Local Coverage Determination (LCD)

Implantable Infusion Pump

L33461

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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
L33461
Original ICD-9 LCD ID
Not Applicable
LCD Title
Implantable Infusion Pump
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL33461
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 07/15/2021
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
12/15/2016
Notice Period End Date
01/29/2017
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

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Issue

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

CMS National Coverage Policy

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

Title XVIII Social Security Act, §1862(a)(1)(D) addresses items and services related to research and experimentation.

42 Code of Federal Regulations, §411.15(k)(1) defines particular services excluded from coverage.

CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §50 Drugs and Biologicals, §50.1 Definition of Drug or Biological, §50.4.1 Approved Use of Drug, §50.4.2 Unlabeled Use of Drug, §50.4.3 Examples of Not Reasonable and Necessary, §50.4.7 Denial of Medicare Payment for Compounded Drugs Produced in Violation of Federal Food, Drug, and Cosmetic Act

CMS Internet-Only Manual, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, §280.14 Infusion Pumps

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

The implantable pump is a sealed, self-powered system, which is inserted under the skin by a physician. It provides a continuous controlled infusion of a drug to a select body site and can be refilled by percutaneous injection. Two separate ports are available: 1 for bolus injections and 1 for continuous infusion. Both may be utilized for blood or cerebrospinal fluid (CSF) withdrawals. An implantable infusion pump is utilized to administer many types of medications through the intra-arterial, intrathecal or epidural route.

Medicare will consider implantable infusion pumps, and associated services, medically reasonable and necessary for the conditions listed in the CMS Internet-Only Manual, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, §280.14 Infusion Pumps.

For the indication of opioid drugs used for the treatment of chronic intractable pain, it is useful to distinguish between pain caused by a malignancy from which the patient is not expected to recover from those non-malignant conditions that are longer term in nature. For terminal malignant conditions, the progression from a non-invasive pain control modality to a more invasive modality, such as use of an implanted pump, may occur more rapidly with less emphasis on behavioral approaches to pain control.

Ziconotide (Prialt®) intrathecal infusion documentation must meet the Food and Drug Administration (FDA)-approved indication that the patient is intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies or intrathecal therapy morphine in the treatment of severe, chronic pain.


Contraindication

The implantation of an infusion pump is contraindicated in the following patients:

    • Those with a known allergy or hypersensitivity to the drug being used (e.g., oral baclofen and morphine)
    • Those who have an infection
    • Those whose body size is insufficient to support the weight and bulk of the device

In those patients with other implanted programmable devices, since crosstalk between devices may inadvertently change the prescription, it is recommended that all devices be checked for possible crosstalk at the time of implantation of the infusion pump, and that appropriate surveillance for such interactions be continued.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
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
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

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

As stated in the applicable section of the Local Coverage Determination (LCD), medical record documentation maintained in the patient's file should support indications. This information is normally found in the office records, history and physical and/or Certificate of Medical Necessity (CMN).

If the indication for the implantable infusion pump is for reasons other than chemotherapy for liver cancer (primary hepatocellular carcinoma or Duke's Class D colorectal cancer in whom the metastases are limited to the liver), antispasmodic drugs for severe spasticity, or opioid drugs for treatment of chronic intractable pain, or the diagnosis is not indicated in the applicable covered indication, documentation supporting medical necessity for the pump and/or medication must be submitted with the redetermination request.

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

Sources of Information
N/A
Bibliography

Brown, DL. Regional Anesthesia & Analgesia. 3rd Ed. Philadelphia, PA: W.B. Saunders; 1996.

Dorland's Illustrated Medical Dictionary. 28th Ed. Philadelphia, PA: W.B. Saunders; 1994.

Drug Facts and Comparisons®. St. Louis, MO; 2016.

Nursing 2008 Drug Handbook. 28th Ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2008.

Salerno E, Willens J. Pain Management Handbook: An interdisciplinary approach. St. Louis, MO; 1996.

Other Contractor Local Coverage Determinations

“Implantable Infusion Pumps,” Florida, Medicare Part B.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
07/15/2021 R21

Punctuation and typographical errors were corrected throughout the LCD.

  • Provider Education/Guidance
11/12/2020 R20

Under CMS National Coverage Policy removed the regulation CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 3, §3.4.1.3. Under Coverage Indications, Limitations and/or Medical Necessity added hyperlink for FDA indications. Under Associated Information removed the verbiage “Ziconotide (Prialt®) intrathecal infusion documentation must meet the Food and Drug Administration (FDA)-approved indication that the patient is intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies or intrathecal therapy morphine in the treatment of severe, chronic pain” and added under Coverage Indications, Limitations and/or Medical Necessity section of this LCD. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted 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
10/24/2019 R19

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: Billing and Coding: Implantable Infusion Pump A56695 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
07/11/2019 R18

All coding located in the Coding Information section and all verbiage regarding billing and coding under the Coverage Indications, Limitations and/or Medical Necessity section has been removed and is included in the related Billing and Coding: Implantable Infusion Pump A56695 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
10/01/2018 R17

Under ICD-10 Codes That Support Medical Necessity Group 3: Codes deleted ICD-10 codes C43.11, C43.12, C44.102, C44.109, C44.112, C44.119, C44.122, C44.129, C44.192, C44.199, D03.11, D03.12, D04.11, D04.12, D22.11, D22.12, D23.11, and D23.12. Under ICD-10 Codes That Support Medical Necessity Group 3: Codes added ICD-10 codes C43.111, C43.112, C43.121, C43.122, C4A.111, C4A.112, C4A.121, C4A.122, C44.1021, C44.1022, C44.1091, C44.1092, C44.1121, C44.1122, C44.1191, C44.1192, C44.1221, C44.1222, C44.1291, C44.1292, C44.1321, C44.1322, C44.1391, C44.1392, C44.1921, C44.1922, C44.1991, and C44.1992. This revision is due to the Annual ICD-10 Code Update and becomes effective October 1, 2018.

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
08/16/2018 R16

Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting was corrected throughout the policy.

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
02/26/2018 R15

Under CPT/HCPCS Codes Group 1: Paragraph, added bupivacaine to the first sentence. This revision is effective for dates of service on and after 02/26/2018.

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
  • Public Education/Guidance
02/26/2018 R14 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 R13

Under CMS National Coverage Policy for Title XVIII of the Social Security Act, §1862(a)(1)(A) revised the verbiage to read “allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member”. For Title XVIII of the Social Security Act, §1833(e) revised the verbiage to read “prohibits Medicare payment for any claim lacking the necessary information to process that claim”. Under Associated Information – Documentation Requirements revised the fourth sentence to read “Documentation supporting medical necessity should be legible, maintained in the patient’s medical record and made available to the A/B MAC upon 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.

 

  • Provider Education/Guidance
10/01/2017 R12

Under ICD-10 Codes that Support Medical Necessity Group 3: Codes deleted ICD-10 codes C96.2, D47.0 and M48.06 and added C96.20, C96.21, C96.22, C96.29, M48.061 and M48.062. These revisions are due to the 2017 Annual ICD-10 Updates.

  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
06/12/2017 R11 Under CPT/HCPCS Codes Group 1: Paragraph: Note: added the second and third paragraph, added CPT codes J2278KD and J9200KD and revised the language for the asterisk. Under CPT/HCPCS Codes Group 1: Codes added CPT codes 62322, 62323, 62326, J2278 and J9200.
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
01/30/2017 R10 Under Coverage Indications, Limitations and/or Medical Necessity in the second paragraph bullet added CPT code 62327. Under CPT/HCPCS Codes Group 1: Paragraph added the following: * CPT 62327 should be reported for trial infusions prior to permanent pump implantation. Under CPT/HCPCS Codes Group 1: Codes added 62327. Under ICD-10 Codes That Support Medical Necessity added CPT code 62327 to the Group 2: Paragraph and the Group 3: Paragraph. This revision is due to the 2017 Annual CPT/HCPCS Code Update and becomes effective 1/1/17.
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
10/13/2016 R9 Under CMS National Coverage Policy for Title XVIII of the Social Security Act, §1862(a)(1)(A) revised the verbiage to read “allows coverage and payment for only those services that are considered to be medically reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member”. For Title XVIII of the Social Security Act, §1833(e) revised the verbiage to read “prohibits Medicare payment for any claim lacking the necessary information to process that claim”. Capitalization, punctuation, typographical errors and titles to cited references were corrected.
  • Provider Education/Guidance
  • Typographical Error
10/01/2016 R8 Under ICD-10 Codes That Support Medical Necessity: Group 1 added C49.A0, C49.A1, C49.A2, C49.A3, C49.A4, C49.A5 and C49.A9. Under ICD-10 Codes That Support Medical Necessity: Group 3 added C49.A0, C49.A1, C49.A2, C49.A3, C49.A4, C49.A5, C49.A9, D49.511, D49.512, G56.13, G56.23, G56.33, G56.43, G57.03, G57.13, G57.23, G57.33, G57.43, G57.63, G57.73, G61.82, M25.541, M25.542, M50.020, M50.021, M50.022, M50.023, M50.121, M50.122, M50.123, M50.221, M50.222, M50.223, M50.321, M50.322 and M50.323. Under ICD-10 Codes That Support Medical Necessity: Group 3 deleted D49.5, M50.02, M50.12, M50.22, M50.32, M50.82 and M50.92. Under ICD-10 Codes That Support Medical Necessity: Group 3 the code descriptions changed for C81.10, C81.11, C81.12, C81.13, C81.14, C81.15, C81.16, C81.17, C81.18, C81.19, C81.20, C81.21, C81.22, C81.23, C81.24, C81.25, C81.26, C81.27, C81.28, C81.29, C81.30, C81.31, C81.32, C81.33, C81.34, C81.35, C81.36, C81.37, C81.38, C81.39, C81.40, C81.41, C81.42, C81.43, C81.44, C81.45, C81.46, C81.47, C81.48, C81.49, C81.70, C81.71, C81.72, C81.73, C81.74, C81.75, C81.76, C81.77, C81.78 and C81.79. This revision is due to the Annual ICD-10 Code Update and becomes effective October 1, 2016.
  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
07/25/2016 R7 Under CPT/HCPCS Codes Group 1: Paragraph removed fluxuride and added sufentanil and clonidine.
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
01/01/2016 R6 Under CPT/HCPCS Codes section and ICD-10 Codes that Support Medical Necessity paragraph sections for Group 1, 2 and 3 HCPCS code Q9977 was deleted and HCPCS code J7999 was added due to the CPT/HCPCS Annual Update for 2016.
  • Revisions Due To CPT/HCPCS Code Changes
11/26/2015 R5 Under HCPCS/CPT Codes removed Q9977 from the paragraph section to the HCPCS/CPT code array. Under ICD-10 that Support Medical Necessity, Group 2, added ICD-10 code S14.134D.
  • Provider Education/Guidance
  • Automated Edits to Enforce Reasonable & Necessary Requirements
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R4 Under Coverage Indications, Limitations and/or Medical Necessity removed J7799 in first bullet and replaced it with the new HCPCS code which is more specific for compounded drugs, Q9977. Under CPT/HCPCS Codes section, Group 1 paragraph, removed J7799KD* NOC drugs, other than inhalation drugs, administered through DME and inserted Q9977 compounded drug, not otherwise classified. Under ICD-9 codes that Support Medical Necessity for Group 2 and Group 3 added new HCPCS code Q9977 compounded drug, not otherwise classified, in the paragraph section for these two Groups. Removed HCPCS code J7799 and replace it with HCPCS code Q9977; this was a better code to use for the compounding of drugs. The change was due to CR 9167 Quarterly HCPCS Code Changes - July 2015 Update.
  • Provider Education/Guidance
  • Automated Edits to Enforce Reasonable & Necessary Requirements
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2015 R3 Under Sources of Information and Basis for Decision removed the reference United States Pharmacopeia Drug Information as this book is no longer accessible in our department. Updated Pain Management Handbook: An interdisciplinary approach with second author and publication site. Updated Nursing 2008 Drug Handbook with most recent edition available and publisher name.
  • Provider Education/Guidance
10/01/2015 R2 Under ICD-10 Codes that Support Medical Necessity the following ICD-10 codes were deleted from Group 2: M47.17 and M47.18, Group 3: M47.17, M47.18, and M51.07. The following ICD-10 codes had descriptor changes in Group 3: M50.01, M50.11, M51.21, M50.31, M50.81 and M50.91. These changes are due to the 3rd quarter ICD-10 code update from CMS. These changes are effective on July 1, 2014.
  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R1 Under Coverage Indications, Limitations and/or Medical Necessity, subtitle "Contraindication" removed the 4th bullet and the statement, "Those with other implanted programmable devices, since crosstalk between devices may inadvertently change the prescription" and inserted the statement, "In those patients with other implanted programmable devices, since crosstalk between devices may inadvertently change the prescription, it is recommended that all devices be checked for possible crosstalk at the time of implantation of the infusion pump, and that appropriate surveillance for such interactions be continued."
  • Provider Education/Guidance
  • Request for Coverage by a Practitioner (Part B)
N/A

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
07/09/2021 07/15/2021 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • Implantable Infusion Pump
  • Infusion Pump

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