IDSA News - November 2017
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HIVMA Releases Guideline on HIV and Chronic Pain

New guidelines released by the HIV Medicine Association (HIVMA) and published in Clinical Infectious Diseases recommend that everyone living with HIV be assessed for chronic pain, a significant problem that affects 39 to 85 percent of people living with HIV. These comprehensive guidelines, the first for HIV and chronic pain, provide the tools and resources HIV specialists need to treat these often-complex patients, many of whom struggle with depression, substance use disorders, and have other health conditions.

Those who screen positive should undergo comprehensive evaluation, including a physical exam, psychosocial evaluation, and diagnostic testing. Nearly half of chronic pain experienced by people with HIV is neuropathic, likely due to inflammation or injury to the central or peripheral nervous system caused directly or indirectly by HIV infection. Non-neuropathic pain typically is musculoskeletal, such as low-back pain and osteoarthritis in the joints. These latter problems will be seen more frequently as HIV patients age.

HIV specialists should work with an interdisciplinary team to offer multi-modal treatment. The guidelines recommend offering alternative, non-pharmacological therapies first, including cognitive behavioral therapy, yoga, physical and occupational therapy, hypnosis, and acupuncture. If medication is needed, the guidelines recommend beginning with non-opioids, such as gabapentin and capsaicin, both of which help with neuropathic pain.

The online version of the guidelines includes a list of resources for physicians to reference to help them treat the patients comprehensively.

The guidelines panel included experts who specialize in HIV, substance abuse, pain, psychiatry, palliative care, and pharmacology. In addition to lead authors, Douglas Bruce, MD, MA, MS, and Peter Selwyn, MD, MPH, the guidelines panel included: Ebtesam Ahmed, PharmD; Carla Alexander, MD; Amanda H. Corbett, PharmD; Kathleen Foley, MD; Kate Leonard, MD; Paula J. Lum, MD, MPH; Jessica Merlin, MD, MBA; and Glenn Jordan Treisman, MD, PhD.

ACIP Makes New Recommendations on Shingles, Mumps Vaccines

The Advisory Committee on Immunization Practices (ACIP) recently approved recommendations for shingles (herpes zoster) vaccines and mumps-containing vaccines, in addition to approving the 2018 immunization schedules.

ACIP advises the Centers for Disease Control and Prevention (CDC). Once CDC approves ACIP’s recommendations, they will be published in the Morbidity and Mortality Weekly Report (MMWR), at which time the recommendations will become official CDC policy.

Shingles Vaccine ACIP voted that herpes zoster subunit (HZ/su) vaccine is:

  • recommended for the prevention of herpes zoster and related complications for immunocompetent adults aged 50 years and older,
  • recommended for the prevention of herpes zoster and related complications for immunocompetent adults who previously received zoster vaccine live (ZVL),
  • preferred over ZVL for the prevention of herpes zoster and related complications.

Mumps-containing Vaccine

  • ACIP voted that persons previously vaccinated with two doses of a mumps-containing vaccine* who are identified by public health as at increased risk for mumps because of an outbreak should receive a third dose of a mumps-containing vaccine to improve protection against mumps disease and related complications.

  • *As stated in Prevention of Measles, Rubella, Congenital Rubella Syndrome, and Mumps, 2013: Summary Recommendations of the Advisory Committee on Immunization Practices (ACIP); wording includes MMR and MMRV

Once published in the MMWR, CDC will add shingles and mumps vaccination information and educational materials to CDC’s website.

2018 Immunization Schedules

ACIP approved the 2018 Recommended Immunization Schedules for Children and Adolescents Aged 18 Years or Younger and the Recommended Schedules for Adults aged 19 Years or Older. The adult schedule will reflect the new herpes zoster vaccine recommendation. The new mumps vaccination recommendation will be reflected in footnotes. The schedules will also incorporate all actions taken by ACIP this year. The 2018 schedules will be released early next year with information about changes.

‘Netconference’ Will Address Hepatitis A and New ACIP Recommendations

CDC will host a “Current Issues in Immunization Netconference” on Wednesday, November 8, at 12:00 – 1:00 p.m. EST. This Netconference, designed to provide health care providers with the most up-to-date information on immunization, will discuss these new recommendations. The netconference will also provide information about hepatitis A guidance and consideration in light of recent hepatitis A outbreaks and current constraints related to the hepatitis A vaccine supply. Registration is available online. Registration is limited; however, an archived version will be posted to CDC’s website shortly after November 8.

Weighing in on HHS Report on Vaccine Innovation

The Department of Health and Human Services is developing a report on prioritization for vaccine research and development efforts, as required by the 21st Century Cures Act.

The report is expected to address barriers to innovation and potential solutions, and methods to identify priority pathogens for vaccine R&D.

IDSA made the following recommendations in a comment letter to HHS:

  • While several methods for optimizing vaccine prioritization exist, no method is perfect and a panel of experts is necessary to determine the US government’s approach.
  • Novel incentives should be developed for companies developing less economically viable vaccines.
  • Lack of epidemiological data for many vector-borne diseases make assessing economic and public health value difficult.
  • Steps need to be taken to address both access barriers for vaccines as well as vaccine hesitancy.
  • Therapeutic and preventive vaccines need to be considered using different criteria.
  • A universal influenza vaccine that confers protection for longer than one year should be a top priority for vaccine developers.
  • Pregnant women and HIV infected persons are underrepresented targets for vaccine studies, and researchers need more guidance on how to safely conduct studies with these patient groups.

IDSA will continue working with HHS to emphasize the public health benefits of vaccines, encourage investment in this area, and inform HHS’s vaccine prioritization efforts.

Updates on NIHís Next Generation Researchers Initiative

As part of IDSA’s commitment to secure the future of the ID physician-scientist workforce, IDSA has been engaged in discussions with the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID) regarding the NIH Next Generation Researchers Initiative (NGRI). IDSA sent comments to NIH in August with HIVMA and the Pediatric Infectious Disease Society (PIDS), followed by a September 1 letter to NIAID.

In response to that outreach, Michael Lauer, MD, deputy director for extramural research at NIH, asked for a call with the societies’ leadership to discuss: stabilizing trajectories for mid-career researchers, incorporating mentorship into career development, monitoring and tracking outcomes, and obtaining diverse researcher feedback. NIAID Deputy Director Hugh Auchincloss, MD, also sent a detailed reply inviting continued conversation about the many aspects of encouraging young scientists to achieve innovative, independent careers.

NIH released an updated policy (Guide Notice NOT-OD-17-101) in late August outlining current plans for the NGRI. As implementation progresses, NIH will consider evidence-based strategies to identify, grow, and retain “early stage” and “early established” investigators. Effective strategies will likely consider factors such as emerging areas of scientific inquiry, needs of the IC portfolios, and projected needs of the scientific workforce.

IDSA also submitted comments in response to a recent National Academies of Science, Engineering, and Medicine (NASEM) Dear Colleague Letter requesting stakeholder feedback. Input from the research community will assist NASEM’s development of a final report that offers recommendations and best practices for supporting the next generation of biomedical researchers.

IDSA to UHC: Donít Deny Payment for Cognitive Services

The IDSA Clinical Affairs Committee (CAC), in collaboration with several medical specialty societies, submitted a letter to UnitedHealthcare (UHC) regarding consultation services reported by CPT® (Current Procedural Terminology) codes 99241-99245 and 99251-99255. UHC had proposed to discontinue payment for those services, citing misuse of the codes and UHC’s desire to align with Medicare policy. “As cognitive physicians, we believe our timely services are integral to the effective treatment of patients who have severe, complex conditions,” said the societies’ letter. “We seek to engage UHC in a discussion of these services in order to explain how consultation services best align with UHC’s Triple Aim of ‘improving health care services, health outcomes, and overall costs of care.’” The societies thanked UHC for delaying implementation of this policy, which was originally planned for October 1, and asked for ongoing discussions.

Reimbursement for Telemedicine Could Get Easier

Telehealth and telemedicine continue to be a part of the legislative and regulatory agenda. More than 10 pieces of federal legislation have been introduced in 2017 that aim to reduce the regulatory burdens facing reimbursement for telemedicine and telehealth. For example, the CHRONIC Care Act, which includes telehealth provisions, was passed in the Senate in late September and now awaits approval in the House. On the regulatory front, the Veterans Administration (VA) has proposed a rule that would allow the VA to preempt state licensure, registration, and certification laws to allow VA physicians to provide telemedicine services across state lines. IDSA continues to monitor federal and regulatory changes to telehealth and telemedicine and will keep members updated.

How to Stay Abreast of CMSís Quality Payment Program

The Quality Payment Program (QPP), which includes the Merit-based Incentive Payment System (MIPS) and the Alternative Payment Model (APM) program, continue to progress. The Centers for Medicare & Medicaid Services (CMS) continually updates its website with new information, tools, and webinars to help providers successfully participate in the QPP. We urge IDSA members to check the QPP website and sign up for email alerts for new information. Scroll to the bottom of the QPP’s main landing page and submit your email address.

IDSA Remains Committed to Fighting Antimicrobial Resistance

IDSA continues working to advance domestic and global policies to address antimicrobial resistance (AMR). Key recent activities include:

Wellcome Trust Global Call to Action:

IDSA Treasurer Helen Boucher, MD, FIDSA, served on a panel in Berlin, Germany in October about measuring success in addressing AMR globally, in which she spoke about the role of health care providers. IDSA Clinical Affairs Committee member Javeed Siddiqui, MD, discussed how telemedicine can allow ID specialists to support the implementation of stewardship globally.

Keynote at World AMR Congress:

IDSA then-President William Powderly, MD, FIDSA, joined the president of the American Society for Microbiology at the World AMR Congress in September for a joint keynote in which he highlighted IDSA’s AMR policy and advocacy efforts and the leading role of ID physicians in implementing antimicrobial stewardship.

WHO Global AMR Activities:

IDSA submitted comments to the World Health Organization (WHO) Interagency Coordination Group (IACG) for AMR, including recommending that WHO and IAGG:

  • advance economic incentives for new antimicrobial drugs, diagnostics and vaccines;
  • promote research that leads to improved use of existing antibiotics;
  • secure an expert infectious diseases workforce to address AMR;
  • coordinate AMR and TB activities; create a mechanism to facilitate collaboration and sharing of resources and knowledge;
  • facilitate multinational research networks; provide nuanced guidance, tools and training on stewardship that are geared towards the constraints and concerns of individual countries; and
  • develop global goals with quantifiable targets, specific timelines and benchmarks for progress.

IDSA offered to provide forums for WHO and the IACG to engage with ID clinicians and scientists and share ID expertise with other countries. The Society also offered feedback on indicators that would be feasible and meaningful for assessing progress on AMR.

Advancing Antibiotic Incentives:

IDSA attended the meeting of DRIVE-AB—a consortium spearheaded by the European Union’s Innovative Medicines Initiative to develop proposals for economic incentives to spur the development of urgently needed new antimicrobial drugs. DRIVE-AB’s recommendations are well-aligned with IDSA’s policies, calling for investment in push incentives (e.g., grants and tax credits that provide support during research and development) and pull incentives (i.e., rewards provided after a new antimicrobial drug is brought to market). DRIVE-AB specifically calls for the development of a generous market entry reward for new antimicrobials that target pathogens identified as priorities by WHO. Under such a proposal, companies receiving the reward would also make commitments regarding stewardship and access. IDSA is convening a working group through our Stakeholder Forum on Antimicrobial Resistance (S-FAR) to develop a complementary market entry reward proposal for the US.

S-FAR, PACCARB and Joint Commission:

IDSA held its annual S-FAR meeting this fall, during which the group strategized about advocacy for federal and global AMR funding and new ways to engage patients in AMR policy efforts. The group also met with staff from the Presidential Advisory Council on Combating Antibiotic Resistant Bacteria (PACCARB) and received an update from the Joint Commission (JC) about implementation of its stewardship requirement, which took effect earlier this year.

The JC has begun surveying hospitals to review their stewardship programs. According to initial findings, 14 out of 211 hospitals were cited for one or more deficiencies in their antimicrobial stewardship programs, including:

  • Antimicrobial stewardship not a leadership priority (1)
  • No evidence of a multidisciplinary team approach (3)
  • Program/policy did not include all of the Centers for Disease Control and Prevention’s core elements (3)
  • Education not provided to staff and/or Licensed Independent Practioner (5)
  • Education not provided to patient/family (2)

FY2018 Funding News

The federal government is now operating on a Continuing Resolution through December 8, with a final funding bill for the new fiscal year yet to be determined by Congress. Over the summer, the House and Senate Appropriations Committees provided increases or flat funding for key IDSA and HIVMA priorities at the National Institutes of Health, Centers for Disease Control and Prevention, Health Resources and Services Administration, Biomedical Advanced Research and Development Authority, State Department, and the US Agency for International Development.

While this was good news, Congress must still come up with a bipartisan budget agreement that provides relief from sequestration cuts and spending caps and then pass a final omnibus appropriations bill. IDSA is making the case for a bipartisan budget agreement and a final FY2018 omnibus funding bill. We recently urged House and Senate Appropriations Committee chairs and ranking members to move forward immediately and include robust resources for ID/HIV programs.

Additionally, Congress is currently negotiating final legislation to renew Department of Defense (DoD) programs for the next fiscal year. IDSA and HIVMA are concerned that provisions in the Senate version of the bill would severely restrict vital DoD ID/HIV research. IDSA and HIVMA are working to oppose these onerous restrictions.

Take Action to Protect Medical Research at DoD

We have told Congress about our opposition to these DoD provisions and we are urging IDSA and HIVMA members to do the same.

As the appropriations process presses on, IDSA and HIVMA will advocate for full funding for our priority programs across the federal government.

IDSA Continues to Press for Diagnostics Reimbursement

IDSA continues to advocate for appropriate reimbursement for ID diagnostic tests to ensure patient access to testing and to spur diagnostics innovation. IDSA successfully defeated recent proposals to curtail reimbursement for important ID diagnostics, and is now working to alter another harmful proposal.

IDSA Defeats CMS “Palmetto” Proposal to Reduce Diagnostics Reimbursement

The Centers for Medicare and Medicaid Services (CMS) last spring issued two draft Local Coverage Determination (dLCD) payment policies for Palmetto GBA’s multiplex nucleic acid tests for respiratory viruses and foodborne gastrointestinal (GI) panels that would severely curtail coverage and reimbursement for both tests. Palmetto GBA is a Medicare contractor that oversees Medicare payments in 45 states. IDSA worked with the Association for Molecular Pathology, the College of American Pathologists, the American Society for Microbiology, and the Pan-American Society for Clinical Virology to submit respiratory virus and GI comment letters on the proposed policies to provide expert clinical perspectives on how these panels are reasonable and necessary for patient care. In response to these efforts, Palmetto retracted both proposals.

IDSA Works to Prevent Proposed 10 Percent Reduction in Diagnostic Reimbursement

Over the past two years, CMS, at the direction of Congress, has attempted to collect data on private payor reimbursement for diagnostic tests on which to base revised Medicare reimbursement. IDSA and other physician organizations have repeatedly expressed concerns that that the data collection would be overly burdensome for clinical laboratories and subsequently result in inadequate reimbursement rates for diagnostic tests. CMS released preliminary diagnostics reimbursement rates in late September for diagnostic tests for 2018. The agency is planning to finalize the proposed rates in November, which are then scheduled to take effect on January 1, 2018. If the preliminary rates are implemented as planned, most ID diagnostic tests will get a 10 percent reduction in 2018, with a possibility of additional 10 percent reductions over the next two years for a total 30 percent reduction by 2020. These rates will not reflect market-based payments, as IDSA believes Congress intended.

IDSA submitted comments to CMS following the release of the preliminary 2018 rates outlining specific concerns and providing recommendations. The Society has also been working with the American Medical Association and a number of laboratorian- and clinician-focused organizations to educate Congress on the potential impacts of decreased reimbursement on patient care. The group met with House Committee on Energy and Commerce and Senate Finance Committee staff this summer to recommend in part that CMS issue an interim final rule so that the agency may conduct a regional survey of private payer payments for clinical tests.

IDSA will continue to advocate for a reimbursement system that promotes innovative diagnostics and improves patient access as CMS moves forward in their efforts to reform clinical laboratory diagnostic reimbursement. Join the Member Advocacy Program (MAP) today to stay abreast of IDSA advocacy efforts and how you can get involved.

FDA Public Workshop on Antimicrobial Susceptibility Tests

IDSA is working with the Food and Drug Administration (FDA), Congress, and other stakeholders to advance policies to incentivize the timely development of antimicrobial susceptibility test (AST) devices. Both IDSA and FDA recognize that approved ASTs enhance patient care and assist in the fight against antimicrobial resistance.

IDSA member and liaison to the Clinical and Laboratory Standards Institute (CLSI) Amy Mathers, MD, served on a recent panel for a FDA stakeholder workshop on AST diagnostic devices. The workshop continued an ongoing dialogue generated by the 2016 FDA draft guidance, “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) Devices.” Dr. Mathers provided an infectious diseases clinician perspective on the use of isolates in clinical trials, clinical trial networks, and the importance of accurate clinical breakpoints. IDSA reps emphasized the importance of having AST devices available to guide appropriate use of antimicrobial drugs.

The 21st Century Cures Act requires FDA to establish a website for interpretive criteria no later than December of this year. Breakpoints will be reviewed every six months, and FDA will publish an annual notice of all website updates in the Federal Register for public comment. FDA also is now permitted by the Cures law to review and utilize breakpoints updated by external standard setting organizations such as CLSI, rather than conducting all breakpoint updates internally, which was extremely time-consuming and contributed to delays in breakpoint updates. FDA is planning an FAQ to address common issues and streamline submissions and reviews.

Following the workshop, IDSA submitted a comment letter to the FDA containing recommendations to address the challenges of AST development, including:

  • Ways to increase coordinated development of ASTs and decrease time to market;
  • Requirements for the use of isolates in clinical trials; improving access to specimens and isolates; age and number of isolates;
  • Fast track/priority review for AST device applications;
  • AST coverage of additional organisms beyond labeled indications;
  • Development of clinical trials networks to reduce time and cost associated with AST development; and
  • Speed and ease of obtaining new antimicrobial agents for device development.

IDSA Member Testifies at New York State Hearing on Lyme Disease

Sunil Sood, MD, a pediatric ID specialist in New York and a member of the joint IDSA, American College of Rheumatology and American Academy of Neurology panel developing Lyme disease guidelines, represented IDSA at a public hearing of the New York State Joint-Senate Task Force on Lyme and Tick-Borne Diseases. State Senator Sue Serino, a strong advocate for evidence-based treatment and diagnostics for Lyme disease, invited IDSA to participate in this hearing, which was aimed at identifying best practices for combating the spread of Lyme and tick-borne diseases in New York.

Dr. Sood presented up-to-date scientific data on Lyme disease and helped dispel myths about chronic Lyme infections. Multiple physicians at the hearing supported IDSA’s positions.

Any IDSA members working on state Lyme disease policy are welcome to utilize IDSA’s Lyme disease primer for state policymakers, which contains useful information to help educate elected officials about Lyme disease.

Science Speaks Covers IDWeek, Union World Conference on Lung Health

When infectious disease physicians and researchers from around the country and around the world gathered in October for IDWeek in San Diego, and the Union World Conference on Lung Health in Guadalajara, Mexico, the IDSA global health Science Speaks blog followed to cover developments and analyses.

Coverage of IDWeek included reports on findings in the Philippines with global implications; the growing urgency surrounding the One Health approach to detecting, preventing and containing disease outbreaks; and highlights of a talk from Dr. Anthony Fauci on his 32 years of testifying before Congress about the origins and impacts of emerging infections.

The following week in Guadaljara, Science Speaks covered the Union international conference focused on “Accelerating Elimination” of tuberculosis, with reports on sessions addressing the upcoming United Nations General Assembly meeting on TB, approaches to childhood TB, and continuing challenges to controlling the disease among marginalized nations and communities.

Congressional Study Tour to CDC Global Health

IDSA hosted four Senate staff on a trip to the Centers for Disease Control and Prevention (CDC) in Atlanta for a full-day briefing on CDC global health programs, with a special focus on global HIV, tuberculosis, global health security and antimicrobial resistance. The trip provided opportunities for congressional staff to see first-hand the importance of funding for public health through interactions with senior CDC staff including CDC Director Brenda Fitzgerald, MD; Principal Deputy Director Anne Schuchat, MD; and Rima Khabbaz, MD, Director, National Center for Emerging and Zoonotic Infectious Diseases.

CDC Director, Brenda Fitzgerald, MD speaking to Senate staffers

Fellowship in Stewardship and Resistance Receives CDC Funding

IDSA, the Society for Healthcare Epidemiology of America (SHEA), and the Pediatric Infectious Diseases Society (PIDS) have been awarded a contract from the Centers for Disease Control and Prevention (CDC) to establish an Antibiotic Stewardship and Resistance Innovative Fellowships (ASRIFs) program to build and connect expertise in public health and healthcare.

Each society is committed to training the next generation of ID physicians, scientists, and public health leaders needed to address antibiotic resistance by connecting public health and healthcare at the individual patient, facility, health system, community, federal, and global levels. Through this fellowship program, IDSA, SHEA, and PIDS will advance innovative approaches to combat antibiotic resistance and promote stewardship and public health by training fellows to make an impact on their institutions, public health, and patient care.

Fellowships will be made available to ID practitioners who have completed their first year of fellowship and will require the associated training programs and healthcare facilities to meet select criteria such as robust antibiotic stewardship and infection control programs and existing relationships with state or local health departments. The one-year fellowships will be administered in partnership with the CDC and IDSA/SHEA/PIDS and will culminate in a presentation of the fellows’ work at IDWeek 2019. In addition, an evaluation of the program by fellow recipients, institutions, health departments, and fellowship staff will be conducted to identify areas to improve the program.

For more information, contact Michele Wagner, at: mwagner@idsociety.org.

HIVMA Clinical Fellowship and Medical Students Program

HIVMA Clinical Fellowship

Applications are being accepted now for the 2018-2019 HIVMA Clinical Fellowship program. The program supports newly trained physicians with gaining HIV clinical experience working with medically underserved patient populations. With a goal of increasing the number of HIV physicians and strengthening commitments to clinical care for HIV-infected patients in minority communities, HIVMA awards grants to support one year of HIV clinical training for up to two fellows per year. Grants are made to institutions to support a stipend of $60,000 as well as additional funding to cover fringe benefits for one year, administrative costs and further educational opportunities. The deadline for applications is January 8, 2018. Strong preference will be given to African American and Latino candidates and to applicants pursuing training in the Southeastern US. More information is here.

HIVMA Medical Students Program

The 2018 HIVMA Medical Students Program is currently accepting applications for up to three years of funding for HIV-related clinical research projects and mentorship. The deadline for applications is February 15, 2018. For more information, please contact Kumba Sennaar at ksennaar@hivma.org or visit the HIVMA website.

PCORI Funding Announcement: Community-Acquired Pneumonia

The Patient-Centered Outcomes Research Institute (PCORI) has listed community-acquired pneumonia (CAP) as a PCORI Priority in its Cycle 3 2017 Pragmatic Clinical Studies Funding Announcement. All interested IDSA members are encouraged to apply.

Since 2015, IDSA has advocated for PCORI to allocate funding for comparative research in the treatment of CAP. PCORI is seeking proposals for studies that address critical healthcare choices faced by patients, their caregivers, clinicians, or delivery systems in this area. First consideration will be given to applications that directly address one or more of several questions related to CAP, which can be found in the announcement.

Proposed studies must involve broadly representative patient populations and be large enough to provide precise estimates of hypothesized effectiveness differences and to support evaluation of potential differences in treatment effectiveness in patient subgroups. The maximum project period is five years.

The application deadline is February 6, 2018. Awards will be announced on August 21, 2018.

Maintaining Our Momentum

Paul Auwaerter, MD, MBA, FIDSA
IDSA President

Thank you for the welcome to the start of my term as President of IDSA. I am honored to hold this position in an organization that, like many of our members, shares deep commitments to advance our knowledge of infectious diseases and to improve the care of our patients. When I was in the early years of my career, I thought of the Society mainly as an organization that produced an annual meeting (now IDWeek) and peer-reviewed journals, Clinical Infectious Diseases, The Journal of Infectious Diseases, and now Open Forum Infectious Diseases.

Along with clinical practice guidelines, each of these member benefits remains highly important to my practice of infectious diseases. As my time with the Society progressed, working with the many superb staff of our Society, I came to value the outstanding reputation IDSA has earned in advising policymakers and regulators. Such work is hard and the process slower than desired, but is so important to our lives as infectious disease professionals.

Paul Auwaerter, MD, MBA, FIDSA
IDSA President

Thank you for the welcome to the start of my term as President of IDSA. I am honored to hold this position in an organization that, like many of our members, shares deep commitments to advance our knowledge of infectious diseases and to improve the care of our patients. When I was in the early years of my career, I thought of the Society mainly as an organization that produced an annual meeting (now IDWeek) and peer-reviewed journals, Clinical Infectious Diseases, The Journal of Infectious Diseases, and now Open Forum Infectious Diseases. Along with clinical practice guidelines, each of these member benefits remains highly important to my practice of infectious diseases. As my time with the Society progressed, working with the many superb staff of our Society, I came to value the outstanding reputation IDSA has earned in advising policymakers and regulators. Such work is hard and the process slower than desired, but is so important to our lives as infectious disease professionals.

Some members may be unaware of the daily work canvassing opinions of our member volunteers in response to important potential legislative actions and translating our beliefs to help inform and hopefully guide our efforts in Washington. This is how the Society advocates for science, public health, and promoting the value of the infectious diseases professional. Our tireless efforts on Capitol Hill help ensure that funding for research is secure and that legislation has the best interests of public health in mind. So far this year, our members have sent nearly 14,000 emails to Capitol Hill and have conducted over 335 meetings with congressional officials and key administration officials. Every IDSA member can add further heft and be a more active member. Many joined the call for advocacy work this past year, and I hope many more will continue to do so. Our Member Advocacy Program (MAP) is a wonderful way to advocate for the field with as much, or as little, time and effort as you have to share.

With more than 7,500 professional attendees in San Diego, I came away from IDWeek 2017 with a sense of enthusiasm from our members. These are both challenging and exciting times for our field. This is a pivotal time in health care and I am excited to begin my presidency at a time when we can use our collective voice to make a difference. I want to thank all of those who made IDWeek such a success including the program committee, those who volunteered their time as speakers, our partner societies, and staff.

During IDWeek, the IDSA Board of Directors approved several new initiatives. Under the excellent leadership of IDSA’s Immediate Past President, Bill Powderly, MD, FIDSA, a new task force will develop recommendations for aligning the Society’s governance structure with its six strategic priorities. This group will also consider diversity and inclusion issues as they relate to governance and will also examine nominations and election processes.

The 2018 IDSA budget approved by the Board included support for efforts critical to infectious diseases, most notably engagement with the Presidential Administration and Congress. A number of newer initiatives speak to growth areas within infectious diseases as well as addressing ongoing challenges: examples include the IDSA Antimicrobial Stewardship Centers of Excellence program, which you can read more about in this newsletter; the establishment of a working group on drug addiction and infectious diseases; the continued development of an antimicrobial stewardship curriculum for fellows; the launch of a pilot program for tele-antimicrobial stewardship programs in long-term care facilities; and the expansion of the Clinical Fellows Meeting held each spring. We will also study the feasibility of creating a Leadership Institute targeted to the needs of ID physicians. I look forward to sharing more information about each of these initiatives as they develop.

Since joining IDSA 25 years ago, I have seen our membership grow tremendously, now reaching over 11,000. We have a powerful collective voice. There is power in numbers, and if you know colleagues who have let their membership lapse or who have never joined, suggest they may help their patients and their profession by aiding in that collective voice. Opportunities to get involved are not limited to advocacy work. Think about what matters most to you as an ID professional. What would you most like to see the Society doing on your behalf? Share your knowledge and those thoughts with us--help us move the needle on the changes and the improvements you would like to see. MyIDSA is one great place to share those thoughts and ideas with the Society, or I invite you to email me at pauwaert@jhmi.edu. I look forward to hearing from you.

IDSA Launches Antimicrobial Stewardship Centers of Excellence Program

Providence Saint John’s Health Center of Santa Monica, California, and Summa Health of Akron, Ohio, are the first recipients of IDSA’s Antimicrobial Stewardship Centers of Excellence (CoE) designation.

Providence Saint John’s Health Center of Santa Monica, California, and Summa Health of Akron, Ohio, are the first recipients of IDSA’s Antimicrobial Stewardship Centers of Excellence (CoE) designation.

The program, launched this month, recognizes institutions that achieve standards established by the Centers for Disease Control and Prevention (CDC) for antimicrobial stewardship programs led by infectious diseases physicians and ID-trained pharmacists.

“IDSA is committed to infectious diseases-led antimicrobial stewardship programs as an essential component in the fight against antimicrobial resistance, which leads to more than 23,000 deaths per year and over $20 billion in unnecessary health care costs,” said IDSA President Paul Auwaerter, MD, MBA, FIDSA. “The IDSA Antimicrobial Stewardship Centers of Excellence program recognizes institutions that lead in establishing highly effective antimicrobial stewardship programs that help clinicians give their patients optimal anti-infective therapies.”

The core criteria for the IDSA Antimicrobial Stewardship Centers of Excellence were developed by a workgroup of ID physicians and ID-trained pharmacists and build upon the criteria detailed in the CDC’s Core Elements of Hospital Antibiotic Stewardship Programs. IDSA’s CoE program places particular emphasis on an institution’s ability to implement stewardship protocols through its electronic health record (EHR) system, as well as provide ongoing education to its medical staff.

The goals of the program are to not only recognize those who have achieved high standards in their stewardship programs, but also to highlight the value of stewardship in preserving the effectiveness of the vulnerable supply of antibiotics.

All health systems are welcome to apply for the CoE designation and can learn more about the criteria at: www.idsociety.org/ascoe.

Updated Guideline on Infectious Diarrhea Now Available

IDSA has published in Clinical Infectious Diseases a new guideline on the detection and treatment of infectious diarrhea. New culture-independent tests are much more sensitive than traditional diagnostic methods in detecting the cause of infectious diarrhea, but because these tests are so sensitive and may detect multiple organisms, infectious disease expertise may be necessary to interpret the clinical significance and facilitate appropriate public health surveillance, according to the new guidelines.

IDSA has published in Clinical Infectious Diseases a new guideline on the detection and treatment of infectious diarrhea. New culture-independent tests are much more sensitive than traditional diagnostic methods in detecting the cause of infectious diarrhea, but because these tests are so sensitive and may detect multiple organisms, infectious disease expertise may be necessary to interpret the clinical significance and facilitate appropriate public health surveillance, according to the new guidelines. An accompanying editorial provides additional perspective from the clinical lab on culture-independent diagnostic tests.

Designed to guide primary care physicians and other healthcare providers who see most children and adults with diarrhea, the guidelines note that the majority of people with diarrhea do not need to be tested. Those who should be considered for diagnostic testing include children younger than five, the elderly, people who are immune-compromised and those with bloody diarrhea, severe abdominal pain, or tenderness or signs of sepsis.

The guidelines include seven tables that busy clinicians can quickly reference for information about the various ways people acquire the microbes, exposure conditions, post-infectious symptoms and clinical presentation, as well as recommended antimicrobial, fluid and nutritional management. The tables also help clinicians assess when a person with diarrhea should be tested and provide treatment considerations. Physicians should ensure that children with mild to moderate dehydration, and children and adults with acute diarrhea and those with mild to moderate dehydration associated with vomiting or severe diarrhea be given oral rehydration solution if tolerated, progressing to intravenous rehydration if oral rehydration is not tolerated.

The guidelines also underscore the vital role primary care clinicians can play in identifying an outbreak.

In addition to lead authors Andi L. Shane, MD, MPH, MSc and Larry Pickering, MD, the guidelines panel includes: J. Robert Cantey, MD; Allen C. Cheng, PhD; John A Crump, MD; Karen Kotloff, MD; Joanne M. Langley, MD; Rajal K. Mody, MD; Theodore S. Steiner, MD; Phillip I. Tarr, MD; Christine Wanke, MD; and Cirle Alcantara Warren, MD.

This guideline will be available in a smartphone format and a pocket-sized quick-reference edition on the IDSA website at www.idsociety.org.

IDWeek 2017 Recap

Remember to Claim Your Credits by Nov 27!

IDWeek 2017 was a record-setting year as more than 7,500 professional attendees from 90 countries converged on San Diego last month.

IDWeek 2017 was a record-setting year as more than 7,500 professional attendees from 90 countries converged on San Diego last month.

The meeting showcased more than 130 scientific sessions produced by the IDWeek Program Committee and another 135 abstract presentation sessions. Abstracts presented in San Diego have also been permanently archived as part of Open Forum Infectious Diseases, IDSA’s open access journal.

Presentations are housed in the IDWeek Digital Library, where you can catch up on sessions you missed or want to re-watch. This feature is accessible free-of-charge to all registered attendees and can be purchased by those who were unable to attend by going to the IDWeek Post Meeting Tools. While you’re there, you can also claim your CME/CPE/MOC credits. The deadline to claim your credits is November 27!

Thank you again to everyone who came, and we hope to see you next year. The IDWeek 2018 Program Committee is already hard at work planning another top-notch meeting. Mark your calendars for October 3-7, 2018 in San Francisco!

Journal Club

  • Is Vancomycin Plus a Beta-Lactam Better for Surgical Prophylaxis than Either Alone?
  • Higher Mortality With Higher Levels of CMV: Is It the Virus or the Treatment?
  • Quantifying Real Tuberculosis Risk with QuantiFERON: Is there a “Borderline” Category?

In this feature, a panel of IDSA members identifies and critiques important new studies in the current literature that have a significant impact on the practice of infectious diseases medicine.

Click here for the previous edition of Journal Club. For a review of other recent research in the infectious diseases literature, see “In the Literature,” by Stanley Deresinski, MD, FIDSA, in each issue of Clinical Infectious Diseases.

Is Vancomycin Plus a Beta-Lactam Better for Surgical Prophylaxis than Either Alone?
Reviewed by Christopher J. Graber, MD, MPH, FIDSA

The role of vancomycin in surgical antimicrobial prophylaxis is unclear. As compared to beta-lactam (including cephalosporin) agents, its primary advantage is its activity against methicillin-resistant Staphylococcus aureus (MRSA), while its disadvantages include prolonged time of administration that may make achieving appropriate serum levels at the time of incision more difficult, potential risk for nephrotoxicity, and lack of activity against Gram-negative pathogens. Combination prophylaxis with vancomycin plus beta-lactams has thus been suggested, but the efficacy of this approach remains unclear.

A recent paper published in PLOS Medicine retrospectively assessed the experience with combination therapy versus either vancomycin or a beta-lactam alone across a cohort of 70,101 surgical procedures throughout the Veterans Administration system from 2008 to 2013, 52,504 in which only a beta-lactam was given, 5,089 in which only vancomycin was given, and 12,508 in which a combination was given. The most common procedures were orthopedic (33,848) and cardiac (19,787). A total of 2,466 (3.5 percent) surgical site infections (SSIs) were observed; of 1,279 with a microbiology result, MRSA was isolated in 101 (7.9 percent), MSSA in 308 (24.1 percent), coagulase-negative staphylococci in 150 (12 percent), and Gram-negative enteric organisms in 512 (40 percent). Combination prophylaxis was associated with a lower incidence of SSI than single-agent prophylaxis only for cardiac surgery patients (adjusted risk ratio 0.61, 95 percent confidence interval [CI] 0.46-0.83). MRSA colonization was associated with a higher risk of SSI across all surgery types (RR 2.02, 95 percent CI 1.74-2.34). Point estimates of relative risk reduction were similar between MRSA-colonized and non-MRSA-colonized cardiac surgery patients (0.58 versus 0.61) but only statistically significant in the larger group of non-MRSA-colonized patients. Combination prophylaxis was associated with a higher overall rate of acute kidney injury (23.8 percent) versus vancomycin (20.8 percent) or beta-lactam (13.9 percent) alone. Risk for Clostridium difficile infection was similar across all prophylaxis regimens.

This paper highlights that combination prophylaxis may be of benefit in some situations (particularly with cardiac surgery) but is not without cost, at least with regard to acute kidney injury.

(Branch-Elliman et al. PLOS Med. 2017;14(7):e1002340.)


Higher Mortality With Higher Levels of CMV: Is It the Virus or the Treatment?
Reviewed by Erica Kaufman West, MD

The current strategy for allogeneic stem cell transplant (SCT) recipients is to provide preemptive antiviral therapy to prevent cytomegalovirus (CMV) end-organ disease. There has been some debate on the threshold at which to begin antiviral therapy, especially with the popularity of using CMV PCR assays. With some evidence showing that even low CMV DNA viral loads are associated with increased mortality, there is a need to evaluate what threshold should trigger antiviral therapy.

A recent article in Transplant Infectious Disease reported the results of a single-center retrospective study looking at CMV DNAemia and one-year overall mortality and non-relapse mortality in allo-SCT patients. There were 151 patients in Spain followed from 2010 to 2015. Viral loads were monitored at least once a week through day +100 for all patients. Treatment was with oral valganciclovir and IV ganciclovir, with IV foscarnet used as second-line therapy. Antiviral therapy was given for a minimum of two weeks, with longer therapy depending on CMV DNA results. Out of 151 patients, 109 had at least one episode of CMV DNAemia (72.2 percent). Antiviral therapy was required in 67 cases (61.5 percent). Only three patients had end-organ disease (one pneumonitis and two intestinal). The one-year overall mortality was 28.5 percent (n = 43), with 35 deaths due to causes other than relapse or progression of disease.

The risk of one-year overall mortality and non-relapse mortality was not increased in patients with low-level CMV DNAemia (< 1,500 copies/mL) and those with no documented CMV DNAemia. In those with CMV DNAemia > 1,500 copies/mL there was a significant increase in both outcomes. However, the peak level of CMV DNA viral load did not correlate with the risk of death nor did the duration of CMV DNAemia. One of the most striking findings was that about three-quarters of patients receiving ganciclovir had post-engraftment neutropenia, in contrast to only one-quarter of those not treated with antivirals. A study powered to differentiate whether it is the high CMV viral load or the effects of the antivirals is sorely needed, since antivirals without hematologic toxicity remain under investigation.

(Solano et al. Transpl Infect Dis. 2017;19:e12717.)

Quantifying Real Tuberculosis Risk with QuantiFERON: Is there a “Borderline” Category?
Reviewed by Nirav Patel, MD

Interferon-gamma release assays (IGRAs), including the QuantiFERON-TB Gold In-Tube (QFT) have been endorsed as a replacement for tuberculin skin testing (TST). However, after adoption of the QFT, there have been notable “conversions” to positive in previously TST serially negative individuals. The lack of a “borderline” category in QFT interpretation is thought to have contributed to these “positive” results, but there remains a concern about the natural history and prognosis of individuals listed as positive conversions.

A study in the Sept. 1, 2017, issue of the American Journal of Respiratory and Critical Care Medicine dramatically clarifies the actual risk of progression to active disease in individuals undergoing serial QFT testing. The investigators rigorously standardized the laboratory procedures surrounding the processing of QFT tests. Furthermore, they defined four categories:

  • Stringent non-converters (< 0.2 IU/mL TB Ag – nil at day 0, day 360, and 720)
  • Stringent persistent positives (> 0.7 IU/mL TB Ag – nil at day 0, 360, and 720)
  • Stringent converters (< 0.2 IU/mL TB Ag – nil at day 0 followed by > 0.7 IU/mL TB Ag – nil at day 360)
  • Uncertain converters (< 0.35 IU/mL TB Ag – nil at day 0 followed by a result ≥ 0.35 IU/mL TB Ag – nil at day 360 with at least one result within 0.2-0.7 IU/mL)

Stringent non-converters were noted to have 0.16 cases/100 person-years compared to stringent converters, who were noted to have 1.6 cases/100 person-years (P = 0.0003), and uncertain converters, who were noted to have 0.66 cases/100 person-years (P = 0.229).

Clearly, there remains ambiguity in the risk faced by uncertain converters, given the non-significant P-value. However, without a “borderline” category like the T-SPOT.TB assay, clinicians have created arbitrary thresholds in interpretation of QFT results without a true basis for risk adjudication. With this study, a more precise risk profile can be established to better interpret serial QFT results.

(Nemes et al. Am J Respir Crit Care Med. 2017 Sep 1;196(5):638-648.)

For a review of other recent research in the infectious diseases literature, see “In the Literature,” by Stanley Deresinski, MD, in each issue of Clinical Infectious Diseases:

October 15

  • Methicillin Resistance: Was Penicillin the Culprit?
  • Tolerant → Resistant
  • Case Vignette: Adenovirus Endotheliitis

October 1

  • Enterococci: How They Got That Way
  • Cerebrospinal Fluid Neutrophilic Pleocytosis in Viral Infections of the Central Nervous System: Does It Matter?
  • Antibiotic Resistance: The Potential Role of Bacteriophage “Superspreaders”
  • Case Vignette: Heater-Cooler Systems Strike Again—Left Ventricular Assist Device Infections With Mycobacterium Chimaera