Breaking News “DOT seeks public comment for new regs”
DOT begins rulemaking on sleep apnea for CMV operators and rail crews.
The Department of Transportation (DOT) has issued an Advanced Notice of Proposed Rule Making (ANPRM) seeking information on sleep apnea in safety sensitive positions within the Federal Motor Carrier Safety Administration (FMCSA) and Federal Rail Authority (FRA). This link is to a press release on the ANPRM that will give you general information.
Links within the news release should let you access all 24 pages of the actual ANPRM.
If you are not used to the alphabet soup of FMCSA rulemaking you need to understand this is the first step in a very long process. Elaine Papp former Chief of the FMCSA medical programs office feels that developing a final rule on sleep apnea will take 4-6 years. A major complicating factor will be the new White House administration that will take office. The Administrator of FMCSA is a White House appointment requiring Senate confirmation. Elaine just did an excellent driver friendly radio show podcast explaining this process if you are interested.
Another hurdle this rulemaking will have is passing a White House Office of Management and Budget (OMB) cost effectiveness analysis. Prior to Burks et al discussed later, good research establishing the rate of sleep apnea crash risk was not available. Even with this new data the OMB cost effectiveness analysis will be a hurdle.
This ANPRM is open to public comments from anyone with an interest in the topic. Comments are not limited to medical groups or associations. As of writing there are already 113 comments submitted. While many are from drivers several are from either DOT medical examiners or sleep medicine professionals. The American Academy of Sleep Medicine (AASM) and American Sleep Apnea Association (ASAA) have both expressed plans to submit extensive comments. Comments are due by June 8, 2016. They can be submitted online via the Regulations.gov portal. Docket FMCSA-2015-0419.
The DOT has included 20 questions they are seeking input from stakeholders on. Skip to page 19 of the ANPRM if you want. You can comment on any or all of the questions or just make general comments. Comments that cite specific research or evidence to support your comment often are given more weight in agency deliberations.
Request for Comments
The Agencies request public comment on the questions below. In your response, please provide supporting materials and identify your interest in this rulemaking, whether in the transportation industry, medical profession, or other.
Questions Reprinted From DOT, ANPRM
The Problem of OSA
1. What is the prevalence of moderate- to-severe OSA among the general adult U.S. population? How does this prevalence vary by age?
2. What is prevalence of moderate-to- severe OSA among individuals occupying safety sensitive transportation positions? If it differs from that among the general population, why does it appear to do so? If no existing estimates exist, what methods and information sources can the agencies use to reliably estimate this prevalence?
3. Is there information (studies, data, etc.) available for estimating the future consequences resulting from individuals with OSA occupying safety sensitive transportation positions in the absence of new restrictions? For example, does any organization track the number of historical motor carrier or train accidents caused by OSA? With respect to rail, how would any OSA regulations and the current PTC requirements interrelate?
4. Which categories of transportation workers with safety sensitive duties should be required to undergo screening for OSA? On what basis did you identify those workers?
Cost & Benefits
5. What alternative forms and degrees of restriction could FMCSA and FRA place on the performance of safety- sensitive duties by transportation workers with moderate-to-severe OSA, and how effective would these restrictions be in improving transportation safety? Should any regulations differentiate requirements for patients with moderate, as opposed to severe, OSA?
6. What are the potential costs of alternative FMCSA/FRA regulatory actions that would restrict the safety sensitive activities of transportation workers diagnosed with moderate-to- severe OSA? Who would incur those costs? What are the benefits of such actions and who would realize them?
7. What are the potential improved health outcomes for individuals occupying safety sensitive transportation positions and would receive OSA treatment due to regulations?
8. What models or empirical evidence is available to use to estimate potential costs and benefits of alternative restrictions?
9. What costs would be imposed on transportation workers with safety sensitive duties by requiring screening, evaluation, and treatment of OSA?
10. Are there any private or governmental sources of financial assistance? Would health insurance cover costs for screening and/or treatment of OSA?
Screening Procedures & Diagnostics
11. What medical guidelines other than the AASM FAA currently uses are suitable for screening transportation workers with safety sensitive duties that are regulated by FMCSA/FRA for OSA? What level of effectiveness are you seeing with these guidelines?
12. What were the safety performance histories of transportation workers with safety sensitive duties who were diagnosed with moderate-to-severe OSA, who are now successfully compliant with treatment before and after their diagnosis?
13. When and how frequently should transportation workers with safety sensitive duties be screened for OSA? What methods (laboratory, at-home,split, etc.) of diagnosing OSA are appropriate and why?
14. What, if any, restrictions or prohibitions should there be on a transportation workers’ safety sensitive duties while they are being evaluated for moderate-to-severe OSA?
15. What methods are currently employed for providing training or other informational materials about OSA to transportation workers with safety sensitive duties? How effective are these methods at identifying workers with OSA?
Medical Personnel Qualifications & Restrictions
16. What qualifications or credentials are necessary for a medical practitioner who performs OSA screening? What qualifications or credentials are necessary for a medical practitioner who performs the diagnosis and treatment of OSA?
17. With respect to FRA should it use Railroad MEs to perform OSA screening, diagnosis, and treatment?
18. Should MEs or other Agencies’ designated medical practitioners impose restrictions on a transportation worker with safety sensitive duties who self- reports experiencing excessive sleepiness while performing safety sensitive duties?
19. What should be the acceptable criteria for evaluating the effectiveness of prescribed treatments for moderate- to-severe OSA?
20. What measures should be used to evaluate whether transportation employees with safety sensitive duties are receiving effective OSA treatment?
There are several efforts underway related to this ANPRM. The AASM leadership along with the AASM Transportation and Safety Task Force are developing comments internally. The American Transportation Research Institute (ATRI) the research arm of the American Trucking Association (ATA) has a data gathering effort among drivers being launched at the Mid America Truck Show in Louisville starting March 31. They will also have data gathering efforts for motor carriers. A special data gathering effort will be directed to sleep medicine testing and treatment firms. Question 9 in the ANPRM asks about testing and treatment costs. An issue that has already come out is that major firms with trucking company contracts are reluctant to share actual cost data, as that is proprietary competitive bidding information. ATRI has a reputation within the trucking industry for doing compilation and aggregation studies of confidential salary, freight rates, turn over, and other sensitive information to produce industry average data. Look for more information on this in future Sleep Scholar articles and in sleep medicine on line news outlets like Sleep Review.
Another breaking news item on the transportation front has been the publication of Burks et al. in Sleep. This news release from the AASM on the study has information on how to request a pre-publication copy. http://www.aasmnet.org/articles.aspx?id=6186 Prior to the publication of Burks the research on sleep apnea crash risk was mixed at best. It has been the topic of a previous Sleep Scholar article of mine and a recent commentary in the Journal of Clinical Sleep Medicine. Burks used data from the Schneider National carrier long standing sleep apnea testing and treatment program. Taking drivers who refused or were never compliant on treatment it analyzed their accident records for the time between diagnosis and termination for cause for non-compliance. Improvements in compliance and removing unsafe non-compliant drivers more quickly has been done since. They used PSG sleep study data from 2005-2008 before HST was widely used. Using a matched pair methodology the study analyzed both sleep apnea and crash in a variety of ways. What is most striking about this study is that it addressed confounding variables in trucking safety such as miles driven, type of driving, experience of driver, and crash preventability. This type of in depth of collaboration between sleep medicine researchers and experts in transportation safety is to be commended. The lead author Stephen Burks is a former truck driver. I am personally proud to have been a driver for Schneider under treatment for sleep apnea during the study period. Research ethics preclude the author confirming if my data was part of the study.
Sleep medicine professionals should carefully address the questions relating to screening for OSA. A current recurring problem is that the screening criteria at times used by DOT medical examiners do not meet the definition of “medical necessity” for testing to be covered by insurance. This is especially true for tests negative for sleep apnea.
Another issue sleep medicine professionals need to address in their comments is striking a balance between screening and testing to ensure no sleep apnea to a medical certainty versus screening and testing to establish a reasonable level of highway safety. Some commenter’s in previous recommendations to FMCSA on sleep apnea have recommended that with a high pre-test probability for OSA that no negative HST be accepted. All negative HST should be confirmed by a PSG. The reaction from trucking has been “After spending $4-500 on an HST that says I don’t have sleep apnea you want me to spend another $ 2,000 on an in-lab study to prove the same thing?” In my personal opinion if recommendations from the sleep medicine community retain this approach to negative testing, the rulemaking will not survive the OMB cost effectiveness analysis.
All CMV drivers have to get a renewed DOT medical exam on a 1 or 2 year cycle depending on a variety of factors. Drivers who had screened high risk and were required to get a sleep study in the past which came back either negative or an AHI low enough to not require treatment (AHI or severity requiring treatment or disqualification for driving is another question) will often screen high risk again. The question requiring comments from sleep medicine will be how long should a negative sleep study be good for? This question was raised in public comments to the 2012 MCSAC-MRB recommendations. The MRB chose not to address it in the final recommendations. Fortunately, in a formal rulemaking like this, FMCSA is legally required to address all reasonable comments. Analysis of change in risk factors along with the type of original test (HST versus PSG) combined with research available on the progression on OSA over time in CMV operators may yield reasonable recommendations.
Those involved with dental sleep medicine should take a careful look at question 16 regarding credentials. They also should look at question 14 about restrictions while undergoing treatment. For oral appliances to be a cost effective option the issues around safety sensitive position workers being able to work while an OAT is being titrated would need to be addressed.
A major research gap dental sleep medicine may have is establishing that drivers being treated with OAT show the same or better actual safety performance than drivers under treatment with other methods such as CPAP. Potential research to address this issue has been discussed but accomplishing and publishing before the June 8 deadline is unrealistic. The problem is that since OAT was not a treatment option recommended by previous FMCSA expert medical panels the pool of study participants is limited. Additionally dental sleep medicine should offer its opinions if compliance monitoring of OAT should be required or just recommended.
A question not even addressed in the ANPRM is: Why isn’t the Federal Aviation Administration (FAA) in this rulemaking? As noted in the preamble to the ANPRM the FAA already has OSA screening and testing requirements for pilots and others requiring Aeromedical exams (AME). The current FAA requirements do NOT require a pilot deemed high risk for OSA by the AME to undergo a sleep study. The pilot’s primary care physician can clear the pilot.
Issues around how the Americans with Disabilities Act (ADA) may play into pre-employment screening or any screening outside of a DOT medical exam will have to be addressed. Those with expertise in sleep medicine may want to look at the base medical qualifications of DOT medical examiners. MD, DO, NP, PA and DC are allowed to train and test to enter the National Registry of Certified Medical Examiners (NRCME) which is required to conduct a DOT medical exam. How scope of practice regulations for Doctors of Chiropractic (DC) will play into screening should be commented on. Sleep medicine professionals should voice their opinion on the appropriateness of OSA screenings conducted by chiropractors. This may require FMCSA to revisit the issue of DC’s being able to conduct DOT exams at all. This is a topic hotly debated among occupational medicine professionals. In my home state of Illinois a DC offering an opinion on any medical condition not commonly treated by a course of chiropractic is a violation of the state chiropractic licensing legislation. On encountering a medical condition not treated by chiropractic a DC may only refer the patient to an appropriate medical professional and may not charge for their services. How this will play out with DC on the NRCME performing OSA screenings and conditional certifications pending a sleep study should be commented on by sleep medicine professionals.
Truckers for a Cause the patient support group for truck drivers with sleep apnea will be doing extensive written comments. We will be developing a collaborative “Google Doc” which we will make accessible through truckersforacause.com. If you have research or objective data addressing any of the ANPRM questions start compiling them or send me an e-mail (firstname.lastname@example.org) Also please submit your thoughts directly via the regulations.gov portal. From previous rulemakings often vendors or others that due to their employment feel direct public comments might be construed as being an official opinion of their employer are at times reluctant to submit comments. We will attempt to provide an option for these types of commenter’s to provide anonymous input. We hope to have this up in mid May.
Please pass this information on to others in sleep medicine. If you are having a meeting of conference before June, please consider adding this as a topic.
Given how long this has been anticipated the next couple of months will be interesting.