IDSA News - October 2009
Vol. 19 No. 10
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From the President: The Importance of Vaccination

According to several recent polls, some Americans remain hesitant to get vaccinated against novel H1N1 influenza or have their children immunized. Unfortunately, these doubts are helping to bring new attention to the broader anti-vaccine movement.

According to several recent polls, some Americans remain hesitant to get vaccinated against novel H1N1 influenza or have their children immunized. Unfortunately, these doubts are helping to bring new attention to the broader anti-vaccine movement, as a recent front-page story in The New York Times illustrates. As experts in infectious diseases, we play an important role in providing information to our patients about the risks and benefits of vaccination, not only against influenza but also other diseases. Our own actions can speak loudly as well.

During this challenging influenza season, IDSA believes vaccination is the best way to protect patients and health providers against influenza, including H1N1, which is why the IDSA Board of Directors recently voted to strengthen the Society’s position supporting mandatory vaccination of HCWs against influenza. (See related IDSA News article about the new policy). Decades of research and experience also tell us that vaccines are a safe and effective way to protect against many once-common and often deadly childhood diseases. Sadly, recent studies demonstrate that these infections are still a threat, and that misinformation about vaccines is doing harm.

A study in the June issue Pediatrics found that children of parents who refuse vaccines are 23 times more likely to get pertussis than fully immunized children. The number of these infections has increased dramatically, jumping from approximately 1,000 cases in 1976 to about 26,000 in 2004. My husband, who is also a physician, came down with pertussis last July, and he is still suffering from this terrible infection, three months later.  Unfortunately, many adults don’t get the vaccines they should, and he missed out on the Tdap vaccine, in part because it wasn’t recommended by his internist. Because many vaccine-preventable diseases are not eradicated, it is important for everyone, children and adults, to be immunized.

In another analysis, published in the May 7 issue of the New England Journal of Medicine, researchers reviewed multiple studies showing an increase in the risk of vaccine-preventable diseases, including pertussis and measles, in areas where vaccine refusal is high. “If the enormous benefits to society from vaccination are to be maintained,” the authors warn, “increased efforts will be needed to educate the public about those benefits and to increase public confidence in the systems we use to monitor and ensure vaccine safety.” Furthermore, the authors stress the important role of clinicians in answering questions and helping parents understand the benefits and risks of vaccines.

To help in the awareness effort, IDSA offers health professionals, parents, the media, and policymakers up-to-date, science-based information about vaccines and the diseases they prevent through the National Network for Immunization Information (NNii), of which IDSA is a founding affiliate. The network’s website includes links to vaccination guidelines and downloadable PowerPoint presentations to help providers communicate about vaccine safety with the public, in addition to other useful resources, such as summaries of articles from the scientific, peer-reviewed literature.

In my February column, I wrote about three separate rulings from the U.S. vaccine court that strongly rejected a link between autism and the measles-mumps-rubella (MMR) vaccine, thimerosal, or a combination of the two. The court’s rejection represented a welcome dose of science in the controversy surrounding autism and vaccines. More funding for vaccine safety research and monitoring is certainly needed, but of the many studies on this subject to date, none has shown that vaccines cause autism.

A cover story in the November issue of Wired magazine clearly explains the lack of evidence for such a link and the risks to all of us posed by vaccine refusal. The article prominently features a strong voice for vaccine science, Paul Offit, MD, who will speak about the anti-vaccine movement during the Special Plenary Session from 5 to 7 p.m. on Thursday during this year’s Annual Meeting in Philadelphia, Oct. 29-Nov. 1. I look forward to hearing his presentation, and I hope you will attend.

The Annual Meeting also marks the end of my term as president of the Society. It has been an honor serving as your president during this busy year of change and milestones, including a new administration in Washington and the emergence of a new pandemic influenza virus. Through it all, IDSA’s commitment to its members has remained the same. On clinical issues affecting ID physicians and the major topics of the day—the response to H1N1, health care reform, antimicrobial resistance and the need for increased antibiotic development, Lyme disease, HIV/AIDS, and global health, to name just a few—IDSA continues to provide important resources to its members and ensure that the expertise of ID physicians is brought to the table.

IDSA Strengthens Mandatory Influenza Immunization Policy for HCWs

To better protect patients and health care workers (HCWs), IDSA recently strengthened its policy on mandatory immunization of HCWs. The strengthened statement applies to both seasonal influenza and 2009 H1N1 influenza. 

To better protect patients and health care workers (HCWs), IDSA recently strengthened its policy on mandatory immunization of HCWs. The strengthened statement applies to both seasonal influenza and 2009 H1N1 influenza. It further specifies that employees who cannot be vaccinated due to medical contraindications, because vaccine is in short supply, or who decline in writing for religious reasons, should be required to wear masks or be reassigned from direct patient care. The policy, which is directed at health care institutions, is available on IDSA’s website.

“We believe immunization is the most effective thing we as HCWs can do to protect our patients – and our ourselves – from influenza, including the 2009 novel H1N1 virus,” IDSA President Anne Gershon, MD, FIDSA said in an e-mail announcing the stronger policy earlier this month. “All of us and all of our colleagues who work in direct patient care should be immunized. We owe it to our patients.”

IDSA’s original policy was part of the Society’s 2007 report, Pandemic and Seasonal Influenza Principles for U.S. Action. The IDSA Board of Directors voted in September to strengthen the policy to address 2009 H1N1, remove the option of declining immunization for philosophical reasons, and specify the steps that should be taken to protect patients from unvaccinated HCWs, including requiring unvaccinated workers to wear masks.

Unvaccinated HCWs can spread influenza to patients, co-workers, and family members without exhibiting symptoms. Surgical masks have been shown to prevent the spread of infection by patients with confirmed cases of influenza, and it makes sense that masks should reduce the risk of unvaccinated HCWs spreading infection to patients or other workers.

The new IDSA policy cites several rationales for the Society’s expanded position, including:

  • Several studies demonstrate that immunizing HCWs against influenza reduces patient morbidity and mortality.
  • Immunizing HCWs against both seasonal and H1N1 influenza protects HCWs against falling ill from these infections as well as missing work, which could further hurt patient care during influenza outbreaks.
  • Decades of scientific data demonstrate that influenza vaccines are safe, effective, and reduce costs.
  • Several large health care systems and hospitals have adopted similar mandatory immunization policies.
  • Physicians and other health care providers have an ethical and moral obligation to prevent the transmission of infectious diseases to their patients.

Although IDSA supports educating HCWs about the benefits and risks of influenza vaccination, even the most successful educational programs still average only 40 to 70 percent coverage, well below acceptable levels.

The Society understands that health care institutions will not be able to fully implement mandatory immunization programs immediately, particularly before the H1N1 vaccine is broadly available, Dr. Gershon said. Last week, New York state officials suspended that state’s requirement that all health care workers be immunized against influenza, citing the currently limited supplies of H1N1 vaccine. Institutions “will need to balance multiple priorities in implementing such policies, taking into account vaccine supply and distribution, mask supplies, the use and content of declination forms, staffing needs, and other local situations, particularly in this challenging influenza season,” Dr. Gershon noted in her e-mail announcing IDSA’s strengthened policy.

IDSA offers many immunization resources on the 2009 H1N1 and seasonal influenza webpage, including links to vaccination information statements, question-and-answer documents explaining vaccine safety and other related issues, and vaccination guidance for state and local health officials. This page is updated regularly.

IDSA Journal Club

October 2009

A comparison of surgical masks and N95 respirators in the prevention of influenza, the effectiveness of inactivated vs. live attenuated influenza vaccine, using procalcitonin levels to guide antibiotic use in patients with lower respiratory tract infections, the use of soap and water for eradicating Clostridium difficile from hands, and pre-masticated food and HIV transmission.

Preventing Influenza: A Comparison of Surgical Masks and N95 Respirators
Reviewed by Nina Kim, MD

Influenza can be transmitted by contact or inhalation of droplets and smaller aerosol particles. The relative contribution of each mode has not been well characterized, and clinical trials examining preventive strategies have been few. A multicenter Canadian study published online in the Journal of the American Medical Association on Oct. 1 sought to address whether N95 respirators are superior to standard face masks in preventing the transmission of influenza among health care workers.

The investigators randomized 478 nurses from emergency departments and medical or pediatric wards from eight hospitals to wear either surgical masks or N95 respirators. The nurses were then followed from January to April 2009 to track influenza infection. The primary outcome was laboratory-confirmed influenza by either detection of viral RNA using PCR from a nasal or nasopharyngeal swab, or at least a four-fold increase in serum antibodies to circulating influenza strain antigens.

Fifty cases of infection were found in the surgical mask group (23.6 percent) compared with 48 in the N95 respirator group (22.9 percent) (absolute risk difference -0.73%, P=0.86). Interestingly, only a minority of these were confirmed by symptom-prompted PCR detection (2.8 percent among surgical mask users versus 1.8 percent among N95 respirator users), and the vast majority were diagnosed by serologic confirmation. No differences were seen in the subset of novel H1N1 cases (8 percent versus 11.9 percent, P=0.18). Of note, only 29 percent of the nurses were vaccinated against seasonal influenza. The authors concluded that surgical masks were not inferior to N95 respirators for preventing influenza.

This study suggests that surgical masks may be sufficient for prevention of influenza transmission in acute care settings. However, the research was limited in its characterization of exposure risks (e.g., frequency of exposure to aerosol-generating procedures) and distribution of these risks between these intervention groups. Perhaps more importantly, the study reminds us of the unacceptably low vaccination rates among health care workers, the alarmingly high rate of asymptomatic or minimally symptomatic influenza, and the necessity of a multifaceted approach when it comes to protecting our patients.

(Loeb et al. JAMA. 2009;302(17): E-pub)

Inactivated Vs. Live Attenuated Influenza Vaccine: Which is More Effective in Adults?
Reviewed by Jason Weinberg, MD

Inactivated influenza vaccine was more effective than the live attenuated form of the vaccine in adults during 2007-2008 influenza season, according to a report in the Sept. 24 issue of the New England Journal of Medicine. The implications of these findings for vaccines for novel influenza A (H1N1), however, remain to be seen. 

The report’s authors enrolled 1,952 adults in a randomized, double-blind, placebo-controlled trial to evaluate the effectiveness of inactivated and live attenuated influenza vaccines. No serious adverse events were attributed to either vaccine during the study. Both vaccines provided some protection against laboratory-confirmed, symptomatic influenza infection, the study’s primary end point. Absolute efficacy against influenza A and B strains was 68 percent for the inactivated vaccine and 36 percent for the live attenuated vaccine. There was a 50 percent reduction in laboratory-confirmed influenza among inactivated vaccine recipients compared with those who received the live attenuated vaccine. Similar absolute and relative efficacies were noted when the analysis was restricted to influenza A, which comprised the majority of influenza cases during the study season.

As the authors speculate, the differences between the vaccines may stem from immune responses to previous influenza strains that cross-react with the vaccine strain and limit its replication. The findings, however, are likely not relevant to all scenarios. For instance, other studies have shown that live attenuated vaccine is more efficacious than inactivated vaccine in children. In addition, it is not yet clear how these findings will relate to vaccines for the novel H1N1 strain, in which a lack of substantial pre-existing cross-protective immune responses to the novel influenza strain may result in similar efficacies for inactivated and live attenuated vaccines. In all cases, continued surveillance will be essential to guide vaccine development and implementation moving forward.

(Monto et al. N Eng J Med 2009;361:1260-7)

Using Procalcitonin Levels to Guide Antibiotic Use in Patients With Lower Respiratory Tract Infections (LRTI)
Reviewed by Rachel Simmons, MD

Appropriate use of antibiotics in LRTI continues to be a challenge for health care providers. Some patients clearly benefit from antibiotics, but overuse contributes to antimicrobial resistance in the community and causes medication-related side effects in some individuals.

An article and accompanying editorial in the Sept. 9 issue of the Journal of the American Medical Association discuss the findings of a multi-center, noninferiority randomized controlled trial using procalcitonin (PCT) levels to tailor antibiotic use in lower respiratory tract infections. The trial included 1,359 adults with LRTI enrolled from emergency departments at six Swiss hospitals. In the control group, antibiotic use was based on recent clinical guidelines. In the procalcitonin group, antibiotics were recommended or discouraged based on serum PCT levels. 

The study population was older with a mean age of 73. Two thirds of the subjects had community-acquired pneumonia, and more than 90 percent of the patients in both groups required hospital admission. The overall rate of adverse events (composite endpoint of death, ICU admission, disease-associated complications, or recurrence of LRTI) was not significantly different between the two groups (15.4 percent in the PCT group versus 18.9 percent in the control group). The overall duration of antibiotic exposure was significantly less in the PCT group compared to the control group (5.7 versus 8.7 days), and the overall rate of antibiotic-related adverse events was also reduced (19.8 percent versus 28.1 percent).

As the largest study to date examining the use of procalcitonin levels in the management of LRTI, the results suggest that a decision algorithm that incorporates rapidly available procalcitonin levels can safely reduce the use of antibiotics in LRTI.  Whether such a computer-based algorithm could be easily operationalized in different clinical settings remains to be studied.

(Schuetz et al. JAMA 2009;302(10):1059-1056 and Yealy et al. JAMA 2009 302(10):1115-1116)

Soap and Water Appears Best for Eradicating Clostridium difficile from Hands
Reviewed by Sara Cosgrove, MD

Washing your hands with good old soap and water is superior to alcohol-based hand rubs for removing C. difficile, according to a study in the October issue of Infection Control and Hospital Epidemiology.

In an experimental model, the hands of 10 volunteers were contaminated with a C. difficile strain that was spore producing but nontoxigenic using two different methods. In the whole-hand protocol, subjects placed an entire hand in a glove containing the organism. For those using the surface contamination protocol, the palm was placed on a pre-contaminated ceramic tile. The latter approach was thought to represent more closely how hands become contaminated in an actual health care setting. Volunteers cleaned their hands on different occasions with warm water with plain soap, cold water with plain soap, warm water with antibacterial soap, antiseptic hand wipes, an alcohol-based hand rub, or with nothing at all, serving as the control.

For volunteers using the whole-hand method, the largest reductions in colony counts were seen in people washing with warm or cold water and plain soap. The alcohol-based hand rub performed poorly; its effect was not statistically different from no hand hygiene at all. In the surface contamination protocol, the results were similar, with the alcohol-based hand rub again performing poorly when compared to all soap and water regimens tested.

Current hand hygiene guidelines note the potential decreased efficacy of alcohol-based hand rubs in killing C. difficile because of its lack of sporicidal activity, but few published studies to date provide evidence for this recommendation. Although this study evaluated the effectiveness of alcohol-based hand rubs in an experimental model rather than in actual clinical practice—and the study does not examine clinical outcomes such as rates of C. difficile transmission with different approaches to hand hygiene—the findings provide important evidence that using soap and water rather than an alcohol-based hand rub after caring for a patient with documented C. difficile infection should be strongly considered in clinical practice.

(Oughton et al. Infect Control Hosp Epidemiol 2009; 30:939-944)

Time to Start Talking to Mothers About Pre-mastication and HIV Transmission?
Reviewed by Christian B. Ramers, MD

Mother-to-child transmission of HIV has been thought to occur via three routes:  in utero, intrapartum, or through breastfeeding. A study in the August issue of Pediatrics suggests a novel mode of transmission—the practice of feeding infants pre-masticated food during the weaning process.

The authors describe three U.S. infants ranging in age from 9 to 35 months old who presented with clinical symptoms that prompted HIV testing. Two were born to HIV-positive mothers who were not breastfeeding, and perinatal infection was ruled out according to HIV-testing guidelines. In the third case, a great aunt involved in caring for the infant was HIV-infected, but the mother was not.  All three infants ingested food on multiple occasions that had been chewed by a caregiver infected with HIV. An investigation excluded other modes of transmission, and phylogenetic analysis of the gp41 region of env and the p17 region of gag supported pre-chewed food as the source of infection (where source case serum was available).

The significance of this novel mode of HIV transmission is unknown, but the prevalence of pre-mastication is likely greater than previously realized. The authors’ review of the limited literature surrounding this practice suggests at least 10.5 percent of caregivers pre-chew their infants’ food (range: 10.5 percent to 86.2 percent in several surveys). 

This study raises questions about the role of this practice in overall mother-to-child transmission, including in cases of so-called “late” transmission as yet attributed to breastfeeding.  While further studies are needed to quantify the risk, the authors recommend that providers discourage this practice and recommend safer feeding methods among caregivers and expecting parents who are HIV-infected or at risk of infection.

(Gauer et al. Pediatrics 2009; 124(2):658-666)

ACIP Makes Recommendations for HPV Vaccine Use in Males

The federal Advisory Committee on Immunization Practices (ACIP) has recommended that Merck’s human papillomavirus (HPV) vaccine, Gardasil, may be given to boys and young men to prevent genital warts. During its October meeting in Atlanta, however, ACIP stopped short of calling for routine use of the vaccine in males, according to IDSA’s ACIP liaison, Samuel Katz, MD, FIDSA. The permissive decision allows physicians and their male patients the opportunity to choose whether to use the vaccine.

Already licensed for use in girls and young women for the prevention of cervical cancer, Gardasil was approved by the Food and Drug Administration (FDA) on Oct. 16 for preventing genital warts in males ages 9 through 26 years old. A quadrivalent vaccine, it protects against two carcinogenic strains of the virus and two linked to genital warts. On the same day, FDA also approved a second HPV vaccine, GlaxoSmithKline’s Cervarix, for girls and young women ages 10 to 25 that protects against two strains linked to cervical cancer.

ACIP voted to include Gardasil in the federal government’s Vaccines for Children program so that the vaccine’s use would be covered for males under the age of 18 who are eligible for the program. The panel stopped shot of encouraging the vaccine’s use in men who have sex with men, but if ongoing studies show its effectiveness in preventing cancers, such as penile and oropharyngeal, the panel might reconsider, Dr. Katz said.

During a discussion of novel H1N1 influenza, priority risk groups for vaccination were re-emphasized, including pregnant women, health care workers, children aged 6 months to 5 years old, and other children with underlying health conditions, according to Dr. Katz. In July, ACIP made recommendations for target groups for H1N1 vaccination (see IDSA News article). Hospitalization rates have been highest among children up to 4 years old, panelists were told at the latest meeting. Pregnant women are especially fragile clinically, in some cases deteriorating rapidly and requiring prolonged intensive care.

ACIP recommendations become official once approved by the Centers for Disease Control and Prevention (CDC) and published in MMWR. For more information, see CDC’s website. The next ACIP meeting is Feb. 24-25, 2010.

NIAID Considers Revamp to Clinical Trials Infrastructure, Works to Address Research Barriers

Officials with the National Institute of Allergy and Infectious Diseases (NIAID) are examining the possibility of expanding the purview of NIAID’s clinical trials networks to include a focus on tuberculosis, hepatitis C, influenza, and possibly antimicrobial resistance. IDSA supported this proposal in an October letter to NIAID Director Anthony S. Fauci, MD, and urged an additional focus on drug-resistant bacterial infections. 

An NIAID working group is exploring what the infrastructure for these new networks might look like and what funding models would be best employed, according to a recent article in NIAID News. The working group was one of eight created following a July NIAID consultation on the clinical trials infrastructure that brought together outside ID researchers, including IDSA’s representative, William Burman, MD, and NIAID officials. During the consultation, Dr. Burman discussed an IDSA policy statement published in Clinical Infectious Diseases in August, which identified and provided solutions to regulatory barriers that slow important ID research.

Authored by Dr. Burman and Robert Daum, MD, and developed with IDSA’s Research Committee, the statement focused on the impact of the Health Insurance Portability and Accountability Act (HIPAA), redundancy in the adverse event reporting process, barriers related to local review of multicenter studies and pediatric research, and the role of institutional review boards (IRBs) in quality improvement projects (see IDSA News article).

An NIAID working group will consider several recommendations that flowed from the July consultation, including: the creation of a centralized IRB at NIAID, the development of an appropriate definition for “adequate” oversight and monitoring, and the simplification of the adverse event reporting system, among other steps.

EIN: H1N1 and Seasonal Influenza Vaccination Questions

The Emerging Infections Network (EIN) is a forum for infectious diseases consultants and public health officials to report information on clinical phenomena and epidemiological issues with public health significance. Any diagnostic or therapeutic recommendations and all opinions presented are those of the individual contributor. They do not necessarily represent the views of EIN, IDSA (EIN’s sponsor), or the Centers for Disease Control and Prevention (CDC), which funds the EIN. The reader assumes all risks in using this information.

With the influenza season picking up steam, EIN members are discussing seasonal and H1N1 flu vaccination, including the use of inactivated and live attenuated influenza vaccine (LAIV). A member from Chicago started a recent discussion by asking if the intranasal form of the H1N1 vaccine and seasonal LAIV could be given simultaneously.

A respondent from Seattle posted an excerpt from a clinician question-and-answer guide from the Centers for Disease Control and Prevention (CDC), whose existing recommendations are that two inactivated vaccines—or an inactivated and a live vaccine—can be given any time before, after, or at the same visit as each other. CDC advises, “Live attenuated seasonal and live 2009 H1N1 vaccines should NOT be administered at the same visit until further studies are done. If a person is eligible and prefers the LAIV formulation of seasonal and 2009 H1N1 vaccine, these vaccines should be separated by a minimum of four weeks.”

A respondent from the CDC also referenced the agency’s recently posted Top 10 list of frequently asked questions—and answers—about the use of influenza vaccine, covering practical considerations for immunization programs and providers, including the use of both live and inactivated forms of seasonal and H1N1 vaccine.

Several EIN members also replied to a member in Arizona who asked about the vaccination of health care workers (HCWs) with the live form of the H1N1 vaccine at institutions with bone marrow transplant (BMT) units:

“We will not give LAIV to the nursing staff and other ‘regular’ BMT HCWs, but our BMT docs are concerned about other HCWs getting LAIV,” the member wrote. “Are you giving LAIV to other staff (e.g., EKG/X-ray/CT techs, phlebotomists, etc.) who go to different areas of the hospital, including the BMT unit? If so, should they (or the patient) wear a surgical mask during the encounter for a period of time after getting LAIV? Is it safe to take care of a BMT patient beyond seven days after receiving LAIV? From my reading, it does not seem like there’s viral shedding beyond seven days in healthy adults.”

A respondent in Florida wrote, “We do not allow any HCWs or employees to get live attenuated flu [vaccine] in our cancer hospital to prevent the rare possibility of transmission.”

A Tennessee member shared this response: “I am in charge of infection control at a children’s cancer hospital. We have been administering LAIV to health care workers here for five years without adverse effects.” Per guidelines from CDC’s Advisory Committee on Immunization Practices, the member continued, “we restrict vaccine from HCWs who will be taking care of inpatient bone marrow transplant patients in the seven days following receipt of vaccine but do not have any other exclusions related to [immunocompromised hosts].”

“In addition, we have conducted two clinical trials in the last three years administering LAIV to children with cancer, including leukemia, and have not seen any adverse events or prolonged shedding in recipients,” the member added. “We believe use of LAIV in hospitals is safe and is a useful adjunct vaccine to offer in the effort to improve HCW vaccination rates.”

Another EIN discussion involved timing. “Now that H1N1 LAIV is becoming available, say you have [an] otherwise healthy child in your office, and it is not recommended to give both seasonal and H1N1 LAIV at the same visit,” a Connecticut EIN member posted. “Which do you give first, knowing that you will have to wait one month between doses of live vaccine? Would you give H1N1 LAIV and wait a month for seasonal LAIV or vice versa?” Some practices have not gotten their allotment of inactivated seasonal influenza vaccine, the member added.

“If you were going to do both vaccines as live intranasal, I’d do the H1N1 first because it's circulating now, and seasonal flu (mostly H3N2) hasn’t arrived yet,” a Minnesota member replied. “Giving nasal H1N1 and [intramuscular] seasonal vaccine simultaneously seems a desirable approach as it only requires one visit, provided you’ve gotten supplies of both vaccines.” Several other respondents also suggested giving the LAIV form of the H1N1 vaccine first, if necessary, citing the current prevalence of H1N1.

CDC’s website and IDSA’s influenza webpage offer additional information for physicians and other health providers about the H1N1 and seasonal influenza vaccines, including vaccination information statements and the latest clinical guidance.

E-mail the Emerging Infections Network.

The Emerging Infections Network (EIN) is a provider-based sentinel network designed to help the public-health community detect trends in emerging infectious diseases.

A joint project of IDSA and the Pediatric Infectious Diseases Society (PIDS) with funding from the Centers for Disease Control and Prevention (CDC), EIN tracks emerging infectious diseases and keeps the public-health community up to date with new disease trends, difficult cases, and other issues affecting members’ clinical practices. The Network provides a great opportunity for members to share knowledge quickly across large geographical distances. Both IDSA and PIDS members are eligible to join. Click here for more information or to join EIN.

Drug Approvals, Recalls, Adverse Events Update

IDSA offers two e-mail services to help members stay informed of updates from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Content normally includes a range of topics, including new drug approvals and warnings. Recent alerts have included:

IDSA members can sign up for these services online. (You must be logged in to have access to this link.)

Is Your Facility Experiencing Antibiotic Shortages?
Report these to FDA and IDSA.

How to Bill for H1N1 Vaccine

During this challenging influenza season, new billing codes have been developed for the administration of the H1N1 vaccine. Medicare will pay physicians for administering the H1N1 vaccine this year, including when it’s given to patients who also receive the seasonal influenza vaccine. But the agency won’t reimburse physicians for the actual H1N1 vaccine because the vaccine will be supplied to providers for free.

To bill Medicare for administering the H1N1 vaccine, use code G9141 (influenza A, H1N1, immunization administration—including counseling the patient or family). It is not necessary to place the H1N1 vaccine code (G9142) on the claim. For more information on Medicare coverage and reimbursement rules for the H1N1 and seasonal influenza vaccines, see this CMS fact sheet and related article.  

The American Medical Association (AMA) has also developed a current procedural terminology (CPT) vaccine administration code, 90470, specific to the 2009 H1N1 virus, and revised existing code 90663 to report either the intranasal or intramuscular formulations of the H1N1 virus.  For purposes of safety tracking, it has been requested that National Drug Codes (NDCs) be added to the claim sheet.  For more information about CPT codes for the H1N1 vaccine, see this AMA webpage and fact sheet. While many private payers are likely to cover administration of the vaccine using these codes, physicians should contact individual insurers for specific billing instructions.

To obtain a supply of the H1N1 vaccine, physician offices will need to contact their state health departments. See the Centers for Disease Control and Prevention (CDC) for a list of state contacts.

For other questions about CPT coding, use IDSA’s “Ask the Coder” e-mail portal to contact a certified professional coder. (You must be logged in to access this link.)

Annual Meeting Features Timely Global Health Sessions

Eric Goosby, MD, the Obama administration’s global AIDS coordinator, will be the keynote speaker at a symposium on “HIV in the Developing World,” Saturday, Oct. 31, at the 47thAnnual Meeting of IDSA, one of several global health-related sessions scheduled during the meeting, Oct. 29-Nov. 1, in Philadelphia.

During the 10:30 a.m. to noon session, Dr. Goosby will give an update on the U.S. response to the global AIDS epidemic. The United States has led worldwide efforts to curb the spread of HIV/AIDS through the President’s Emergency Plan for AIDS Relief (PEPFAR), first enacted in 2003 and reauthorized last year. Dr. Goosby is charged with implementing the newly reauthorized program. 

The symposium will also feature presentations by Quarraisha Abdool Karim, MD, of the Mandela School of Medicine and Columbia University, and Mark Cotton, MD, of Stellenbosch University in South Africa, who are expected to discuss the deadly intersection of HIV and tuberculosis in the developing world, the importance of reducing HIV infection in women, and HIV treatment and prevention in infants and children. 

A second global health symposium, “HIV and Tuberculosis,” scheduled for Saturday, Oct. 31, 5:30 to 7:30 p.m., will focus on the twin epidemics of HIV and TB. William J. Burman, MD, medical director of the infectious diseases clinic of Denver Public Health, will detail the promise of new TB drugs and how innovations on the horizon could change the treatment of this ancient disease.

Other presenters will include Richard Chaisson, MD, FIDSA, of Johns Hopkins University; Gerald Friedland, MD, FIDSA, of Yale University; and Madhukar Pai, MD, of McGill University. Dr. Friedland will discuss the threat of drug-resistant TB, while Dr. Pai will address the challenge of diagnosing TB infection in HIV-positive patients.

For more information, visit the Annual Meeting website and the online program planner, which you can use to search for specific sessions and speakers, creating your own, day-by-day, personalized itinerary for the meeting. You can also follow IDSA on Twitter for important meeting updates.

Global Center Calls for Bold New HIV Treatment Targets

Physician-scientists working on the front lines of the HIV/AIDS epidemic have urged the White House to set bold new HIV treatment targets for the PEPFAR program, the President’s Emergency Plan for AIDS Relief. Earlier this month, the Center for Global Health Policy joined with a coalition of other advocacy groups—including Health GAP, amfAR (the Foundation for AIDS Research), the Treatment Action Group, and The AIDS Institute—in calling for PEPFAR to reach 6 million people with treatment by 2013 and 7 million by 2014. 

"The rapid scale up to provide antiretrovirals to millions of people through PEPFAR and other programs has made AIDS a manageable chronic disease in many resource-constrained environments,” said Kenneth Mayer, MD, co-chair of Global Center’s Scientific Advisory Committee, in a press release. “However, the majority of people who need life-saving treatment are not receiving it. With data suggesting that earlier treatment may prevent long-term consequences of HIV disease and may make HIV-positive people less infectious, there is increased urgency to expand access to these medications.”

The Global Center and its partners also sent a memo to U.S. Global AIDS Coordinator Eric Goosby, MD, detailing this HIV treatment imperative and noting that these aggressive new targets will allow the United States to continue its strong leadership in combating global AIDS. The targets can easily be reached if the funding for global AIDS, included when lawmakers reauthorized PEPFAR last summer, as the Lantos-Hyde Act, is actually provided.

Where Will PEPFAR Find 140,000 New Health Care Workers?

It seems there are still more questions than answers about how the President’s Emergency Plan for AIDS Relief (PEPFAR) will achieve a key milestone: recruiting and retaining 140,000 new health care workers over the next five years in countries hard hit by the AIDS epidemic.

Congress included that provision when lawmakers reauthorized PEPFAR last year, part of a broader effort to strengthen developing countries’ health systems. But turning that promise into a reality is a tall order, given the severity of current workforce shortages, the time, effort, and expense involved in training new doctors and nurses, and the brain drain of health care professionals from resource poor countries to more affluent ones. You can read more about this issue at the Center for Global Health Policy’s blog, ScienceSpeaks.

During a recent presentation at the Global Health Council, Karin Turner, a senior USAID official whose portfolio includes health system strengthening and heath care workforce issues for Southern Africa, said there was still some “fogginess” on how this effort would unfold in the context of PEPFAR’s pivot to focus more on health system strengthening.

Some of the uncertainties Turner highlighted:

  • Will program officials and implementers be looking more at general health outcomes or HIV outcomes under the new PEPFAR law?
  • What is PEPFAR II’s vision of health systems?
  • Will the focus be on building sustainability or meeting new targets, or both?

Read more about this topic and other global health news at

Is Europe Moving Ahead of the U.S. on Antimicrobial Resistance Policy Efforts?

New Reports Highlight Antibiotic Resistance, Ways to Spur Drug Development

Two recent European reports, reminiscent of IDSA’s 2004 “Bad Bugs, No Drugs” report,  describe the growing problem of antimicrobial resistance in Europe and highlight possible strategies, including incentives, to stimulate the development of new antibiotics. Both were part of an international conference sponsored by the European Union (EU) and held Sept. 17 in Stockholm.

The first report, drafted by the European Center for Disease Prevention and Control and the European Medicines Agency, analyzes the growing gap between the resistance problem in the EU and the diminishing antibacterial pipeline. The report outlines the scope of the burden posed by drug resistance in Europe, where approximately 25,000 people die each year from just five infections: methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus faecium, third-generation cephalosporin-resistant Escherichia coli and Klebsiella pneumoniae, and carbapenem-resistant Pseudomonas aeruginosa. These five infections result in about 2.5 million extra hospital days and more than 900 million Euros (approximately $1.4 billion) in additional hospital costs, according to the report’s authors, who call for a European and global strategy to combat antibiotic resistance.

The other major report, from the London School of Economics and Political Science (LSEPS), outlines potential policy options, including financial and other incentives to spur antibacterial drug and related diagnostic research and development. The analysis, which generated media coverage on the websites of CNN and TIME magazine, includes strategies such as direct research funding and tax incentives, intellectual property mechanisms and monetary prizes, and possible regulatory tools, among other possible ways to encourage the much needed research and development in this area.

IDSA is looking for opportunities to leverage the EU’s advances in this policy area to motivate greater U.S. action and already has called upon the Food and Drug Administration (FDA) to commission a study similar to the LSEPS report that will analyze policy options in this country. In early November, EU and U.S. political leaders plan to meet to discuss these issues at a summit in Washington, D.C., where President Obama and the Swedish prime minister (Sweden currently holds the EU presidency) are expected to agree to establish a joint transatlantic task force on antimicrobial resistance. IDSA will continue to monitor these discussions and weigh in as appropriate. For more information about the Society’s efforts to address antibiotic resistance, see IDSA’s website.

CDC Issues Revised Guidance for Preventing H1N1 in Health Facilities

The Centers for Disease Control and Prevention (CDC) in mid-October issued its latest guidance on preventing the transmission of novel H1N1 influenza in health care settings. CDC emphasized a multipronged approach, but affirmed its earlier recommendation that health care workers (HCWs) in close contact with patients with confirmed or suspected cases of H1N1 wear N95 respirators.

CDC advises health care facilities to use a hierarchy of controls, including personal protective equipment as one element, to prevent the transmission of influenza and help facilities get the most benefit from  respirator supplies, the availability of which CDC acknowledges is already an issue at many institutions. In its guidance, CDC highlights the fundamental importance of immunizing HCWs against H1N1. After immunizations, CDC’s hierarchy of controls, from highest rank to lowest priority, include:

  • Eliminating potential exposures, such as postponing elective visits by patients with suspected or confirmed influenza, or minimizing outpatient visits for patients with mild influenza-like illness who are not at risk for complications
  • Engineering controls, which might involve installing partitions in triage areas and other public spaces
  • Administrative controls, such as promoting and providing influenza vaccination, enforcing policies about working when sick, and implementing hand and cough hygiene strategies
  • Personal protective equipment

While the guidance calls for HCWs to wear N95 respirators, fit-tested to meet Occupational Safety and Health Administration (OSHA) requirements, when caring for H1N1 patients, it also details other options when respirators are in short supply. These include prioritizing respirator use, keeping in mind the duration and intensity of exposure, personal risk factors for complications of infection, and vaccination status. Under these priority conditions, CDC advises, HCWs who do not receive respirators should wear surgical masks. The updated guidance notes that the recommendations will be updated as necessary as new information becomes available.

IDSA shares the practical concerns about CDC’s guidance regarding the use of respirators voiced by the Society for Healthcare Epidemiology (SHEA), which issued a press release in response to CDC’s updated recommendations. Both SHEA and IDSA have stressed the importance of a range of infection control measures, including immunization against influenza, to prevent the transmission of H1N1, most notably in statement presented at a recent Institute of Medicine forum. IDSA also recently adopted a strengthened policy supporting mandatory immunization of HCWs as the most effective way to protect both patients and HCWs against H1N1 and seasonal influenza (see IDSA News article).

To read more about CDC’s latest recommendations, see this story from the Center for Infectious Disease Research and Policy.

IDSA Weighs In Regarding New Physician Payment Models

IDSA continues to weigh in regarding new physician payment methods being considered by policymakers, including how ID physicians’ services could be incorporated into accountable care organizations (ACOs). Under the ACO model, a group of physicians or possibly a hospital would be responsible for quality and the overall annual Medicare spending for their patients. Earlier this month, IDSA sent a letter to the Medicare Payment Advisory Commission (MedPAC) to clarify the Society’s position and to explain how ID physicians’ infection control services could be incentivized through the establishment of ACOs, gainsharing arrangements, or other new and emerging payment methodologies that foster physician and hospital collaborations. The letter followed an earlier meeting with MedPAC staff to discuss ACOs, resource use reporting, and Medicare’s proposal to eliminate payments for consultations (see IDSA News article).

Congress Extends Ryan White Program Until 2013

Congress this month passed a four-year extension of the Ryan White HIV/AIDS Program, which helps ensure that more than half a million low-income, uninsured, or underinsured people living with HIV/AIDS have access to care. The legislation, which President Obama is expected to sign into law shortly, would implement three policies supported by the HIV Medicine Association (HIVMA) and the Ryan White Medical Providers Coalition (RWMPC):

  • A four-year extension of the program with technical fixes
  • A 5 percent increase, per year, in the authorized funding for all of parts of the program, including Part C
  • No changes to the core medical services definition in the program

HIVMA and RWMPC issued a press release applauding Congress’ extension of the program and plan to work with the HIV/AIDS community and federal officials to implement the legislation in the coming months. For a summary of the bill, visit this webpage.

Announcing the New IDSA/HIVMA Board Members

IDSA and HIVMA members have elected the following members to positions on the boards of directors:


Vice President:

Thomas G. Slama, MD, FIDSA
Indiana University School of Medicine
Indianapolis, IN


Cynthia L. Sears, MD, FIDSA
Johns Hopkins University School of Medicine
Baltimore, MD


Andrew T. Pavia, MD, FIDSA
University of Utah
Salt Lake City, UT

Wesley C. Van Voorhis, MD, PhD, FIDSA
University of Washington
Seattle, WA

State and Regional Societies Representative:

Johan S. Bakken, MD, PhD, FIDSA
St. Luke’s ID Associates
Duluth, MN


Vice Chair:

Judith A. Aberg, MD, FIDSA
New York University School of Medicine
New York, NY

Infectious Diseases seat:

Judith S. Currier, MD, MSc, FIDSA
University of California, Los Angeles, Center for Clinical AIDS Research & Education
Los Angeles, CA

Internal Medicine seat:

Kathleen A. Clanon, MD
Alameda County Medical Center
Oakland, CA

Pediatric/Adolescent ID seat:

Theresa L. Barton, MD
University of Texas Southwestern
Dallas, TX

Congratulations to the 2009 Society Award Winners!

IDSA and the Education and Research Foundation offer awards to individuals to honor outstanding achievements in the field of infectious diseases. Award recipients are pioneers in the study of newly emerging diseases, inspiring and supportive teachers, and those who paved the way for lifesaving vaccines. 

Alexander Fleming Award
The Alexander Fleming Award is granted in recognition of a career that reflects major contributions to the acquisition and dissemination of knowledge about infectious diseases.

Arnold S. Monto, MD, FIDSA, is one of the world’s foremost experts in respiratory illnesses. Dr. Monto is professor of epidemiology at the University of Michigan School of Public Health and the principal investigator in many studies funded by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). His contribution is seminal in our understanding of the pathogenesis, treatment, and prevention of influenza virus infections—his work is now the gold standard for dealing with influenza outbreaks and our understanding of the herd immunity caused by targeted influenza vaccination.

Oswald Avery Award
The Oswald Avery Award recognizes outstanding achievement in an area of infectious diseases by an individual member or fellow of IDSA who is 45 or younger.

Jean-Laurent Casanova, MD, PhD, is recognized for his pioneering work in the discovery, development, and scientific and clinical understanding of the field of innate immunity. Dr. Casanova is a professor of pediatrics and head of the Laboratory of Human Genetics of Infectious Diseases at The Rockefeller University in New York. Dr. Casanova’s research has revolutionized our understanding of the genetics involved in the predisposition and susceptibility to pediatric infectious diseases.

Mentor Award
The Mentor Award was created to recognize individuals who have served as exemplary mentors and is presented to an IDSA member or fellow who has been exceptional in guiding professional growth of infectious diseases professionals. 

Richard L. Guerrant, MD, FIDSA, is a world-renowned expert on enteric infections. Dr. Guerrant is the Thomas H. Hunter Professor of International Medicine in the division of infectious diseases and international health at the University of Virginia School of Medicine in Charlottesville. He has mentored more than 150 students and fellows and shaped the careers of academic and scientific leaders in tropical medicine, such as Drs. James M. Hughes, Jonatahan I. Ravdin, Ted Steiner, Cynthia L. Sears, and Cirle Warren. 

Society Citation
The Society Citation is a discretionary award given in recognition of exemplary contribution to IDSA, an outstanding discovery in the field of infectious diseases, or a lifetime of outstanding achievement in a given area—either in research, clinical investigation, or clinical practice.

Warren D. Johnson Jr., MD, FIDSA, is a well-known researcher on tropical medicine. Dr. Johnson is B.H. Kean Professor of Tropical Medicine and director of the Center for Global Health at Weill Medical College of Cornell University in New York. He has contributed greatly in reducing infant mortality from diarrheal diseases in Port-au-Prince, Haiti. He has trained several generations of researchers from Haiti, Brazil, Tanzania, and the United States, impacting the health of these countries. His research has been pivotal in understanding the natural history and therapy of leishmaniasis and leptospirosis in Brazil, and the epidemiology of AIDS and isosporiasis in Haiti.

Clinical Teacher Award
The Clinical Teacher Award honors a career involved in teaching clinical infectious diseases to fellows, residents, or medical students and recognizes excellence as a clinician and motivation to teach the next generation.

Joshua Fierer, MD, FIDSA, a committed clinician and teacher, has mentored more than 15 fellows as an individual mentor in his laboratory and co-mentored numerous trainees from around the world, including Drs. Theo Kirkland, Mark Swancutt, Ferric Fang, and Lars Eckman. His mentees describe him as a compassionate, good-humored mentor with an encyclopedic knowledge of infectious diseases. Dr. Fierer is professor of medicine and pathology in residence at the University of California in San Diego.

Watanakunakorn Award
Named to honor the memory of Dr. Chatrchai Watanakunakorn, this award is given annually by the IDSA Education and Research Foundation to an IDSA member or fellow in recognition of outstanding achievement in the clinical practice of infectious diseases.

Lawrence J. Eron, MD, FIDSA, a recognized early pioneer in telemedicine, is known among his peers as a “doctor’s doctor.” Colleagues and residents describe Dr. Eron as a consummate clinician, loved by his patients and admired by other physicians, who often consult him about infectious diseases. He is a great communicator, sensitive to the needs of his local community, and a thoughtful leader involved in the improvement of health care, always ready to promote cost-effective quality care. Dr. Eron is an associate professor of medicine at the University of Hawaii in Honolulu.

The awards will be presented during the Opening Plenary Session at the 47th Annual Meeting of IDSA in Philadelphia on Oct. 29. More information about this year's Society Award winners is available online.

IDSA Congratulates the 2009 Joint Research Award Winners

The IDSA Education and Research Foundation (ERF) and the National Foundation for Infectious Diseases (NFID) have joined forces to offer the IDSA ERF/NFID Joint Research Awards. Our goal is to support needed research by promising young researchers who may not otherwise find funding as federal and other institutional research support becomes more difficult to obtain.

Merle A. Sande/Pfizer Fellowship Award in International Infectious Diseases

Jennifer Downs, MD, an infectious disease fellow at Weill Medical College of Cornell University, will focus on Tanzania’s Lake Zone region, where she will screen 350 women for female genital schistosomiasis to establish its prevalence and collect data on disease associations (human papillomavirus (HPV) and HIV), the utility of antigen tests, symptoms, and social and psychiatric ramifications. The second phase of the study will involve a cohort study of 75 women diagnosed with female genital schistosomiasis (FGS), who will be treated with one dose of praziquantel and followed for six months to assess for resolution.

Astellas Young Investigator Awards

William J. Muller, MD, PhD, assistant professor of pediatrics in the Feinberg School of Medicine at Northwestern University, will develop and test vaccine candidates for herpes simplex virus (HSV) infections, and seek better understanding of  the immune responses needed to control mucosal viral infections and chronic viral infections.


Manuela Raffatellu, MD, assistant professor in the department of microbiology and molecular genetics at the University of California at Irvine, has focused on elucidating the many complexities of Salmonella interaction with both immunocompetent and immunocompromised hosts. Dr. Raffatellu’s goal is to establish new paradigms on how mucosal pathogens interact with the host.



ASP Young Investigator Award in Geriatrics

H. Keipp B. Talbot, MD, MPH, will be identifying immune correlates in older adults that will serve as endpoints to measure the effectiveness of novel influenza vaccines. Specifically, her study aims to define which cellular and humoral immune responses correlate with protection from influenza infection in adults 50 years of age or older. Dr. Talbot is assistant professor of medicine in the division of infectious diseases and assistant director of research of the Center for Quality Aging at Vanderbilt University.

Wyeth Young Investigator Award in Vaccine Development

Mark Daniel Hicar, MD, PhD, a clinical fellow in pediatric infectious diseases at Vanderbilt Children’s Hospital, will investigate the functional aspects of the HIV antibodies he has identified, defining the biochemical and structural features of HIV envelope trimer-specific antibodies and their relation to neutralization and binding of the envelope protein.



More information about the 2009 Joint Research Award Winners is available online.

Members on the Move

Carol J. Baker, MD, FIDSA, has been appointed chair of the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC). Dr. Baker previously served as a member of the committee. Her appointment is effective immediately and continues through June 2010. Dr. Baker is a professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine and is the executive director of Texas Children's Center for Vaccine Awareness and Research. An IDSA past president, she is also chair of IDSA’s special Lyme disease review panel.

Gregory C. Gray, MD, MPH, FIDSA, has been named professor and chair of the Department of Environmental and Global Health at the University of Florida’s College of Public Health and Health Professions. He has served as director of the Center for Emerging Diseases at the University of Iowa College of Public Health for the past eight years. Dr. Gray serves on the IDSA National and Global Public Health Committee.

Welcome, New Members!


Bamford, Laura, MD
Berroya, Maye, MD
Bland, Christopher, PharmD
Brosgart, Carol, MD
Daniels, Robert, PharmD
Duharte-Vidaurre, Luis, MD
Gaitanis, Melissa, MD
Goldman, David, MD
Golightly, Linnie, MD
Jimenez, Humberto, PharmD
Kibirige-Shacklett, Catherine, PhD
Lacy, Melinda, PharmD
Nguyen, Minh-Hong, MD
Nguyen, Bach-Yen, MD
Pedneault, Louise, MD
Sanabria, Jose, MD
Sopirala, Madhuri, MD
Srivastava, Vipul, MD
Sudduth, Elizabeth, MD
Theiler, Regan, MD, PhD
Tignor, Matthew, MD
Tsuzuki, Daisuke, MD, PhD
Weinstein, Lenny, DO


Adudans, Steve, MD, MSc
Beieler, Alison, PA-C
Boulden, Melissa, MS, PA-C
Child, Michael
Cologna, Peter
Edozien, Anthony, MD
Farley, John, MD, MPH
Forrester, Jennifer, MD
Gilbert, Michael, MD
Jacobs, Alice, MD
Johnson, Livette, MD
Joseph, Jonathan, MD
McDaniels, Deborah, NP
Rios, Arnulfo
Rudman, Jim
Rudnick, Marlene, MD
Simon, Matthew, MD
Speidel, Katie, PharmD
Stagnar, Cristy, MS
Tunca Gonen, Berivan, MD
Verma, Nishant, MD, MBBS


Al-Dabbagh, Mona, MD
Blatz, Peter, MD
Bobula, Steven, MD
Bond, Brooke, MD
Bowman, Michael, MD
Calvo, Katya, MD
Carlson, Misty, DO, MPH
Chattergoon, Michael, MD, PhD
Cheikh, Eyad, MD
Cho, Oh-hyun, MD
Chong, Yong Pil, M
Erritouni, Mohamed, MD
Faiad, Graciela, MD
Farabishahadel, Alireza, MD
Han, Alice, MD
Heysell, Scott, MD, MPH
Iuliano, A. Danielle, MPH, PhD
Kainth, Mundeep, DO
Kelesidis, Theodoros, MD
Kessler, Jason, MD
Khalid, Ayesha, MD
Kim, Jong Hun, MD
Kumar, Rakesh, MD
Little, Malaika, MD
Lontok, Josephine, MD
Moodley, Amaran, MD
Ozer, Egon, MD, PhD
Patel, Shephali, MD
Qureshi, Nadia, MD
Ramsahai, Shweta, MD
Selke, Henry, DO
Seshabhattar, Praveen, MD
Somersan, Selin, MD
Sureshkumar, Dorairajan, MD
Thomas, Tania, MD, MPH
Welc, Christina, DO
Yong, Lee, MD

“Ask the Coder” Answers CPT Questions

Have a tough coding question? Picking the right code level is often difficult due to a lack of familiarity with the rules governing inpatient consultations, subsequent hospital visits, prolonged services, and incident-to billing. “Ask the Coder” can help. If you have a question about evaluation and management (E&M) or current procedural terminology (CPT) service codes, simply fill out the form on the “Ask the Coder” portal, and your question will be sent to a certified professional coder for a response.

The answers provided through “Ask the Coder” are provided on an “as is” basis. Readers must use their own independent professional judgment in making coding decisions. The reader assumes all risks in using this information. The service is for IDSA members and their office staff.