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
Conflicts?
• Nothing Current
ObjectivesYou 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
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?
It’s the Lawhttps://www.virtuox.net/dyndocs/Documents/LCDforPAP.pdf
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.
Oxygen for OSA
6
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
http://www.cgsmedicare.com/jc/pubs/news/2013/111
3/cope23913.htmlprimary treatment of OSA.
Oxygen and PAP for
OSA & COPD
8
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-for-
service Medicare.
Oxygen and PAP for
OSA & COPD
9
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.
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.
Algorithm to Assist in Analyzing
OSA/Home Oxygen Testing Scenarios
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
https://med.noridianmedicare.com/documents/6547796/6558289/Respiratory+A
ssist+Devices.pdf/39126d12-28d0-4bc1-8ab8-5f71db06de43
Google: CMS.GOV DME RAD
Case 1: History
• Pt is a 71-yo MWM retired farmer, non-smoker, 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.
Playing the Game
• Lab: Abnormal overnight oximetry
– ABGs= 70/57/7.41
– FVC = 45% pred; PiMax = -50 cmH2O
– EMG = Motor neuron disease
• Diagnosis: ALS, hypersomnolence,
nocturnal hypoxemia
Must a formal sleep study be done?
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 H2O or
Forced vital capacity is < 50% predicted, and
C. Chronic obstructive pulmonary disease does not contribute significantly to the patient’s pulmonary limitation
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.
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?
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
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
• 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%).
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.)
IV. Hypoventilation Syndrome
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
E0450
LP- 6 PB 2800
Retired Ventilators
T-Bird
LP-10 PLV-100
PB-540
E0463/4
Pulmonetics
LTV Series
Astral 150
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
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.
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
1999. 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.
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
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
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
The Real Problem
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%
New Vent Codes
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
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.
Restrictive Thoracic Disorders
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.
NAMDRC COPD
Working Group Report
RecommendedRevisedAlgorithmforNIVviaHMVinCOPD
SEVERECOPD
ABGwhileawakebreathingusualFiO2demonstratesPaCO2>52mmHg
PrescribeBPAP
• FailureonaBPAPDevice• Progressivelyincreasedhoursof
nocturnalanddiurnaluse/needforba erybackup/volumetargetedmodes
• Enhancedalarmrequirement
Successfullyachieveven la ongoals
Con nueBPAP
Ini ateHMV
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 trial10 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.
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.
Home Mechanical Ventilation, Respiratory Failure
and Coverage Criteria Recommendations
On June 29, 2001, CMS issued a Decision Memo (CAG-
00052N) 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.”
LCD ID- L33800
Original ICD-9 LCD ID- L11504
LCD Title= Respiratory Assist Devices
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. 100-3) in Chapter 1, Part 4, Section 280.1 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.”
LCD ID- L33800
Original ICD-9 LCD ID- L11504
LCD Title= Respiratory Assist DevicesVENTILATOR 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.
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.
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 PaO2 of 60
mm Hg or greater on room air and,
Ventilatory failure – inability to maintain PaCO2 of 50
mm Hg or below
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.
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.
• 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
Conclusions
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
