Jurisdiction 9 Review to Finalization Timelines for LCDs

LCD	Title	Comment Open	Comment End	Status*		Days in review
DL34217	Intensity Modulated Radiation Therapy (IMRT)	2/4/2016	4/10/2016	NRTF	N/A	381
DL36696	Hyperbaric Oxygen (HBO) Therapy	6/2/2016	8/8/2016	NRTF	N/A	261
DL36698	Intraoperative Neurophysiological Testing	6/2/2016	8/8/2016	NRTF	N/A	261
DL34213	Diagnostic and Therapeutic Colonoscopy	10/6/2016	12/15/2016	NRTF	N/A	132
DL34317	Chest X-Ray Policy	10/6/2016	12/15/2016	NRTF	N/A	132
DL34324	Cardiovascular Stress Testing, Including Exercise and/or Pharmacological Stress and Stress Echocardiography	10/6/2016	12/15/2016	NRTF	N/A	132
DL36864	GlycoMark Testing for Glycemic Control	10/6/2016	12/15/2016	NRTF	N/A	132
DL36846	Measurement of Salivary Hormones	10/6/2016	12/15/2016	NRTF	N/A	132
DL34203	Cataract Surgery in Adults	2/8/2017	4/10/2017	NRTF	N/A	16
DL37120	4Kscore Assay	2/8/2017	4/10/2017	NRTF	N/A	16
DL37066	Coenzyme Q10 (CoQ10)	2/8/2017	4/10/2017	NRTF	N/A	16
DL37060	MolDX: Vita Risk™ Pharmacogenetic Test for Dry Age-related Macular Degeneration (AMD)	2/8/2017	4/10/2017	NRTF	N/A	16
DL37090	MolDX: VectraDA, a Multibiomarker Disease Activity Test for Rheumatoid Arthritis (RA)	2/8/2017	4/10/2017	NRTF	N/A	16
DL37054	MolDX: Xpresys Lung	2/8/2017	4/10/2017	NRTF	N/A	16
DL37086	Repetitive Transcranial Magnetic Stimulation (rTMS) in Adults with Treatment Resistant Major Depressive Disorder	2/8/2017	4/10/2017	NRTF	N/A	16
DL35163	Plastic Surgery	2/8/2017	4/10/2017	NRTF	N/A	16
DL37080	MolDX: Prolaris™ Prostate Cancer Genomic Assay for Men with Favorable Intermediate Risk Disease	2/8/2017	4/10/2017	NRTF	N/A	16
DL37101	MolDX: Comprehensive Genomic Profiling to Guide Treatment in Patients with Advanced Primary Peritoneal, Fallopian Tube and Ovarian Cancer	2/8/2017	4/10/2017	NRTF	N/A	16
DL37114	Visual Electrophysiology Testing	2/8/2017	4/10/2017	NRTF	N/A	16
DL37105	MolDX: Comprehensive Genomic Profiling to Guide Treatment in Patients with Metastatic Colorectal Cancer	2/8/2017	4/10/2017	NRTF	N/A	16
DL37070	MolDX: DecisionDx-UM (Uveal Melanoma)	2/8/2017	4/10/2017	NRTF	N/A	16
DL37109	MolDX: Comprehensive Genomic Profiling to Guide Treatment in Patients with Metastatic Melanoma	2/8/2017	4/10/2017	NRTF	N/A	16
DL36704	MolDX- CDD: ProMark Risk Score	6/2/2016	8/8/2016	RTF	N/A	221
DL36886	MolDX-CDD: Percepta© Bronchial Genomic Classifier	10/6/2016	12/15/2016	RTF	N/A	92
DL34218	Injections - Tendon, Ligament, Ganglion Cyst, Tunnel Syndromes and Morton's Neuroma	10/6/2016	12/15/2016	RTF	N/A	92
DL34211	Trigger Point Injections	10/6/2016	12/15/2016	RTF	N/A	92
DL36882	MolDX: APC and MUTYH Gene Testing	10/6/2016	12/15/2016	RTF	N/A	92
DL36941	MolDX - CDD: Oncotype DX® Breast Cancer for DCIS (Genomic Health ™)	10/6/2016	12/30/2016	RTF	L	77

*NRTF _ Not released to final.   RTF_ Released to final

MolDX Tier 2 pricing as of April 2017

http://www.palmettogba.com/palmetto/moldx.nsf/docscat/MolDx%20Website~MolDx~Browse%20By%20Topic~General~2016%20MoPath%20Tier%202%20Fee%20Schedule%20(M00005%20V9)


Captured 4/2017.

2016 MoPath Tier 2 Fee Schedule (M00005, V9)

As per Change Request (CR) 9465, CMS released the 2016 clinical laboratory fee schedule for tests reported with Tier 1 CPT codes. The table below lists the fees established for Tier 2 covered tests. Please note the genes are sorted by CPT code and then by alpha per gene. In Tier 2 codes multiple genes are listed under a single code. The required identifier assigned and submitted with each test enables MolDX to apply the appropriate fee for the specific test performed.  

HCPCS Code	Descriptor	Allowed
81400	ACE, idv	$82.58
81400	F13B, V34L	$64.52
81400	F2, 1199G>A	$70.20
81400	F5, HR2	$58.84
81400	F7,  R353Q	$64.52
81400	FGB,  -455G>A	$70.20
81400	HPA, antigen ea	$46.46
81400	IL28B, rs12979860	$55.23
81400	SERPINE1, 4G	$58.84
81401	ABL1, T315I	$153.01
81401	CYFB_MYH11, cv	$138.82
81401	CCND1_IGH, ta majbp qual qual	$93.94
81401	E2A_PBX1, ta qual quan,	$105.30
81401	EML4_ALK, ta or ia	$128.48
81401	ETV6_RUNX1, ta qual quan	$90.31
81401	EWSR1_ERG, ta qual quan	$151.42
81401	EWSR1_FLI1, ta qual quan	$162.85
81401	EWSR1_WT1, ta qual quan	$203.84
81401	F11, cv	$75.88
81401	FIP1L1_PDGFR, qual quan	$90.82
81401	FOXO1_PAX3, ta, qual quan	$120.75
81401	FOXO1_PAX7, ta, qual quan	$120.75
81401	IGH/BCL2, sbp	$123.36
81401	MUTYH, cv	$105.81
81401	PAX8_PPARG, ta	$54.19
81401	RUNX1_RUNX1T1, ta qual quan	$106.05
81401	TPMT, cv	$111.61
81401	TYMS, trv	$169.10
81401	VWF, cv (2N)	$278.18
81402	IGH_BCL2 majbp & mcr bp	$123.36
81402	KIT, cv	$98.13
81403	CEBPA, fgs	$235.54
81403	EPCAM, kfv	$93.94
81403	F8, intron 1 and 22a	$81.05
81403	IDH1, exon 4	$67.70
81403	IDH1_ IDH2, exon 4 panel	135.40
81403	IDH2, exon 4	$67.70
81403	JAK2, exon 12 and 13	$109.14
81403	MUTYH, kfv	$93.94
81403	RET, kfv	$93.94
81403	VHL , dup_del	$83.60
81403	VWF, tsa	$300.03
81404	CDKN2A, fgs	$373.14
81404	KIT, tga	$213.47
81404	NRAS, exon 1, 2	$148.04
81404	PDGFRA, tsa	$111.44
81404	PRSS1, fgs	$248.76
81404	RET, cv	$94.97
81404	VHL, fgs	$639.96
81405	MEN1, fgs	$426.32
81405	RET, tsa	$379.47
81405	VWF, tsa 2N	$278.18
81406	RET, fgs	$384.51

Sidebar: AMA CPT from Method Stack Coding to Coding by Gene Name

The Transition for Method-Based Stack Codes to Gene-Specific Codes

(This entry is a side-bar to a blog on CMS pricing of BRCA codes, here.)

Between the 1990s and 2013, the AMA provided a "method based" code set for human genetic testing.   This involved a small number of codes that described lab steps, such as DNA extraction and DNA amplication, typically paying about $20 each.   For example, a particular genetic analysis might be billed as "DNA extraction x 1, $20" and "DNA amplification x 10, $200."   During part of this period, I worked as a regional CMS medical director and later, in 2008, HHS asked me to write a white paper on the coding system and suggest pathways for improvement.  This was based on HHS's annoyance that the CPT coding system, through 2008, was inadequate and did not seem to be changing.  As of March 2017, the Quinn 2008 white paper was still online at HHS (here).

Beginning at the AMA CPT editorial panel meeting in Los Angeles in October 2010, AMA began producing the multi-hundred gene code set which we use today.  The code set published for the 2012 AMA CPT, but was not adopted for use by CMS until January 2013, due to disputes about pricing methods.   In CY 2013, the genetic codes were gapfilled by CMS MACs, a cumbersome and slow process.   Commercial claims processing was also delayed in 2013, since the codes were active but there was no reference CMS fee schedule for pricing.  Countless US insurers had to set up de novo prices without the crutch of a public CMS fee schedule.

Informal Draft White Paper on Digital Genomics

March 2017 version of a draft white paper on digital genomics is in the cloud, here.

Informal Notes from Advamed's March 2017 Digital Health Conference in SF

Meeting notes are posted:  Here.


Advamed
March 2, 2017
San Francisco
Digital Health Conference



.

2017-02-23: ImmunoOncology Overview; La Jolla Oncology Economics Summit

DECK
   Here.

ZIP FILES OF OPEN ACCESS INFORMATION

   News Articles: here.
   Open Access Reviews: here.

LINKS USED IN DECK

Blockbuster drugs will reach $34B (4/2016) here.
Merck soars, BMS tumbles (8/2016) here.

Google: Immunotherapy + Cancer (7.6M hits, 2/2017), here.
     Google News:  here.
PBS NewsHour, Cancer Immunotherapy (2/2017), here.
ImmunoOncology CME, here.

Keytruda homepage, here.

Early History Immuno-Oncology
  William Coley wikipedia, here.   Book, Commotion in the Blood, here.
    BCG modern treatment for bladder cancer, here.

Medpage: Immunotherapy Tops Cancer Advances (2/2017), here.
ASCO Clinical Cancer Advances 2017: Burstein et al; Webpage here, article here.

Her2 Book (Bazell, 1998), here.   Her2 Movie, "Living Proof," here.

Dendreon company, Provenge, Wikipedia, here.

Engineering Therapeutic T Cells, Esensten, 2017, Ann Rev Pathology (subscription), here.
The Checkpoint Immunotherapy Revolution, Alexander, 2016, P&T (open access), here.
Illustrations of Cancer Cell, T Cell: From Burstein (above).

NCCN launches PDL1 harmonization study: subscription articles here, here.
Zip file of news articles: here.

Mutational burden: Final common pathway, Tran et al., 2017, subscription, here.

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