Annual Compliance Notice to Providers 2013

ACL laboratories Compliance Guidance to Providers - 2013
Annual Compliance Notice to Providers 2013
The Medicare and Medicaid Programs look to clinical laboratories to provide education to physician
clients regarding medical necessity and laboratory billing compliance. This annual notice specifies current
Medicare requirements and ACL Laboratories policies. Please review the information contained in this
notice and contact Kathy Lindgren, ACL Compliance Officer, at 800-877-7016 ext. 7916, if you have any
questions or concerns.
Lab Ordering Documentation
Physicians and non-physician providers authorized to order clinical laboratory testing must provide to
ACL written or electronic orders that include sufficient information to identify the ordering provider’s
National Provider Identifier (NPI). In addition, the ordering provider must maintain documentation of the
order for 7 years from the date of service. Medical Record documentation may be written or electronic,
must be signed or electronically authorized, and support the specific services ordered for the patient’s
date of service.
Requirements for Diagnostic Information
Physicians and non-physician providers ordering laboratory testing must provide diagnostic information in
the form of ICD-9 codes specific to the ordered test(s) at the time of order. When testing is ordered to
determine or confirm a diagnosis, ICD-9 codes describing signs, symptoms or chief complaints should be
Tests ordered in the absence of confirmed diagnoses, signs, symptoms or complaints are considered
screening. Medicare does not generally pay for tests when ordered as screening, unless the test(s) are
eligible for preventive services coverage. Screening tests not covered by Medicare are the financial
responsibility of the patient.
Medical Necessity
Medicare will only pay for laboratory testing that meets Medicare policy guidelines and is reasonable and
necessary to treat or diagnose an individual patient. Even if a service is medically determined to be
"reasonable and necessary," individual patient coverage may be limited if the service is provided more
frequently than allowed under Medicare coverage policies.
Click here to see a complete list of tests subject to 2013 Medicare coverage policies.
Only tests that meet Medicare coverage policies may be submitted for reimbursement. Individuals who
knowingly cause a false claim to be submitted to Medicare may be subject to sanctions or remedies
available under civil, criminal and administrative law.
To avoid false claim submission, be sure to:
1. Only order testing necessary for diagnosis or treatment. Note that all individual components of a
panel or profile must be necessary for the panel/profile to qualify for Medicare reimbursement.
2. Provide a diagnosis, sign, symptom or complaint specific to each test ordered.
3. Document the necessity of testing in the patient’s medical record.
4. Inform the patient via an ABN when testing does not meet Medicare coverage policies, or is being
ordered more frequently than allowed by policy.
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ACL laboratories Compliance Guidance to Providers - 2013
Preventive Services
Medicare provides reimbursement for specific laboratory tests when all of the following criteria are met:
1. The test is reasonable and necessary for the prevention or early detection of illness,
2. It is recommended by the US Preventive Services Task Force (USPSTF) with a grade of A or B,
3. It is appropriate for individuals entitled to benefits of the Medicare Program.
Click here to see a complete list of tests covered by the Preventive Services program.
In many cases, specific screening ICD-9 codes must be provided with the test order for benefits to apply.
Tests with Preventive Services coverage are subject to frequency edits. Patients should be informed via
an ABN when tests are ordered more frequently than benefits allow.
Advanced Beneficiary Notice of Noncoverage (ABN)
ABN Form CMS-R-131 is to be used to notify a Medicare Fee for Service beneficiary of testing we believe
Medicare will not reimburse. A similar Notice of Noncoverage form is available from ACL for use when
notifying a Medicare Advantage patient of testing we believe will not be reimbursed based on Medicare
coverage policy.
Reasons Medicare and Medicare Advantage Plans may not pay for testing include:
1. The test is subject to a Medicare coverage policy and the diagnosis provided is not included in
the policy (Medicare does not pay for this test for your condition).
2. The test has Preventive Services coverage, or other coverage limitations and is being ordered
more frequently than allowed (Medicare does not pay for this test as often as this).
3. The test has not been deemed effective by Medicare for diagnosis or treatment (Medicare does
not pay for experimental or research use tests)
4. The test does not have Preventive Services coverage and is ordered for routine screening. This
is an optional use of the ABN. (Medicare does not pay for tests when ordered as screening)
When testing is ordered for reasons Medicare will not reimburse, the patient must be allowed to make an
informed consumer decision as to whether to have testing performed and assume financial responsibility
of the costs.
Click here to see Medicare ABN Form CMS-R-131
Click here to see the Medicare Advantage Notice of Noncoverage Form
Although profiles and test combinations offer convenience in ordering, they may also result in the routine
ordering of more tests than necessary to diagnose and treat patients. ACL limits the offering of profiles to
those approved by the American Medical Association (AMA) and those approved by the laboratory’s
pathology medical directors.
Please know what tests are included in the profile you order. To prevent test duplication, do not
separately order individual tests already included in the profile. Also, if every test included in the profile is
not necessary for diagnosis or treatment, order the individual tests needed rather than the profile.
When in doubt as to which tests are included in a profile, please check the ACL Directory of
Services at:
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ACL laboratories Compliance Guidance to Providers - 2013
Reflex and Confirmation Testing
Reflex testing occurs when initial test results are positive or outside normal parameters and general
medical practice indicates a second related test is medically appropriate to confirm or validate the initial
test results.
The ACL Directory of Services identifies reflex and/or confirmation testing under ‘Test Performance’.
When indicated, ACL will bill reflex and confirmation tests as well as the initial test.
CPT Coding and Medicare / Medicaid Reimbursement
ACL Laboratories maintains a directory of services that lists our clinical test menu, test order codes and
CPT codes used to bill third parties. Correct CPT coding can vary by carrier; therefore, the codes
referenced are intended as general guidelines and should not be used without confirming their
appropriateness with applicable payers.
The ACL Directory of Service can be accessed at:
The 2013 Medicare Clinical Laboratory Fee Schedule can be accessed at:
The 2013 Wisconsin Medicaid fee schedule can be accessed at:
The 2013 Illinois Department of Healthcare and Family Services fee schedule can be accessed
Clinical Consultant
ACL Laboratories is affiliated with more than 80 board-certified pathologists in a variety of specialties that
are available to provide technical or consultative services regarding appropriate test use and ordering.
Please call the ACL Client Service department at 800-877-7016 for test assistance.
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ACL laboratories Compliance Guidance to Providers - 2013
Lab Tests with Medicare Specific Diagnosis Coverage
Lab Test Description
CPT Code(s)
Alpha-fetoprotein (AFP, AFET)
Blood Counts (CBCNO, CBCA,
85205, 85207,
85048, 85049
Glucose (GLU, GLUPL)
82947, 82962
Collagen Crosslinks
Digoxin (DIG)
Fecal Occult Blood (IFOB)
Hepatitis Panel (ACUTE)
HIV Screening (HIVSCR)
HIV Quantitative (HIVDNR, HIVQTM)
Prothrombin Time (PTINR)
87535, 87536
80061, 82495,
84778, 83704
83540, 82728,
84443, 84439,
84436, 84479
Iron Studies (FERR, IRON, IRONP,
Thyroid Testing (TSH, TSHR, FT4,
TT4, FT3, TT3)
CA 125 (C125)
CA 15-3/CA 27.29 (CAN153, C2729)
CA 19-9 (CA199)
Urine Culture (URC)
Allergy Testing (RAST)
86003, 86001
Glycated Hemoglobin (GLYH)
Prostate Specific Antigen (PSA)
Circulating Tumor Cell Marker
Assays (CFCCT)
Cytogenetic Studies
PAP Tests
Flow Cytometry
Heavy Metal Testing:
Lead, Lithium
Thallium, Zinc, etc.
Drug Testing, Qualitative
Vitamin D Assays (25VDR, VITD25,
88230 – 88275
88164, 88175
Additional Frequency
Yes, once annually
Yes, once every 3 months and
1 day
Yes, once annually
Yes, annual. More often if
treatment dictates
Yes, once annually
83655, 80178,
84999, 84630
80100, 80101
82306, 82652
Yes, 86003 limited to 24
allergens annually
Yes, once every 24 months
Yes, up to 4 annually
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ACL laboratories Compliance Guidance to Providers - 2013
Lab Tests that have Screening Coverage through Medicare Preventive
Lab Test Description
Covered ICD-9
Screening Codes
Frequency Limitations
Lipid Testing: CHOL, TRIG, HDL
80061, 82465
83718, 84478
82947, 82950
P3000, G0147
V81.0 V81.1 V81.2
Once every 5 years
V77.1 TS
Low risk: V72.31
V76.2 V76.47
High risk: V15.89
One per year
Two per year
Once every 24 months
Primary V73.89
Secondary, as
appropriate V69.8,
V22.0, V22.1,
Not pregnant
V74.5 & V69.8
Pregnant women
V74.5 & V69.8 &
V22.0, V22.1 or
Males & Not
pregnant V74.5
& V69.8 Pregnant
women V74.5 &
V22.0, V22.1 or
V23.9 Pregnant &
at increased risk
V74.5 & V69.8 &
V22.0, V22.1 or
Pregnant women
V73.89 & V22.0,
V22.1 or V23.9
Pregnant & at
increased risk
V73.89 & V69.8 &
V22.0, V22.1 or
One per year
One per year
Glucose Testing: GLU, GLUPL,
PAP Testing
Fecal Occult Blood Testing:
Chlamydia, Gonorrhea
Syphilis Testing
Hepatitis B Surface Antigen
G0328, 82270
G0432, G0433
87491, 87591
86592, 86780
87340, 87341
One per year
One per year
If pregnant, 3 times per
One per year
If pregnant, 2 times per
One per year
One per pregnancy
2 times per pregnancy if at
continued increased risk
One per pregnancy
2 times per pregnancy if at
continued increased risk
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8901 W Lincoln Avenue
West Allis, WI 53227
(888) 719-3569
Patient Name:
Identification Number:
Advance Beneficiary Notice of Noncoverage (ABN)
NOTE: If Medicare doesn’t pay for the Laboratory Test(s) below, you may have to pay.
Medicare does not pay for everything, even some care that you or your health care provider have good
reason to think you need. We expect Medicare may not pay for the Laboratory Test(s) below.
Laboratory Test(s):
Reason Medicare May Not Pay:
☐ Medicare does not pay for these test(s) for your condition
☐ Medicare does not pay for these test(s) as often as this
(denied as too frequent)
☐ Medicare does not pay for experimental or research use
☐ Medicare does not pay for these test(s) when ordered as
routine screening
Read this notice, so you can make an informed decision about your care.
Ask us any questions that you may have after you finish reading.
Choose an option below about whether to receive the Laboratory Test(s) listed above.
Note: If you choose Option 1 or 2, we may help you to use any other insurance that you might
have, but Medicare cannot require us to do this.
Check only one box. We cannot choose a box for you.
☐ OPTION 1. I want the Laboratory Test(s) listed above. You may ask to be paid now, but I
also want Medicare billed for an official decision on payment, which is sent to me on a Medicare
Summary Notice (MSN). I understand that if Medicare doesn’t pay, I am responsible for
payment, but I can appeal to Medicare by following the directions on the MSN. If Medicare
does pay, you will refund any payments I made to you, less co-pays or deductibles.
☐ OPTION 2. I want the Laboratory Test(s) listed above, but do not bill Medicare. You may
ask to be paid now as I am responsible for payment. I cannot appeal if Medicare is not billed.
☐ OPTION 3. I don’t want the Laboratory Test(s) listed above. I understand with this choice I
am not responsible for payment, and I cannot appeal to see if Medicare would pay.
Additional Information: If you choose Option 3, you should notify your doctor who ordered these Laboratory
Test(s) that you did not receive them.
This notice gives our opinion, not an official Medicare decision. If you have other questions on this notice or
Medicare billing, call 1-800-MEDICARE (1-800-633-4227/TTY: 1-877-486-2048).
Signing below means that you have received and understand this notice. You also receive a copy.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
The valid OMB control number for this information collection is 0938-0566. The time required to complete this information collection is estimated to average 7 minutes
per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If
you have comments concerning the accuracy of the time estimate or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA
Reports Clearance Officer, Baltimore, Maryland 21244-1850.
Form CMS-R-131 (03/11)
Form Approved OMB No. 0938-0566
Aurora Health Care, Milwaukee, Wisconsin
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8901 W Lincoln Avenue
West Allis, WI 53227
(888) 719-3569
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