- Email: [email protected]
Use It or Lose It
CHEST
Commentary
Use It or Lose It Medicare’s New Paradigm for Durable Medical Equipment Coverage? Lee K. Brown, MD, FCCP
The 2008 National Coverage Determination by the US Centers for Medicare and Medicaid Services (CMS) authorizing coverage of positive airway pressure (PAP) treatment of obstructive sleep apnea on the basis of diagnosis by portable monitoring was seen by some as a major advance in reimbursement policy for sleep medicine services. However, along with the national coverage decision came additional rules (local coverage determinations) setting forth the conditions that would apply in order for reimbursement to continue beyond 90 days. These rules specified the means by which adherence must be measured, a rigid threshold for the acceptable degree of adherence, and a requirement for face-to-face evaluation by the clinician to document clinical response, all of which must take place within a specific timeframe. Whether CMS or the local carriers anticipated the difficulties that would be experienced by clinicians, durable medical equipment (DME) companies, and patients in complying with these rules is unknown. What has become abundantly clear to many is the burden that these rules impose on clinicians and DME providers and, more importantly, that indiscriminate enforcement may well result in adverse consequences for some patients. The latter include not only the inconvenience and added expense for patients of complying with the rules, but those resulting from failure by CMS to recognize that a doseresponse relationship exists with respect to the degree of PAP adherence and clinical outcome. Moreover, there is reason to believe that patients of low socioeconomic class, or who are unmarried, or who have psychiatric disease will have more difficulty achieving the required adherence and therefore will, in effect, be victims of government-mandated discrimination in the provision of a vital healthcare service. CHEST 2010; 138(4):785–789 Abbreviations: CMS 5 Centers for Medicare and Medicaid Services; CPAP 5 continuous positive airway pressure; DME 5 durable medical equipment; ESS 5 Epworth Sleepiness Scale; LCD 5 local coverage determination; MAC 5 Medicare Administrative Contractor; NCD 5 national coverage determination; OSA 5 obstructive sleep apnea; PAP 5 positive airway pressure; PM 5 portable monitoring; RCT 5 randomized controlled trial; SE 5 standard error
If you want a golden rule that will fit everything, this is it: Have nothing in your houses that you do not know to be useful or believe to be beautiful. –William Morris (1834-1896) Manuscript received May 5, 2010; revision accepted May 6, 2010. Affiliations: From the Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, University of New Mexico School of Medicine; and the Program in Sleep Medicine, University of New Mexico Health Sciences Center. Correspondence to: Lee K. Brown MD, FCCP, Department of Internal Medicine, University of New Mexico School of Medicine, 1101 Medical Arts Ave NE, Bldg #2, Albuquerque, NM 87102; e-mail: [email protected] © 2010 American College of Chest Physicians. Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/ site/misc/reprints.xhtml). DOI: 10.1378/chest.10-1168 www.chestpubs.org
A
19th-century English designer, writer, and socialist, William Morris is credited with originating the idea that is often abbreviated as “use it or lose it.” Were he still with us, he might have been surprised to learn that the US Centers for Medicare and Medicaid Services (CMS) seemingly adopted his advice with respect to reimbursement for positive airway pressure (PAP) therapy. In March of 2008, responding to a petition that CMS accept the results of limited sleep testing by portable monitoring (PM) as evidence justifying PAP treatment of obstructive sleep apnea (OSA), CMS announced a revised national coverage determination (NCD).1 However, in addition to endorsing PM, CMS slipped a Trojan horse into the NCD: limiting coverage for PAP to an initial 12-week CHEST / 138 / 4 / OCTOBER, 2010
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period, following which it would be necessary to document that the patient was benefiting from this therapy in order for reimbursement to continue. Moreover, when the various Medicare Administrative Contractors (MACs) issued local coverage determinations (LCDs), they uniformly interpreted “benefiting from therapy” as requiring evidence of adherence as well as clinical improvement. The LCDs are quite specific and virtually the same word-for-word, requiring a visit to the treating physician between the 31st and 91st day after starting PAP, and objective evidence of adherence with PAP treatment: usage of ⱖ 4 h per night on 70% of nights during a consecutive 30-day period.2 If there is a lesser degree of adherence, or failure to document both this and symptomatic improvement, the MAC will deny coverage of PAP as not medically necessary. These policies became effective beginning in 2008, and a number of operational problems quickly became apparent. The LCDs essentially mandate that PAP devices supplied to Medicare beneficiaries be equipped with compliance cards, because hours-of-use meters may not satisfy the “30 consecutive days” rule in cases in which patient adherence varies widely throughout the 90 days. Although virtually all modern PAP generators have this ability, our experience has been that suppliers of PAP devices do not always remember to insert the memory card, the memory function does not always work if the card is defective or improperly installed, and other types of device failure can prevent the collection and display of valid data. For instance, in one brand of PAP device, a pressure sensor critical to adherence monitoring sometimes fails because of contamination from condensation water, and the device will report no time at pressure. Barnes et al3 found that adherence measurement malfunctioned in 5/28 (18%) of the CPAP generators used by patients in their randomized controlled trial (RCT) of treatment of mild OSA, and Weaver et al4 reported adherence data loss in 17/166 (10%) of subjects. Furthermore, someone must download the adherence data during the specified range of days, and those data must be made available to the treating physician on a timely basis. Our experience in New Mexico has been that durable medical equipment suppliers are reluctant to take on this burden themselves, despite the seemingly strong incentive to do so in order to continue to receive reimbursement. Our center had routinely performed this service for our patients previous to the LCD, and we continue to do so. However, the timing requirements sometimes make this an onerous task for patients who travel from distant parts of our very rural state for care. Whenever all of these factors do not align perfectly, the Medicare patient with OSA is faced with the choice of paying for PAP on their own or risking the health consequences of going
untreated. This rather stark choice aside, the CMS “use it or lose it” policy also raises significant issues, both medical and ethical, that must be addressed. In this issue of CHEST (see page 875), Aloia et al5 report on retrospective data from 150 patients with OSA who began treatment with continuous PAP (CPAP). Patients underwent a battery of neuropsychological tests and completed the Epworth Sleepiness Scale (ESS) prior to initiating CPAP and again at 3 and 6 months following the start of treatment. These results were correlated with downloaded adherence data (time at pressure) obtained in standard fashion. Based on the LCD criteria for PAP use, patients were separated into an adherent group (average use about 5.5 h/night at both 3 and 6 months) and a nonadherent group (averaging about 2 h/night at 3 and 6 months). Fifty-five patients (37%) were poor adherers, but achieved similar improvements in neuropsychological tests compared with the good adherers. The authors concluded that patients with adherence levels below the LCD criteria still appear to benefit from treatment, but would risk losing their benefits under the new reimbursement rules. This article is the first, to my knowledge, to call attention to the possible effects of the adherence requirements of the LCDs on patient outcome, although many previous reports have demonstrated that lesser degrees of PAP use than required by the LCDs can lead to significant improvement in important outcome variables. Following the provocative systematic review by Wright et al6 criticizing the body of evidence then available with respect to outcomes from PAP treatment of OSA, a veritable avalanche of data has become available. Although many report mean adherence values that largely conform to LCD criteria, some describe considerably lower mean adherence but still report positive outcomes. Other studies specifically correlate levels of adherence with outcome and still demonstrate benefit from usage less than the LCDs require. In the former group are early studies such as those by Engleman et al7-9: RCTs in which adherence was only 3.7 6 0.4 and 2.8 6 0.7 h/night (mean 6 standard error [SE])7,8 and 2.8 6 2.1 h/night (mean 6 SD)9 but nevertheless demonstrate significant improvements in sleepiness,7,9 symptom score,7-9 cognitive performance,7-9 mood,7-9 and health/functional status.9 It is particularly interesting that two of these studies were restricted to patients with overall mild OSA.8,9 Although all of these studies involved fairly small numbers of subjects, a larger RCT by Redline et al10 is available comparing CPAP to conservative therapy in 111 subjects with mild OSA. There were improvements in mood, health/functional status, energy/fatigue, and sleepiness (ESS) despite using CPAP on only 44% 6 34% (mean 6 SD) of nights, averaging 3.1 h/night. There are also studies using
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“harder” outcome variables, such as BP and mortality, although not all are RCTs. For instance, Faccenda et al11 compared CPAP to a tablet placebo in 68 patients with OSA (mean apnea-hypopnea index, 35; range, 15-129) with 24-h recording of BP as the outcome variable. After 4 weeks, despite mean CPAP adherence of only 3.3 h/night (range, 0-8.1 h/night), diastolic BP decreased by 1.5 mm Hg (95% CI, 0.1-3.0). In a retrospective review of 85 consecutive patients diagnosed with OSA, Malik et al12 found a significant decrease in BP after 4 to 6 weeks of CPAP treatment among the subgroup of patients who initially presented with hypertension, with no difference in response between those using CPAP , 4 h/night and those with greater adherence. Furthermore, as in many therapeutic modalities there exists a dose-response relationship that reinforces the concept that some adherence is better than no treatment at all. CamposRodriguez at al13 examined 5 years of retrospective data relating CPAP adherence and mortality, and found significant differences in cumulative survival between nonusers (, 1 h/night), moderate adherers (1-6 h/night), and high adherers (. 6 h/night). The same investigator found a correlation between diastolic BP response to CPAP and hours of use in a long-term (2-year) prospective trial.14 Weaver et al,4 in a multicenter study aimed at uncovering doseresponse relationships to CPAP use, analyzed data on patients with severe OSA who exhibited an average adherence of 4.7 6 2.1 h/night (mean 6 SD) (range, 0-8.1 h/night). Subjects were divided into groups with ⱕ 2, 2 through 7 in 1-h increments, and ⱖ 7 h of use per night. Graded dose-response relationships were demonstrated in the proportion of subjects whose ESS, mean latency (from multiple sleep latency testing), and functional outcomes of sleep questionnaire score normalized after initially presenting with abnormal values. Furthermore, optimal thresholds of CPAP use differed depending on the outcome variable being examined. Similar dose-response relationships were demonstrated in an earlier prospective study by Kingshott et al.15 These findings support the contention that patients derive benefit from levels of PAP adherence significantly below the hurdle imposed by the Medicare LCDs. In addition to the science, however, there are ethical considerations at play. Patient compliance with prescribed treatments has long been a thorny issue in the delivery of health care, and a robust literature has accumulated primarily concerning oral medication use.16 Nonadherence results in enormous losses (estimated at about $100 billion each year) due to poor outcomes.16,17 A number of characteristics have been identified that seem to correlate with nonadherence to PAP, and not surprisingly, one of these may be failure to comply with medication regimens www.chestpubs.org
for other chronic diseases. One retrospective study in the United States has supported this contention,18 although a large prospective study in Spain failed to find such a relationship.19 Other reported associations with nonadherence to PAP include age, sex, race, socioeconomic status, marital status, psychiatric comorbidity such as claustrophobia, and personality type (negative affectivity and social inhibition).20-25 Some uncertainty remains with respect to a few of these attributes, with conflicting data in the literature particularly relating to age, sex, and race.24-26 Several years ago, DiMatteo27 reviewed the extensive literature concerning adherence to medical recommendations in general and found consistent support for the contention that educational level and socioeconomic status drive adherence. She also found that age correlated with adherence when assessed by objective measures, in that younger adults complied less frequently with treatment than older individuals. Although her review did not address race or ethnicity as a factor, later reports have appeared addressing this and strongly support a disproportionate reduction in adherence in African Americans being treated for hypertension, congestive heart failure, diabetes, and for medication use in general.28-33 It is therefore highly likely that adherence disparities in PAP use do exist with respect to race/ethnicity and age, but proof will require studies with greater power than have heretofore been published. Even given our present state of knowledge, it is clear that certain categories of patients (low socioeconomic status, unmarried, those with psychiatric comorbidity) will more frequently have difficulty attaining adherence to PAP therapy. The LCDs arguably discriminate against these individuals by raising additional hurdles for them to jump in order to receive reimbursement for their treatment. There is also an extensive literature demonstrating that certain interventions can be brought to bear that will improve adherence to PAP. These include cognitive behavioral therapy, home visits, telephone calls, group education, multiple follow-up visits, and changes in PAP generator characteristics.34-38 Some of these interventions may not achieve success until . 90 days after PAP initiation.37,38 The LCDs make little provision for the time it can take to implement these methods, and actually mandate additional polysomnographic testing of uncertain efficacy to gain approval for another period of reimbursement.2 One last argument should be mentioned, concerning the singularity with which noninvasive PAP devices have been subjected to adherence requirements. For consistency, I navigated to the internet site39 listing every active LCD by the same MAC that promulgated the PAP LCD referenced above.2 The 54 LCDs cover services or devices ranging (alphabetically) from Ankle-Foot/Knee-Ankle-Foot Orthosis CHEST / 138 / 4 / OCTOBER, 2010
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to Wheelchair Seating, all updated within the last 2 years. Only “Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea” and “Respiratory Assist Devices” (eg, bilevel PAP) are subject to detailed adherence requirements. A few LCDs mandate physician assessment at intervals, but only one (“Transcutaneous Electrical Nerve Stimulators”) requires the reporting of device usage (but only an estimate) despite the fact that this pricey electronic apparatus could be equipped to collect objective data. A substantial number of LCDs apply to costly devices that could be equipped for objective measurement of usage, including oxygen concentrators, mechanical in-exsufflation devices, power wheelchairs, and pneumatic compression apparatus; however, only PAP and respiratory assist devices are singled out in this manner by CMS. The reasoning behind this situation is not certain. Sleep medicine specialists have long been obsessed with the issue of patient adherence to PAP therapy, hence, the development of sophisticated usage monitoring and thus the temptation for CMS to use this capability. A desire for cost savings almost certainly drove the decision, but many other treatment devices are equally expensive or even more so but have no adherence criteria. In the past, our field has suffered the calumny that OSA is not a legitimate disorder and that treatment is superfluous,6 but I trust that this discredited contention did not play a role in the CMS decision. Finally, it is possible that the unremitting pressure of budgetary woes to which Medicare is subject has led CMS to begin examining therapeutic adherence as part of a strategy to limit reimbursement. If so, then our profession is in for a deluge of paperwork that will dwarf that which we experience today, and our society must come to grips with the inequities that will inevitably follow. Acknowledgments Financial/nonfinancial disclosures: The author has reported to CHEST the following conflicts of interest: Within the last 3 years, Dr Brown served on the boards of directors of the American Academy of Sleep Medicine, Associated Professional Sleep Societies LLC, American Board of Sleep Medicine, and American Sleep Medicine Foundation, and served on the Health Policy Committee of the American Thoracic Society. He chairs the Polysomnography Practice Advisory Committee of the New Mexico Medical Board and serves on the New Mexico Respiratory Care Advisory Board. He currently receives no grant or commercial funding pertinent to the subject of this article.
References 1. Centers for Medicare and Medicaid Services. Medicare National Coverage Determinations Manual. Chapter 1, part 4 (Sections 200-310.1) Coverage Determinations. https://www4. cms.hhs.gov/manuals/downloads/ncd103c1_Part4.pdf. Accessed April 29, 2010.
2. CIGNA Government Services. LCD for positive airway pressure (PAP) devices for the treatment of obstructive sleep apnea (L11518). http://www.cms.gov/mcd/viewlcd.asp?lcd_ id511518&lcd_version552&show5all. Accessed April 30, 2010. 3. Barnes M, Houston D, Worsnop CJ, et al. A randomized controlled trial of continuous positive airway pressure in mild obstructive sleep apnea. Am J Respir Crit Care Med. 2002;165(6):773-780. 4. Weaver TE, Maislin G, Dinges DF, et al. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep. 2007;30(6):711-719. 5. Aloia MS, Knoepke CE, Lee-Chiong T. The new local coverage determination criteria for adherence to positive airway pressure treatment: testing the limits? Chest. 2010; 138(4):875-879. 6. Wright J, Johns R, Watt I, Melville A, Sheldon T. Health effects of obstructive sleep apnoea and the effectiveness of continuous positive airways pressure: a systematic review of the research evidence. BMJ. 1997;314(7084):851-860. 7. Engleman HM, Martin SE, Deary IJ, Douglas NJ. Effect of continuous positive airway pressure treatment on daytime function in sleep apnoea/hypopnoea syndrome. Lancet. 1994;343(8897):572-575. 8. Engleman HM, Martin SE, Deary IJ, Douglas NJ. Effect of CPAP therapy on daytime function in patients with mild sleep apnoea/hypopnoea syndrome. Thorax. 1997;52(2):114-119. 9. Engleman HM, Kingshott RN, Wraith PK, Mackay TW, Deary IJ, Douglas NJ. Randomized placebo-controlled crossover trial of continuous positive airway pressure for mild sleep apnea/hypopnea syndrome. Am J Respir Crit Care Med. 1999;159(2):461-467. 10. Redline S, Adams N, Strauss ME, Roebuck T, Winters M, Rosenberg C. Improvement of mild sleep-disordered breathing with CPAP compared with conservative therapy. Am J Respir Crit Care Med. 1998;157(3 Pt 1):858-865. 11. Faccenda JF, Mackay TW, Boon NA, Douglas NJ. Randomized placebo-controlled trial of continuous positive airway pressure on blood pressure in the sleep apnea-hypopnea syndrome. Am J Respir Crit Care Med. 2001;163(2):344-348. 12. Malik J, Drake CL, Hudgel DW. Variables affecting the change in systemic blood pressure in response to nasal CPAP in obstructive sleep apnea patients. Sleep Breath. 2008;12(1): 47-52. 13. Campos-Rodriguez F, Peña-Griñan N, Reyes-Nuñez N, et al. Mortality in obstructive sleep apnea-hypopnea patients treated with positive airway pressure. Chest. 2005;128(2): 624-633. 14. Campos-Rodriguez F, Perez-Ronchel J, Grilo-Reina A, LimaAlvarez J, Benitez MA, Almeida-Gonzalez C. Long-term effect of continuous positive airway pressure on BP in patients with hypertension and sleep apnea. Chest. 2007;132(6):1847-1852. 15. Kingshott RN, Vennelle M, Hoy CJ, Engleman HM, Deary IJ, Douglas NJ. Predictors of improvements in daytime function outcomes with CPAP therapy. Am J Respir Crit Care Med. 2000;161(3 pt 1):866-871. 16. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353(5):487-497. 17. Cutler DM, Everett W. Thinking outside the pillbox— medication adherence as a priority for health care reform. N Engl J Med. 2010;362(17):1553-1555. 18. Platt AB, Kuna ST, Field SH, et al. Adherence to sleep apnea therapy and use of lipid-lowering drugs: a study of the healthy-user effect. Chest. 2010;137(1):102-108. 19. Villar I, Izuel M, Carrizo S, Vicente E, Marin JM. Medication adherence and persistence in severe obstructive sleep apnea. Sleep. 2009;32(5):623-628.
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20. Joo MJ, Herdegen JJ. Sleep apnea in an urban public hospital: assessment of severity and treatment adherence. J Clin Sleep Med. 2007;3(3):285-288. 21. Platt AB, Field SH, Asch DA, et al. Neighborhood of residence is associated with daily adherence to CPAP therapy. Sleep. 2009;32(6):799-806. 22. Simon-Tuval T, Reuveni H, Greenberg-Dotan S, Oksenberg A, Tal A, Tarasiuk A. Low socioeconomic status is a risk factor for CPAP acceptance among adult OSAS patients requiring treatment. Sleep. 2009;32(4):545-552. 23. Broström A, Strömberg A, Mårtensson J, Ulander M, Harder L, Svanborg E. Association of Type D personality to perceived side effects and adherence in CPAP-treated patients with OSAS. J Sleep Res. 2007;16(4):439-447. 24. Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008;5(2):173-178. 25. Weaver TE, Sawyer AM. Adherence to continuous positive airway pressure treatment for obstructive sleep apnoea: implications for future interventions. Indian J Med Res. 2010;131:245-258. 26. Scharf SM, Seiden L, DeMore J, Carter-Pokras O. Racial differences in clinical presentation of patients with sleepdisordered breathing. Sleep Breath. 2004;9(1):4-6. 27. DiMatteo MR. Variations in patients’ adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004;42(3):200-209. 28. Ndumele CD, Shaykevich S, Williams D, Hicks LS. Disparities in adherence to hypertensive care in urban ambulatory settings. J Health Care Poor Underserved. 2010;21(1):132-143. 29. Shaya FT, Du D, Gbarayor CM, Frech-Tamas F, Lau H, Weir MR. Predictors of compliance with antihypertensive therapy in a high-risk medicaid population. J Natl Med Assoc. 2009;101(1):34-39. 30. Bosworth HB, Dudley T, Olsen MK et al. Racial differences in blood pressure control: potential explanatory factors. Am J Med. 2006;119(1):70.e9-15.
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31. Wu J-R, Moser DK, Chung ML, Lennie TA. Predictors of medication adherence using a multidimensional adherence model in patients with heart failure. J Card Fail. 2008;14(7):603-614. 32. Yang Y, Thumula V, Pace PF, Banahan BF III, Wilkin NE, Lobb WB. Predictors of medication nonadherence among patients with diabetes in Medicare Part D programs: a retrospective cohort study. Clin Ther. 2009;31(10):2178-2188., discussion 2150-2151. 33. Gerber BS, Cho YI, Arozullah AM, Lee SY. Racial differences in medication adherence: A cross-sectional study of medicare enrollees. Am J Geriatr Pharmacother. 2010;8(2): 136-145. 34. Likar LL, Panciera TM, Erickson AD, Rounds S. Group education sessions and compliance with nasal CPAP therapy. Chest. 1997;111(5):1273-1277. 35. Hoy CJ, Vennelle M, Kingshott RN, Engleman HM, Douglas NJ. Can intensive support improve continuous positive airway pressure use in patients with the sleep apnea/hypopnea syndrome? Am J Respir Crit Care Med. 1999;159(4 Pt 1): 1096-1100. 36. Richards D, Bartlett DJ, Wong K, Malouff J, Grunstein RR. Increased adherence to CPAP with a group cognitive behavioral treatment intervention: a randomized trial. Sleep. 2007;30(5):635-640. 37. Sin DD, Mayers I, Man GCW, Pawluk L. Long-term compliance rates to continuous positive airway pressure in obstructive sleep apnea: a population-based study. Chest. 2002;121(2): 430-435. 38. Ballard RD, Gay PC, Strollo PJ. Interventions to improve compliance in sleep apnea patients previously non-compliant with continuous positive airway pressure. J Clin Sleep Med. 2007;3(7):706-712. 39. Centers for Medicare and Medicaid Services. List of LCDs. http://www.cms.gov/mcd/results_index.asp?from5%27lmrp contractor%27&contractor5140&name5CIGNA1Govern ment1Services1%2818003%2C1DME1MAC%29&letter_ range54. Accessed May 3, 2010.
CHEST / 138 / 4 / OCTOBER, 2010
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Commentary
Use It or Lose It Medicare’s New Paradigm for Durable Medical Equipment Coverage? Lee K. Brown, MD, FCCP
The 2008 National Coverage Determination by the US Centers for Medicare and Medicaid Services (CMS) authorizing coverage of positive airway pressure (PAP) treatment of obstructive sleep apnea on the basis of diagnosis by portable monitoring was seen by some as a major advance in reimbursement policy for sleep medicine services. However, along with the national coverage decision came additional rules (local coverage determinations) setting forth the conditions that would apply in order for reimbursement to continue beyond 90 days. These rules specified the means by which adherence must be measured, a rigid threshold for the acceptable degree of adherence, and a requirement for face-to-face evaluation by the clinician to document clinical response, all of which must take place within a specific timeframe. Whether CMS or the local carriers anticipated the difficulties that would be experienced by clinicians, durable medical equipment (DME) companies, and patients in complying with these rules is unknown. What has become abundantly clear to many is the burden that these rules impose on clinicians and DME providers and, more importantly, that indiscriminate enforcement may well result in adverse consequences for some patients. The latter include not only the inconvenience and added expense for patients of complying with the rules, but those resulting from failure by CMS to recognize that a doseresponse relationship exists with respect to the degree of PAP adherence and clinical outcome. Moreover, there is reason to believe that patients of low socioeconomic class, or who are unmarried, or who have psychiatric disease will have more difficulty achieving the required adherence and therefore will, in effect, be victims of government-mandated discrimination in the provision of a vital healthcare service. CHEST 2010; 138(4):785–789 Abbreviations: CMS 5 Centers for Medicare and Medicaid Services; CPAP 5 continuous positive airway pressure; DME 5 durable medical equipment; ESS 5 Epworth Sleepiness Scale; LCD 5 local coverage determination; MAC 5 Medicare Administrative Contractor; NCD 5 national coverage determination; OSA 5 obstructive sleep apnea; PAP 5 positive airway pressure; PM 5 portable monitoring; RCT 5 randomized controlled trial; SE 5 standard error
If you want a golden rule that will fit everything, this is it: Have nothing in your houses that you do not know to be useful or believe to be beautiful. –William Morris (1834-1896) Manuscript received May 5, 2010; revision accepted May 6, 2010. Affiliations: From the Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, University of New Mexico School of Medicine; and the Program in Sleep Medicine, University of New Mexico Health Sciences Center. Correspondence to: Lee K. Brown MD, FCCP, Department of Internal Medicine, University of New Mexico School of Medicine, 1101 Medical Arts Ave NE, Bldg #2, Albuquerque, NM 87102; e-mail: [email protected] © 2010 American College of Chest Physicians. Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/ site/misc/reprints.xhtml). DOI: 10.1378/chest.10-1168 www.chestpubs.org
A
19th-century English designer, writer, and socialist, William Morris is credited with originating the idea that is often abbreviated as “use it or lose it.” Were he still with us, he might have been surprised to learn that the US Centers for Medicare and Medicaid Services (CMS) seemingly adopted his advice with respect to reimbursement for positive airway pressure (PAP) therapy. In March of 2008, responding to a petition that CMS accept the results of limited sleep testing by portable monitoring (PM) as evidence justifying PAP treatment of obstructive sleep apnea (OSA), CMS announced a revised national coverage determination (NCD).1 However, in addition to endorsing PM, CMS slipped a Trojan horse into the NCD: limiting coverage for PAP to an initial 12-week CHEST / 138 / 4 / OCTOBER, 2010
Downloaded from chestjournal.chestpubs.org by Kimberly Henricks on October 7, 2010 © 2010 American College of Chest Physicians
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period, following which it would be necessary to document that the patient was benefiting from this therapy in order for reimbursement to continue. Moreover, when the various Medicare Administrative Contractors (MACs) issued local coverage determinations (LCDs), they uniformly interpreted “benefiting from therapy” as requiring evidence of adherence as well as clinical improvement. The LCDs are quite specific and virtually the same word-for-word, requiring a visit to the treating physician between the 31st and 91st day after starting PAP, and objective evidence of adherence with PAP treatment: usage of ⱖ 4 h per night on 70% of nights during a consecutive 30-day period.2 If there is a lesser degree of adherence, or failure to document both this and symptomatic improvement, the MAC will deny coverage of PAP as not medically necessary. These policies became effective beginning in 2008, and a number of operational problems quickly became apparent. The LCDs essentially mandate that PAP devices supplied to Medicare beneficiaries be equipped with compliance cards, because hours-of-use meters may not satisfy the “30 consecutive days” rule in cases in which patient adherence varies widely throughout the 90 days. Although virtually all modern PAP generators have this ability, our experience has been that suppliers of PAP devices do not always remember to insert the memory card, the memory function does not always work if the card is defective or improperly installed, and other types of device failure can prevent the collection and display of valid data. For instance, in one brand of PAP device, a pressure sensor critical to adherence monitoring sometimes fails because of contamination from condensation water, and the device will report no time at pressure. Barnes et al3 found that adherence measurement malfunctioned in 5/28 (18%) of the CPAP generators used by patients in their randomized controlled trial (RCT) of treatment of mild OSA, and Weaver et al4 reported adherence data loss in 17/166 (10%) of subjects. Furthermore, someone must download the adherence data during the specified range of days, and those data must be made available to the treating physician on a timely basis. Our experience in New Mexico has been that durable medical equipment suppliers are reluctant to take on this burden themselves, despite the seemingly strong incentive to do so in order to continue to receive reimbursement. Our center had routinely performed this service for our patients previous to the LCD, and we continue to do so. However, the timing requirements sometimes make this an onerous task for patients who travel from distant parts of our very rural state for care. Whenever all of these factors do not align perfectly, the Medicare patient with OSA is faced with the choice of paying for PAP on their own or risking the health consequences of going
untreated. This rather stark choice aside, the CMS “use it or lose it” policy also raises significant issues, both medical and ethical, that must be addressed. In this issue of CHEST (see page 875), Aloia et al5 report on retrospective data from 150 patients with OSA who began treatment with continuous PAP (CPAP). Patients underwent a battery of neuropsychological tests and completed the Epworth Sleepiness Scale (ESS) prior to initiating CPAP and again at 3 and 6 months following the start of treatment. These results were correlated with downloaded adherence data (time at pressure) obtained in standard fashion. Based on the LCD criteria for PAP use, patients were separated into an adherent group (average use about 5.5 h/night at both 3 and 6 months) and a nonadherent group (averaging about 2 h/night at 3 and 6 months). Fifty-five patients (37%) were poor adherers, but achieved similar improvements in neuropsychological tests compared with the good adherers. The authors concluded that patients with adherence levels below the LCD criteria still appear to benefit from treatment, but would risk losing their benefits under the new reimbursement rules. This article is the first, to my knowledge, to call attention to the possible effects of the adherence requirements of the LCDs on patient outcome, although many previous reports have demonstrated that lesser degrees of PAP use than required by the LCDs can lead to significant improvement in important outcome variables. Following the provocative systematic review by Wright et al6 criticizing the body of evidence then available with respect to outcomes from PAP treatment of OSA, a veritable avalanche of data has become available. Although many report mean adherence values that largely conform to LCD criteria, some describe considerably lower mean adherence but still report positive outcomes. Other studies specifically correlate levels of adherence with outcome and still demonstrate benefit from usage less than the LCDs require. In the former group are early studies such as those by Engleman et al7-9: RCTs in which adherence was only 3.7 6 0.4 and 2.8 6 0.7 h/night (mean 6 standard error [SE])7,8 and 2.8 6 2.1 h/night (mean 6 SD)9 but nevertheless demonstrate significant improvements in sleepiness,7,9 symptom score,7-9 cognitive performance,7-9 mood,7-9 and health/functional status.9 It is particularly interesting that two of these studies were restricted to patients with overall mild OSA.8,9 Although all of these studies involved fairly small numbers of subjects, a larger RCT by Redline et al10 is available comparing CPAP to conservative therapy in 111 subjects with mild OSA. There were improvements in mood, health/functional status, energy/fatigue, and sleepiness (ESS) despite using CPAP on only 44% 6 34% (mean 6 SD) of nights, averaging 3.1 h/night. There are also studies using
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“harder” outcome variables, such as BP and mortality, although not all are RCTs. For instance, Faccenda et al11 compared CPAP to a tablet placebo in 68 patients with OSA (mean apnea-hypopnea index, 35; range, 15-129) with 24-h recording of BP as the outcome variable. After 4 weeks, despite mean CPAP adherence of only 3.3 h/night (range, 0-8.1 h/night), diastolic BP decreased by 1.5 mm Hg (95% CI, 0.1-3.0). In a retrospective review of 85 consecutive patients diagnosed with OSA, Malik et al12 found a significant decrease in BP after 4 to 6 weeks of CPAP treatment among the subgroup of patients who initially presented with hypertension, with no difference in response between those using CPAP , 4 h/night and those with greater adherence. Furthermore, as in many therapeutic modalities there exists a dose-response relationship that reinforces the concept that some adherence is better than no treatment at all. CamposRodriguez at al13 examined 5 years of retrospective data relating CPAP adherence and mortality, and found significant differences in cumulative survival between nonusers (, 1 h/night), moderate adherers (1-6 h/night), and high adherers (. 6 h/night). The same investigator found a correlation between diastolic BP response to CPAP and hours of use in a long-term (2-year) prospective trial.14 Weaver et al,4 in a multicenter study aimed at uncovering doseresponse relationships to CPAP use, analyzed data on patients with severe OSA who exhibited an average adherence of 4.7 6 2.1 h/night (mean 6 SD) (range, 0-8.1 h/night). Subjects were divided into groups with ⱕ 2, 2 through 7 in 1-h increments, and ⱖ 7 h of use per night. Graded dose-response relationships were demonstrated in the proportion of subjects whose ESS, mean latency (from multiple sleep latency testing), and functional outcomes of sleep questionnaire score normalized after initially presenting with abnormal values. Furthermore, optimal thresholds of CPAP use differed depending on the outcome variable being examined. Similar dose-response relationships were demonstrated in an earlier prospective study by Kingshott et al.15 These findings support the contention that patients derive benefit from levels of PAP adherence significantly below the hurdle imposed by the Medicare LCDs. In addition to the science, however, there are ethical considerations at play. Patient compliance with prescribed treatments has long been a thorny issue in the delivery of health care, and a robust literature has accumulated primarily concerning oral medication use.16 Nonadherence results in enormous losses (estimated at about $100 billion each year) due to poor outcomes.16,17 A number of characteristics have been identified that seem to correlate with nonadherence to PAP, and not surprisingly, one of these may be failure to comply with medication regimens www.chestpubs.org
for other chronic diseases. One retrospective study in the United States has supported this contention,18 although a large prospective study in Spain failed to find such a relationship.19 Other reported associations with nonadherence to PAP include age, sex, race, socioeconomic status, marital status, psychiatric comorbidity such as claustrophobia, and personality type (negative affectivity and social inhibition).20-25 Some uncertainty remains with respect to a few of these attributes, with conflicting data in the literature particularly relating to age, sex, and race.24-26 Several years ago, DiMatteo27 reviewed the extensive literature concerning adherence to medical recommendations in general and found consistent support for the contention that educational level and socioeconomic status drive adherence. She also found that age correlated with adherence when assessed by objective measures, in that younger adults complied less frequently with treatment than older individuals. Although her review did not address race or ethnicity as a factor, later reports have appeared addressing this and strongly support a disproportionate reduction in adherence in African Americans being treated for hypertension, congestive heart failure, diabetes, and for medication use in general.28-33 It is therefore highly likely that adherence disparities in PAP use do exist with respect to race/ethnicity and age, but proof will require studies with greater power than have heretofore been published. Even given our present state of knowledge, it is clear that certain categories of patients (low socioeconomic status, unmarried, those with psychiatric comorbidity) will more frequently have difficulty attaining adherence to PAP therapy. The LCDs arguably discriminate against these individuals by raising additional hurdles for them to jump in order to receive reimbursement for their treatment. There is also an extensive literature demonstrating that certain interventions can be brought to bear that will improve adherence to PAP. These include cognitive behavioral therapy, home visits, telephone calls, group education, multiple follow-up visits, and changes in PAP generator characteristics.34-38 Some of these interventions may not achieve success until . 90 days after PAP initiation.37,38 The LCDs make little provision for the time it can take to implement these methods, and actually mandate additional polysomnographic testing of uncertain efficacy to gain approval for another period of reimbursement.2 One last argument should be mentioned, concerning the singularity with which noninvasive PAP devices have been subjected to adherence requirements. For consistency, I navigated to the internet site39 listing every active LCD by the same MAC that promulgated the PAP LCD referenced above.2 The 54 LCDs cover services or devices ranging (alphabetically) from Ankle-Foot/Knee-Ankle-Foot Orthosis CHEST / 138 / 4 / OCTOBER, 2010
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to Wheelchair Seating, all updated within the last 2 years. Only “Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea” and “Respiratory Assist Devices” (eg, bilevel PAP) are subject to detailed adherence requirements. A few LCDs mandate physician assessment at intervals, but only one (“Transcutaneous Electrical Nerve Stimulators”) requires the reporting of device usage (but only an estimate) despite the fact that this pricey electronic apparatus could be equipped to collect objective data. A substantial number of LCDs apply to costly devices that could be equipped for objective measurement of usage, including oxygen concentrators, mechanical in-exsufflation devices, power wheelchairs, and pneumatic compression apparatus; however, only PAP and respiratory assist devices are singled out in this manner by CMS. The reasoning behind this situation is not certain. Sleep medicine specialists have long been obsessed with the issue of patient adherence to PAP therapy, hence, the development of sophisticated usage monitoring and thus the temptation for CMS to use this capability. A desire for cost savings almost certainly drove the decision, but many other treatment devices are equally expensive or even more so but have no adherence criteria. In the past, our field has suffered the calumny that OSA is not a legitimate disorder and that treatment is superfluous,6 but I trust that this discredited contention did not play a role in the CMS decision. Finally, it is possible that the unremitting pressure of budgetary woes to which Medicare is subject has led CMS to begin examining therapeutic adherence as part of a strategy to limit reimbursement. If so, then our profession is in for a deluge of paperwork that will dwarf that which we experience today, and our society must come to grips with the inequities that will inevitably follow. Acknowledgments Financial/nonfinancial disclosures: The author has reported to CHEST the following conflicts of interest: Within the last 3 years, Dr Brown served on the boards of directors of the American Academy of Sleep Medicine, Associated Professional Sleep Societies LLC, American Board of Sleep Medicine, and American Sleep Medicine Foundation, and served on the Health Policy Committee of the American Thoracic Society. He chairs the Polysomnography Practice Advisory Committee of the New Mexico Medical Board and serves on the New Mexico Respiratory Care Advisory Board. He currently receives no grant or commercial funding pertinent to the subject of this article.
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