Monday, January 2, 2017

HPV: Diagnostics, Coding and Insurance Coverage

HPV:  Diagnostics, Coding and Insurance Coverage
October 8, 2016
Lori-Lynne A. Webb

Human Papilloma Virus also known as HPV is the most common sexually transmitted infection in the United States. HPV is a virus, and is so common that nearly all sexually active men and women get it at some point in their lives. There are more than 150 different types and strains of HPV, and some of the types can cause health problems including genital warts and cancers. HPV is so common that nearly all sexually active men and women get it at some point in their lives.
HPV is named for the warts (papillomas) some HPV types can cause. There are some strains of HPV that can lead to cancer.  Most commonly these HPV strains have been linked to cervical cancer in women.  Unfortunately, there are more than 40 HPV types that can infect the genital areas of both men and women.  However, research has created vaccines that can prevent infection with some of the most common types of HPV.

Human Papillomavirus (HPV), low-risk types are associated with strain(s)  6, 11, 42, 43, 44.  High risk strains have been identified as strain(s) 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68. 

According to the Advisory Committee on Immunization Practices (ACIP) during its February 2015 meeting, it has been recommended that the  9-valent (9 different strains HPV vaccine; also known as 9vHPV) as one of three HPV targeted vaccines that can be used for routine vaccination.  The HPV vaccine is recommended for routine vaccination at age 11 or 12 years and they also recommend vaccination for females aged 13 through 26 years and males aged 13 through 21 years not vaccinated previously.  

Previously, the quadravalent (4-strain) HPV vaccine was only effective against HPV strain(s) 6, 11, 16 and 18.  The 9-valent vaccine is effective against HPV strains 6, 11, 16, 18, 31, 33, 45, 52, and 58.  

Prevention of cervical cancer due to HPV can be initiated with regular screening performed at the same time as the Papanicolaou screening test, also known as a Pap Smear, for cervical cancer.   The PAP looks for abnormal cells on the cervix that could turn into cancer over time. Screening does not eliminate the problem, it allows for these types of diagnoses to be found and treated before they turn into cancer.

ACOG has recommended that women should start getting regular Pap tests at age 21. For women ages 30 and older, the HPV test can be used along with the Pap test. Cervical cancer often does not cause symptoms until it is advanced. The Pap Smear and the HPV tests look for different things: The Pap test is a screening to check the cervix for abnormal cells that could turn into cervical cancer. The HPV test is performed to check the cervix for the virus (HPV) that can cause abnormal cells and cervical cancer.

CMS Policy:
In July of 2015, the Centers for Medicare & Medicaid Services (CMS) came out with the implementation of payment for screening for cervical cancer with HPV testing under National Coverage Determination policy 210.2.1.  Up until this change was implemented, Medicare was covering a screening pap and pelvic exam for its female beneficiaries every 12 or 24 month interval, based upon whether the patient was considered low or high risk.  Unfortunately, at that time HPV screening and testing was not paid for by CMS.   However, CMS has since determined that HPV screening/testing    
In conjunction with the Pap and Pelvic exam is of value, and will allow a screening test once per every 5 years, for beneficiaries aged 30 to 65 years

For Medicare beneficiaries (and some private payers too) HCPCS has implemented code G0476.  HCPCS 2017 Code : G0476; Infectious Agent Detection By Nucleic Acid (Dna Or Rna); Human Papillomavirus (Hpv), High-Risk Types (Eg, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) For Cervical Cancer Screening, Must Be Performed In Addition To Pap Test . 

The ICD-10cm codes used in conjunction with G0476 are:
1.     ICD-10 Z11.51 Encounter for screening for human papillomavirus (HPV) and Z01.411 Encounter for gynecological examination (general)(routine) with abnormal findings  
2.     Z01.419 Encounter for gynecological examination (general)(routine) without abnormal findings

Once the claim is submitted to your CMS carrier (Such as Medicare,  True Blue, etc) 
a)     Medicare/Medicaid will not apply beneficiary coinsurance and deductibles to claims with the HCPCS code  G0476, HPV screening
b)    Part B claims can only be accepted with a Place of Service Code equal to ‘81’, Independent Lab or ‘11’, Office;

c)     This is only effective for claims with dates of service on or after July 9, 2015

d)    If your clams contain HCPCS G0476, HPV screening, more than once in a 5-year period [at least 4 years and 11 months (59 months total) must elapse from the date of the last screening] they will be denied.

e)     CMS will deny line-items on claims containing HCPCS G0476, HPV screening, If the beneficiary is less than 30 years of age or older than 65 years of age.

f)      If you know that the patient is not eligible for payment, then be sure to have the ABN signed, on file and submit the claim with the GA modifier. 

Some provider offices were having problems getting the code G0476 paid, with diagnosis code Z12.4 Encounter for screening for malignant neoplasm of cervix.  The issue with this ICD-10 code is that
a)     CMS policies are only for those FEDERAL programs such as Medicare/Medicaid/Tricare. and they don't necessarily pertain to private insurance payers (such as Blue Cross/Blue Shield/Aetna/etc... )
b)    The HCPCS code G0476 is actually the HCPCS code for the "lab test itself"    therefore that is why only those particular ICD-10 codes would be applicable. 
c)     The ICD-10cm code Z12.4 Encounter for screening for malignant neoplasm of cervix is exactly that -  it is for the"Encounter"  the Office/Visit  aka E&M code.  It not appropriate to append a ICD-10 “encounter for” code to a "lab test" code such as the G00476.
In January of 2015, CPT has revised the HPV test codes by deleting laboratory codes  87620-87622 and adding three new codes 87623-87625 Human Papilloma Virus (HPV).  These new codes have been added to differentiate between high and low risk HPV types.  Low-risk types would be reported with code 87623 and high-risk types with code 87624. Again, these are laboratory codes, not the codes you would normally use in the providers office. 

HPV Vaccinations and Cervical Cancer

Cervical Cancer has been one of the most common causes of cancer death for American women prior to Pap test.
Since the Pap test, cervical cancer mortality has declined by almost 70%.  Most cervical cancers occur in unscreened or
inadequately screened women. According to the American Cancer society, most cases of cervical cancer are diagnosed in women younger than 50, and more than 20% are diagnosed in women over the age of 65.  In the U.S., Hispanic women have been shown to be the most likely demographic to get cervical cancer, followed by African-Americans, Asians, Pacific Islanders, and Whites.  In women over the age of 30 HPV infections are more likely to be persistent and/or  high-grade.  Most HPV-related lesions progress slowly into a cervical cancer.  This slow rate of growth is somewhere between 3 – 7 years on average for a severe dysplasia to progress to invasive cancer.

The HPV strain 16 accounts for nearly 55 – 60%, and the HPV 18 strain accounts for approximately 10 – 15% of those that develop cervical cancer.  The ACS notes that about 10 other HPV strains cause remaining 25 – 35% of cervical cancers.  HPV vaccines are used to prevent HPV infection and therefore cervical cancer.  ACOG and the World Health Organization (WHO) have recommended for women who are 9 to 25 years old, and who have not been exposed to HPV receive the vaccination for HPV virus.  Since the vaccine only covers the partial listing of HPV strains, routine PAP smears should still be a part of cervical cancer screening.  Normally, the vaccines require two or three doses depending on how old the patient is. Vaccinating girls around the ages of nine to thirteen is typically recommended. The vaccines provide protection for at least eight years.  It has also been recommended that young and adolescent men ages 9–26 receive the HPV vaccine for the prevention of genital warts and anal cancer. 

The first FDA approved HPV vaccination came out in 2006 and were targeted to the four most common strains of HPV.  However, improvements and more research has continued to develop better vaccines which now target up to nine of the most common strains of HPV that can potentially cause cervical cancer. 

Coding, Clinical Documentation and Reimbursement

When coding the vaccinations for the HPV vaccine (such as GARDASIL®9 Human Papillomavirus 9-valent Vaccine, Recombinant) Below represents what would normally be coded from the physician/provider office. Modifier -51 should not be reported for vaccines  when performed with the administration procedure code .

Human Papillomavirus vaccine, types 6, 11, 16, 18, quadrivalent (4vHPV), 3 dose schedule, for intramuscular use
Human Papillomavirus vaccine, types 16, 18, bivalent (2vHPV), 3 dose schedule, for intramuscular use
Human Papillomavirus vaccine types 6, 11, 16, 18, 31, 33, 45, 52, 58, nonavalent (9vHPV), 3 dose schedule, for intramuscular use
Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); one vaccine (single or combination vaccine/toxoid)
Encounter for Immunization

The clinical documentation for injections and infusions that are “vaccination” based need to clearly reflect this is a “vaccine” as a prophylactic measure and not a diagnostic or therapeutic service.  In addition be sure to inform the provider that these items should be clearly reflected in the record:

·         The site of the injection/infusion
·         The route of the administration (eg.  Intramuscular, subcutaneous, subdermal, intradermal)
·         The substance administered (eg Gardasil-9)
·         The number of units administered  
·         The medical necessity (eg diagnosis)

As, HPV vaccines are fairly new on the market not all insurance payers will reimburse for this service.   CMS/Medicaid eligible or those that have no insurance, may qualify for the Vaccines for Children (VFC) program or have these vaccines proved at a local Health Departments.   Private insurance payers such as Blue Cross, Blue Shield, Aetna, UHC, etc.. will varies based upon how the patient’s insurance plan is written and whether they have immunization coverage as a benefit

As a provider office, it is important that you check with the patients’ plan ahead of time to determine if they will pay for the cost of the vaccine.  If the private insurance payer does not cover the vaccine, the patient would be responsible for the cost.   In this instance it would be advisable to have the patient also sign an Advance Notice of potential non-payment and collect the cost of the service in advance. 

The “average” cost per single dose of an HPV vaccine can ranges between $175 – 250.00 per vial of vaccine serum,  plus an administration fee for the administration of the serum.   Three doses of the vaccine, spaced one month apart  are required to complete the series.  It is imperative that the patient understands the financial cost and the requirement of 3 visits to the provider to obtain the complete series for protection against HPV.

Lori-Lynne A. Webb, CPC, CCS-P, CCP, CHDA, COBGC and ICD10 cm/pcs Ambassador/trainer is an E&M, and Procedure based Coding, Compliance, Data Charge entry and HIPAA Privacy specialist, with over 25 years of experience.  Lori-Lynne’s coding specialty is OB/GYN office & Hospitalist Services, Maternal Fetal Medicine, OB/GYN Oncology, Urology, and general surgical coding.  She can be reached via e-mail at or you can also find current coding information on her blog site:   

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