BCBSNJ Medical Policy for - (D M E) Policy Number

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Horizon BCBSNJ
Uniform Medical Policy Manual	Section:	D M E
	Policy Number:	049
	Effective Date:	09/08/2020

	Original Policy Date:	07/26/2016
	Last Review Date:	09/08/2020
	Date Published to Web:	03/27/2019

Subject:
Home Positive Pressure Ventilation

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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(NOTE: This policy does not address negative-pressure body ventilators or abdominal ventilators because positive-pressure ventilators have, with few exceptions, replaced negative-pressure ventilators in the home. Furthermore, this policy does not address the use of other respiratory assist devices including biPAP or CPAP.)

The main function of the respiratory system is to get oxygen into the body and to remove carbon dioxide. When a patient's lungs are no longer able to adequately perform this function mechanical ventilation is used.

Chronic respiratory failure is defined as the long-term inability to maintain oxygen and carbon dioxide levels within normal limits. Many disease conditions may lead to chronic respiratory failure including, but not limited to neuromuscular diseases, thoracic restrictive diseases (including thoracic cage abnormalities and morbid obesity), chronic obstructive pulmonary disease, and hypoventilation syndromes such as obesity hypoventilation. Conditions such as these may be relatively stable over time or progressive in nature. Chronic respiratory failure is a common condition that may require long-term home mechanical ventilation.

Noninvasive ventilation differs from invasive ventilation (E0465) using an invasive interface between the patient and ventilator. In the home setting invasive ventilator support is provided via tracheostomy tube. Noninvasive ventilator support uses interfaces such as nasal masks; orofacial masks mouthpieces, nasal pillows, or full-face mask.

Mechanical ventilation is intended for adult and infant patients weighing at least 5 kg (Il Ibs) with tidal volumes of at least 50ml and may be used for both invasive and non-invasive ventilation.

Please note that this policy does not address the use of other respiratory assist devices including BiPAP or CPAP.

Positive pressure ventilators can be set up to function in a bi-level mode, and should not be provided when a bi-level device will meet the member’s needs.

DEFINITIONS

Bi-level positive airway pressure (e.g., BiPAP^™) delivers two pressure levels according to the respiratory cycle and improves ventilation, oxygenation, and alveolar recruitment. BiPAP provides both an inspiratory positive airway pressure as well as a continuous expiratory positive airway pressure, and the difference between these reflects the tidal volume.

Hypercapnia--a greater than normal level of carbon dioxide in the blood.

Hypoventilation-- breathing at an abnormally slow rate, resulting in an increased amount of carbon dioxide in the blood.

Hypoxemia--abnormally low levels of oxygen in the blood. Hypoxemia may be mild to severe and may lead to shortness of breath.

Negative pressure ventilation--delivered via a sealed full-body chamber. Negative pressure ventilators apply intermittent sub-atmospheric pressure around the chest and abdomen.

Positive pressure support-- delivered via a mechanical ventilation driver utilizing an external interface such as a nasal mask, nasal pillow, full-face or total-face mask.

Respiratory failure-- inadequate gas exchange by the respiratory system, which results in abnormal levels of arterial oxygen, carbon dioxide or both

Rural Area—defined as rural locations at the county level, and all counties outside of a Metropolitan Statistical Area (MSA), as defined by the Office of Management and Budget, were considered to be rural (Farley et al., 2002). This definition is consistent with the county-based geographic boundaries used in many of the Medicare payment schedules for provider services. County categories were established to define differing degrees of rurality, using values of the Urban Influence Codes (UICs) developed by the Economic Research Service (ERS) of the U.S. Department of Agriculture (USDA) (Ghelfi and Parker, 1995). Codes 1 and 2 define large and small counties in the MSAs, and codes 3 through 9 define categories of counties outside the MSAs (non-metropolitan counties). The UICs classify non-metropolitan counties on two dimensions: (1) the size of the largest town in the county and (2) adjacency to a metropolitan county.

Regulatory Status
In April 2017, the FDA approved the VOCSN Unified Respiratory System, by Ventec Life Systems, Inc. The device is a Class II continuous ventilator. VOCSN integrates five separate devices including a ventilator, oxygen concentrator, cough assist, suction, and nebulizer into one unified respiratory system. The VOCSN FDA-approved indication for use is to provide continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. It may be used in invasive and non-invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively.

Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

Indications for Non-Invasive Positive Pressure Ventilation

Non-invasive positive pressure ventilation (NIPPV) is considered medically necessary when ALL of the following are met (A-E):
I. The physician documentation includes objective evidence that the member’s condition is so severe that management with a bi-level device with pressure support is not possible (i.e., CO2 and O2 levels could not be adequately corrected, a low or fluctuating tidal volume requires more precise monitoring and volume settings that cannot be accomplished with a bi-level device with or without back up, AND

II. Treatment of any of the following respiratory insufficiency conditions:

Restrictive lung disease

Chronic obstructive pulmonary disease (COPD)

Progressive neuromuscular disorders

(

NOTE

: Examples of progressive neuromuscular disorders

include, but are not limited to:

i. ALS

ii. Hereditary progressive muscular dystrophy

iii. Multiple Sclerosis

iv. Spinal muscle atrophy unspecified

v. Myasthenia gravis without acute exacerbation

vi. Myotonic muscular dystrophy

vii. Primary lateral sclerosis)

AND

III. Member has had optimal medical therapy for underlying respiratory disorders;

AND

IV. Member is able to protect airway and clear secretions adequately;

AND

V. Member's reversible contributing factors have been treated (e.g., obstructive sleep apnea, hypothyroidism, congestive heart failure, severe electrolyte disturbance).

Indications for Invasive Positive Pressure Ventilation

An invasive positive pressure ventilator (IPPV) is considered medically necessary when the member meets both of the following criteria:
I. The member meets criteria for non-invasive positive pressure ventilation; AND

II. The member has a condition or their condition has progressed such that they have persistent symptomatic respiratory failure that can no longer be corrected with a noninvasive interface.

Use of Positive Pressure Ventilators for any of the following is not considered medically necessary:

I. Treatment of obstructive sleep apnea as the clinical outcomes have not been shown to be superior to other standard treatments (e.g., CPAP, BiPAP).

II. Treatment of a condition with non-invasive positive pressure ventilator that can be managed by a respiratory assist device, bi-level pressure capability without backup feature, used with noninvasive interface (E0470) or respiratory assist device, bi-level pressure capability with backup feature, used with noninvasive interface (E0471) is considered more than medically necessary and would preclude the use of a non-invasive positive pressure ventilator (E0466) when basic PAP could be equally efficacious.

III. Clinical conditions that require bi-level functionality for intermittent and relatively short durations of respiratory support would not be considered medically necessary for a positive pressure ventilator (E0466) even though the ventilator equipment may have the capability of operating in a bi-level PAP mode.

IV. A positive pressure ventilator would not be considered medically necessary solely for the treatment of obstructive sleep apnea, even though the ventilator equipment may have the capability of operating in a CPAP (E0601) or bi-level PAP (E0470) mode.

Multi-Function/Multi-Use Ventilators (VOCSN) (E0467)

A multi-use ventilator (E0467) is considered medically necessary for individuals new to home mechanical ventilation who meet criteria for a home ventilator and when the ordering physician provides documentation to support the need for 2 or more of the additional functions (i.e., oxygen, cough stimulator, suction pump, nebulization).

(NOTE: Ventilator technology has evolved to the point where it is possible to have a single device capable of operating in numerous modes, from basic continuous positive pressure (CPAP and bi-level PAP) to traditional pressure and volume ventilator modes. This creates the possibility that one piece of equipment may be able to replace numerous different pieces of equipment. Equipment with multifunction capability creates the possibility of errors in claims submitted for these items.

General principles of correct coding require that products assigned to a specific HCPCS code only be billed using the assigned code. Thus, using the HCPCS codes for CPAP (E0601) or bi-level PAP (E0470, E0471) devices for a ventilator (E0466) used to provide CPAP or bi-level PAP therapy is incorrect coding. Claims for ventilators billed using the CPAP or bi-level PAP device HCPCS codes will be denied as incorrect coding.)

Second Ventilators and Back-Up Ventilators

A back-up ventilator that is intended to be used in case of failure or malfunction of the primary ventilator is not considered medically necessary.

A second ventilator is considered medically necessary if it is required to serve a different purpose than the primary ventilator, as determined by the member’s medical needs.

The following are examples of situations in which a member’s medical needs would warrant both a primary ventilator and a secondary ventilator:

A member requires one type of ventilator (e.g., a negative pressure ventilator with a chest shell) for part of the day and needs a different type of ventilator (e.g., positive pressure ventilator with a nasal mask) during the rest of the day.
A member who is confined to a wheelchair requires a ventilator mounted on the wheelchair for use during the day and needs another ventilator of the same type for use while in bed. Without two pieces of equipment, the member may be prone to certain medical complications, may not be able to achieve certain appropriate medical outcomes, or may not be able to use the medical equipment effectively.

(NOTE: Backup equipment must be distinguished from a second ventilator.
A Back-up Ventilator is defined as an identical or similar device used to meet the same medical needs for the member but provided at the bedside as a precaution in case of malfunction of the primary ventilator.

A Second ventilator is one which serves a different purpose than the primary ventilator, as determined by the patient's medical needs.)

[INFORMATIONAL NOTE: The member’s Durable Medical Equipment (DME) provider is responsible for ensuring that the member’s medical needs will be met on a continuous and ongoing basis. They are responsible to ensure there is a contingency plan in place to address any interruptions in the use of the equipment such as emergency situations or mechanical failures that would be life-threatening to the member.

The expectation is that an acceptable plan would involve input from the treating physician and would take into account:

The severity of the member’s condition,
If the member is in a rural area residence and
Time constraints to provide emergency support]

Medicare Coverage:
The Centers for Medicare & Medicaid Services (CMS) National Coverage Determinations Manual (Internet-Only Manual, Publ. 100-03) in Chapter 1, Part 4, Section 280.1 stipulates that ventilators (E0465, E0466) are covered for the following conditions: “[N]euromuscular diseases, thoracic restrictive diseases, and chronic respiratory failure consequent to chronic obstructive pulmonary disease.” Noridian Healthcare Services, LLC, the Local DME Medicare Carrier for jurisdiction JA, issued Local Coverage Determination (LCD): Respiratory Assist Devices (L33800). Per L33800, the determination to use a ventilator versus a bi-level PAP device, is made based upon the specifics of each individual beneficiary's medical condition. In the event of a claim review, there must be sufficient detailed information in the medical record to justify the treatment selected.

Using the HCPCS codes for CPAP (E0601) or bi-level PAP (E0470, E0471) devices for a ventilator (E0465, E0466) used to provide CPAP or bi-level PAP therapy is incorrect coding. Claims for ventilators billed using the CPAP or bi-level PAP device HCPCS codes will be denied as incorrect coding. Also, per L33800 Respiratory Assist Devices, claims for ventilators used to provide CPAP or bi-level CPAP therapy for conditions described in L33800 will be denied as not reasonable and necessary.

For additional information and eligibility, refer to the below NCDs and LCDs:

National Coverage Determination (NCD) for Durable Medical Equipment Reference List (280.1). Available at: https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx.

Local Coverage Determination (LCD): Respiratory Assist Devices (L33800). Available at: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=1&bc=AAgAAAAAAAAA&#aFinal

Local Coverage Article: Respiratory Assist Devices - Policy Article (A52517). Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=1&bc=AAgAAAAAAAAA&#aFinal.

Local Coverage Determination (LCD): Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718) and Local Coverage Article: Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea - Policy Article (A52467). Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=1&bc=AAgAAAAAAAAA&#aFinal.

HCPCS code E0467 is covered when used for Neuromuscular diseases, thoracic restrictive diseases, and chronic respiratory failure consequent to chronic obstructive pulmonary disease when reasonable and necessary.

The following HCPCS codes for individual items are included in the functionality of code E0467:
· Ventilators (HCPCS codes E0465, E0466)
· Oxygen and oxygen equipment (HCPCS codes E0424, E0431, E0433, E0434, E0439, E0441, E0442, E0443, E0444, E1390, E1391, E1392, and K0738)
· Nebulizers and related accessories (HCPCS codes E0565, E0570, E0572, E0585, A4619, A7003, A7004, A7005, A7006, A7007, A7012, A7013, A7014, A7015, A7017, A7525, and E1372)
· Aspirator and related accessories (HCPCS codes E0600, A4216, A4217, A4605, A4624, A4628, A7000, A7001, A7002, and A7047)
· Cough Stimulator (multiple items)

Therefore, claims for any of the HCPCS codes listed above that are submitted on the same claim or that overlap any date(s) of service for E0467 will be denied as noncovered.

For additional information, refer to Correct Coding and Coverage of Ventilators - Revised January 2019. Available at:https://med.noridianmedicare.com/web/jadme/policies/dmd-articles/correct-coding-and-coverage-of-ventilators-revised-january-2019.

Additionally, per Local Coverage Article: Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea - Policy Article (A52467), the following positive airway pressure devices HCPCS codes for individual items are included in the functionality of code E0467:

HCPCS codes E0470, E0471, E0472, E0601, A4604, A7027, A7028, A7029, A7030, A7031, A7032, A7033, A7034, A7035, A7036, A7037, A7038, A7039, A7044, A7045, A7046, E0561, E0562.

Claims for any of the HCPCS codes listed above that are submitted on the same claim or that overlap any date(s) of service for E0467 is considered to be unbundling and will be denied.For additional information, refer to Local Coverage Article: Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea - Policy Article (A52467).

On 4/09/20, CMS announced a clarification that Medicare’s coverage of multi-function ventilator (HCPCS code E0467) is limited to beneficiaries who are prescribed and meet the medical necessity coverage criteria for a ventilator, AND require at least one of the four additional functions (namely, oxygen concentrator, cough stimulator, suction pump, and nebulizer). For additional information and eligibility, refer to MLN Matters Number: SE20012 Article Release Date: April 3, 2020. Available at: https://www.cms.gov/Outreach-and-Education/Outreach/FFSProvPartProg/Provider-Partnership-Email-Archive.

CMS also announced that effective immediately, suppliers may provide and bill for multi-function ventilators described by code E0467 as an upgrade in situations where beneficiaries only meet the coverage criteria for a ventilator. Per MLN SE20012, beneficiaries may be billed for the difference between the ventilator and the upgrade to E0467 when the supplier has obtained a signed Advance Beneficiary Notice (ABN) from the beneficiary for the multi-function ventilator. For additional information and eligibility, refer to MLN Matters Number: SE20012 April 3, 2020. Available at: https://www.cms.gov/Outreach-and-Education/Outreach/FFSProvPartProg/Provider-Partnership-Email-Archive.

COVERAGE OF SECOND VENTILATOR
Medicare does not cover spare or back-up equipment. Claims for backup equipment will be denied as not reasonable and necessary (same/similar equipment).

Backup equipment must be distinguished from multiple medically necessary items which are defined as, identical or similar devices each of which meets a different medical need for the beneficiary. Multiple medically necessary items may be covered when it is required to serve a different medical purpose that is determined by the beneficiary's medical needs.

Medicaid Coverage:

FIDE SNP:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Home Positive Pressure Ventilation
Home Positive Pressure Ventilation in Adults
Non-Invasive Home Positive Pressure Ventilation in Adults
Invasive Home Positive Pressure Ventilation in Adults
Ventilators, Home Positive Pressure, Adults
Ventilation, Home Positive Pressure, Adults
Positive Pressure Ventilation, Home, Adults
Multi-Function/Multi-Use Ventilators (VOCSN)
VOCSN (Multi-Function/Multi-Use Ventilators)

References:
1. Make BJ, Hill NS, Goldberg AI, et al. Mechanical ventilation beyond the intensive care unit: report of a consensus conference of the American College of Chest Physicians (ACCP). Chest. 1998; 113(5Suppl):289S-344S.

2. McKim DA, Road J, Avendano M, et al. Home mechanical ventilation: A Canadian Thoracic Society clinical practice guideline. Canadian Respiratory Journal : Journal of the Canadian Thoracic Society. 2011;18(4):197- 215.

3. Laura M. Sterni, Joseph M. Collaco, Christopher D. Baker, John L. Carroll, Girish D. Sharma, Jan L. Brozek, Jonathan D. Finder, Veda L. Ackerman, Raanan Arens, Deborah S. Boroughs, Jodi Carter, Karen L. Daigle, Joan Dougherty, David Gozal, Katharine Kevill, Richard M. Kravitz, Tony Kriseman, Ian MacLusky, Katherine Rivera-Spoljaric, Alvaro J. Tori, Thomas Ferkol, and Ann C. Halbower; Am J Respir Crit Care Med Vol 193, Iss 8, pp e16–e35, Apr 15, 2016n DOI: 10.1164/rccm.201602-0276ST Internet address: www.atsjournals.org

4. Erika J. MacIntyre, Leyla Asadi, Doug A. Mckim, and Sean M. Bagshaw, “Clinical Outcomes Associated with Home Mechanical Ventilation: A Systematic Review,” Canadian Respiratory Journal, vol. 2016, Article ID 6547180, 10 pages, 2016. doi:10.1155/2016/6547180. Accessed 2/6/2017 at https://www.hindawi.com/journals/crj/2016/6547180/

5. Louise Rose RN PhD, Douglas A McKim MD FRCPC, Sherri L Katz MD FRCPC, David Leasa MD FRCPC, Mika Nonoyama RRT PhD, Cheryl Pedersen MSc, Roger S Goldstein MB BCh FRCPC, and Jeremy D Road MD FRCPC on behalf of the CANuVENT Group, Home Mechanical Ventilation in Canada: A National Survey, RESPIRATORY CARE • MAY 2015 VOL 60 NO 5 695. Accessed 2/6/2017 at http://rc.rcjournal.com/content/respcare/60/5/695.full.pdf

6. Centers for Medicare and Medicaid Services, Decision Memo for Noninvasive Positive Pressure RADs for COPD (CAG-00052N) National Coverage Decision June 29, 2001. Accessed 2/3/2017 at URL address: http://www.cms.gov/medicare-coverage-database/details/nca-decision- memo.aspx?NCAId=56&ver=&viewAMA=Y&bc=AAAAAAAAIAAA&

7. National Heart, Lung and Blood Institute. What is a Ventilator? February 1, 2011. Accessed 2/3/2017 at URL address: http://www.nhlbi.nih.gov/health/health-topics/topics/vent/

8. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) for Durable Medical Equipment Reference List (280.1) Ventilators 5/5/2005. Accessed 2/3/2017 at URL address: http://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=190&ncdver=2&NCAId=3&ver=5&NcaName=Air- Fluidized+Beds+for+Pressure+Ulcers&bc=ACAAAAAAIAAA&

9. Kohorst Joan MA RRT, Blakely Patricia RRT, et.al. Respiratory Care Journal, AARC Guideline: Long- term Invasive Mechanical Ventilation in the Home, August 2007 Vol. 52 No. 1. Accessed 2/3/2017 at URL address: http://www.rcjournal.com/cpgs/pdf/08.07.1056.pdf

10. Centers for Disease Control, Ventilator Associated Events (Adult locations only), April 2015 Accessed 2/3/2017 at URL address: http://www.cdc.gov/nhsn/PDFs/pscManual/10-VAE_FINAL.pdf

11. Hall Jesse B. MD, McShane, Pamela J. MD. Overview of Mechanical Ventilation, November 2013 Merck Manual. Accessed 2/3/2017 at URL address: http://www.merckmanuals.com/professional/critical-care-medicine/respiratory-failure-and- mechanical-ventilation/overview-of-mechanical-ventilation

12. ResMed: Reimbursement Fast Facts: Ventilators. Accessed 2/3/2017 at URL address: http://www.resmed.com/content/dam/resmed/global/documents/articles/1017230_Reimburseme nt_FF_Ventilator.pdf

13. Leger, Patrick MD; Nicholas Hill, MD, FCCP; and Gerard Criner, MD, FCCP. American College of Chest Physicians. Clinical Indications for Noninvasive Positive Pressure Ventilation in Chronic Respiratory Failure Due to Restrictive Lung Disease, COPD, and Nocturnal Hypoventilation—A Consensus Conference Report, August 1999, Vol 116, No 2.
14. Javaheri S, Brown LK, Randerath WJ. Positive airway pressure therapy with adaptive servoventilation Chest 2014; 146(2):514-523. doi:10.1378/chest.13-1776.

15. National Coverage Determination (NCD) for Home Use of Oxygen (240.2), Publication Number 100-3, Version Number 1, Effective Date, 10/27/1993

16. Farley, Donna O., Lisa R. Shugarman, Pat Taylor, J. Scott Ashwood. Medicare Rural Payment Issues: Primary Care Services and Geographic Definitions. PM-1388-CMS, July 2002. Accessed 2/3/2017 at URL address: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and- Reports/Reports/downloads/farley3_2002_3.pdf

17. Agency for Healthcare Research and Quality, Project Title: Noninvasive Positive-Pressure Ventilation (NPPV) for Acute Respiratory Failure, April 21, 2011. Accessed 2/3/2017 at URL address: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and- reports/?pageaction=displayproduct&productid=662

18. Correct Coding and Coverage of Ventilators – Revised Effective May 2016 Accessed 2/3/2017 at URL address: https://www.dmepdac.com/resources/articles/2016/05_24_16b.html

19. FDA Premarket Notification Database accessed 2/3/2017 at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

20. British Thoracic Society/Intensive Care Society (BTS/ICS) guideline on ventilator management of acute hypercapnic respiratory failure in adults, accessed 1/21/2019 at URL https://thorax.bmj.com/content/thoraxjnl/71/Suppl_2/ii1.full.pdf

21. Implementation of a Bundled Payment for Multi-Component Durable Medical Equipment (DME). Available at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10854.pdf

22. FDA VOCSN Unified Respiratory System. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162877.pdf

23. Hayes, Inc. Hayes Search and Summary. VOCSN Unified Respiratory System (Ventec Life Systems Inc.). Lansdale, PA Hayes, Inc. January 11, 2019.

24. Agency for Healthcare Research and Quality Noninvasive Positive Pressure Ventilation in the Home Final Technology Assessment Project ID: PULT0717 2/4/2020, accessed 2/5/2020. Available at https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/hmv/hmv-ta-fullreport.pdf

25. Agency for Healthcare Research and Quality Evidence-based Practice Center Systematic Review Protocol Project Title: Home Mechanical Ventilators Project ID: PULT0717 Initial publication date: February 2, 2018 accessed 2/5/2020. Available at https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/topicrefinement/hmv-protocol.pdf

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

HCPCS

* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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