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.

RAC Audits on Same Day Neulasta

As we discussed in the most recent WSMOS newsletter, we have been working with Dr. Bernice Hecker, CMD for Noridian (NAS) and ASCO to resolve the RAC audits on Neulasta when administered the same day as chemotherapy. Today, November 20, an article providing support for the administration of Neulasta on the same day as chemotherapy was posted on the Noridian (NAS) website. In addition, ASCO recently sent a letter to CMS requesting that these audits be halted. Click Here to read ASCO’s letter.

The positive response by NAS (through publication of the supportive article) and ASCO's letter to CMS, prompted by the engagement of WSMOS and other state societies, demonstrate the importance and value of staying engaged and supporting WSMOS and the value of ASCO's new State Affiliate Council (SAC)

Below is the text and click here for the full NAS article.

Medicare Part B

PEGFILGRASTIM (NEULASTA) - J2505

Medicare covers the use of Pegfilgrastim (Neulasta), J2505, to decrease the incidence of infection, as manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The initial 2002 FDA approval and label specified administration starting 24 hours after and no sooner than 14 days before delivery of cytotoxic chemotherapy.

Coverage of Same Day Dosing
Within two years of drug approval, presentations on the utility and non-inferiority of same day dosing of Neulasta with chemotherapeutic agents appeared as abstracts. By 2009, Whitworth and Schuman independently proclaimed the administration of “pegfilgrastim on day 1 appears to be safe, effective and convenient” and “same day…may be determined to be a convenient, safe and effective approach” respectively. A 2010 metaanalysis concluded “the results indicated that same-day administration was statistically non-inferior to next-day administration according to neutropenia duration.” Based on the evidence, the administration of same-day pegfilgrastim has become an accepted standard of care and in particular, in situations where patients are believed to be a higher risk of potential non-compliance with day 2 administration.

Coverage of Less than 14 Day Dosing
In multiple trials of every other week myelosuppressive chemotherapy, pegfilgrastim given within 14 days of the next cycle has been shown to be effective in maintaining dose-density and reducing neutropenic events without any significant concerns for safety. on this evidence, the administration of pegfilgrastim before the traditional 14 day window has become an accepted standard of care to maintain dose-density or reduce neutropenic complications in regimens with substantial myelosuppression.

Sources for Same Day Dosing:
• Gynecologic Oncology, Volume 112 dated March 2009, Pgs. 601-604 “The safety and efficacy of day 1 versus day 2 administration of pegfilgrastim in patients receiving myelosuppressive chemotherapy for gynecologic malignancies”
• Journal of Support Oncolology, Volume 7, Issue 6 dated November-December 2009, Pgs. 225-8 “Pegfilgrastim dosing on same day as myelosuppressive chemotherapy for ovarian or primary peritoneal cancer”
• Journal of Oncology Practice, Volume 6, Issue 3 dated May 2010, Pgs. 133-40 “Pegfilgrastim on the Same Day Versus Next Day of Chemotherapy in Patients With Breast Cancer, Non-Small-Cell Lung Cancer, Ovarian Cancer, and Non-Hodgkin's Lymphoma: Results of Four Multicenter, Double-Blind, Randomized Phase II Studies”

Sources for Less than 14 Day Dosing:
Haematologica, Volume 91, Issue 4 April dated 2006, Pgs. 496-502 “Dose-dense R-CHOP-14 supported by pegfilgrastim in patients with diffuse large B-cell lymphoma: a phase II study of feasibility and toxicity”
• Journal of Clinical Oncology, Volume 23, Issue 33 dated November 20, 2005, Pgs. 8340-7, “Efficacy of pegfilgrastim and darbepoetin alfa as hematopoietic support for dose-dense every-2-week adjuvant breast cancer chemotherapy”
• British Journal of Cancer, Volume 100, Issue 2 dated January 27, 2009, Pgs. 305-10, “A randomized pilot Phase II study of doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC) given 2 weekly with pegfilgrastim (accelerated) vs 3 weekly (standard) for women with early breast cancer”
• Clinical Colorectal Cancer, Volume 9, Issue 2 dated April 2010, Pgs. 95-101, “A randomized, placebo-controlled phase ii study evaluating the reduction of neutropenia and febrile neutropenia in patients with colorectal cancer receiving pegfilgrastim with every-2-week chemotherapy”
• Lung, Volume 184, Issue 5 dated September-October 2006, Pgs. 279-85, “Achieving full-dose, on-schedule administration of ACE chemotherapy every 14 days for the treatment of patients with extensive small-cell lung cancer”