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Relevant, Timely Medical and Radiation Oncology News
Constant advancements medical technology and healthcare regulations mean the oncology industry is dynamic and fast-changing. To keep clients on the leading edge of what's happening, Revenue Cycle Inc. maintains the news section of its website as a clearinghouse for oncology news, CPT® coding and/or business operations. Whether it's a legal change that could affect our industry or a tip about oncology coding, you'll find it here.
For more information about how our team of expert consultants can help your practice stay current on these industry changes, visit our medical and radiation oncology service page.
April 2015 Medical Oncology News (View More News and Articles)
Utilizing Sandoz’s First FDA-approved Biosimilar
By Gigi Price, R.N., O.C.N., CHONC
Throughout the year, the FDA reviews new data submitted by pharmaceutical manufacturers and research entities. Once the agency has completed an intensive review of this information, it grants labeling changes to existing approved drugs, adds new indications for use, initiates an accelerated approval, proceeds with regular approval or decides more information is required from related research entities prior to granting approval for use in humans.
Sandoz is the first company to receive approval of a biosimilar—a product similar to an FDA-approved drug—in the U.S. through the new FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act. This biosimilar, Zarxio™, is a trademark of Novartis AG and manufactured by Sandoz, its generic pharmaceuticals division. Zarxio was approved on March 6, 2015 for the same indications as Neupogen® and is used in hematology and oncology settings.
The formulation of Zarxio (filgrastim-sndz) differs from that of U.S.-licensed Neupogen in one inactive component. Zarxio is used in patients with:
- Cancer Receiving Myelosuppressive Chemotherapy
- Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy
- Cancer Undergoing Bone Marrow Transplantation
- Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy
- Severe Chronic Neutropenia
The Zarxio package insert provided by Sandoz includes information relating to dosing for each of the above diagnoses, such as for “patients with cancer receiving myelosuppressive chemotherapy or induction and/or consolidation chemotherapy for AML, the recommended starting dose is 5 mcg/kg/day by subcutaneous injection, by short intravenous infusion (15 to 30 minutes), or by continuous intravenous infusion.”
ASCO includes the following information: “Sandoz Inc., the manufacturer of ZARXIO™, is holding the release of the biosimilar pending a court hearing on its pricing. Sandoz will either delay the release of ZARXIO™ to April 10 or until it receives a favorable ruling.”
Zarxio is available in:
Injection: 300 mcg/0.5 mL in a single-use prefilled syringe with BD UltraSafe PassiveTM Needle Guard (NDC 61314-304-01)
Injection: 480 mcg/0.8 mL in a single-use prefilled syringe with BD UltraSafe PassiveTM Needle Guard (NDC 61314-312-01)
People with latex allergies should not administer the Zarxio prefilled syringe, because the needle cap contains natural rubber latex (derived from latex).
If required for intravenous administration, Zarxio may be diluted in 5% Dextrose Injection, USP to concentrations between 5 mcg/mL and 15 mcg/ml. Zarxio diluted to concentrations from 5 mcg/mL to 15 mcg/mL should be protected from adsorption to plastic materials by the addition of Albumin (Human) to a final concentration of 2 mg/mL. When diluted in 5% Dextrose Injection, USP, or 5% Dextrose plus Albumin (Human)‚ Zarxio is compatible with glass, polyvinylchloride, polyolefin and polypropylene.
Stay abreast of FDA approvals, updates and guidelines with support from Revenue Cycle Inc. Through staff education, proper documentation, and effective checks and balances, our consultants will help you make sure specific payor guidelines are applied so that your documentation and billing compliance goals are met. For more information regarding Revenue Cycle Inc.’s services, please contact our consulting team at 512-583-2000.
March 2015 Radiation Oncology News (View More News and Articles)
SGR Patch Likely for April; Permanent Fix could be 4-6 Months Down the Road
By Teri Bedard BA, R.T.(R)(T), CPC
At the end of the day on March 31, 2015 the current SGR (Sustainable Growth Rate) patch will expire. Unless Congress takes action, the current Medicare Physician Fee Schedule (MPFS) conversion factor (CF) of $35.7547 will be adjusted to decrease approximately 20 percent. At a recent AMA conference, Representative Tom Price (R-GA), who is an MD and chairs the House Budget Committee, said, "I believe ... in March we'll come up with a patch, likely for 4 to 6 months, and then come forward with full-scale repeal." Many believe the permanent fix of the SGR would be tied to the reauthorization of the Children's Health Insurance Program (CHIP), which expires at the end of September.
Former Mississippi Governor Haley Barbour also indicated that members of Congress are working for a repeal of the SGR by September 30. Health and Human Services (HHS) Secretary Sylvia Burwell, who also appeared at the conference, stated that the president’s fiscal year 2016 budget proposal calls for a fix and that she hopes it can be changed in full.
Secretary Burwell addressed comments received by CMS on meaningful use. Concerns voiced by providers indicated that many thought the objectives and timing of meeting the criteria were “too much, too fast.” In response, CMS has recently announced plans to make “meaningful use more straightforward, flexible and focused on outcomes and interoperability.”
Another concern is the transition to ICD-10 scheduled for October 1, 2015. Rep. Price urged AMA attendees to visit with senators and representatives on Capitol Hill and request a delay in implementation, or permission to use a hybrid system that would allow a practicing physician to choose between using ICD-9 or ICD-10.
In a separate meeting, members of the House of Representatives’ Energy & Commerce Subcommittee on Health expressed support of the ICD-10 implementation date of October 1, 2015 and have urged fellow lawmakers to not delay any further. Members of the subcommittee cited the significant amounts of time and money invested by CMS and providers to prepare for this 2015 implementation date and asserted that any delay could be financially burdensome. CMS and many providers would incur additional costs to keep ICD-9 systems current, retrain employees and once again prepare for the transition.
Representatives of 3M and other healthcare companies testified with lawmakers to keep the October 1, 2015 deadline for the ICD-10 transition. A representative from the American Urological Association suggested, however, that the implementation was too costly for some providers to bear and voiced support of the delay. A recent study by the American Academy of Professional Coders (AAPC) concluded that ICD-10 implementation costs in small physician practices (defined by AAPC as less than 10 providers) were approximately $750 per provider.
In addition, CMS recently announced successful end-to-end testing of ICD-10 reporting from January 26-February 3. Reporting was performed by health care providers, clearinghouses and billing agencies. Approximately 660 providers and nearly 15,000 test claims were submitted for the test week. Overall findings supported that claims were able to be successfully submitted with ICD-10 coding. For those claims that were rejected, most had errors unrelated to the diagnosis coding (ICD-9 or ICD-10).
Two more testing weeks are scheduled: April 27-May 1 (volunteers have been selected) and July 20-July 24 (volunteer forms will be available March 13 on the MAC and CEDI websites). Those who volunteered and participated in the January testing will be automatically eligible to volunteer in the upcoming sessions.
We all need to stay tuned because the next few weeks should be interesting! One thing on which we can agree: our industry is ever-changing. Staying abreast of Congressional action, CMS changes and proposed rules, AMA perspectives and news from other healthcare organizations can be overwhelming. Call on the consultants at Revenue Cycle Inc. to keep you informed. Understanding the needs of your practice, we’ll distill these constant developments and navigate you through our changing climate so that your staff and operations stay efficient, compliant and profitable. Contact us at 512-583-2000 or email@example.com for more information.