Moving the HME Industry Forward

Respiratory/Sleep

OSA and the Transportation Industry – Rulemaking Recommendations Take Shape

August 29, 2016

WASHINGTON, DC – Sleep apnea rulemaking recommendations from the Medical Review Board (MRB) are in. MRB reviewed comments from medical professionals and associations in preparation for the Federal Motor Carrier Safety Administration’s (FMCSA’s) and Federal Railroad Administration’s (FRA’s) Advanced Notice of Proposed Rulemaking (ANPRM) on obstructive sleep apnea.  

FMCSA tasked the MRB with reviewing and analyzing all ANPRM comments to identify factors that could influence next steps in obstructive sleep apnea (OSA) rulemaking. A letter from Gina C. Pervall, MD, CIME, chairman of the Medical Review Board, to the FMCSA administrator, highlights recommendations.*

General Recommendations Regarding OSA Include:
• CMEs must screen drivers presenting for medical certification for OSA diagnostic testing in accordance with previous recommendations;
• CMEs cannot issue a medical card for more than 1 year to a driver with an established diagnosis of OSA, regardless of severity;
• a CME may certify a driver with an OSA diagnosis if the driver is being treated effectively; and
• for certification purposes, “effective treatment” or “treated effectively” is defined as the resolution of moderate to severe OSA to mild or better, as determined by a board-certified sleep specialist.

Immediate Disqualification – Drivers should be disqualified immediately and referred for OSA diagnostic testing if any of the following conditions exist:
• individuals who have admitted fatigue or sleepiness during the wake period;
• individuals who have been involved in a sleep-related motor vehicle crash or accident or near crash;
• drivers found non compliant with treatment per previous recommendations;

Additional Recommendations
• The CME should have the discretion to disqualify any driver who appears to be at extremely high risk.
• Drivers disqualified for any of the above reasons must remain disqualified until evaluated and treated effectively.  

Treatment: Positive Airway Pressure (PAP)
• Based on the available medical literature, PAP therapy is the preferred OSA treatment.
• Adequate PAP pressure should be established through one of the following methods: 1) Titration study with polysomnography; 2) auto-titration system.

A driver may be certified initially for up to 1 year if the following conditions are met:
1) The driver must document PAP use for a time period no less than 30 consecutive days (minimum records requirement – initial certification);
2) The driver’s PAP use records must demonstrate at least 4 hours per night use on 70 percent of nights (minimum compliance standard); and
3) The driver does not report excessive sleepiness during the major wake period.

Treatment: Oral appliance
MRB recommends that a driver with a diagnosis of moderate to severe OSA should try PAP therapy before oral appliance therapy, unless a board-certified sleep specialist has determined that an alternative therapy such as PAP is intolerable for a driver, in which case the driver should have the option to pursue oral appliance therapy to treat OSA.

Stated rationale: Based on the available medical literature, drivers with a diagnosis of moderate to severe OSA are less likely to achieve resolution of moderate to severe OSA with an oral appliance than with PAP therapy. There is limited data regarding compliance and long-term efficacy of oral appliances.

Additional covered treatments are: bariatric surgery; oropharyngeal surgery (facial bone surgery); and tracheostomy.

* Article is a summary.