CMS Reimbursement of CPAP, Oxygen, BPAP, HMV for Sleep Disordered Breathing Peter C Gay Professor of Medicine Mayo Clinic Rochester, MN

Transcription

1 45th Annual New Mexico Thoracic Society Lung Disease Symposium CMS Reimbursement of CPAP, Oxygen, BPAP, HMV for Sleep Disordered Breathing Peter C Gay Professor of Medicine Mayo Clinic Rochester, MN

2 Conflicts? Nothing Current

3 Objectives You will: Know How to Prescribe PAP + O2 Have Perspective on Current NPPV (RAD) Rules Understand the Dramatic Shift and Difficulties in Current Rules Have Hope for the Future

4 Introduction PAP, PAP and Oxygen What are the differences in indications, and applications for: High level RADS Home Vents How did we get here and why do we need different widgets? Where do we need to get?

5 It s the Law LCD= L33718 Obstructive sleep apnea per Medicare: CPAP will be covered under Medicare in adult patients with OSA if either of the following criteria is met: 1)AHI 15, or 2)AHI 5 and 14 with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease or history of stroke.

6 Oxygen for OSA 6

7 Home Oxygen for Treatment of Obstructive Sleep Apnea (OSA) Medicare does not reimburse for oxygen for OSA Frequently Asked Questions: Oxygen Use in Beneficiaries with Obstructive Sleep Apnea 3/cope23913.htmlprimary treatment of OSA.

8 Oxygen and PAP for OSA & COPD If a new Medicare beneficiary is already on PAP and O2, are both therapies eligible for reimbursement? For PAP: a. The original testing done to diagnose OSA may be used to qualify for Medicare coverage if the results meet or exceed Medicare AHI/RDI requirements; and, b. The 90-day compliance period is replaced with an in-person physician visit that documents (1) compliant use of the equipment and (2) benefit from therapy For Home Oxygen: For beneficiaries who start oxygen while enrolled in a Medicare managed care plan, the blood oxygen testing used by the plan for qualification may be used for qualification purposes by fee-forservice Medicare. 8

9 Oxygen and PAP for OSA & COPD A beneficiary with OSA and chronic, severe lung disease (i.e., COPD) has DAYTIME SpO2 is < 88% and the beneficiary s physician was prescribed home oxygen therapy. In this instance, would home oxygen be covered? Yes, home oxygen would be covered. This beneficiary meets the Oxygen LCD Group I criteria. Oximetry testing while the beneficiary is awake may be used for qualification of home oxygen. While awake OSA does not affect blood oxygen levels. 9

10 Oxygen and PAP for OSA & COPD Patients with OSA and chronic lung disease (e.g. COPD) has a PSG titration that lasted >2 hours and AHI <10/hr with SpO2 <88% for >5 min and oxygen is prescribed in conjunction with PAP. Is this covered? Yes, home oxygen would be covered. The question restates the titration PSG requirements described in the LCDs. A titration PSG meeting these requirements can be used for qualification of home oxygen.

11 Algorithm to Assist in Analyzing OSA/Home Oxygen Testing Scenarios

12 Local Coverage Determination (LCD) for Respiratory Assist Devices (L11504 ) CMS Criteria Categories I. Restrictive Thoracic Disorders II. Severe COPD III. Central Sleep Apnea IV. Hypoventilation Syndromes ssist+devices.pdf/39126d12-28d0-4bc1-8ab8-5f71db06de43 Google: CMS.GOV DME RAD

13 Case 1: History Pt is a 71-yo MWM retired farmer, nonsmoker, who developed a foot drop in 1995 and over the last 6-12 mos. progressive dyspnea, weakness, some choking, 30 lbs. wt. loss, and now uses a walker at home. He naps regularly during the day and regards himself as sleepy. He can lie on his back with the aid of several large pillows but now prefers a recliner and he has never snored.

14 Playing the Game Lab: Abnormal overnight oximetry ABGs= 70/57/7.41 FVC = 45% pred; PiMax = -50 cmh 2 O EMG = Motor neuron disease Diagnosis: ALS, hypersomnolence, nocturnal hypoxemia Must a formal sleep study be done?

15 I. Restrictive Thoracic Disorders A. Documentation in the pt s medical record of progressive neuromuscular disease (e.g., ALS) or a severe thoracic cage abnormality (e.g., post-thoracoplasty for TB), and B. 1. PaCO2, awake, breathing the pt's usual FIO2, is > 45 mmhg, or 2. Sleep oximetry demonstrates O2 saturation < 88% for 5 min, done while breathing the patient s usual FIO2, or 3. For a progressive neuromuscular disease (only), Maximal inspiratory pressure is < -60cm H 2 O or Forced vital capacity is < 50% predicted, and C. Chronic obstructive pulmonary disease does not contribute significantly to the patient s pulmonary limitation

16 Case 2: History Pt is 72-yo WWF, former smoker with severe COPD on home O2, hx. of PAF, hypertension, with 1 recent hospitalization. 3 weeks of progressive dyspnea, worsening cough but no fever or chills. No chest pain or known CAD She never snores but always feels unrested and fatigued. No history of depression or alcohol.

17 Playing the Game Pt admitted to step-down ICU and given NPPV, O2, optimal medications PFTs showed FEV1 of 15% pred ABG the day prior to dismissal: 60/75/7.38 on 2LPM NC-O2 Do you need a sleep study to prescribe home NPPV use?

18 II. Severe COPD: A)1. PaCO2 > 52 mm Hg, on pt s usual FIO2 and, 2. Sleep oximetry demonstrates oxygen saturation <88% for at least 5 minutes, done on O2 at 2 LPM or the pt s usual FIO2 (whichever is higher) and, B) OSA (and CPAP therapy) considered and ruled out- does not require a PSG If all of the above criteria for COPD pts are met, a EO470 device (no backup rate) is covered for first 3 months of therapy and thereafter pending successful reassessment

19 III. Central Sleep Apnea Central sleep apnea (CSA) is defined as: (1) An apnea hypopnea index >5; AND (2) Central apneas/hypopneas >50% of the total apneas/hypopneas; AND (3) Central apneas or hypopneas >5/Hr; AND (4) Symptoms of either excessive sleepiness or disrupted sleep. Complex sleep apnea (CompSA) is a form of central apnea specifically identified by the persistence or emergence of central apneas or hypopneas upon exposure to CPAP or an E0470 device when obstructive events have disappeared. These patients have predominately obstructive or mixed apneas during the diagnostic PSG occurring >5/hour. With use of a CPAP or E0470, they show a pattern of apneas and hypopneas that meets the definition of CSA described above. Revision Effective Date: 01/01/2006

20 IV. Hypoventilation Syndrome An E0471 device is covered for a beneficiary with hypoventilation syndrome if both criteria A, B, and either criterion C or D are met: A. A covered E0470 device is being used. B. Spirometry shows an FEV1/FVC >70%. (Refer to SEVERE COPD (above) for device coverage for FEV1/FVC < 70%).

21 IV. Hypoventilation Syndrome C. An awake PaCO2, while breathing the beneficiary s prescribed FIO2, shows that the beneficiary s PaCO2 worsens greater than or equal to 7 mm HG compared to the ABG result performed to qualify the beneficiary for the E0470 device (criterion A under E0470). D. A facility-based PSG or HST demonstrates oxygen saturation <88% for >5 minutes of nocturnal recording time (minimum recording time of 2 hours) that is not caused by obstructive upper airway events i.e., AHI <5 while using an E0470 device. (Refer to the Positive Airway Pressure Devices LCD for information about E0470 coverage for obstructive sleep apnea.)

22 RADs vs Vents Frequent and Substantial Servicing vs Capped Rental CMS used term therapeutic ventilator without real definition, just as no true definition for a RAD with a backup rate. CMS final regulation 1/27/06 shifted payment for any RADs in frequent and substantial payment category to capped rental Capped rental payment continues 13 mos (mandated by Deficit Reduction Act). Frequent and substantial payment, continues for the time the beneficiary requires the device

23 E0450 LP- 6 PB 2800

24 Retired Ventilators PB-540 LP-10 PLV-100 T-Bird

25 E0463/4 Pulmonetics LTV Series Astral 150

26 Why Do Need So Many Widgets? We Need More Ventilation Scotty? What do you need to ventilate? When does a RAD fail? Is this one or another better? The Needed Aspects for Success More horsepower Special features Mouthpiece and other unique modes Battery backup Alarms and Better Monitoring

27 How Did We Get Here? The problem: Current reimbursement policy creates a disconnect between a patient s clinical status/needs and reimbursement because payment policies focus on devices rather than the clinical situation.

28 How Did We Get Here? FDA approved HMV (home mechanical ventilator) in 1977 focused upon ventilator dependent pediatric pts with a trach. BPAP (Bilevel positive airway pressure) were specifically addressed in the Federal Register and defined as respiratory assist devices or RADs in No distinction made in the Healthcare Common Procedure Coding System (HCPCS) whether or not a backup rate feature was employed. However, effective Jan 1, 1992, code E0453 with wording therapeutic ventilator; suitable for use 12 hours or less per day was added to the HCPCS.

29 How Did We Get Here? Reimbursement ruling was changed to ensure that all BPAPs, even when used as a ventilator with a backup rate, were nevertheless paid as a capped rental item (CR). As later clarified in 2006 in the Federal Register, Ventilators that are excluded from the FSS payment category are paid in accordance with section 1834(a)(7) of the Act under the CR category on a rental basis. This ruling clarified reimbursement policy for BPAPs vs. HMVs, but did not help identify the clinical situations appropriate for FSS or CR equipment

30 How Did We Get Here? Increased acceptance and use of NPPV for management of chronic respiratory failure especially after episode of acute respiratory failure New RCT evidence supporting decreased mortality using NIV with a backup rate for severe COPD with chronic hypercapnic respiratory failure- T Kohnlein et al Lancet 2014 J Lewarski AARC Times Jan 2017

31 How Did We Get Here? Restrictive capped rental RAD policy and barriers to more sophisticated modes especially backup rate feature Changing healthcare models with value-based care initiatives that penalize poor outcomes especially readmission Post-acute bundled payment spawns management teams encouraging NIV use with HMV for COPD protocols

32 The Real Problem

33 The Real Problem In 2015, Medicare expenditures for HMV NIV rose to $343 million 2009, NMD accounted for 56% of claims with chronic respiratory failure at 29% 2015, chronic respiratory failure rose to 85% of E0464 claims while NMD fell to 7%

34 New Vent Codes

35 NAMDRC Working Group Report on the Use of Noninvasive Home Mechanical Ventilation in Adult Patients with Chronic Hypercapnic RF THE AUTHORS- Charles Atwood, MD UPMC, Pittsburgh, PA Joshua Benditt, MD U Washington, Seattle, WA Kent Christopher, MD Denver, Colorado Gerry Criner, MD Temple U, Philadelphia, PA Peter Gay, MD Mayo Clinic, Rochester, MN Nick Hill, MD Tufts U, Boston, MA Sai Parthasarathy, MD U Arizona, Tucson, AZ Lisa Wolfe, MD Northwestern U, Chicago, IL

36 Restrictive Thoracic Disorders Suggested Change: a. An ABG PaCO2 done while awake is >45mm Hg, or b. Sleep oximetry demonstrates SpO2 > 88% for > 5 min of nocturnal recording time (minimum recording time of 30 minutes), or Comment: The change to delete and breathing the beneficiary s prescribed FI02 is discussed below under the Severe COPD section since the rationale is the same for both sections. Insisting upon a demonstration period of 2 hrs desaturation puts patients at undue risk as also discussed below.

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38 Severe COPD Suggested Change: Patients with COPD must have GOLD Stage 3 or 4 airway obstruction and a PaCO2 done while awake is > 52 mmhg. Comment: Recent evidence, especially from the Kohnlein study, supports the hypercapnia requirement. Chronic CO2 retainers appear to be the group most likely to benefit. There should be no stipulation about the FIO2 with the ABG as the issue at hand is about ventilation and not oxygenation. Based on our comments below, we recommend deleting criterion B and covering both E0470 and E0471 if the remaining two criteria are met. Contingent upon such revisions, situations 1 and 2 currently used to justify coverage of an E0471 device should be removed in their entirety.

39 NAMDRC COPD Working Group Report Recommended Revised Algorithm for NIV via HMV in COPD SEVERE COPD ABG while awake breathing usual FiO 2 demonstrates PaCO 2 > 52 mmhg Prescribe BPAP Successfully achieve ven la on goals Con nue BPAP Failure on a BPAP Device Progressively increased hours of nocturnal and diurnal use/need for ba ery backup/volume targeted modes Enhanced alarm requirement Ini ate HMV

40 Central or Complex Sleep Apnea If all of the above criteria are met, either an E0601, E0470 or an E0471 device (based upon the judgment of the treating physician) will be covered for beneficiaries with documented CSA or CompSA for the first three months of therapy. Comment: The recent findings from the SERVE-HF trial 10 surprisingly identified the fact the patients with symptomatic CHF with reduced LV function in fact had a higher mortality with the previously preferred E071 device adaptive servo-ventilator. This limits alternative therapy for central apnea in these patients based on current American Academy of Sleep Medicine guidelines to oxygen and CPAP (E0601) which is not permitted presently.

41 Hypoventilation Syndrome Suggested Change: An initial PACO2 done while awake is > 45 mm Hg. Comment: As with the COPD discussion above, criteria should not force oxygen therapy on the patient when assessing hypercapnia Current Language: Spirometry shows an FEV1/FVC >70%. Suggested Change: Spirometry shows an FEV1/FVC > 70%. (Refer to SEVERE COPD (above) for information about device coverage for beneficiaries with FEV1/FVC <70%). This also includes patients with parenchymal lung disease leading to restriction AND hypercapnia that do not meet the criteria for the first category, Restrictive Thoracic Disease.

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43 Home Mechanical Ventilation, Respiratory Failure and Coverage Criteria Recommendations On June 29, 2001, CMS issued a Decision Memo (CAG N) to the DME MACs regarding the role of Respiratory Assist Devices (RADs) and the need for a backup rate for patients with severe COPD. In part, the memo stated that noninvasive mechanical ventilation is distinguished from the invasive ventilation administered via a securely intubated airway, in a patient for whom interruption or failure of respiratory support leads to death.

44 LCD ID- L33800 Original ICD-9 LCD ID- L11504 LCD Title= Respiratory Assist Devices

45 LCD ID- L33800 Original ICD-9 LCD ID- L11504 LCD Title= Respiratory Assist Devices VENTILATOR WITH NOINVASIVE INTERFACES The Centers for Medicare & Medicaid Services (CMS) National Coverage Determinations Manual (Internet-Only Manual, Publ ) in Chapter 1, Part 4, Section stipulates that ventilators (E0450, E0460-E0464) are covered for the following conditions: Neuromuscular diseases, thoracic restrictive diseases, and chronic respiratory failure consequent to chronic obstructive pulmonary disease. Each of these disease categories are comprised of conditions that can vary from severe and life-threatening to less serious forms. These disease groups may appear to overlap conditions described in the Respiratory Assist Devices LCD but they are not overlapping. Choice of an appropriate device i.e., a ventilator versus a bi-level PAP device is made based upon the severity of the condition. CMS distinguished the use of respiratory product types in a National Coverage Analysis Decision Memo (CAG-00052N) in June 2001 saying that RAD is distinguished from ventilation in a patient for whom interruption or failure of respiratory support leads to death.

46 LCD ID- L33800 Original ICD-9 LCD ID- L11504 LCD Title= Respiratory Assist Devices VENTILATOR WITH NOINVASIVE INTERFACES The conditions described in the Respiratory Assistance Devices (RAD) local coverage determination are not life-threatening conditions where interruption of respiratory support would quickly lead to serious harm or death. These policies describe clinical conditions that require intermittent and relatively short durations of respiratory support. Thus, any type ventilator would not be eligible for reimbursement for any of the conditions described in the RAD LCD even though the ventilator equipment may have the capability of operating in a bi-level PAP (E0470, E0471) mode. Bi-level PAP devices (E0470, E0471) are considered as reasonable and necessary in those clinical scenarios. Claims for ventilators (E0450, E0460-E0464) used for the treatment of conditions described in the RAD LCD will be denied as not reasonable and necessary.

47 NAMDRC Working Group Report on the Use of Noninvasive Home Mechanical Ventilation in Adult Patients with Chronic Hypercapnic RF The purpose of this document is to review available evidence and provide expert consensus opinion regarding the use of home non-invasive mechanical ventilation in adults, attempting to describe different clinical scenarios that dictate the need for different levels of ventilator assistance and support.

48 Definitions: Respiratory Failure Respiratory Failure: Respiratory failure is the inability of the respiratory system to maintain gas exchange within normal limits. The degree of respiratory failure may range from mild to severe with the severity determining the urgency and extent of treatment. It is generally divided into 2 forms: Oxygenation failure inability to maintain PaO 2 of 60 mm Hg or greater on room air and, Ventilatory failure inability to maintain PaCO 2 of 50 mm Hg or below

49 Definitions: Respiratory Failure Definitions: Mechanical Ventilator andmechanical Ventilation Mechanical Ventilator: A mechanical ventilator is a device capable of delivering pressurized gas (either through a secured artificial airway or through a mask or mouthpiece) in a manner that repeatedly supplies a physiological tidal volume to the lungs sufficient to improve or fully sustain respiration. Mechanical Ventilation: Mechanical ventilation is the use of a mechanical ventilator on a patient in whom interruption or failure of this device can reasonably be expected to lead to eventual or rapid clinical deterioration leading to medical harm or even death.

50 Establishment of Distinct Categories of Mechanically Ventilated Patients 1. Create a distinct category for use of a mechanical ventilator 16 hours/day or greater 2. Create a distinct category for use of a mechanical ventilator greater than nocturnally alone or approximately > 8 hours, but<16 hrs/24 hrs. 3. Create a distinct category for use of a mechanical ventilator (bi level device, or RAD) just nocturnally or up to 8 hours /24 hrs.

51 Conclusions Evidence based outcome data supports use of backup rate and high IPAP in severe COPD HMV devices offer many advantages but expense is significantly greater with little scientific information available regarding clinical practice DME MAC determination essentially terminates non-invasive HMV use for all pts unless severe or life-threatening documentation

52 Conclusions The landscape will certainly drastically change for NPPV patients and possibly even for those with a tracheostomy when HMV treatment plans are sought NAMDRC BOD is presently crafting a response plan possibly including a legislative approach to appropriately address this immense barrier to proper patient care