Oncotype DX New Study Results

DCIS - Genomic Health Announces Positive Topline Results of Second Large, Independent Validation Study of Oncotype DX® in DCIS Breast Cancer

Complete Data to be Submitted for Presentation at the 2014 San Antonio Breast Cancer Symposium

REDWOOD CITY, Calif., June 11, 2014 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced positive preliminary results from a second large, independent clinical validation study of Oncotype DX® in patients with a pre-invasive form of breast cancer, also known as DCIS (ductal carcinoma in situ).

The study, conducted by the Ontario DCIS Study Group in Canada, met its primary endpoint by demonstrating that the Oncotype DX DCIS Score™ predicts the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast.

New Premera G-CSF Policy

Premera has posted a new G-CSF policy on their Website. The policy which is effective August 30, 2014 describes the conditions under which Tbo-filgrastim (Granix®),  Filgrastim (Neupogen®) and Pegfilgrastim (Neulasta®) may be considered medically necessary and covered.  

Please take the time to read the policy and policy guidelines on the Premera Website: https://www.premera.com/medicalpolicies/CMI_158401.htm

New FDA Approval for Cyramza

On April 21, 2014, the FDA approved Lilly’s Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach. 

Cyramza is an angiogenesis inhibitor that blocks the blood supply to tumors. It is intended for patients whose cancer cannot be surgically removed (unresectable) or has spread (metastatic) after being treated with a fluoropyrimidine- or platinum-containing therapy.

For more information and to access the FDA press release:
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394107.htm

Clinical and reimbursement information is available at:
www.cyramzahcp.com

 

New FDA Approval for Vectibix

On May 23, 2014 the Food and Drug Administration (FDA) approved a new indication for Vectibix® (panitumumab) as follows: 

Vectibix® is indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) metastatic colorectal cancer (mCRC) as determined by an FDA-approved test for this use:

  • As first-line therapy in combination with FOLFOX
  • As monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy

Vectibix® is not indicated for the treatment of patients with KRAS-mutant mCRC or for whom KRAS mutation status is unknown.  

Please click here to link to the Vectibix® Prescribing Information (PI), including Boxed WARNING.

 

UPDATE: SGR PATCH & ICD-10 DELAY

On March 31, Congress passed another temporary fix to the flawed sustainable growth rate (SGR) formula. This is the 17th temporary fix to the SGR formula. The bill, Protecting Access to Medicare Act of 2014 (H.R. 4302) is expected to be signed by President Obama and would delay until March 2015 the pending 24% cut to Medicare physician payments.

Among other provisions, the bill includes:

  • A 12-month patch for the SGR and continues the 0.5% update through calendar year 2014 and a zero percent payment update from January 1, 2015 to March 31, 2015;
  • An extension of the work GPCI floor until April 1, 2015;
  • A minimum 1-year delay (the bill language states HHS may not adopt ICD-10 as the standard code set until October 1, 2015) in transition from ICD–9 to ICD–10 code sets;
  • The establishment of a market-based payment system for diagnostics under the Clinical Laboratory Fee Schedule (CLFS);
  • Development of quality incentives, including penalties for certain computed tomography services to improve radiation dosing safety  and to promote the use of appropriate use criteria (AUC) for advanced diagnostic imaging.;
  • A delay of the Recovery Audit Contractor enforcement of the “two-midnight rule” through March 31, 2015;
  • A new skilled nursing facility value based purchasing program (SNF VBP) to begin in fiscal year 2019;
  • An extension of the Qualifying Individual (QI) Program that assists Medicare beneficiaries with incomes between 120%-135% of the federal poverty level (FPL) by covering the cost of their Medicare Part B premiums.

New MOC Rules

Maintenance of certification (MOC) rules on Board Certification changed on January 31, 2014 and all US Board certified oncologists, including those who are "grandfathered" must enroll with ABIM by March 31 to ensure they are reported as meeting MOC requirements. ABIM will begin publicly reporting physicians’ status as Certified or Not Certified and Meeting MOC Requirements or Not Meeting MOC requirements.  After March 31, physicians can change their reported status by logging in ABIM.org and enrolling in the program.

If you do not log in and activate your program by March 31 you will be reported as "Certified, Not Meeting MOC Requirements."  Enroll now through the ABIM physician portal at :

https://www.abim.org/online/default.aspx

The Centers for Medicare and Medicaid Services (CMS) have granted ZALTRAP® (Ziv-Aflibercept) Injection for Intravenous Infusion a permanent J Code. J9400.

The Centers for Medicare and Medicaid Services (CMS) have granted ZALTRAP® (Ziv-Aflibercept) Injection for Intravenous Infusion a permanent J Code. J9400. This new HCPCS code is effective for dates of service on or after January 1, 2014. Please be sure to prepare your systems for the introduction of this new code. 

Click here for info.

 

Effective January 1, 2014, CMS has assigned a new HCPCS code for Neupogen®, J1442 injection, filgrastim 1 mcg.

On November 29, 2013, CMS released the Healthcare Common Procedure Coding System (HCPCS) code set updates that will be effective January 1, 2014. • Effective January 1, 2014, CMS has assigned a new HCPCS code for Neupogen®, J1442 injection, filgrastim 1 mcg. This new HCPCS code replaces the old Neupogen® HCPCS codes of J1440 for 300 mcgs and J1441 for 480 mcgs. • As a result of the new Neupogen® HCPCS code, providers will need to enter the Neupogen® units used in the billing process to distinguish which Neupogen® dose was used (e.g. 300 mcg single use vial/prefilled syringe or 480 mcg single use vial/prefilled syringe). • For additional details relative to this change, here is the CMS website: http://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS.html For the full Prescribing Information on Neupogen® (filgrastim), please go to: http://www.neupogen.com