Sunday, June 25, 2017

Example of Proactive Payer Non Coverage: Aetna & Cardiac & Cancer Biomarkers Non Covered

Example of Pro-active NON COVERAGE policy, listed 100+ tests as non covered.

Aetna considers any of the following tests for assessing CHD risk experimental and investigational because their clinical value has not been established:
A.                  Activated factor VII
B.      Adiponectin
C.       Angiotensin gene (CardiaRisk AGT)
D.      Anti-thrombin III
E.       Apelin
F.       Apolipoprotein A-I (apo AI) (Boston Heart HDL Map panel)
G.      Apolipoprotein E (apo E)
H.      Apolipopritein E genotyping
I.         ASCVD risk testing (individual or panel) (eg, c-peptide, islet cell antibodies, nonesterified fatty acids (free fatty acids), proinsulin and total insulin)
J.        B-type natriuretic peptides (see CPB 0618 - Brain Natriuretic Peptide Testing)
K.       Carotid ultrasound screening of asymptomatic persons for carotid artery stenosis
L.       Cathepsin S
M.    Chromosome 9 polymorphism 9p21
N.      Circulating microRNAs (e.g., miR-1, miR-16, miR-26a, miR-27a, and miR-29a, miR-133a, and miR-199a-5p; not an all-inclusive list)
O.      Coenzyme Q10 (CoQ10)
P.       Coronary artery reactivity test
Q.      Cystatin-C
R.      Factor II (thrombin) (F2 gene)
S.       Factor V Leiden (F5 gene)
T.       Fibrinogen
U.      4q25 genotype testing (eg, 4q25-AF Risk Genotype Test, Cardio IQ 4q25-AF Risk Genotype Test)
V.      Galectin-3
W.    Genetic testing  (for genetic testing for familial hypercholesterolemia, see CPB 140 - Genetic Testing)
X.       Growth stimulation expressed gene 2 (ST2)
Y.       HDL subspecies (LpAI, LpAI/AII and/or HDL3 and HDL2)
Z.       Homocysteine testing
AA.  Interleukin 6 (IL-6)
BB.  Interleukin 6 -174 g/c promoter polymorphism
CC.   Interleukin 17 gene polymorphism
DD. Interleukin 18 (IL-18)
EE.   Kinesin-like protein 6 (KLP6)
FF.    LDL gradient gel electrophoresis
GG. LDL subspecies (small and large LDL particles)
HH. Leptin
II.       Lipidomic and metabolomic risk markers
JJ.      Lipoprotein remnants: intermediate density lipoproteins (IDL) and small density lipoproteins
KK.   Lipoprotein(a) (Lp(a)) enzyme immunoassay
LL.    Lipoprotein-associated phospholipase A2 (Lp-PLA2) (PLAC)
MM.            Long chain omega-3 fatty acids composition in red blood cell
NN. LPA Intron-25 genotype testing (eg, Cardio IQ Intron-25 Genotype Test, LPA Intron-25 Genotype Test)
OO. MaxPulse testing
PP.   Measurement of free fatty acids
QQ. Mid-regional pro-atrial natriuretic peptide
RR.   MIRISK VP test
SS.    Myeloperoxidase (MPO)
TT.   NMR Lipoprofile
UU. Osteoprotegerin
VV.  Oxidized phospholipids
WW.           Peroxisome proliferator-activated receptor
XX.   Plasminogen activator inhibitor (PAI–1)
YY.   Pregnancy-associated plasma protein-A (PAPP-A)
ZZ.    Protein C
AAA.            Prothrombin gene mutation testing
BBB.            Receptor for advanced glycosylation end products (RAGE) gene Gly82Ser polymorphism testing
CCC.             Resistin
DDD.           Retinol binding protein 4 (RBP4)
EEE.              Serum sterols (eg, Boston Heart Cholesterol Balance Test)
FFF.Singulex SMC testing for risk of cardiac dysfunction and vascular inflammation (eg, SMC Endothelin, SMC IL-6, SMC IL 17A, SMC c TnI and SMC TNF-α)
GGG.           Skin cholesterol (eg, PREVU)
HHH.           SNP-based testing (eg, Cardiac Healthy Weight DNA Insight, Healthy Woman DNA Insight Test, Heart Health Genetic Test)
III.     Soluble cell adhesion molecules (e.g., intercellular adhesion molecule-1 [ICAM-1], vascular cell adhesion molecule-1 [VCAM-1], E-selectin, and P-selectin)
JJJ.   Thromboxane metabolite(s) testing
KKK.             Tissue plasminogen activator (tPA)
LLL. Toll-like receptor 4 (TLR4) Asp299Gly (rs4986790) polymorphism
MMM.      Transforming growth factor beta
NNN.          Troponin I (eg, PATHFAST cTnI-II)
OOO.          Tumor necrosis factor alpha (TNF-a)
PPP.             Total cholesterol content in red blood cell membranes
QQQ.          Vertical Auto Profile (VAP) with or without vertical lipoprotein particle (VLP) technology
RRR.             Visfatin
SSS.von Willebrand factor antigen level.

Aetna considers each of the following experimental and investigational.  The peer reviewed medical literature does not support these tests as having sufficient sensitivity or specificity necessary to define their clinical role:
1.      CEA used for all other indications including any of the following:
a.                  As a screening test for colorectal cancer; or 
b.      As a sole determinant to treat a colorectal cancer member with adjuvant therapy or systemic therapy for presumed metastatic disease; or
c.       For diagnosis of esophageal carcinoma; or
d.      For screening, diagnosis, staging or routine surveillance of gastric cancer.
2.      AFP for the diagnosis of trophoblastic tumors and oncologic indications other than those listed above.
3.      Assaying for loss of heterozygosity (LOH) on the long arm of chromosome 18 (18q) or deleted in colon cancer (DCC) protein (18q-LOH/DCC) for colorectal cancer
4.      Biomarker Translation (BT) test for breast cancer and other indications
5.      BioSpeciFx, including Comprehensive Tumor Profiling for any indication
6.      BRAF mutation analysis in lung cancer
7.      Breast Cancer Gene Expression Ratio (HOXB13:IL17BR)
8.      CA 125 for all other indications including use as a screening test for colorectal cancer or ovarian cancer (other than as indicated above) or for differential diagnosis of members with symptoms of colonic disease
9.      CA 19-9 for all other indications including breast, colorectal, esophageal, gastro-esophageal, liver, or uterine cancer; pancreatic pseudocyst; screening persons with primary sclerosing cholangiitis without signs or symptoms of cholangiocarcinoma; or screening persons with primary sclerosing cholangitis for development of cholangiocarcinoma.
10.  Carcinoembryonic antigen cell adhesion molecule 6 (CEACAM6) (e.g., Benign Diagnostics Risk Test) for breast atypical hyperplasia and for predicting the risk of breast cancer.
11.  Carcinoembryonic antigen cellular adhesion molecule-7 (CEACAM-7) expression as a predictive marker for rectal cancer recurrence
12.  Caris Target Now Molecular Profiling Test
13.  CDX2 as a prognostic biomarker for colon cancer
14.  CEA, Cyfra21-1 (a cytokeratin 19 fragment), p53, squamous cell carcinoma antigen (SCC-Ag) and vascular endothelial growth factor C (VEGF-C) for diagnosis of esophageal carcinoma
15.  Circulating cell-free nucleic acids in colorectal cancer
16.  Circulating tumor cell (CTC) assays (e.g., CellSearch assay) for all indications, including, but not limited to metastatic breast, colorectal, melanoma, and prostate cancers
17.  CK5, CK14, p63, and Racemase P504S testing for prostate cancer
18.  c-Met expression for predicting prognosis in persons with advanced NSCLC and colorectal cancer, and other indications
19.  Cofilin (CFL1) as a prognostic and drug resistance marker in non-small cell lung cancer
20.  ColonSentry test for screening of colorectal cancer
21.  ColoPrint, CIMP, LINE-1 hypomethylation, and Immune cells for colon cancer
22.  Colorectal Cancer DSA (Almac Diagnostics, Craigavon, UK)
23.  ConfirmMDx for prostate cancer
24.  CxBladder test for bladder cancer
25.  Cyclin D1 and FADD (Fas-associated protein with death domain) for head and neck squamous cell carcinoma
26.  Decipher test (a RNA biomarkers assay) for prostate cancer
27.  Decision DX-Melanoma (Castle Biosciences, Phoenix, AZ)
28.  DCIS Recurrence Score
29.  Des-gamma-carboxy prothrombin (DCP) (also known as "prothrombin produced by vitamin K absence or antagonism II" [PIVKA II]) for diagnosing and monitoring hepatocellular carcinoma (HCC) and other indications
30.  EarlyCDT-Lung test
31.  EGFR gene expression analysis for transitional (urothelial) cell cancer
32.  EGFRVIII for glioblastoma multiforme
33.  EML4-ALK as a diagnostic tool for stage IV non-small-cell lung cancer
34.  Estrogen and progesterone receptors when used alone to assign a member with breast cancer to prognostic groupings since they are relatively weak predictors of long-term relapse and breast cancer related mortality rates
35.  Excision repair cross-complementation group 1 protein (ERCC1) for persons with NSCLC, colon or with gastric cancer who are being considered for treatment with platinum-based chemotherapy, and other indications
36.  Fibrin/fibrinogen degradation products (FDP) test (e.g., DR-70 or Onko-Sure) for colorectal cancer
37.  FoundationOne and FoundationOne Heme
38.  Galectin-3 for prostate cancer
39.  Gene hypermethylation for prostate cancer
40.  GeneKey (GeneKey Corp., Boston, MA)
41.  GeneSearch Breast Lymph Node (BLN) assay
42.  Glutathione-S-transferase P1 (GSTP1) for screening, detection and management of prostate cancer
43.  Guanylyl cyclase c (GCC or GUCY2C) (e.g., Previstage GCC Colorectal Cancer State Test) for colorectal cancer
44.  Guardant360
45.  HER2 testing of appendiceal cancer
46.  HERmark testing for breast cancer and other indications
47.  HMGB1 and RAGE in cutaneous malignancy (e.g., basal cell carcinoma, melanoma, and squamous cell carcinoma)
48.  Human epididymis protein 4 (HE4) (e.g., Elecsys HE4 assay) for endometrial cancer, ovarian cancer, or evaluation of pelvic mass, including to assist in the determination of referral for surgery to a gynecologic oncologist or general surgery, and for other indications
49.  IHC4 (e.g., NexCourse IHC4 by AQUA Technology) for breast cancer
50.  Insight DX Breast Cancer Profile
51.  Ki67 for breast cancer
52.  Ki-67 in upper tract urinary carcinoma
53.  4Kscore
54.  Lectin-reactive alpha-fetoprotein (AFP-L3) for liver cancer
55.  Liquid biopsy (e.g., CancerIntercept, GeneStrat, FoundationACT) for any indication, including, but not limited to, breast cancer, colorectal cancer, lung cancer, melanoma, or ovarian cancer. 
56.  Long non-coding RNA in gallbladder cancer
57.  Mammaprint
58.  Mammostrat
59.  Mass spectrometry-based proteomic profiling (e.g., Xpresys Lung) for indeterminate pulmonary nodules
60.  Microarray-based gene expression profile testing using the MyPRS test for multiple myeloma
61.  Micro-RNAs (miRNAs) miRview mets and miRview mets2 (Rosetta Genomics Laboratories, Philadelphia, PA; Rosetta Genomics Ltd., Rehovot, Israel)
62.  MLH1 tumor promoter hypermethylation for endometrial cancer
63.  Molecular Intelligence Services, including MI Profile and MI Profile PLUS (formerly Target Now Molecualr Profiling Test, including Target Now Select and Target Now Comprehensive)
64.  Molecular subtyping profile (e.g., BluePrint) for breast cancer
65.  MUC1 in gastric cancer
66.  Mucin 4 expression as a predictor of survival in colorectal cancer
67.  Mucin 5AC (MUC5AC) as serum marker for biliary tract cancer
68.  My Prognostic Risk Signature (MyPRS) (Signal Genetics LLC, New York, NY)
69.  NRAS mutation for selecting persons with metastatic colorectal cancer who may benefit from anti-VEGF antibody bevacizumab; to predict disease prognosis and select persons with melanoma who may benefit from tyrosine kinase inhibitor therapies, and other indications
70.  OncoVantage
71.  OVA1 test
72.  OvaCheck test
73.  OvaSure
74.  OncInsights (Intervention Insights, Grand Rapids, MI)
75.  p16 protein expression as a prognostic marker in non-oropharyngeal squamous cell carcinoma (cancer of the oral cavity, hypopharynx, or larynx)
76.  Pathwork Tissue of Origin test
77.  Perceptua Bronchial Genomic Classifier
78.  Phosphatidylinositol-4,5-bisphosphonate 3-kinase, catalytic subunit alpha polypeptide gene (PIK3CA) for predicting disease prognosis and selecting individuals with metastatic colorectal cancer who are being considered for treatment with EGFR antagonists cetuximab and panitumumab, and other indications
79.  PreOvar test for the KRAS-variant to determine ovarian cancer risk
80.  Prolaris for prostate cancer
81.  ProOnc TumorSourceDx test (Prometheus Laboratories, San Diego, CA) to identify tissue or origin for metastatic tumor
82.  Prostate core mitotic test
83.  Prostate Px and Post-Op Px for predicting recurence of prostate cancer
84.  Proveri prostate cancer assay (PPCA)
85.  PSA for screening women with breast cancer or for differentiating benign from malignant breast masses
86.  PTEN gene expression for non-small cell lung cancer
87.  Ras oncogenes (except KRAS and BRAF)
88.  ResponseDx Colon
89.  Ribonucleotide reductase subunit M1 (RRM1) for persons with NSCLC who are being considered for treatment with gemcitabine-based chemotherapy, and other indications
90.  ROMA (Risk of Ovarian Malignancy Algorithm) for ovarian cancer
91.  Rotterdam Signature 76-gene panel
92.  Serum amyloid A as a biomarker for endometrial endometrioid carcinoma to monitor disease recurrence and rtargetesponse to therapy
93.  TargetPrint gene expression test for evaluation of estrogen receptor, progesterone receptor, and HER2receptor status in breast cancer
94.  The 41-gene signature assay
95.  Theros CancerType ID (bioTheranostics Inc., San Diego, CA)
96.  Thymidylate synthase
97.  TMPRSS fusion genes for prostate cancer
98.  Topographic genotyping (Pancragen (formerly PathFinderTG))
99.  Total (whole) gene sequencing for cancer
100.                                        TP53 mutation analysis for ovarian cancer
101.                                        UroCor cytology panels (DD23 and P53) for bladder cancer
102.                                        Vascular Endothelial Growth Factor (VEGF)
103.                                        Vascular endothelial growth factor receptor 2 (VEGFR2) expression for identifying persons with colorectal cancer that is likely to respond to VEGF inhibition, and other indications
104.                                        Any of the following circulating tumor markers also is considered experimental and investigational for screening asymptomatic subjects for cancer, diagnosis, staging, routine surveillance of cancer and monitoring the response to treatment:
Cathepsin-D, Cathepsin-L
Motility-related protein (MRP)
Cyclin E (fragments or whole length)
Multidrug resistance glycoprotein (Mdr1)
Murine double minute 2 (MDM2)
Early prostate cancer antigen (EPCA)
Guanylyl cyclase C (Previstage GCC molecular test)
p53 (TP53)
Thrombospondin-1 (THBS-1)
PCA3 (DD3) / UpM3
Thymosin B15
Human kallikrein 2 (HK2)
Prostate stem cell antigen (PSCA)
Topoisomerase II Alpha (TOP2A)
M 26
Thymosin B15
M 29
Nuclear Matrix Protein 66 (NMP66)
Anti-malignin antibody screen (AMAS) test