On July 28, 2014, the U.S. Food and Drug Administration (FDA) expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use.
The FDA is also approving new labeling to reflect that Imbruvica’s clinical benefit in treating CLL has been verified. In February 2014, Imbruvica received accelerated approval to treat CLL based on its effect on overall response rate. New clinical trial results examining progression-free survival and overall survival have confirmed the drug’s clinical benefit.
Read the FDA press release here.
August 13, 2014
Sign up today for an informational webinar on claims and coding for Xofigo®. Presenters will provide information on payer requirements for the coding and billing of Xofigo®, as well as considerations for claims submission and appeal.
The presenters will also provide an update on:
• Coding specifics for Xofigo® in the freestanding center and hospital outpatient department
• MAC billing and coding trends
• Claims submission and an overview of the appeals process.
To reserve your space, please visit www.regonline.com/XofigoWebinars to
register. Download this brochure for the full schedule of webinars and more information.
August 1, 2014
Pharmacyclics Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Imbruvica™ (ibrutinib) as a single agent for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. This indication is based on overall response rate (ORR). An improvement in survival or disease-related symptoms has not been established. Imbruvica is the first oncedaily, single-agent, oral kinase inhibitor for patients with CLL who have received one prior therapy and is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc. Read the full press release here.
April 21, 2014
Yesterday the Arizona House of Representatives unanimously passed legislation that would make oral anti-cancer treatments more affordable and accessible to patients. The measure passed 57-0 and is now heading to the Senate Health Committee for review.
As you know, insurance companies often create inequity for patients by requiring cost-sharing to be much higher for oral chemotherapies that are covered under the pharmacy benefit (some percentage of the total cost of the drug), as compared to coverage under the medical benefit for IV-infused therapies (generally a copay of $50 or less). The legislation prohibits insurance companies from imposing a higher co-payment, deductible, or co-insurance for an oral drug than required for comparable IV-infused therapy.
This is great news but there is still work to be done! The bill now moves to the Senate for review and hopefully passage. Please contact your state senator today to encourage support for HB2078. TACOS remains very active in the Fair Access to Cancer Treatment (FACT) Coalition and State Patient Equal Access Coalition (SPEAC), both of which are focused on bringing oral parity legislation to Arizona. We will keep you updated on this important legislation.
March 7, 2014
On November 29, 2013, CMS released the Healthcare Common Procedure Coding System (HCPCS) code set updates that will be effective January 1, 2014.
For the full Prescribing Information on Neupogen® (filgrastim), please go to:
December 16, 2013
On July 23, the House Energy and Commerce Health Subcommittee voted to approve legislation that would repeal the sustainable growth rate (SGR) formula in the current Medicare physician payment system and create a fee-for-service system in which providers report quality measures. Providers would also have the ability to leave the fee-for-service system and opt for new ways of delivering care.
Under the proposed legislation, physicians would receive a 0.5 percent annual increase per year for the first five years of the new payment system. Beginning in 2019, they would be eligible for an additional 1 percent update based on their performance against quality measures.
Lawmakers have yet to identify ways to pay for the legislation. However, that task is not quite as challenging as it could be, since the projected 10-year cost to replace the current SGR formula was recently lowered from $245 billion to $138 billion.
Information from BNA Health Care Daily Report.
July 24, 2013
TACOS is pleased to partner with the American Society of Hematology (ASH) to present the 2013 ASH® State-of-the-Art Symposium (SAS), taking place October 11-12 in Los Angeles. This meeting is designed to provide attendees with ample opportunities to discuss actual patient cases and practice challenges. The meeting's content will cover the most recent advances in hematologic malignancies including a special focus on myelodysplastic syndromes.
ASH is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians and designates this educational activity for a maximum of 10.5 AMA PRA Category 1 Credits™.
As a member of TACOS you receive a special discounted registration rate to attend this meeting. For a registration discount code, email ASH at firstname.lastname@example.org.
Best of ASCO Los Angeles is coming to you! Join your colleagues on August 16-17 for the 2013 Best of ASCO Meeting and experience the top science and education from the world's premier oncology event, ASCO's Annual Meeting. 2013 Meeting Highlights include:
Every member of the oncology team should take advantage of this year's dynamic and engaging program. Can't make it to Los Angeles? Consider attending a Best of ASCO Meeting in Chicago (August 9-10), or Boston (August 23-24).
There is still time to register and save! Registration fees increase onsite; register now!
This live activity has been approved for a maximum of 15.5 AMA PRA Category 1 CreditsTM.
On Feb. 8, the U.S. Food and Drug Administration (FDA) approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.
Read the FDA press release here.
The U.S. FDA has approved Synribo (omacetaxine mepesuccinate) for Injection, for subcutaneous use, for the treatment of adult patients with chronic or acclerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).
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.
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.
Noridian Administrative Services has revised their coverage of Pegfilgrastim. Read their article, which offers a number of useful sources on same-day and less than 14-day dosing.
InsideHealthPolicy featured an article on Arizona's duals plan, which aims to to better coordinate care for the vulnerable duals population by placing all 120,000 dually eligible beneficiaries who are already enrolled in Medicaid managed care plans into a Medicare Advantage special needs plan (D-SNP) operated by the same insurer.
Click here to access the complete article (log in required.)
Noridian has updated information about temporary coverage and coding information in response to provider queries about leucovorin and doxil shortages.
Noridian has listed revisions effective April 15, 2012, to the codes used to describe Positron Emission Tomography (PET) scans and the diagnoses that may justify use of the scan if all other Medicare requirements for coverage are met.
The Centers for Medicare and Medicaid Services (CMS) has issued J9307, a new national permanent Healthcare Common Procedure Coding System (HCPCS) J-code for Allos Therapeutics Inc.'s FOLOTYN® (pralatrexate injection).
Healthcare professionals and patients may call the Allos Support for Assisting Patients (ASAP) program for questions about the new HCPCS code, or any other coverage, coding, or payment issues related to FOLOTYN at 1-877-ASAP102.
Click here for more information.
HealthDataInsights, Inc., the Medicare Recovery Audit Contractor (RAC) for Region D, identified on its website CMS-approved audit issues.
The following claims will be edited automatically and monies recouped in these areas if they were billed incorrectly: