New Government O2 Criteria and Expert Panel. Jennifer Despain, RPSGT, RST, AS

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1 New Government O2 Criteria and Expert Panel Jennifer Despain, RPSGT, RST, AS Lead Sleep Technologist, Central Utah Clinic Sleep Disorders Center; Provo, Utah Objectives: Review new government O2 criteria guielines and how to implement them Discuss new government back-up rate device qulaifications and how to implement them Manage decisions based on these guidelines while running a sleep study during the night

2 Jennifer Despain NEW GOVERNMENT CRITERIA FOR SUPPLEMENTAL OXYGEN AND BACK UP RATE DEVICES

3 Objectives Know the new supplemental oxygen requirements Know the new back-up rate device requirements Make appropriate decisions based on the requirements

4 Why all the changes? Cost of CPAP machine: $500 Cost of an ASV machine: $5, Pagel, James. Primary Care Sleep Medicine: A Practical Guide. Springer: 2014.

5 Supplemental Oxygen Requirements for use with CPAP:

6 Supplemental Oxygen Requirements For CPAP :

7 So What Does This Mean to Me? As a Tech Running a Study: -Stay alert -Pay attention to the amount of time oxygen is <88% -Make sure the patient is titrated -Keep track of the time the patient is being titrated especially on split night studies (they need 2+ hours on therapy)

8 Back up Rate Device Requirements

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14 How do patients qualify for a back up rate device? With a Comorbidity Need to have met the requirements for one of these: Restrictive Thoracic Disorders Severe COPD Hypoventilation Syndrome Without a Comorbidity Need to have been diagnosed with one of these: Central Sleep Apnea Complex Sleep Apnea

15 Restrictive Thoracic Disorders An E0470 or E0471 device is covered when criteria A C are met. A. There is documentation in the beneficiary s medical record of a neuromuscular disease (for example, amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (for example, post-thoracoplasty for TB). B. One of the following: 1) An arterial blood gas PaCO2, done while awake and breathing the beneficiary s prescribed FIO2 is greater than or equal to 45 mm Hg, or 2) Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for greater than or equal to 5 minutes of nocturnal recording time (minimum recording time of 2 hours), done while breathing the beneficiary s prescribed recommended FIO2, or 3) For a neuromuscular disease (only), either i or ii, i. Maximal inspiratory pressure is less than 60 cm H20, or ii. Forced vital capacity is less than 50% predicted C. Chronic obstructive pulmonary disease does not contribute significantly to the beneficiary s pulmonary limitation.

16 Severe COPD An E0470 device is covered if criteria A - C are met. A. An arterial blood gas PaCO2, done while awake and breathing the beneficiary s prescribed FIO2, is greater than or equal to 52 mm Hg. B. Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for greater than or equal to a cumulative 5 minutes of nocturnal recording time (minimum recording time of 2 hours), done while breathing oxygen at 2 LPM or the beneficiary s prescribed FIO2 (whichever is higher). C. Prior to initiating therapy, sleep apnea and treatment with a continuous positive airway pressure device (CPAP) has been considered and ruled out. (Note: Formal sleep testing is not required if there is sufficient information in the medical record to demonstrate that the beneficiary does not suffer from some form of sleep apnea (Obstructive Sleep Apnea (OSA), CSA and/or Comp SA) as the predominant cause of awake hypercapnia or nocturnal arterial oxygen desaturation).

17 Hypoventilation An E0470 device is covered if both criteria A and B and either criterion C or D are met. A. An initial arterial blood gas PaCO2, done while awake and breathing the beneficiary s prescribed FIO2, is greater than or equal to 45 mm Hg. B. Spirometry shows an FEV1/FVC greater than or equal to 70%. (Refer to SEVERE COPD (above) for information about device coverage for beneficiaries with FEV1/FVC less than 70%.) C. An arterial blood gas PaCO2, done during sleep or immediately upon awakening, and breathing the beneficiary s prescribed FIO2, shows the beneficiary's PaCO2 worsened greater than or equal to 7 mm Hg compared to the original result in criterion A (above). D. A facility-based PSG or HST demonstrates oxygen saturation less than or equal to 88% for greater than or equal to 5 minutes of nocturnal recording time (minimum recording time of 2 hours) that is not caused by obstructive upper airway events i.e., AHI less than 5. (Refer to the Positive Airway Pressure Devices LCD for information about E0470 coverage for obstructive sleep apnea.)

18 Things that have changed for Complex Sleep Apnea (Diagnosed on CPAP) Mixed apneas are no longer counted as Central Events Patient must have an obstructive AHI of less than 5 at the pressure Patient must have a central AHI of over 5 at the pressure Patient must have at least 10 central events at the pressure

19 Requirements For CSA Diagnosis (Not on CPAP) AHI greater than 5 Sum of central apneas/hypopneas is greater than 50% of the total apneas/hypopneas CAHI is greater than 5 per hour Presence of at least one of the following: Sleepiness Difficulty Initiating or Maintaining Sleep Awakening Short of Breath Snoring Witnessed Apneas There is no evidence of daytime or nocturnal hypoventilation

20 For the Night Tech: Depending on the software you use you may have to hand calculate the obstructive and central AHI s to see if a patient qualifies. Here is a sheet you can use based on epochs at the current pressure to know if a patient will qualify for a back-up rate device or you can use the equation: events/sleep time

21 Time to Ask The Experts and Each Other 1. What is a Central Hypopnea? In this issue of SLEEP, Randerath and colleagues 4 present validation for an algorithm to distinguish between obstructive and central hypopneas employing esophageal manometry in a selected population with an unclear initial study. A logical sequential approach is used with obstruction defined by either (1) inspiratory flattening or paradoxical movement or (2) early arousal, abrupt ventilatory recovery, or occurrence in stage R. In managing patients with these disorders, distinguishing central from obstructive events would seem the first step in determining both the mechanism of the problem and the range of treatment options. In the case of apneas, central events can be inferred by the absence of respiratory effort. Hypopneas are not as intuitive. Diverse methods for distinguishing between obstructive and central hypopneas have been employed, though they have not been systematically validated by a gold standard such as esophageal manometry. In heart failure where both obstructive and central events coexist, operational definitions have hinged on indicators of obstruction including paradoxical movement of the rib cage and abdomen, flattening of inspira-tory flow envelope, and low inspiratory flow amplitude relative to effort.

22 Case Study 1-Age 66 Male Patient was a splitnight study during the diagnostic portion of the study he had an AHI of 77.6 some of these were central in nature. Once CPAP was applied he began to have Cheyne Stokes breathing with the majority of the events being central apneas. At the current pressure on CPAP his obstructive AHI was less than 5 his central AHI was 80.0 events per hour. What would you do? Coronary Artery Disease Congestive Heart Failure Stroke Medication Hydralazine Height 5 7 Weight 224 lbs

23 What happened: The patient was switched to ASV therapy. His final AHI on ASV was 15.2 events per hour, however the majority of these were central events that occurred right after the patient was put on the machine. After he had been on the machine for several minutes he no longer had central events and had only three hypopneas during the hour of sleep he was on the machine. His oxygen levels remained above 90%

24 Case Study 2-59 Male Weight 339 lbs Height 6 0 Samoan Hypertension Kidney Disease (On Dialysis) Patient was brought in for a splitnight study. During the diagnostic portion of the study he had 212 central apneas, 1 obstructive apnea, and 46 obstructive hypopneas. He had severe snoring and a Cheyne Stokes breathing pattern.

25 What happened Patient was tried first on CPAP. The patients snoring disappeared however the central apneas worsened. The patient was then tried on ASV where he did fairly well however he continued to have moderate respiratory events and irregular breathing. Finally, he was tried on AVAPs where his AHI got down to 10.1 events per hour (these were hypopneas) with his oxygen levels staying in the 90s.

26 Some things to keep in mind -Patient s medications -Patient s health history -Information from the medical director (what does he/she want you to do) -Lab protocols -What are the centrals being caused by (are they post arousal) Remember to try and pay attention to both what is happening in the moment and the big picture during the night

27 Case Study 3 34 Female Patient underwent a baseline polysomnogram that showed an obstructive AHI of 3.0 and a central AHI of 6.2 with moderate snoring. ADD Anxiety PTSD Hypothyroidism Adderall Lexapro

28 What Happened? Patient went on CPAP therapy at a pressure of 6 cm and was fixed.

29 Time for Some Questions:

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