The following information has been received by ANCO.
****ASH NEWS****
The American Society of Hematology's (ASH) Practice Update was published and is available online at http://www.hematology.org/Practice/Practice-Updates/4373.aspx. This edition features:
Attempt to Repeal SGR Fails in Senate; Slight Increase in Fees Still Likely in 2010
Health Reform Legislation Moves Forward
ASH Comments on Proposed Oncology Electronic Health Record Requirements
ASH Requesting Member Assistance on Validation of PQRI Hematology Measures
Electronic Health Records: HITECH ACT Financial Incentives
Annual Clotting Factor Furnishing Fee Update
****ACCC NEWS****
The Association of Community Cancer Center's (ACCC) Connect was published and is available online at http://www.accc-cancer.org/mediaroom/newsletters/2009/media_ACCConnect_10-21-2009.html. ANCO is an Institutional Member of ACCC. This edition features:
• Call your Senators: Urge Repeal of the SGR
• How to Bring Out the Best in Your Cancer Service Line
• FDA Approves Elitek for New Indication
• Prometheus Laboratories Launches Three New Diagnostic Tests
• Does Mammography Sometimes Detect Too Much Breast Cancer?
• Heard on ACCC's ListServ: Verbal Orders Given by RadOnc to Radiation Therapist
****CMA NEWS****
The California Medical Association (CMA) Alert was published and is available online at http://www.calphys.org/html/news.asp. This edition features:
• Senate Fails to Advance Bill to Repeal Medicare SGR
• CMA Sues State to End Medical Board Furloughs
• Physicians' Personal Data Stolen
• Orange County Physician Becomes CMA President
• Highlights from CMA's 2009 House of Delegates
• State Temporarily Exempts H1N1 from Mercury-Free Vaccine Law
• 2009 State Legislative Update
• CMA Announces HIT List Program
• Next Week is Health Care Decisions Week: Physicians Urged to Talk to Patients About End-of-Life Wishes
• Best Practices: Monitoring Financial Benchmarks
• CMA's Annual CEO Report Available Online
****CMS NEWS****
MM6632 – FDG PET for Solid Tumors and Myeloma
http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM6632.pdf
MM6672 – Magnetic Resonance Imaging (MRI)
http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM6672.pdf
MM6589 – Implementation of Health Insurance Portability and Accountability Act of 1996 (HIPAA) version 5010 for Transaction 835 - Health Care Claim Payment/Advice
http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM6589.pdf
****PALMETTO/J1MAC NEWS****
2010 Medicare Participation Enrollment & Fee Schedule Information
We are excited to provide you with a CD-ROM packed full of useful
information, which will include the 2010 Medicare Participation Enrollment
form along with some valuable additional information. We anticipate that
the CD-ROM will be mailed in November 2009.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7X2L3Y4207?opendocument
Annual Clotting Factor Furnishing Fee Update
CR 6673, from which this article is taken, announces that for calendar year
(CY) 2010, the blood clotting factor furnishing fee of $0.170 per
international unit (I.U.) is added to the payment limit for a blood
clotting factor that is not included on the Average Sales Price (ASP) or
Not Otherwise Classified (NOC) files. Please review and share with your
staff members.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7X2REF5488?opendocument
FDG PET for Solid Tumors and Myeloma
CR 6632, from which this article is taken, announces that the Centers for
Medicare & Medicaid Services (CMS) is revising the Medicare National
Coverage Determinations Manual, Section 220.6 (Positron Emission Tomography
(PET) Scans). Please review and share with your staff members.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7X2R6T8231?opendocument
MACtoberfest Kicks Off at 8 a.m. Thursday, October 28!
Palmetto GBA J1 MACtoberfest is almost here! To get an overview of the
conference, join us for a general session at 8 a.m. on Thursday, October
28! Click on the link below for more details. Thank you for your
participation!
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7X2PFM1227?opendocument
Magnetic Resonance Imaging (MRI)
Historically, the use of Magnetic Resonance Imaging (MRI) for blood flow
determination has been a Medicare non-covered procedure. CR 6672, from
which this article is taken, announces that the Centers for Medicare &
Medicaid Services (CMS) found that the non-coverage of MRI for blood flow
determination is no longer supported by the available evidence. Therefore,
effective September 28, 2009, CMS is removing blood flow measurement as a
nationally non-covered indication for MRI and is giving local Medicare
contractors the discretion to cover (or not to cover) this use of MRI in
blood flow measurement.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7X2RB72121?opendocument
Notice of New Interest Rate for Medicare Overpayments & Underpayments: 1st
Notification for FY 2010
The Department of the Treasury has notified the Department of Health and
Human Services that the private consumer rate has been changed to 10.875
percent effective October 22, 2009, for Medicare overpayments and
underpayments. Please review and share with your staff members.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7X3L5K1568?opendocument
November 2009 J1 A/B MAC Medicare Advisory
The J1 November 2009 Medicare Advisory is now available. Please review and
share with your staff members.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7X3RZ23866?opendocument
The ANCO Online ListServ has moved and is now sent directly from the ANCO office computer. Please contact ListServ@anco-online.org if you wish to update or unsubscribe your e-mail address. Thanks!
Monday, October 26, 2009
Sunday, October 18, 2009
[ANCO Online ListServ] CMS, DHCS/MediCal & Palmetto/J1MAC News
The following information has been received by ANCO.
****CMS NEWS****
SE0926 – 2009 - 2010 Seasonal Influenza (Flu) Resources for Health Care Professionals
http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0926.pdf
The Centers for Medicare & Medicaid Services’ (CMS) Provider Communications Group will host a national provider conference call on the 2009 Physician Quality Reporting Initiative (PQRI). This toll-free call will take place from 2:30 p.m. – 4:30 p.m., EDT, on Thursday, October 15, 2009.
The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) made the PQRI program permanent, but only authorized incentive payments through 2010. Eligible professionals who meet the criteria for satisfactory submission of quality measures data for services furnished during the reporting period, January 1, 2009 - December 31, 2009, will earn an incentive payment of 2.0 percent of their total allowed charges for Physician Fee Schedule (PFS) covered professional services furnished during that same period. The 2009 PQRI consists of 153 quality measures and 7 measures groups.
The topics covered on this national provider call will include:
· Alternative NPI Feedback Report Distribution Process;
· Updates on 2008 PQRI and 2007 re-run PQRI incentive payments; and
· An explanation of the paper and electronic remittance advice statement for determining incentive payments.
Following this presentation, the lines will be opened to allow participants to ask questions of CMS PQRI subject matter experts.
Educational products are available on the PQRI dedicated web page located at http://www.cms.hhs.gov/PQRI , on the CMS website, in the Educational Resources section,as well as educational products are available on the e-prescribing dedicated web page located at http://www.cms.hhs.gov/ERxIncentive. Feel free to download the resources prior to the call so that you may ask questions of the CMS presenters.
Conference call details:
Date: October 15, 2009
Conference Title: 2009 Physician Quality Reporting Initiative-National Provider Call
Time: 2:30 p.m. EDT
In order to receive the call-in information, you must register for the call. It is important to note that if you are planning to sit in with a group, only one person needs to register to receive the call-in data. This registration is solely to reserve a phone line, NOT to allow participation. Registration will close at 2:30 p.m. EDT on October 14, 2009, or when available space has been filled. No exceptions will be made, so please be sure to register prior to this time.
To register for the call participants need to go to:
http://www.eventsvc.com/palmettogba/101509
Fill in all required data.
Verify your time zone is displayed correctly the drop down box.
Click "Register".
You will be taken to the “Thank you for registering” page and will receive a confirmation e-mail shortly thereafter. Note: Please print and save this page, in the event that your server blocks the confirmation e-mails. If you do not receive the confirmation e-mail, please check your spam/junk mail filter as it may have been directed there.
For those of you who will be unable to attend, a transcript of the call will be available at least one week after the call at http://www.cms.hhs.gov/pqri on the CMS website.
If you require services for the hearing impaired please send an email to:Medicare.TTT@PalmettoGBA.com.
Medicare Fee-for-Service Professional Providers and Suppliers:
Version 2.7 of the MREP software is available for download at http://www.cms.hhs.gov/AccesstoDataApplication/02_MedicareRemitEasyPrint.asp on the CMS website. For a description of the changes in this version, see the “What’s New” section of the MREP User Guide – Version 2.7 at http://www.cms.hhs.gov/AccesstoDataApplication/Downloads/EasyPrintUserGuide.pdf.
SE0922 – Alternative Process for Individual Eligible Professionals to Access Physician Quality Reporting Initiative (PQRI) and Electronic Prescribing (E-Prescribing) Feedback Reports
http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0922.pdf
MM6455 – Ensuring Only Clinical Trial Services Receive Fee-for-Service (FFS) Payment on Claims Billed for Managed Care Beneficiaries
http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM6455.pdf
****DHCS/MEDI-CAL NEWS****
The following notice has been posted to the Medi-Cal Web site, www.medi-cal.ca.gov, as of October 5, 2009:
The Department of Health Care Services' Fiscal Intermediary (FI) contractor for the Medi-Cal program, EDS, was acquired by HP (Hewlett-Packard Company) in August 2008. In the months since then, a number of internal company transitions were successfully implemented by HP. The business processes and systems used by the Medi-Cal program in its operations and interactions with providers have not been impacted by the acquisition. Business has continued as usual.
One of the final stages in the transition plan involves "retiring" the EDS name and logo, and replacing them with the new corporate division name, "HP Enterprise Services," and the HP logo.
This transition to the HP Enterprise Services name will take place in the coming weeks. Providers may notice a number of "EDS" references, including addresses, in various documents and manual pages changed to "HP Enterprise Services." Documents and references with such name changes include:
* Provider manual pages, bulletins and Web site references
* Letters and correspondence
* Forms and online user guides
* E-mails with an "@hp.com" address rather than an "@eds.com" address
* The HP name when calling personnel or published telephone numbers
No changes in personnel or telephone numbers used by providers, including the Telephone Service Center number (1-800-541-5555), will occur as a result of this transition. Likewise, mailing addresses used by providers to conduct business with Medi-Cal and the FI will remain the same.
****PALMETTO/J1MAC NEWS****
October Update to the 2009 Medicare Physician Fee Schedule Database
(MPFSDB) (HI, NV)
Effective October 5, 2009, for dates of service performed on or after
January 1, 2009, the Centers for Medicare and Medicaid Services (CMS) have
made a change to a CPT code on the 2009 Medicare Physician Fee Schedule
Database (MPFSDB). Please review and share with staff members.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7WNLA25127?opendocument
Medicare Remit EasyPrint (MREP) Software for J1 Part B
Medicare Remit EasyPrint (MREP) version 2.7 is available for download. You
can save time and money by taking advantage of FREE MREP software now
available to view and print the ANSI 835! Please visit our Web site at
www.palmettogba.com for downloading the 2.7 Version.
http://www.palmettogba.com/palmetto/Providers.nsf/vMasterDID/7HVMA20718?opendocument
The ANCO Online ListServ has moved and is now sent directly from the ANCO office computer. Please contact ListServ@anco-online.org if you wish to update or unsubscribe your e-mail address. Thanks!
****CMS NEWS****
SE0926 – 2009 - 2010 Seasonal Influenza (Flu) Resources for Health Care Professionals
http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0926.pdf
The Centers for Medicare & Medicaid Services’ (CMS) Provider Communications Group will host a national provider conference call on the 2009 Physician Quality Reporting Initiative (PQRI). This toll-free call will take place from 2:30 p.m. – 4:30 p.m., EDT, on Thursday, October 15, 2009.
The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) made the PQRI program permanent, but only authorized incentive payments through 2010. Eligible professionals who meet the criteria for satisfactory submission of quality measures data for services furnished during the reporting period, January 1, 2009 - December 31, 2009, will earn an incentive payment of 2.0 percent of their total allowed charges for Physician Fee Schedule (PFS) covered professional services furnished during that same period. The 2009 PQRI consists of 153 quality measures and 7 measures groups.
The topics covered on this national provider call will include:
· Alternative NPI Feedback Report Distribution Process;
· Updates on 2008 PQRI and 2007 re-run PQRI incentive payments; and
· An explanation of the paper and electronic remittance advice statement for determining incentive payments.
Following this presentation, the lines will be opened to allow participants to ask questions of CMS PQRI subject matter experts.
Educational products are available on the PQRI dedicated web page located at http://www.cms.hhs.gov/PQRI , on the CMS website, in the Educational Resources section,as well as educational products are available on the e-prescribing dedicated web page located at http://www.cms.hhs.gov/ERxIncentive. Feel free to download the resources prior to the call so that you may ask questions of the CMS presenters.
Conference call details:
Date: October 15, 2009
Conference Title: 2009 Physician Quality Reporting Initiative-National Provider Call
Time: 2:30 p.m. EDT
In order to receive the call-in information, you must register for the call. It is important to note that if you are planning to sit in with a group, only one person needs to register to receive the call-in data. This registration is solely to reserve a phone line, NOT to allow participation. Registration will close at 2:30 p.m. EDT on October 14, 2009, or when available space has been filled. No exceptions will be made, so please be sure to register prior to this time.
To register for the call participants need to go to:
http://www.eventsvc.com/palmettogba/101509
Fill in all required data.
Verify your time zone is displayed correctly the drop down box.
Click "Register".
You will be taken to the “Thank you for registering” page and will receive a confirmation e-mail shortly thereafter. Note: Please print and save this page, in the event that your server blocks the confirmation e-mails. If you do not receive the confirmation e-mail, please check your spam/junk mail filter as it may have been directed there.
For those of you who will be unable to attend, a transcript of the call will be available at least one week after the call at http://www.cms.hhs.gov/pqri on the CMS website.
If you require services for the hearing impaired please send an email to:Medicare.TTT@PalmettoGBA.com.
Medicare Fee-for-Service Professional Providers and Suppliers:
Version 2.7 of the MREP software is available for download at http://www.cms.hhs.gov/AccesstoDataApplication/02_MedicareRemitEasyPrint.asp on the CMS website. For a description of the changes in this version, see the “What’s New” section of the MREP User Guide – Version 2.7 at http://www.cms.hhs.gov/AccesstoDataApplication/Downloads/EasyPrintUserGuide.pdf.
SE0922 – Alternative Process for Individual Eligible Professionals to Access Physician Quality Reporting Initiative (PQRI) and Electronic Prescribing (E-Prescribing) Feedback Reports
http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0922.pdf
MM6455 – Ensuring Only Clinical Trial Services Receive Fee-for-Service (FFS) Payment on Claims Billed for Managed Care Beneficiaries
http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM6455.pdf
****DHCS/MEDI-CAL NEWS****
The following notice has been posted to the Medi-Cal Web site, www.medi-cal.ca.gov, as of October 5, 2009:
The Department of Health Care Services' Fiscal Intermediary (FI) contractor for the Medi-Cal program, EDS, was acquired by HP (Hewlett-Packard Company) in August 2008. In the months since then, a number of internal company transitions were successfully implemented by HP. The business processes and systems used by the Medi-Cal program in its operations and interactions with providers have not been impacted by the acquisition. Business has continued as usual.
One of the final stages in the transition plan involves "retiring" the EDS name and logo, and replacing them with the new corporate division name, "HP Enterprise Services," and the HP logo.
This transition to the HP Enterprise Services name will take place in the coming weeks. Providers may notice a number of "EDS" references, including addresses, in various documents and manual pages changed to "HP Enterprise Services." Documents and references with such name changes include:
* Provider manual pages, bulletins and Web site references
* Letters and correspondence
* Forms and online user guides
* E-mails with an "@hp.com" address rather than an "@eds.com" address
* The HP name when calling personnel or published telephone numbers
No changes in personnel or telephone numbers used by providers, including the Telephone Service Center number (1-800-541-5555), will occur as a result of this transition. Likewise, mailing addresses used by providers to conduct business with Medi-Cal and the FI will remain the same.
****PALMETTO/J1MAC NEWS****
October Update to the 2009 Medicare Physician Fee Schedule Database
(MPFSDB) (HI, NV)
Effective October 5, 2009, for dates of service performed on or after
January 1, 2009, the Centers for Medicare and Medicaid Services (CMS) have
made a change to a CPT code on the 2009 Medicare Physician Fee Schedule
Database (MPFSDB). Please review and share with staff members.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7WNLA25127?opendocument
Medicare Remit EasyPrint (MREP) Software for J1 Part B
Medicare Remit EasyPrint (MREP) version 2.7 is available for download. You
can save time and money by taking advantage of FREE MREP software now
available to view and print the ANSI 835! Please visit our Web site at
www.palmettogba.com for downloading the 2.7 Version.
http://www.palmettogba.com/palmetto/Providers.nsf/vMasterDID/7HVMA20718?opendocument
The ANCO Online ListServ has moved and is now sent directly from the ANCO office computer. Please contact ListServ@anco-online.org if you wish to update or unsubscribe your e-mail address. Thanks!
Tuesday, October 13, 2009
ASH & Palmetto/J1MAC News
The following information has been received by ANCO.
****ASH NEWS****
The American Society of Hematology (ASH) Practice Update was published and is available online at http://www.hematology.org/Practice/Updates/. This edition features:
Update on Health Reform: Senate Finance Committee Vote on Health Reform Delayed, Obstacles to Passage Continue
Hematology Services Identified as Potential Issues in National Rollout of RAC Program
ASH Requesting Member Assistance on Validation of PQRI Hematology Measures
2009 PQRI National Provider Call with Question and Answer Session Scheduled for October 15
FDA Announces Change in Heparin USP Monograph
ASH Requests National Coverage Determination for Allogeneic Hematopoietic Cell Transplantation (HCT) for Myelodysplastic Syndrome (MDS)
DHHS Releases Guidance to Providers on Data Breaches - Congressional Leadership Requests Repeal of "Harm Standard" for Breach Notification
First Coast Service Options and Wisconsin Physician Service Release Revised LCDs on ESAs
****PALMETTO/J1MAC NEWS****
Influenza Vaccine Payment Allowances - Annual Update for 2009-2010 Season
The Centers for Medicare & Medicaid Services (CMS) issued Change Request
(CR) 6608 in order to update payment allowances, effective September 1,
2009, for influenza vaccines when payment is based on 95 percent of the
average wholesale price (AWP). Please review and share with your staff
members.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7WLPW23552?opendocument
J1 Part B LCD Update
The notice for the following J1 Part B LCDs began October 1 : Category III
CPT Codes L28248, Implantable Infusion Pump For Treatment of Chronic
Intractable Pain L28268 and MammaPrint Test – Breast Cancer Prognosis
L30376. The J1 Part B Erythropoietin Stimulating Agents (ESA) L29888 LCD
has been revised. Please review and share with your staff members.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7WLNLS0502?opendocument
Medicare Fee-for-Services (MFFS) Billing for the Administration of the
Influenza A (H1N1) Virus Vaccinea
This article was revised on September 10, 2009.The title of the article was
changed and there were references to two MLN Matters® articles (MM6626 and
MM6617) added to the Additional Information section. All other information
remains the same. This article explains Medicare coverage and reimbursement
rules for the H1N1 vaccine. All providers administering this vaccine should
review this article and be sure that their billing staffs are aware of this
information.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7WKRME0800?opendocument
Registration is Open for J1 MACtoberfest October 29-30
Registration is now open for MACtoberfest, our fall face-to-face education
series, in Las Vegas October 29 through 30. It's the last in-person event
of the year and provides an opportunity to interact face to face with
Palmetto GBA representatives and other key Medicare partners.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7W4L6L1805?opendocument
Influenza, H1N1 and Pneumococcal Vaccines and Administration Reimbursement
Updated reimbursement amounts are now available for influenza, H1N1, and
pneumococcal vaccines and administration. These services are paid at 100
percent. Coinsurance and the annual deductible do not apply.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7KDJPF8521?opendocument
The ANCO Online ListServ has moved and is now sent directly from the ANCO office computer. Please contact ListServ@anco-online.org if you wish to update or unsubscribe your e-mail address. Thanks!
****ASH NEWS****
The American Society of Hematology (ASH) Practice Update was published and is available online at http://www.hematology.org/Practice/Updates/. This edition features:
Update on Health Reform: Senate Finance Committee Vote on Health Reform Delayed, Obstacles to Passage Continue
Hematology Services Identified as Potential Issues in National Rollout of RAC Program
ASH Requesting Member Assistance on Validation of PQRI Hematology Measures
2009 PQRI National Provider Call with Question and Answer Session Scheduled for October 15
FDA Announces Change in Heparin USP Monograph
ASH Requests National Coverage Determination for Allogeneic Hematopoietic Cell Transplantation (HCT) for Myelodysplastic Syndrome (MDS)
DHHS Releases Guidance to Providers on Data Breaches - Congressional Leadership Requests Repeal of "Harm Standard" for Breach Notification
First Coast Service Options and Wisconsin Physician Service Release Revised LCDs on ESAs
****PALMETTO/J1MAC NEWS****
Influenza Vaccine Payment Allowances - Annual Update for 2009-2010 Season
The Centers for Medicare & Medicaid Services (CMS) issued Change Request
(CR) 6608 in order to update payment allowances, effective September 1,
2009, for influenza vaccines when payment is based on 95 percent of the
average wholesale price (AWP). Please review and share with your staff
members.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7WLPW23552?opendocument
J1 Part B LCD Update
The notice for the following J1 Part B LCDs began October 1 : Category III
CPT Codes L28248, Implantable Infusion Pump For Treatment of Chronic
Intractable Pain L28268 and MammaPrint Test – Breast Cancer Prognosis
L30376. The J1 Part B Erythropoietin Stimulating Agents (ESA) L29888 LCD
has been revised. Please review and share with your staff members.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7WLNLS0502?opendocument
Medicare Fee-for-Services (MFFS) Billing for the Administration of the
Influenza A (H1N1) Virus Vaccinea
This article was revised on September 10, 2009.The title of the article was
changed and there were references to two MLN Matters® articles (MM6626 and
MM6617) added to the Additional Information section. All other information
remains the same. This article explains Medicare coverage and reimbursement
rules for the H1N1 vaccine. All providers administering this vaccine should
review this article and be sure that their billing staffs are aware of this
information.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7WKRME0800?opendocument
Registration is Open for J1 MACtoberfest October 29-30
Registration is now open for MACtoberfest, our fall face-to-face education
series, in Las Vegas October 29 through 30. It's the last in-person event
of the year and provides an opportunity to interact face to face with
Palmetto GBA representatives and other key Medicare partners.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7W4L6L1805?opendocument
Influenza, H1N1 and Pneumococcal Vaccines and Administration Reimbursement
Updated reimbursement amounts are now available for influenza, H1N1, and
pneumococcal vaccines and administration. These services are paid at 100
percent. Coinsurance and the annual deductible do not apply.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7KDJPF8521?opendocument
The ANCO Online ListServ has moved and is now sent directly from the ANCO office computer. Please contact ListServ@anco-online.org if you wish to update or unsubscribe your e-mail address. Thanks!
Thursday, October 8, 2009
ACCC, CMA, & Palmetto/J1MAC News
The following information has been received by ANCO.
****ACCC NEWS****
The Association of Community Cancer Center's (ACCC) Connect was published and is available online at http://www.accc-cancer.org/mediaroom/newsletters/2009/media_ACCConnect_10-7-2009.html. ANCO is an Institutional Member of ACCC. This edition features:
• Oncology Leaders: A Summit for You
• Reach Out to Congress: Stop Payment Cuts to Cancer Care
• NCI Announces New NCCCP Sites Funding Opportunity
• CMS Revises October 2009 ASP and NOC Drug Pricing
• FDA Clears Test for Ovarian Cancer that Could Guide Surgical Decisions
• Heard on ACCC's ListServ: Cancer Registry Reporting, Staffing, and Workload
• Online Presentations Available from ACCC's Oncology Economics Conference
****CMA NEWS****
The California Medical Association (CMA) Alert was published and is available online at http://www.calphys.org/html/news.asp. This edition features:
• AMA Creates CPT Codes for H1N1 Vaccine; Many Billing Questions Remain
• First Doses of H1N1 Delivered to Physicians This Week
• CMA Has Serious Concerns About Senate Health Reform Bill
• CMA Proposes Health Reform Amendments to Protect Physicians from Increased Liability
• Attorney General Opinion Reinforces California's Ban on the Corporate Practice of Medicine
• New Federal Regulations Require Physicians to Notify Patients of Security Breaches
• Don't Forget Blue Cross Switches to Paperless EOBs
• CMA Published Blue Cross Tool Kit
• CMA's Coalition Invited to Next Round of Federal Applications to be California's Regional Health IT Extension Center
• Best Practices: Performing an EHR Needs Assessment
• CMA's Annual House of Delegates Convenes Next Week
****PALMETTO/J1MAC NEWS****
2009 PQRI National Provider Call: October 15, 2009
The Centers for Medicare & Medicaid Services' (CMS) Provider Communications
Group will host a national provider conference call on the 2009 Physician
Quality Reporting Initiative (PQRI). This toll-free call will take place
from 2:30 p.m. to 4:30 p.m. EDT, on Thursday, October 15, 2009. The topics
covered on this national provider call will include: the Alternative
National Provider Index (NPI) Feedback Report Distribution Process, updates
on 2008 PQRI and 2007 re-run PQRI incentive payments and an explanation of
the paper and electronic remittance advice statement for determining
incentive payments.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7WKH2M3117?opendocument
Announcing the Release of the Revised CMS-855 Medicare Enrollment
Applications
While Medicare contractors will continue to accept the February 2008
version of the Medicare enrollment application through November 30, 2009,
physicians, non-physician practitioners and other suppliers should begin to
use the new Medicare enrollment applications immediately. Please review and
share with your staff.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7VRSEK1310?opendocument
Expansion of the Current Scope of Editing for Ordering/Referring Providers
for Claims Processed by Medicare Carriers and Part B Medicare
Administrative Contractors (MACs)
This article was revised on September 14, 2009, to provide further
clarification of what will happen during the two phases of implementing
this change. The article is based on change request (CR) 6417, which
requires Medicare implementation of system edits to assure that Part B
providers and suppliers bill for ordered or referred items or services only
when those items or services are ordered or referred by physician and
non-physician practitioners who are eligible to order/refer such services.
Physician and non-physician practitioners who order or refer must be
enrolled in the Medicare Provider Enrollment, Chain and Ownership System
(PECOS) and must be of the type/specialty who are eligible to order/refer
services for Medicare beneficiaries. Be sure billing staff are aware of
these changes that will impact Part B provider and supplier claims for
ordered or referred items or services that are received and processed on or
after October 5, 2009.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7RSNP30613?opendocument
The ANCO Online ListServ has moved and is now sent directly from the ANCO office computer. Please contact ListServ@anco-online.org if you wish to update or unsubscribe your e-mail address. Thanks!
****ACCC NEWS****
The Association of Community Cancer Center's (ACCC) Connect was published and is available online at http://www.accc-cancer.org/mediaroom/newsletters/2009/media_ACCConnect_10-7-2009.html. ANCO is an Institutional Member of ACCC. This edition features:
• Oncology Leaders: A Summit for You
• Reach Out to Congress: Stop Payment Cuts to Cancer Care
• NCI Announces New NCCCP Sites Funding Opportunity
• CMS Revises October 2009 ASP and NOC Drug Pricing
• FDA Clears Test for Ovarian Cancer that Could Guide Surgical Decisions
• Heard on ACCC's ListServ: Cancer Registry Reporting, Staffing, and Workload
• Online Presentations Available from ACCC's Oncology Economics Conference
****CMA NEWS****
The California Medical Association (CMA) Alert was published and is available online at http://www.calphys.org/html/news.asp. This edition features:
• AMA Creates CPT Codes for H1N1 Vaccine; Many Billing Questions Remain
• First Doses of H1N1 Delivered to Physicians This Week
• CMA Has Serious Concerns About Senate Health Reform Bill
• CMA Proposes Health Reform Amendments to Protect Physicians from Increased Liability
• Attorney General Opinion Reinforces California's Ban on the Corporate Practice of Medicine
• New Federal Regulations Require Physicians to Notify Patients of Security Breaches
• Don't Forget Blue Cross Switches to Paperless EOBs
• CMA Published Blue Cross Tool Kit
• CMA's Coalition Invited to Next Round of Federal Applications to be California's Regional Health IT Extension Center
• Best Practices: Performing an EHR Needs Assessment
• CMA's Annual House of Delegates Convenes Next Week
****PALMETTO/J1MAC NEWS****
2009 PQRI National Provider Call: October 15, 2009
The Centers for Medicare & Medicaid Services' (CMS) Provider Communications
Group will host a national provider conference call on the 2009 Physician
Quality Reporting Initiative (PQRI). This toll-free call will take place
from 2:30 p.m. to 4:30 p.m. EDT, on Thursday, October 15, 2009. The topics
covered on this national provider call will include: the Alternative
National Provider Index (NPI) Feedback Report Distribution Process, updates
on 2008 PQRI and 2007 re-run PQRI incentive payments and an explanation of
the paper and electronic remittance advice statement for determining
incentive payments.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7WKH2M3117?opendocument
Announcing the Release of the Revised CMS-855 Medicare Enrollment
Applications
While Medicare contractors will continue to accept the February 2008
version of the Medicare enrollment application through November 30, 2009,
physicians, non-physician practitioners and other suppliers should begin to
use the new Medicare enrollment applications immediately. Please review and
share with your staff.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7VRSEK1310?opendocument
Expansion of the Current Scope of Editing for Ordering/Referring Providers
for Claims Processed by Medicare Carriers and Part B Medicare
Administrative Contractors (MACs)
This article was revised on September 14, 2009, to provide further
clarification of what will happen during the two phases of implementing
this change. The article is based on change request (CR) 6417, which
requires Medicare implementation of system edits to assure that Part B
providers and suppliers bill for ordered or referred items or services only
when those items or services are ordered or referred by physician and
non-physician practitioners who are eligible to order/refer such services.
Physician and non-physician practitioners who order or refer must be
enrolled in the Medicare Provider Enrollment, Chain and Ownership System
(PECOS) and must be of the type/specialty who are eligible to order/refer
services for Medicare beneficiaries. Be sure billing staff are aware of
these changes that will impact Part B provider and supplier claims for
ordered or referred items or services that are received and processed on or
after October 5, 2009.
http://www.palmettogba.com/palmetto/providers.nsf/vMasterDID/7RSNP30613?opendocument
The ANCO Online ListServ has moved and is now sent directly from the ANCO office computer. Please contact ListServ@anco-online.org if you wish to update or unsubscribe your e-mail address. Thanks!
Saturday, October 3, 2009
[ANCO Online ListServ] ASH & CMS News
The following information has been received by ANCO.
****ASH NEWS****
The U.S. Food and Drug Administration (FDA) released an alert noting a change to the United States Pharmacopeia (USP) monograph for heparin, effective October 1, 2009. The change will include a new USP reference standard and test method that is used to determine the potency of the drug. The manufacturing and testing requirements under the new monograph will lessen the potential for contamination of heparin and enhance the production of a high quality drug. However, harmonization of the standard will result in approximately a 10% reduction in the potency of the heparin marketed in the United States.
The change in heparin potency may have clinical significance in some situations, such as when heparin is administered as a bolus intravenous dose and an immediate anticoagulant effect is clinically important. In such situations healthcare providers should consider the change in potency of heparin when making decisions about what dose to administer. The change in heparin potency is expected to be less clinically significant when it is administered subcutaneously due to the low and highly variable bioavailability of heparin when administered by this route. Healthcare providers should also be aware of the decrease in heparin potency as they monitor the anticoagulant effect of the drug; more heparin may be required to achieve and maintain the desired level of anticoagulation in some patients.
Manufacturers will not begin shipping heparin products manufactured and tested according to the new USP monograph until October 8th or later.
There will be simultaneous availability of heparin manufactured to meet the “old” and “new” USP monograph, with potential differences in potency. This overlap of products on the market is necessary to make certain that there is an adequate supply of heparin available for all patients. Products using the new “USP unit” potency definition are anticipated to be available on or after October 8. FDA is working with the manufacturers of heparin to ensure that an appropriate identifier is placed on heparin made under the new USP monograph. Most manufacturers will place an “N” next to the lot number.
Consider the potential potency variation when administering heparin,particularly in situations where assurance of aggressive anticoagulation is essential to treat or prevent life-threatening thromboses. Clinicians should now consider the potential for up to 10% estimated decrease in heparin activity per “USP unit” when deciding what dose to administer in such cases.
The potency change may require more frequent or intensive aPTT or ACT monitoring.
Clinical judgment is essential in determining dose of heparin. Heparin dosing is always individualized to the patient-specific situation. The FDA-approved labeling for heparin has not changed, including the recommended doses. Individualization of heparin dosing has long been the standard for clinical use of the drug and FDA reiterates the importance of clinical judgment in heparin dosing.
To view the FDA announcement and more information regarding the heparin dosing changes visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm184674.htm.
****CMS NEWS****
The Centers for Medicare and Medicaid Services (CMS) has posted the revised October 2009 ASP and NOC pricing files, which are available for download at http://www.cms.hhs.gov/McrPartBDrugAvgSalesPrice/01a1_2009aspfiles.asp.
The ANCO Online ListServ has moved and is now sent directly from the ANCO office computer. Please contact ListServ@anco-online.org if you wish to update or unsubscribe your e-mail address. Thanks!
****ASH NEWS****
The U.S. Food and Drug Administration (FDA) released an alert noting a change to the United States Pharmacopeia (USP) monograph for heparin, effective October 1, 2009. The change will include a new USP reference standard and test method that is used to determine the potency of the drug. The manufacturing and testing requirements under the new monograph will lessen the potential for contamination of heparin and enhance the production of a high quality drug. However, harmonization of the standard will result in approximately a 10% reduction in the potency of the heparin marketed in the United States.
The change in heparin potency may have clinical significance in some situations, such as when heparin is administered as a bolus intravenous dose and an immediate anticoagulant effect is clinically important. In such situations healthcare providers should consider the change in potency of heparin when making decisions about what dose to administer. The change in heparin potency is expected to be less clinically significant when it is administered subcutaneously due to the low and highly variable bioavailability of heparin when administered by this route. Healthcare providers should also be aware of the decrease in heparin potency as they monitor the anticoagulant effect of the drug; more heparin may be required to achieve and maintain the desired level of anticoagulation in some patients.
Manufacturers will not begin shipping heparin products manufactured and tested according to the new USP monograph until October 8th or later.
There will be simultaneous availability of heparin manufactured to meet the “old” and “new” USP monograph, with potential differences in potency. This overlap of products on the market is necessary to make certain that there is an adequate supply of heparin available for all patients. Products using the new “USP unit” potency definition are anticipated to be available on or after October 8. FDA is working with the manufacturers of heparin to ensure that an appropriate identifier is placed on heparin made under the new USP monograph. Most manufacturers will place an “N” next to the lot number.
Consider the potential potency variation when administering heparin,particularly in situations where assurance of aggressive anticoagulation is essential to treat or prevent life-threatening thromboses. Clinicians should now consider the potential for up to 10% estimated decrease in heparin activity per “USP unit” when deciding what dose to administer in such cases.
The potency change may require more frequent or intensive aPTT or ACT monitoring.
Clinical judgment is essential in determining dose of heparin. Heparin dosing is always individualized to the patient-specific situation. The FDA-approved labeling for heparin has not changed, including the recommended doses. Individualization of heparin dosing has long been the standard for clinical use of the drug and FDA reiterates the importance of clinical judgment in heparin dosing.
To view the FDA announcement and more information regarding the heparin dosing changes visit http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm184674.htm.
****CMS NEWS****
The Centers for Medicare and Medicaid Services (CMS) has posted the revised October 2009 ASP and NOC pricing files, which are available for download at http://www.cms.hhs.gov/McrPartBDrugAvgSalesPrice/01a1_2009aspfiles.asp.
The ANCO Online ListServ has moved and is now sent directly from the ANCO office computer. Please contact ListServ@anco-online.org if you wish to update or unsubscribe your e-mail address. Thanks!
Friday, October 2, 2009
[ANCO Online ListServ] CMS & Palmetto/J1MAC News
The following information has been received by ANCO.
****CMS NEWS****
The revised publication titled ICD-10-CM/PCS: An Introduction Fact Sheet (August 2009), which provides general information about the International Classification of Diseases, 10th Edition, Clinical Modification/Procedure Coding System (ICD-10-CM/PCS) including benefits of adopting the new coding system, structural differences between ICD-9-CM and ICD-10-CM/PCS, and implementation planning recommendations, is now available in print format from the Centers for Medicare & Medicaid Services Medicare Learning Network. To place your order, visit http://www.cms.hhs.gov/MLNGenInfo/ , scroll down to “Related Links Inside CMS” and select “MLN Product Ordering Page.” If you are unable to access the hyperlink in this message, please copy and paste the URL into your Internet browser.
The Centers for Medicare & Medicaid Services’ (CMS) Provider Communications Group will host a national provider conference call on the 2009 Physician Quality Reporting Initiative (PQRI). This toll-free call will take place from 2:30 p.m. – 4:30 p.m., EDT, on Thursday, October 15, 2009.
The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) made the PQRI program permanent, but only authorized incentive payments through 2010. Eligible professionals who meet the criteria for satisfactory submission of quality measures data for services furnished during the reporting period, January 1, 2009 - December 31, 2009, will earn an incentive payment of 2.0 percent of their total allowed charges for Physician Fee Schedule (PFS) covered professional services furnished during that same period. The 2009 PQRI consists of 153 quality measures and 7 measures groups.
The topics covered on this national provider call will include:
· The Alternative National Provider Index (NPI) Feedback Report Distribution Process;
· Updates on 2008 PQRI and 2007 re-run PQRI incentive payments; and
· An explanation of the paper and electronic remittance advice statement for determining incentive payments.
A PowerPoint slide presentation will be posted to the PQRI webpage at http://www.cms.hhs.gov/PQRI, on the CMS website for you to download prior to the call so that you can follow along with the presenter. Following this presentation, the lines will be opened to allow participants to ask questions of CMS PQRI subject matter experts.
Educational products are available on the PQRI dedicated web page located at http://www.cms.hhs.gov/PQRI , on the CMS website, in the Educational Resources section, as well as educational products are available on the e-prescribing dedicated web page located at http://www.cms.hhs.gov/ERxIncentive. Feel free to download the resources prior to the call so that you may ask questions of the CMS presenters.
Conference call details:
Date: October 15, 2009
Conference Title: 2009 Physician Quality Reporting Initiative-National Provider Call
Time: 2:30 p.m. EDT
In order to receive the call-in information, you must register for the call. It is important to note that if you are planning to sit in with a group, only one person needs to register to receive the call-in data. This registration is solely to reserve a phone line, NOT to allow participation.
Registration will close at 2:30 p.m. EDT on October 14, 2009, or when available space has been filled. No exceptions will be made, so please be sure to register prior to this time.
To register for the call participants need to go to: http://www.eventsvc.com/palmettogba/101509
Fill in all required data.
Verify your time zone is displayed correctly the drop down box.
Click "Register".
You will be taken to the “Thank you for registering” page and will receive a confirmation e-mail shortly thereafter. Note: Please print and save this page, in the event that your server blocks the confirmation e-mails. If you do not receive the confirmation e-mail, please check your spam/junk mail filter as it may have been directed there.
For those of you who will be unable to attend, a transcript of the call will be available at least one week after the call at http://www.cms.hhs.gov/pqri on the CMS website.
If you require services for the hearing impaired please send an email to:Medicare.TTT@PalmettoGBA.com.
To ensure the quality of heparin and to guard against potential contamination, the (USP), a nonprofits standards-setting organization, adopted new manufacturing controls for heparin effective, today, Oct. 1, 2009. These changes include a modification of the reference standard for the drug’s unit dose – a 10% reduction in potency. Embedded below is a copy of the FDA press release, which includes a link to an FDA health alert.
While there are concerns that quantities of the former dosage may linger for some months, it is important to share this update with health care providers, advocacy groups and others. Text of the news release follows.
FDA NEWS RELEASE
For Immediate Release: Oct. 1, 2009
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
Adjustments may be needed to achieve desired anticoagulant effect
The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.
To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofits standards-setting organization, adopted new manufacturing controls for heparin effective Oct. 1, 2009. These changes include a modification of the reference standard for the drug’s unit dose.
Manufacturers in the United States and Canada label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.
A unit is the measure of a drug’s activity in the body. For heparin, a unit dose is the measure of the drug’s ability to block the blood’s natural clotting ability (anticoagulation). Heparin’s potency is determined by the dose of the drug required to produce a specific level of anticoagulation.
Manufacturers for the U.S. market have begun to make heparin using the new USP standard. The FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.
“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said Jenkins.
Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.
By federal law, prescription and over–the–counter medicines available in the United States must meet USP's public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.
The monograph was revised, in part, in response to a 2007-2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the United States. The monograph was changed to include a test for the contaminant.
For more information go to:
FDA Alert to Health Care Professionals
http://www.fda.gov//Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm184502.htm
USP Heparin Information
http://www.usp.org/hottopics/heparin.html
****PALMETTO/J1MAC NEWS****
Falls Evaluation: Translating Evidence-based Interventions into Your
Practice
Under Part B’s Physician Quality Reporting Initiative (PQRI), the Centers
for Medicare & Medicaid Services (CMS) makes available additional revenues
to practices that report at least three applicable quality measures. Two
such quality measures are #154 and #155 - Falls: Risk Assessment and Falls:
Plan of Care, respectively. It is important that physicians and independent
therapy practices understand the PQRI process and how it incorporates fall
evaluations. Please review and share with your staff.
http://www.palmettogba.com/palmetto/Providers.nsf/vMasterDID/7W5MUJ1150?opendocument
The ANCO Online ListServ has moved and is now sent directly from the ANCO office computer. Please contact ListServ@anco-online.org if you wish to update or unsubscribe your e-mail address. Thanks!
****CMS NEWS****
The revised publication titled ICD-10-CM/PCS: An Introduction Fact Sheet (August 2009), which provides general information about the International Classification of Diseases, 10th Edition, Clinical Modification/Procedure Coding System (ICD-10-CM/PCS) including benefits of adopting the new coding system, structural differences between ICD-9-CM and ICD-10-CM/PCS, and implementation planning recommendations, is now available in print format from the Centers for Medicare & Medicaid Services Medicare Learning Network. To place your order, visit http://www.cms.hhs.gov/MLNGenInfo/ , scroll down to “Related Links Inside CMS” and select “MLN Product Ordering Page.” If you are unable to access the hyperlink in this message, please copy and paste the URL into your Internet browser.
The Centers for Medicare & Medicaid Services’ (CMS) Provider Communications Group will host a national provider conference call on the 2009 Physician Quality Reporting Initiative (PQRI). This toll-free call will take place from 2:30 p.m. – 4:30 p.m., EDT, on Thursday, October 15, 2009.
The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) made the PQRI program permanent, but only authorized incentive payments through 2010. Eligible professionals who meet the criteria for satisfactory submission of quality measures data for services furnished during the reporting period, January 1, 2009 - December 31, 2009, will earn an incentive payment of 2.0 percent of their total allowed charges for Physician Fee Schedule (PFS) covered professional services furnished during that same period. The 2009 PQRI consists of 153 quality measures and 7 measures groups.
The topics covered on this national provider call will include:
· The Alternative National Provider Index (NPI) Feedback Report Distribution Process;
· Updates on 2008 PQRI and 2007 re-run PQRI incentive payments; and
· An explanation of the paper and electronic remittance advice statement for determining incentive payments.
A PowerPoint slide presentation will be posted to the PQRI webpage at http://www.cms.hhs.gov/PQRI, on the CMS website for you to download prior to the call so that you can follow along with the presenter. Following this presentation, the lines will be opened to allow participants to ask questions of CMS PQRI subject matter experts.
Educational products are available on the PQRI dedicated web page located at http://www.cms.hhs.gov/PQRI , on the CMS website, in the Educational Resources section, as well as educational products are available on the e-prescribing dedicated web page located at http://www.cms.hhs.gov/ERxIncentive. Feel free to download the resources prior to the call so that you may ask questions of the CMS presenters.
Conference call details:
Date: October 15, 2009
Conference Title: 2009 Physician Quality Reporting Initiative-National Provider Call
Time: 2:30 p.m. EDT
In order to receive the call-in information, you must register for the call. It is important to note that if you are planning to sit in with a group, only one person needs to register to receive the call-in data. This registration is solely to reserve a phone line, NOT to allow participation.
Registration will close at 2:30 p.m. EDT on October 14, 2009, or when available space has been filled. No exceptions will be made, so please be sure to register prior to this time.
To register for the call participants need to go to: http://www.eventsvc.com/palmettogba/101509
Fill in all required data.
Verify your time zone is displayed correctly the drop down box.
Click "Register".
You will be taken to the “Thank you for registering” page and will receive a confirmation e-mail shortly thereafter. Note: Please print and save this page, in the event that your server blocks the confirmation e-mails. If you do not receive the confirmation e-mail, please check your spam/junk mail filter as it may have been directed there.
For those of you who will be unable to attend, a transcript of the call will be available at least one week after the call at http://www.cms.hhs.gov/pqri on the CMS website.
If you require services for the hearing impaired please send an email to:Medicare.TTT@PalmettoGBA.com.
To ensure the quality of heparin and to guard against potential contamination, the (USP), a nonprofits standards-setting organization, adopted new manufacturing controls for heparin effective, today, Oct. 1, 2009. These changes include a modification of the reference standard for the drug’s unit dose – a 10% reduction in potency. Embedded below is a copy of the FDA press release, which includes a link to an FDA health alert.
While there are concerns that quantities of the former dosage may linger for some months, it is important to share this update with health care providers, advocacy groups and others. Text of the news release follows.
FDA NEWS RELEASE
For Immediate Release: Oct. 1, 2009
Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Alert: New USP Standards for Heparin Products Will Result in Decreased Potency
Adjustments may be needed to achieve desired anticoagulant effect
The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.
To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofits standards-setting organization, adopted new manufacturing controls for heparin effective Oct. 1, 2009. These changes include a modification of the reference standard for the drug’s unit dose.
Manufacturers in the United States and Canada label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.
A unit is the measure of a drug’s activity in the body. For heparin, a unit dose is the measure of the drug’s ability to block the blood’s natural clotting ability (anticoagulation). Heparin’s potency is determined by the dose of the drug required to produce a specific level of anticoagulation.
Manufacturers for the U.S. market have begun to make heparin using the new USP standard. The FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give health care providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.
“Although the FDA-approved labeling for heparin has not changed, including the recommended doses, it is essential that health care professionals be aware of the potential difference in potency between the old and new vials of heparin when administering the drug,” said Jenkins.
Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and health care professionals differentiate it from the former product.
By federal law, prescription and over–the–counter medicines available in the United States must meet USP's public standards, when such standards exist. The revised standards for heparin are contained in a new USP monograph.
The monograph was revised, in part, in response to a 2007-2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the United States. The monograph was changed to include a test for the contaminant.
For more information go to:
FDA Alert to Health Care Professionals
http://www.fda.gov//Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm184502.htm
USP Heparin Information
http://www.usp.org/hottopics/heparin.html
****PALMETTO/J1MAC NEWS****
Falls Evaluation: Translating Evidence-based Interventions into Your
Practice
Under Part B’s Physician Quality Reporting Initiative (PQRI), the Centers
for Medicare & Medicaid Services (CMS) makes available additional revenues
to practices that report at least three applicable quality measures. Two
such quality measures are #154 and #155 - Falls: Risk Assessment and Falls:
Plan of Care, respectively. It is important that physicians and independent
therapy practices understand the PQRI process and how it incorporates fall
evaluations. Please review and share with your staff.
http://www.palmettogba.com/palmetto/Providers.nsf/vMasterDID/7W5MUJ1150?opendocument
The ANCO Online ListServ has moved and is now sent directly from the ANCO office computer. Please contact ListServ@anco-online.org if you wish to update or unsubscribe your e-mail address. Thanks!
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