Local Coverage Determination (LCD)

Respiratory Therapy and Oximetry Services

L33446

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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
L33446
Original ICD-9 LCD ID
Not Applicable
LCD Title
Respiratory Therapy and Oximetry Services
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 06/24/2021
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

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member

42 CFR §410.32(b) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions

42 CFR §411.15(k)(1) Particular services excluded from coverage

CMS Internet-Only Manual, Pub. 100-01, Medicare General Information, Eligibility and Entitlement Manual, Chapter 1, §10.3 Supplementary Medical Insurance (Part B) - A Brief Description

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 6, §10 Medical and Other Health Services Furnished to Inpatients of Participating Hospitals, §20 Outpatient Hospital Services, §20.2 Outpatient Defined, and §20.4.1 Diagnostic Services Defined

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §70 Sleep Disorder Clinics and §80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 16, §20 Services Not Reasonable and Necessary

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Respiratory therapy services provided in a facility are usually the responsibility of the facility’s nursing staff and/or respiratory therapy department.

Payment to a physician may be allowed for respiratory services only when the services are rendered as an integral, although incidental, part of the physician’s professional services in the course of diagnosis or treatment of an injury or illness. It is expected that respiratory therapy services will most often be used in cases of acute respiratory disease or acute exacerbation of chronic disease. Nevertheless, selected chronic stable conditions could require respiratory services. Acute disease states are expected to either subside after a short period of treatment, or, if no response occurs, transfer the patient to a higher level of care. 

  • Respiratory therapy services performed in a nursing facility or office setting may be eligible for payment to a physician if 1 of the following conditions is met:
    • The service is personally performed by the physician or qualified Non-Physician Practitioner (NPP) if provision of the service is within the scope of his/her license.
       or,
    • The service is performed by ancillary personnel employed by the physician, under the direct personal supervision of the physician, and is furnished during a course of treatment in which the physician performs an initial service and subsequent service(s), which reflect his/her active participation in and management of the course of treatment.

 Medically necessary reasons for pulse oximetry include: 

  • The patient exhibits signs or symptoms of acute respiratory dysfunction such as:
    • Tachypnea
    • Dyspnea
    • Cyanosis
    • Respiratory distress
    • Confusion
    • Hypoxia
  • The patient has chronic lung disease, severe cardiopulmonary disease, or neuromuscular disease involving the muscles of respiration, and oximetry is needed for at least 1 of the following reasons:  
    • Initial evaluation to determine the severity of respiratory impairment
    • Evaluation of an acute change in condition
    • Evaluation of exercise tolerance in a patient with respiratory disease
    • Evaluation to establish medical necessity of an oxygen therapeutic regimen
  • The patient has sustained severe multiple trauma or complains of acute severe chest pain
  • The patient is under treatment with a medication with known pulmonary toxicity and oximetry is medically necessary to monitor for potential adverse effects of therapy

Note:

*The results of tests performed by a durable medical equipment (DME) supplier or their employees to qualify patients for home oxygen service are not covered.

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
N/A
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

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N/A

Revenue Codes

Code Description

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N/A

CPT/HCPCS Codes

Please accept the License to see the codes.

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

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Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

Documentation that supports the medical necessity of the respiratory therapy services and shows it is an integral, although incidental part of the physician’s professional services, must be included in the patient’s medical records and be available to the A/B MAC upon request. In addition to the physician’s initial assessment (history and physical examination), the documentation might include: 

  • Physician’s orders
  • Plan of treatment
  • The patient’s response to treatment
  • An ongoing assessment for the patient’s continued need for treatment
  • In case of consecutive days of care, the medical record should indicate why the patient was not transferred to a higher level of care
  • Documentation of frequency must be consistent with the patient plan of care (POC)

When multiple medications are administered and the medications cannot be mixed and administered at 1 time, the patient’s record must be documented to explain the medical necessity for the separate administrations. 

Continuous Overnight Oximetry

The patient's record must document that the oximeter is preset and self sealed and cannot be adjusted by the patient. In addition, the device must provide a printout that documents an adequate number of sampling hours, percent of oxygen saturation, and an aggregate of the results. This information must be available if requested. In all instances, there must be a request documented in the medical record from the treating physician for these services.

Documentation supporting medical necessity should be legible, maintained in the patient's medical record, and must be made available to the A/B MAC upon request. 

Utilization Guidelines

In outpatient or home management for patients with chronic cardiopulmonary problems, oximetric determinations once or twice a year are considered reasonable. In all instances, there must be a documented request by a physician/NPP in the medical record for these services. Regular or routine testing will not be allowed for reimbursement. In all circumstances, testing would be expected to be useful in the continued management of a patient particularly in acute exacerbations or unstable conditions (e.g., acute bronchitis in a patient with Chronic Obstructive Pulmonary Disease (COPD)) where increased frequency of testing would be considered, on an individual consideration basis, for coverage purposes.

Only 1 service (oximetry determination) per day will be allowed for testing at a reasonable frequency and if medically necessary regardless of whether the patient is sitting, standing or lying, with or without exercise or oxygen use, unless medical necessity can be demonstrated for additional needs on an individual consideration basis.

More frequent testing may be allowed, on an individual consideration basis, when there is documentation of an acute exacerbation of a chronic pulmonary disease or other acute illnesses with signs indicating or suggesting increased hypoxemia.

Sources of Information
N/A
Bibliography

Bafadhel M, McKenna S, Terry S, et al. Blood eosinophils to direct corticosteroid treatment of exacerbations of chronic obstructive pulmonary disease: A randomized placebo-controlled trial. Am J Respir Crit Care Med. 2012;186(1):48-55.

Braunwald E, Fauci AS, Kasper DL, Hauser SL, Longo DL, Jameson JL. Harrison’s Principles of Internal Medicine. 15th ed. USA: McGraw-Hill Professional; 2001.

Filart RA, Bach JR. Pulmonary physical medicine interventions for elderly patients with muscular dysfunction. Clin Geriatr Med. 2003;19(1):189-204.

Garcha DS, Thurston SJ, Patel AR, et al. Changes in prevalence and load of airway bacteria using quantitative PCR in stable and exacerbated COPD. Thorax. 2012;67(12):1075-1080.

International Classification of Functioning, Disability and Health (ICF). Geneva: World Health Organization (WHO); 2001.

Miravitlles M. Long-term antibiotics in COPD: More benefit than harm? Prim Care Respir J. 2013;22(3):261-262.

Mahler DA, Fierro-Carrion G, Baird JC. Evaluation of dyspnea in the elderly. Clin Geriatr Med. 2003;19(1):19-33.

Schermer T, Leenders J, in't Veen H , et al. Pulse oximetry in family practice: Indications and clinical observations in patients with COPD. Fam Pract. 2009;26(6):524-531.

Seemungal TA, Wilkinson TM, Hurst JR, Perera WR, Sapsford RJ, Wedzicha JA. Long-term erythromycin therapy is associated with decreased chronic obstructive pulmonary disease exacerbations. Am J Respir Crit Care Med. 2008;178(11):1139-1147.

Serisier DJ. Risks of population antimicrobial resistance associated with chronic macrolide use for inflammatory airway diseases. Lancet Respir Med. 2013;1(3):262-274.

Taiwo OA, Cain HC. Pulmonary impairment and disability. Clin Chest Med. 2002;23(4):841-851.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
06/24/2021 R15

Under CMS National Coverage Policy updated section headings for regulations. Under Bibliography changes were made to citations to reflect AMA citation guidelines. Punctuation and typographical errors were corrected throughout the LCD.

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 policy.

  • Provider Education/Guidance
10/24/2019 R14

This LCD is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: Respiratory Therapy and Oximetry Services A56730 article.

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 policy.

  • Provider Education/Guidance
07/25/2019 R13

All coding located in the Coding Information section has been moved into the related Billing and Coding: Respiratory Therapy and Oximetry Services A56730 article and removed from the LCD. 

All verbiage regarding billing and coding under the Coverage Indications, Limitations and/or Medical Necessity section and the Associated Information section has been removed and is included in the related Billing and Coding: Respiratory Therapy and Oximetry Services A56730 article. Formatting was corrected throughout the LCD. 

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 policy.

  • Provider Education/Guidance
07/04/2019 R12

Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted and defined where appropriate throughout the LCD. 

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 policy.

  • Provider Education/Guidance
10/26/2018 R11

Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 code R06.2.

  • Provider Education/Guidance
  • Reconsideration Request
10/26/2018 R10

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes ICD-10 codes I78.0 and Q25.72 have been added. This revision is due to a reconsideration request.

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 policy.

 

  • Reconsideration Request
05/10/2018 R9

Punctuation was corrected and words were capitalized or changed to lower case as appropriate throughout the policy. CPT® was inserted throughout the policy where applicable. Under CMS National Coverage Policy removed italics from the CMS Internet Only Manual regulations. Under Coverage Indications, Limitations and/or Medical Necessity added “/her” to the first and second sub-bullet. Under Note: added CPT® code 94762 in the first and second sentence in the first paragraph and revised “his” to now read “their” in the last paragraph. Under CPT/HCPCS Codes Group 1: Paragraph added verbiage related to CPT® codes 94760, 94761, and 94762.  The Group 2: Paragraph and Group 2: Codes were added. Under Bibliography changes were made to citations to reflect AMA citation guidelines. The author initials were revised for Jameson in the second citation.

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 policy.

  • Provider Education/Guidance
  • Typographical Error
02/26/2018 R8 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
10/01/2017 R7

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added ICD-10 codes I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89 and R06.03 and the code description was revised for J15.6. Under ICD-10 Codes that Support Medical Necessity Group 2: Codes deleted ICD-10 code I27.2, added I27.20, I27.21, I27.22, I27.23, I27.24, I27.29, I27.83, I50.810, I50.811, I50.812, I50.813, I50.814, I50.82, I50.83, I50.84, I50.89 and R06.03 and the code description was revised for I50.1. These revisions are due to the 2017 Annual ICD-10 Updates.

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 policy.

  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
06/05/2017 R6 Under ICD-10 Codes that Support Medical Necessity - created Group 2 Paragraph with verbiage “Medicare is establishing the following limited coverage for CPT/HCPCS code 94762:” Under ICD-10 Codes that Support Medical Necessity Group 2: Codes – added codes G47.10, G47.30, G47.31, G47.32, G47.33, G47.34, G47.35, G47.36, G47.37, I26.01, I26.90, I27.0, I27.2, I27.81, I27.82, I27.89, I27.9, I50.1, I50.20, I50.21, I50.22, I50.23, I50.30, I50.31, I50.32, I50.33, I50.40, I50.41, I50.42, I50.43, I50.9, J43.0, J43.1, J43.2, J43.8, J43.9, J44.9, R09.01, R09.02, R40.0, R40.1, R68.13, Z86.74. Under Group 2 Medical Necessity ICD-10 Codes Asterisk Explanation: *Note: - added “These codes are to be used only for those patients who exhibit signs and symptoms of oxygen deprivation (supported by the patients medical record).”
  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
10/01/2016 R5 Under ICD-10 Codes That Support Medical Necessity added J95.860, J95.861, J95.862, J95.863, J98.51 and J98.59. This revision is due to the Annual ICD-10 Code Update and becomes effective 10/01/16.
  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
06/23/2016 R4 Under CMS National Coverage Policy for 42 CFR §410.32(b) the title “diagnostic x-ray and other diagnostic tests” was removed and replaced with the full title “Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions” and for 42 CFR §411.15(k)(1) the title “diagnosis or treatment of illness” was removed and replaced with the title “Particular services excluded from coverage”. Under Coverage Indications, Limitations and/or Medical Necessity revised the sentence in the second paragraph from “Nevertheless, selected chronic stable conditions could require the services.” to now read “Nevertheless, selected chronic stable conditions could require respiratory services.” The word “The” was added to the beginning of the sentences “Patient exhibits signs or symptoms of acute respiratory dysfunction such as:” and “Patient has chronic lung disease, severe cardiopulmonary disease, or neuromuscular disease involving the muscles of respiration, and oximetry is needed for at least one of the following reasons:”. The word “an” was added to the verbiage “Evaluation to establish medical necessity of oxygen therapeutic regimen” to read “Evaluation to establish medical necessity of an oxygen therapeutic regimen”. The word “The” was added to the beginning of the sentences “Patient has sustained severe multiple trauma or complains of acute severe chest pain.” and “Patient is under treatment with a medication with known pulmonary toxicity and oximetry is medically necessary to monitor for potential adverse effects of therapy.” Under CPT/HCPCS Codes-Group 1: Paragraph removed the verbiage “Note: Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book. The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web”. Under ICD-10 Codes that Support Medical Necessity removed the verbiage “Note: Providers should continue to submit ICD-10-CM diagnosis codes without decimals on their claim forms and electronic claims.”. Under Associated Information – Documentation Requirements the word “carrier” was deleted in the first paragraph and replaced with the verbiage “A/B MAC” .The letter “s” was removed from the word “records” in the second paragraph and the word “the” was removed from the verbiage in the fifth paragraph. Under Sources of Information and Basis for Decision supplement numbers, page numbers and author’s names were added throughout this section. Punctuation and capitalization were corrected throughout the policy.
  • Provider Education/Guidance
  • Typographical Error
01/01/2016 R3 The description changed for CPT code 94640 under the CPT/HCPCS Codes section.
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2015 R2 Under CMS National Coverage Policy for citation CMS IOM Pub 100-01 Chapter 1 removed reference to §10.1 and 10.2; for citation CMS IOM Pub 100-02 Chapter 6 removed §70. Under Sources of Information and Basis for Decision corrected citations to meet 508 compliance and corrected the spelling of exacerbations.
  • Provider Education/Guidance
  • Typographical Error
  • Other (Annual Validation)
10/01/2015 R1 In CMS National Coverage Policy added “CMS” to all Internet-Only Manual citations. Added citations for Internet-Only Manuals Pub 100-01 Sections 10.1, 10.2, and 10.3 as well as Pub 100-02 Chapter 6 Sections 10, 20, 20.2, 20.4.1, and 70. Removed “sleep disorder clinics and diagnostic tests”. In Sources of Information and Basis for Decision removed “Describes that the prevalence of dyspnea in the elderly could be as high as 38% and raises the question of how much of this is related to obesity and deconditioning as opposed to actual pulmonary impairments” and “Describes the role of both PFTs and CPET in the evaluation of pulmonary impairments.” Also added source Miravitlles M. Long-term antibiotics in COPD: more benefit than harm? Prim care Respir Jour. 2013;22. Formatted all citations to comply with AMA formatting.
  • Other (Annual Validation)
N/A

Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
06/18/2021 06/24/2021 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • Therapy
  • Respiratory
  • Oximetry

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