Thursday, August 10, 2017

The Quirky World of Clinical Chemistry Panel Pricing

CMS has quirky rules for pricing clinical chemistry test panels, and ACLA and NILA have challenged the agency that these rules are over-ridden by new law under PAMA (here).  For an overview of the panel policy system, here.   This blog is a deep dive into the inside workings of the special code and pricing levels themselves.

Tests Never Overpay the Panel Price Cap
The result of the rules is that CMS never pays more for components of a panel than it would pay for the whole panel.  For example, if a panel has 8 components, they might be priced at $10 each, but the whole panel is priced at just $15.   And, you only do 7 of the panel tests, they won't be paid 7x$10=$70 - rather, they won't be paid more than $15 which is the panel price cap.

Complicated Rules
The way CMS gets to this result is actually more complex and involves the creation of 18 phantom automatic test panel codes and prices, which exist down at the bottom of the CLFS fee schedule, but are never used on claims.   These codes, called ATP codes, set the price for all the individual tests that are found on clinical chemistry panels, and the prices have nothing to do with the fee schedules prices of the single components (which might be between $5 and $15 or higher for which analyte). For an overview of the ATP and panel system, here.

For example, a panel of 5 tests is priced at ATP05 for $10.73.   If there were an AMA CPT panel of six tests and only 5 of the tests were medically necessary, it would be the same as a panel of 5 tests: ATP05 $10.73.   If AMA made up a new clinical chemistry panel tomorrow, and it had 5 tests, it would price at ATP05 $10.73.

Here are the rules as I understand them:

1.  Pay only for medically necessary tests.  If a panel has 10 tests which individually add up to $100, and all ten are medically necessary, pay the ATP10 at $11.91.   If only 7 tests are medically necessary, CMS has a predetermined price waiting for you, ATP07 at $11.21.

2.  Never double pay for the same test.  A doctor orders Panel with 10 tests and another Panel B with 5 tests, but CMS knows that 3 of the analytes overlap.  CMS will pay the phantom price ATP12 or $12.39 (10 tests + 5 tests - 3 overlapping tests = 12 tests).

3.  Because codes are crosswalked to ATP prices, rather than single test prices, parts of a panel can never be higher than the whole panel. 

Quirky Fee Schedule for ATP's
The actual ATP prices are somewhat quirky.  [Screen shot at bottom.]  For example, ATP09 and APT10 are the same price, $11.91.  Some ATPs are for multiple tests - ATP16 is for anywhere from 13-16 tests at one price: $14.49.   THere is no ATP13, 14, or 15, only ATP16.  There is a code for ATP22, 22+ tests, and a code for ATP23, 23+ tests, which are the same price, $16.64.

What's the Price Increment for One More Test?
The delta from level to level in the ATP codes is variable.  [Screen shot at bottom.] Rising from 5 to 6 tests (ATP05 to ATP06) raises you from $10.73 to $10.76, or plus three cents.   But from 6 to 7 tests rises from $10.76 to $11.21, or plus 45 cents.  Generally, each new test adds between 20 and 50 cents, but not always.  Remember, that as individual analytes, the additional test might have been coded and priced at $10 or more.

MAC Variation
There are some variation among MACs.  For example, Washington State pays exactly $8.76 from ATP03 up to ATP12, regardless of level, whereas the national price ramps up from $9.12 to $12.39 over the same range.   Washington State catches up and pays the national limit for ATP22 and ATP23.
Adjacent state Idaho seems to have only one price discrepant from the national rate (ATP02 at $4.33), while nearby Oregon rates are the same except as national price except at three upper payment levels (ATP20, 21, 22).

NLA and "Midpoint"
The fee schedule has no "floor" for ATP prices, and the national limit or NLA is usually the price.  However, the fee schedule continues to have a column called the "national mid point" price which runs about $5 higher than the NLA.  This column does nothing today, but it's apparently a ghostly relic of a time when some carriers had substantially higher prices than the current NLA.

Excel spreadsheet in the cloud here.

Screen shot below (click to enlarge).


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I have three blogs on this topic.
Overview of Chemistry Panel Policy (July 26), here.
    Even Nerdier Deep Diving into Panel Pricing and ATP Codes (August 10), here.
NILA and ACLA Statements re PAMA and Panel Pricing (August 10), here.


Thursday, July 27, 2017

2015 Speech on Healthcare Global Budgeting by Patrick Conway MD, CMS/CMMI

On December 18, 2015, Patrick Conway gave a talk and interview at Johns Hopkins School of Public Health on global budget (DRG, bundling, future payment models, etc) for healthcare.

He was interviewed by Dr. David Chin.   The one-hour Youtube video is here:



An unofficial transcript is in the cloud, here.

I noted that in several of the speeches archived with transcripts on this page, Dr. Conways notes that it's been very hard to get CMMI demo programs certified by the CMS Actuary as statistically valid and cost-savings, an endorsement that would allow each demonstration's expansion to broader populations.

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See another, a one hour presentation by Dr Conway, Christiana Care, transcript and Youtube link in the cloud, here.

See another, a 35 minute presentation at NASI, by Dr Conway, transcript and Youtube link in the cloud, here.

See another, a 20 minute presentation for Patient Safety Movement, may be 2017, transcript and Youtube link in the cloud, here.

Video online at Youtube, 8 minutes, CMMI staff talk about "Their Mission."  Youtube, Here.   Transcrip in the cloud, here.

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Archive (as of July 2017) of 120 project reports at CMMI, collated into one document with hotlinks to each.

Includes table of CMMI telehealth-containing projects.  In the cloud, here.  

Friday, July 21, 2017

Feedlink for Blog Readers & Daily Email Signup for Discoveries in Health Policy

We've set up a basic FEEDBURNER website that facilitates enrollment in this blog in your own blog aggregator aka blog reader.  

FEEDBURNER also has a no-frills little box where you can sign up for an automated, once-daily email delivery of new posts.

Click HERE.  
You should see this screen:


http://feeds.feedburner.com/discoveriesinhealthpolicy/tmVH

With some blog readers, you should also be able to add our feed just by searching for "discoveries in health policy."  The blog reader I use on both web and phone is Feedly.

To be continued - We're working on a more sophisticated system that will provide an option for once-a-week updates.


Thursday, July 20, 2017

Feedburner Link for Discoveries in Health Policy

This leads to a basic Feedburner home page for Discoveries in Health Policy:

http://feeds.feedburner.com/discoveriesinhealthpolicy/tmVH

http://feeds.feedburner.com/discoveriesinhealthpolicy/tmVH

At the home page, this link remains the browser bar address.

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Alternate

http://feeds.feedburner.com/discoveriesinhealthpolicy/DYVg

http://feeds.feedburner.com/discoveriesinhealthpolicy/DYVg


Saturday, July 1, 2017

FireNewsFeed Aggregator

I don't recall ever hearing about FIRENEWSFEED.

It seems to be a very simple interface that aggregates headline stories from maybe 50 sources and compiles them into about 10 categories.

Find it here:
http://firenewsfeed.com/


For an example of the TECH aggregator:
http://firenewsfeed.com/technology


For an example of the Source/BusinessInsider aggregator:
http://firenewsfeed.com/source/4





FireNewsFeed doesn't seem to have any "About" homepage and it's hard to find any news about the website itself on the web.   Interesting.  Very clean and simple.  There doesn't seem to be an Iphone app but you could probably just bookmark the website homepage (as listed above).


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:
 
a2-PAG
CA-SCC
MAM-6
TAG12
AMACR
Cathepsin-D, Cathepsin-L
Motility-related protein (MRP)
TAG72
Bcl-2
Cyclin E (fragments or whole length)
Multidrug resistance glycoprotein (Mdr1)
TAG72.3
BCM
DU-PAN-2
Murine double minute 2 (MDM2)
TAG72.5
CA195
Early prostate cancer antigen (EPCA)
NSE
TATI
CA242
Guanylyl cyclase C (Previstage GCC molecular test)
p53 (TP53)
Thrombospondin-1 (THBS-1)
CA50
Hepsin
PCA3 (DD3) / UpM3
Thymosin B15
CA549
Human kallikrein 2 (HK2)
PNA/ELLA
TNF-a
CA72-4
LASA
Prostate stem cell antigen (PSCA)
Topoisomerase II Alpha (TOP2A)
CAM17-1
LPA
SCC
TPA
CAM26
M 26
SLEX
Thymosin B15
CAM29
M 29
SPAN-1
Nuclear Matrix Protein 66 (NMP66)
CAR-3
MSA
SLX
Anti-malignin antibody screen (AMAS) test
CYFRA21-1
MCA
ST-439


B