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You are here: Home / Archives for September 2011

New Rules to Empower Patients to Increase Secure Access to their Health Information

September 28, 2011 by SleepDT Leave a Comment

HHS Secretary Kathleen Sebelius today proposed new rules that would expand the rights of patients to access their health information through the use of health information technology (IT). Specifically, the new rules would empower patients and allow them to gain access to test results reports directly from labs. They would ensure that labs covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) provide such information, upon request, directly to patients or their personal representatives. The announcement came at the kick-off of the first-ever HHS Consumer Health IT Summit, which brought consumers, providers, and the public and private sectors together to discuss how best to empower consumers to be partners in their health and care through health IT.

“When it comes to health care, information is power. When patients have their lab results, they are more likely to ask the right questions, make better decisions and receive better care,” said Secretary Sebelius.“This Summit offers a unique opportunity for the public and private sectors alike to share strategies to improve consumer access to their health information, while safeguarding the privacy and security of their data.”

The Notice of Proposed Rulemaking (NPRM), jointly drafted by the Centers for Medicare & Medicaid Services, the HHS Office for Civil Rights (OCR), and the Centers for Disease Control and Prevention, proposes to amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and HIPAA privacy regulations to strengthen patients’ rights to access their own laboratory test result reports.

Secretary Sebelius also announced the appointment of Leon Rodriguez as the new Director of the Office for Civil Rights. Rodriguez brings his Department of Justice experience to HHS and will be dedicated to ensuring consumers’ health information is kept private and secure.

“Consumers need to know that private and secure access to their health information is a given,” stated OCR Director Rodriguez. “The privacy and security of health data will be a top priority for OCR during my tenure.”

Secretary Sebelius also unveiled today an innovative voluntary Personal Health Record (PHR) Model Privacy Notice, which creates an easy-to-read, standardized template allowing consumers to compare and make informed decisions based on their privacy and security policies and data practices about PHR products. The new template is similar to the Nutrition Facts Labels in that it presents certain complex information in a simple way to improve transparency and consumer understanding about data practices. By making this Model Privacy Notice available, PHR companies can help build greater trust in PHRs.

“As technology improves more aspects of our daily lives, it makes sense to marry cutting-edge technology with our medical and personal health records so that we can improve both the quality and efficiency of the care that people receive,” said National

Coordinator for Health Information Technology, Farzad Mostashari, M.D., Sc.M. “We are encouraging everyone to visit our website at www.HealthIT.gov to read our newly released Strategic Plan that sets forth our comprehensive plans for consumer empowerment for the next five years.“

The Summit highlighted vital benefits of electronic health records and health IT, including:

  • Health IT empowers patients. For example, people at risk for heart attacks may use mobile health applications to manage their weight, diet, and medication adherence.
  • Health IT can facilitate lasting quality improvements, which can lead to greater efficiency and cost savings in the long-term.
  • Health IT is driving innovation in all parts of consumers’ lives – from new interactive applications to devices like digital pedometers and other devices that capture important health information from everyday experiences.
  • Health IT helps coordinate better care, and can be a powerful tool if you or a loved one is managing a serious medical condition.
  • Health IT has robust security and all users, from patients to caregivers to doctors, can easily and safely access and share health information electronically.
  • Health IT may help diagnose health problems sooner, avoid medical errors and provide safer care which can result in lower costs.

For more information about the proposed amendments to the CLIA and HIPAA Privacy regulations, please visithttps://www.cms.gov/apps/media/fact_sheets.asp.

Filed Under: Uncategorized Tagged With: CPAP, Heated Breathing Tube, hose systems, Hybernite, Plastiflex, Rainout Control

New Rules to Empower Patients to Increase Secure Access to their Health Information

September 28, 2011 by SleepDT Leave a Comment

HHS Secretary Kathleen Sebelius today proposed new rules that would expand the rights of patients to access their health information through the use of health information technology (IT). Specifically, the new rules would empower patients and allow them to gain access to test results reports directly from labs. They would ensure that labs covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) provide such information, upon request, directly to patients or their personal representatives. The announcement came at the kick-off of the first-ever HHS Consumer Health IT Summit, which brought consumers, providers, and the public and private sectors together to discuss how best to empower consumers to be partners in their health and care through health IT.

“When it comes to health care, information is power. When patients have their lab results, they are more likely to ask the right questions, make better decisions and receive better care,” said Secretary Sebelius.“This Summit offers a unique opportunity for the public and private sectors alike to share strategies to improve consumer access to their health information, while safeguarding the privacy and security of their data.”

The Notice of Proposed Rulemaking (NPRM), jointly drafted by the Centers for Medicare & Medicaid Services, the HHS Office for Civil Rights (OCR), and the Centers for Disease Control and Prevention, proposes to amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and HIPAA privacy regulations to strengthen patients’ rights to access their own laboratory test result reports.

Secretary Sebelius also announced the appointment of Leon Rodriguez as the new Director of the Office for Civil Rights. Rodriguez brings his Department of Justice experience to HHS and will be dedicated to ensuring consumers’ health information is kept private and secure.

“Consumers need to know that private and secure access to their health information is a given,” stated OCR Director Rodriguez. “The privacy and security of health data will be a top priority for OCR during my tenure.”

Secretary Sebelius also unveiled today an innovative voluntary Personal Health Record (PHR) Model Privacy Notice, which creates an easy-to-read, standardized template allowing consumers to compare and make informed decisions based on their privacy and security policies and data practices about PHR products. The new template is similar to the Nutrition Facts Labels in that it presents certain complex information in a simple way to improve transparency and consumer understanding about data practices. By making this Model Privacy Notice available, PHR companies can help build greater trust in PHRs.

“As technology improves more aspects of our daily lives, it makes sense to marry cutting-edge technology with our medical and personal health records so that we can improve both the quality and efficiency of the care that people receive,” said National

Coordinator for Health Information Technology, Farzad Mostashari, M.D., Sc.M. “We are encouraging everyone to visit our website at www.HealthIT.gov to read our newly released Strategic Plan that sets forth our comprehensive plans for consumer empowerment for the next five years.“

The Summit highlighted vital benefits of electronic health records and health IT, including:

  • Health IT empowers patients. For example, people at risk for heart attacks may use mobile health applications to manage their weight, diet, and medication adherence.
  • Health IT can facilitate lasting quality improvements, which can lead to greater efficiency and cost savings in the long-term.
  • Health IT is driving innovation in all parts of consumers’ lives – from new interactive applications to devices like digital pedometers and other devices that capture important health information from everyday experiences.
  • Health IT helps coordinate better care, and can be a powerful tool if you or a loved one is managing a serious medical condition.
  • Health IT has robust security and all users, from patients to caregivers to doctors, can easily and safely access and share health information electronically.
  • Health IT may help diagnose health problems sooner, avoid medical errors and provide safer care which can result in lower costs.

For more information about the proposed amendments to the CLIA and HIPAA Privacy regulations, please visithttps://www.cms.gov/apps/media/fact_sheets.asp.

Filed Under: Uncategorized Tagged With: Articles, Blog

Faulty Sleep Lab Test Results to be Reviewed

September 28, 2011 by SleepDT Leave a Comment

In order to assure safety of approximately 1000 patients, Interior Health would investigate all sleep-related cases conducted by Kelowna General Hospital from August 29, 2007 to September 8, 2011.

Procedure has already started, and 13 of them have been called while the rest of them would soon be contacted. Main reason for the review is that IH has doubts on accuracy of the reports.

Sleep tests were taken for problems like sleep apnea, snoring, insomnia, narcolepsy and parasomnias.

Another thing which IH would be checking is whether doctors, who conducted the tests, had required credentials, degree and permission, informed Dr. Michael Murray, Senior IH Medical Director.

He further affirmed that patient’s safety is foremost for them and all this is done to ensure that patient’s have right reports for their follow-up treatments.

Some tests were found having some error in random sampling procedure and therefore, strong independent check-up was needed to cross-check them with original findings. If any change is found, they would be informed and according to that, they would be given new report which would enclose follow-up procedure and other mandatory terms.

Read Statement

Filed Under: Uncategorized Tagged With: Articles, Blog

US Medicare Coverage Decision: SomnoDent Assigned Medicare Code

September 28, 2011 by SleepDT Leave a Comment

SomnoMed provides diagnostic and treatment solutions for Sleep Breathing Disorders such as Obstructive Sleep Apnea and manufactures the SomnoDent product range. SomnoMed announces that the Pricing, Data Analysis, and Coding (PDAC) Medicare Contractor and each of the four Durable Medicare Equipment (DME) Medicare Administrative Contractors (MACs) have determined that the appropriate Medicare Healthcare Common Procedural Coding System (HCPCS) code to use when billing for the SomnoDent product range is E0486.

SomnoMed, Inc., manufacturer of the world’s leading oral appliance, SomnoDent for the treatment of Obstructive Sleep Apnea announces that the PDAC Medicare Contractor and each of the four DME MACs have determined that the appropriate HCPCS code to use when billing for the SomnoDent Classic, SomnoDent Flex, and SomnoDent Edentulous is E0486.

According to each of the four DME MAC jurisdictions, in order to be designated code E0486, the oral appliance must be used to reduce upper airway collapsibility, be adjustable, and custom fabricated. A custom-fabricated oral appliance is defined as one that is individually made for a specific patient.

“SomnoMed appreciates the timely decision made by PDAC and the DME MACs and especially those Centers for Medicare & Medicaid Services (CMS) clinicians involved in reviewing SomnoMed’s evidence based application”, said Ralf Barschow, CEO. “SomnoMed would also like to recognize the American Academy of Dental Sleep Medicine (AADSM) and American Academy of Sleep Medicine (AASM) for continuing to develop new standards of practice as well as the American Sleep Apnea Association (ASAA) for their continued dedication to inform and enhance the well-being of those affected by this chronic disease.”

Obstructive Sleep Apnea affects tens of millions of Americans and is associated with obesity, diabetes, high blood pressure, increased risk of heart attack, stroke, memory/performance problems, depression and higher accident rates (J Clin Sleep Med 2009:5(3):263-276). SomnoDent is a medical device used to treat Obstructive Sleep Apnea. Considered a sleeping disorder, this medical condition must be treated with a medical device.

While there are an increasing number of generic oral appliances available, only SomnoDent is independently clinically validated, has a three year warranty and incorporates proprietary materials and design features to maximize patient comfort. SomnoMed firmly believes that dental sleep medicine clinicians will continue to embrace patient-focused and evidence-based medical devices.

Read full announcement

Source: Frisco, TX (PRWEB)

Filed Under: Uncategorized Tagged With: CPAP, Heated Breathing Tube, hose systems, Hybernite, Plastiflex, Rainout Control

AASM shifts sleep strategy

September 28, 2011 by Randy Clare Leave a Comment
 
‘
This would be a decrease in referrals’ for HME providers

 

A proposal that would allow sleep centers to provide CPAP equipment to Medicare beneficiaries could threaten the role of HME providers in the market. The American Academy of Sleep Medicine (AASM) on Sept. 16 released a final draft of its proposal to create a pilot program with an “integrated sleep management delivery model.” The pilot would be tested in partnership with the Center for Medicare and Medicaid Innovation. ”The idea is to move sleep medicine from being just diagnostic to more management and outcomes-based,” said Dr. Nancy Collop, AASM president. “It hopefully improves patient care and puts the sleep physician at the controls in getting the patient through the process.”

 Under the AASM plan, participating sleep centers would need to receive AASM accreditation for sleep centers, DME programs and out-of-center sleep testing; partner with a dental sleep medicine professional experienced in oral appliance therapy; partner with a surgeon experienced in upper airway surgery to treat OSA; have a tracking mechanism to record patient follow-up and outcomes; and have a compliance program to prevent fraud and abuse.   

Many commercial insurers already allow sleep labs to bill for both the sleep test and the CPAP equipment–something Medicare rules prohibit. To date, that’s been an advantage for HME providers who currently tread a thin line between competing with labs and getting referrals from them.

 ”There’s been this one segment isolated from the lab being a total competitor and that’s Medicare,” said one provider. “This would be a decrease in the number of referrals to us.” The proposal is the latest effort by the AASM to keep up with a changing industry. In 2010, it began offering a DME accreditation program; earlier this year, it launched an accreditation program for out-of-center sleep testing. Collop emphasized that the proposal is still in its early stages and said there may be room in the future for partnerships with HME providers.

 ”The focus right now is on the fragmentation of care,” she said. “Lots of times patients get lost in the system and our goal is to try and improve communication, not necessarily to exclude people.”

 If HME providers don’t want to find themselves shut out of the CPAP business, they need to do a better job–as an industry–of proving their value to other healthcare providers, says Lisa Feierstein. ”We understand the complexity and the special needs around patient care in the continuum,” said Feierstein, founder of Raleigh, N.C.-based Active Healthcare. “The better DME providers understand that it’s more than a piece of equipment. There’s a whole process around compliance.”

 

By Theresa Flaherty, Managing Editor HME News

Filed Under: Uncategorized

Teens, Too, Need Help With Sleep

September 27, 2011 by Randy Clare Leave a Comment

By TIMOTHY W. MARTIN Wall Street Journal 09/27/2011

More than two-thirds of U.S. high school students don’t get enough sleep on school nights, and they’re more likely than their well-rested peers to drink, smoke, and seriously consider suicide, according to a federal study released Monday.

Sleep researchers have long known teens don’t get enough sleep, advocating that school districts start classes later. But this study is the first to assess on a national scale whether sleep deprivation is associated with risky health behaviors, according to the Centers for Disease Control and Prevention, which did the study.

The study didn’t assess whether lack of sleep causes teens to engage in risky behavior, however. Many overachieving high-school students lack sleep because they’re busy, experts note.

The study analyzed 11 health-risk behaviors between those who sleep at least eight hours a night—the CDC-recommended amount—versus those who slept less. About 69% of more than 12,100 teens in a 2007 survey said they got eight hours or less of nightly rest on school nights.

More than half of weary-eyed teens reported alcohol use, compared to 37% of more well-rested adolescents. Nearly a quarter of sleep-deprived teens smoked, compared to 15% of those who got a good night’s rest. Sleep deprivation also increased the likelihood a high-school student had seriously contemplated suicide, to 17% compared with 9.8%.

Tired teens were also more likely to be less physically active, use marijuana, be sexually active and feel sad or hopeless, among other behaviors. There was no link between television watching and a lack of sleep.

A chronic lack of sleep impairs the ability to comprehend consequences and increases the likelihood a teen gives in to peer pressure, the study said. More than half of those surveyed got six or seven hours of sleep on school nights. Some 10% reported five hours, and 5.9% said they got four hours or fewer.

The report doesn’t suggest that lack of sleep prompts teens to engage in unhealthy behaviors.

“An incorrect interpretation of this research would be that only sleepy kids have sex,” said Bill Albert, chief program officer at the National Campaign to Prevent Teen and Unplanned Pregnancy. “The CDC is only making associations, not suggesting a causal link.”

One problem is that the biological clock changes in adolescence, making many teens want to go to bed and get up roughly two hours later than they did before reaching puberty—often meaning later than the 8 a.m. hour that many schools start, said Lela McKnight-Eily, a researcher for the CDC’s Division of Adult and Community Health and the study’s lead author.

“During adolescence, there is a shift in certain hormones that occur with puberty that cause the circadian rhythm to change,” Dr. McKnight-Eily said.

The report used data from the national Youth Risk Behavior Survey and an unedited version was published online last week by Preventive Medicine.

Filed Under: Uncategorized

Why doctors should be careful with Groupon and other social coupons

September 26, 2011 by Randy Clare Leave a Comment

 

by ADAM BANKS | in PHYSICIAN
I just received a Groupon for dental services.  I have seen Groupon’s in the past for medical services and I can’t figure out how selling medical services via a social coupon (the generic name for Groupon like sites) is legal.   This is dangerous, uncharted territory. Consult your attorney before running a Groupon.

As I run practices in New York, I will focus on the their statutes.  New York has some of the strictest “corporate practice of medicine laws,” but almost all states have similar laws prohibiting fee-splitting and all states (and the Fed’s) prohibit kick-backs.

 

First lets look at the body of law that prohibits a medical professional from entering into a fee splitting arrangement with a third party.

New York’s State Department of Education (the governing body for “health professionals,” a very broad category including Physical Therapists, Doctors, Podiatrists, Chiropractors, Acupuncturists, Athletic Trainers and Massage Therapist – among many others) clearly defines fee splitting as professional misconduct:

29.1 General Provisions – Unprofessional Conduct – Rules of the NY Board of Regents

Unprofessional conduct in the practice of any profession licensed, certified or registered pursuant to title VIII of the Education Law, shall include:

  • directly or indirectly offering, giving, soliciting, or receiving or agreeing to receive, any fee or other consideration to or from a third party for the referral of a patient or client or in connection with the performance of professional services;
  • permitting any person to share in the fees for professional services, other than: a partner, employee, associate in a professional firm or corporation, professional subcontractor or consultant authorized to practice the same profession, or a legally authorized trainee practicing under the supervision of a licensed practitioner.

This prohibition shall include any arrangement or agreement whereby the amount received in payment for furnishing space, facilities, equipment or personnel services used by a professional licensee constitutes a percentage of, or is otherwise dependent upon, the income or receipts of the licensee from such practice.

It is considered fee splitting when a physician pays a fee on a per patient basis or a percentage basis (most social coupons are structured on a 50/50 split of the total amount sold).  It would be legal to pay a flat rate for marketing, such as an ad in a phone book (sorry for the antiquated reference), all advertisers pay the same rates, and there is no differentiation in price for the number of patients that are generated from the ad.

Now lets look at the body of law that prevents an organization from splitting fees with a health professional:

NY State Public Health Law Section 4510(1) states that no entity can refer patients to medical practice for a profit: Medical referral service businesses prohibited.

No person, firm, partnership, association or  corporation,  or  agent  or  employee thereof,  shall  engage  in  for profit any business or service which in whole or in part includes the referral or recommendation of persons to a physician, dentist, hospital, health related facility, or dispensary for any form of medical or dental  care  or  treatment  of  any  ailment  or physical  condition.  The imposition of a fee or charge for any such referral or recommendation shall create a presumption that the business or service is engaged in for profit.

The law further prohibits the practice across state lines: “No physician,  dentist,  hospital,  health  related  facility  or dispensary shall enter into a contract or other  form  of  agreement  to accept  for  medical  or dental care or treatment any person referred or recommended for such care or treatment by a medical or  dental  referral service  business  located  in or doing business in another state …”

The above statues should be enough to cause someone to think twice about this form of “marketing.”  A health professionals license is on the line, in New York a provider’s license  may be revoked, suspended or annulled for professional misconduct if a physician requests, receives, participates in or profits from “the division, transference, assignment, rebate, splitting or refunding of a fee” or “a commission, discount or gratuity” in connection with “providing professional care or services.”

Take Medicare?  Be doubly cautious

If that isn’t enough to keep you away from social coupons, consider the Anti-Inducement Provision, Section 1128A(a)(5) of the Act, which provides for the imposition of civil monetary penalties against any person who offers or transfers remuneration to any individual eligible for benefits under [Medicare or a state health care program] that such person knows or should know is likely to influence such individual in order to receive from a particular provider, practitioner, or supplier any item or service for which payment may be made, in whole or in part, under [Medicare or a state health care program].

The anti-kickback laws

And finally we get to the state and federal anti-kickback laws. These laws broadly prohibit the offer, solicitation, payment or receipt of anything of value, direct or indirect, overt or covert, in cash or in kind, intended to induce referral of patient for items or services reimbursed by all federal programs, including Medicare, Medicaid and programs covering veteran’s benefits. See Social Security Act § 1128B.

The violation of any of these laws puts your medical license at risk, and most are federal crimes.

We are staying far away from social coupons in our practice.  I am going to sit back and see how this one plays out.

Adam Banks is the CEO of NY SportsMed, and consults on practice development, management and 

 

Filed Under: Uncategorized

Sleepy Drivers

September 20, 2011 by agpubs 1 Comment

Signals are being given that the National Transportation Safety Board (NTSB) and Federal Motor Carrier Safety Administration (FMCSA) are nearing sleep apnea testing regulations for truckers.  Everyone is concerned about safety, but none of the interested parties wants another regulation that is just going to be a nuisance costing more money and posing greater risk liability.  Many legitimate objections have been raised:

  • What is the scientific basis for diagnosis of sleep apnea that mandates treatment?
  • What is the scientific basis for standards of successful treatment?
  • What is a reasonable time period to allow from diagnosis to successful treatment?
  • Being diagnosed with sleep apnea is a “scarlet letter” decreasing employment opportunities and health insurability should a trucker terminate employment.
  • “The National Sleep Foundation appears to be a lobby for sleep companies trying to fleece truckers.”
  • There is little or no data showing that truckers are tired or that drivers with sleep apnea are causing large numbers of wrecks
  • Federal regulations already require a physician to examine for sleep apnea
  • Truckers who would normally bring up the subject of daytime sleepiness with their physicians won’t do so if the threat of a $2,000 to $5,000 laboratory sleep study hangs over them
  • Most truckers’ benefits will not cover costs in that price range
  • CPAP and pharmaceutical manufacturers pay millions of dollars in perks and unreported cash to physicians for listening to their pitch.  Medical consumers cannot make independent and informed purchasing decisions listening to advice from physicians getting such “Sunshine Payments”.

According to the white paper by ACS (Affiliated Computer Services, Inc.), a Xerox Company in business process and information technology services, “The real problem the trucking industry is currently facing is sleep apnea.”  They suggest in this paper that the following steps would be an adequate solution:

  1. Truck drivers will get screened for sleep apnea by their employers at a credible sleep lab.

2. Drivers found to have sleep apnea will be required to receive medical treatment.

3. Carriers will have to ensure their drivers with sleep apnea are taking their treatments.

4. Drivers receiving treatments will be required to remove data from their CPAP and upload the data on a device which would transfer the results to a sleep lab.

5. A receipt will be printed from the printer located next to the computer, giving the driver proof of their upload.

6. The data will then be centralized to distribute data to the driver, carrier, and physician. This data must be transparent so all parties can manage and document the findings.

7. The data will have the ability to be shared and documented through a web-portal.  The web-portal will provide substantiated analytical proof of compliance that the driver is receiving proper medical attention for their sleep apnea.

Does this sound like they want to impose a police state, “big brother is watching you” dictum or what?  It could reasonably be construed as an attempt by a big CPAP/sleep lab consortium to fleece the trucking industry with increased liability and risk, and truckers with bearing exorbitant regulatory costs.  This white paper does not give any alternative solutions to CPAP and overnight sleep lab testing.  ACS found this very serious problem and they can provide all the answers.  But do they really?

For driver safety regulations to be effective, they must be based on a win-win situation.  Let’s impose common sense to the problem.  There are certain points that seem obvious, undeniable and logical.

  • Studies of all human drivers have shown a link between sleepiness, untreated apnea and motor vehicle accidents.
  • Drivers with sleep apnea do not sleep as well as drivers who do not have sleep apnea.
  • Tired, sleepy drivers are more likely to crash than drivers who are alert and well-rested.
  • Obesity, diabetes, smoking, high blood pressure, cardiovascular disease, male gender and large neck size have all been linked to sleep apnea.
  • People having these characteristics should be referred to their physicians for sleep testing and proper treatment if indicated.

These points are the basis for the recommendations of the National Review Board to the Federal Motor Safety Administration.  All references specific to truckers were removed.  It is easy to see in this context that good principles of road safety apply to all motorists – not just truckers.  This is not arguable.  The unhappiness is over implementation of these guidelines relative to truckers.  There appear to be commercial interests that want to make these into rules specific to truckers.  We like to think of the United States of America as a free country.  Events comparable to September 11, 2001 however have required some compromises of freedom for security and safety.

In July 1997 a college student, Maggie McDonnell was struck and killed in a head-on motor vehicle accident by a driver who fell asleep at the wheel.  The driver at fault had not slept in over 30 hours.  Because there were no drowsy driving laws the offender received a $200 fine and a suspended sentence.  Maggie’s mother campaigned successfully and in 2003 New Jersey passed a vehicular homicide law.  It made vehicular accidents caused by someone driving without sleep during the preceding 24 hours a felony offense carrying a $100,000 fine and up to 10 years in jail.  To date no other state has passed a vehicular homicide law for driving while drowsy.  Certainly what is fair for the general population is fair for truckers.  An accident where a drowsy auto driver runs into a truck has the same damage and injury potential as one where the trucker hits the auto.  If sleepy driver regulation is not wanted by the general population for themselves, it certainly seems unfair to impose it just on truckers.

Good sleep is extremely important to good health.  Acute lack of sleep causes alterations in physical well being, irritability, mood and overall cognitive functioning, including reduced acuity in controlling a motor vehicle.  Chronic lack of sleep can cause depression, lethargy, fatigue and contribute to numerous morbid medical conditions.  Scientific research has strongly associated sleep apnea with high blood pressure, severely increased risk of heart attack, stroke, diabetes, weight gain, immune system disorders, and reduced sexual libido.  Epidemiologic research has demonstrated that motor vehicle accidents caused by falling asleep at the wheel are more prevalent than those caused by excessive alcohol use.

Unpopular but necessary to address, sleep apnea has more acceptable alternatives than uncomfortable and expensive CPAP machines and uncomfortable, expensive and threatening overnight studies in a sleep lab.  Inexpensive and reliable home sleep studies are available.  Recent guidelines published by the American Academy of Sleep Medicine (Collop et al., 2007) recommend that the same technology used in sleep laboratories be used for unattended portable monitoring in the home.  Such technology includes the use of a thermal oronasal airflow sensor to detect apnea, a nasal airflow cannula to determine hypopnea, respiratory effort belts using respiratory inductive plethysmography technology, pulse oximetry, and body position.  This technology is available today and has been found to be easy to use with high specificity and sensitivity.

In a recent study involving 73 patients comparing the attended sleep laboratory data collection method against the MediByte® unattended portable home monitoring method, Driver et al. (in press) found that the association for the detection of sleep apnea between the two methods were very high: a Pearson correlation of 0.92, accounting for 85% of the variance in the data.  When apnea was moderate to severe, the sensitivity and specificity of the unattended home method was 80% and 97%, respectively.  When the apnea+hypopnea index was greather than 30 times per hour (i.e., severe) the positive predictive value of the MediByte unattended home recorder was 100%, while the negative predictive value was 88%.  The authors concluded that the home recorder accurately identified patients without sleep apnea and had a high sensitivity for moderate to severe apnea patients.

With the aging baby boomer demographics, unattended home sleep apnea testing presents an inexpensive opportunity to increase sleep apnea screening in the USA.  It is also an efficient and convenient technique to evaluate the efficacy of oral appliance therapy.  In most of Europe unattended home sleep testing has been used for many years to economically and reliably diagnose and monitor sleep apnea.  Recent improvements in technology coupled with approval of home sleep testing by the Center for MediCare / MediCaid in 2008 reinforce the view that home sleep testing is a valid and widely accepted option for both diagnosis and monitoring of snoring and sleep apnea.  Now is the time to take advantage of this modern technique to properly address the important issue of sleep apnea diagnosis and management of sleepy drivers.

The diagnosis and treatment of sleep apnea is rapidly approaching critical mass in terms of recent new technological innovations and gaining public awareness.  Numerous intraoral appliances that are FDA approved, and AASM approved for mild to moderate sleep apnea are already being prescribed and fitted by dentists qualified to practice sleep dentistry.  They are comfortable and have a very high compliance rate according to patient testimonials.  Other intraoral sleep apnea devices are in late stage development as comfortable alternatives to CPAP that are both inexpensive and highly effective.    Compliance chips to monitor usage of oral appliances are also in late stage development.  Both technologies, inexpensive intraoral appliances and compliance chips are expected to be available for market by the end of the year.   Collaboration between the trucking industry, the insurance industry, the medical and dental community of interest and the regulatory agencies offer far more affirmative possibilities to make safer roadways than a biased white paper and behind the scenes lobbying efforts by those standing to reap huge financial gain from poorly conceived regulatory mandates.

Allen J. Moses, DDS, Chicago, IL, USA

Richard A. Bonato, PhD, Ottawa, Canada

Filed Under: Uncategorized

Natus Acquires Embla Systems

September 16, 2011 by admin Leave a Comment

Natus Medical Incorporated (Nasdaq:BABY) today 9/16/2011 announced that it has acquired Embla Systems LLC, a leader in the development, manufacturing, and sales of devices used in the diagnosis of sleep apnea. Embla is the largest company in the world focused solely on sleep diagnostics (Polysomnography or PSG and Home Sleep Testing). The company offers a wide spectrum of innovative sleep diagnostic solutions including Embletta home sleep testing devices and three leading PSG platforms: Sandman, REMbrandt, and RemLogic, and Enterprise Sleep Business Management Systems. This breadth of product offerings provides a unique set of tools to help optimize the efficiency of sleep labs.

Natus acquired all outstanding shares of Embla capital stock for $16.1 million in cash, exclusive of direct costs of the acquisition. Embla reported revenue of approximately $30 million for its fiscal year ended December 31, 2010.

Natus expects the acquisition will be accretive to earnings in 2012, adding $0.08 to non-GAAP earnings per share for the year. The non-GAAP results will exclude amortization of acquired intangible assets and potential restructuring and other one-time charges related to the acquisition.

“The Embla acquisition affirms our leadership position in diagnostic neurology products,” said Jim Hawkins, Chief Executive Officer of Natus. “With this acquisition, Natus will now hold the number one position in the worldwide sleep diagnostic market with annual revenue approaching $35 million.”

“Additionally, with approximately 40% of Embla’s revenue coming from international markets, this acquisition positions Natus as the leader in sleep diagnostics outside the United States,” added Hawkins. “More than 100 million people worldwide are suspected to have obstructive sleep apnea. Because of lack of awareness among both patients and physicians more than 80% of those affected remain undiagnosed.”

Natus funded the acquisition through available cash. The purchase price is subject to adjustment based on net working capital as of the purchase date.

Sleep Apnea

Sleep apnea is a sleep disorder characterized by abnormal pauses in breathing or instances of abnormally low breathing during sleep. There are three forms of sleep apnea: central (CSA), obstructive (OSA), and complex or mixed sleep apnea (i.e., a combination of central and obstructive) constituting 0.4%, 84% and 15% of cases respectively. Studies have shown that as many as one in every 15 Americans is affected by at least moderate sleep apnea. One study showed that in middle-age as many as 9% of women and 24% of men were affected, undiagnosed, and untreated. Conditions linked to obstructive sleep apnea include coronary artery disease, congestive heart failure, hypertension, pulmonary hypertension, stroke, and clinical depression, as well as other illnesses including asthma, chronic obstructive pulmonary disease, and diabetes mellitus.

About Embla

Embla Systems began development of medical devices for the detection of sleep apnea beginning in the mid 1990′s. The company has consistently developed innovative products to assist sleep labs in the diagnosis of the condition. In international markets the company is a leader in devices used for sleep studies performed in the patient’s home. With headquarters in Denver, Colorado, the company also has facilities near Buffalo, New York; Ottawa, Ontario, Canada; the Netherlands; and Germany.

Additional information about Embla can be found at http://www.embla.com.

Additional information about Natus Medical can be found at www.natus.com.

Filed Under: Uncategorized

Kids’ Sleep Disorders Perplex Most Doctors, Study Finds

September 12, 2011 by Randy Clare Leave a Comment

By Stephanie Pappas | LiveScience.com – Mon, Aug 29, 2011

American pediatricians want to help their patients with sleep problems, but a new study finds that few have the proper knowledge and training to do so.

According to a national random survey of primary care pediatricians, only about 18 percent had ever received any formal training on sleep disorders and less than 20 percent answered more than half of eight basic questions about sleep issues correctly.

“Knowledge is lacking,” said study researcher Ramalinga Reddy, a doctor at the Children’s Pulmonary/Sleep Center at the Mercy Children’s Hospital in Toledo, Ohio. Few medical schools and residency programs provide training in pediatric sleep problems, Reddy told LiveScience, despite the fact that 96 percent of pediatricians surveyed said they thought it was their duty to advise patients and families on sleep issues. [Read: Top 10 Spooky Sleep Disorders]

Sleep studies

Although adult sleep disorders are more well known, children experience sleep problems, too. Studies estimate that between 10 percent and 33 percent of children and 40 percent of adolescents experience sleep problems including trouble sleeping, snoring and sleep apnea, a condition that causes people to stop breathing briefly while asleep. About 1 percent to 3 percent of youth have sleep apnea, while as many as 27 percent of children and teens snore.

Reddy and his colleagues conducted the survey by mailing questionnaires to 700 general pediatricians who were members of the American Academy of Pediatrics. About half, or 349, responded, enabling the researchers to make inferences about the total population of American pediatricians with 95 percent confidence and a sampling error of plus or minus 5 percent.

The respondents answered questions about how much formal sleep disorder training they’d had and whether they screened their patients for sleep disorders. The responses showed that doctors often do reach out to their patients about sleep: Almost three-quarters regularly asked kids and their parents about sleep problems, and more than half also asked about bedtimes, bedwetting and snoring or sleep apnea.

But the pediatricians’ knowledge of sleep problems was less robust. When asked eight basic true/false sleep questions, such as “school-age children who are sleepy should be encouraged to take at least one nap per day,” only 19.1 percent scored five out of eight or above. The median, or middle score in the range, was around three correct answers. (By the way, the correct answer to the nap question above is “false.”)

Why sleep matters

Those low scores and the lack of formal training is a problem, Reddy said, pointing out that sleep problems in children are linked to obesity, asthma and even greater risk-taking in teens. Many people believe that “sleep debts” during the week can be made up on the weekends, but research suggests that once sleep is lost, it’s lost forever.

Pediatricians should have more formal training opportunities in sleep issues, starting in medical school and continuing throughout their careers, Reddy said. His institution has started holding regular half-hour lectures on sleep for pediatric residents.

But part of the problem is that talking sleep doesn’t pay for doctors, Reddy said. One respondent reported lacking the time and resources to counsel parents on sleep routines for their children, as insurance companies reimburse for procedures, not doctor-patient conversations.

“Politicians and the health care industry need to look into this and provide the proper attention to sleep in children,” Reddy said.

The researchers reported their results online today (Aug. 29) in the journal Pediatrics.

Filed Under: Uncategorized
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