Chapter 3 - A paradigm shift

In reply—Bias and Male Circumcision

Cardiopulmonary Resuscitation During the Coronavirus Crisis: Important Updates for the Cardiothoracic and Vascular Anesthesia Community

Effective immunization programs have markedly diminished the incidence of vaccine-preventable diseases. As a result, there now exists in society a lower awareness of the actual risks associated with the diseases themselves and a greater prominence of the potential risks of adverse effects associated with vaccines.Concern regarding public reactions to new vaccine safety issues may place pressure on policymakers and/or health care providers to act quickly in response to new information. However, this concern must be tempered by the necessary caution required to assess the intended and unintended risks and benefits of any action undertaken. The interplay of these potentially competing demands is well illustrated by the recent safety concern involving the use of thimerosal in vaccines.Thimerosal is a mercury-containing compound that has been widely used as an antimicrobial agent in vaccines for over 60 years. Human exposure to mercury may have potentially significant health consequences. By mid-1999, the Food and Drug Administration (FDA) had discovered that children could be exposed to an amount of mercury from vaccines that exceeded 1 of 3 existing federal safety thresholds. After this realization, the organized medical and public health communities in the United States became involved in a series of urgent and intense discussions to determine an appropriate response to the issue. This manuscript describes and analyzes the process that led to the July 7, 1999, joint American Academy of Pediatrics (AAP)/US Public Health Service (PHS) statement on thimerosal,1 with the goal of suggesting improvements for managing similar vaccine safety concerns in the future.We conducted structured interviews with over 15 individuals involved in the discussions and negotiations leading to the joint AAP/PHS statement on thimerosal. The individuals represented both the governmental agencies and nongovernmental organizations involved, including the FDA, the Environmental Protection Agency (EPA), the Centers for Disease Control and Prevention (CDC), the National Vaccine Program Office (NVPO), the AAP, and the American Academy of Family Physicians (AAFP). Interviews were conducted through face-to-face meetings or by telephone between January and April 2001. Table 1 lists the individuals interviewed who allowed their identities to be published.The development and implementation of immunization policy in the United States is a cooperative effort among many entities in the public and private sectors (Table 2).The concern over thimerosal in vaccines originated from a confluence of independent events, 1 informal and 1 formal, within the FDA. In the spring of 1998, some individuals within the FDA's Center for Biologics Evaluation and Research (CBER) began to informally consider the increased number of recommended vaccines and the amount of substances, such as mercury, contained in them to which vaccine recipients were exposed. Available literature to help quantify their concern was limited.The formal identification of thimerosal as a concern arose through the FDA's efforts to comply with the Food and Drug Administration 2Modernization Act.2 As mandated by Congress, Section 413(a) of the Act required the FDA to compile a list of drugs and foods that contain "intentionally introduced" mercury compounds and to provide a quantitative and qualitative analysis of these compounds within 2 years of the Act's enactment.The FDA's previous formal review of thimerosal in biological products had occurred in 1976. The convergence of concerns over mercury in vaccines that occurred within the CBER beginning in April 1998 prompted the agency to reassess the risks of thimerosal.3One of the steps of this risk assessment was to investigate the potential exposure of humans to thimerosal in vaccines. Based on the information submitted by industry and FDA internal data, the CBER determined that thimerosal was present in over 30 licensed vaccines in the United States.4,5 The amount of mercury by weight present in each of these vaccines was calculated. The CBER then referred to the recommended childhood immunization schedule to determine the amount of mercury to which young children may be exposed. Of the vaccines that a child could receive in the first 2 years of life, those that contained thimerosal were the 2 available formulations of the hepatitis B vaccine and some formulations of the diphtheria-tetanus-acellular pertussis and Haemophilus influenzae type b vaccines. Looking at cumulative exposure over the first 6 months of life, an infant 6 months old who received all recommended vaccine doses on schedule could be exposed to up to 187.5 μg of mercury.Another step in the risk assessment process was to determine whether thimerosal actually constituted a true health risk; that is, whether there were data demonstrating that this amount of mercury could be potentially harmful to children. To identify whether there were any known health risks from exposure to thimerosal, the CBER conducted a literature review and queried the Vaccine Adverse Event Reporting System, a national surveillance system for voluntarily reported adverse events associated with vaccines. The CBER found that at low doses, thimerosal has been associated with rare hypersensitivity reactions, such as persistent skin sensitization at the site of vaccination. At very high doses (ie, 1000 times higher than levels found in vaccines), thimerosal has been reported to cause neurologic and renal toxicity.An early assessment of the health risks of all forms of mercury by the World Health Organization (WHO) found that insufficient information was available to perform risk calculations for human exposure to ethyl mercury compounds, the type of mercury contained in thimerosal.6 However, the WHO did note that the limited data available suggested that ethyl mercury was probably less hazardous than methyl mercury, because it is metabolized faster in the body.The WHO and 3 US governmental agencies—the FDA, the EPA, and the Agency for Toxic Substances and Disease Registry (ATSDR)—had developed independent guidelines for safe exposure to methyl mercury (Table 3).7–10 Because no guidelines exist for ethyl mercury exposure, the FDA used the guidelines for safe exposure to methyl mercury as a guide for determining whether the mercury (ethyl) dose from thimerosal in vaccines approached a level of concern or health risk.The existence of 3 differing US federal guidelines for methyl mercury was a source of confusion and contention in determining the appropriate response to concern regarding thimerosal in vaccines. Each agency developed their guidelines for different purposes. The most conservative of these guidelines was the level established by the EPA to serve as a warning of mercury in the environment to trigger additional investigation. The ATSDR guideline is set below levels that might cause an adverse health impact in those most sensitive to a particular substance. The FDA guidelines were developed as safe limits for long-term consumption of food contaminated with mercury, particularly fish, which is the main exposure route of humans to methyl mercury. No guidelines were available to assess the risk of exposure in bolus doses by intramuscular injection.Nevertheless, the existing methyl mercury guidelines were the best information available at the time for assessing risk from ethyl mercury exposure. The CBER calculated exposure limits for each of these guidelines based on the average weight at various percentiles in female infants between birth and 26 weeks of age (Table 4). Based on these calculations, the CBER determined that potential exposure to mercury from the recommended childhood vaccines in the first 6 months of life could exceed the EPA methyl mercury guideline, but not the ATSDR, FDA, or WHO guidelines. However, the CBER was unable to determine with certainty whether exposure to thimerosal in vaccines was harmful.In April 1999, results from the preliminary risk assessment were discussed at an internal FDA meeting, and participants realized that there was a clear need for additional data. The CBER began to consult with toxicologists both within the FDA and at the National Center for Environmental Health, and several vaccine researchers, including Neal Halsey, MD, Director of the Institute for Vaccine Safety at Johns Hopkins University. The FDA also initiated discussions with vaccine manufacturers regarding the need to develop thimerosal-free vaccines.3Dr Halsey was invited by the FDA to an internal meeting in mid-June 1999 where he was asked to provide feedback on the results of their preliminary risk assessment regarding thimerosal. On learning of the FDA data, and personally verifying the calculations of the levels of mercury to which children could be exposed, he believed that the issue warranted serious concern and urgent action. At the time, Dr Halsey was soon to complete his term as Chair of the AAP Committee on Infectious Diseases (COID). Dr Halsey previously worked within the CDC's immunization program and had been a member of the Advisory Committee on Immunization Practices (ACIP). As such, he had extensive experience and professional relationships within the US immunization policymaking arena. Beginning around June 24, 1999, Dr Halsey informed many of these contacts of his concern regarding the potential health effects of thimerosal and the results of the FDA's preliminary risk assessment. After notifying the Director of the CDC's National Immunization Program, Dr Halsey met with CDC personnel at the National Immunization Conference on June 25. He also informed several other individuals, including the incoming Chair of the COID, the Chair of the ACIP, and a member of the AAP Board of Directors. In addition to his concern regarding the potential health effects of mercury exposure in infants, Dr Halsey expressed the need for urgent action on the issue because the FDA was planning to send a letter to vaccine manufacturers in the beginning of July 1999 regarding the need to remove thimerosal from vaccines, at which point the information about thimerosal would become public. He believed that publicity surrounding this issue, without action on the part of the PHS and/or the AAP, could result in long-term damage to public confidence in the national immunization system.After Dr Halsey informed these initial contacts of his concerns regarding thimerosal, conversations began to occur among the parties. The Interagency Vaccine Group (IAG) held a conference call on June 28 and reviewed the information from the FDA's preliminary risk assessment. After this call, the IAG formed a special workgroup to address the thimerosal issue. CDC immunization officials also conferred with the AAP, vaccine companies, and internal CDC toxicologists.Significant differences of opinion surfaced regarding the accuracy of the exposure and risk-assessment information concerning thimerosal, its importance, and the need for any immediate discussion or action.To quickly bring representatives of several organizations involved in immunization policymaking together to discuss the issue, a meeting was organized by Dr Halsey and Dr Cooper for June 30, 1999, at the AAP offices in Washington, DC. The selection of the venue for this meeting was deliberate. The initial course of action for the government normally would have been for the ACIP and the National Vaccine Advisory Committee (NVAC) to meet to discuss the issue. However, governmental advisory boards are required by the Federal Advisory Committee Act to provide adequate public notice of meetings and publish meeting agendas in the Federal Register. Given how quickly some individuals believed a meeting should occur, it was not possible to officially convene these advisory bodies in such a short time frame. By having an informal meeting at the offices of the AAP, a frank discussion of the scientific and biological veracity of all available information could take place without delay. As a result, however, this meeting precluded the formal involvement of the ACIP and the NVAC.Drs Cooper and Halsey developed a list of invitees, which included representatives of the CDC, FDA, EPA, AAP, vaccine manufacturers, and toxicologic consultants. An initial goal of the meeting was to achieve consensus on a course of action, as many believed that public presentation of differing views would likely confuse practitioners and parents, and potentially undermine confidence in the national immunization system.At the meeting, FDA representatives shared the results of their preliminary risk assessment, outlining what was known and unknown about the issue and describing the difficulties in determining whether the level of mercury in vaccines should be of concern. Because of the complexities in interpreting the data regarding the potential risk of harm from thimerosal, there was disagreement among the parties present as to its significance. Disagreements existed between organizations, within organizations, and among the toxicologists present at the meeting. Some participants believed strongly that the potential threat to health from thimerosal was significant; others believed that there was no clear evidence that thimerosal was harmful, particularly when compared with the clear health risks of delaying childhood vaccines. The 2 AAP committees represented at the meeting, the COID and the Committee on Environmental Health, were in sharp disagreement on this point. There was also a varied sense of exigency, with some participants believing that urgent action was required, whereas others thought the process should slow down to include other parties in the discussion and address perceived significant gaps in the scientific data. Actions proposed by participants at the meeting ranged from immediately stopping administration of all vaccines containing thimerosal to children under 6 months of age to encouraging vaccine manufacturers to expedite the elimination of thimerosal from vaccines.An overriding concern expressed by all parties at the meeting was the need to maintain the public's trust in the US immunization system by striking the appropriate balance between acknowledgment of the potential risk of harm from thimerosal and the actual risk of harm from not immunizing against vaccine-preventable diseases.It became clear during the June 30, 1999 meeting that no consensus would be reached that day regarding an appropriate course of action. Sharp disagreements regarding the clinical significance of thimerosal exposure were not resolved. Specific individuals who felt most strongly regarding the potential health risk of thimerosal exposure stated that they would independently make public statements if their respective organizations did not support their contentions. The meeting concluded with all participants agreeing that no statement would be released by any individual or organization until after the July 4th weekend, and that discussions between the PHS and the AAP would continue in an attempt to achieve a unified public statement. Leadership in both the AAP and the PHS believed that releasing a joint public statement was crucial for preserving the public's trust in the immunization system.PHS officials in the CDC and elsewhere believed that vaccine manufacturers should be encouraged to expedite the elimination of thimerosal from vaccines, but did not want to make any changes to the childhood immunization schedule. However, CDC officials also felt strongly that it would be in the best interests of the national immunization system and the public's trust for a statement to be developed jointly with the AAP. This prompted David Satcher, MD, PhD, the US Surgeon General and Assistant Secretary for Health, to be involved in the negotiations.After the June 30 meeting, there was significant debate within the AAP as to the appropriate course of action to be taken. Over the next several days, there was constant reconsideration and revision of positions taken among both individuals and committees.On review of available information and opinions, the AAP Board of Directors decided to put forth the position in their negotiations with the PHS that the birth dose of the hepatitis B vaccine be temporarily delayed. They considered the risk of disease to be low except for infants of HBsAg-positive mothers. The Board of Directors believed that hospitals should already have procedures in place to determine the hepatitis B status of mothers and treat the infants of HBsAg-positive status mothers appropriately.Other parties were informally involved in the discussions leading to the joint statement. The AAFP did not think the issue warranted such urgency and believed that the health effects data for methyl mercury on which the EPA guidelines were based were questionable.Many conference calls, meetings, and sharing of draft statements occurred within and between the AAP and the PHS over the course of the July 4, 1999 holiday weekend. The Surgeon General held several discussions with the AAP president to negotiate a compromise position. Although they were extremely concerned about both the short- and long-term consequences of delaying administration of the hepatitis B vaccine, PHS officials agreed to the recommendation to present a unified position to the public.The joint statement was officially released in the late afternoon of July 7, 1999,11 and was published in the MMWR Morbidity and Mortality Weekly Report on July 9, 1999.1First and foremost, it is clear that all parties involved in this process acted in the manner they believed was in the best interest of children in the United States. Even parties that differed most strongly never doubted the intent or purpose of those with whom they disagreed.Only 2 weeks transpired between the time that leaders of the major national organizations involved in US immunization policy learned about the issue of thimerosal in vaccines and the release of the joint AAP/PHS statement. During that time, these individuals and their organizations worked diligently to develop a response that they believed balanced the potential risk from exposure to thimerosal with the actual risk of vaccine-preventable disease and would ensure continued public confidence in the nations' immunization system. Considering the complexity of the information available and the gaps in information relevant to specific concerns, it is not surprising there was significant disagreement regarding the potential risk associated with thimerosal. To some, the process could be considered a success, in that compromise was reached and the "crisis" was addressed. However, others have publicly the that the recommendation to the birth dose of hepatitis B vaccine practitioners and put infants at risk for hepatitis B vaccine as to that the process was a of how not to public health of the IAG would have first learned of the thimerosal issue from FDA who would have informed the of its review of the thimerosal in vaccines. In this however, an individual of the government was the first to many of these soon the FDA should have is a of as is how information should have been other parties. The FDA was to an issue with the IAG when there were many surrounding the potential health risks In the FDA must be sensitive to issues to any under its IAG is to among federal agencies with vaccine issues through meetings and other To the IAG must achieve a balance between that are informed of and agencies to data to other parties the information is released to the public. such to be there must be confidence among the parties that their all from and shared efforts with each the must be as independent and to its of this issue is to ensure that the and of the are not under the or perceived or of any the through the that serious be by the Office of the Secretary for Health and Human to the of the of the including the of and the of meeting that occurred at the AAP offices in Washington, on June 30, 1999, was a in the discussions leading to the joint statement. the of this type of meeting and the in which it was organized was for the AAP, the of action was of the of the Board of are as to the of who or was concern expressed from many was the of vaccine industry representatives at the meeting. The meeting occurred the time of the vaccine safety in Congress, and in a environment in which of between industry and immunization policymakers had been Some participants at the meeting believed that having industry representatives at a meeting could have this may also have the of some meeting the of the vaccine industry to a immunization system be Vaccine manufacturers a of vaccine development and and their in different of immunization policy is concern is that some parties did not in this meeting such as the AAFP or representatives of hospitals that would be by the in the hepatitis B the of the 2 federal immunization advisory the ACIP and the did not in the initial thimerosal because of the perceived of the Federal Advisory Committee Act on meetings on very short The CDC and the have reviewed the and have found that exist for meetings on an to the birth dose of hepatitis B vaccine was not taken by any to the the risk of thimerosal exposure with the known risk of of hepatitis B disease was for However, in some leading to the joint AAP/PHS of the potential impact of delaying the birth dose of the hepatitis B vaccine did not receive some in of stopping the birth dose of hepatitis B vaccine, there was acknowledgment of the potentially significant of the of hospitals the the for this policy to these or the of procedures for determining the hepatitis B status of mothers. There to be effort to the existing literature on the impact of changes in immunization and the times for the of there was an confidence by some in the of hospitals to all mothers for hepatitis B status previous had of such of the impact of the joint statement on infant hepatitis B are now beginning to be have that some hospitals all with hepatitis B vaccine, including those to HBsAg-positive possible is the of information or of the recommendation by hospitals and Because of the of appropriate for and the hepatitis B status of this in policy has led to the of at 1 infant from hepatitis have also that many hospitals have not to doses of the hepatitis B vaccine the of thimerosal-free The of the first dose of hepatitis B vaccine at birth is illustrated by a recent that that children who received the first dose at birth were likely to complete the hepatitis B times of regarding immunization that all parties involved to the short- and long-term intended and unintended consequences of their proposed This type of analysis could take the of the and structured risk assessment process used by other government such as the of the major issues concern and urgency among all parties was the manner in which the would the issue. over the accuracy of in and for vaccine issues in is well However, an overriding issue is the of how should concern over the time of for public or individual health with policymaking must balance concern over the risk of public regarding safety issues with concern over the to ensure that information be to the public.The FDA the safety and of products they are for use and the process of a constant of products available to However, the of thimerosal an to FDA In the when thimerosal was for use in this there were limited available to assess for the of there is no for the FDA to vaccine with is in to some other federal such as the In was that be by the EPA years. Because no such process has been for the FDA, thimerosal not In for a containing mercury, the of most concern is on system At this time, the FDA has no for of the products it the FDA not have a to identify the cumulative amount of thimerosal, which children would receive over the course of the recommended immunization schedule. Each vaccine was for use as an independent agent and the amount of thimerosal contained in each individual vaccine no concern. was when the cumulative amount from all the vaccines contained in the recommended immunization schedule was calculated that concern that should consider to the FDA the to perform of vaccine In that the FDA its and the FDA develop a for of the cumulative amount of to which individuals may be exposed as a result of specific federal of the issues to all parties involved was the existence of differing federal for exposure to mercury from the EPA, the FDA, and the Although each agency had a different purpose in a specific safety the that there was no clear federal consensus on this issue was This allowed different parties to the discussion to over to support their federal agencies that have differing safety for exposure to specific to develop a federal consensus on safe exposure levels determine under which the different guidelines are to be than 1 federal is each agency should be with the for determining a different safety AAP is an organization for its to the of the health and of children. the internal debate that place within the AAP on this issue involved disagreement on the course of action that would be of to the children of the United AAP Board of Directors to its committees for and information regarding specific issues on which it must set However, the exists that the course of within the was in some than the Board of Directors on this issue from specific individuals were to the they may have represented the of the AAP is very that all be to maintain use of this in times of This help ensure that the consensus of than specific individuals, are to help guide the AAP Board of Directors regarding policy have on a of immunization The of these has been and At point efforts have been to information of those involved in immunization policy and in the or review of from the Institute of are now to in such committees for of and having their publicly and public if have the potential to cause significant and professional involvement of leading in the on childhood vaccines were to soon after the June 30, 1999, meeting at the AAP As such, concern over the manner in which any action or might be perceived in this type of environment a of concern and over many this was perceived as a course of action under by a process not in the best interests of the immunization system or children. This also to the development of a and the to act in interviewed but not of the parties involved in this As such, have an and assessment of the events that place in late June and early July However, there exists the that some information may not have been In these interviews were conducted 2 years after this process there may be some of the information process that in the in immunization as a result of concern to thimerosal was and Although there are significant differences of opinion regarding the of the the immunization system in the United States and was by the Program for and Health,

One year ago, the American Academy of Pediatrics (AAP) published a landmark policy statement identifying racism as a core social determinant of health and a driver of health inequities.1 Seventy-five years ago, the AAP admitted its first Black members, Drs Alonzo deGrate Smith and Roland Boyd Scott. As the AAP continues to evolve its equity agenda, it is essential that the tortuous experiences of Drs deGrate Smith and Scott on their pathway to AAP membership be truthfully acknowledged and reckoned with.At the time of their initially rejected applications in 1939, both Drs deGrate Smith and Scott were busy clinicians and well-established leaders in the pediatric academic community as faculty at the Howard University College of Medicine in Washington, DC. Dr deGrate Smith, through the practice pathway, and Dr Scott, via examination, were among the earliest pediatricians to achieve certification under the Advisory Board of Medical Specialties (ABMS) when the American Board of Pediatrics (ABP) was established in 1933. However, the ABMS required American Medical Association (AMA) membership to honor certification, and the local AMA chapter, the Medical Society of the District of Columbia, was segregated.2 According to the oral history interview of Dr Melvin E. Jenkins Jr, advocacy on the part of the inaugural ABP president, Dr Borden Veeder, was necessary to permanently eliminate this exclusionary barrier and to make certification possible for all eligible candidates regardless of race or ethnicity.3 Drs deGrate Smith and Scott faced other systemic barriers, including the inability to gain admitting privileges to care for even their own patients at local hospitals in the District of Columbia. This was a hurdle that Dr Scott was not able to overcome until 1955, fully 6 years after he had already been appointed Chair of Pediatrics at Howard University.4Although AAP bylaws did not explicitly prohibit physicians of color from membership, and Drs deGrate Smith and Scott were finally admitted in 1945, it is clear that the AAP Executive Board struggled with unbiased consideration of their applications. The characterizations related to Drs deGrate Smith and Scott in the following passages excerpted directly from meeting transcripts of AAP Executive Board meetings in November 1939, November 1944, and June 1945 are elucidating, instructive, and painful to read. The verbatim dialogue and proceedings highlight the racist attitudes and beliefs from which early AAP leaders were clearly not immune.In the United States there is a tendency to be ahistorical when it comes to race. The lack of acknowledgment, or worse, the intentional whitewashing of history and the longitudinal relationship of 400 years of oppression on the present-day expression of racism is not uncommon. As the AAP turns the corner toward the 2030 centennial anniversary of its founding, we cannot do so without authentically acknowledging, owning, and reconciling past discriminatory transgressions like the shameful gauntlet to membership experienced by Drs Alonzo deGrate Smith and Roland Boyd Scott.In honoring the memory of these two trailblazers and their contributions to pediatrics and the AAP,7 be it resolved that, we, the Board of Directors of the AAP:The AAP as an organization is on a firm pathway to broadly establishing an equity agenda through meaningful diversity and inclusion and a societal commitment to combating bias and discrimination in all its forms, including structural and systemic anti-Black racism (Fig 1). This country is already majority represented by children of color when it comes to the pediatric population.Embracing racial and ethnic socialization is critical for all children and families as well as for the pediatricians who care for them. Healing starts at home with truth, reckoning, and honest reconciliation.The AAP is proud to transparently acknowledge, proud to publicly reconcile, and proud to continue to lead on behalf of the best interests of children, adolescents, and young adults and the people who care for them.Sara H. Goza, MD, FAAPLee Savio Beers, MD, FAAPKyle E. Yasuda, MD, FAAPWarren M. Seigel, MD, FAAPMark Del Monte, JDWendy S. Davis, MD, FAAPWarren M. Seigel, MD, FAAPMargaret C. Fisher, MD, FAAPMichelle D. Fiscus, MD, FAAPRichard H. Tuck, MD, FAAPDennis M. Cooley, MD, FAAPGary W. Floyd, MD, FAAPMartha C. Middlemist, MD, FAAPYasuko Fukuda, MD, FAAPLisa A. Cosgrove, MD, FAAPCharles G. Macias, MD, FAAPConstance S. Houck, MD, FAAPJoseph L. Wright, MD, FAAP

The latest attempt at the evaluation and management (E/M) documentation guidelines has been put on hold. A newly formed Current Procedural Terminology (CPT) Editorial E/M Workgroup was developed as an outgrowth of the failed Centers for Medicare and Medicaid Services (CMS) E/M Documentation Guideline (EMDG) Project, which used clinical examples to guide physicians to pick the appropriate level of service. After Secretary Thompson halted the EMDG Project, the Medicare Payment Advisory Commission (MedPAC) and the Practicing Physician Action Group (PPAG) determined that perhaps it was not just the documentation guidelines that needed fixing, but the E/M codes themselves needed to be reevaluated as well. Therefore, the charge of the new workgroup will be to evaluate the current levels of E/M codes and make changes as necessary so that the codes more clearly describe what physicians do and to improve the ability of physicians to accurately use the codes in submitting claims.The workgroup will conduct surveys of practicing physicians, review Medicare and private sector utilization data, collect oral and written testimonies, and review other data as available. Initial panel review of the workgroup recommendations will be in August 2002 during the CPT meeting in Washington, DC. The final workgroup review, after input from the CPT Advisory Committee, will be in November 2002 at the CPT meeting in New Orleans. The workgroup will be expected to meet 5 or 6 times in the Chicago or DC areas.The American Academy of Pediatrics (AAP) was named as one of 7 specialty societies (along with the American Academy of Family Physicians, American College of Physicians-American Society of Internal Medicine, American Urological Association, American Academy of Neurology, American College of Surgeons, and American Orthopaedic Association) to have a representative on this new workgroup. The AAP Executive Committee picked Stuart Cohen, MD, as the AAP representative. Dr Cohen is a primary care pediatrician in the San Diego area who was on the Task Force on Reimbursement and is currently on the American Medical Association (AMA) House of Delegates for the AAP.The AAP had the opportunity to provide comments to the CMS about the November 1, 2001, release of the final rule. The following briefly summarizes some of the issues affecting pediatrics.The AAP emphasized its concerns about the 5.4% decrease in the 2002 conversion factor. The AAP urged the CMS to support the Medicare Physician Payment Fairness Act of 2001, which would decrease the conversion factor 0.9% instead of 5.4%.When contracting with carriers, it is important for pediatricians to remember that the resource-based relative value scale (RBRVS) is an adjustment factor for Medicare, which does not relate to children.CPT codes 90471 and 90472 have been before the AMA/Specialty Society Relative Value Scale (RVS) Update Committee (RUC) on several occasions, and in February 2001, the RUC again recommended work relative value units (RVUs) of 0.17 and 0.15, respectively. When the CMS published the 2002 final rule, however, it printed only the practice expense (PE) and professional liability insurance (PLI) RVUs, completely disregarding the RUC work recommendations with the statement that "[immunization administration services] are services performed by a nurse and have no physician work." The failure of the CMS to print work RVUs results in a considerable undervaluing of the service of immunization administration for 2002. It also incorrectly leads observers to believe that there is no physician work inherent in the administration of immunizations. In its comments, the CMS suggested that the physician work is already accounted for within the work RVUs of the preventive medicine codes. This is not the case, however, because the vignettes used to value preventive medicine services make no reference to the physician work of counseling and obtaining informed consent during the administration of immunizations.Over the past few years, the CMS has asked for "real" evidence demonstrating why physician work values should be published for the service of immunization administration. The primary charge of the RUC is to determine the existence of work and practice expense for each code presented. The RUC has agreed on several occasions that immunization administration does require physician work. The AAP believes that the validation process used by the RUC should be sufficient to assuage the concern of the CMS that the work involved in the administration of immunizations is "real" work.Federal and state law and medical ethics demand that pediatricians provide information and counsel parents and guardians about the risks and benefits of the immunizations that their children are scheduled to receive. The administration of immunizations to children is a very different service than the administration of immunizations to adults. At the time each dose is administered, physicians are required to explain the benefits to the patient and the community as well as the possibility of adverse reactions to vaccines; these are mandatory components of the National Childhood Vaccine Injury Act. In some cases, children also may receive vaccines from a variety of sources (eg, public health departments, influenza clinics). This further complicates the pediatrician's task of trying to form a comprehensive vaccine history using scattered records to piece together one child's medical history.With the increase in the amount of misinformation disseminated by anti-vaccine groups, the time that physicians spend on education and cognitive discussion has increased. Additionally, because children receive more vaccines than adults do, pediatricians must not experience any "missed opportunities" to immunize a patient. This means that many vaccines are administered during the course of an otherwise standard "sick" visit, rather than just exclusively during well-child examinations. By failing to publish the RUC-recommended work RVUs for 90471 and 90472, the CMS is, in essence, unilaterally determining payment policy for the service of immunization administration.Additionally, the CMS has changed 90471 and 90472 from "noncovered" to "active" status. Now carriers who use RBRVS to determine fee schedules will be compelled to use incomplete information for 90471 and 90472 when determining reimbursement for immunization administration. Because work RVUs typically account for close to 55% of a code's total RVUs, physicians who provide immunizations to their patients will be losing out on 55% of the reimbursement for that service. The AAP took action in December by posting a sample letter about vaccine fees on the Members Only Section of the AAP Web site (http://www.aap.org/moc) under "What's New." Pediatricians were given the opportunity to fax this letter to their senators and representatives to ask for assistance.The AAP was disappointed with the failure of the CMS to recognize codes 99289, physician constant attention of the critically ill or injured patient during an interfacility transport (first 30–74 minutes), and 99290, each additional 30 minutes, and the subsequent decision to create 2 new Health Care Financing Administration Common Procedure Coding System (HCPCS) Level II codes, G0240 and G0241, for use in the Medicare population. Furthermore, the relative values that the CMS assigned the new G codes (4.0 and 2.0, respectively) were not in line with the RUC-recommended values for that service (4.8 and 2.4, respectively).The CMS had several reasons for not recognizing these codes. It is the intent of the AAP to revise the codes, with the hope that the CMS will be receptive to working with the AAP in that endeavor.

Management of Nonobstetric Pain During Pregnancy and Lactation

In 2004, the American Academy of Pediatrics (AAP) Board of Directors formed the Task Force on Mental Health and charged it with developing strategies to improve the quality of child and adolescent mental health* services in primary care. The task force acknowledged early in its deliberations that enhancing the mental health care that pediatricians and other primary care clinicians† provide to children and adolescents will require systemic interventions at the national, state, and community levels to improve the financing of mental health care and access to mental health specialty resources. Systemic strategies toward achieving these improvements are the subject of other publications of the task force: “ Strategies for System Change in Children's Mental Health: A Chapter Action Kit ” (chapter action kit),1 “Improving Mental Health Services in Primary Care: Reducing Administrative and Financial Barriers to Access and Collaboration,”2 and “Enhancing Pediatric Mental Health Care: Strategies for Preparing a Community.”3 The task force also recognized that enhanced mental health practice will require competencies not currently achieved by many primary care clinicians; in the policy statement “The Future of Pediatrics: Mental Health Competencies for Pediatric Primary Care,”4 the task force collaborated with the AAP Committee on Psychosocial Aspects of Child and Family Health to outline these competencies and propose strategies for achieving them. This report offers strategies for preparing the primary care practice itself for provision of enhanced mental health care services. The task force proposes incrementally applying chronic care principles to the care of children with mental health and substance abuse problems as primary care clinicians apply them to the care of children with chronic medical conditions such as asthma. Most primary care clinicians will find that significant gaps exist between their current practice and the proposed ideal. The task force offers guidance in … Address correspondence to Jane Meschan Foy, MD, Department of Pediatrics, Wake Forest University School of Medicine, Medical Center Blvd, Winston-Salem, NC 27157. E-mail: jmfoy{at}wfubmc.edu

To the Editor. One of the areas of controversy in the practice of pediatric emergency medicine is the evaluation of the infant who presents with its first febrile seizure. I applaud the American Academy of Pediatrics (AAP) Provisional Committee on Quality Improvement's attempt to clarify the issues regarding the treatment of these infants. I must, however, question both the recommendations and the methods by which they were developed.Whenever a committee of the AAP presents practice parameters, recommendations must reflect the practice patterns of the medical community and the state of the art scientific evidence available to substantiate the recommendation. The Committee recommends “after the first seizure with fever in infants younger than 12 months, performance of a lumbar puncture must be strongly considered.” Neither the prevailing practice patterns of pediatric emergency physicians nor the most recent literature were considered. The makeup of the Committee as listed in the abstract lists general pediatricians and consultants in the field of neurology and epilepsy as the developers of this practice parameter. Absent from the Subcommittee on Febrile Seizures was any representation from the Section on Pediatric Emergency Medicine. The references used to support this recommendation cannot be considered contemporary. The most recent article quoted in references substantiating this recommendation is 13 years old.Pediatric emergency physicians manage fevers with seizures as a daily part of their clinical practice.1 If the child is previously healthy, has not been treated previously with an antibiotic, and has a simple febrile seizure, he/she is managed as any child with an acute fever. Simple febrile seizures are a normal variant. This question of lumbar puncture for the first febrile seizure was recently addressed in the pediatric emergency medicine literature.1A case study was presented, a simple febrile seizure in a previously healthy 8-month-old infant who was not currently on antibiotics and at the time of examination in the emergency department was alert, smiling, and had a normal white blood cell count. The pediatric emergency discussants indicated that lumbar puncture for such a case scenario would not be indicated. Studies have addressed the issue both retrospectively and prospectively.23 A recent review by Green et al2 found that all children who presented with fever, seizures, and meningitis either appeared extremely ill, had meningeal signs, or had febrile seizures with complex features. The authors conclude that lumbar puncture for simple febrile seizures was not indicated unless the child had an indication independent of the seizure for requiring the study.2Indications for lumbar puncture in a febrile child age 6 months to 5 years old include presence of meningeal signs and toxicity consistent with the diagnosis of meningitis. Lumbar puncture should be strongly considered in this age group for children who present with seizure activity at the time of arrival in the emergency department, or with findings on physical examination such as rash, cyanosis, hypotension, respiratory distress, or abnormal neurologic examination.4Children with complex febrile seizures should strongly be considered for performance of a lumbar puncture.3 The recommendation algorithm would be better served highlighting theseindications rather than their basis of particular age subgroups.Such practice parameter recommendations become significant medical legal literature. The Academy would have been better served if the recommendations regarding the evaluation of the child with a first simple febrile seizure reflected both current practice patterns in pediatric emergency departments and current contemporary pediatric literature.In Reply. The American Academy of Pediatrics (AAP) Subcommittee on Febrile Seizures thanks Dr Nozicka, Medical Director of Pediatric Services at the Columbia Hospital and State Medical Center, for his thoughtful comments. The Subcommittee members recognize that the most controversial area of the practice parameter on febrile seizures is the recommendation regarding lumbar punctures.It should be noted that these recommendations were developed only after an extensive review of the literature and consultation with 11 experts in the field, various AAP sections and committees including the Committee on Pediatric Emergency Medicine and Section on Emergency Medicine, the American Academy of Pediatrics' Board of Directors as well as committees from the American College of Emergency Physicians, Child Neurology Society, the American Academy of Family Physicians, the American Academy of Neurology, the American Neurologic Association, and the Epilepsy Foundation of America. As might be anticipated, there was a range of reactions to the practice parameter. Most reviewers were supportive of the recommendations but two groups had differing opinions. One society considered our recommendation “a lumbar puncture in children less than 12 months of age with first febrile seizure should be strongly considered” as too weak and wanted us to “strongly recommend” routine lumbar puncture in all children less than 18 months with a first febrile seizure. In contrast, another society thought that a lumbar puncture should not be recommended unless the child had definite signs of meningitis. It is the nature of this type of exercise that there will be differences of opinion. However, it should be stressed that our recommendations were based on a careful analytic review of the literature. Unfortunately, the technical report, which describes and analyzes each article we reviewed, was not published in its entirety in Pediatrics due to space considerations. The full technical report is available through the American Academy of Pediatrics' Division of Publications.As reported in the literature, between 1% and 5% of children with first febrile seizures may have abnormal cerebrospinal examinations. In some children (particularly the very young), the only presenting clinical sign is a seizure and fever. Therefore, young children are at high risk for undiagnosed meningitis. In Dr Nozicka's letter, young age at the time of the first febrile seizure is not considered high risk, but we do not feel that this view is supportable either based on the literature or on clinical experience.As noted in the technical report, clearly the clinical evaluation of young febrile children requires skills that vary between examiners. As such, the Subcommittee deliberately chose a conservative approach with an emphasis on the value of the lumbar puncture in diagnosing meningitis. Practice parameters are meant solely to give guidance and not to eliminate clinical judgment. Although this practice parameter states that a lumbar puncture should be “strongly considered” in certain situations, we are not suggesting it be mandated. If the pediatrician feels confident in his examination of the child, is comfortable that he/she will have adequate follow-up of the patient over the next 24 hours, and it is in her/his judgment that a lumbar puncture is not indicated, this practice parameter would not presume to change that approach. Alternatively, in situations that are not optimal, ie, a young child with a first febrile seizure seen in an emergency department by physicians who may be less experienced and where follow-up is likely to be less than ideal, it would appear that a lumbar puncture would be the appropriate diagnostic approach.

Section on Allergy and Immunology

Most physicians can now access new resources by using Internet service providers. There will be a vast amount of coding information in the months to come, much with free access or as a service to members. Below are some Web sites that are good resources for coding and related information, in addition to the American Academy of Pediatrics (AAP).http://www.aap.orgThere are excellent coding resources at the AAP. The Division of Health Care Finance and Practice maintains a FaxBack Coding Hotline. AAP members can call 800/433-9016, ext 4022, and leave their name and fax number, and a sheet will be faxed where they can fill out their questions. The answers will come by FaxBack service within 1 week. A copy of the fax is available in the AAP manual Coding for Pediatrics 2002. To order Coding for Pediatrics, call 888/227-1770. With the purchase of this manual, you will receive a subscription to the AAP coding newsletter, Pediatric Coding Companion. This is a quarterly newsletter that will keep you informed of any changes that happen throughout the year. The newsletter is also available separately as a subscription product.http://www.medem.comThe AAP, along with 6 other physician associations and medical specialty societies, went in on this new Web site to provide reliable medical information.http://www.ama-assn.orgEven nonmembers can access breaking news on the status of the newest Evaluation and Management (E/M) documentation guidelines and preview the entire set (draft June 2000). In addition, under the Policy and Advocacy section, there is a wealth of information about compliance issues. To catch the latest on Current Procedural Terminology, Fifth Edition (CPT-5), go to http://www.ama-assn.org/ama/pub/category/3883.html.An excellent coding resource produced by the American Medical Association is a newsletter called CPT Assistant. To order, call 800/621-8335.http://www.cms.govA good way to stay abreast of issues involving compliance and fraud and abuse, new payment policies and rules, and updates to the resource-based relative value scale.http://www.gpoaccess.gov/fr/index.html.Obtain copies of the Federal Register here.To obtain the fee schedules from the Federal Register, follow these steps.http://www.brightfutures.orgBright Futures is a national child health promotion and disease prevention initiative. Launched in 1990, the initiative is dedicated to developing educational materials for health and education professionals and families. Some of its material includes the following:http://www.ahima.orgThe American Health Information Management Association (AHIMA) is the dynamic professional association that represents more than 40,000 specially educated health information management professionals who work throughout the health care industry. This association is developing Coding Assessment and Training Solutions, a Web-based coding educational program for health care organizations.http://www.SCCoding.orgThe Society for Clinical Coding, affiliated with AHIMA, was developed to assist coders and other professionals with their work. The society provides news about current coding issues and concerns and a mechanism for networking with other professionals. Check out its Web site for the latest on CPT/ICD-9-CM coding issues.http://www.cdc.gov/nchshttp://www.cdc.gov/nchs/icd9.htmThe National Center for Health Statistics (NCHS) is the federal government’s principal vital and health statistics agency. Since 1960, the agency has provided a wide variety of data with which to monitor the nation’s health. Since then, the NCHS has received several legislative mandates and authorities. The NCHS is a part of the Centers for Disease Control and Prevention, US Department of Health and Human Services.http://www.aha.orgThe ICD-9-CM is published by the Department of Health and Human Services and maintained by the ICD-9-CM Central Office at the American Hospital Association.http://www.aapcnatl.orgThe American Academy of Professional Coders (AAPC) is a nonprofit association for health care professionals. At this Web site there is information about certification programs, educational curricula, and membership services offered by the AAPC.http://www.cdc.govhttp://www.nih.govThe American Academy of Pediatrics has the following coding publications available for purchase:Coding for Pediatrics, Pediatric Coding Companion newsletter, ICD-9-CM Coding Flip Chart, CPT manual, ICD-9-CM manual.To order, call 888/227-1770.The American Medical Association has the following coding publications available for purchase:CPT Assistant monthly newsletter, CPT manual, ICD-9-CM manual, HCPCS, CPT Companion, plus many more.To order, call 800/621-8335.

To describe the implementation of a program for the use of palivizumab in a general pediatrics office and evaluate adherence to the 2009 American Academy of Pediatrics (AAP) guidelines. Pediatricians in a large practice were educated in the diagnosis and management of bronchiolitis, with specific attention to the AAP's palivizumab administration guidelines. During the 2009-2010 and 2010-2011 respiratory syncytial virus seasons, children were systematically identified and enrolled for palivizumab administration. Indication for administration was determined by gestational age, age at the beginning of the respiratory syncytial virus season, pertinent diagnoses, and presence of risk factors. In the 2009-2010 season, 161 children were enrolled to receive palivizumab, 86 of whom (53%) conformed with AAP guidelines. In contrast, in 2010-2011, a total of 85 children were enrolled to receive palivizumab, and 73 (86%) conformed with the guidelines. As a consequence, the total cost of palivizumab (US $: 511 559 vs 1 500 670) and the cost per child (US $: 6018 vs 9438) were lower in 2010-2011 than in 2009-2010. However, of the children selected within the AAP guidelines, only 29% received the appropriate number of doses, whereas 62% and 9% received fewer or excessive doses, respectively; these findings were similar for the 2 seasons. In a primary practice, use of palivizumab outside of the AAP guidelines was frequent and manifested as inadequate indications or inadequate number of doses. The former improved with education and standardization of care (suggesting provider problems), while the latter did not (suggesting system problems). Additional interventions are required.

* Abbreviation: AAP — : American Academy of Pediatrics The factors that affect the health of children cross all sectors of society, as do the resources, skills, and talents needed to improve child health.1–3 Health care providers and organizations are challenged in addressing these health conditions within the bounds of the health care system and are increasing their involvement in community-based efforts to improve health by working together in collaborative efforts that involve multiple sectors and stakeholders, including the corporate sector.4 It is important for the American Academy of Pediatrics (AAP) to interact with the corporate sector in a way that emphasizes its mission, vision, and values, in addition to the traditional guidelines that focused on financial transparency and the management of conflict of interest.5 For example, the AAP has endorsed the Council on Medical Subspecialty Societies guidelines,6 which provide guidance to member societies in the development of policies and procedures that safeguard the independence of their programs, policies, and advocacy positions. In addition to these guidelines, the AAP has developed a robust mechanism for identifying and resolving conflicts of interest. However, there has been recognition by leadership that although crucial, these safeguards did not provide a mechanism for explicitly identifying and discussing mission alignment that would allow increased collaboration and collective impact. As a consequence, the AAP developed a tool to move the conversation toward one that is values based and mission oriented, borrowing from the concept of “shared values.” This concept has been in circulation in the corporate world since 2006, when it was advanced by Porter and Kramer to describe ways in which corporations could meet their mission of sustainability and profitability while also achieving positive social aims.7 The Academy’s use of the term “shared values” is derived from … Address correspondence to Sandra Hassink, MD, American Academy of Pediatrics, 141 Northwest Pt Blvd, Elk Grove Village, IL 60007-1019. E-mail: shassink{at}aap.net

To determine whether obesity should be added to the current American Academy of Pediatrics (AAP) criteria for cholesterol screening in childhood, the charts of 99 children referred for evaluation of either hypercholesterolemia (n = 53) or obesity (n = 45) were reviewed. Compared with obese children, nonobese hypercholesterolemic subjects were younger (8.4 vs 11.4 years) and had lower mean body mass index and % ideal body weight. Frequency of elevated (> 90th percentile for age) total and low-density lipoprotein cholesterols were similar in both groups. Fifty-three of 65 children who met the current AAP criteria were hypercholesterolemic, however, 23/76 hypercholesterolemic children failed to satisfy these screening criteria. Thirty-six of 45 obese children had cholesterol levels > 90th percentile, suggesting increased risk for hypercholesterolemia in this group. If obesity was added to the AAP criteria, 66/80 hypercholesterolemic subjects would have been identified. These modified criteria, vs AAP standards, significantly improved both their sensitivity (70 vs 87%, p < 0.02) and negative predictive value (45 vs 30%, p < 0.02). Pending further studies in larger pediatric populations, these data indicate that obesity should be considered a risk factor for hypercholesterolemia in childhood, and we recommend modifying the AAP screening criteria to include obese children.

The Viability of Using Alternative Sites to Increase Rates of Adolescent Vaccination (or: “A Rising Tide Floats All Boats”)

* Abbreviations: AAP = : American Academy of Pediatrics • UTI = : urinary tract infection • HIV = : human immunodeficiency virus • STD = : sexually transmitted disease • CIS = : carcinoma in situ The negative conclusions on newborn circumcision drawn by the recent American Academy of Pediatrics (AAP) Task Force on Circumcision are misleading and contrary to the current medical evidence, including data in the body of the report itself1 and in the references cited therein. As professionals closely involved with clinical investigations on newborn circumcision,2–7 we are compelled to express our concern about this report. The Task Force states that newborn circumcision is not recommended and that the procedure is “not essential to the child's current well-being.”1 The media and the public are now understandably convinced that the AAP has adopted an anticircumcision stance compared with its previous neutral position on newborn circumcision.2 This attitude has not only been taken by the activist anticircumcision forces but also by the respected media: eg, “Circumcision Loses a Key Endorsement” ( Washington Post ),8 “Circumcision Benefits Disputed” ( Chicago Sun-Times ),9 “Pediatricians Turn Away From Circumcision” ( CNN ),10 and “Circumcision Opponents Energized by About-Face of Academy of Pediatrics” ( Forward ).11 One would assume that in the decade since the 1989 report,2 new evidence must have appeared demonstrating substantial disadvantage of newborn circumcision. However, the opposite is true. Considerable published data from the past 10 years (much of it cited in the current report) confirm and reinforce previous evidence on the medical benefits of newborn circumcision, particularly in protecting against urinary tract infection (UTI) and human immunodeficiency virus (HIV) infection. Pain—a major disadvantage of the procedure—has been shown to be safely and effectively controlled by local anesthesia. With more proven advantages and fewer disadvantages, how could the Task Force issue a statement that could only be interpreted as reversing previous policy and discouraging newborn circumcision? The report of the 1989 Task Force, for which 1 of the authors (E.J.S.) …