FDA Approval of Imbruvica (ibrutinib) for the treatment of patients with mantle cell lymphoma

HORSHAM, PA, NOVEMBER 13, 2013 – Janssen Biotech, Inc. [“Janssen”] today announced the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA™ (ibrutinib) capsules for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.1 This indication is based on overall response rate (ORR). An improvement in survival or disease-related symptoms has not been established. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm374857.htm

New FDA Approval for REVLIMID

FDA approved lenalidomide capsules (REVLIMID, Celgene Corporation), for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

More Information: fda.gov

Governor Signs Standardized Prior Authorization Legislation

WSMOS was front and center in the lobbying for passage of SB 5267 in both the House and Senate.

On May 10, 2013 Governor Jay Inslee signed Senate Bill 5267.

SB 5267 provides for a committee, chaired by Senator Randi Becker and Representative Eileen Cody, to be selected to define the components of 4 standardized forms to be used for prior authorization of medications including chemotherapy as well as medical procedures and tests.

Insurers will be limited to the use of these forms.

The legislation further mandates that definite timelines be drawn for responses to authorization requests including “urgent” requests and when lack of a timely response constitutes authorization.

If this committee does not make final recommendations by November 15, 2013, then the Office of the Insurance Commissioner will be authorized to take over that responsibility.

The legislation mandates that the authorization standardization be implemented by January 1, 2015.
WSMOS highlighted the impact of the current status quo where practices are faced with a wide variety of prior authorization forms demanded by individual insurers and even within insurers with multiple insurance plans. This situation raises practice costs and creates unnecessary stress on employees and most importantly for patients awaiting scans and treatment.

WSMOS will continue to advocate for our patients and our practitioners to push this process to full implementation.

Jonathan Britell
WSMOS

Genomic Health Announces Medicare Expanded Coverage Policy for Oncotype DX® Breast

Click Here for more information.

Update on Medicare Denials on 96361

Below is an update regarding the 96361 add-on code edits and subsequent erroneous  denials:

CMS TO CORRECT 96361 EDIT

The CMS add-On Code edit file released for April 1, 2013 listed CPT code 96360 (IV infusion, hydration; initial 31 minutes to 1 hour) as the only primary code for add-on code 96361 (each additional hour of hydration). Because of this erroneous edit, practices have been experiencing denials when billing hydration (96361) as a secondary or subsequent service after a different initial service.

Please alert your billing staff to this issue and make sure you do not write off the claims for 96361 that were denied in error due to this add-on code edit.

Noridian reports that CMS is taking steps to correct this edit error. In the Add-On Code Edits version for July 1, 2013, CMS will be expanding this list so that the primary codes will be listed as 96360, 96365, 96374, 96409, and 96413. In the meantime, it is suggested that oncologists may choose to delay submission of claims for CPT code 96361 to July 1, 2013 or later. CMS indicates that the changes are retroactive to 4/1/2013.  Providers may resubmit their claims or file appeals depending upon the local contractor rules.  A/B MACs are NOT required to automatically reprocess claims.

ASCO News on Sequester Payment Cuts

As the two percent across-the-board reduction in Medicare provider payments takes effect today, ASCO is calling for elimination of the cuts, which will disproportionately reduce payments for critical cancer drugs.

In a letter to Health and Human Services Secretary Kathleen Sebelius, ASCO, the Community Oncology Alliance, ION Solutions, and the U.S. Oncology Network have joined forces to ask the Centers for Medicare & Medicaid Services to exercise its “authority to modify implementation of the sequester payment cut to exclude Part B drugs.”

The Administration has decided to apply the sequester cut both to payments for Part B drugs and to the six percent services payment. The result, after accounting for patient copayments, will be to cut reimbursement to ASP plus 4.3 percent, effectively imposing a 28 percent cut for payments intended to compensate for the significant operating expenses of procuring, preparing, and handling Part B drugs.

Concerned with sequestration’s impact on community-based oncology practices that currently care for Medicare beneficiaries, ASCO is urging its members to contact their Congressional representatives to let them know the effect these cuts will have on the cancer patients they serve.  For more information on how to get involved, visit ACT Network.

For more details on the impact of sequestration on medical practice, check out the American Medical Association’s FAQs on the 2013 Sequestration.

Avastin® (bevacizumab), is NOW APPROVED in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatinbased

Click Here to view Avastin Day 1

Click Here to view Avastin Prescribing Information

 

*WSMOS is not responsible for the accuracy or content of the information submitted by our corporate members.

Genomic Health Announces New Evidence Further Demonstrating Clinical Utility and Cost-

January 23, 2013

Genomic Health Announces New Evidence Further Demonstrating Clinical Utility and Cost- Effectiveness of Oncotype DX in Colon Cancer Data Presented at the 2013 Gastrointestinal Cancers Symposium Show Test Significantly Changes Treatment Decisions, May Reduce Medical Costs While Increasing Patient Well-Being Journal of Clinical Oncology Accepts for Publication Second Successful Validation Study Confirming Oncotype DX Colon Cancer Test Provides Value Beyond Conventional Markers click here for more info.

*WSMOS is not responsible for the accuracy or content of material submitted by our corporate members.