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.

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.

AASM Limits the Number of Medical Directorships

The American Academy of Sleep Medicine has limited physicians to being medical director of no more than 3 sleep centers/labs: http://www.aasmnet.org/Resources/PDF/Dec2008CenterStandards.pdf


This requirement is being phased in and appears to take effect July 1,2009.

________________________________

update (2/14/09) It has been clarified by the AASM on their discussion forum that this requirement takes effect July 1, 2009. A physician is limited to 3 medical directorships and/or board-certified sleep specialist positions (the combination can not exceed 3). A PhD. sleep specialist is limited to 3 board-certified sleep specialist positions.

Accreditation and Reimbursement

A reader asks, via email:
Is Somnus Sleep Clinic accredited by JCAHO and AASM? How do these processes work? Must one occur before the other? Is accreditation required for reimbursment?

Somnus Sleep Clinic is accredited by The American Academy of Sleep Medicine (AASM). In Mississippi and many other states, AASM accreditation is necessary for a sleep center/lab to receive reimbursement for a sleep study from Blue Cross/Blue Shield plans. In some states, other insurance companies also have this restriction.

I don't know too much about JCAHO accreditation of sleep labs/centers. I believe that in some states (not MS), some insurance companies will reimburse for sleep studies at labs/centers accredited by either the AASM or JCAHO. I believe that JCAHO accreditation is mainly for hospital-based sleep labs/centers.

If any reader has more info about JCAHO accreditation for sleep labs/centers, please leave a comment

Billing for Interrupted Sleep Studies

This appeared in the current issue of Medical Economics (I am quoting it in full to better illustrate how wrong the answer is):

Q: We perform sleep and polysomnography studies, which are frequently interrupted because the patient repeatedly stops breathing and we need to implement continuous positive airway pressure therapy. Until now, we didn't think we could bill for those interrupted studies, but we were recently told it is appropriate to do so. How do we proceed?
A: There are actually two proper ways to report the service, according to Current Procedural Terminology. The first is to report the appropriate code from the 95803-95811 range with the modifier –52 for reduced services. The second is to report the appropriate code with the modifier –53 for discontinued services.
The modifier selection would be determined by the amount of data collected during the study. If there is sufficient data to form a diagnostic opinion, –52 would seem the appropriate choice. If there is insufficient data, modifier –53 would be appropriate. However, it is a decision that should be made by the physician. As you know, CPT definition does not guarantee coverage by the insurer.

Occasionally a patient comes in for a diagnostic polysomnogram (95810) and due to the severity of the sleep apnea, CPAP is applied (while continuing polysomnographic monitoring). Sometimes patients are scheduled for split-night studies, in which for the first several hours diagnostic polysomnography is performed, and if there appears to be significant sleep apnea, cpap is applied for the rest of the night with continued polysomnographic monitoring. In both of these situations, the correct CPT billing code to use is (95811), the code for a CPAP titration study.

I am not too familiar with the -53 modifier. I use the -52 modifier when a study is terminated prior to 6 hours of recording time. I do plan to look more into the difference between the -52 and -53 modifiers.

On a broader note, this answer in Medical Economics-written by a non-physician- illustrates that the field of Medicine needs physicians with legal and business experience, and perhaps dual degrees (MD/JD and MD/MBA). Non-physicians often have difficulties truly understanding what what is involved in a medical business. For example, sleep labs organized as Independent Diagnostic and Testing Facilities (IDTF's) that have physician ownership or part ownership are limited in the number of referrals that can come from the physician. Say, for example, that an IDTF with a physician owner and several non-physician owners is told by their lawyer that only 40% of the sleep studies can be ordered/referred by the physician owner. Seems simple enough. However, how do you count a cpap titration? If a Primary care doc orders the psg, it shows sleep apnea, the sleep doc - who is a part owner of the IDTF- sees the patient and arranges for the titration study, who is considered to be the referring doc for the cpap titration? Does it make any difference if the original order form signed by the primary care doc has a pre-printed line next to the order for the polysomnogram indicating that a cpap titration will be performed if clinically appropriate? In my experience, many lawyers have difficulties understanding the process by which a patient initially presents with symptoms of OSA and, after seeing several doctors and going through several sleep studies, eventually receives a cpap machine. I think that part of the problem is that Federal regulations are unclear on the matter. We probably need more doctors in government, too.

More on Medicare Coverage of CPAP machines

A few weeks ago I posted on the subject of new medicare requirements for the coverage of a cpap machine.

An interesting part of the new requirements appears to mandate that the physician who will be prescribing the cpap machine see the patient prior to the initial psg:

INITIAL COVERAGE:A single level continuous positive airway pressure (CPAP) device (E0601) is covered for the treatment of obstructive sleep apnea (OSA) if criteria A - C are met:
The patient has a face-to-face clinical evaluation by the treating physician prior to the sleep test to assess the patient for obstructive sleep apnea.
The patient has a Medicare-covered sleep test that meets either of the following criteria (1 or 2):
The patient and/or their caregiver has received instruction from the supplier of the CPAP device and accessories in the proper use and care of the equipment.If a claim for a CPAP (E0601) is submitted and all of the criteria above have not been met, it will be denied as not medically necessary.

Currently most of the medicare patients who come through Somnus Sleep Clinic are referred directly for a polysomnogram, I see them after the polysomnogram. If they need cpap, I will typically schedule them for the titration study and then see them back again after that to prescribe cpap. I guess I need to start seeing patients with Medicare prior to their initial psg.

Medicare and CPAP

Along with allowing home limited-channel polysomnographic testing to qualify a patient for a cpap machine, CMS also instituted a 12-week trial period for cpap:

The use of CPAP is covered under Medicare when used in adult patients with OSA. Coverage of CPAP is initially limited to a 12-week period to identify beneficiaries diagnosed with OSA as subsequently described who benefit from CPAP. CPAP is subsequently covered only for those beneficiaries diagnosed with OSA who benefit from CPAP during this 12-week period.

This trial period applies whether osa was diagnosed by traditional polysomnography or by home testing.

I have heard from several sources that objective data will be required to demonstrate compliance (compliance download). Does anyone have any info about this, and when it will take effect (one source has told me Nov 1, 2008)???? If anyone could provide a link, it would be appreciated. thanks

Patient Problems at Sleep Labs

A reader commented:
"The problems of sleep labs are not just compliance with regulations. Sleep lab operators need to run good facilities which are tolerable for patients. It took me a long time to recover from the emotional torment of lousy techs who answer every question "you would have to ask your doctor." Insurance companies pay through the nose for the testing, but there is never a doctor available to help the hapless patient. When I couldn't fall asleep during titration and asked for sleeping pills, the tech said he would ask a supervisor, the supervisor hummed and hawed "What kind of meds did you bring with you?" "None, " I said, "never needed any." "Then I will call the doctor, maybe we can get some presecribed for you for tonight." When the doctor did not call back, she said "He hasn't called, but actually you were sleeping beautifully for nearly 3 hours you just woke up a few minutes agao and began calling out for help, which is why I came in!"

Thanks for reading. Actually, the problem is with government regulation. From your description I am assuming that sleep center you went to was an Independent Diagnostic and Testing Facility (IDTF)- a slight majority of sleep centers are IDTF's as opposed to hospital-associated sleep centers or sleep centers that are an extension of a physician practice.
Somnus sleep clinic, which I am a minority owner of, is an IDTF. Because of anti-kickback rules, only a minority of patients can see me prior to the sleep study. Government regulations require a majority of patients to be referred by an outside physician directly for a sleep study.
As medical director, I am available to the technicians for patient emergencies. However, if the techs call me in the middle of the night for a directly referred patient who can't sleep, it puts me in a legally awkward situation of giving a medication to someone who is not my patient. And where is the sleeping pill supposed to come from? Should I call in a prescription to an all-night pharmacy and have the patient drive to go get it (with all the electrodes pasted in their hair)? I guess I could give them one of the samples from my private practice- however new CMS (Medicare) regulations that take effect Jan 1 2009 put new restrictions on the interactions between physicians and IDTF's.
If all of this seems confusing to you, I would encourage you to look through the archives and look at my posts on management of a sleep lab and ownership of a sleep lab.
And technicians are supposed to tell you to ask your doctor about any medical inquiries.

If any sleep physicians out there who practice in IDTF's or hospital-associated sleep labs have a solution for patient requests for hypnotics, I'd be interested in hearing them.

Starting a Sleep Lab, part three

There are 3 basic types of sleep labs: hospital associated, extension of a physician practice, and independent diagnostic and testing facility (IDTF).
Assuming that a physician is not starting a sleep lab in association with a hospital, the basic choice comes down to IDTF or extension of a physician practice.
In my case, I started Somnus Sleep Clinic with some non-physician owners, so IDTF was the only option.
For a physician or physician group, either form could be appropriate. The key difference is how patients are referred to the sleep lab.

For an IDTF, the Feds mandate that most of the referrals for sleep studies come from outside physicians. Practically, what this means is that the outside physicians refer the patients directly for the sleep study. The sleep physician then sees the patient (if the patient is going to be seen by the sleep physician) after the sleep study (within 3 months will meet AASM guidelines). You need to put some type of statement on the psg order form (which should be signed by the outside referring physician) that a cpap titration will be performed if clinically appropriate- then both studies will count as ordered by the outside physician.

For a sleep lab that is an extension of a physician practice, most of the sleep study referrals (85% is a figure I've heard several times before) need to come from inside the practice. Practically, what this means is that the sleep studies need to come from either the practice's own patients and/or patients referred to the practice for a sleep evaluation (and seen by the practice prior to the sleep study). The order for the sleep study needs to come from a physician in the practice.

There are some other differences between IDTF's and physician practice sleep labs, more to come later.

Home Testing not covered in many states

The AASM just linked to a new Local Coverage Determination for the following states:
Illinois, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska and Wisconsin.

Here is the link

http://www.aasmnet.org/Resources/PDF/WPSIC.pdf


Based on a quick read of the LCD, it appears that home testing will not be covered in the above states.

Symphony of Destruction

Sleep Review Magazine has a Podcast series on portable monitoring. The series starts off with a talk by Mary Susan Esther, MD, President-elect of the AASM. Dr. Esther's talk is followed by that of Dr. Chediak, current AASM President. In the coming days, talks will be added by industry representatives.

Type 4 Devices for Home Testing for OSA

I received the press release below via email. The two main type 4 devices that meet CMS criteria for home testing for OSA are the Itamar Watch-PAT100 and the Resmed ApneaLink (with the optional oximeter). Neither device is acceptable by the AASM for accredited sleep centers. The AASM has approved certain type 3 devices for accredited sleep centers.
Press Release

Hold until 18:00 (13 March, 2008)

"Watch-PAT100 included as an accepted ambulatory device for Medicare and Medicaid beneficiaries"

Itamar Medical Inc. is pleased to report that the Centers for Medicare and Medicaid Services (CMS) has released today its final National Coverage Decision (NCD) where it has decided to cover the Watch-PAT 100 for home diagnosis of obstructive sleep apnea. This decision will make the Watch-PAT available to Medicare beneficiaries nationwide.

"Today's decision will mean that Medicare beneficiaries in the United States will have access to one of the most accurate, convenient, and cost-effective home sleep testing diagnostic device for sleep apnea," said Itamar Medical Inc. CEO Israel Schreiber. "Medicare now joins the Department of Veterans Affairs, Kaiser Permanente, and other organizations and physicians nationwide in recognizing the usefulness and benefits of Watch-PAT in the diagnosis of sleep apnea."

"The Watch-PAT is already a widely used home sleep testing device, and this coverage decision means that all Medicare beneficiaries suspected of having obstructive sleep apnea will have access to a device that was designed to provide uniquely convenient and comfortable use with proven accurate and reliable performance," said Gary Sagiv, Itamar Medical Inc's Vice President.

Aetna Follows CMS Policy on Home Testing

Please see my earlier posts today about CMS approving home testing for OSA.

Aetna's Policy is very similar to Medicare's:

Aetna considers the diagnosis and treatment of obstructive airway disease medically necessary according to the criteria outlined below.
Diagnosis
Aetna considers any of the following diagnostic techniques medically necessary for members with symptoms suggestive of OSA:
Full-channel nocturnal polysomnography (NPSG) (Type I device) performed in a healthcare facility;
Unattended home sleep monitoring using a Type II, III, or IV device.
Split-night study NPSG in which the final portion of the NPSG is used to titrate continuous positive airway pressure (CPAP);
Note: On occasion, an additional full-night CPAP titration NPSG may be necessary if the split-night study did not allow for the abolishment of the vast majority of obstructive respiratory events or prescribed CPAP treatment does not control clinical symptoms.
Limited-channel NPSG for members with a high pretest probability of OSA (as suggested by the simultaneous presence of snoring, excessive daytime sleepiness, obesity, and observed apneas or nocturnal choking or gasping);
Video-EEG-NPSG (NPSG with video monitoring of body positions and extended EEG channels) to assist with the diagnosis of paroxysmal arousals or other sleep disruptions that are thought to be seizure related when the initial clinical evaluation and results of a standard EEG are inconclusive.
Thank you to my colleague in Ohio for sending me the link to Aetna's policy.

The Key Line in the CMS decision

Please see my post earlier today for the full CMS decision on Home Testing.

I found this line interesting:

unattended home sleep monitoring device of Type IV, measuring at least three channels

I only have a basic understanding of the main Type 4 device on the market, the Resmed ApneaLink. My understanding is that it utilizes a nasal pressure transducer. I just googled it and came up with this site:

http://www.resmed.com/en-us/products/clinical_systems/apnealink/apnealink.html?menu=products

It looks like there is an optional oximeter available, that adds 2 channels (pulse and oximetry) to the nasal pressure transducer channel, giving the required 3 channels.

Are most doctors who are currently using the Resmed ApneaLink also using the optional oximeter??? If anyone has some info about this device, please leave a comment. Thanks.

CMS Approves Home Testing for Obstructive Sleep Apnea

Decision Summary
We received a request to reconsider the 2005 National Coverage Determination (NCD) for CPAP Therapy for OSA (CAG-00093R) to allow coverage of CPAP based upon a diagnosis of OSA by home sleep testing (HST). After considering public comments and additional information, we are making the following changes to the NCD for CPAP. The revised indications and limitations NCD are noted in Appendix B.
Coverage of CPAP is initially limited to a 12 week period for beneficiaries diagnosed with OSA as subsequently described. CPAP is subsequently covered for those beneficiaries diagnosed with OSA whose OSA improved as a result of CPAP during this 12 week period.We remind the reader that Durable Medical Equipment, Prothetics, Orthotics, and Supplies (DMEPOS) suppliers are required to provide beneficiaries with necessary information and instructions on how to use Medicare-covered items safely and effectively. 42 CFR 424.57(c)(12). Failure to meet this standard may result in revocation of the DMEPOS supplier’s billing privileges. 42 CFR 424.57(d).
CPAP for adults is covered when diagnosed using a clinical evaluation and a positive:
polysomnography (PSG) performed in a sleep laboratory; or
unattended home sleep monitoring device of Type II; or
unattended home sleep monitoring device of Type III; or
unattended home sleep monitoring device of Type IV, measuring at least three channels
We remind the reader that, in general, pursuant to 42 CFR 410.32(a) diagnostic tests that are not ordered by the beneficiary’s treating physician are not considered reasonable and necessary. Pursuant to 42 CFR 410.32(b) diagnostic tests payable under the physician fee schedule that are furnished without the required level of supervision by a physician are not reasonable and necessary.
A positive test for OSA is established if either of the following criterion using the Apnea-Hypopnea Index (AHI) or Respiratory Distress Index (RDI) are met:
AHI or RDI greater than or equal to 15 events per hour, or
AHI or RDI greater than or equal to 5 and less than or equal to 14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke. The AHI is equal to the average number of episodes of apnea and hypopnea per hour. The RDI is equal to the average number of respiratory disturbances per hour.
If the AHI or RDI is calculated based on less than two hours of continuous recorded sleep, the total number of recorded events to calculate the AHI or RDI during sleep testing is at least the number of events that would have been required in a two hour period.
We are deleting the distinct requirements that an individual have moderate to severe OSA and that surgery is a likely alternative.
I wish to thank my colleague in Ohio for sending this to me.

The decline of physician-practice sleep labs

There are 3 basic business structures of sleep labs:
1. hospital-owned
2. independent diagnostic and testing facility (IDTF's)
3. extension of a physician practice

At the AASM Sleep Management course I went to in February, it was reported that business structure 3 comprised less than 5% of sleep labs. The differences between the 3 business structures can be complex, and I plan to talk about this more in future posts. To briefly illustrate the complexity, I will just mention at this time that physicians are often part-owners of IDTF's and hospital associated sleep labs. Physicians sometimes fully own an IDTF.

In my brief career in sleep medicine, the decline of stucture #3 has been a disturbing trend. Sleep Review Magazine reports on how a new interpretation of an old Florida law has led to severe restriction on this type of lab:

In responding to a request from Jacksonville Heart Center (Jax Heart), the State of Florida Board of Medicine finds that physicians of physician-owned labs must directly supervise sleep studies.
In its request, Jax Heart, a group practice comprised of 17 cardiovascular physicians, proposed to establish an eight-bed sleep center as part of its medical practice. The request stated, in part, “.... For sleep studies performed after normal business hours, a Jax Heart physician would be on-call and immediately available by phone."
.....the main issue with the request submitted by Jax Heart was whether the sleep center’s services were being conducted under the “direct supervision” of Jax Heart.
The State of Florida Board of Medicine stated, “If the Sleep Center does provide services under the direct supervision of Jax Heart, the Petitioner’s proposed arrangement does not constitute a ‘referral’ that is precluded by Section 458.053(5), Florida Statutes.
“We found that the law dictated that patients needing a sleep study would be supervised differently depending upon whether the lab was owned by a physician group rather than an IDTF/Hospital,” said Masters.
Ultimately, the Board found that Jax Heart would not be providing services under the “direct supervision” (meaning supervision by a physician who is present in the office suite and immediately available to provide assistance and direction throughout the time services are being performed), and that Jax Heart’s proposed referral of patients to its sleep center is precluded by Section 458.053(5), Florida Statutes.
“It is also important to note that the declaratory statement did not say that physicians are not able to own their own lab—rather that they must provide direct supervision for patient care in a sleep center,” Masters said. “Secondly, the Board reinforced that physician-owned sleep labs must only treat their patients in the sleep center. This provision would not change even if the Direct Supervision requirement was changed to be an exception.”
Read the entire decision here.
Basically, the state of Florida is requiring sleep labs that are an extension of a physician practice to have a physician present whenever sleep studies are run. This is a poorly written article; as I pointed out above, a physician can own all or part of an IDTF. There is a definite distinction between a physician-owned sleep lab and a sleep lab that is an extension of a physician practice.

Respiratory Therapists Try to Take over Polysomnography in California

I previously posted on the attempt of respiratory therapists to take control over polysomnography in California.
The process is moving forward. As reported by Sleep Review Magazine,
Introduced by State Sen Jeff Denham (R-Merced), the “Polysomnographic Technologist Act” Senate Bill 1125 aims to prevent criminal abuse and ensure proper medical diagnosis, as well as ensure a standard of training and accountability for the profession.
"Hundreds and possibly thousands of unlicensed technicians are working with patients in vulnerable circumstances where most have not had a criminal background check and competency testing is optional. Failure to perform competently and protect the consumer holds little or no consequence for unlicensed personnel," said Stephanie Nunez, executive officer for the Respiratory Care Board of California.
The actual text of the bill is here. Some key parts of the bill:
"Board" means the Respiratory Care Board of California.

b) The failure of an employer to provide documents as required bythis section is punishable by an administrative fine not to exceedfifteen thousand dollars ($15,000) per violation. This penalty shallbe in addition to, and not in lieu of, any other civil or criminalremedies. 3818. The board shall issue, deny, suspend, place probationaryterms upon, and revoke licenses to practice polysomnography andpolysomnography-related respiratory care services.
The board shall determine the hours of credit tobe granted for the passage of particular examinations. 3819.5. The board may require successful completion of one ormore professional courses offered by the board, the AmericanAssociation for Respiratory Care, the California Society forRespiratory Care, or the National Board for Respiratory Care in anyor all of the following circumstances: (a) As part of continuing education. (b) Prior to initial licensure.
As I interpret it, this California bill would give respiratory therapists, through their board, the power to license sleep lab technicians and fine labs that hire technicians not licensed by their board. This law is a slap in the face to the majority of sleep technicians who are not respiratory therapists.

IDTF's can no longer perform sleep studies in hotels

Sleep Review reports that:
Hotels/Motels Not Appropriate for Sleep Studies, CMS Says
New regulatory standards for independent diagnostic testing facilities released by CMS last month are scheduled to take effect January 1, 2008.
Among the standards is one that rules out the use of hotels and motels for performing sleep studies.
For more info, see here.
I believe that this ruling only applies to IDTF's. As an AASM accreditation site visitor, I have inspected a university-owned sleep lab that was based in a hotel. It was a nice operation. I don't agree with this CMS decision, though it will affect only a few sleep labs.

Portable Monitoring Webinar

From the American Academy of Sleep Medicine website:

Get an in-depth overview of the new guidelines for portable monitoring and answers to frequently asked questions by registering for Portable Monitoring Discussion Forum.
AASM Portable Monitoring Task Force chair Nancy Collop, MD, will lead this 60-minute Webinar on December 18, 2007, at 12 p.m. CST. Please note that registrants must submit questions in advance to rrosenberg@aasmnet.org. The deadline to submit questions has been extended to 5 p.m. CST, December 14, 2007.
Log on to www.aasmnet.org/SleepEdSeries.aspx to register for Portable Monitoring Discussion Forum.
The new guideline will be published in the December issue of the Journal of Clinical Sleep Medicine; visit www.aasmnet.org/PortableMonitoring.aspx for comprehensive information.

Preliminary Approval for Home Testing for OSA

Home testing for OSA preliminarly approved: http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?from2=viewdraftdecisionmemo.asp&id=204&

Not only were type 2 (unattended polysomnogram) and type 3 devices (four channel) approved, but unexpectedly type 4 (1 or 2 channel) devices were also approved.

I am glad that I sold off my shares of Sleep Holdings Inc last week. I wish I would have bought Respironics instead of Resmed on Friday- Respironics makes the superior pulse oximeter (type 4 device)- the 920 M series.