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CDNA

CareDx

$3.55

-0.21 (-5.59%)

13:07
10/03/16
10/03
13:07
10/03/16
13:07

CareDx calls for reversal of reimbursement cut to diagnostic test

CareDx said this morning it is calling for a reversal of a decision by the Centers for Medicare & Medicaid Services to reduce reimbursement for its diagnostic test AlloMap -- the only FDA-cleared blood test to monitor heart transplant patients for rejection, and the only alternative to more costly and invasive biopsies, according to the company. "This decision is unwise, unfair, and misaligned with President Obama's Precision Medicine Initiative," remarked CEO Peter Maag, who called on CMS to reconsider and reverse its proposed 32% decrease in reimbursement -- from $2,821 to $1,920.93. Maag expressed confidence that CMS will reconsider the decision, saying, "The transplant community of providers, patients, and caregivers will continue to engage with CMS during the reconsideration process." If left unchanged, the new rate would take effect as of January 1, 2017. "This process is only being used due to the delay in implementation of PAMA, where this type of reduction in reimbursement would not be permitted... AlloMap is used in the vast majority of heart transplant centers nationwide, with more than 75,000 commercial tests performed to date. During this time CareDx has never increased the price of AlloMap. CareDx has continued to further invest in improvements of the technology and new transplant services despite not having made a profit on AlloMap," the company added.

  • 15

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CDNA CareDx
$3.55

-0.21 (-5.59%)

06/13/16
LEER
06/13/16
NO CHANGE
LEER
CMS price proposals for diagnostic tests a negative for most, says Leerink
Leerink analyst Dan Leonard expects several diagnostics stocks to underperform following proposed price cuts or low initial reimbursement rates by the Centers for Medicare and Medicaid Services, or CMS, for diagnostic tests. If finalized, the preliminary pricing would negatively impact CareDx (CDNA), Veracyte (VCYT), and InVitae (NVTA), the analyst tells investors in a research note, adding that he also sees an indirect negative read-through for Illumina (ILMN).
06/13/16
CANT
06/13/16
NO CHANGE
Target $13
CANT
Buy
Cantor sees 'flawed methodology' with new CMS rates
Cantor Fitzgerald analyst Bryan Brokmeier says shares of Veracyte (VCYT) may be under pressure this morning following Friday's release of a proposed gapfill Medicare reimbursement rate reduction on the company's Afirma GEC. Along with the 30% reduction on Afirma's GEC, the release from the Centers for Medicare and Medicaid Services resets rates on 15 other molecular diagnostic tests, including reductions in CareDx's (CNDA) AlloMap, which is down 74%, Genomic Health's (GHDX) Oncotype Dx Colon, which is down 73%, and Rosetta Genomics' (ROSG) Cancer Origin Test, which is down 57%, Brokmeier tells investors in a research note. The analyst, however, believes the preliminary proposed gapfill rate is based on a "flawed methodology" because it is the median proposed rate submitted by all Medicare Administrative Contractors, including those that have little or no experience administering claims on these tests, Brokmeier contends. He points out that Medicare represents approximately 20% of Afirma GEC test volume for Veracyte. Based on 2015 volume, the 30% Medicare rate reduction for Afirma would reduce total revenues by $3.7M or 7.5%, he adds. The analyst keeps a Buy rating on Veracyte with a $13 price target.
06/20/16
PIPR
06/20/16
NO CHANGE
PIPR
Final PAMA rule better than expected, says Piper Jaffray
Piper Jaffray analyst William Quirk says the final Protecting Access to Medicare Act published Friday by Centers for Medicare & Medicaid Services is better than expected. PAMA is delayed until 2018 from 2017 as expected, Quirk tells investors in a research note. Hospital labs will be required to submit private payer rates to CMS, a positive relative to prior expectations, the analyst notes. He views the decision as beneficial for Quest Diagnostics (DGX) and LabCorp (LH). Further, CMS will require labs to submit only in-network rates and out-of-network "final" rates, which is a positive for specialty labs who have in-network rates at or above Medicare including CareDx (CDNA), Genomic Health (GHDX), Myriad Genetics (MYGN), Oxford Immunotec (OXFD) and Veracyte (VCYT), Quirk writes.
07/07/16
PIPR
07/07/16
NO CHANGE
PIPR
New FDA recommendation positive for lab companies, says Piper Jaffray
Piper Jaffray analyst William Quirk says that the FDA has issued draft guidance to streamline its approval process for next-generation sequencing, or NGS, germline tests, which could be a substitute for a Premarket Notification or 510k. The analyst believes streamlined regulatory approaches for NGS tests are a positive for labs with NGS laboratory-developed tests such as CareDx (CDNA), Quest Diagnostics (DGX), Genomic Health (GHDX), LabCorp (LH), Myriad Genetics (MYGN), Natera (NTRA), Oxford Immunotec (OXFD), Sequenom (SQNM), Trovagene (TROV), and Veracyte (VCYT).

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PRTY

Party City

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1.5 (10.17%)

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MU

Micron

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BIIB

Biogen

$279.98

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Amgen

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Celgene

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Gilead

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IONS

Ionis Pharmaceuticals

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WFT

Weatherford

$5.49

-0.25 (-4.36%)

14:31
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Weatherford with hefty option blocks ahead of earnings »

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$NSD

NASDAQ Market Internals

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JPM

JPMorgan

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$NYE

NYSE Market Internals

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WEX

WEX

$102.16

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NBLX

Noble Midstream

$48.99

-0.715 (-1.44%)

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SBUX

Starbucks

$61.56

0.6 (0.98%)

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JCP

J.C. Penney

$5.45

-0.07 (-1.27%)

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GRUB

GrubHub

$41.43

6.41 (18.30%)

, YELP

Yelp

$35.79

1.21 (3.50%)

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GRUB

GrubHub

$41.43

6.41 (18.30%)

YELP

Yelp

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DISH

Dish

$63.30

0.76 (1.22%)

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ALKS

Alkermes

$57.13

0.13 (0.23%)

13:46
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INTC

Intel

$36.93

0.06 (0.16%)

, MBLY

Mobileye

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MBLY

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ALKS

Alkermes

$57.13

0.13 (0.23%)

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BIDU

Baidu

$186.67

-0.32 (-0.17%)

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SNCR

Synchronoss

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