ASCO, ASH, & CMS News

The following information has been received by ANCO.


****ASCO NEWS****
There is currently a nationwide shortage of injectable racemic leucovorin, available only as a generic drug and only from two manufacturers in the US (Bedford Laboratories and Teva Pharmaceuticals). According to the FDA and the American Society of Health-System Pharmacists (ASHP), the companies have not provided information on how long this shortage, caused by unspecified "manufacturing delays," is expected to last.

What about using levoleucovorin? Levoleucovorin is the levo isomeric form of racemic (d,l )-leucovorin, and is the pharmacologically active isomer of leucovorin. Levoleucovorin is available under the brand name "Fusilev" (Spectrum Pharmaceuticals). According to the FDA website, limited supplies of levoleucovorin continue to be available (the ASHP does not list a shortage of this drug). Unlike leucovorin, levoleucovorin is not FDA-approved for use in colorectal cancer or other malignancies (with the exception of use for rescue after high-dose methotrexate therapy in osteosarcoma). However, it has been used off-label in the treatment of malignancies, as a substitute for leucovorin, though noninferiority in terms of efficacy has not been tested either for metastatic disease or adjuvant therapy.

If clinicians and patients are considering the use of levoleucovorin, they should note the following:

The dose for levoleucovorin is 50% of the usual dose of racemic leucovorin

Levoleucovorin is not FDA-approved for malignancy indications (except as noted above)

The cost of levoleucovorin may be significantly higher than for leucovorin

For the time being, you may wish to check with your Medicare contractor and private insurance carriers for coverage determinations.

The CMS HCPCS code for levoleucovorin is J0641 (effective January 1, 2009). Please see the prescribing label for complete information. (http://www.fda.gov/cder/foi/label/2008/020140s001lbl.pdf).

What about using oral leucovorin? According to the ASHP, leucovorin tablets are still available. Oral leucovorin is not FDA-approved for use in treatment of malignancies (except for methotrexate rescue in osteosarcoma), although its use has been evaluated in that setting. The use of oral leucovorin may be limited by the large number of tablets needed and by the fact that oral absorption of leucovorin is saturable and highly variable.,

What about using capecitabine to substitute for the combination of 5FU/leucovorin? Capecitabine is an oral pro-drug of 5FU. For some treatment regimens, for some malignancies, substitution of capecitabine for the combination of 5FU/leucovorin is supported based on high quality randomized clinical trials. However, such data are not available for all 5FU/leucovorin containing regimens.

Capecitabine has been found to be noninferior to IV FU/leucovorin as single agents for both metastatic colorectal cancer and adjuvant therapy for stage III colon cancer., , In a large randomized phase III trial for patients with metastatic colorectal cancer, the combination of capecitabine and oxaliplatin was found to be noninferior to IV 5-FU/leucovorin and oxaliplatin (FOLFOX). However, in the BICC-C trial, capecitabine and irinotecan (CAPIRI) was less efficacious and more toxic compared to IV 5-FU/leucovorin and irinotecan (FOLFIRI) at the doses of CAPIRI utilized in that trial. No efficacy data are available from two trials testing capecitabine with oxaliplatin in the adjuvant therapy setting for colon cancer to date.

The side effect profile of capecitabine differs from that for 5FU/leucovorin (e.g. more hand-foot syndrome). When using capecitabine, issues such as patient compliance and gastrointestinal absorption also merit consideration. Complete prescribing information is available at: http://www.fda.gov/cder/foi/label/2005/020896s016lbl.pdf.

These decisions obviously need to be made by the treating physician in the context of individual patient circumstances.

What if I have patients enrolled in clinical trials using leucovorin? You should contact the study sponsor for instructions on how to proceed.

What can the FDA do? If shortages are projected to last for several weeks or months, the FDA has authority to investigate alternative sources of leucovorin, including foreign manufacturers. The FDA may also temporarily designate alternative drugs as acceptable but has not done so as of yet.

What can CMS do? ASCO has made CMS aware of this shortage and is advocating for coverage of appropriate alternatives during this shortage.

What is ASCO doing to assist members? ASCO is working with the FDA and CMS to identify and address issues that may surface as providers implement alternative treatment plans during this shortage. Specifically, ASCO will let members know when adequate supplies are expected. We will provide updates as new information becomes available from the manufacturers, FDA, CMS and other insurers. If you have questions, please contact us at policy@asco.org.

This alert is not medical or reimbursement advice or ASCO clinical guidance. Physicians should exercise professional clinical judgment in treating individual patients.

Additional Resources

American Hospital Formulary Service (AHFS) Drug Information® Off-label Use Determinations. Levoleucovorin, August 2008. Available at www.ahfsdruginformation.com.

AHFS Drug Information®. Leucovorin Calcium Monograph. Available at ASHP Web site.

ASHP Bulletin, Leucovorin Injection (Drug Shortages). Available at www.ASHP.org.


ASCO will be hosting a national audioconference on Adapting to Changes in Medicare for 2009 on Thursday, January 22 from 4:00 to 5:30 PM ET. You and your practice staff are invited to participated in this free audioconference. Registration instructions can be found in the attached announcement.


****ASH NEWS****
The American Society of Hematology's (ASH) Practice Update has been published and is available at http://www.hematology.org/policy/practice/. This edition features:

ASH Continues to Work to Add NIH Funding to Economic Recovery Package

ASH Urges MedPAC to Recommend a Realistic 2009 Physician Fee Update

PQRI 2009 Specifications Released – ASH to Organize Educational Session

Quick Reference on von Willebrand Guideline Now Available

Medicare Implements January 2009 HOPPS Update

Medicare Learning Network Education Material Mailing List Available

Medicare Hosts National Provider Conference Call on PQRI

Medicare Releases Quarterly CCI Update


****CMS NEWS****
The Centers for Medicare & Medicaid Services (CMS) is pleased to announce the scheduled release of modifications to the Healthcare Common Procedure Coding System (HCPCS) code set. These changes have been posted to the HCPCS website at http://www.cms.hhs.gov/HCPCSReleaseCodeSets/02_HCPCS_Quarterly_Update.asp in the Downloads section under “Other Codes, April 2009.” Changes are effective on the date indicated on the update.


The Centers for Medicare & Medicaid Services (CMS) will hold a Special Open Door Forum (ODF) to discuss the implementation of the Internet-based Provider Enrollment, Chain and Ownership System (PECOS) for physicians and non-physician practitioners.

Today, physicians and non-physician practitioners in 44 States and Washington, D.C. can use Internet-based PECOS to enroll, make a change in their Medicare enrollment, view their Medicare enrollment information on file with Medicare, or check on the status of a Medicare enrollment application via the Internet.

CMS expects to expand the availability of Internet-based PECOS for physicians and non-physician practitioners located in California, Texas, Virginia, Oklahoma, New Mexico, Colorado, and Puerto Rico by end of January 2009. In addition, CMS will make Internet-based PECOS available next year to organizational providers and suppliers (except durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers).
During this Special ODF, CMS staff will discuss:
* Advantages of Internet-based PECOS,
* Use of National Plan and Provider Enumeration System User ID and password,
* Process associated with submitting an enrollment application via Internet-based PECOS, and
* Certification Statement and supporting documentation.
Afterwards, there will be an opportunity for the public to ask questions.

Additional Information
For information about Internet-based PECOS, including important information that physicians and non-physician practitioners should know before submitting a Medicare enrollment application via Internet-based PECOS, go to http://www.cms.hhs.gov/MedicareProviderSupEnroll/.

We look forward to your participation.
Special Open Door Forum Participation Instructions:
Dial: 1-800-837-1935 Conference ID 75911902
Note: TTY Communications Relay Services are available for the Hearing Impaired.
For TTY services dial 7-1-1 or 1-800-855-2880 and for Internet Relay services click here http://www.consumer.att.com/relay/which/index.html
A Relay Communications Assistant will A Relay Communications Assistant will help.
An audio recording of this Special Forum will be posted to the Special Open Door Forum website at http://www.cms.hhs.gov/OpenDoorForums/05_ODF_SpecialODF.asp and will be accessible for downloading beginning January 23, 2009.

For automatic emails of Open Door Forum schedule updates (E-Mailing list subscriptions) and to view Frequently Asked Questions please visit our website at http://www.cms.hhs.gov/opendoorforums/


MM6070 – Calendar Year (CY) 2009 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment
http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM6070.pdf

SE0822 – Clarification of Medicare Payment for Routine Costs in a Clinical Trial
http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0822.pdf