January 15, 2008
Dear Health Care Provider,

We at Genomic Health are pleased to inform you that the Oncotype DX ® Breast Cancer Assay is now included in the 2008 NCCN Clinical Practice Guidelines in Oncology Breast Cancer. NCCN, an alliance of 21 world-leading cancer centers dedicated to improving the quality and effectiveness of care provided to patients with cancer, annually updates their comprehensive clinical practice guidelines for treatment recommendations relying on evidence based consensus.
Please click here to read entire letter.

FDA Alert on ESA Safety and Effectiveness

FDA ALERT [11/8/2007]: FDA is issuing this alert to update healthcare professionals about revisions to the product labeling for the erythropoiesis-stimulating agents (ESAs) [Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)]. These revisions are intended to clarify the evidence for safety and effectiveness and provide more explicit directions and recommendations to prescribers on their use.

The changes for use in patients with cancer include a warning to state that the risks of shortened survival and tumor progression have not been excluded when ESAs are dosed to reach a hemoglobin value of <12 g/dL. The risks for higher mortality and/or shortened time to tumor progression were demonstrated in studies where ESAs were dosed with the intent to achieve Hgb values greater than or equal to 12 g/dL as compared to placebo or observational controls. The revised labeling also includes a tabular summary of the clinical studies that demonstrated more rapid tumor growth or more deaths in those patients treated with an ESA. The table includes data on the achieved hemoglobin level in these studies, which in some cases was less than the targeted value.

The dosing recommendations for anemic patients with chronic renal failure have been revised to recommend maintaining hemoglobin levels within 10-12g/dL. Directions are also provided for patients whose Hgb level does not increase to the recommended level after following appropriate dose titrations. In addition, quality of life claims in the previous labeling were removed, with the exception of improved exercise tolerance and functional ability for chronic renal failure patients. These revisions are consistent with recommendations made at the May 10, 2007, Oncologic Drugs Advisory Committee (ODAC) and the September 11, 2007, meeting of the Cardiovascular & Renal Drugs Advisory Committee (CRDAC) and the Drug Safety & Risk Management Advisory Committee (DSRMAC).

The revised product labeling includes a strengthened Boxed Warning and Warnings, changes to the Indications and Usage, Clinical Experience, and Dosage and Administration sections of the labeling for all ESAs.

Go to http://www.fda.gov/cder/drug/infopage/RHE/ to download the new labeling.  If you encounter any problems with this link, simply go to the FDA home page at http://www.fda.gov.

MEDICARE FINAL RULE ANNOUNCES 2008 PHYSICIAN FEES AND REFORMS FOR ACCURATE PAYMENTS AND QUALITY

The Centers for Medicare & Medicaid Services ( CMS ) today issued a final physician payment rule designed to improve accuracy of Medicare payments and give physicians and health care professionals additional financial incentives to provide higher quality and value in the delivery of care.

Under the new rule, Medicare estimates that it will pay approximately $58.9 billion to about 900,000 physicians and other health care professionals. The revised payments, quality incentive rates and related policy changes, which will become effective January 1, 2008, are included in the Medicare Physician Fee Schedule (MPFS) final rule. The rule went on display today at the Federal Register.

The final rule, effective for services on or after January 1, 2008, will go on display today and will be published in the Federal Register on November 27, 2007.   The rule can be found at http://www.cms.hhs.gov/center/physician.asp.

For more information, please see fact sheets on Preventive Services, Physician Participation, and Imaging Services at www.cms.hhs.gov/apps/media/?media=facts.

For more information on the CMS Press Release issued today http://www.cms.hhs.gov/apps/media/press_releases.asp

CMS AWARDS TWO CONTRACTS TO PROCESS AND PAY MEDICARE PART A AND PART B CLAIMS IN 7 STATES AND D.C.

Highmark Medicare Services Inc., headquartered in Camp Hill , Pa. , will be responsible for Jurisdiction 12, which includes the states of Delaware , Maryland , New Jersey and Pennsylvania , as well as the District of Columbia . Palmetto GBA, headquartered in Columbia , S.C. , will serve Jurisdiction 1, which includes California , Hawaii , Nevada , American Samoa , Guam and the Northern Mariana Islands . By 2011, a total of 15 new MACs will cover every state and the District of Columbia . The first three MACs are processing Medicare claims in 10 western and four midwestern states. 

For more information, see http://www.cms.hhs.gov/MedicareContractingReform/

FDA: MEDICARE'S NATIONAL COVERAGE DETERMINATION ON THE USE OF EPOGEN IS CONSISTENT WITH APPROVED LABELING AND PUBLISHED RESEARCH
CONTACT: Yoni Cohen, Stark (202) 225-3202

NPPES and the NPI Registry

Many of you have noted the recent instability of NPPES and the NPI Registry. CMS has begun implementing changes that should eliminate the instability. We expect that these changes will be completed as soon as possible. NPPES will remain in operation while these changes are being made but the NPI Registry will remain down until all changes have been implemented. We expect the NPI Registry to be back in operation as soon as possible. We apologize for this inconvenience.

The downloadable file is available at http://nppesdata.cms.hhs.gov/cms_NPI_files.html on the web.

From: Kelly, Michele, NHIC
For immediate distribution: CMS JSM/TDL-07535 Medigap Identifiers - NEW 09/25/07

What follows is an important message from CMS that is for immediate distribution:

Alert Language for Immediate Use

The Centers for Medicare & Medicaid Services (CMS) has made a decision to delay the use of the new Coordination of Benefits Agreement (COBA) Medigap claim-based identifiers on incoming Part B claims or claims for durable medical equipment, prosthetics, orthotics, and medical supplies (DMEPOS) until October 1, 2007.  This represents a change from previous CMS direction issued in accordance with Transmittal 283, Change Request (CR) 5662, and the accompanying MLN Matters Article.

Because of the CMS delay, physicians and other suppliers shall inform their billing vendors not to include any newly assigned 5-byte COBA Medigap claim-based identifiers, as referenced at: http://www.cms.hhs.gov/COBAgreement/Downloads/Medigap%20Claim-based%20COBA%20IDs%20for%20Billing%20Purpose.pdf, on incoming Medicare claims before October 1, 2007.  If participating providers or suppliers include the newly assigned COBA Medigap claim-based ID on incoming claims before October 1, 2007, Medicare will not cross the claims over to the Medigap insurer. 

Providers that use PC-Ace or other free billing Medicare software need to ensure this product is updated to reflect the newly assigned 5-byte COBA Medigap claim-based IDs but must ensure that the new identifiers will not be applied on incoming Medicare claims before October 1, 2007.

Effective with October 1, 2007, and as specified in Transmittal 283, CR 5662, physicians and other suppliers that bill using paper forms, i.e., those granted an exception for billing electronically under the Administrative Simplification Compliance Act (ASCA), shall include the newly assigned 5-byte identifier (number will fall in the range 55000 through 59999) within item 9-D of incoming paper CMS-1500 claim forms. These providers should complete items 9A through 9D, in accordance with previous procedures, to ensure they will successfully trigger a Medigap claim-based crossover.  Providers that are required to bill Medicare electronically using the Health Insurance Portability and Accountability Act (HIPAA) American National Standards Institute (ANSI) X12-N 837 professional claim shall include the newly assigned 5-byte only COBA Medigap claim-based ID (range=55000 to 59999) in field NM109 of the NM1 segment within the 2330B loop.  Retail pharmacies that bill National Council for Prescription Drug Programs (NCPDP) batch claims to Medicare shall include the newly assigned Medigap identifier within field 301-C1 of the T04 segment of their incoming NCPDP claims.

JSM/TDL-07535

President Signs Bill Delaying Tamper-Resistant Prescription Pad Requirement

On Saturday, September 29, 2007, President George W. Bush signed the “Extenders Law,” delaying the implementation date for all paper Medicaid prescriptions to be written on tamper-resistant paper.

Under the new law, all written Medicaid prescriptions must be on tamper-resistant prescription pads as of April 1, 2008. 

CMS will issue additional guidance on this implementation delay as it becomes available.

New Peer-Reviewed Journal Reference Sources

In response to requests from ASCO, the Centers for Medicare & Medicaid Services (CMS) has updated the list of peer-reviewed journals that Medicare contractor medical directors may use as references of off-label uses of anti-cancer drugs. On Friday, CMS issued a transmittal announcing that the following journals will be accepted as of October 22, 2007... Learn More >>

ICD-9 Reminder

Remember there is no grace period for implementation of the new/revised ICD-9 codes effective October 1, 2007. A PDF List of the new diagnosis codes is available HERE from the CMS Website:

And the ICD-9 Index Addenda and Tabular Addenda are available HERE from the CDC Website.

Thank you MOASC Members…

 …who have communicated with us regarding your experiences with CMS,PRG Schultz, and their auditing process.

Jane Crosby, PRG Schultz oncology representative, has stated, and will follow with written verification to MOASC,  that the audit dates are of 4 years from “paid date” of claim.  This is consistent with previous communication between MOASC, CMS and PRG Schultz.

From the information MOASC has received from members, some requests for monies back to CMS, on Lupron and Zolodex,  may fall outside this 4 year period. 

If you have received any audit requests from PRG Schultz, as a contractor for CMS, please fax or e-mail to Pat Tyler, MOASC Reimbursement Specialist, 909-985-8581 or pat@moasc.org .

Sincerely,
Mariana

UPDATE:

MOASC's PRG Schultz contact received an answer from upper management late Friday afternoon (09/27/07) regarding the four year time limit for demand letters. For the demonstration, the RACs had to send the demand letter for an overpayment no more than 4 years after the paid date of the original claim. For any overpayments now and in the future, the RACs must send the demand letter for an overpayment no more than 3 years after the paid date of the origianl claim.

IVIG Reminder

The following comes as a reminder to you from Pat Tyler, MOASC Reimbursement Specialist.

If you have any questions, please do not hesitate to contact her at 800-310-3553 x2.

Remember all Managers , the changes that became effective 7-1-07 for I V I G .

For services prior to 7-l-07 report J1567 (injection, immunte globulin, intravenous, non-lyophilized 500 mg)

For services on or after July 1, 2007 , report one of the following:

Q4087 (injection, immune globulin (Octagam), intravenous, non-lyophilized 500mgs

Q4088 (injection, immune globulin (Gammagard), intravenous, non-lyophilized 500mgs

Q4091 (injection, immune globulin (Flebogamma), intravenous, non-lyophilized 500mg

Q4092 (injection, immune globulin (Gamunex), intravenous non-lyophilized 500mg

Q4089 (injection, RhoD immune globulin (human),(Rhophylac) intramuscular or intravenous, 100iu 

NCD Grassroots Program

Protect Cancer Patients is the online headquarters of a national campaign to protect cancer patients on Medicare from a decision denying them needed medicines.  Our goal is to convince the Administration to reverse a recent decision which would effectively deny senior citizen cancer patients' coverage and access to drugs prescribed by their doctors to combat anemia and reduce transfusions due to strong chemotherapy The purpose of the program is to enable patients, providers and caregivers to voice their opinions and experiences on the NCD to policy makers. NCD Grassroots Program Components:

- A toll free hotline (1-800-386-8881) that patients and HCPs can call to register in this initiative 

- A website (www.protectcancerpatients.org) where both HCPs and patients can go to register for this initiative, share their stories and/or view what others have to say about this situation

Please visit the website today and let your voice be heard.

HCFA 1500 and UB-92 Claim Forms Cut-off Date EDS Medi-Cal

Beginning September 17, 2007, claims received on the old HCFA 1500 or UB-92 claim forms will be rejected and returned to the provider.

To ensure claims processing, providers must submit claims on the new CMS-1500 or UB-04 claim form. Over-One-Year claims must also be billed using the new CMS-1500 or UB-04 claim forms beginning September 17, 2007.

For more detailed information, please see the Claim Form Article located on the Medi-Cal Web site.

Should you have any questions or need additional information, please call the Telephone Service Center (TSC) at 1-800-541-5555 or visit the Medi-Cal Web site at www.medi-cal.ca.gov.

Regards,
Norlanie A. Mostajo
PRO HIPAA Project Lead

The NPI is here. The NPI is now. Are you using it?

The NPI Registry and the downloadable file are now available. To view the Registry, visit https://nppes.cms.hhs.gov/NPPES/NPIRegistryHome.do on the web. The downloadable file is available at http://nppesdata.cms.hhs.gov/cms_NPI_files.html on the web.

Additionally, the final module in the NPI Training Package is now available. Module 4, Data Dissemination, is now available on the CMS website. This module describes the policy by which CMS will make certain NPPES data available, as well as the data CMS is disclosing.

As always, more information and education on the NPI can be found through the CMS NPI page www.cms.hhs.gov/NationalProvIdentStand on the CMS website. Providers can apply for an NPI online at https://nppes.cms.hhs.gov or can call the NPI enumerator to request a paper application at 1-800-465-3203. Having trouble viewing any of the URLs in this message? If so, try to cut and paste any URL in this message into your web browser to view the intended information.

Getting an NPI is free - not having one can be costly.

SAVE THE DATE! 

'08 Current Controversies in Pulmonary & Critical Care Medicine NEW 10/11/07

Continuing Education Conference will be February 1-2, 2008 Carmel, CA . Watch our website at www.thoracic.org/ca.html for emerging details and registration info!

Download the brochure>>

MOASC Partners With RemitData

Using just a few of RemitDATA’s management tools you too will be able to answer the key questions of successful practices, such as:

-How often am I being denied – for what reasons – on which procedures – by which payers?
-How do my reimbursement metrics above compare to my peers?
-Are we leaving any money on the table and if so where?
-How can I maximize my cash flow, and decrease my costs of collections?

Help MOASC set the standard of successful practices by utilizing this exciting new partnership with RemitDATA. And, for a limited time, MOASC members can try RemitDATA for 30 days at NO CHARGE to see if it would be a great resource for your practice.

Please call 866-885-2974 x 2011, or email mtrogdon@remitdata.com, or click www.remitdata.com for more info. RemitDATA – helping you ‘Get What’s Coming To You!’

See what practices have to say >>

Special J-Code Review Offer for MOASC Members

Leaverage the expertise of an oncology consultant pharmacist and enhance your practice performance. By working with Oncology Pharmaceutical Services, you can benefit from an on-site consultant pharmacist, powerful network drug contracting and related services.

To make arrangements for this J-Code Review offer please call Randy Harken at (310)-694-6871 or email at randy.harken@usoncology.com