CMS Manual System

Department of Health &
Human Services (DHHS)

Pub 100-04 Medicare Claims Processing

Centers for Medicare &
Medicaid Services (CMS)

Transmittal 1913

Date: February 5, 2010

Change Request 6775
SUBJECT: Outpatient Intravenous Insulin Treatment (Therapy)
I. SUMMARY OF CHANGES: Effective December 23, 2009, CMS determines that the evidence is
adequate to conclude that outpatient intravenous insulin therapy (OIVIT) does not improve health outcomes
in Medicare beneficiaries and is not reasonable and necessary under section 1862(a)(1)(A) of the Social
Security Act. Therefore, OIVIT and services comprising an OIVIT regimen are nationally non-covered by
Medicare.
NEW / REVISED MATERIAL
EFFECTIVE DATE: DECEMBER 23, 2009
IMPLEMENTATION DATE: MARCH 8, 2010
Disclaimer for manual changes only: The revision date and transmittal number apply only to red
italicized material. Any other material was previously published and remains unchanged. However, if this
revision contains a table of contents, you will receive the new/revised information only, and not the entire
table of contents.
II. CHANGES IN MANUAL INSTRUCTIONS: (N/A if manual is not updated)
R=REVISED, N=NEW, D=DELETED
R/N/D

CHAPTER / SECTION / SUBSECTION / TITLE

R

4/Table of Contents

N

4/320/Outpatient Intravenous Insulin Treatment (OIVIT)

N

4/320.1/HCPCS Coding for OIVIT

N

4/320.2/Medicare Summary Notices (MSNs), Reason Codes, and
Remark Codes

III. FUNDING:
SECTION A: For Fiscal Intermediaries and Carriers:
No additional funding will be provided by CMS; contractor activities are to be carried out within their
operating budgets.
SECTION B: For Medicare Administrative Contractors (MACs):
The Medicare Administrative Contractor is hereby advised that this constitutes technical direction as defined
in your contract. CMS does not construe this as a change to the MAC Statement of Work. The contractor is
not obligated to incur costs in excess of the amounts allotted in your contract unless and until specifically
authorized by the contracting officer. If the contractor considers anything provided, as described above, to
be outside the current scope of work, the contractor shall withhold performance on the part(s) in question
and immediately notify the contracting officer, in writing or by e-mail, and request formal directions
regarding continued performance requirements.

 IV. ATTACHMENTS:
Business Requirements
Manual Instruction
*Unless otherwise specified, the effective date is the date of service.

 Attachment - Business Requirements
Pub. 100-04

Transmittal: 1913

Date: February 5, 2010

Change Request: 6775

SUBJECT: Outpatient Intravenous Insulin Treatment (Therapy)
EFFECTIVE DATE: DECEMBER 23, 2009
IMPLEMENTATION DATE: MARCH 8, 2010
I. GENERAL INFORMATION
A. Background: The Centers for Medicare & Medicaid Services (CMS) internally generated a request for a
National Coverage Determination on Outpatient Intravenous Insulin Therapy (OIVIT). On December 23, 2009,
CMS issued a non-coverage decision on the use of OIVIT.
B. Policy: Effective December 23, 2009, CMS determines that the evidence is adequate to conclude that
OIVIT does not improve health outcomes in Medicare beneficiaries, is not reasonable and necessary under
section 1862(a)(1)(A) of the Social Security Act, and services comprising an OIVIT regimen are nationally noncovered under Medicare.
NOTE: A new HCPCS code effective December 23, 2009, to be implemented with the April 2010 Integrated
Outpatient Code Editor (IOCE) and Medicare Physician Fee Schedule Database (MPFSDB), was created for
use with this non-coverage decision.
NOTE: Effective April 5, 2010, HCPCS code 99199, unlisted special service, procedure, or report, is no longer
an appropriate code to be used for OIVIT. Effective April 5, 2010, HCPCS code 94681, exhaled air analysis
CO2, should not be used in conjunction with OIVIT or diabetes-related conditions (250.00-250.93). Claims
billed with these CPT codes will be returned to provider/returned as unprocessable to be billed with new code
G9147, Outpatient Intravenous Insulin Treatment (OIVIT) either pulsatile or continuous, by any means, guided
by the results of measurements for: respiratory quotient; and/or, urine urea nitrogen (UUN); and/or, arterial,
venous or capillary glucose; and/or potassium concentration.
II. BUSINESS REQUIREMENTS TABLE
Use“Shall" to denote a mandatory requirement
Number

6775.1

6775.2

Requirement

Effective for claims with dates of service on and after
December 23, 2009, contractors shall be aware that
OIVIT and services comprising an OIVIT regimen are
nationally non-covered by Medicare. See Pub. 100-03,
NCD Manual, section 40.7, and Pub. 100-04, Claims
Processing Manual, chapter 4, section 320, for specific
coverage and claims processing instructions.
Effective April 5, 2010, G9147 shall be used on claims

CMS / CMM / MCMG / DCOM
Change Request Form: Last updated 06 August 2008
Page 1

Responsibility (place an “X” in each applicable
column)
A
/
B

D
M
E

F
I

C
A
R
R
I
E
R

M
A
C

M
A
C

X

X

X

X

X

X

R
H
H
I

Shared-System
Maintainers
F
M V C
I
C
M W
S
S
S
F
S

OTHER

IOCE

 Number

6775.3

6775.3.1

Requirement

billing for non-covered OIVIT and any services
comprising an OIVIT regimen
Effective April 5, 2010, HCPCS code 99199 shall not be
used on claims billing for non-covered OIVIT and any
services comprising an OIVIT regimen.
Claims for non-covered OIVIT and any services
comprising an OIVIT regimen billed with HCPCS code
99199 shall be returned to provider/returned as
unprocessable using:

Responsibility (place an “X” in each applicable
column)
A
/
B

D
M
E

M
A
C

M
A
C

F
I

C
A
R
R
I
E
R

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Remittance Advice Remark Code (RARC) N56: The
procedure code billed is not correct/valid for the services
billed or the date of service billed.

6775.4

6775.4.1

CARC 11: The diagnosis is inconsistent with the
procedure.
RARC N56: The procedure code billed is not
correct/valid for the services billed or the date of service
billed.

6775.5

RARC MA66: Missing/incomplete/invalid principal
procedure code.
When denying claims for non-covered OIVIT and any
services comprising an OIVIT regimen billed with CPT
code G9147, contractors shall use:

CMS / CMM / MCMG / DCOM
Change Request Form: Last updated 06 August 2008
Page 2

Shared-System
Maintainers
F
M V C
I
C
M W
S
S
S
F
S

OTHER

MPFSDB
April 2010

Claims Adjustment Reason Code (CARC) 189: NOS or
unlisted procedure code (CPT/HCPCS) was billed when
there is a specific procedure code for this
procedure/service.

RARC MA66: Missing/incomplete/invalid principal
procedure code.
Effective April 5, 2010, HCPCS code 94681 shall not be
used on claims billing for non-covered OIVIT and any
services comprising an OIVIT regimen OR for claims
billing diabetes-related conditions 250.00-250.93.
Claims for non-covered OIVIT and any services
comprising an OIVIT regimen or claims billing diabetesrelated conditions 250.00-250.93 billed with HCPCS
code 94681 shall be returned to provider/returned as
unprocessable using:

R
H
H
I

 Number

Requirement

Responsibility (place an “X” in each applicable
column)
A
/
B

D
M
E

M
A
C

M
A
C

F
I

C
A
R
R
I
E
R

X

X

R
H
H
I

Shared-System
Maintainers
F
M V C
I
C
M W
S
S
S
F
S

OTHER

MSN 16.10: Medicare does not pay for these item(s) or
service(s)
CARC 96: Non-covered charge(s)
CARC M51: Missing/Incomplete /Invalid Procedure
Code(s)

6775.6

III.
Number

6775.7

RARC N386: This decision was based on an NCD. An
NCD provides a coverage determination as to whether a
particular item or service is covered. A copy of this
policy is available at
http://www.cms.hhs.gov/mcd/search.asp. If you do not
have web access, you may contact the contractor to
request a copy of the NCD.
X
For claims with dates of service between December 23,
2009, and April 5, 2010, contractors shall not search their
files, but may go back and adjust claims that are brought
to their attention.
PROVIDER EDUCATION TABLE
Requirement

A provider education article related to this instruction will
be available at
http://www.cms.hhs.gov/MLNMattersArticles/ shortly
after the CR is released. You will receive notification of
the article release via the established "MLN Matters"
listserv.
Contractors shall post this article, or a direct link to this
article, on their Web site and include information about it
in a listserv message within one week of the availability of
the provider education article. In addition, the provider
education article shall be included in your next regularly
scheduled bulletin. Contractors are free to supplement
MLN Matters articles with localized information that

CMS / CMM / MCMG / DCOM
Change Request Form: Last updated 06 August 2008
Page 3

Responsibility (place an “X” in each applicable
column)
A
/
B

D
M
E

M
A
C

M
A
C

X

F
I

C
A
R
R
I
E
R

X

X

R
H
H
I

Shared-System
Maintainers
F
M V C
I
C
M W
S
S
S
F
S

OTHER

 Number

Requirement

Responsibility (place an “X” in each applicable
column)
A
/
B

D
M
E

M
A
C

M
A
C

F
I

C
A
R
R
I
E
R

R
H
H
I

Shared-System
Maintainers
F
M V C
I
C
M W
S
S
S
F
S

OTHER

would benefit their provider community in billing and
administering the Medicare program correctly.
IV.

SUPPORTING INFORMATION

Section A: For any recommendations and supporting information associated with listed requirements,
use the box below:
Use "Should" to denote a recommendation.
X-Ref
Requirement
Number

Recommendations or other supporting information:

N/A
Section B: For all other recommendations and supporting information, use this space: N/A
V. CONTACTS
Pre-Implementation Contact(s): Patricia Brocato-Simons, coverage, 410-786-0261,
Patricia.Brocatosimons@cms.hhs.gov, William Ruiz, institutional claims processing, 410-786-9283,
William.Ruiz@cms.hhs.gov, Bridgitte Davis, Bridgitte.davis@cms.hhs.gov , 410-786-4573
Post-Implementation Contact(s): CMS ROs
VI. FUNDING
Section A: For Fiscal Intermediaries (FIs), Regional Home Health Intermediaries (RHHIs), and/or
Carriers:
No additional funding will be provided by CMS; contractor activities are to be carried out within their operating
budgets.
Section B: For Medicare Administrative Contractors (MACs):
The Medicare Administrative Contractor is hereby advised that this constitutes technical direction as defined in
your contract. CMS does not construe this as a change to the MAC Statement of Work. The contractor is not
obligated to incur costs in excess of the amounts allotted in your contract unless and until specifically
authorized by the contracting officer. If the contractor considers anything provided, as described above, to be
outside the current scope of work, the contractor shall withhold performance on the part(s) in question and
immediately notify the contracting officer, in writing or by e-mail, and request formal directions regarding
continued performance requirements.

CMS / CMM / MCMG / DCOM
Change Request Form: Last updated 06 August 2008
Page 4

 Medicare Claims Processing Manual
Chapter 4 - Part B Hospital
(Including Inpatient Hospital Part B and OPPS)
Table of Contents
(Rev.1913, 02-05-10)

320 – Outpatient Intravenous Insulin Treatment (OIVIT)
320.1 – HCPCS Coding for OIVIT
320.2 – Medicare Summary Notices (MSN), Reason Codes, and Remark Codes

 320 – Outpatient Intravenous Insulin Treatment (OIVIT)
(Rev. 1913, Issued: 02-05-10, Effective: 12-23-09, Implementation: 03-08-10)
Effective for claims with dates of service on and after December 23, 2009, the Centers for
Medicare and Medicaid Services (CMS) determines that the evidence is adequate to conclude
that OIVIT does not improve health outcomes in Medicare beneficiaries. Therefore, CMS
determines that OIVIT is not reasonable and necessary for any indication under section
1862(a)(1)(A) of the Social Security Act, and services comprising an OIVIT regimen are
nationally non-covered.
See Pub. 100-03, Medicare National Coverage Determinations Manual, Section 40.7, Outpatient
Intravenous Insulin Treatment (Effective December 23, 2009), for general information and
coverage indications.

320.1 – HCPCS Coding for OIVIT
(Rev. 1913, Issued: 02-05-10, Effective: 12-23-09, Implementation: 03-08-10)
Effective April 5, 2010, HCPCS code G9147 is to be used on claims billing for non-covered
OIVIT and any services comprising an OIVIT regimen.
NOTE: Effective April 5, 2010, HCPCS codes 99199 or 94681(with or without diabetes related
conditions 250.00-250.93) are not to be used on claims billing for non-covered OIVIT and any
services comprising an OIVIT regimen. Claims billing for HCPCS codes 99199 and 94681 for
non-covered OIVIT are to be returned to provider/returned as unprocessable.

320.2 – Medicare Summary Notices (MSN), Reason Codes, and Remark Codes
(Rev. 1913, Issued: 02-05-10, Effective: 12-23-09, Implementation: 03-08-10)
When returning non-covered OIVIT claims billed with HCPCS 99199 to provider/returning as
unprocessable, contractors shall use:
Claims Adjustment Reason Code (CARC) 189: NOS or unlisted procedure code (CPT/HCPCS)
was billed when there is a specific procedure code for this procedure/service,
Remittance Advice Remark Code (RARC) N56: The procedure code billed is not correct/valid for
the services billed or the date of service billed, and,
RARC MA66: Missing/incomplete/invalid principal procedure code.
When returning non-covered OIVIT claims billed with HCPCS 94681 with or without diabetesrelated conditions 250-00-250.93 to provider/returning as unprocessable, contractors shall use:
CARC 11: The diagnosis is inconsistent with the procedure,
RARC N56: The procedure code billed is not correct/valid for the services billed or the date of
service billed, and,

 RARC MA66: Missing/incomplete/invalid principal procedure code.
When denying claims for non-covered OIVIT and any services comprising an OIVIT regimen
billed with HCPCS code G9147, contractors shall use:
MSN 16.10 - Medicare does not pay for these item(s) or service(s),
CARC 96: Non-covered charge(s),
CARC M51: Missing/Incomplete /Invalid Procedure Code(s), and,
RARC N386: This decision was based on an NCD. An NCD provides a coverage determination
as to whether a particular item or service is covered. A copy of this policy is available at
http://www.cms.hhs.gov/mcd/search.asp. If you do not have web access, you may contact the
contractor to request a copy of the NCD.