Local Coverage Determination (LCD)

Diagnostic Aerosol or Vapor Inhalation

L33969

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L33969
Original ICD-9 LCD ID
Not Applicable
LCD Title
Diagnostic Aerosol or Vapor Inhalation
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 10/01/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A

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Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Diagnostic Aerosol or Vapor Inhalation. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Diagnostic Aerosol or Vapor Inhalation and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

Internet Only Manual (IOM) Citations:

  • CMS IOM Publication 100-08, Medicare Program Integrity Manual,
    • Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

  • Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. 
  • Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations. 
  • Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

History/Background and/or General Information

Aerosol or vapor inhalation involves the administration of drugs or solution of drugs by the nasal or oral respiratory route for local or systemic effect. The drugs or solution of drugs commonly administered via a nebulizer or aerosol include distilled water, hypertonic saline, and bronchodilators such as anticholinergics and B-Agonists.

Inhalation therapy is used in the therapeutic treatment of patients with known lung disease, as well as for producing bronchodilation, mobilizing sputum, and inducing sputum production for diagnostic purposes.

This policy addresses the use of aerosol or vapor inhalation for sputum mobilization, bronchodilation, and sputum induction for diagnostic purposes.

If a patient is unable to produce sputum, inhalation of a nebulized solution of 3 or 4 ml of distilled water or hypertonic sodium chloride results in the induction of an adequate specimen for examination. Any type of nebulizer may be used; however, ultrasonic nebulizers, which produce a concentrated mist, are preferred. The procedure is terminated when an adequate specimen is obtained, the nebulizer solution is exhausted, or after a maximum of 15-20 minutes. The procedure is most often used for patients suspected of having tuberculosis or a lung malignancy, and to search for Pneumocystis carinii infection in patients with the acquired immunodeficiency syndrome (AIDS).

Covered Indications

The use of an aerosol or vapor inhalation for diagnostic purposes will be considered medically reasonable and necessary for the following indications:

  • For the induction/mobilization of sputum in a patient who presents with signs and symptoms of a respiratory infection (e.g., fever, dyspnea, chest congestion, cough) or suspected lung malignancy, and who is unable to produce an adequate sputum specimen for examination by conventional methods;
  • For the induction/mobilization of sputum in a patient who continues to demonstrate signs and symptoms of a respiratory infection (e.g., fever, dyspnea, chest congestion, cough) despite antibiotic treatment, and who is unable to produce an adequate sputum specimen for follow-up examination by conventional methods; and/or
  • To produce bronchodilation prior to a pulmonary function test (PFT), when the patient’s functional ability to perform the test is decreased and would otherwise result in an inconclusive finding.

Limitations

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
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Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

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N/A

CPT/HCPCS Codes

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N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

Please refer to the Local Coverage Article: Billing and Coding: Diagnostic Aerosol or Vapor Inhalation (A57058) for documentation requirements that apply to the reasonable and necessary provisions outlined in this LCD.

Utilization Guidelines

Please refer to the Local Coverage Article: Billing and Coding: Diagnostic Aerosol or Vapor Inhalation (A57058) for utilization guidelines that apply to the reasonable and necessary provisions outlined in this LCD.

Sources of Information

First Coast Service Options, Inc. reference LCD number – L28855

Bibliography
  1. Fauci A, Braunwald E, Isselbacher K, et al. Harrison’s principles of internal medicine. 14th ed. New York: McGraw-Hill; 1998.
  2. van den Berg J, Kerstjens H, Postma D, van der Bij W, Koeter G. Sputum Induction in Research: Beware of the Beast. Am J Respir Crit Care. 2003;168(10):1253. Accessed September 28, 2005.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
10/01/2019 R4

Revision Number: 4
Publication: September 2019 Connection
LCR A2019-004

Explanation of Revision: Based on CR 10901, the LCD was revised to remove all billing and coding and all language not related to reasonable and necessary provisions (“Bill Type Codes”, “Revenue Codes”, “CPT/HCPCS Codes”, “ICD-10 Codes that Support Medical Necessity”, “Documentation Requirements” and “Utilization Guidelines” sections of the LCD) and place them into a newly created billing and coding article. In addition, during the process of moving the ICD-10-CM diagnosis codes to the billing and coding article, the ICD-10-CM diagnosis code ranges were broken out and listed individually. The effective date of this revision is for claims processed on or after January 8, 2019, for dates of service on or after October 3, 2018.

Also, the following unspecified ICD-10-CM diagnosis codes were removed as it is the provider’s responsibility to code to the highest level of specificity: C34.00, C34.10, C34.30, C34.80, C34.90, C78.00, C78.30, D02.20, D14.30, J18.9, J43.9, J45.901, J45.902, J45.909, J96.00, J96.10, J96.20, J96.90, J96.91, J96.92, R04.9, R06.00, T48.905A, T48.905D, and T48.905S. The effective date of this revision is for dates of service on or after 11/12/2019.

In addition, based on CR 11333 (Annual 2020 ICD-10-CM Update) the newly created billing and coding article was revised. The descriptor was revised for ICD-10-CM diagnosis code J44.0. The effective date of this revision is for dates of service on or after 10/01/2019.

10/01/2019: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this LCD.

  • Revisions Due To ICD-10-CM Code Changes
  • Other (Other revisions based on CRs 10901, 11333)
10/01/2017 R3

 

Revision Number:  3

 

Based on CR 10153 (2018 ICD-10 Update) LCD was evaluated and impacts identified.  The new ICD-10-CM changes are effective for dates of service on or after 10/01/2017.

 

  • Revisions Due To ICD-10-CM Code Changes
01/01/2016 R2 Revision Number: 1
Publication: December 2015 Connection
LCR A2016-001

Explanation of revision: Annual 2016 HCPCS Update. Descriptor revised for CPT code 94640. The effective date of this revision is based on date of service.
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2015 R1 The language and/or ICD-10-CM diagnoses were updated to be consistent with the current ICD-9-CM LCD’s language and coding.
  • Provider Education/Guidance
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Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
10/02/2019 10/01/2019 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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