of your state.

I welcome reader comments regarding this subject

Napping in the NBA

http://www.nytimes.com/2011/03/07/sports/basketball/07naps.html?_r=1&src=me&ref=sports


Some N.B.A. teams have received an education in the art of napping from Dr. Charles Czeisler, the director of the Division of Sleep Medicine at Harvard Medical School.

Czeisler said that players who got nine hours of sleep were more likely to react quicker, remember plays better and generally maintain their health more consistently.

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still working on this

Reggie White Sleep Disorder Centers

The above is from the open h0use of the Tupelo branch of Reggie White Sleep Disorder Centers

How to Find a Medical Director for your Sleep Lab

I was recently contacted by a non-physician regarding how to find a medical director for a sleep lab she is opening. This sleep lab is not in my state (Mississippi). Here is my answer to her:

You can try advertising- either on the American Academy of Sleep Medicine Job Board, or in one of the sleep journals (either "Sleep" or "The Journal of Clincal Sleep Medicine"). You can also post the position at the Annual Sleep Meeting.

Another option is calling sleep physicians in your state (medical directors of existing sleep labs) and asking them if they are interested in being medical director of your sleep lab.

Medicare qualifications for a Sleep Technician

Sleep studies performed on patients with medicare at an IDTF must be done by appropriately certified technicians. Below is the regulation (copied from an old reader comment):

CMS document 410.33 (2)(c) states "Nonphysician personnel. Any non-physician personnel used by the IDTF to perform tests must demonstrate the basic qualifications to perform the tests in question and have training and proficiency as evidenced by licensure or certification by the appropiate State health or education department. In the absence of a State licensing board, the technician must be certified by an appropiate national credentialing body. The IDTF must maintain documentation available for review that these requirements are met."

In most states there is no state licensure for sleep technicians.

It is fairly well accepted that the RPSGT and RRT credentials meet CMS requirements. It is unclear if RN (or LPN) is acceptable. The CPSGT credential is probably not sufficient, but I have not seen this officially.

If any readers have any clarification on this regulation, I would appreciate a comment.

Please note, this regulation applies only to IDTF's, not to hospital-associated sleep labs or to sleep labs organized as an extentsion to a physician practice.

Billing for Sleep Studies

I recently received an email asking about billing globally for sleep studies vs billing the professional and technical components separately. I came across this reference today:

http://www.arkmedicare.com/provider/viewarticle.aspx?articleid=8365

CPT 95805: Multiple sleep latency or maintenance of wakefulness testing, recording, analysis and interpretation of physiological measurements of sleep during multiple trials to assess sleepiness.
CPT 95810: Polysomnography; sleep staging with 4 or more additional parameters of sleep, attended by a technologist.
CPT 95811: Polysomnography; sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bi-level ventilation, attended by a technologist.

If a provider bills for the codes listed above without modifiers, the technical AND professional components are included in payment. If the professional component was not provided by a facility, the facility should bill the code using the TC modifier and the interpreting physician may bill with the -26 modifier. If the facility employs a provider who performs the professional component, then the facility may bill for the global code (without a modifier or the code with the -26 AND -TC modifiers).

prn MSLT's

A doctor asked on the AASM message board about prn (as needed) MSLT's. In his sleep medicine group, doctors sometimes order a nocturnal polysomnogram to evaluate for OSA, with instructions to the technicians to perform an MSLT if OSA is not found.

Should the practice of "prn" MSLT be abandoned? Is it a bad idea?

Here is my answer to the the doctor's question?

yes and yes.

If you think someone has narcolepsy/idiopathic hypersomnia it is reasonable to order a psg/MSLT with instructions that the MSLT be canceled if OSA is present (with the sleep physician being avaliable in the am to review the psg in borderline cases).
I think it is unreasonable and puts too much responsibility on the techs to have them decide whether an MSLT is neeed on large numbers of patients being evaluated for OSA.

CPT code 94660

94660 is the cpt code for CPAP initiation and management. This is a poorly understood code; there is always disagreement when someone asks about it at an American Academy of Sleep Medicine business seminar.

I used to bill this along with a level 3 (99213) evaluation and management code when I saw someone in the office, prescribed CPAP, and the patient's CPAP machine was set up on site. Usually on-site CPAP set up was done only for patients with Blue Cross/Blue Shield plans; it was done by a DME company that I had no ownership interest in.

I did find a mention of this code in an article in the American College of Chest Physicians. Although BC/BS payed for both codes (99213/94660) in Mississippi, apparently most insurers won't recognize both codes by the same provider on the same day: the 94660 code
is mutually exclusive of all E/M services during the same session by the same provider, according to the article (see the evaluation and management services section).

I do recommend that physicians not use the code 94660 with medicare/medicaid patients. If CPAP is being set up on site at your office (while the physician is present in the office complex), most insurers will not pay both codes at the same time. I do advise checking with the major insurers in your state to find out their policies for reimbursement of the 94660 code.

Sleeping Pills and Obstructive sleep apnea

This question was recently posted on Medscape's Physician connect:

I am treating a man who has sleep apnea and uses CPAP. He is on Trileptal and Lamictal. Recent problems with insomnia has made me suggest Sonata. Are there any concerns about this? Contraindications?

This is my answer (which also includes a response to a few of the comments posted on Physician Connect):

If a person is on an effective cpap pressure, the adverse effects of hypnotics should be no different than in someone without osa. I have treated thousands of patients with osa; some of them require ambien/lunesta/Sonata. I occasionally use benzodiazepines, especially restoril. There have been several studies showing that moderate doses of alcohol do not effect cpap requirements (not that I recommend alcohol). I do agree with having the patient check with the sleep clinic, however. What the patient is calling "insomnia" may be a sign of problems with cpap and should be addressed by his sleep physician.

Man Dies during Sleep Study

(from the Atlanta Journal-Constitution, via Drudge) A 25 year old man recently died during a sleep study at Emory:

Harris, a medical assistant, entered the Emory sleep center on Jan. 22, said his mother....... By the next morning he was dead.
Emory said in a statement that he died of sudden cardiac arrest....

The article doesn't give many details and doesn't specify whether Mr. Harris was having a diagnostic study or a CPAP titration study.
Usually the most dangerous part of a sleep study is the drive to the sleep center.

Sleep Apnea in the Wall Street Journal

The Wall Street Journal has an article today giving a good overview of obstructive sleep apnea:

http://online.wsj.com/article/SB10001424052748704107204575039101390202576.html?mod=WSJ_hp_editorsPicks

Problems with Pediatric Sleep Medicine

Pediatric sleep medicine is a difficult field. Pediatric sleep studies are hard to interpret and firm guidelines for diagnosing sleep apnea in children are lacking. The new scoring manual (The AASM Manual for the Scoring of Sleep and Associated Events) has brought some much needed uniformity to the scoring of respiratory events for children (and also adults), however.

One of the problems with this field is that good textbooks are lacking; there is nothing comparable to Kryger, Roth, and Dement's "Principles and Practice of Sleep Medicine", which focuses on adult sleep medicine.

I have a teenager with a slow-wave sleep parasomnia coming in next week. I unwrapped my copy of the 2nd edition of "A Clinical Guide to Pediatric Sleep" by Jodi A. Mindell, Phd, and Judith A. Ownes, MD, Phd. Both are luminaries in the field of pediatric sleep medicine. This clinical guide appears to primarily aimed at pediatricians and family practitioners. I found several errors when briefly skimming through this book. Most notably, in several places in the book tricyclic antidepressants are called "potent SWS suppressants", while in reality the tricyclics have variable effects on SWS (slow wave sleep) and may actually slightly increase SWS.

Several years ago when I read Sheldon, Ferber, and Kryger's "Principles and Practice of Pediatric Sleep Medicine", I found the chapters uneven in quality but am not able to recall enough to offer a detailed criticism in this post.

If anyone has come across a good pediatric sleep medicine textbook, please leave it's name in the comment section. thanks.

Sleep Center Accreditation

Sleep Review magazine's November issue is now available online.
It has an article about accreditation; I agree with every word of it:

http://www.sleepreviewmag.com/issues/articles/2009-11_02.asp

Medpedia

sleepdoctor is now included in Medpedia's News and Analysis Section.

Here is some more information about Medpedia:

http://www.medpedia.com/press

I encourage you to check out Medpedia:

http://www.medpedia.com/home

Here is the link for their Sleep Disorders Community:

http://www.medpedia.com/communities/148-Sleep-Disorders

SIDS and Slow Wave Sleep

There's an interesting discussion about the possible relationship between SIDS and Slow Wave sleep here:

http://sleepdoctor.blogspot.com/2009/10/osa-sleep-deprivation-and-alcohol.html