Oncology Newsfeed

Comparative Effectiveness in Oncology

The take-home message from ACCC’s panel discussion about comparative effectiveness at ACCC’s Annual National Meeting on Thursday morning: CE is coming, so be involved.

"ACCC needs to be at the table with other oncology organizations," said ACCC-President Elect Al B. Benson III, MD, FACP. "Oncology must have a definitive voice in the CE debate and how it evolves."

Oncology is already included in six national CE priorities, including colorectal screening; imaging (PET and MRI); and effectiveness of genetic and biomarker testing in preventing and treating breast, colorectal, prostate, lung, and ovarian cancer and possibly other clinical conditions.

Why do we need comparative effectiveness at all? Because there's a lot of evidence of inappropriate use of healthcare technologies, including overuse and underuse and improper use; evidence of large variations in practice; and evidence that FDA market approval and clearance are often not sufficient to support clinical and policy decisions.

One enormous challenge in CE will be the accuracy of data collected, especially when "we have a very imperfect system of electronic medical records," according to Dr. Benson. Still, "If you collect the right data, you can influence future research and influence practice," said Dr. Benson.

"The problem is infrastructure," he said. "We do not have the infrastructure to link various databases and apply principles of CE. There are a number of important databases in oncology that are not linked. They are limited and may not contain all the information that personalized medicine requires." Collecting specific biologic marker data will become increasingly more important, he said.

Benson noted the growing importance of the cancer registry in relation to CE. "Tumor registrars are often the lost children in the medical records department. They are inadequately funded. They are dependent on the oncologist filling out the forms."

"If you collect the right data, you can influence future research and influence practice."

Posted 03/18/2010

A Spirited Exchange on Workforce Issues

On Thursday morning more than 450 cancer care providers gathered in Baltimore, Md., for ACCC's 36th Annual National Meeting. At the first session of the day, a "National Perspective on Workforce Shortages," attendees awakened to a spirited exchange between Associate Administrator of the Bureau of Health Professions Janet Heinrich, DrPH, RN, FAAN, and ACCC-member Richard Reiling, MD.

"Twenty-five counties in North Carolina do not have a general surgeon," said Dr. Reiling. "What's wrong with being a general surgeon? What's the problem with being a hematologist/oncologist.? How do we encourage people to enter these professions? How do we expand beyond the numbers and dollars?"

Although Dr. Heinrich acknowledged the importance of his workforce shortage questions, she provided no new answers except to respond that the Bureau has "pooled a group of experts in planning its workforce analysis group." She noted the growing specialization of medicine, nursing, and pharmacy, and the need to rethink the definition of primary care. And she noted the need to rethink utilization of nurse practitioners, physician assistants, and pharmacists.

One challenge is "limited workforce data," according to Dr. Heinrich. "We haven't had many resources to do workforce analysis. Just $2 million. Much work remains to build the data we need if we are to inform national and state policy on workforce issues." She also noted that "we haven't done as much as we should have in sharing and identifying good training models."

In oncology, Heinrich noted that the Bureau has funded a small number of projects in advanced education nursing in oncology and a patient navigator demonstration program. Heinrich noted that the Bureau will announce another competition for a patient navigator demonstration program that will focus on cancer care. The program will fund health centers and other healthcare facilities to develop programs for nonmedical health workers to reach out to people with cancer and/or other chronic diseases. ACCC will notify member once the announcement of the new program is made.

The Bureau has $700 million to distribute for grants, loans, and scholarships. Much of the funding goes to strengthen primary care and provide incentives for practicing primary care, as well as to encourage health providers to go into underserved shortage areas and identify where these shortage areas are. The Bureau also ensures that practitioners have current and appropriate skills to provide quality care.

ACCC is planning its on Workforce Shortage initiative in 2010. Details to come.

Posted 03/18/2010

New 5-Day Dosing Regimen for Decitabine

Eisai Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a five-day dosing regimen for Dacogen® (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS). The new outpatient dosing option provides physicians and patients with the flexibility of a dosing regimen with a reduced infusion time. Dacogen is the only hypomethylating agent approved for a five-day dosing regimen. The new regimen will be administered at a dose of 20 mg/m² continuous intravenous (IV) infusion over one hour repeated daily for five days per cycle. The cycle is repeated every four weeks.

The previously approved Dacogen three-day regimen is administered in an in-patient setting at a dose of 15 mg/m² continuous IV infusion over three hours repeated every eight hours for three days per cycle and repeated every six weeks.

Read more.

Posted 03/15/2010

New C Codes Available

Effective April 1, 2010, for the Hospital Outpatient Prospective Payment System (HOPPS) only, new HCPCS codes are available for: Folotyn (pralatrexate injection), 1 mg, C9259; Arzerra (ofatumumab injection, 10 mg, C9260; Fludarabine phosphate, oral, 1 mg, C9262.

Read more.

Posted 03/10/2010

ICD-10-CM Conference Call: March 23

The Centers for Medicare & Medicaid Services (CMS) will offer a “Basic Introduction to ICD-10-CM” conference call on Tuesday, March 23, 2010, from 1:00 pm – 2:30 pm ET. Among the topics to be discussed will be an overview of ICD-10-CM/PCS requirements and a basic introduction to ICD-10-CM, key similarities and differences between ICD-9-CM and ICD-10-CM, and the impact of ICD-10-CM on medical record documentation. Click here to register.

Click here to register.

Posted 03/10/2010

New Features on NCI Recovery Act Website

The National Cancer Institute (NCI) invites you to learn about the new services and research that are being funded through the Recovery Act. NCI's Recovery Act website has expanded to include new features on the people behind the science and videos from the field on navigators helping cancer patients. Recently added highlights include:

ACTNOW Trials At-A-Glance and In-Depth. Studies in the NCI's Accelerating Clinical Trials of Novel Oncologic PathWays (ACTNOW) initiative are high-priority early-phase clinical trials of new cancer treatments on an accelerated timeline, including a number of correlative studies. Researchers hope that this will help shorten the time between drug discovery and ultimately, approval and safe use of these treatments by cancer patients. A new ACTNOW table on the NCI Recovery Act Web site lists each ACTNOW trial by cancer type and contains links to descriptions of the trials, including trial objectives, patient enrollment criteria, and current trial locations.

Article on Recovery Funding of Comparative Effectiveness Research. Comparative Effectiveness Research (CER), also known as Patient-Centered Outcomes Research, is a key priority of the American Recovery and Reinvestment Act. A new article on the NCI Recovery Act website highlights Recovery Act-funded initiatives that are helping to improve patient outcomes while making cancer care more personalized, efficient, and cost-effective.

Posted 03/10/2010

HHS Announces Proposed Rule On Temporary, Permanent EHR Certification

David Blumenthal, the national coordinator for health information technology, March 2 announced the release of a proposed rule from the Department of Health and Human Services (HHS) outlining processes for both temporary and permanent certification of electronic health record (EHR) technology.

Click here for more information.

Eligible professionals and eligible hospitals who seek to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs are required by statute to use Certified EHR Technology. Once certified, Complete EHRs and EHR Modules would be able to be used by eligible professionals and eligible hospitals, or be combined, to meet the statutory requirement for Certified EHR Technology.

Posted 03/3/2010

Senate Approves 26-Day Delay in Physician Payment Cuts

The Senate voted late Tuesday, March 2, to stave off Medicare cuts to physicians until the end of March, finally overcoming a one-man blockade by Sen. Jim Bunning (R-Ky.). By a 78-19 vote, the Senate passed the $10 billion bill, which extends a number of programs, including federal programs for unemployment assistance, COBRA assistance, flood insurance, and highway funding. In particular, it offers physicians a temporary reprieve from 21 percent cuts to reimbursement under Medicare. The cuts will now go into effect March 28 unless Congress passes a longer-term fix.

After Congress failed to pass a bill last week to stave off the cuts mandated under the sustainable growth rate (SGR) formula, the reductions technically went into effect on March 1. But the Centers for Medicare & Medicaid Services (CMS) effectively postponed them by instructing contractors to hold claims until March 12, betting on Congressional action to stop the cuts before then.

Posted 03/3/2010

ACCC Submits Comments to CMS about Meaningful Use Criteria of EHR Technology and EHR Incentive Program

On March 2, 2010, the Association of Community Cancer Centers submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding the interim final rule that specifies the initial set of standards, implementation specifications, and certification criteria for electronic health record (EHR) technology. ACCC voiced a number of concerns. Overall, ACCC believes that there are too many criteria proposed for Stage 1, that some of the proposed criteria are overly demanding, and that the proposed criteria may mean that relatively few eligible professionals and eligible hospitals would benefit from the Health information Technology (HIT) stimulus dollars approved under the American Recovery and Reinvestment Act.

ACCC noted that CMS has estimated that 47 to 79 percent of eligible professionals and an unspecified number of hospitals could face Medicare penalties in 2015 for failing to meet EHR meaningful use criteria. “We find this estimate troubling and we believe it suggests that the meaningful use criteria envisioned by CMS are overly ambitious,” ACCC noted in its comments.

ACCC also urged the Office of the National Coordinator (ONC) to pay particular attention to the comments submitted by EHR vendors regarding the initial set of certification criteria. "Both ONC and CMS need to have reasonable expectations with respect to EHR vendor capabilities lest overly ambitious regulatory requirements significantly delay the availability of EHR technology," ACCC noted.

Further detailing its concerns, on March 2, 2010, ACCC also submitted comments to CMS about the Electronic Health Record Incentive Program.

CMS envisions a phased approach to defining meaningful use with three stages, but the proposed rule only addresses meaningful use criteria under Stage 1. CMS plans to propose the Stage 2 criteria by the end of 2011 (that is, in time for the 2013 payment year) and the Stage 3 criteria by the end of 2013 (in time for the 2015 payment year). For Stage 2 meaningful use criteria, CMS announces its intent to build up several functionality measures, including requiring: 1) the electronic transmission of CPOE-entered orders; 2) the incorporation of the full array of diagnostic test data into EHR as structured data, including radiology and nuclear medicine tests (rather than only clinical lab test results); 3) increased exchange of electronic and structured data (rather than unstructured data); and 4) actual electronic submission of data, such as syndromic surveillance data, to public health agencies (rather than only the performance of a capability test).

ACCC believes that the proposed meaningful use criteria for Stage 1 are far too ambitious and urged CMS to re-examine its plans for Stage 2 and Stage 3.

Posted 03/3/2010

ACCC Hosts Conference Call About Physician Supervision Requirements

More than 350 ACCC members listened in to a discussion about the physician supervision requirement in the 2010 Hospital Outpatient Department Rule. They joined oncology policy experts for insight into which nonphysician practitioners are allowed to provide direct supervision for hospital outpatient therapeutic services.

ACCC members can access an analysis of the Rule. Click here Go to the ACCC Members-only section; click on Member Content; click on Advocacy and you'll find the analysis of the 2010 rule. Go to page 74 for the Physician Supervision Requirements.

Click here to read an interesting Listserve thread from January 2010 about the Physician Supervision Requirements.

Posted 02/24/2010

2010 Clinical Research Award Nominations Now Open

ACCC’s Clinical Research Award is given annually to an individual, or individuals, whose research has significantly and positively impacted the oncology patient, family and/or community. Previous award winners include Charles Balch, MD; Donald Morton, MD; and David H. Johnson, MD, to name a few. Nominations are open until Friday March 12, 2010. Contact Jason Peller at 301.984.9496 ext. 217 or email jpeller@accc-cancer.org for additional information.

Click here for the Clinical Research Nomination Form 2010.

Posted 02/23/2010

Amgen and Centocor Ortho Biotech Products Finalize ESA Risk Evaluation and Mitigation Strategy With FDA

Amgen Inc. and Centocor Ortho Biotech Products, L.P., announced that the U.S. Food and Drug Administration (FDA) has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include Aranesp® (darbepoetin alfa), EPOGEN® (Epoetin alfa) and PROCRIT® (Epoetin alfa). The FDA has determined that a REMS is necessary for ESAs to ensure the benefits of these drugs outweigh the risks of shortened overall survival and/or increased tumor progression or recurrence as identified in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers.

As part of the REMS, a medication guide explaining the risks and benefits of ESAs must be provided to all patients receiving ESAs. To ensure continued access to ESAs for healthcare providers who prescribe, or prescribe and dispense, ESAs to patients with cancer, providers are required to train and enroll in the ESA APPRISE (Assisting Providers and cancer Patients with Risk Information for the Safe use of ESAs) Oncology Program and to document that a discussion about the risks of ESAs took place with each patient prior to the initiation of each new course of ESA therapy. The ESA APPRISE Oncology Program will be launched on March 24, 2010. Direct patient registration or approval prior to ESA administration is not required through the ESA APPRISE Oncology Program.

Read more.

To access the ESA APPRISE Oncology Program website, visit www.esa-apprise.com.

For information about the complete ESA APPRISE Oncology program, please visit www.amgen.com or www.centocororthobiotech.com. For full prescribing information and medication guides, please visit www.aranesp.com, www.epogen.com, and www.procrit.com.

Posted 02/17/2010

GlaxoSmithKline Introduces Online Program to Improve Patient Access to GSK Oncology and Specialty Medicines

GlaxoSmithKline announced the launch of CARES by GSK, a comprehensive program that provides a single point of contact to GSK services and programs designed to improve access to GSK oncology and specialty medications. In addition to the comprehensive offerings that include specialty reimbursement services and free medicine, CARES by GSK now offers its first oncology co-pay assistance program to further help eligible patients with limited insurance coverage to have better access to GSK oral oncology and specialty medicines.

A range of services within the CARES by GSK program are now accessible via a single point of contact, with counselors who will help patients who are prescribed GSK oncology and specialty medicines. CARES by GSK counselors can verify benefits for patients with all types of insurance, analyze insurance coverage, provide a co-pay forecast and research pharmacies that offer the lowest available co-pays for each patient based on his or her insurance coverage. Counselors can also administer co-pay assistance for patients on oral medications, explain the prior authorization process for certain oral oncology and specialty medications, provide guidance for how to appeal denied and underpaid claims, research foundations that provide patient assistance and support, and screen for eligibility for GSK patient assistance programs that offer medicines at low or no cost, such as Commitment to Access.

CARESbyGSK, click here to visit.

Posted 02/12/2010

FDA Approves Lapatinib/Letrozole Combination for Advanced Breast Cancer

The US Food and Drug Administration (FDA) has approved an expanded indication for lapatinib (Tykerb, GlaxoSmithKline) in combination with letrozole (Femara, Novartis AG) for the treatment of hormone-positive and human epidermal growth factor receptor 2 (HER2)–positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated. The approval was based on data from a company-sponsored double-blind, multicenter study (n = 219) showing that the addition of lapatinib to letrozole almost tripled progression-free survival rates compared with letrozole alone (35.4 weeks vs 13.0 weeks; hazard ratio, 0.71; P = .019); improvement in overall survival has not been determined yet.

Lapatinib previously was approved in combination with capecitabine (Xeloda, Hoffmann-LaRoche, Inc) for the treatment of advanced or metastatic HER2-positive breast cancer in patients who have received prior therapy including an anthracycline, a taxane, and trastuzumab.

Posted 02/2/2010

2010 ASP Pricing Files Available From CMS

The Centers for Medicare & Medicaid Services (CMS) has posted the January 2010 Average Sales Price (ASP) and Not Otherwise Classified (NOC) pricing files and crosswalks.

Click here.

Posted 2/8/2009

CMS Approves Three Organizations to Accredit Suppliers of Advanced Imaging Services

The Centers for Medicare & Medicaid Services (CMS) is designating three national accreditation organizations – the American College of Radiology (ACR), the Intersocietal Accreditation Commission (IAC), and The Joint Commission (TJC) - to accredit suppliers furnishing the technical component (TC) of advanced diagnostic imaging procedures. The accreditation requirement will apply only to the suppliers furnishing the imaging services, and not to the physician’s interpretation of the images.

As required by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), all suppliers of the TC of advanced imaging will have to become accredited by an accreditation organization designated by the Secretary of Health and Human Services by Jan. 1, 2012. The accreditation requirement applies to physicians, non-physician practitioners, and physician and non-physician organizations that are paid for providing the technical component of advanced imaging services under the Medicare Physician Fee Schedule.

MIPPA specifically excluded from the accreditation requirement certain imaging services such as x-rays, ultrasound, and fluoroscopy procedures. The law also excludes from the CMS accreditation requirement diagnostic and screening mammography, which are subject to quality oversight by the Food and Drug Administration under the Mammography Quality Standards Act.

Posted 02/2/2010

Romiplostim Receives New J Code

Amgen announced that the Centers for Medicare and Medicaid Services (CMS) established a product-specific Healthcare Common Procedures Coding System (HCPCS) J-code, or permanent code, for Nplate® (romiplostim). Effective for dates of service on or after January 1, 2010, the new J-code for Nplate® is J2796. The new J-code, J2796 for 10 mcg units of Nplate®, should be used instead of the current miscellaneous J-code (J3590) as well as the current C-code (C9245) when used on a claims form starting on January 1, 2010.

The new J2796 code is included in the 2010 version of coding manuals that providers rely on for coding information. It is expected that this new code should be implemented by payers within the first 90 days of the calendar year.

Posted 01/26/2010

Genomic Health Announces Worldwide Availability of the Oncotype DX(R) Colon Cancer Test

Genomic Health, Inc. announced worldwide commercial availability of its Oncotype DX(R) colon cancer test, the first multigene expression test developed for the assessment of risk of recurrence in patients with stage II disease. The 12-gene advanced diagnostic test is clinically validated to predict individual recurrence risk in stage II colon cancer patients following surgery, as reported at the 2009 American Society of Clinical Oncology (ASCO) meeting.

Additionally, two new studies released online for presentation at the upcoming ASCO Gastrointestinal Cancers Symposium provide further support for the use of the Oncotype DX colon cancer test as an independent predictor of recurrence risk in stage II colon cancer patients. The new results also suggest a potential role for the test in patients with stage III disease pending further study.

For its colon cancer program, Genomic Health and its collaborators used the same rigorous clinical development strategy and standardized quantitative technology designed for the company's Oncotype DX breast cancer test. The NSABP conducted three development studies and Cleveland Clinic conducted one development study, all of which were funded by Genomic Health, analyzing 761 genes from 1,851 patients with stage II colon cancer. The final set of seven recurrence and five reference genes were then independently evaluated in 1,436 stage II colon cancer patients in the QUASAR validation study.

Availability in New York is pending review by the state, as is required for all laboratory developed tests.

Genomic Health, Inc. is a life science company focused on the development and commercialization of genomic-based clinical laboratory services for cancer that allow physicians and patients to make individualized treatment decisions.

Posted 01/21/2010

New HCPCS Code For Taxotere® (docetaxel) Injection Concentrate (J9171)

In its annual update to the Healthcare Common Procedure Coding System (HCPCS) for 2010, the Centers for Medicare and Medicaid Services (CMS) has assigned a new HCPCS billing code and unit to Taxotere© (docetaxel) Injection Concentrate (J9171) for dates of service on or after January 1, 2010.

This change applies to all payers. Medicare contractors will be required to accept this new code on January 1, 2010; other payers, including private payers and Medicaid programs, may update their systems on an alternate schedule.

J9171 (docetaxel, injection, per 1 mg) should replace J9170 (docetaxel, injection, per 20 mg). The retired J9170 code and 20-mg billing unit should not be used on or after January 1, 2010.

In response to this upcoming coding change, we kindly request that your organization upload J9171 into your claims processing systems for dates of service on or after January 1, 2010. We also request that you work with the provider community where appropriate to notify and assist with this transaction in order to ensure a smooth transition.

We hope this information is helpful in determining the appropriate changes to your contractor’s systems to support claims processing for Taxotere® Please share this information with the appropriate personnel to assit in processing of claims and proper levels of Taxotere®.

If you have any questions regarding this new J-Code for Taxotere® or other questions regarding reimbursement for Taxotere® or other sanofi-aventis products, please feel free to contact your sanofi-aventis Reimbursement Manager (RM) or the PACT+ ®Program at 1-800-996-6626 or www.pactplusonline.com. For full prescribing information including Boxed Warning, click here.

Posted 01/12/2010