Update on Medicare Competitive Bidding Demonstration for Lab Services
ASM’s Legislative Communications Site
On April 8, United States Federal District Court Judge, Thomas J. Whelan granted a preliminary injunction on the U.S. Department of Health and Human Services, prohibiting the Centers for Medicare & Medicaid Services (CMS) from announcing bid winners in the Medicare Competitive Bidding Demonstration for Clinical Laboratory Services. The preliminary injunction also enjoined CMS from otherwise implementing and carrying out the demonstration project in the San Diego metropolitan area, and further disclosing any information included in the bid applications. The decision was timely in that CMS was supposed to announce bid winners for the San Diego demonstration site on April 11. Because a preliminary injunction only delays the implementation of the demonstration until further Court order, it is critical that Congress act now to provide a permanent solution. ASM encourages you to contact your Members of Congress and urge them to co-sponsor and vote in favor of S. 2099, the Preserving Access to Laboratory Services Act of 2007 and H.R. 3453, the Community Clinical Laboratory Fairness in Competition Act of 2007.
ASM-CDC-APHL Meeting on Enteric Disease Testing Issues
On April 3-4, Vickie Baselski, chair of the Committee on Professional Affairs, and Bob Jerris, member of the Professional Affairs Committee represented ASM at a meeting to discuss the role of clinical diagnostic and public health laboratories in enteric disease surveillance and response, in Atlanta, GA. ASM was asked to cosponsor this year’s meeting with Centers for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL). The ASM has two major action items from the 2008 meeting: the Society is participating in a workgroup helping to write the interpretation section of a Morbidity and Mortality Weekly Report Guideline on the issue, and the ASM is also responsible for gathering current coding, billing and compliance information on enteric diseases.
ASM Responds to Medically Unlikely Edits (MUE) Proposal
The ASM continues to comment on Medically Unlikely Edit (MUE) proposals regarding correct coding for Medicare laboratory testing based on appropriate utilization. The PSAB Committees on Professional Affairs and Laboratory Practices reviewed the MUE Phase VII proposal, and on April 7, the ASM submitted comments which included several edits for tests performed to detect infectious diseases by any method including molecular methods. The Phase VII edits are slated for a July 1 implementation date.
ASM Invited to Appoint Delegate to the USP
The ASM received a letter from the United States Pharmacopeia (USP), inviting the Society to appoint a delegate to the USP Convention, for a term that expires in 2010. The USP is a nonprofit, science based public health organization that maintains the US National Formulary and sets standards for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States. Among its many responsibilities, the USP sets and maintains procedures for testing products for sterility, antimicrobial preservative effectiveness, and a number of other sentinel microbiology procedures. PSAB chair, Ruth Berkelman recommended to CPC the nomination of Alice Weissfeld, Ph.D., former chair and current member of the Committee on Professional Affairs, to serve as ASM’s delegate to the USP. The CPC approved Dr. Weissfeld’s nomination in early April.
ASM Posts Revised Sentinel Guideline on Burkholderia
ASM’s Sentinel Level Clinical Microbiology Laboratory Guideline Webpage
The ASM Sentinel Clinical Laboratory Guideline on Burkholderia mallei and B. pseudomallei was recently revised and posted on ASM’s website. Peter Gilligan, Ph.D., and Mary York, Ph.D. are the authors of this guideline which can be downloaded from ASM’s Sentinel Level Clinical Microbiology Laboratory Guideline Webpage.
ASM Posts LOCS Advisory on Measles Outbreak
On April 4, the ASM posted Laboratory Outreach Communications (LOCS) Advisory regarding the measles outbreaks in the United States. The LOCS Advisory was sent to ASM from the Centers for Disease Control and Prevention (CDC). The purpose of LOCS is to create a volunteer communications infrastructure for the exchange of laboratory related information between the CDC and others in the laboratory community.
Minority Microbiology Mentor Newsletter Available
The April issue of the Minority Microbiology Mentor Newsletter has been published by the Committee on Microbiological Issues Impacting Minorities (CMIIM).
ASM Submits Funding Statements to Congress
The ASM submitted FY 2009 funding recommendations to Congress on the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Science Administration, the U.S. Department of Agriculture, the Environmental Protection Agency and the Department of Energy. A compilation of the ASM recommendations to Congress as well as a budget analysis for the federal agencies that support R&D have been developed.
|ASM News, Journal Articles and Updates|
New from ASM Press
Cumitech 46: Laboratory Procedures for Diagnosis of Blood-Borne Parasitic Diseases
Coordinating Editor: Lynne Shore Garcia
Cumitech 46 provides guidance to the laboratory and to other members of the patient care team in the appropriate selection, ordering, and application of tests for diagnosis and management of blood-borne parasitic infections. It details the reasons that examinations for parasites may be requested, reviews physician options for test selection and ordering, and discusses laboratory procedures used for examining clinical specimens. Additionally, extensive information describing newer methods and their relevance to the laboratory test menu is included. Brief and relevant geographic, demographic, and medical information pertaining to blood-borne parasitic diseases is also covered.
Food-Borne Viruses: Progress and Challenges
Series Editor: Michael P. Doyle, University of Georgia; Editors: Marion P. G. Koopmans, Centre for Infectious Diseases Control Netherlands; Dean O. Cliver, University of California, Davis; Albert Bosch, University of Barcelona
Food-borne viruses are recognized as a major health concern, but their distribution, definition, and impact are poorly understood. The volume Food-Borne Viruses goes a long way in correcting that problem. Written by leading scientists in the field, it brings together the latest knowledge on these viral strains, their detection and control, and associated challenges. Additionally, the volume points to important new directions for future research.
New AAM Fellows
For More Information
Photographs and brief biosketches are available for each of the thirty-eight Fellows that were elected to the American Academy of Microbiology in January.
National Registry of Microbiologists Newsletter
The Winter 2008 edition of the National Registry of Microbiologists (NRM) quarterly newletter, “The Loop” was released at the end of February.
|Federal Agency Updates|
Morbidity and Mortality Weekly Report
The March 21 issue of the Morbidity and Mortality Weekly Report (MMWR Volume 57, Number 11 ) has a number of items that may be of interest:
Trends in Tuberculosis: United States 2007
A Surveillance Summary of Acute Viral Hepatitis in 2006
Summary of Notifiable Diseases in the United States, 2006
FDA Takes Next Step in Establishing Overseas Presence
The Food and Drug Administration (FDA) has received approval from the State Department to establish eight full-time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government.
FDA Guidance Document on Influenza Devices
The Food and Drug Administration (FDA) released a draft guidance document that outlines the FDA's current thinking on the performance characteristics of devices that detect influenza viral antigens or viral genomes. The draft guidance makes recommendations to manufacturers regarding studies needed to establish analytical and clinical performance of devices that detect or diagnose the flu.
CMS Releases New ABN Form
Beneficiary Notice Initiative (BNI) web page
Recently, the Centers for Medicare and Medicaid Services (CMS) issued a new Advanced Beneficiary Notice (ABN) that will replace the General Use ABN and the Lab ABN. ABNs are forms that provide financial liability and appeal rights and protections to beneficiaries when providers order tests that may or may not be covered under Medicare. CMS will provide a 6-month transition period, beginning March 3, 2008 until September 1, 2008 for all providers and suppliers to use the new ABN form (CMS-R-131). The revised ABN form and instructions will be posted on the Beneficiary Notice Initiative (BNI) web page.
Newly Licensed Smallpox Vaccine to Replace Old Smallpox Vaccine
For More Information
The Centers for Disease Control and Prevention (CDC) began distribution of a new generation smallpox vaccine, ACAM2000™ (Acambis, Inc., Cambridge, Massachusetts), to civilian laboratory personnel, the military, and state public health preparedness programs. ACAM2000 will be replacing Dryvax® smallpox vaccine (Wyeth Pharmaceuticals, Inc., Marietta, Pennsylvania) because of withdrawal of the Dryvax license. Wyeth intends to withdraw the Dryvax license and asked that all remaining quantities of vaccine held by civilian and military users be quarantined by February 29, 2008, for the purpose of destruction. All programs that hold supplies of Dryvax vaccine must provide documentation of Dryvax vaccine destruction to the CDC Drug Service by March 31, 2008.
|Other Information and Updates|
Agents of Bioterrorism: Sentinel Training for Clinical Laboratories
For more information
The National Laboratory Training Network (NLTN) is offering a one day, advanced level program to provide an overview of the clinical laboratory’s role in the presumptive identification of primary agents of bioterrorism including anthrax, plague, tularemia, brucellosis, glanders, and melioidosis. Laboratory demonstrations will outline the microbiology of these agents so that participants can recognize the culture, staining and biochemical characteristics. In addition, safety implications of handling suspect organisms in clinical isolates and culture and suspect toxins will be emphasized. Policies related to chain-of-custody specimens will also be reviewed. The meeting is scheduled to take place on May 15 in Columbus, GA.
New from CLSI
To purchase CLSI Guidelines
MM17-A, Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline. This guideline provides recommendations for analytic verification and validation of multiplex assays, as well as a review of different types of biologic and synthetic reference materials.
I/LA30-A, Immunoassay Interference by Endogenous Antibodies; Approved Guideline
This guideline discusses the nature and causes of interfering antibodies, as well as their effects on immunoassays and mechanisms by which interference occurs. Methods to identify and characterize the interferences are addressed along with assessment of
methods used to eliminate interference.
M31-A3, Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals; Approved Standard, Third Edition
This document provides the currently recommended techniques for antimicrobial agent disk and dilution susceptibility testing, criteria for quality control testing, and interpretive criteria for veterinary use.
M37-A3, Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents; Approved Guideline, Third Edition
This document addresses the required and recommended data needed for selection of appropriate interpretive standards and quality control guidance for new veterinary antimicrobial agents.
World Malaria Day
For more information
April 25, 2008 marks the first annual World Malaria Day. World Malaria Day was established and approved by the World Health Organization in March 2007, and replaces “Africa Malaria Day” which has been commemorated every year since 2001. The Malaria Consortium has been responsible for organizing events around the world to commemorate World Malaria Day.
STD Awareness Month
For more information
The American Social Health Association (ASHA) and the National Coalition of STD Directors (NCSD) recognize April as National STD Awareness Month and emphasize testing as a key component for sexual health. According to ASHA, there are nearly 19 million new cases of sexually transmitted diseases (STDs) in the U.S. each year, but obvious symptoms often do not develop and many people who contract an STD are unaware they and their partners are at risk. The Centers for Disease Control and Prevention (CDC) recommends routine chlamydia testing for women under age 26, and for women who are pregnant or have new or multiple partners. CDC also recommends routine HIV testing for those ages 13-64.
Articles of Interest
New kind of killer virus discovered in Bolivia
New Scientist, April 18, 2008
A team of disease hunters has announced the discovery of a deadly new virus, found in a remote village in South America.
Revealed: the Asian source of the annual flu epidemic
New Scientist, April 17, 2008
Now the biggest analysis of flu strains ever has shown it comes from eastern and Southeast Asia, a product of the connectedness of people and the patchiness of the region's rainy seasons.
First successful libraries of avian flu virus antibodies created
Science Daily, April 17, 2008
An international group of American and Turkish research scientists, led by Sea Lane Biotechnologies, has created the first comprehensive monoclonal antibody libraries against avian influenza (H5N1) using samples from survivors of the 2005/2006 "bird flu" outbreak in Turkey.
Lyme bacteria can 'hide' from medicine, study says
San Mateo County Times, April 17, 2008
A recent study from the University of California, Davis, provides the first evidence that the bacteria causing Lyme disease can evade antibiotics by "hiding out" in tissue throughout the body and remain infectious long after treatment ends.
West Nile virus on the decline?
Edmonton Sun, April 14, 2008
Last year was big for West Nile in Canada with 2,353 cases, mostly in the Prairie provinces, but there is a slight chance this year could see lower numbers, says Dr. Harvey Artsob, director of zoonotic diseases at Winnipeg's National Microbiology Laboratory.
USDA scientists say irradiation could be key to food safety
Los Angeles Times, April 11, 2008
They say the process destroys E. coli and other potentially deadly microbes that chlorine doesn't kill in fruits and vegetables.
Bacteria tails could protect against 'dirty' bomb
New Scientist, April 11, 2008
A drug made out of Salmonella can protect mice and monkeys from high doses of radiation. It might help protect rescuers who have to enter a radioactive area after attack with a nuclear or "dirty bomb," and also cancer patients undergoing radiation therapy.
Getting jump on killer bacteria
The Intelligencer, April 10, 2008
A four member team from Belleville hospital employed a new detection system called Agar to root out the deadly superbug VRE (Vancomycin-Resistant Enterococci) and there is no doubt that the process will save lives.
Cancer treatment from a common avian virus under study
News-Medical.Net, April 7, 2008
Researchers on the Blacksburg and College Park, Maryland campuses of the Virginia-Maryland Regional College of Veterinary Medicine have been awarded a major new grant from the National Institutes of Health (NIH) to support innovative work that seeks to develop a treatment for cancer from a common avian virus.
Alligator blood 'may fight bugs'
BBC News, April 6, 2008
Proteins isolated from alligator blood may lead to new antibiotics to treat "superbugs" such as MRSA.
Mud harnessed to fight infection
U.S. News & World Report, April 6, 2008
Researchers searched world, found 3 clays that beat back the toughest germs.
Deadly bug early detection hope
BBC News, April 4, 2008
Scientists have developed a method for quickly detecting a deadly superbug which infects weakened immune systems.
Single virus gene may cause obesity
New Scientist, April 4, 2008
If obesity seems to be spreading like a virus, that could be because it is. We're now closer to understanding how adenovirus-36 (Ad-36), thought to be responsible for some cases of obesity, causes fat cells to grow.
Soil 'ultra-bugs' thrive on a diet of antibiotics
New Scientist, April 3, 2008
Call them the "ultra-bugs," bacteria that are not merely resistant to antibiotics, but feed on them. They lurk in dirt from parks, farms and gardens. While the ultra-bugs don't normally cause disease, researchers are concerned the bacteria might pass drug resistance onto their deadly kind.
Thousands hit by Brazil outbreak of dengue
CNN, April 3, 2008
More than 55,000 cases of dengue, a sometimes deadly mosquito-borne disease, have been reported in a southeastern Brazilian state in the past four months.
Scientists uncover how HIV hides inside cells
U.S. News & World Report, April 1, 2008
U.S. researchers say they've discovered how HIV, the virus that causes AIDS, hides in human cells to avoid being destroyed by the body's immune cells.