Clinical Microbiology Procedures Handbook, Volumes 1-3

742 Pages·2010·33.25 MB·English

by  Garcia

THIRD EDITION
Clinical
Microbiology
Procedures
Handbook
E D l TO R l N C H I E F, Third Edition and 2007 Update
Lvnne S. Garcia

4
LSG & Associates, Santa Monica, California
E D I TO R I N C H I E F, Original and Second Editions
Henry D. Isenberg
(Deceased)
ASM
PRESS
Washington, DC
Address editorial correspondence to ASM Press, 1752 N St., N.W., Washington, DC
20036-2904, USA
Send orders to ASM Press, P.O. Box 605, Hemdon, VA 20172, USA
Phone: [phone]
Fax: [phone]
E-mail: [email protected]
Online: http://estore.asm.org
Copyright 0 2010 ASM Press
American Society for Microbiology
1752 N St., N.W.
Washington, DC 20036-2904
Library of Congress Cataloging-in-PublicationD ata
Clinical microbiology procedures handbook.-3rd ed. / editor in chief, third edition and
2007 update, Lynne S. Garcia.
p. ; cm.
“Editor in chief, original and second editions Henry D. Isenberg.”
Includes bibliographical references and index.
ISBN- 13: 978-1-55581 -527-1
ISBN- 10: 1-55581 -527-8
1. Diagnostic microbiology-Laboratory manuals. I. Garcia, Lynne Shore.
11. Isenberg, Henry D.
[DNLM: 1. Microbiological Techniques-methods-Laboratory Manuals.
WQ 25 C6415 20101
QR67.C555 2010
6 16.9’041 4 ~ 2 2
2010014355
10 9 8 7 6 5 4 3 2 1
All rights reserved
Printed in the United States of America
Preface
T
he third edition of the Clinical Microbiology Procedures Handbook
i
(CMPH) is based on the value and user requirements following the first and
second editions of CMPH, the companion volume Essential Procedures for
Clinical Microbiology, and the 2007 update of the second edition.
Almost all of the sixteen sections of the second edition of CMPH have been
revised and updated; sections that did not require extensive revision will be updated
during the next cycle of changes.
The purpose of the third edition of CMPH remains constant. That is to provide
everyone engaged in the microbiological analysis of clinical specimens with pro-
cedures that will enable them to correctly perform the appropriate tasks. CMPH
remains a cookbook that provides step-by-step descriptions of the numerous pro-
cedures used by workers at the bench.
As with the second edition of CMPH and the 2007 update of the second edition,
there is increased emphasis on molecular approaches, bioterrorism, infection control
in medical facilities, and the host’s immunological responses to microbial chal-
lenges. Also, continued emphasis is placed on the need to respond to governmental
regulations and fiscal constraints. Highly experienced workers with many years of
bench experience have written these procedures, and the format adheres to CLSI
document GP02-5A (5th ed., 2006).
All procedures have been reviewed extensively by section editors, the editor in
chief, and the ASM Press editors. We continue to encourage the users of these
documents to bring new methods of universal relevance to our attention so they
can be incorporated into the next update and shared with the clinical microbiology
community.
Readers are reminded that naming any specific product in CMPH is not intended
as an endorsement of that specific product or a suggestion to exclude other equally
acceptable products. CMPH is for laboratory use only by qualified, experienced
individuals or by personnel under the direct supervision of qualified, experienced
individuals. Every effort has been made to ensure that the contents of this update
are comprehensive, accurate, reliable, and reproducible.
Not all existing microbiological protocols are included; however, the editors and
authors are familiar with all commonly used protocols. As newer protocols become
more widely accepted and used, they will be incorporated into future CMPH re-
visions.
The third edition of CMPH is available in print, on CD, and as a downloadable
PDF.
Lynne S. Garcia
xxiii
J
Contents
VOLUME 1
Editorial Board ix
Contributors xi
How To Use This Handbook xvii
Abbreviations xix
Preface wciii
Acknowledgments xxv
Reader Response Form wcvii
Disclaimer mix
Procedure Coding, Reimbursement, and Billing Compliance 1. O. 1
Specimen Collection, Transport, and Acceptability 2.0.1
Aerobic Bacteriology 3.0.1
Anaerobic Bacteriology 4.0.1
VOLUME 2
Antimicrobial Susceptibility Testing 5.0. I
Aerobic Actinomycetes 6.0.1
Mycobacteriology and Antimycobacterial Susceptibility Testing 7.0.1
Mycology and Antifungal Susceptibility Testing 8.0.1
Parasitology 9.0.1
VOLUME 3
10 Viruses and Chlamydiae 10.0.1
11 Immunology 11. O. 1
12 Molecular Diagnostics 12.0.1
13 Epidemiologic and Infection Control Microbiology 13.0.1
14 Quality Assurance, Quality Control, Laboratory Records, and
Water Quality 14.0.1
15 Biohazards and Safety 15.0.1
16 Bioterrorism 16.0.1
INDEX 1.1
vii
1 Procedure Coding,
SECTION
Reimbursement, and Billing
Compliance
Alice S. Weissfeld
SECTION EDITOR:
Vickie S. Baselski
ASSOCIATE SECTION EDITOR:
1.1. Introduction
Alice S. Weissfeld and Vickie S. Baselski ........................................... .l.1 .1
1.2. Procedure Coding, Reimbursement, and Billing Compliance
Alice S. Weissfeld and Vickie S. Baselski ........................................... .1.2.1
1.0.1
1.1 Introduction
When the first edition of this handbook biology laboratories is provided for back- President. Statutes form the basis for sub-
was published, regulatory billing compli- ground. This may be reviewed in detail in sequent regulations that are rules estab-
ance for laboratory tests was not a major the Institute of Medicine’s report Medi- lished by a federal agency in response to
laboratory issue. Most hospital laborato- care Laboratory Payment Policy, Now its interpretation of a statute that it is its
ries generally performed services for their and in the Future (2). The history of re- duty to enforce. A number of federal agen-
own inpatients (and, occasionally, affili- imbursement and compliance begins with cies are directly or indirectly involved
ated outpatients), and tests were billed ac- Title XVIII, commonly known as the So- with laboratory reimbursement and com-
cording to a formula established by the cial Security Act. This act outlines the pliance. The CDC is responsible for the
business office. In the setting of prospec- principles of the Medicare program, spec- scientific and quality aspects of laboratory
tive payment (e.g., diagnosis-related ifying broad benefit categories, including testing under the Clinical Laboratory Im-
groups), payment credit was allocated physician and hospital services. In accor- provement Act (1967) and Clinical Labo-
based on a different formula. Today, how- dance with section 1862 (a)(l)(A), the ratory Improvement Amendment (CLIA)
ever, microbiologists must be aware not Medicare program provides payment only (1988). The CDC is advised in this process
only of the scientific basis of infectious- for diagnostic laboratory tests “that are by the Clinical Laboratory Improvement
disease diagnostics but also of the costing, reasonable and necessary for the diagnosis Advisory Committee. The Food and Drug
coding, billing, and reimbursement for in- or treatment of illness or injury.” It does Administration (FDA) is responsible for
dividual tests for patients seen in a broad not, however, authorize payment for new product clearance and, since 2003, for
spectrum of health care settings with cov- screening diagnostic services. Over the en- test complexity categorization under
erage by an enormous number of health suing 35 years since Title XVIII became CLIA. Medicare regulators have histori-
care plans. Jargon previously unknown in law, the interpretive determination of cally interpreted tests that are subject to
the clinical laboratory, such as reflex test- whether a test meets the criteria of being FDA approval or clearance but that have
ing, upcoding, downcoding, local cover- reasonable and necessary to justify pay- not obtained, such as “not reasonable or
age decision (LCD), and national cover- ment by Medicare has become known as necessary” for payment purposes. The
age decision (NCD), is now so extensive “medical necessity.” Most other third- FDA is assisted by its Microbiology Medi-
that a glossary of common terminology is party payers have established similar pay- cal Device Advisory Committee. The
included in this section (Appendix 1.1-1). ment guidelines with which the laboratory Centers for Medicare & Medicaid Ser-
The goal is to be reimbursed adequately must be familiar. It is notable that both vices (CMS), previously known as the
for all appropriate work performed in a Medicare and other payers may make spe- Health Care Financing Administration
manner that is in compliance with all reg- cific exceptions to allow payment for (HCFA), administers the Medicare Pro-
ulations. screening services (eg, coverage of Pap gram. CMS interprets statutes and regu-
The issues discussed in this section are smears or prostate-specific antigen test- lations and issues these interpretations
complex. In keeping with the mission of ing). In the event that a coverage policy dis- through a variety of official documents
this handbook, a model compliance pro- allows payment for a service on the basis of (e.g., The Medicare Program Integrity
cedure has been written. As with any pro- medical necessity, it is possible to transfer Manual [ 11, program memoranda and
cedure, we expect some customization to financial liability to the patient providing transmittals, and change requests) to de-
occur. The model procedure deals primar- an advanced beneficiary notice (ABN) has fine coverage criteria, establish national
ily with some of the more important reg- been properly executed which informs the limitation amounts, and establish national
ulatory principles. It should not, in any sit- patient of their financial responsibility. In coverage decisions (NCDs). CMS also
uation, take the place of guidance 2009, a laboratory-specific ABN, CMS-R- contracts with independent insurers
established by your own compliance com- 131-L, was discontinued and replaced known generically as contractors and spe-
mittee or of legal advice from your own with a generic ABN, CMS-R-131. Infor- cifically as carriers (for part B outpatient
institution’s legal counsel. It simply rep- mation may be accessed at http://www. services), as fiscal intermediaries (FIs; for
resents a starting point for review of sa- cms.hhs.gov/BNUO2~ABN.asp. part A inpatient services or part B services
lient issues. The Social Security Act is known as a through part A providers), and, more re-
A brief historical overview of the eco- statute, i.e., a piece of legislation voted cently, as Medicare administrative con-
nomic challenges faced by clinical micro- into law by Congress and signed by the tractors (MACs; for part A and part B ser-
1.1.1
1.1.2 Procedure Coding, Reimbursement, and Billing Compliance
vices) to administer claims to reimburse for review and update was implemented in were introduced in 2002. Category I11
physicians or laboratories. CMS is advised 2003, and under the Medicare Improve- codes are generally not reimbursable. In
in developing coverage policies by the ments for Patients and Providers Act of some cases, newer emerging technologies
Medicare Carrier Advisory Committee 2008, CMS can now propose new NCDs may also be assigned an interim HCPCS
(MCAC) and other contractor committees for preventive (screening) services. Three code. The ICD-9-CM system is a public
such as technology assessment groups. In- NCDs were developed in infectious-dis- domain consensus document developed
dividual carriers, Fls, and MACs may also ease diagnostics by a committee cochaired by the World Health Organization. It in-
set payment policies, known as LCDs, for by the American Society for Microbiol- cludes specific diagnoses as well as signs
their own geographic regions. Examples ogy: urine culture, human immunodefi- and symptoms or medical conditions that
of LCDs in infectious-disease diagnostics ciency virus (HIV) diagnosis, and HIV represent the physician’s reason for order-
include syphilis testing, blood cultures, monitoring and prognosis. The Negotiated ing a test. It also has a series of preventive-
antimicrobial susceptibility testing, Rulemaking Committee also developed a medicine screening codes (V codes) that
TORCH (Toxoplasma, rubella, cytomeg- number of administrative policies which in general do not support medical neces-
alovirus, and herpes simplex virus) test- became effective in 2003. A database in- sity. It is of note that a major update,
ing, and human papillomavirus testing. dex for current NCDs may be accessed at ICD-10, should be implemented by Oc-
Any information on institutional billing http://www.cms.hhs.gov/transmittals/ tober 2013. Correct coding is the corner-
and reimbursement should include a downloads/rl7ncd.pdf. Again, billings to stone of reimbursement and compliance.
search for LCDs specific to infectious-dis- other payers may require submission of Finally, in 1997, in response to a major
ease diagnostic testing. For this, a specific other specific forms, but coverage criteria antifraud and abuse campaign in the Medi-
website exists at http://www.cms.hhs.gov/ are often modeled after Medicare billing care program (Operation Restore Trust),
mcd/overview.asp (Appendix 1.1-2). guidelines. the Office of the Inspector General pub-
Medicare generally requires that labora- Coding is the process of assigning a lished a series of compliance documents,
tories submit billings electronically, but it procedure code such as a Current Proce- including one for clinical laboratories.
may occasionally accept handwritten bills dural Terminology (CPT), or a diagnosis One such document, the Office of Inspec-
on HCFA form 1500 for part B and HCFA or condition, code, usually the Interna- tor General’s Compliance Program Guid-
for UB92 for part A, both universal insur- tional Classification of Diseases, Clinical ance for Clinical Laboratories, published
ance billing forms. Payment denials may Modification (ICD-9-CM), code, for the in August 1998, contains an outline for the
be appealed through a formal process and purpose of submitting a claim for reim- design of individual institutional compli-
ultimately referred to an administrative bursement. CPT codes are property of the ance plans to ensure correct coding, ap-
law judge. As a result of deliberations by American Medical Association but have propriate billing, and honest and ethical
a Negotiated Rulemaking Committee on been named as the official CMS HCFA laboratory business practice (3). This doc-
clinical laboratory diagnostic tests man- Common Procedure Coding System ument, although more than a decade old,
dated by the Balanced Budget Act of (HCPCS). CPT codes are updated an- still forms the basis for laboratory billing
1997, 23 NCDs were developed which nually by a lengthy, systematic process. compliance and for the model compliance
take precedence over any existing LCDs Most codes are Category I and represent plan presented in this section.
for the same tests. Implementation for generally accepted procedures, but Cate-
these NCDs occurred in 2002, a process gory I11 codes for emerging technologies
REFERENCES
1. Centers for Medicare and Medicaid Ser- 3. Office of the Inspector General. 1998. Com-
vices. 2008. Medicare Program Integrity pliance program guidance for clinical labora-
Manual. Centers for Medicare and Medicaid tories. Fed. Regist. 63:45076-45087.
Services, Baltimore, MD. http://www.cms.
hhs.gov/rnanuals/iom/ItemDetail.asp?ItemID=
CMSOl9033.
2. Institute of Medicine. 2000. Medicare Lab-
oratory Payment Policy: Now and in the Fu-
ture. National Academy Press, Washington,
DC.
Introduction 1.1.3
APPENDIX 1. l-1 Glossary of Reimbursement and Compliance Terminology and Acronyms
Terminology
Terminology Definition
Abuse Systematically accepting improper payment without knowledge of
illegality (see Fraud)
Add on A test added after the original date of service
Bundling Placing codes together in a panel
Carrier CMS contractor for part B claims
Carve out Exclude from a capitated contract and bill fee-for-service
Code jamming Inserting ICD-9 codes to pass claims review
Code stacking The use of two or more procedural codes to denote a single
reportable test result
Code steering Encouraging ICD-9 code use to satisfy medical necessity
Comparative Assessment of clinical comparability of procedures that may result
effectiveness in reimbursement of a new technology at the rate of an older
technology
Composite The use of two or more test codes simultaneously in accordance
with standard of care and not otherwise described as a panel
Contractor Generic term for Medicare claims administrator
Covered lives Population insured by a managed-care contract
Crosswalked Deemed equivalent (see Mapped)
Custom panel User-defined composite of test codes performed simultaneously
which is not a standard of care
Downcoding Using a lower paying code to encourage utilization
E codes Codes for external sources of injury
Fair market value A reasonable payment amount for a specified service
Fraud Knowingly or willingly accepting improper payments with
knowledge of illegality (see Abuse)
Frequency limits Number of times a service may be reimbursed
Gap fill Temporary assignment of reimbursement
Inducement Service or item with monetary value given to encourage utilization
by a purchaser of laboratory services
Kickback Acceptance of an inducement
Mapped Deemed comparable (see Crosswalked)
Medical necessity Determination of ICD-9-CM codes for which a CPT code will be
reimbursed as reasonable and necessary
Modifiers Two-character (numeric for CPT and alpha for HCPCS) units
appended to a CPT code to indicate a condition affecting
payment
Neg Reg Negotiated Rulemaking Committee on diagnostic clinical laboratory
tests
Not medically Determination that an ICD-9 CM does not justify payment for a
necessary CPT code
Panel CMS-approved test composite encompassed in a single CPT code
Program integrity Process by which CMS monitors for fraud and abuse
Reasonable charge Based on inherent reasonableness, authority to arbitrarily increase or
methodology decrease payment
Reflex Second related test automatically performed when an initial test
result is positive or abnormal
Remittance advice Provides explanation of any adjustment made to expected payment
codes for a service; includes claim adjustment reason codes and
remittance advice remark codes
Sink testing Fraudulently reporting results for tests not performed
Standing orders Preapproved set of test codes performed on a regular defined basis
Unbundling Coding individual tests rather than a single defined panel
Upcoding Using a higher-paying code to maximize reimbursement
V codes Generally, health screening codes
Zero tolerance Absolute institutional policy that no fraudulent practice will be
allowed
1.1.4 Procedure Coding, Reimbursement, and Billing Compliance
APPENDIX 1. l-1 (continued) Acronyms
Acronym Definition
ABN Advanced beneficiary notice
ALJ Administrative law judge
AMA American Medical Association
APC Ambulatory payment classification in the OPPS
ASR Analyte-specific rule
BBA '97 Balanced Budget Act of 1997
CAC Camer Advisory Committee
CAP College of American Pathologists
CCI Correct Coding Initiative (also known as the National Correct Coding
Initiative, NCCI)
CDC Centers for Disease Control and Prevention
CERT Comprehensive Error Rate Testing Program
CLFS Clinical laboratory fee schedule (see NLA)
CLIA '67 Clinical Laboratory Improvement Act of 1967
CLIA '88 Clinical Laboratory Improvement Amendments of 1988
CLIAC Clinical Laboratory Improvement Advisory Committee
CMD Contractor medical director
CMS Centers for Medicare and Medicaid Services
CPT Current Procedural Terminology
DRG Diagnosis-related group in the IPPS
EOMB Explanation of medical benefits (also explanation of benefits, EOB)
ESRD End-stage renal disease (dialysis center)
FBI Federal Bureau of Investigation
FDA Food and Drug Administration
FI Fiscal intermediary
FTE Full-time equivalent
HCFA Health Care Financing Administration (now CMS)
HCPAC Health Care Professionals Advisory Committee
HCPCS HCFA Common Procedure Coding System
HIPAA Health Insurance Portability and Accountability Act
ICD-9-CM International Classification of Diseases, 9th ed., Clinical Modification
ICD- 10 International Classification of Diseases, 10th ed.
IDE Investigational device exemption
IOM Institute of Medicine
IPPS Inpatient prospective payment system (see DRG)
LCD Local coverage decision (previously known as LMRP)
LMIP Laboratory Management Index Program
LMRP Local medical review policy (now LCD)
MAC Medicare administrative contractor (for A and B claims)
MedPAC Medicare Payment Advisory Council
MIPPA Medicare Improvement for Patients and Providers Act of 2008
MMA '03 Medicare Modernization Act of 2003
MUE Medically unlikely edit for frequency in the CCI edits
NCD National coverage decision (previously known as NCP)
NCP National coverage policy (now NCD)
NLA National limitation amount in the CLFS
NPI National provider identifier
OCE Outpatient code editor (for OPPS)
OIG Office of the Inspector General
OPPS Outpatient prospective payment system
PCC Pathology coding caucus
PFS Physician fee schedule
PPAC Practicing Physician Advisory Council
RAC Recovery audit contractor
SBT Standardized billable test
SNF Skilled-nursing facility (nursing home)
Introduction 1.1.5
APPENDIX 1 .I-2 Websites and Guidance Documents
I. WEBSITES
A. All contractor LCDs, http://www.cms.hhs.gov/mcd/overview.asp
B. CMS website, http://www.cms.hhs.gov (to subscribe to regular updates, go to http://
www.cms.hhs.gov/AboutWebsite/EmailUpdates/list.asp)
C. General Accounting Office, http://www.gao.gov (search “Medicare” for recent re-
ports)
D. FDA, http://www.fda.gov (to subscribe to regular updates, go to http://www.fda.gov/
AboutFDNContactFDNSt ayInformed/GetEmailUpdates/default.h tm)
E. Health Care Compliance Association, http://www.hcca-info.org
F. IOM study on Medicare Laboratory Payment Policy (http://www.iom.edu/iom/iom
+
home/nsf/pages/clinlab home +page)
G. Medicare Clinical laboratory fee schedules, http://www.cms.hhs.gov/ClinicalLab
FeeSched/02-clinlab.asp#TopOfPage
H. Medicare fee schedules: general information, http://www.cms.hhs.gov/Fee
ScheduleGenInfo/
I. Medicare manuals, http://www.cms.hhs.gov/Manuals/Ol-0verview.asp
J. Medicare physician fee schedule, http://www.cms.hhs.govPhysicianFeeSched/
K. Medicare Learning Network, http://www.cms.hhs.gov/MLNGenInfo/
L. Medicare Payment Advisory Commission, http://www.medpac.gov
M. National Center for Health Statistics for ICD-9-CM updates, http://www.cdc.gov/
nchs/icd.htm
N. National Correct Coding Initiative, http://www.cms.hhs.gov/NationalCorrectCod
InitEd/
0. National Technical Information Service for published NCCI edits, http://
www.ntis.gov
P. OIG website for Compliance Program, Fraud Alerts, Advisory Opinions, Red Book,
Work Plan, http://oig.hhs.gov (to subscribe to regular updates, go to http://
oig.hhs.gov/mailinglist.asp)
Q. Strategic Management (previously The American Compliance Institute), http://
www.strategicm.com/
II. OTHER GUIDANCE DOCUMENTS
A. ABN current format and instructions, http://www.cms.hhs.govlBNY02_ABN.asp
B. Guidance for industry and FDA staff--commercially distributed analyte-specific re-
agents, frequently asked questions, http://www.fda.gov/MedicalDevices/Device
RegulationandGuidance/GuidanceDocuments/ucmO7842.3h tm
C. Medical devices: classification/reclassificationr, estricted devices, analyte-specific re-
agents, Fed. Regist. 62:62243-62260 (1997)
D. Medicare: HCFA faces challenges to control improper payments, T-HEHS-00-74,9
March 2000, http:/lwww.gao.gov
E. Medicare Claims Review Program: NCCI edits, MUEs, CERT, and RAC, Medicare
Learning Network Publication (October 2008), http://www.cms.hhs.gov/MLNProd
ucts/downloads/MCRPBooklet.pdf
F. Medicare clinical trials policies, http://www.cms.hhs.gov/ClinicalTrialPolicies/
G. Medicare Fraud & Abuse, Medicare Learning Network Publication (January 2009),
http://www.cms.hhs.gov/MLNProducts/downloads/110107-Medicare-Fraud-and-
Abuse-brochure.pdf
H. Medicare program: application of inherent reasonableness to all Medicare part B
services (other than physician services), Fed. Regist. 67:76684-76697 (2002)
I. Medicare Program: criteria and procedures for extending coverage to certain devices
and related services, Fed. Regist. 60:484 17-48425 ( 1995)
J. Medicare program: establishment of procedures that permit public consultation under
the existing process for making coding and payment determinations for clinical lab-
oratory tests and new durable medical equipment, Fed. Regist. 66:58743-58745
(2001)
K. Medicare program: negotiated rulemaking: coverage and administrative policies for
clinical diagnostic laboratory services; final rule, Fed. Regist. 66:58787-58836
(2001)