November 2013

Dear Valued Health Care Provider,

This is your annual notification of laboratory compliance issues, as required by the Office of Inspector General
(OIG). Please carefully review this summary of billing policies and Medicare and Medicaid rules for clinical laboratory
testing. This notice will review coverage decisions and policies now in effect.
Providence Laboratory Billing Policy: All tests that are both ordered and performed are billed to the appropriate
payer under the guidelines provided by the payer and in accordance with all federal, state, and local laws and
regulations.
Orders: Our laboratory can only perform tests when properly ordered by a legally authorized provider. In Oregon,
a legally authorized provider is identified as a licensed physician, dentist, or mid-level practitioner (ORS 438.430)
hereafter referred to as clinician. Orders submitted under the office MAs or RNs name only are not acceptable.
Orders must include the patient's full legal name, date of birth, reason for the test ordered, date and time of
collection, source when applicable, and clinicians name. Medicare requires hand-written orders to be signed and
dated by the provider; however pre-printed laboratory requisitions and electronic orders authorized by the provider
and printed do not require signature. Reoccurring orders must include both the frequency and duration for the
order, not to exceed 1 year. Oregon Laboratory Services will only accept add-on orders to specimens already
collected at the written or electronic request of the clinician. These may be submitted in EPIC, by fax
(503-215-6127) or by accessing the electronic form, Providence Laboratory Services Oregon Order Form
and Authorization. (https://healthplans.providence.org/about-us/Documents/contact-forms/add-on-orderform-and-authorization.htm). Oregon Laboratory Services will not accept verbal orders as a valid order.
Specimen Integrity: In order to assure patient safety and provide accurate results on the correct patient, our
laboratory requires that all samples be labeled with two patient identifiers. Please make sure that all samples
collected in your office are labeled at the time of collection, in the presence of the patient. Use the patients first
and last name as the primary identifier, and then you may use the patients date of birth, chart number, or
requisition number as the second identifier. In addition, please include the actual date and time of specimen
collection. This information helps you better interpret the results and it helps us monitor specimen quality.
Diagnosis Codes: As the ordering practitioner, you are obligated to provide the signs and symptoms, ICD9 code
or descriptive diagnosis that best describes the patients condition and that documents your reason for ordering
the test. Using V70.0 or other screening codes is not specific enough to assure insurance coverage for your
patients. For you to participate as a Medicare provider, you are required to provide evidence of medical necessity
for each order.

PROVIDENCE HEALTH & SERVICES | PHYSICIAN SALES AND SERVICE

National Coverage Decisions (NCDs) and Medical Necessity: The Center for Medicare and Medicaid
Services (CMS) developed 23 coverage policies to assure appropriate laboratory utilization. Please see
http://www.cms.gov/medicare-coverage-database/indexes/lab-ncd-index.aspx for an alphabetical listing to select
the most current on-line version of the coverage rules. Limited coverage tests are identified with an asterisk (*)
on our Providence Health and Services Laboratory Requisition. When the ICD9 code you provide does not meet
medical necessity requirements, Medicare patients must be advised in advance. Use the CMS approved Advance
Beneficiary Notice of Non-Coverage (ABN) to document your discussion. This gives you the opportunity to
review the need for the test with the patient, notifies them that they may be responsible for the charges, and
provides the patient the option to not have their test(s) or service(s) performed. Because ABNs must include a
cost estimate for tests ordered, price lists by region for tests with coverage policies are posted on our laboratory
intranet web site at: http://in.providence.org/or/departments/labservices/Pages/Compliance.aspx. Give one
completed copy of the ABN to the patient and scan the second page into EPIC or send the original to our
laboratory with your orders and specimens.
Non-Covered Services: There has been an increase in requests for testing that Medicare considers
non-covered. Often these are kits sent to outside laboratories for tests including genetic markers, BRAC
analysis and Prometheus kit tests. Compliant billing requires that the performing laboratory directly bill the
patient for all non-covered services. Additionally, these orders often require pre-authorization, your signature as
the ordering provider, and a signed patient consent. You are responsible for completing the paperwork required
by the testing laboratory. While we may assist in the collection of specimens we are not responsible for
shipping, billing, or result delivery. We will ship the kit if the supplies include a pre-paid shipping label.
Pre-Authorization: Many insurance companies require physician pre-authorization (PA) prior to ordering or
collecting certain tests, i.e. allergen tests or genetic markers. Please check with the health plan prior to ordering
tests on your patients. If the test requires pre-authorization, please include the PA # on the laboratory order to
prevent delays in processing.
Referral Tests: When tests ordered are not available for analysis within our Laboratories, we forward them to
carefully selected referral laboratories. Reference laboratories must meet our criteria for quality and service, and
they must be properly accredited for the testing ordered. Reference laboratories must meet all of the rules
established by the Clinical Laboratory Improvement Act and by their accrediting agency. We will only send tests
to laboratories with which we have an arrangement for service. Through such arrangements we are able to
enhance connected care with quicker turn-around-times and interfaced electronic result reporting.
Pap Smear Orders: CMS provides very specific direction for assuring coverage of Pap Smears. Medicare covers
screening Pap Smear tests only when ordered with one of these four ICD9 codes: V76.2 (screening, cervix),
V15.89 (high risk), V76.47 (screening, vaginal), or V76.49 (screening, other sites). These four codes are
pre-printed on our laboratory requisition for your convenient selection. Diagnostic PAPs require a separate ICD9
code provided by you.
PSA Tests: CMS provides even more specific coverage rules for PSA testing. Screening PSAs are covered for
Medicare patients only when ordered with ICD9 code V76.44. Medicare patients must always be presented
with an ABN when a screening PSA is ordered for any reason other than V76.44. Indicate other appropriate
ICD9 codes when ordering diagnostic PSAs.
Panel Tests: Organ or disease related panels are charged and reimbursed only when all test components are
medically necessary. All components of panels offered by Providence Laboratories may be ordered individually.
Providence Laboratories does not recognize custom panel orders designed by other laboratories. To prevent
delays with testing, and to be sure you receive the tests intended, please order using specific test names and
numbers as provided in our test directory.
CBC Tests: The AMA (American Medical Association) definition for a CBC (complete blood count) does not
include a differential. A CBC order will include the hemogram only. Please specify CBC with diff when you
need the differential included. These orders will include an automated or manual differential (as determined by
internal criteria).

Medicare Laboratory Fee Schedule: Medicare publishes the reimbursement fee schedule for 2013
on the CMS site, http://www.cms.hhs.gov/ClinicalLabFeeSched/02_clinlab.asp#TopOfPage. The Medicaid
reimbursement amount will be equal to or less than the amount of Medicare reimbursement.
Additional Charges: Some laboratory tests may trigger additional automatic orders and appropriate charges
based on laboratory policy reflecting best standards of care. Our test directory provides specific information
including criteria that will lead to these charges, along with specific CPT codes. The on-line directory is
available at: http://www.providence.org/oregon/programs_and_services/lab_services/default.htm. Examples
include:
If pathological organisms are present on cultures, additional testing and charges for organism
identification and susceptibility testing are applied.
A Positive DAT on cord blood will trigger orders and charges for antibody screening.
Body Fluid Cell Counts with WBCs present will reflex to include a differential WBC count.
Negative or indeterminate results on rapid Beta Strep tests will be followed up with a throat culture to
screen for group A Strep.
Lower respiratory, wound, body fluid, CSF, and genital cultures include Gram Stains.
Reflex Testing: In other cases, defined results will trigger additional testing and charges only when so
requested with the initial order. Typically, reflex or if will be included in the test name. Examples include:
Pap Smear, HPV if ASCUS.
UA, C & S IF, which will add a urine culture based on results of the urinalysis
PSA Reflex, which adds a Free PSA based on results of the PSA Total, Diagnostic.
Respiratory Virus Reflex Panel, which consists of up to four PCR tests, and then adds a respiratory virus
culture if all PCR tests are negative.
Supplies: Providence Laboratory Services will provide supplies required for the collection of specimens that are
to be sent to our laboratory. Anti-Kickback statutes govern these practices, and our laboratory monitors the
volume of supplies provided to your offices. Supply volumes must reasonably match volumes of testing
received.
Clinical Consultant: Consultation services regarding appropriateness of testing and interpretation of results is
available to you by contacting our Medical Directors at 503.893.7800.
James Durham, MD, Medical Director
Brook Howard, MD, Medical Director
Allan Sacker, MD, Medical Director
Jeff Harter, MD, Medical Director
June Olson, MD, Medical Director
James Booth, MD, Medical Director
Pifu Luo, MD, Medical Director
Margret Oethinger, PhD, MD, Medical Director
Yibin Zhang, MD, Medical Director

Regional Laboratories, PWFMC

POP 3, PMH, TOC Laboratories
PSVMC Laboratory
PPMC Laboratory, Point of Care Testing
PHRMH Laboratory
PNMC Laboratory
PMMC Laboratory
PSH Laboratory
Marion County Laboratory

We hope you find this information useful in your practice. Please dont hesitate to call 503.215.6555 for
further information.
Mary OBrien, MS, MT (ASCP)
Regional Operations Manager
Providence Laboratory Services Oregon Region