Obstructive Sleep Apnea Diagnosis and Treatment - part 10 pot

Legal Implications of Obstructive Sleep Apnea 409 clearly reproduced on a video monitor or a compact printer, the sleep specialist’s interpretation of the test can occur anytime and at any place. Often the physician’s diagnosis of OSA occurs without the physician examining or even speaking with the patient. Questions may arise whether the sleep study patient and the distant reading physician have established a physician-patient relationship for purposes of a malpractice action. The trend in recent case law is for courts to imply the existence of a physician- patient relationship among physicians unknown to the patient if the physician affirmatively undertakes to diagnose and/or treat the patient (32). A Texas case, Dougherty v. Gifford (33), is instructive. There, the patient’s specialist sent a biopsy to his contracted pathologist who practiced in the regional medical center in Paris, Texas. The pathologist diagnosed cancer and aggressive treatments ensued, only to be discontinued when the pathologist admitted to having misread the biopsy (34). Like most distant readers of sleep tests, the pathologist in Paris never intended to create a professional relationship with the patient. The pathologist never met the patient, did not review the patient’s records, and only reviewed the specimen provided. The pathologist communicated the results to the patient’s treating physician, who retained primary responsibility for the patient’s care (35). Nonetheless, the court found on these facts that a physician-patient relationship was created by the acceptance of the pathology work, the conduction of the tests, the preparation of a lab report, and the acceptance of a fee for the services rendered. The court stated that there could be no doubt that the diagnostic services f urnished on behalf of the patient constituted the practice of medicine (36). As stated by the Tennessee Supreme Court in a similar case: In light of the increasing complexity of the health care system, in which patients routinely are diagnosed by pathologists or radiologists or other consulting physicians who might not ever see the patient face-to-face, it is simply unrealistic to apply a narrow definition of the physician-patient relationship in determining whether such a relationship exists for purposes of a medical malpractice case. Based upon the foregoing authorities, we hold that a physician-patient relationship may be implied when a physician affirmatively undertakes to diagnose and/or treat a person, or affirmatively participates in such diagnosis and/or treatment (37). Telemedicine Aspects of the Physician-Patient Relationship The free flow of sleep data to physicians who are not only invisible to the patient but also reside in a state different from the patient challenges traditional notions of the physician’s license to practice medicine. All states have adopted laws which define the types of activity constituting the practice of medicine within their borders. Such laws generally prohibit persons from engaging in the unlicensed practice of medicine, and further punish physicians for aiding and assisting others in the unlicensed practice of medicine. The threshold question is whether the professional interpretation of a sleep study constitutes the practice of medicine. Although each state defines the practice of medicine somewhat differently, the recent trend is for states to include the interpretation of diagnostic tests within the practice of medicine definition. Colorado’s practice of medicine definition, which specifically includes the interpretation of tests, is representative. In full, the Colorado law provides that: Practice of medicine In Colorado means holding out one’s self to the public within this state as being able to diagnose, treat, prescribe for, palliate, or prevent any human 410 Brown disease, ailment, pain, injury, deformity, or physical or mental condition, whether by the use of drugs, surgery, manipulation, electricity, telemedicine, the interpretation of tests, including primary diagnosis of pathology specimens, images, or photographs, or any physical, mechanical, or other means whatsoever (38) (emphasis added). At least 14 states have passed legislation specifically restricting the practice of telemedicine across state lines. For example, the Missouri statute defines the “practice of medicine across state lines” to mean: 1. The rendering of a written or otherwise documented medical opinion concerning the diagnosis or treatment of a patient within this state by a physician located outside this state as a result of transmission of individual patient data by electronic or other means from within this state to such physician or physician’s agent; or 2. The rendering of treatment to a patient within this state by a physician located outside this state as a result of transmission of individual patient data by electronic or other means from within this state to such physician or physician’s agent, definition (39). An Oregon law specifically issues a special purpose license to outside physicians to practice within Oregon by distant communications, but only after the physician has first personally examined the patient (40). Other states, such as Alabama, issue a three-year special purpose license (41). If the interpretation of the sleep study constitutes the practice of medicine, the next question is “which licensing authority governs?” The general rule in malpractice actions is that the patient’s location at the time of service determines the location where the treatment occurs (42). As stated by the Ninth Circuit Court of Appeals in Wright v. Yackley (43): In the case of personal services focus must be on the place where the services are rendered, since this is the place of the receiver’s (here the patient’s) need. This need is personal and the services rendered are in response to the dimensions of that personal need. They are directed to no place but to the needy person herself. Although improper licensure may not, by itself, indicate negligence in all malpractice actions (44), proper licensure can be a condition to the presentation of a clean, nonfraudulent claim to a government healthcare program for reimbursement (45). Physician’s Duties to Diagnose and Treat Obstructive Sleep Apnea Upon establishment of the physician-patient relationship, a physician owes his patient the duty of reasonable care present in the community when treating his patient (31). A 1993 Louisiana case found a hospital and its physicians liable for the death of patient William Cornett as a result of the defendants’ failure to treat the decedent’s OSA (6). Mr. Cornett suffered from acromegaly, a generally nonmalig- nant pituitary tumor causing excessive secretion of growth hormones and the resulting enlargement of facial features, limbs, and soft tissues of the body (46). The condition may cause OSA, from which Mr. Cornett also suffered (46). In March 1986, a family practice resident at the defendant hospital examined Mr. Cornett, who complained of chest pains and sleep apnea. The resident referred the patient to the hospital’s endocrinology clinic for acromegaly. The hospital failed to schedule the appointment (46). Legal Implications of Obstructive Sleep Apnea 411 Seven months later, Mr. Cornett presented at the hospital’s emergency room believing he was in a diabetic coma. He again explained his four- to five-year history of sleep apnea, and Mr. Cornett fell asleep during his diabetes testing, which proved negative. Concerned about Mr. Cornett’s somnolence, the emergency room physician ordered arterial blood gas testing, which indicated elevated carbon dioxide levels and low oxygen levels. The emergency room physician testified at trial that Mr. Cornett requested treatment for sleep apnea because he had fallen asleep while driving. The doctor diagnosed acromegaly and sleep apnea. To confirm the diagnosis of acromegaly, the physician ordered diagnostic tests at the hospital’s endocrinology clinic. These tests confirmed the diagnosis of the pituitary condition (47). Mr. Cornett presented at the endocrinology clinic two weeks later when a different hospital physician confirmed a diagnosis of acromegaly and central hypoxia. This physician ordered pulmonary function testing at the hospital’s chest clinic, but Mr. Cornett died before his scheduled appointment date. The cause of death was documented as cardiopulmonary arrest as a consequence of pituitary tumor (47). Expert testimony at trial indicated that Mr. Cornett’s death was more likely caused by sleep apnea and, had the hospital and its physicians provided appropriate medical treatment for OSA, Mr. Cornett would have survived. The last two hospital physicians who examined Mr. Cornett acknowledged that OSA is a potentially fatal condition. Each also testified that they failed to inform Mr. Cornett of the risk of death presented by untreated sleep apnea. The hospital’s own medical expert acknowledged that sleep apnea may lead to life-threatening cardio-respiratory events and that the disease is a recognized emergency. The appellate court affirmed the trial court’s holding the hospital and the physicians liable for professional negligence (48). Physician’s Duty to Obtain Patient’s Informed Consent for Obstructive Sleep Apnea Surgery Physicians have a general duty to provide their patients with sufficient information concerning their diagnosis, the nature and reason for the proposed treatment, the risks or dangers involved, the prospects for success and alternatives methods of treatment and the risks and benefits of such treatment (49). An unpublished decision of the Tennessee Court of Appeals discusses a physician’s duty to inform a sleep apnea patient of CPAP treatment before performing uvulopalatopharyngo- plasty (UPPP) (50). The case involved a board-certified otolaryngologist who scheduled a nonur- gent tonsillectomy for his 49-year-old male patient. The patient asked whether the procedure would help his snoring. Examining the patient further, the physician diagnosed mild sleep apnea and recommended surgical treatment. The patient testified at trial that he heard the doctor say that the doctor would trim his uvula, but the physician’s notes indicated “surgery discussed, risks, and complications, schedule tonsillectomy, septoplasty, UVPP (uvulopharyngoplasty)” (51). In fact, the defendant physician performed the UPPP procedure. At no time did the physician advise his patient as to any nonsurgical alternatives to remedy his snoring. The patient suffered various neurological disorders following the surgery and brought a malpractice action against the physician. Plaintiff based his claim on the physician’s failure to inform his patient of noninvasive alternatives and failure to inform him of the diagnosis of OSA so that the patient could be properly informed of risks that stemmed from that diagnosis. In support, Plaintiff’s medical expert testified that the physician should have informed Plaintiff of noninvasive snoring 412 Brown treatments, such as CPAP and laser surgery. The expert further testified that the physician should have ordered a sleep study to determine the presence of sleep apnea and the severity of the condition. However, on cross-examination, the expert admitted that even he did not send all of his patients who presented with OSA symptoms for a sleep study and that a sleep study was not required to identify the location in the throat that caused the snoring (52). The physician presented the medical testimony of two fellow otolaryngolo- gists. These doctors testified that the treating physician informed the patient of the procedure and risks consistent with the standards of the community. The jury also considered the broad language of the written consent form signed by the patient. On the basis of the expert testimony and the patient’s written consent, the jury determined that the physician properly informed his patient and found for the physician (53). What is unknown is a physician’s responsibility to recognize the documented link between sleep apnea and hypertension, cardiovascular disease, and other dis- eases (3) when performing routine examinations. The Cornett case discussed above indicates the risks attendant to physicians who fail to recognize the urgency of the disease. Increased awareness of sleep medicine and recognition by the American Board of Medical Specialties of sleep medicine as a subspecialty (54) may bring minimum sleep inquiries into the community standard of practice for cardiologists, pulmonologists or family practice physicians whose patients present with typical OSA markers. Physician’s Duties and Liabilities to Third Parties for the Acts of Their Obstructive Sleep Apnea Patients Duty to Warn and Report Impaired Driving Because hypersomnolence generally follows untreated OSA, a physician may have additional legal and ethical duties to the public to inform the patient of the risks of fatigued driving caused by the failure or refusal to treat the disease. In appropriate cases, the physician may be required by law to report the patient’s condition to applicable state motor vehicle agencies. Although no case found expressly discusses a physician’s duty to third parties in the context of an OSA patient, under the proper facts, a physician owes a duty to use reasonable care to protect the driving public if the physician’s negligence in diagnosis or treatment of his patient contributes to Plaintiff’s injuries (55). One principal case holds that a physician who “takes charge” of a patient whom the physician knew or should have known was likely to cause bodily harm to others adopts the duty of reasonable care to prevent the patient from causing harm to others (56). However, courts readily distinguish a physician’s prescribing narcotic drugs or similar treatment plans from situations in which the physician “takes charge” of the patient. The courts reason “that whether the patient takes the medication and then drives is beyond the doctor’s control. In fact, whether the patient consumes the medication at all is beyond the doctor’s control” (57). This same result would logically follow upon an injury caused by an OSA patient’s failure to comply with his or her CPAP treatment. However, the law requires a physician to warn the patient of the risks flowing from the use or misuse of the treatment (58). In Gooden v. Tips (59), a physician prescribed Quaalude tablets for his patient but failed to warn her not to drive under its influence. The patient’s drug-induced driving injured third parties, who brought Legal Implications of Obstructive Sleep Apnea 413 suit against the physician. The court ruled that the physician was liable to the injured third parties not because the physician had a duty to prevent his patient from driving, but because the physician had the duty to warn the patient not to drive, which he failed to do (30). A treating physician may have a similar duty to warn an OSA patient that the disease may cause a risk of drowsy driving if left untreated or treated improperly. In addition to legal duties under common law negligence, physicians may have a statutory obligation to report impaired driving to the department of motor vehicles. For example, Vermont, Oregon, New Jersey, California, Delaware, Pennsylvania, and Nevada require physicians to report specific disorders of their patients to appropriate state agencies, typically the state department of motor vehicles (60). Other states permit physicians to report their patients’ impaired driving conditions, but do not require reporting. Still other state laws permit the report to be made anonymously, while some laws offer physicians complete immunity from liability if they have reported the patient’s condition to the applicable agency prior to a patient’s injury (61). According to the American Medical Association’s “Physician’s Guide to Assessing and Counseling Older Drivers,” patients with a diagnosis of narcolepsy should cease driving altogether (62). The Guide suggests that patients with sleep apnea may drive if they do not suffer excessive daytime drowsiness as a consequence of therapy or otherwise (63). Physicians in reporting states should check with the department of motor vehicles in their states to determine if a sleep disorder is a specified condition for which reporting is required. Even if reporting is not required, physicians face legal and ethical dilemmas if they judge the patient unfit to drive but the patient refuses to comply. In 2000, the American Medical Association adopted Ethical Opinion E-2.24 to address physicians’ ethical obligations in this regard (63). According to the Opinion, if clear evidence of substantial driving impairment implies a “strong threat” to patient and public safety, and if the patient ignores the advice to discontinue driving, then the AMA believes it is desirable and ethical for the physician to notify the applicable department of motor vehicles. However, the Opinion clarifies that the physician must follow state law if reporting is required. The Opinion also advises that physicians should disclose and explain their responsibility to report to their patients. Reporting a patient’s impaired driving condition impacts an array of legal issues, including patient confidentiality. If a state law requires or permits disclosure, patient authorization may be required prior to the disclosure. The Privacy Standards applicable to protected health information under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) will not stand in the way if state law requires or permits disclosure without authorization. HIPAA permits healthcare providers to disclose protected health information without individual authorization as “required by law” (64) or to avert a serious threat to health or safety (65). However, HIPAAs provisions yield to more stringent state laws. Accordingly, prior patient authorization may still be required under state law even though HIPAA may permit an unauthorized disclosure. LEGAL OBLIGATIONS OF PERSONS EMPLOYING OBSTRUCTIVE SLEEP APNEA PATIENTS Because science and the law recognize OSA as an impairment which, if untreated, may adversely affect work performance and safety, the law imposes distinct legal duties on employers of OSA patients. These duties include taking reasonable 414 Brown accommodations to the extent required by federal and state disability laws, vicarious liability for the acts of drowsy employees, and, in certain industries, the adoption of fitness for duty standards that recognize the risks posed by employees with sleep apnea. Disability Laws The Americans with Disabilities Act (ADA) (66), along with the Rehabilitation Act of 1973 (67) and similar state civil rights laws (68), prohibits discrimination by certain employers against qualified individuals with a disability (69). A “qualified individual” is one who is capable of performing the essential function of a job with or without reasonable accommodations (70). For example, if driving is an essential function of one’s job and if an employee cannot safely drive due to his combined conditions of severe OSA, narcolepsy and cataplexy, then the employee is not a “qualified individual” eligible for ADA protections (71). The same holds true if sleep apnea prevents an employee from working overtime in his job as a power company lineman when working overtime shifts is an essential function of being a lineman (72). If the employee is not a qualified individual, then the employer has no obligation under the ADA to make the employee’s job easier or even to make the job available at all (73). Qualified individuals have often claimed OSA is an ADA disability and that such persons therefore deserve redress for lost employee benefits, promotions or even their jobs due to their disability. However, the allegation of a particular diagnosis, standing alone, is insufficient to establish a disability under the ADA (74). The answer whether OSA is an ADA disability requires an individualized, case-by-case approach to evaluate whether the employee’s impairment is severe enough to constitute a disability for ADA purposes (75). Thus, the proper legal inquiry in such matters is not whether sleep apnea is a disability for purposes of ADAs protections, but whether the individual’s sleep apnea substantially limits his or her major life activities as those terms are defined by the ADA. 1 To establish a prima facie case of discrimination under the ADA, the employee must show that: (i) he is disabled within the meaning of the ADA, (ii) he is qualified to perform the essential functions of his job either with or without reasonable accom- modation, and (iii) he has suffered from an adverse employment decision because of his disability (76). To prove the existence of a disability, the employee must show that (i) he suffers from an impairment; (ii) the impairment affects major life activities; and (iii) the impairment “substantially limits” such major life activities (77). Although the ADA does not define “impairment,” regulations promulgated under the ADA by the Employee Equal Opportunities Commission do (78). These regulations define a physical or mental impairment to include, in part, any physio- logical disorder or condition affecting a person’s neurological, musculoskeletal, respiratory or cardiovascular systems (79). 1 Under certain circumstances sleep apnea is considered a disability for some federal benefit programs, such as Veteran’s Affairs, 38 CFR § 4.97. Persons seeking social security disability benefits must prove that they have a “disability,” which is defined to mean the “inability to engage in any substantial gainful activity” due to a “physical or mental impairment” that could cause death or might reasonably be expected to last continuously for at least twelve months. See 42 U.S.C. § 423(d) (1) (A). Legal Implications of Obstructive Sleep Apnea 415 Courts discussing OSA in the context of these ADA regulations routinely find—and employers routinely concede—that OSA is a physical impairment in satisfaction of the first prong of the analysis (80). Sleep apnea affects one’s ability to breathe during sleep. As a consequence, one may not achieve a sound sleep at night and may drop off to sleep uncontrollably during the work day. This condition could reasonably be considered a respiratory disorder within the definition of “physical impairment” (81). The second prong of the test requires that the impairment affect a major life activity. The regulations make clear that “breathing” is included in the definition of a “major life activity” for purposes of meeting the ADA test (78). “Sleeping,” however, is conspicuously absent from the regulatory list of major life activities. ADA claimants with OSA can finesse the point by claiming that their sleep apnea substantially limits their breathing during sleep, thus impacting both activities (82). In fact, most courts interpret ADA regulations to find that “sleeping” is a major life activity for ADA purposes (83). “Sleeping is a basic activity that the average person in the general population can perform with little or no difficulty, similar to the major life activities” that do appear in the regulations: walking, seeing, hearing, speaking, breathing, learning, and working (84). Interestingly, courts have also ruled that staying awake, in and of itself, is not a major life activity (85), and that general sleeplessness is insufficient to show a significant impairment to one’s activity of sleeping (86). Having determined that sleep apnea is an “impairment” affecting a “major life activity,” the determination whether sleep apnea is a disability under the ADA depends, in each case, whether the claimant can prove that sleep apnea substantially limits the claimant’s sleep or breathing for purposes of ADA protection. Such proof must satisfy yet another three part evaluation relative to (i) the nature and severity of the impairment; (ii) the duration or expected duration of the impairment; and (iii) the permanent long-term impact, or the expected permanent or long-term impact of or resulting from the impairment (87). In addition, courts will consider the measures used by the claimant to mitigate or treat his condition (86), such as, in the case of sleep apnea, CPAP (82). The courts recognize that a determination of ADA disability for persons with OSA depends on the severity of the impairment, which presents in a wide spectrum: In general terms sleep apnea can be so severe such that it does impact on the major life activity of sleep. [Citation omitted]. Sleep apnea, however, is also a condition that varies in severity from very mild asymptomatic snoring to severe snoring and extremely restless sleep with extreme daytime hypersomnolence or excessive sleepiness during the day (88). The use of CPAP therapy to correct or mitigate OSA symptoms is a key factor in determining the severity of the employee’s disease in the determination of ADA disability. Thus, in a situation where common OSA therapies such as CPAP and surgery failed to alleviate an employee’s fatigue resulting from severe sleep apnea, the United States District Court of Eastern Pennsylvania permitted the jury to consider whether the employee’s OSA constituted a severe impairment for ADA disability purposes (89). Cases involving successful use of CPAP reach different conclusions (90). The case of an obese police officer, 46-year-old Ike Mont-Ros, is instructive (82). Officer Mont-Ros was diagnosed with sleep apnea in 1993. His employer paid for his CPAP 416 Brown machine to alleviate his symptoms and, when Officer Mont-Ros’ knees became too brittle for regular police work, accommodated Mont-Ros’ request for light-duty, daytime dispatch duties. Armed with a physician’s opinion that Officer Mont-Ros was not qualified to perform police work due to his orthopedic problems, the police department fired Officer Mont-Ros on grounds that he was hired originally to perform police duties at police officer pay, not civilian dispatch duties compensated at lower rates. Mont-Ros sued the City of West Miami for intentional discrimination against him due to his sleep apnea disability. Using the applicable three-part tests, the court held that Officer Mont-Ros failed to provide sufficient evidence to support his contention that his sleep apnea constituted a disability under the ADA. While expert testimony showed that OSA is a severe, potentially life-threatening disease, Mont-Ros failed to show the severity of the disease in his specific case. Finally, the court noted that because OSA is treat- able and can be corrected with the use of CPAP at night, Officer Mont-Ros could not demonstrate that he is substantially limited in any major life activity. As Officer Mont-Ros’ own medical expert point out, “much like the use of glasses to correct ones vision, the use of the nasal CPAP machine at night will alleviate Plaintiff’s condition during sleeping hours and, thus, reduce the daytime drowsiness (91).” Thus, in the worker’s compensation context, OSA patients using CPAP earn no impairment ratings because “treated OSA has no permanent disability” (92). Employers’ Liability for Employee’s Negligence The application of traditional vicarious liability rules renders employers vicariously liable for the acts of their employees when performed in the scope of their employment (93). Thus, when Norman Munnal killed a woman when he fell asleep at the wheel of a tractor-trailer while driving for his trucking company employer, it was W.L. Logan Trucking Company that faced liability for its driver’s acts (94). The trucking company invoked Ohio’s version of the “sudden blackout” doctrine to defend Munnal’s conduct (95). The employer alleged that it was the driver’s “sudden unconsciousness” that caused the truck to move left of center, and that Munnal cannot be liable for losing control under these circumstances (95). As we have seen, the sudden blackout defense fails if defendant knew that consciousness loss was likely to occur or was otherwise foreseeable (95). Munnal testified that he had a propensity to fall asleep at unpredictable times and that he had fallen asleep at the wheel at least once before (96). A sleep test ordered after the accident revealed that he suffered from severe OSA (96). At trial, Munnal’s sleep disorders specialist opined that many sleep apnea patients engage in automatic behavior, such as driving, while unknowingly unconscious (97). The expert distin- guished automatic behavior from fainting following a sudden blackout, and opined that distance truck driving was not the right profession for someone with untreated sleep apnea (96). Even though Munnal testified that he had no knowledge of his sleep apnea before the accident (96), the court ruled that the employee driver was aware of his excessive fatigue and propensity to falling asleep at inopportune times (98). Because of this prior knowledge, the court held Munnal negligent for failing to operate the truck in a safe manner, and further found Munnal’s employer trucking company liable for the driver’s acts while in the scope of his employment (98). Under the rule in this case, employers’ risk management programs would likely benefit from an Legal Implications of Obstructive Sleep Apnea 417 employee OSA screening and therapy compliance program for employees working at safety-sensitive tasks such as driving. Employers are also exposed to allegations of direct liability if they negligently hire persons with OSA and entrust vehicles to them. To prevail on these direct liability allegations, the injured party must prove that the employee’s fatigue was due to the disease, was known to the employer, and proximately caused the accident leading to damages (99). Growing awareness of general sleep health and expressions of public policy against drowsy driving of the kind codified in New Jersey by Maggie’s law and New York’s Bell Regulations (limiting medical residents’ work hours) (100) sets the stage for actions against employers brought by unknown third parties injured by overworked, and likely fatigued, employees. The legal question in such circumstances is whether the employer owes a duty to control the off-duty conduct of its employee. Although the general rule is that employers owe no duty to third parties for the off-duty acts of their employees, (101) at least one court has re-fashioned tort principles to find an employer liable for accidents caused by employees presumably fatigued due to over-scheduling by their employer (102). The same result obtains on similar facts under workmen’s compensation law (103). Regulatory Screening for Obstructive Sleep Apnea in Safety-Sensitive Positions Because sleep apnea is a relatively common medical condition which, if untreated, contributes to daytime sleepiness and impaired job performance (2), public policy suggests that certain industries directly affecting public safety screen employees in safety-sensitive positions for sleep apnea or other fatigue-enhancing sleep disorders. Thus, each of the air, rail, ferry, distance trucking, and nuclear power industries have or propose regulatory fitness for duty programs addressing OSA. The National Transportation Safety Board (NTSB) has issued three investigation reports finding that the undiagnosed or untreated OSA of a train or ship operator contributed to the subject incident (104). The latest, in 2004, involved a 2001 collision of two trains arising from the crewmembers’ fatigue caused primarily by the engi- neer’s untreated and the conductor’s insufficiently treated OSA (105). The 2004 NTSB Report recommended that the Federal Railroad Administration (FRA) take remedial steps regarding employee fatigue (106), and the FRA issued its Safety Advisory 2004-04 on September 21, 2004 in response. The Advisory suggests that railroads adopt procedures to recognize sleep disorders, screen employees, and permit impaired persons to perform safety-sensitive tasks only after proper treatment (107). Federal regulations require that only physically fit persons are eligible to operate a commercial motor vehicle in interstate commerce (108). Persons are considered physically fit if they obtain medical certification from a physician certifying that the applicant does not have an established medical history or clinical diagnosis of, among other ailments, a respiratory dysfunction or other condition which is likely to cause loss of consciousness or any other loss of ability to control a commercial motor vehicle safely (109). The current Medical Examination Form, updated in 2000, makes specific inquiry whether the applicant suffers from “sleep disorders, pauses in breathing while asleep, daytime sleepiness, (or) loud snoring (110).” In 1991, the Federal Motor Carrier Safety Administration published advisory criteria to assist medical examiners determine a driver’s physical qualifications for 418 Brown commercial driving. The guidance regarding pulmonary/respiratory disorders identifies OSA as a condition which, if untreated, renders applicants unqualified to operate a commercial vehicle: Individuals with suspected or untreated sleep apnea (symptoms of snoring and hypersomnolence) should be considered medically unqualified to operate a commercial vehicle until the diagnosis has been dispelled or the condition has been treated success- fully. In addition, as a condition of continuing qualification, commercial drivers who are being treated for sleep apnea should agree to continue uninterrupted therapy as long as they maintain their commercial driver’s license. They should also undergo yearly multiple sleep latency testing (MSLT) (111). Guidance respecting seizures, epilepsy and interstate commercial driving reaches a similar conclusion as to chronic sleep apnea: Patients with sleep apnea syndrome having symptoms of excessive daytime somnolence cannot take part in interstate driving, because they likely will be involved in haz- ardous driving and accidents resulting from sleepiness. Even if these patients do not have the sleep attacks, they suffer from daytime fatigue and tiredness. These symptoms will be compounded by the natural fatigue and monotony associated with the long hours of driving, thus causing increased vulnerability to accidents. Therefore, those patients who are not on any treatment and are suffering from symptoms related to EDS should not be allowed to participate in interstate driving. Those patients with sleep apnea syndrome whose symptoms (e.g., EDS, fatigue, etc.) can be controlled by surgical treatment, for example, permanent tracheostomy, may be permitted to drive after three- month period free of symptoms, provided there is constant medical supervision. Laboratory studies (e.g., polysomnographic and MSLTs) must be performed to docu- ment absence of EDS and sleep apnea (112). As to pilots, the Federal Aviation Administration Guide for Aviation Medical Examiners provides that any degree of sleep apnea is disqualifying for medical certification for all classes of pilots (113). However, aviation medical examiners may reissue a pilot’s medical certificate without administrative appeal if the pilot presents a current report of a treating physician that the pilot’s OSA treatment therapy has eliminated symptoms of the disease along with specific comments regarding the pilot’s daytime sleepiness (114). In 1989, the Nuclear Regulatory Commission (NRC) adopted its first Fitness for Duty Program focusing on detection of drug and alcohol impairments on per- sonnel with access to protected areas of nuclear power reactors licensed by the NRC (115). Congressmen and others petitioned the NRC to expand the regulations to expand the program to include screening for sleep apnea and other disorders. The NRC published proposed rules to that effect in August 2005 (116). LAWS REGULATING DIAGNOSTIC TESTING AND TREATMENT OF OBSTRUCTIVE SLEEP APNEA State Certificate of Need and Licensure Laws The majority of states allocate healthcare resources within their borders through the Certificate of Need (CON) process. Most CON laws require healthcare facilities, such as hospitals, magnetic resonance imaging centers and other outpatient diagnostic centers, to apply for and receive a CON prior to obtaining a state license or otherwise operating. Penalties for operating a healthcare facility without a CON range from civil fines to criminal penalties. CON laws routinely exempt a variety of healthcare activities from the lengthy and expensive CON process. These exemptions include the individual or group [...]... Tri-County Electric Coop., 793 S.W.2d 348 (Mo 1990) (electric lineman worked 86 of 100 hour work period during snow emergency and fell asleep at the 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 Legal Implications of Obstructive Sleep Apnea 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 423 wheel); Van Devander v Heller Electric Co., 405 F.2d 1108 ... S.W.2d 726, 732 (Tenn 1998) Russell v Brown, No E200 4-0 1855-COA-R3-CV, 2005 WL 1991609 (Tenn.Ct.App.) (August 18, 2005) Russell v Brown, No E200 4-0 1855-COA-R3-CV, 2005 WL 1991609 *2 (Tenn.Ct.App.) (August 18, 2005) Russell v Brown, No E200 4-0 1855-COA-R3-CV, 2005 WL 1991609 *5 (Tenn.Ct.App.) (August 18, 2005) Russell v Brown, No E200 4-0 1855-COA-R3-CV, 2005 WL 1991609 *13 (Tenn.Ct.App.) (August 18, 2005)... action, 102 103 motivation, 113 MRI, 79 nasal congestion, 108 109 vs oral appliances, 222–223 OSA, 101 , 152–153 upper airway imaging, 77 vs other treatments, 110 111 pediatric SDB, 272–275 practical aspects, 103 104 preeclampsia, 115–116 pressure level and airflow, 109 – 110 side effects, 108 109 split-night study, 107 UARS, 153, 314 COPD See Chronic obstructive pulmonary disease Coronary artery disease... costs, and fatalities by treating obstructive sleep apnea Sleep 2004; 27(d):453, 458 Kryger MH, Roth T, Dement WC, eds Principles and Practice of Sleep Medicine Philadelphia, PA: W.B Sanders, 1994 Shahar E, Whitney CW, Redline S, et al Sleep- disordered breathing and cardiovascular disease: cross-sectional results of the Sleep Heart Health Study Am J Respir Crit Care Med 2001; 163:19–25 Campos-Rodriguez... titration protocol, 228 TMJ discomfort, 226 treatment outcome prediction, 223–224 types, 217–218 UARS, 314–315 upper airway imaging, 77–79 Orlistat (Xenical), 236 Orthostatic hypotension UARS, 313 OSA See Obstructive sleep apnea OSAH See Obstructive sleep apneahypopnea OSAHS See Obstructive sleep apneahypopnea syndrome OSLER See Osler sleep resistance (OSLER) test Osler sleep resistance (OSLER) test, 97 Osteogenic... techniques, 157 regulatory screening in safety-sensitive positions, 417 Observation scales manifest sleepiness, 96–97 Obstructive sleep apnea (OSA) See also Geriatric obstructive sleep apnea; Pediatric obstructive sleep apnea adjunctive and alternative therapies, 233–246, 241 alcohol, 8–9 allergies, 9 behavioral therapies, 233–234, 241 blood pressure, 10 body habitus, 250 bronchial asthma, 341–345... central apnea, 103 Cheyne-Stokes respiration, 153–154 CHF, 400 cost and reimbursement, 116–117 CSA, 153–154 decompensated patients with cardiorespiratory failure, 106 107 ESRD, 397 failure, 114 first night, 104 106 geriatric SDB, 288 health outcomes, 114–115 home setting, 107 108 indications, 152–155 interface, 109 left-to-right cardiac shunt (LRS), 115–116 mode of action, 102 103 motivation, 113 MRI,... 21–34 SDB See Sleep- disordered breathing Secobarbital (Seconal), 301 Seconal, 301 Secondary sleep apnea, 237 Sedative hypnotics, 233–234, 301 Selective serotonin reuptake inhibitors (SSRI), 239, 296, 298–299 Self-referral laws, 419 Serotonin sleep apnea, 239 Serzone, 299 Severe obesity bilevel pressure and adaptive servo-ventilation, 127–128 439 Short Form-36 (SF-36), 222 Short-term potentiation (STP),... 440 [Sleep- disordered breathing (SDB) surgery] Powell-Riley protocol, 195–196 preoperative evaluation, 192–193 preparation, 197 procedures, 197–205 rationale, 192 Sleep Heart Health Study, 8, 25, 282, 283, 284, 299, 337 Sleep hygiene, 3 Sleep- onset REM period (SOREMP), 355 Sleep- related breathing disorder (SRBD), 305 Alzheimer’s disease, 370–371 Sleep- related eating disorder (SRED), 359–360 Sleep- related... better diagnostic and treatment options for sleep apnea sufferers There have been strong efforts in the public awareness and advocacy sectors, notably the National Commission on Sleep Disorders Research which issued its final report “Wake Up America: A National Sleep Alert” in 1993 after its two-year study, and more recently, the Institute of Medicine’s report, Sleep Disorders and Sleep Deprivation: . employees in safety-sensitive positions for sleep apnea or other fatigue-enhancing sleep disorders. Thus, each of the air, rail, ferry, distance trucking, and nuclear power industries have or. (Tenn. 1998). 50. Russell v. Brown, No. E200 4-0 1855-COA-R3-CV, 2005 WL 1991609 (Tenn.Ct.App.) (August 18, 2005). 51. Russell v. Brown, No. E200 4-0 1855-COA-R3-CV, 2005 WL 1991609 *2 (Tenn.Ct.App.). 2005). 52. Russell v. Brown, No. E200 4-0 1855-COA-R3-CV, 2005 WL 1991609 *5 (Tenn.Ct.App.) (August 18, 2005). 53. Russell v. Brown, No. E200 4-0 1855-COA-R3-CV, 2005 WL 1991609 *13 (Tenn.Ct.App.)

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