Immunizations (L31084)

Contractor Information

Contractor Name
Wisconsin Physicians Service Insurance Corporation
Contractor Number
00951, 00952, 00953, 00954, 52280, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402
Contractor Type
Carrier - FI - MAC

LCD Information

Document Information
LCD ID Number
L31084

LCD Title
Immunizations

Contractor's Determination Number
ALRG-003

AMA CPT/ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2010 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Primary Geographic Jurisdiction


Oversight Region


Original Determination Effective Date
For services performed on or after 11/15/2010

Original Determination Ending Date


Revision Effective Date
For services performed on or after 02/21/2011

Revision Ending Date


CMS National Coverage Policy
Title XVIII of the Social Security Act section 1862 (a)(1)(A). This section allows coverage and payment of those services that are considered to be medically reasonable and necessary.

Title XVIII of the Social Security Act section 1862 (a)(7). This section excludes routine physical examinations and services

Title XVIII of the Social Security Act section 1833 (e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Medicare Benefit Policy Manual, Chapter 16 - General Exclusions From Coverage
90 - Routine Services and Appliances, (Rev. 1, 10-01-03)

Formerly
MCM 2320, MCM Rev 4480, TR 1695
IL 10/11/95 BPO-PR2
Indications and Limitations of Coverage and/or Medical Necessity
With the exception of vaccinations for pneumococcal pneumonia, hepatitis B, and influenza, which are specifically covered under the law, vaccinations or inoculations are generally excluded as immunizations unless, they are directly related to the treatment of an injury or direct exposure such as antirabies treatment, tetanus antitoxin or booster vaccine, botulin antitoxin, antivenin, or immune globulin.

Immunizations, vaccinations, or inoculations are covered by Medicare only when there has been direct exposure of the associated disease to the patient and there is significant risk that the patient could contract the disease as a result of the exposure. They are not covered as routine immunizations.

Each specific immunization has specific coverage criteria.
The following immunizations are covered postexposure:

A. Tetanus Toxoid (CPT 90703)
These injections are covered when given for an acute injury to a person who is incompletely immunized.
1. Recommendations on tetanus prophylaxis are based on the condition of the wound and the patient's immunization history.
a. For more serious wounds, toxoid should be administered if the patient has not had a booster dose within the past 5 years.

A wound with any of the following clinical features is a tetanus-prone wound:
more than 6 hours old;
stellate;
avulsion;
abrasion;
greater than 1 cm deep;
injury due to missile, crush, burn, or frostbite;
signs of infection;
devitalized tissue;
a wound which affords anaerobic conditions or which has been incurred in a circumstance with probability of exposure to tetanus spores.

b. In cases of clean, minor wounds, tetanus toxoid should be administered only if the patient has not had a booster dose within the past 10 years. For more serious wounds, toxoid should be administered if the patient has not had a booster dose within the past 5 years.

2. When a patient has not received primary immunization or the primary immunization status is not known, and the patient has sustained a high-risk wound. Coverage includes:
a. The initial injection;
b. A second injection in 1 month; and
c. A third injection 6-10 months later.

3. When a tetanus booster is given to a patient in the absence of an injury/potential exposure, the injection does not meet the coverage criteria for Medicare (even though it may be appropriate preventative treatment). Preventative services should not be billed to Medicare.

B. Tetanus and Diphtheria toxoids (90702, 90714, 90718) - These injections are temporarily being covered when given for an acute injury to a person who is incompletely immunized. This is due to the limited availability of the Tetanus toxoid.
When the availability of tetanus toxoid increases we may rescind coverage of these codes.

C. Diphtheria, antitoxin (CPT 90296) will be covered for the treatment of diptheria.

D. Hepatitis A vaccine (CPT codes 90632, 90633, 90634)

Hepatitis A is an acute, usually self-limiting infection of the liver caused by hepatitis A virus (HAV). The virus has a worldwide distribution and causes about 1.5 million cases of clinical hepatitis each year. The disease burden due to hepatitis A in the United States has been estimated to be approximately 143,000 infections per year, of which 75,800 result in clinical hepatitis.
Humans are the only reservoir of the organism. Transmission occurs primarily through the fecal-oral route, and is closely associated with poor sanitary conditions. The most common modes of transmission include close personal contact with an infected person and ingestion of contaminated food and water. The virus is shed in the feces of persons with both asymptomatic and symptomatic infection. Under favorable conditions HAV may survive in the environment for months. Blood born transmission of HAV occurs, but is much less common.

The average incubation period is 28 days, but may vary from 15 50 days. Approximately 10 12 days after infection the virus can be detected in blood and feces. In general, a person is most infectious from 14 21 days before the onset of symptoms, through 7 days after the onset of symptoms. Once a person has had Hepatitis A they have lifetime immunity so vaccines are unnecessary for these individuals.

Hepatitis A Vaccine will be covered for those patients who have been exposed either by close personal contact with an infected person or after ingestion of contaminated food or water.

Several vaccines against hepatitis A are now available that are highly efficacious and provide long-lasting protection in adults and in children above one to two years of age.
For those requiring both immediate and long-term protection, the vaccine may be
administered concomitantly with Immune globulin (IG).

Immunization for adults, children and adolescents consists of a two-dose regimen with the second dose being administered 6-18 months later depending on the vaccine used.
Examples of the vaccines available are:
HAVRIX ® (Hepatitis A Vaccine, Inactivated)
AQTA ® (Hepatitis A Vaccine, Inactivated)

E. Rabies Prophylaxis (CPT codes 90675, 90676)
Rabies is a disease that rarely affects humans. It is carried by animals, and transmitted by bite or scratch. The most common carriers are skunks, foxes, bats, raccoons, or domestic animals that have had infectious encounters with a carrier. When a human has had an encounter with an animal, the physician can determine if the encounter was at high risk for rabies exposure.

1. Postexposure prophylaxis treatment utilizes two rabies immunizing products concurrently:
a. Vaccines - induce an active immune response that requires about 7-10 days to develop, but persists for as long as a year or more. Types can include:
- Human Diploid Cell Rabies Vaccine (HDCV)
- Rabies Vaccine, Adsorbed (RVA)
b. Globulins - provide rapid passive immunity that persists for a short time (half-life of about 21 days). Types can include:
- Rabies Immune Globulin (RIG)
- Antirabies Serum, Equine (ARS) - preferred over RIG due to less side effects than RIG.

2. Post-exposure injections are given in the following way:
a. When the patient has not been previously immunized
- RIG; half the dose IM, the other half in the wound (bite), on the day of the exposure; and
- HDCV, IM, on the day of exposure and days 3, 7, 14, and 28.
b. When the patient has been previously immunized
- HDCV on the day of the exposure and day 3.

F. Non-Coverage
The following CPT-4 codes represent immunizations that are considered routine preventative immunizations or they are not a disease entity endemic in the United States and therefore are not covered by Medicare:
90476, 90477 adenovirus
90581 anthrax
90585, 90586 BCG
90636 Hepatitis A/Hepatitis B
90644 Meningococcal conjugate vaccine, serogroups c & y and hemophilus influenza b vaccine, tetanus toxoid conjugate (hib-mency-tt), 4-dose schedule, when administered to children 2-15 months of age, for intramuscular use
90645-90648 Hemophilus influenza
90649 HPV
90650 HPV Vaccine , Types 16, 18, Bivalent 3 dose schedule for IM use
90665 Lyme disease
90680 Rotavirus
90681 Rotavirus, live attenuated, 2 dose schedule, oral
90690-90693 Typhoid
90696 DTAP-IPV
90698 DTAP P HIB IPV
90700 DTaP
90701 DPT
90704 Mumps
90705 Measles
90706 Rubella
90707 MMR
90708 Measles and rubella
90710 MMRV
90712, 90713 Poliovirus
90715 Tdap
90716 Varicella
90717 Yellow fever
90719 Diphtheria toxoid
90720 DTP-Hib
90721 DtaP-Hib
90723 DtaP-HepB-IPV
90725 Cholera
90727 Plague
90733 Meningococcal any group S
90734 Meningococcal Subgroups A, C, Y, and W-135
90735 Japanese encephalitis
90736 Zoster, (shingles) vaccine, live
90738 Japanese encephalitis virus vaccine inactivated, for IM use (Status I code will deny as not avalid code for Medicare)
90748 HepB-Hib (Status I code will deny as not valid codes for Medicare)
90749 Unlisted vaccine

G. When immune globulin treatment is administered, see the policy, Immune Globulins, for coverage criteria.

H. Drug Wastage
Medicare provides payment for the discarded drug/biological remaining in a single-use drug product after administering what is reasonable and necessary for the patient's condition. If the physician has made good faith efforts to minimize the unused portion of the drug/biological in how patients are scheduled and how he ordered, accepted, stored, used the drug, and made good faith efforts to minimize the unused portion of the drug in how it is supplied, then the program will cover the amount of drug discarded along with the amount administered. Documentation requirements are given below. Coding and billing instructions can be referenced in attached Article. Reference to national policy: Medicare Claims Processing Manual Pub. 100-04, Chapter 17, Section 40.

I. For coverage information regarding Influenza, pneumonia and hepatis B see:
Medicare Claims processing manual, IOM Pub. 100-04, Chapter 18, Preventive & Screening Services
Medicare Benefit Manual, IOM Pub. 100-02, Chapter 15, Covered medical & other Health Services


Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

012x Hospital Inpatient (Medicare Part B only)
013x Hospital Outpatient
022x Skilled Nursing - Inpatient (Medicare Part B only)
023x Skilled Nursing - Outpatient
071x Clinic - Rural Health
072x Clinic - Hospital Based or Independent Renal Dialysis Center
075x Clinic - Comprehensive Outpatient Rehabilitation Facility (CORF)
077x Clinic - Federally Qualified Health Center (FQHC)
083x Ambulatory Surgery Center
085x Critical Access Hospital

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

Note: Type of Bill and Revenue Codes DO NOT apply to Part B.

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.
Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
TOB Note (above): Code 73X end-dated for Medicare use March 31, 2010; code 77X is effective for dates of service on or after April 1, 2010.


Note: We have identified Type of Bill (TOB) and Revenue Center (RC) codes applicable for use with
CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all TOB and/or RC codes listed. CPT/HCPCS codes are required to be billed with specific TOB and RC codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM) Pub. 100-04, Claims Processing Manual, for further guidance.


0550 Skilled Nursing - General Classification
0559 Skilled Nursing - Other Skilled Nursing
0636 Pharmacy - Drugs Requiring Detailed Coding
0771 Preventive Care Services - Vaccine Administration

CPT/HCPCS Codes
90296 DIPHTHERIA ANTITOXIN, EQUINE, ANY ROUTE
90476 - 90650 ADENOVIRUS VACCINE, TYPE 4, LIVE, FOR ORAL USE - HUMAN PAPILLOMA VIRUS (HPV) VACCINE, TYPES 16, 18, BIVALENT, 3 DOSE SCHEDULE, FOR INTRAMUSCULAR USE
90675 - 90738 RABIES VACCINE, FOR INTRAMUSCULAR USE - JAPANESE ENCEPHALITIS VIRUS VACCINE, INACTIVATED, FOR INTRAMUSCULAR USE
Not Otherwise Classified (NOC)
90749 UNLISTED VACCINE/TOXOID

ICD-9 Codes that Support Medical Necessity
Note: ICD-9 codes must be coded to the highest level of specificity

Tetanus Toxoid (CPT 90703):

870.0 - 897.7 LACERATION OF SKIN OF EYELID AND PERIOCULAR AREA - TRAUMATIC AMPUTATION OF LEG(S) (COMPLETE) (PARTIAL) BILATERAL (ANY LEVEL) COMPLICATED
910.0 - 919.9 ABRASION OR FRICTION BURN OF FACE NECK AND SCALP EXCEPT EYE WITHOUT INFECTION - OTHER AND UNSPECIFIED SUPERFICIAL INJURY OF OTHER MULTIPLE AND UNSPECIFIED SITES INFECTED
V03.7 NEED FOR PROPHYLACTIC VACCINATION WITH TETANUS TOXOID ALONE

Tetanus and Diptheria toxoids
(90702, 90714, 90718)

870.0 - 897.7 LACERATION OF SKIN OF EYELID AND PERIOCULAR AREA - TRAUMATIC AMPUTATION OF LEG(S) (COMPLETE) (PARTIAL) BILATERAL (ANY LEVEL) COMPLICATED
910.0 - 919.9 ABRASION OR FRICTION BURN OF FACE NECK AND SCALP EXCEPT EYE WITHOUT INFECTION - OTHER AND UNSPECIFIED SUPERFICIAL INJURY OF OTHER MULTIPLE AND UNSPECIFIED SITES INFECTED
V03.7 NEED FOR PROPHYLACTIC VACCINATION WITH TETANUS TOXOID ALONE

Diphtheria, antitoxin
(CPT 90296):

032.0 - 032.3 FAUCIAL DIPHTHERIA - LARYNGEAL DIPHTHERIA
032.81 - 032.85 CONJUNCTIVAL DIPHTHERIA - CUTANEOUS DIPHTHERIA
032.89 OTHER SPECIFIED DIPHTHERIA
032.9 DIPHTHERIA UNSPECIFIED

Rabies Prophylaxis
(CPT codes 90675, 90676):

V01.5 CONTACT WITH OR EXPOSURE TO RABIES

Hepatitis A vaccine
(CPT codes 90632, 90633, 90634):

V01.79 CONTACT OR EXPOSURE TO OTHER VIRAL DISEASES
V02.60 CARRIER OR SUSPECTED CARRIER OF VIRAL HEPATITIS UNSPECIFIED
V02.69 CARRIER OR SUSPECTED CARRIER OF OTHER VIRAL HEPATITIS


Diagnoses that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

General Information

Documentations Requirements
Documentation supporting the medical necessity of this item, such as ICD-9 codes, must be submitted with each claim. Claims submitted without such evidence will be denied as being not medically necessary.

Documentation in the progress notes must identify the exposure, describe the wound, describe the immunization status of the patient, and be available if requested.

Claims for non-covered services do not have to be submitted to Medicare. When the patient requests a non-covered routine immunization service to be billed to Medicare for denial, indicate that by using the GY modifier.

Drug Wastage Documentation Requirements
Any amount wasted must be clearly documented in the medical record with:
- Date and time.
- Amount of medication wasted.
- The reason for the wastage.
Appendices
Utilization Guidelines
1. All materials used to administer the injection are included in the CPT code.

2. Vaccinations or inoculations are excluded as immunizations unless they are directly related to the treatment of an injury or direct exposure to a disease or condition, such as anti-rabies treatment, tetanus antitoxin or booster vaccine, botulin antitoxin, antivenin sera, or immune globulin. In the absence of injury or direct exposure, preventive immunization (vaccination or inoculation) against such diseases as smallpox, polio, diphtheria, etc., is not covered. However, pneumococcal, hepatitis B, and influenza virus vaccines are exceptions to this rule. (See items A, B, and C below.) In cases where a vaccination or inoculation is excluded from coverage, related charges are also not covered.
IOM 100-2 CH 15 Section 50.4.4.2

Providers should bill with the GY on the administration code if it is for the administration of a non-covered immunization.
Sources of Information and Basis for Decision
Grabenstein, John, D.; ImmunoFacts ® Vaccines & Immunological Drugs; Facts and Comparisons, Inc.,
1995
Centers for Disease Control and Prevention. Prevention of hepatitis A through active or passive immunization. Recommendation of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report, 1999, 48(RR 12): 1 37.

Public health control of hepatitis A: Memorandum from a WHO meeting. Bulletin of the World Health Organization, 1995, 73:15 20.
Advisory Committee Meeting Notes
Meeting Date:
Wisconsin 06/18/2010
Illinois 05/19/2010
Michigan 05/12/2010
Minnesota 05/06/2010
J5: Iowa, Kansas, Missouri, Nebraska 06/24/2010
Date of the Open Meeting: 04/22/2010

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from Interventional Radiology, Vascular Surgery, Nephrology, and other interested specialties.
Start Date of Comment Period
06/24/2010
End Date of Comment Period
08/08/2010
Start Date of Notice Period
10/01/2010
Revision History Number
-
Revision History Explanation
04/19/2010 In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of American Somoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands were removed from this LCD because claims processing for those states are transitioning from FI Contractor  Wisconsin Physician Services (WPS - 52280) to MAC Part A Contractor   Palmetto.

8/1/2010 - The description for Bill Type Code 12 was changed
8/1/2010 - The description for Bill Type Code 13 was changed
8/1/2010 - The description for Bill Type Code 22 was changed
8/1/2010 - The description for Bill Type Code 23 was changed
8/1/2010 - The description for Bill Type Code 71 was changed
8/1/2010 - The description for Bill Type Code 72 was changed
8/1/2010 - The description for Bill Type Code 75 was changed
8/1/2010 - The description for Bill Type Code 83 was changed
8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0550 was changed
8/1/2010 - The description for Revenue code 0559 was changed
8/1/2010 - The description for Revenue code 0636 was changed
8/1/2010 - The description for Revenue code 0771 was changed

10/18/2010 - In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Colorado, New Mexico, Oklahoma and Texas were removed from this LCD because claims processing for those states are transitioning from FI Wisconsin Physicians Service (52280) to MAC Part A Trailblazer (04901).

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:
90476 descriptor was changed in Group 1
90477 descriptor was changed in Group 1
90581 descriptor was changed in Group 1
90585 descriptor was changed in Group 1
90586 descriptor was changed in Group 1
90632 descriptor was changed in Group 1
90633 descriptor was changed in Group 1
90634 descriptor was changed in Group 1
90636 descriptor was changed in Group 1
90644 descriptor was changed in Group 1
90645 descriptor was changed in Group 1
90646 descriptor was changed in Group 1
90647 descriptor was changed in Group 1
90648 descriptor was changed in Group 1
90649 descriptor was changed in Group 1
90650 descriptor was changed in Group 1
90675 descriptor was changed in Group 1
90676 descriptor was changed in Group 1
90680 descriptor was changed in Group 1
90690 descriptor was changed in Group 1
90691 descriptor was changed in Group 1
90692 descriptor was changed in Group 1
90693 descriptor was changed in Group 1
90698 descriptor was changed in Group 1
90700 descriptor was changed in Group 1
90701 descriptor was changed in Group 1
90702 descriptor was changed in Group 1
90703 descriptor was changed in Group 1
90704 descriptor was changed in Group 1
90705 descriptor was changed in Group 1
90706 descriptor was changed in Group 1
90707 descriptor was changed in Group 1
90708 descriptor was changed in Group 1
90710 descriptor was changed in Group 1
90713 descriptor was changed in Group 1
90716 descriptor was changed in Group 1
90717 descriptor was changed in Group 1
90718 descriptor was changed in Group 1
90719 descriptor was changed in Group 1
90720 descriptor was changed in Group 1
90721 descriptor was changed in Group 1
90723 descriptor was changed in Group 1
90725 descriptor was changed in Group 1
90727 descriptor was changed in Group 1
90733 descriptor was changed in Group 1
90734 descriptor was changed in Group 1
90735 descriptor was changed in Group 1
90736 descriptor was changed in Group 1

02/21/2011 In accordance with Section 911 of the Medicare Modernization Act of 2003, the states of Delaware, District of Columbia, Maryland, New Jersey and Pennsylvania were removed from this LCD because claims processing for these states are transitioning from FI Wisconsin Physician Service (WPS 52280) to MAC Part A contractor Highmark (12901).

04/01/2011 Corrected typo in reference to Benefit chapter.
Reason for Change
Last Reviewed On Date
02/24/2011
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Page Last Updated: Wednesday, 05-Oct-2011 11:23:52 CDT