The American College of Obstetricians and Gynecologists (ACOG) issued a new recommendation Aug. 23 that advises girls ages 11 to 12—generally before they become sexually active—to receive the human papilloma virus (HPV) vaccination. In some cases, ACOG says, it may be appropriate to vaccinate girls even younger.

“The ideal time for girls to receive the HPV vaccination is before they become sexually active and become exposed to HPV,” said Diane F. Merritt, MD, chair of ACOG’s Committee on Adolescent Health Care. “For this reason, we recommend that girls get vaccinated by age 11 or 12 and possibly as early as age 9, depending on risk factors. For those already sexually active, we also recommend the HPV vaccination for adolescents and young women up to age 26.”

HPV is a sexually transmitted viral infection which has been associated with cervical cancer. Approximately 70 percent of cervical cancers are caused by just two out of 100 identified HPV strains: HPV 16 and 18. About 90 percent of genital warts, another consequence of HPV infection, are associated with two other strains known as HPV 6 and 11.

There are currently two HPV vaccines approved by the U.S. Food and Drug Administration (FDA): Cervarix® and Gardasil®. The Cervarix® vaccine protects against the cancer-causing HPV strains 16 and 18. The Gardasil® vaccine protects against HPV 16 and 18, as well as HPV 6 and 11.

For this service, you would generally report CPT® code 90649 Human Papilloma virus (HPV) vaccine, types 6, 11, 16, 18 (quadrivalent), 3 dose schedule, for intramuscular use or 90650 Human Papilloma virus (HPV) vaccine, types 16, 18, bivalent, 3 dose schedule, for intramuscular use for the vaccine and 90471 Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); one vaccine (single or combination vaccine/toxoid) or 90472 Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); each additional vaccine (single or combination vaccine/toxoid) (List separately in addition to code for primary procedure) for the administration.

ACOG continues to advise against HPV testing for adolescents or young women before vaccination, ruling it pointless and unreliable.

Committee Opinion #467, “Human Papillomavirus Vaccination,” is published in the September 2010 issue of Obstetrics & Gynecology.

The Center for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) is updating its recommendations for the 2010-11 influenza season in the United States in light of data suggesting:

• increased risk of febrile seizures in children aged 6 months through 4 years following 2010 Fluvax or Fluvax Jr.;
• higher frequency of reported fever in children aged 5 years through 8 years following Fluvax compared to previous seasons; and
• higher frequency of fever in children aged 5 years through 8 years following Afluria in one clinical trial in 2009.

ACIP Recommendations:

• Afluria should not be used in children aged 6 months through 8 years.
• Other age-appropriate, licensed seasonal influenza vaccine formulations should be used for prevention of influenza in children aged 6 months through 8 years.
• If no other age-appropriate, licensed seasonal influenza vaccine is available for a child aged 5 years through 8 years old who has a medical condition that increases their risk for influenza complications, Afluria may be given, and providers should discuss the benefits and risks of influenza vaccination with the parents or caregivers before administering Afluria.

The ACIP met Aug. 5 to discuss recommendations for United States use of seasonal influenza trivalent inactivated vaccine (TIV) [Afluria] manufactured by CSL Limited during 2010-11.

A clinical trial conducted in the United States of 2009 Northern Hemisphere TIV reported a higher frequency of fever following Afluria among children aged 6 months through 8 years old compared to a different TIV. A warning was added July 30 to the Afluria package insert to inform U.S. health care practitioners that administration of CSL’s 2010 Southern Hemisphere seasonal influenza vaccine has been associated with an increased number of reports relative to previous years of fever and febrile seizures following influenza vaccination in children predominantly below the age of 5 years.

There are two types of seasonal influenza vaccines for children: TIV (the flu shot) and the live attenuated vaccine (nasal spray).

The following vaccines will be available for children and adults this season:

A more detailed table is available on the CDC website.

In other news, the World Health Organization (WHO) International Health Regulations (IHR) Emergency Committee and the WHO Director-General, Dr. Margaret Chan, declared, Aug. 10, an end to the 2009 H1N1 influenza pandemic. The U.S. Public Health Emergency determination for 2009 H1N1 Influenza expired June 23. Current influenza outbreaks, including those primarily caused by the 2009 H1N1 virus, show an intensity similar to that seen during seasonal epidemics, the U.S. Department of Health and Human Services (HHS) said in an Aug. 10 news release. More information about the WHO declaration and recommendations for the post pandemic period are available on the WHO website.

Although H1N1 and seasonal flu activity is down, the CDC issued Aug. 4 an advisory to health professionals, alerting them to an increase in cases of influenza A(H3N2) virus. A strain of the virus is included in this season’s flu vaccine. The CDC urges physicians in the report to consider influenza as a possible diagnosis when evaluating patients with acute respiratory illness and to use antivirals oseltamivir (Tamiflu) and zanamivir (Relenza) to treat the flu virus. Physicians should not use the antivirals amantadine and reimantadine because of high levels of resistance to these drugs among recently circulating influenza viruses, the CDC said.

Sources: CDC Aug. 6 Media Statement, HHS Aug. 10 news release, American Medical News

Last year, approximately 162 million doses of the H1N1 vaccine were distributed and roughly 90 million were administered. What happened to the remaining 72 million doses? The federal government estimates that as many as 40 million of those vaccines have expired, and the rest are sitting in cold storage somewhere.

Under the government’s Voluntary Central Vaccine Recovery Program, physicians in May were allowed to ship expired H1N1 vaccine doses, free of charge, to a facility contracted with the U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC). Physicians will get another chance to unload their expired vaccines sometime this fall, the CDC said.

As for H1N1 vaccines that haven’t expired, physicians should hold on to them until sufficient quantity of the 2010-2011 seasonal vaccine is available, HHS spokesman Bill Hall said. These doses can still be used in patients at high risk for contracting the virus, such as those traveling to the Southern Hemisphere, according to the CDC.

CDC’s Advisory Committee on Immunization Practices (ACIP) recommends that for the 2010–2011 flu season, children aged 6 months to 8 years who did not receive any doses of a monovalent 2009 influenza A(H1N1) vaccine should receive two doses of a 2010-11 seasonal influenza vaccine, regardless of previous influenza vaccination history.

The 2009 H1N1 virus, which was first identified April 2009, will be included in the 2010-2011 seasonal influenza vaccine starting this fall, according to the Food and Drug Administration (FDA).

The World Health Organization (WHO) has recommended that the Northern Hemisphere’s 2010–2011 seasonal influenza vaccine contain the following three vaccine viruses:

• an A/California/7/2009 (H1N1)–like virus,
• an A/Perth/16/2009 (H3N2)–like virus, and
• a B/Brisbane/60/2008–like virus.

Approximately 170 million doses of seasonal flu vaccine expected to be available in the United States this year should begin shipping sometime in late September, according to an ACIP June 2010 meeting presentation.

The first 1 million doses of smallpox vaccine were delivered to the Strategic National Stockpile (SNS), according to a U.S. Department of Health and Human Services (HHS) July 14 press release. The Danish manufacturer, Bavarian Nordic, is expected to deliver another 19 million doses sometime between now and 2013 as part of a BioShield contract administered by the Biomedical Advanced Research and Development Authority (BARDA), a part of the HHS Office of the Assistant Secretary for Preparedness and Response.

The modified Vaccinia Ankara (MVA) or Imvamune is intended for use in people who have weakened immune systems in the event of an emergency, such as a bioterrorism attack.

Bavarian Nordic, awarded the $505 million contract in 2007, is reportedly developing a freeze-dried version of Imvamune, which the company says may have an improved shelf life, reduce storage costs, and simplify transportation logistics.

In other news, the Assistant Secretary for Preparedness and Response announced July 13 a $54 million multiple year contract with Emergent BioDefense Operations Lansing (EBOL), for the domestic development of the anthrax vaccine in the company’s Lansing, Mich. facility. If product is licensed, according to a MedicalCountermeasures.gov press release, the manufacturing capacity for anthrax vaccine will increase multifold.

Sources: HHS July 14 press release, Medical Counter Measures July 13 press release

The U.S. Centers for Disease Control and Prevention (CDC) reviewed/updated July 1 the CDC Vaccine Price Lists, which provide current contract and private sector vaccine prices. Contract prices are for CDC vaccine contracts that are established for the purchase of vaccines by immunization programs receiving CDC immunization grant funds (i.e., state health departments, certain large city immunization projects, and certain current and former U.S. territories).

As of May 14, the CDC vaccine price list also shows the National Drug Code (NDC) code and contract number for each vaccine.

The CDC Vaccine Price Lists are available on the CDC website.

The CDC also updated on June 24 the Immunization Program Operations Manual with new chapters and updated on June 16 the hepatitis A and B vaccines supply list. Of note:

“Merck’s adult and dialysis formulations of their hepatitis B vaccine (Recombivax HB®) currently are not available. The adult formulation will not be available during the remainder of 2010; the dialysis formulation is expected to become available in Q3 of 2010. Production and supply of GSK’s adult hepatitis B vaccine (Adult Engerix-B®) and Adult hepatitis A/hepatitis B combination vaccine (Twinrix®) currently are sufficient to meet demand for routine adult usage of this vaccine as well as CDC’s ongoing High Risk Adult Hepatitis B Initiative.”

The adult formulation of hepatitis A vaccine (VAQTA®) from Merck also will not be available in 2010. “GSK is currently out of stock on both presentations (syringe and vial) of its adult hepatitis A vaccine (though some distributors may still have product available) but anticipates that sufficient supply of at least one presentation will be available to meet demand for routine adult usage of this product by the end of June. In addition, GSK’s adult hepatitis A/ hepatitis B combination vaccine (Twinrix®) currently is available as an alternative product.”

Health care professionals may also be interested in a self-study education program called “Adult Immunization 2010” now available courtesy of the CDC.

With news of Provenge (sipuleucel-T) being approved April 29 by the U.S. Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS) has opened a national coverage analysis (NCA) for the autologous cellular immunotherapy treatment of prostate cancer.

Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment. Provenge is designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of Provenge, administered intravenously in a three-dose schedule given at about two-week intervals, is manufactured by obtaining a patient’s immune cells from the blood, using a machine in a process known as leukapheresis. To enhance the patient’s response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer.

CMS is commissioning a technology assessment from an external entity and plans to convene a meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) this year.

Public comments on the evidence regarding the effects of this treatment on health outcomes in patients with prostate cancer are being accepted during the initial 30-day public comment period, which began June 30. Instructions on submitting public comments can be found on the CMS Coverage Information Exchange webpage. You can also submit a public comment by clicking on the highlighted word comment in the title bar at the top of the CMS webpage.

New Category I CPT® influenza vaccine codes announced in 2009 and slated for publishing in the 2011 CPT® manual are effective July 1. All four codes have the pending approval icon as the vaccines are not yet approved by the U.S. Food and Drug Administration (FDA).

90664 Influenza virus vaccine, pandemic formulation, live, for intranasal use

90666 Influenza virus vaccine, pandemic formulation, split virus, preservative free, for intramuscular use

90667 Influenza virus vaccine, pandemic formulation, split virus, adjuvanted, for intramuscular use

90668 Influenza virus vaccine, pandemic formulation, split virus, for intramuscular use

For more information, go to the American Medical Association’s (AMA) CPT® website.

The Centers for Medicare and Medicaid Services (CMS) released May 28 the hospital Outpatient Prospective Payment System (OPPS) July 2010 update, which includes a number of changes to and billing instructions for various Medicare Part B payment policies.

Read more »

The U.S. Food and Drug Administration (FDA) revised its recommendations for rotavirus vaccines on May 14 after determining that it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq.

After the FDA learned that components of an extraneous virus (PCV1) were present in Rotarix, the agency recommended that clinicians and public health professionals in the United States temporarily suspend the use of the vaccines to prevent rotavirus disease. Read more »

The American Medical Association (AMA) recently posted on its website updates to several CPT® Category I codes and a listing of Category III codes that extends into 2014.

Category I Code Additions

• 90664  Influenza virus vaccine, pandemic formulation, live, for intranasal use
• 90666  Influenza virus vaccine, pandemic formulation, split virus, preservative free, for intramuscular use
• 90667  Influenza virus vaccine, pandemic formulation, split virus, adjuvanted, for intramuscular use
• 90668  Influenza virus vaccine, pandemic formulation, split virus, for intramuscular use

Read more »