Annual Notice to Physicians

23 August 2016
 
Dear ALI Client:
 
The Office of the Inspector General (OIG), in its Guidance for Clinical Laboratories, believes that labs are in a unique position to be able to educate their clients by providing annual written notice with the following important information:
 
  • Organ or disease related panels will only be paid when all components are medically necessary;
  • The OIG takes the position that an individual who knowingly causes a false claim to be submitted may be subject to sanctions or remedies available under civil, criminal, and administrative law;
  • Medicaid reimbursement amounts will be equal to or less than the amount of Medicare reimbursement.  A link to the 2016 Clinical Laboratory Fee Schedule (in both CSV and Excel formats) can be found by visiting this URL:
 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/index.html
 
  • Using a customized profile may result in the ordering of tests which are not reasonable or necessary and will not be covered by Medicare;
  • Medicare coverage is limited to items and services that are reasonable and necessary for the diagnosis or treatment of an illness or injury and are within the scope of a Medicare benefit category. National coverage determinations (NCDs) are made through an evidence-based process, with opportunities for public participation. In the absence of a national coverage policy, an item or service may be covered based on a local coverage determination (LCD).  All test orders that do not satisfy NCD or LCD medical necessity guidelines must be accompanied by a properly executed Advance Beneficiary Notice (ABN).  Links to the current National and Local Coverage Determinations can be found at the following websites:
 
Lab National Coverage Determinations (NCDs) Alphabetical Index:
https://www.cms.gov/medicare-coverage-database/indexes/lab-ncd-index.aspx
 
Lab Local Coverage Determinations (LCDs) Alphabetical Index (enter as a guest doing business in Maine/select Medical Policy & Review/Medical Policy Center/View a list of active LCDs for your region):https://ngsmedicare.com/ngs/portal/ngsmedicare/

  • Federal law requires that a clinical consultant be available in all clinical laboratories.  If you have any questions regarding the appropriate choice of lab tests or need consultation, please call Orin W. Buetens, MD, ALI Medical Director at (207) 973-7617. 
 
Should you have any questions or need additional information regarding lab testing, please call Paula Thomas, ALI Clinical Support Coordinator, at (207) 949-3603.  For compliance questions or concerns, please call me at (207) 973-7649. 
 
Kind regards,
 
Susan P. Martin, MSM, CHC
Chief Compliance Officer – AHS

Medicare National Coverage Determinations (NCD) and Applicable ALI Test Options
NCD ALI Test
Alpha-fetoprotein AFP
Blood Counts CBC
HM
HGB
HCT
PLT
WBC
Blood Glucose Testing GLU
Carcinoembryonic Antigen CEA
Collagen Crosslinks, any Method NTX
Digoxin Therapeutic Drug Assay DIGO
Fecal Occult Blood Test Occult Blood
Gamma Glutamyl Transferase GGT
Glycated Hemoglobin/Glycated Protein HGBAG
Hepatitis Panel/Acute Hepatitis Panel HEP 1
Human Chorionic Gonadotropin BHGC
Human Immunodeficiency Virus (HIV) Testing (Diagnosis) HIV  
Human Immunodeficiency Virus (HIV) Testing (Prognosis Including Monitoring) HIVPCRQ
Lipid Testing HDL 2
CHOL
HDL
LDL
TRIG
Partial Thromboplastin Time (PTT) PTT
Prostate Specific Antigen PSA
Prothrombin Time (PT) PT/INR
Serum Iron Studies IRON
FERR
TRNSF
BLOCK 3
Thyroid Testing TSH
T3 or T4 update
T4
T4, free
Tumor Antigen by Immunoassay - CA 125 CA125
Tumor Antigen by Immunoassay - CA 15-3/CA 27.29 CA153
CA 27 29
Tumor Antigen by Immunoassay - CA 19-9 CA199
Urine Culture, Bacterial C URINE
UA-REFLEX
   
Medicare Local Coverage Determinations (LCD) and Applicable ALI Test Options
LCD ALI Test
B-type Natriuretic Peptide (BNP) Testing PROBNP
RAST Type Tests IGE
Allergy testing
Urine Drug Testing (as of 12/01/15) UDR
Vitamin D Assay Testing VIT D 25