Local Coverage Determination (LCD)

Implantable Infusion Pump

L33461

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
Palmetto GBA	A and B MAC	10112 - MAC B	J - J	Alabama
Palmetto GBA	A and B MAC	10212 - MAC B	J - J	Georgia
Palmetto GBA	A and B MAC	10312 - MAC B	J - J	Tennessee
Palmetto GBA	A and B and HHH MAC	11202 - MAC B	J - M	South Carolina
Palmetto GBA	A and B and HHH MAC	11302 - MAC B	J - M	Virginia
Palmetto GBA	A and B and HHH MAC	11402 - MAC B	J - M	West Virginia
Palmetto GBA	A and B and HHH MAC	11502 - MAC B	J - M	North Carolina

LCD Information

Document Information

LCD ID
L33461

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 03/07/2024

Revision Ending Date
N/A

Retirement Date
N/A

Notice Period Start Date
12/15/2016

Notice Period End Date
01/29/2017

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Issue

Issue Description

This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity.

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 CFR §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

Contractor Advisory Committee (CAC) Meetings

MAC Meeting Information URLs

Proposed LCD Posting Date

Comment Period Start Date

Comment Period End Date

Reason for Proposed LCD

Requestor Name	Requestor Letter
	View Letter

Requestor Information

Contact for Comments on Proposed LCD

Coding Information

ICD-10-CM Codes that Support Medical Necessity

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

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

Azur Pharma Inc. (2010). PRIALT®: Highlights of prescribing information. Philadelphia, PA: Author.

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.

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation	Reasons for Change
03/07/2024	R22	Under *Bibliography* removed the following source: “Implantable Infusion Pumps,” Florida, Medicare Part B” as it is no longer accessible and changes were made to citations to reflect AMA citation guidelines.	Provider Education/Guidance
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 21^stCentury 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 21^stCentury 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 21^stCentury 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 21^stCentury 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 21^stCentury 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 21^stCentury 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)

Associated Documents

Attachments
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Updated On	Effective Dates	Status
03/01/2024	03/07/2024 - N/A	Currently in Effect	You are here
07/09/2021	07/15/2021 - 03/06/2024	Superseded	View
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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Implantable Infusion Pump

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