CMS Seeks Participants for Medicare Imaging Demonstration

The Centers for Medicare & Medicaid Services (CMS) announced July 22 that it is soliciting proposals for participation in the Medicare Imaging Demonstration (MID). The MID was authorized by section 135(b) of the Medicare Improvements for Patients and Providers Act of 2008 and will test whether the use of decision support systems (DSSs) can improve quality of care and reduce unnecessary radiation exposure and utilization by promoting appropriate ordering of advanced imaging services. The two-year demonstration will assess the impact that DSSs used by physician practices have on the appropriateness and utilization of advanced medical imaging services ordered for the Medicare fee-for-service population. A DSS provides immediate feedback based on current medical specialty guidelines to the physician on the appropriateness of the test ordered for the patient.

Eleven advanced imaging procedures—Spect MPI, MRI lumbar spine, CT lumbar spine, MRI brain, CT brain, CT sinus, CT thorax, CT abdomen, CT pelvis, MRI Knee, and MRI shoulder—will be included in the demonstration.

CMS said it is seeking participation of some 2,500 to 3,000 physicians from at least 500 practices. Interested parties have 60 days to apply to participate.

Posted 07/23/2010

ACCC Summary and Analysis of Proposed 2011 Medicare HOPPS Rule and Physician Fee Schedule Available

On July 21 more than 200 ACCC members listened to a discussion of the proposed HOPPS rule and Physician Fee Schedule.

ACCC members can view a detailed summary of the proposed 2011 HOPPS rule and Physician Fee Schedule. After you log on to the Members-Only section, select MEMBER CONTENT from the menu at left.

Posted 07/21/2010

ACCC Releases 2010 Survey on Cancer Care Trends

The Association of Community Cancer Centers (ACCC) has released its "Cancer Care Trends in Community Cancer Centers" survey, a joint project between ACCC and Eli Lilly. Research and analysis were conducted by Kantar Health. This is the second year in which the survey has been conducted.

Results suggest that many of the nation’s cancer programs are delaying construction projects, information technology improvements, and some radiation technology equipment purchases, as well as freezing hiring as a result of the current economic recession.

"This year's survey of ACCC-members provides insight into the effects of the recession on cancer programs and organizational strategies that may help the cancer care team adapt to the changes in the healthcare marketplace," said Al B. Benson III, MD, FACP, ACCC President.

Survey results show that many hospitals are adapting to the recession by initiating cost-cutting efforts and affiliating with other local providers. The recession is also affecting patients with cancer: Hospitals are seeing an increasing number of patients with growing financial needs.

"ACCC has great concerns about the ability of cancer patients to afford the medication they need and the quality care they deserve," said Dr. Benson. "In addition, ACCC is concerned that more oncologists are closing their practices as they move to full-time employment with the hospital. ACCC will closely observe this trend of alternative employment arrangements between oncology practices and hospital cancer programs."

Read more.

Posted 07/15/2010

Final Rules Released on Meaningful Use of EHR

U.S. Department of Health and Human Services Secretary Kathleen Sebelius announced two final rules to support "meaningful use" of electronic health records. One regulation, issued by CMS, defines the minimum requirements that providers must meet through their use of certified EHR technology to qualify for the payments. The other rule, issued by the Office of the National Coordinator for Health Information Technology (ONC), identifies the standards and certification criteria for the certification of EHR technology, so eligible professionals and hospitals may be assured that the systems they adopt are capable of performing the required functions.

As much as $27 billion may be expended in incentive payments over ten years. Eligible professionals may receive as much as $44,000 under Medicare and $63,750 under Medicaid, and hospitals may receive millions of dollars for implementation and meaningful use of certified EHRs under both Medicare and Medicaid. There will also be greater flexibility with respect to eligible professionals and hospitals in meeting and reporting certain objectives for demonstrating meaningful use. The final rule divides the objectives into a “core” group of required objectives and a “menu set” of procedures from which providers may choose any five to defer in 2011-2012. This gives providers latitude to pick their own path toward full EHR implementation and meaningful use.

An objective of providing condition-specific patient education resources for both EPs and eligible hospitals and the objective of recording advance directives for eligible hospitals are in line with recommendations from the Health Information Technology Policy Committee.

Posted 07/13/2010

Berwick Sworn in as CMS Administrator

Donald M. Berwick was sworn in July 12 as administrator of the Centers for Medicare & Medicaid Services. President Obama bypassed the Senate confirmation process and appointed Berwick CMS administrator July 7. The agency had been without a permanent administrator since 2006.

Berwick, a pediatrician, is a clinical professor of pediatrics and health care policy at the Harvard Medical School and the Harvard School of Public Health. He also is president and chief executive officer of the Institute for Healthcare Improvement, a Cambridge, Mass.-based not-for-profit organization that promotes the improvement of healthcare.

Posted 07/13/2010

House Members Send Letter Urging CMS to Stop Inpatient Hospital Pay Cuts

In a July 12 letter, 242 House members urged the Centers for Medicare & Medicaid Services to re-examine its proposal to reduce Medicare payments to inpatient hospitals due to changes in documentation and coding practices that were included in the agency's fiscal year 2011 hospital inpatient prospective payment system (IPPS) proposed rule.

In the letter to CMS Administrator Donald Berwick, the lawmakers wrote that "the coding 'offset’ assumes that hospital payments have increased solely due to changes in coding, or classification of patients, as opposed to hospitals' treatment of more complex and more severely ill patients. We believe that this assertion fails to take into consideration that hospital patients are indeed sicker."

As reported in the July 13 BNA “Healthcare Daily Report,” the draft rule for FY 2011, issued April 19, set out a large proposed cut to adjust for additional payments that CMS estimates were made due to changes in documentation and coding following CMS's changes to Medicare-Severity Diagnosis-Related Groups (MS-DRGs) for determining inpatient PPS payment amounts. CMS in the rule proposed a 2.9 percent cut—$3.7 billion—to recoup one-half of the payments that the agency said were made in FY 2008 and FY 2009 due to documentation and coding changes that did not reflect increases in patients' severity of illness. The agency is expected to issue a final rule by Aug. 1.

The lawmakers' letter states that the Medicare Payment Advisory Commission has projected a negative 5.9 percent overall Medicare margin for hospitals in FY 2010 and recommended a full inflation update for hospital payments in FY 2011. "If the proposed rule is enacted, the projected inflationary increase for next year, 2.4 percent, would be more than eliminated," the lawmakers wrote.

Posted 07/13/2010

ACCC Efforts Pay Off: Drug Reimbursement in Hospital Outpatient Departments Set to Increase in 2011

The proposed 2011 Hospital Outpatient Prospective Payment System rule has been put on public display by the Centers for Medicare & Medicaid Services (CMS). In the 2011 proposed rule, CMS announced that reimbursement for drugs and pharmacy services will increase to ASP+6 percent from the current level of ASP+4 percent. ACCC has advocated for this change for the past three years, ever since reimbursement began to decrease in 2007.

In meetings with CMS staff and in testimony before the APC Panel, ACCC has stated that hospitals should be reimbursed at least ASP+6 percent, if not higher, for drugs and their associated pharmacy costs. ACCC data have shown that pharmacy overhead costs are higher than CMS allows for, and, therefore, the ASP+ number should be higher. Each year, CMS listened, but continued to decrease the reimbursement. ACCC continued to push for its position, and it appears that all of that effort has finally paid off.

While ACCC does not agree with every aspect of the proposed rule and will be submitting comments to CMS about those issues, ACCC is pleased that CMS has finally recognized our efforts and our data.

The comment period for this rule closes on August 31. ACCC will submit comments during that period. We anticipate the final rule by Nov. 1, 2010.

Click here to read payment allowance limits for Medicare Part B drugs effective July 1.

Posted 07/7/2010

CMS Posts Proposed 2011 Physician Fee Schedule

The proposed 2011 rule relating to the Medicare physician fee schedule and other Part B issues has been put on public display by the Centers for Medicare & Medicaid Services (CMS). ACCC is analyzing the proposed rule and will report details soon.

CMS proposes a 6.1 percent cut for physician services that would take effect Jan. 1, 2011. However, due to other formulaic changes in how payments are determined, including a rebasing of the Medicare Economic Index, the impact on medical and radiation oncology services will be much less, ranging from a 1 percent reduction to a 1 percent increase in payments.

The proposed rule was published the same day that President Obama signed the Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010 (H.R. 3962). The measure replaced the 21.3 percent reduction in physician payment rates required by the sustainable growth rate formula for 2010 with a 2.2 percent increase in effect through Nov. 30. It makes the conversion factor $36.8729.

The rule also would institute changes in the Physician Quality Reporting Initiative that offers an incentive payment to doctors and other professionals covered by the fee schedule and would extend the payments through 2014. Beginning in 2011, 20 more PQRI measures would be added, including those for reporting through registries and electronic health records. It would also add a group practice reporting option that would allow those with fewer than 200 professionals to participate.

Click here to read the proposed Medicare physician fee schedule.

Posted 06/25/2010

CMS Posts Corrections to Third Quarter Medicare Drug Payments

The Centers for Medicare & Medicaid Services (CMS) has corrected an error in the Q3 2010 Medicare reimbursement allowable for Abraxane (J9264). CMS has posted the revised file that shows the updated Medicare Q3 2010 ASP + 6 percent allowable for Abraxane as $9.399 per 1 mg.

Click here to read payment allowance limits for Medicare Part B drugs effective July 1.

Posted 07/7/2010

President Obama Signs Physician-Fix Legislation

On June 25, 2010, President Obama signed into law The Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010, passed by the House on June 24 and the Senate on June 18. Included in the law is a six-month physician pay patch that will block a 21.3 percent cut in Medicare physician payments, replacing it with a 2.2 percent increase costing $6 billion. The legislation is retroactive to June 1 and runs through Nov. 30.

The cuts are the result of a sustainable growth rate (SGR) formula established by Congress in 1997 to control spending. The SGR reduces physician payments when Medicare expenditures on physician services exceed a predetermined target.

The provision to block the cuts, known on Capital Hill as the ‘Doc Fix,’ was originally included in the tax extenders bill held up in the Senate. With the extenders bill lacking the votes for passage, pressure from the medical community forced the Senate to take the Doc Fix out of the bill and passed it as a stand-alone measure. The measure, originally a 19-month extension passed by the House, was changed because that measure lacked funding.

The cuts officially became law on June 1 but the Center for Medicare and Medicaid Services (CMS) asked contractors to hold claims until Congress discussed a solution. That hold was lifted on June 18 when the Senate sent the new bill back to the House for approval and CMS began processing claims with the cuts.

The law does not include funding to reprocess claims filed since June 18 but experts suggests CMS already has the funds necessary for reprocessing. In addition, CMS has stated it expects to begin processing claims with the new increase no later than July 1.

Members of the medical community expressed support of the extension but added that a long series of short-term Medicare patches will not solve the problem that Congress has created in the last decade.

The SGR formula links physician reimbursement rates to increases in the gross domestic product (GDP). Because spending on physician services has outpaced increases in the GDP, the formula has called for cuts in reimbursements each year over most of the past decade, and Congress has always voted to push those cuts down the road, granting small rate increases instead. Both ACCC and the American Society of Clinical Oncology have called for a long-term solution.

Posted 06/28/2010

2010 Physician Quality Reporting Initiative (PQRI) Program Reminder

It is not too late to start participating in the 2010 Physician Quality Reporting Initiative (PQRI) and potentially qualify to receive incentive payments. A new six month reporting period begins on July 1, 2010. The 2010 Physician Quality Reporting Initiative (PQRI) has two reporting periods: 12-months (January 1-December 31, 2010) and 6-months (July 1-December 31, 2010). For 2010, eligible professionals (EPs) who satisfactorily report PQRI measures for the 6-month reporting period will become eligible to receive a PQRI incentive equal to 2.0 percent of their total Medicare Part B allowed charges for services performed during the reporting period.

If you have not participated in the PQRI program, you can begin by reporting PQRI data for July 1-December 31, 2010, using any of the following four options:

1. Claims-based reporting of individual measures for 80% or more of applicable patients on at least 3 individual measures or on each measure if less than 3 measures apply
2. Claims-based reporting of one measures group for 80 percent or more of applicable Medicare Part B FFS patients of each EP (with a minimum of 8 patients)
3. Registry-based reporting of at least 3 individual PQRI measures for 80% or more of applicable Medicare Part B FFS patients of each EP
4. Registry-based reporting of one measures group for 80 percent or more of applicable Medicare Part B FFS patients of each EP (with a minimum of 8 patients).

Learn more.

Posted 06/24/2010

ONC Issues Final Rule to Establish the Temporary Certification Program for EHR Technology

The Office of the National Coordinator for Health Information Technology (ONC) issued a final rule to establish a temporary certification program for electronic health record (EHR) technology. The temporary certification program establishes processes that organizations will need to follow in order to be authorized by the National Coordinator to test and certify EHR technology.

Use of “certified EHR technology” is a core requirement for providers who seek to qualify to receive incentive payments under the Medicare and Medicaid Electronic Health Record Incentive Programs provisions authorized in the Health Information Technology for Economic and Clinical Health (HITECH) Act. HITECH was enacted as part of the American Recovery and Reinvestment Act (ARRA) of 2009. The Centers for Medicare & Medicaid Services will soon issue final regulations to implement the EHR incentive programs.

Learn more.

Posted 06/24/2010

July 2010 Average Sales Price (ASP) Files Are Now Available

The Centers for Medicare and Medicaid Services (CMS) has posted the July 2010 ASP and NOC pricing files and crosswalks. The ASP pricing files for April 2010, January 2010, October 2009, and July 2009 have also been updated. All are available for download.

Click here.

Posted 06/24/2010

FDA Approves Jevtana® (cabazitaxel) Injection

Sanofi-aventis announced June 17 that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for Jevtana® (cabazitaxel) Injection in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen.

Jevtana, a microtubule inhibitor, in combination with prednisone was approved based on results from the Phase 3 TROPIC clinical study involving 755 patients with mHRPC previously treated with a docetaxel-containing treatment regimen. Results from this trial demonstrated a statistically significant 30 percent [HR=0.70 (95 percent CI: 0.59-0.83); P<0.0001] reduction in risk of death from mHRPC among patients taking Jevtana in combination with prednisone compared with an active chemotherapy regimen consisting of a standard dose of mitoxantrone and prednisone. Investigator-assessed tumor response rates using Response Evaluation Criteria in Solid Tumors (RECIST) were 14.4 percent and 4.4 percent for cabazitaxel-treated and mitoxantrone-treated patients respectively, p=0.0005. No complete responses were observed on either arm.

Posted 06/18/2010

FDA approves Tasigna® for Newly Diagnosed CML Patients

On June 17, following a priority review, the U.S. Food and Drug Administration (FDA) approved Tasigna® (nilotinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. With this approval, Tasigna becomes the first new therapeutic option for newly diagnosed patients since the introduction of Gleevec® (imatinib). The U.S. approval was based on results of the ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients) Phase III clinical trial, which were published in The New England Journal of Medicine (NEJM).

Tasigna is a potent and selective inhibitor of the Bcr-Abl protein that causes production of cancer cells in Ph+ CML2,3. It is also active against a broad spectrum of Bcr-Abl mutations associated with resistance to Gleevec. The first clinical trials of Tasigna began only 21 months after its discovery, with the drug receiving its first regulatory approval as a second-line treatment in 2007.

Posted 06/18/2010

New HCPCS Code for Oforta (Fludarabine Phosphate Tablets)

The Centers for Medicare & Medicaid Services (CMS) has assigned a new Healthcare Common Procedure Coding System (HCPCS) billing code to Oforta™ (fludarabine phosphate tablets): Q2025 (fludarabine phosphate, oral, 1 mg).

Q2025 (fludarabine phosphate, oral, 1 mg) should replace code J8999 (Prescription drug, oral, chemotherapeutic, not otherwise specified) when submitting Medicare claims for OFORTA™ for dates of services on or after July 1, 2010.

Correct billing for OFORTA™ must be billed to reflect a 1 mg billing unit. Example: One 10 mg tablet = 10 billing units of Q2025.

Other payers, including private payers and Medicaid programs, may update their claims processing systems with this new code on an alternate schedule. Many payers will continue to require the NDC, rather than Q2025, when billing for OFORTA™.

DME MACs still require providers to list the 11-digit NDC code (00024-5820-20), manufacturer’s name (sanofi-aventis), drug name (OFORTA™), and the number of tablets reported as units in the narrative field of the CMS-1500 claim form.

For any questions regarding billing and reimbursement of OFORTA™, contact the PACT+® Program at 1-800-996-6626, www.pactplusonline.com, Monday–Friday, 9 am–8 pm ET.

Posted 06/8/2010

CMS Issues Another Clarification to Physician Supervision Requirements for Hospital Outpatients

The Centers for Medicare & Medicaid Services (CMS) issued a transmittal on May 28 clarifying its policies requiring physician supervision of diagnostic and therapeutic services provided to hospital outpatients. According to the transmittal, “physician assistants, nurse practitioners, clinical nurse specialists, and certified nurse midwives who operate within the scope of practice under state law may order and perform diagnostic tests” outlined in the Medicare manual and previous guidance. However, they “are not permitted to function as supervisory 'physicians' for the purposes of other hospital staff performing diagnostic tests.”

The transmittal stated that physician assistants, nurse practitioners, clinical nurse specialists, and certified nurse midwives only require physician supervision “included in any collaboration or supervision requirements particular to that type of practitioner when they personally perform a diagnostic test.”

ACCC is analyzing the language and will post analysis soon on its website.

Posted 06/2/2010

FDA Public Health Alert: Healthcare Professionals Warned Not To Use Certain Intravenous Ondansetron and Ciprofloxacin Due To Potential Contamination

On May 29, 2010, the U.S. Food and Drug Administration (FDA) alerted healthcare professionals not to use certain intravenous bags of ondansetron, ciprofloxacin, and metronidazole because of potential contamination. FDA has received reports of floating matter in IV bags manufactured by Claris Lifesciences Limited.

Read more.

Posted 06/2/2010

Peripheral T-Cell Lymphoma Registry Gets Underway

If your center sees at least one newly diagnosed patient with peripheral T-cell lymphoma (PTCL) each year, you may be able to participate in COMPLETE (Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment), a new international registry of patients with PTCL. The Registry is an observational study and is designed to complement clinical studies in PTCL.

Email complete.ptcl@actsolutions.org, or call 215.801.4017 for more information.

Posted 06/2/2010

Update: Holding of June 2010 Claims for Services Paid under the 2010 Medicare Physician Fee Schedule

The Continuing Extension Act of 2010, enacted on April 15, 2010, extended the zero percent (0%) update to the 2010 Medicare Physician Fee Schedule (MPFS) through May 31, 2010. The Centers for Medicare & Medicaid Services (CMS) believes Congress is working to avert the negative update scheduled to take effect June 1, 2010. To avoid disruption in the delivery of healthcare services to beneficiaries and payment of claims for physicians, non-physician practitioners, and other providers of services paid under the MPFS, CMS has instructed its contractors to hold claims containing services paid under the MPFS (including anesthesia services) for the first 10 business days of June. This hold will only affect MPFS claims with dates of service June 1, 2010, and later. This hold should have minimum impact on provider cash flow because, under the current law, clean electronic claims are not paid any sooner than 14 calendar days (29 for paper claims) after the date of receipt.

Be on the alert for more information about the 2010 Medicare Physician Fee Schedule Update.

Posted 05/28/2010

NCI Community Cancer Centers Program (NCCCP) Releases Request for Information

The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) has released a Request for Information (RFI) to those cancer programs interested in participating in the NCCCP network and receiving the complete Request for Proposal (RFP). The RFI provides an opportunity for NCI to obtain comments related to the potential future RFP’s statement of work, requirements, and deliverables. Comments are due by June 30, 2010.

Learn more.

The NCCCP began as a pilot program in 2007 as a network of community hospital cancer centers that is working to provide the most current, research-based cancer care spanning the full cancer continuum – from prevention, screening, diagnosis, treatment and survivorship through end-of-life care, with an emphasis on minority and underserved populations. NCCCP centers are studying ways to reduce healthcare disparities, improve access to clinical trials, improve overall quality of care, promote an infrastructure to collect high-quality biospecimens such as blood and tissue samples for research, and to link with national computer networks that support research. The centers also work to improve survivorship, palliative care services, and patient advocacy.

Posted 05/27/2010

Palmetto Re-Tapped as J11 MAC Contractor, to Process Claims For 18 States

A disputed, five-year federal contract worth $304.5 million to process Part A, Part B, home health, and hospice claims in 18 states was re-awarded Friday to Palmetto GBA, the Centers for Medicare & Medicaid Services (CMS) said in a memo to congressional staff. Palmetto initially won the contract in January 2009, but it was blocked by a protest to the Government Accountability Office and remained in limbo for 15 months. The agency told health staffers in an e-mail Monday that it had “conducted a thorough review of revised final proposal revisions and determined Palmetto GBA represented the best value to the Government.”

The J11 Medicare Administrative Contractor processes Part A/Part B claims in North Carolina, South Carolina, Virginia, and West Virginia, as well as home health and hospice claims for 16 states (that include North Carolina and South Carolina).

Palmetto also serves as the J1 MAC, which serves California and Nevada. That award was also protested, but the GAO upheld CMS' decision to issue the contract to Palmetto, despite efforts by the former California carrier, National Heritage Insurance Co. Palmetto also holds the DME MAC contract for 15 states, Puerto Rico and the Virgin Islands.

In documents sent to Capitol Hill today, CMS said that MACs now conduct “65 percent of claims administrative services ... and expects to complete the implementation of the remaining contracts by October 2011.”

Stemming from the Medicare Modernization Act, the MAC program was envisioned as a way to streamline Medicare claims processing and reduce the number of contractors that act as middle men from about 45 down to 15. The effort to merge Part A and Part B claims processing activities, as well as DME, home health and hospice claims, has, however, faced hurdles.

Posted 05/24/2010

A Call to Action! Review and Comment on Proposed Changes to CoC Standards

Representing ACCC, Immediate Past-President, Luana R. Lamkin, RN, MPH, attended a recent meeting of the American College of Surgeons (ACoS) Commission on Cancer (CoC), which proposed several key changes to its current standards. A number of the new standards focus on patient support and quality measurement. While final review will take place this summer, ACCC members are encouraged to review the current draft standards and submit comments through June 30 at: http://www.facs.org/cancer/coc/cps2011.html. The May 2010 meeting marked the culmination of two years of work, including the Cancer Program Standards revision project and two National Cancer Data Base (NCDB) programs.

While all standards, revisions, deletions, and additions are available on the CoC website, ACCC members may want to look specifically at the following proposed additions, deletions, and changes.

Proposed Additional Standards

1. Seventy-five percent of the appointed physician and non-physician members, respectively, attend each meeting of the cancer committee, or other appropriate leadership body, annually.
2. Palliative care services are available onsite or by referral.
3. Cancer risk assessment, genetic counseling, and testing services are provided onsite or by referral.
4. The cancer committee, or other appropriate leadership body, develops a policy and procedure to provide a clear scope of activities, roles, and responsibilities of patient navigation services within the healthcare team. The policy is reviewed at least annually.
5. The cancer committee, or other appropriate leadership body, develops a process to monitor screening of cancer patients for psychosocial distress.
6. The cancer committee, or other appropriate leadership body, works with the psychosocial representative to monitor the effectiveness of psychosocial activities on an annual basis. The activities and findings are documented in a Psychosocial Services Annual Summary Report presented to the cancer committee annually.
7. The cancer committee, or other appropriate leadership body, develops a process to implement and monitor dissemination of a comprehensive care summary and follow-up plan to cancer patients completing cancer treatment. The process is monitored, evaluated, and presented at least annually to the cancer committee, or other appropriate leadership body, and documented in minutes.
8. A Cancer Liaison Physician serves in a leadership role within the cancer program and is responsible for evaluating and interpreting the facility's performance using the National Cancer Data Base (NCDB) data and reporting to the cancer committee at least every three months.
9. It is recommended that each program develop a Cancer Program Activities Manual that describes the activities of the cancer program. The description of this manual should be included in the introduction section of the Cancer Program Standards Manual.
10. It is recommended that that each program develop a Cancer Registry Policy and Procedure Manual that describes the activities of the cancer registry.

Proposed Deleted Standards

1. Standard 2.3: Based on category requirements, one coordinator is designated for each of the specified areas of cancer program activity.
2. Standard 2.6: The cancer committee, or other appropriate leadership body, establishes the cancer conference frequency and format on an annual basis.
3. Standard 2.11: Each year, the cancer committee, or other appropriate leadership body, analyzes patient outcomes and disseminates the results of the analysis.
4. Standard 4.5: Nursing provides leadership for oncology patient care.

Proposed Changes to Existing Standards

1. Under Eligibility Requirements, that language of "Board Certified or Board eligible” revised to: “Board Certified or in the process of being Board Certified."
2. Standard 2.10: The standard and definition have been changed to specify that the cancer committee, or appropriate leadership body, will address data inequities identified by the quality control review.
3. Standard 2.5: The definition has been changed to indicate that only a clinical and programmatic goal is required. All programs will set an annual goal in each of these areas. The status of each goal is evaluated and documented at least twice annually. Goals can carry over from one year to the next as long as new goals are also established each year.
4. Standard 2.8: The standard and documentation have been changed to increase the percentage of cases presented annually at cancer conference (from 10 percent to 15 percent), to specify that 80 percent of the cases discussed involve planning the first course of treatment, and to include the discussion of site-specific prognostic indicators. A Commendation rating is given if 25 percent or more of the annual analytic caseload is discussed at conference annually.
5. Standard 3.1: The standard has been changed to require abstracting by a CTR. The standard will be phased-in over three years. After that time, abstracting by non CTRs is not permitted.
6. Standard 4.4: The definition has been changed to indicate that the nursing service or department verifies the credentials of the nurses and reports this finding to the cancer committee at least annually.
7. Standard 5.2: The standard has been changed to increase the required clinical trial accrual rate and the commendation clinical trial accrual rate for most categories. The increased rates will be phased-in over three years. Proposed minimum accrual would be as follows: Integrated (network) programs, 6 percent; NCI-designated programs, 15 percent; Teaching (Academic) programs, 6 percent; VA Programs, 2 percent; Pediatric Programs, 30 percent; community programs (> 500 cases) 4 percent; community programs (< 500 cases), 2 percent; and freestanding programs, 2 percent.
8. Standard 6.2: The standard has been changed to focus on annual development of a screening or early detection program by the cancer committee and includes a process to follow up on positive findings identified during the program.
9. Standard 6.3: The standard has been changed to focus on the cancer committee’s monitoring of community outreach activities through the preparation of a community outreach annual summary report, which is prepared by the community outreach coordinator and presented to the committee at least annually. The standard will be moved to the quality improvement chapter.
10. Standard 7.2: The commendation rating has been changed to include CTR attendance at a national, regional, or state cancer-related meeting once during the three year survey cycle.
11. Standard 8.2: The standard has been changed to strengthen the role of the quality improvement coordinator in quality improvement activities and to focus on the implementation of improvements that are directly related to completed studies of quality. The existing commendation for this standard has been deleted.

Posted 05/19/2010

Congratulations to ACCC Secretary and Board Member Virginia T. Vaitones, MSW, OSW-C

Virginia T. Vaitones, MSW, OSW-C, received the prestigious Association of Oncology Social Work (AOSW) Leadership in Oncology Social Work Award at the recent AOSW meeting in Phoenix, Ariz.

Ginny is an oncology social worker at the Penobscot Bay Medical Center, Cancer Care Center, in Rockport, Maine. She has served on ACCC’s Board of Trustees since March 2008 and served on various committees, including the Guidelines Committee, the Program Committee, and the Patient Advocacy Committee. She currently is ACCC Secretary and chairs the Patient Advocacy Subcommittee of the Governmental Affairs Committee. (She was co-chair, 2006-2007.) She has provided a strong voice to the ACCC’s advocacy efforts. In January 2010, for example, Ginny participated in an educational briefing on Capitol Hill, where she helped raise awareness among legislators and their staffs about new oral anti-cancer agents, how they may change oncology care, and the difficulties cancer programs have in securing these medications for patients. In addition, she has advocated for proper reimbursement for pharmacy overhead services in the hospital outpatient department. Over the years, she has worked with ACCC to support such legislation as Senator Kennedy’s Comprehensive Cancer Care bill, as well as legislation to eliminate the Medicare waiting period.

Since 2005, Ginny has been a driving force within ACCC’s Guidelines Committee. As a long-time Committee member, Ginny helped craft the ACCC guideline on patient navigation within ACCC’s Cancer Program Guidelines. She detailed the components that a model patient navigation program should have. The guideline helps define patient navigation within the context of cancer care and outlines key elements needed to provide comprehensive patient navigation services.

ACCC congratulates her for work well done!

Posted 05/17/2010

CMS Issues Change on Payment Reduction to Certain Diagnostic Imaging Procedures

The Centers for Medicare & Medicaid Services (CMS) issued a one-time change notification regarding the multiple procedure payment reduction on the technical component of certain diagnostic imaging procedures. Effective July 1, 2010, for implementation on July 6, CMS will increase the technical component from 25 percent to 50 percent.

Click here to view the transmittal. Go to page 2 to view current payment, and payment as of July 1.

Posted 05/12/2010

Cancer Costs Double in Less than 20 Years

Over a period of nearly two decades, the medical costs of cancer care almost doubled in constant dollars, but remained proportional to other medical costs, according to a study published in the recent Cancer journal. (Tangka FJ et al. "Cancer treatment cost in the United States: Has the burden shifted over time?" Cancer 2010; 116: DOI: 10.1002/cncr.25150.) Over the same time—from 1987 to 2005—cancer costs shifted away from inpatient care, according to Florence Tangka, PhD, of the CDC, and colleagues.

Across payers, cancer inpatient costs fell from 64.4 percent of total costs in 1987 to 27.5 percent during 2001-2005. In real terms, total inpatient spending on cancer dropped from $15.9 billion to $13.2 billion, essentially because the probability of receiving inpatient cancer treatment decreased markedly for every payer, the researchers said. At the same time, outpatient costs attributable to cancer increased nearly fourfold, from $7.5 billion to $30.3 billion.

Read more.

Posted 05/10/2010

New England Journal of Medicine Tackles Solutions to Medicare Physician Payment System

The May 5, 2010, New England Journal of Medicine explores problems with the Medicare physician payment system, "an arbitrary, if elegantly conceived, formula for total payments to physicians—the sustainable growth rate (SGR)." The SGR will reduce Medicare's physician payments, which already trail those from private insurers, as far into the future as the eye can see, according to the article. Moreover, there is widespread consensus that the relative fees in the current system are a significant cause of the growing imbalance in supply and utilization between primary care and specialty services in the U.S. health care system. That imbalance, in turn, is widely perceived as a major cause of both excessive costs and inadequate quality of care.

Read more.

Posted 05/10/2010

FDA Approves Provenge, Plans Underway to Treat 2,000 Patients

The U.S. Food and Drug Administration (FDA) approved Provenge (Sipuleucel-T) for use in treating metastisized prostate cancer as of April 29. Provenge is an immune therapy created by harvesting immune cells from a patient, genetically engineering them to fight prostate cancer, and then infusing them back into the patient. Provenge is the first treatment of its kind to win FDA approval. The FDA decision comes almost exactly one year after encouraging evidence from Phase III clinical trials showed that the therapy would extend life a median 4.1 months over placebo—about half of patients were below that amount and half were above. But some of the patients remain alive years after the treatment. In the most recent trial, 32 percent of Provenge-treated patients remained alive three years after treatment. Only 23 percent of placebo-treated patients survived that long.

Dendreon had already begun developing three manufacturing plants for Provenge before FDA approval (as early as 2006). In the next year, Dendreon will complete construction and secure licensure for these plants. With the facilities they already have the company is looking to provide full treatments for about 2,000 patients in the months ahead. Those patients will be treated in about 50 oncology clinics around the U.S. and Canada, all (or most) of which were involved in Provenge/Sipuleucel-T clinical trials. A Dendreon spokesmen said that Provenge will be priced around $31,000 per infusion, with three infusions necessary for a full treatment ($93,000 total). They anticipate that most insurance carriers will cover the treatment, and they have set up a patient financial assistance program. The “Dendreon On-Call” service will be available to provide oncology support for patients as well as guide them in accessing the treatment.

Posted 04/29/2010

13 ACCC-Member Cancer Programs Added to NCCCP

The National Cancer Institute Community Cancer Centers Program (NCCCP) will add 14 new hospitals to its current network. Of these, 13 are ACCC-member cancer programs. Congratulations to:

• Albert Einstein Medical Center, Philadelphia, Pa. (Einstein Cancer Center and Einstein Center One)
• Geisinger Medical Center, Danville, Pa. (Geisinger Medical Center Cancer Institute)
• Gundersen Lutheran Medical Center, La Crosse, Wisc. (Gundersen Lutheran Center for Cancer & Blood Disorders)
• Lehigh Valley Hospital, Allentown, Pa. (John and Dorothy Morgan Cancer Center)
• Maine Medical Center, Portland, Maine (Maine Medical Center Cancer Institute)
• Mercy Medical Center, Des Moines, Iowa (Mercy Cancer Center)
• Northside Hospital, Atlanta, Ga. (Northside Hospital Cancer Care Program)
• Norton Suburban Hospital, Louisville, Ky. (Norton Cancer Institute)
• Providence Portland Medical Center, Portland, Ore. (Providence Cancer Center)
• The Queen's Medical Center, Honolulu, Hawaii (The Queen's Cancer Center)
• St. Joseph Mercy Hospital, Ann Arbor, Mich. (St. Joseph Mercy Cancer Care Center)
• St. Luke's Regional Medical Center, Boise, Idaho (Mountain State Tumor Institute)
• Saint Mary's Health Care, Grand Rapids, Mich. (The Lacks Cancer Center)

NCI, part of the National Institutes of Health (NIH), is using $80 million from the American Recovery and Reinvestment Act (ARRA) to expand research benefitting patients at the 16 member hospitals of the NCCCP and to add 14 new hospitals to the current network. The expansion uses approximately $40 million of ARRA funds to support additional research opportunities within the original network of 16 NCCCP sites and another $40 million of ARRA funds to expand the network to include 14 new community cancer centers, for a total of 30 sites in 22 states.

The NCCCP began as a pilot program in 2007 as a network of community hospital cancer centers that is working to provide the most current, research-based cancer care spanning the full cancer continuum – from prevention, screening, diagnosis, treatment and survivorship through end-of-life care, with an emphasis on minority and underserved populations. The program is designed as a community-based platform to support basic, clinical, and population-based initiatives that are working to produce effective new prevention strategies and treatments for cancer patients.

NCCCP centers are studying ways to reduce healthcare disparities, improve access to clinical trials, improve overall quality of care, promote an infrastructure to collect high-quality biospecimens such as blood and tissue samples for research, and to link with national computer networks that support research. The centers also work to improve survivorship, palliative care services, and patient advocacy.

For more information about the program, visit http://ncccp.cancer.gov.

Posted 04/28/2010

Neulasta Co-Pay Support Program Updated

Amgen Inc. announced an update to its Neulasta FIRST STEP™ Program, a co-pay support program that assists eligible, commercially insured patients receiving Neulasta®. The program now covers deductibles as outlined in a letter mailed to business directors of hospitals and oncology office practice managers in community oncology clinics.

During the first cycle of a new chemotherapy regimen, Amgen will pay an eligible patient’s entire Neulasta® deductible, co-insurance, and/or co-payment requirements. For all subsequent chemotherapy cycles, Amgen will pay the Neulasta® out-of-pocket amount in excess of an eligible patient’s required portion of $50 per cycle.

Click here to read the letter and learn more.

Posted 04/20/2010

Donald M.Berwick Nominated to CMS Administrator Post

On April 19 President Obama nominated Harvard professor Donald M. Berwick, MD, MPP, to be administrator of the Centers for Medicare & Medicaid Services (CMS). The top CMS post has been vacant since late 2006. Dr. Berwick must be approved by the Senate Finance Committee and the full Senate before beginning his position, according to BNA Health Care Daily Report.

Dr. Berwick is president and chief executive officer of the Institute for Healthcare Improvement (IHI), a not-for-profit organization promoting the improvement of health care. He is also a clinical professor of pediatrics and healthcare policy at the Harvard Medical School and professor of health policy and management at the Harvard School of Public Health. Dr. Berwick is a pediatrician on the adjunct staff in the Department of Medicine at Boston Children’s Hospital and a consultant in pediatrics at Massachusetts General Hospital.

Among other positions, Dr. Berwick served as chair of the National Advisory Council of the Agency for Healthcare Research and Quality (1999-2001) and is an elected member of the Institute of Medicine (IOM). He was vice chair of the U.S. Preventative Services Task Force (1990-1996). From 1987 through 1991, Dr. Berwick was co-founder and co-principal investigator for the National Demonstration Project on Quality Improvement in Health Care (NDP). He was appointed by President Clinton to serve on the Advisory Commission on Consumer Protection and Quality in the Healthcare Industry in 1997 and 1998.

He has published more than 130 scientific articles in numerous professional journals on topics related to healthcare policy, decision analysis, technology assessment, and healthcare quality management.

Posted 04/20/2010

Physician Pay Cut Delayed through May 31

On April 15, President Obama signed the Continuing Extension Act of 2010, delaying the 21 percent Medicare payment reimbursement cut for physicians through May 31, reports BNA Daily Health Care Report.

Late on April 15, the House passed the bill by a 289-112 vote. The bill passed the Senate earlier by a 59-38 vote. With passage of the legislation (H.R. 4851), physicians will not face a reduction in reimbursement.

The Centers for Medicare & Medicaid Services (CMS) has been holding claims, waiting for congress to act on the bill. In a statement, the agency said that it "has instructed Medicare contractors to begin processing claims under the new law for services provided by physicians, non-physician practitioners (NPPs) and others paid under the MPFS [Medicare Physician Fee Schedule]. Most claims with dates of service April 1 and later were held by Medicare in anticipation of congressional action."

The bill also includes a provision that would allow certain hospital-based physicians to be eligible for health IT "meaningful use" incentives under the American Recovery and Reinvestment Act (ARRA).

Posted 04/19/2010

Healthcare Reform and Oncology: More than 350 ACCC Members Listen In To Conference Call Analysis

On April 13, 2010, more than 350 ACCC members listened to a conference call about healthcare reform and its effects on cancer care. The complete slide show and phone call recording are available to ACCC members.

Read more.

Posted 04/16/2010

Oncology Nursing and Social Work Professional Associations Release Position on Patient Navigation

The Oncology Nursing Society (ONS), the Association of Oncology Social Work (AOSW), and the National Association of Social Workers (NASW) worked together to develop a joint position statement on the role of oncology nursing and oncology social work in patient navigation. The joint position is a direct result of a think tank that convened in Pittsburgh, PA, in June 2009, during which representatives from ONS and AOSW worked collaboratively, along with representation from NASW, to discuss the role of patient navigation and identify needs of the healthcare professional in this emerging new role for oncology nurses and social workers as they care for patients from pre-diagnosis through all phases of the cancer experience.

Read more.

The Association of Community Cancer Centers' Center for Provider Education provides ACCC members with an extensive online resource about Cancer Care Patient Navigation.

Posted 04/14/2010

Healthcare Reform Establishes New Requirements for Tax-Exempt Hospitals

The recently enacted healthcare reform legislation includes important new requirements for tax-exempt hospitals. The Patient Protection and Affordable Care Act of 2010 (the “Act”) was signed into law by President Obama on March 23, 2010. Most of the provisions in the Act applicable to tax-exempt hospitals are effective for tax years beginning after March 23, 2010. Tax-exempt hospitals will want to review existing policies and procedures prior to the start of the next tax year to ensure compliance.

The new requirements apply to any Section 501(c)(3) organization that operates a facility which is required by a state to be "licensed, registered or similarly recognized as a hospital," and to any other organization that has the principal function or purpose of providing hospital care as the basis for its tax-exempt status. If an organization operates more than one hospital facility, requirements apply separately to each hospital.

New Exemption Requirements: New Section 501(r) of the Internal Revenue Code imposes four requirements on hospitals seeking to qualify for and maintain tax-exempt status.

Read more about the exemption requirements in a document prepared by the law firm of Hogan & Hartson.

Posted 04/6/2010

ACCC to Study Challenges in Treating Small-Population Cancers in the Community Setting

The Association of Community Cancer Centers (ACCC) has launched a ground-breaking program to provide community-based cancer care providers the tools they need to improve the quality of care for patients with small-population cancers, such as chronic myeloid leukemia (CML).

"Caring for patients with less common cancers presents unique challenges for community-based cancer care providers," said ACCC President Al B. Benson III, MD, FACP. “Physicians treating small-population cancers have limited time and resources to incorporate emerging clinical data into practice. Other health professionals, including nurses, social workers, and pharmacists, see these diseases less frequently and need information to better support the physician and the patient.”

The project is made possible by an educational grant from Novartis Oncology and will take about two years to complete.

ACCC surveys revealed that many community-based cancer care providers see a relatively high number of patients with breast, lung, colon, or prostate cancer. Practice patterns are relatively well-established for these cancers and resources are available for both providers and patients. Patients with a small-population cancer, however, usually are underserved or elderly and may not have the resources or desire to be treated far away from their homes.

ACCC’s first objective will be to raise awareness among the public and healthcare providers about the challenges presented by small-population cancers, and the need to assess barriers to treatment and best practices within the community setting. Barriers include limited physician and cancer team knowledge of emerging data, difficulties in incorporating new clinical information into practice, and inadequate managerial and administrative processes in treating small-population cancers like CML.

Read more.

Posted 04/5/2010

Medicare Will Cover PET Scans to Detect Bone Metastasis of Cancer Under CED Only

On March 29, affirming an earlier proposed coverage decision, the Centers for Medicare & Medicaid Services (CMS) announced that Medicare will cover positron emission tomography (PET) scans to identify bone metastasis of cancer only under Coverage With Evidence Development (CED).

ACCC submitted comments to CMS on December 30, 2009, in which it agreed that NaF-18, or sodium fluoride-18 (a radioactive tracer), PET is promising. ACCC believes that the evidence is sufficient to cover the test as prescribed by physicians, however, without CED.

In a final decision memo dated Feb. 26, CMS said it will cover NaF-18 PET imaging only when the beneficiary's treating physician determines that an NaF-18 PET study is needed to “inform the initial antitumor treatment strategy or to guide subsequent antitumor treatment strategy after the completion of initial treatment.” CMS also said it would cover the imaging procedure when the beneficiary is enrolled in, and the NaF-18 PET provider is participating in, a specific type of prospective clinical study.

In ACCC's comments, we noted that, "Rather than limiting coverage to beneficiaries who participate in a study, we recommend that CMS encourage beneficiaries and providers to participate in studies but not require participation for coverage of NaF-18 PET."

In a Nov. 30, 2009, proposed decision memo, CMS said that the available evidence is not sufficient to determine that the results of NaF-18 PET imaging improve health outcomes of beneficiaries with cancer (229 HCDR, 12/2/09).

According to the final memo, NaF-18 PET has been recognized as "an excellent technique for imaging areas of altered osteogenic activity in bone."

CMS said the new coverage policy will be implemented July 6.

Posted 03/31/2010

ACCC Submits Comments to CMS About Radiation Therapy for Localized Prostate Cancer

On March 22, 2010, the Association of Community Cancer Centers (ACCC) provided comments to the Centers for Medicare & Medicaid Services (CMS) regarding the Medicare Development & Coverage Advisory Committee (MEDCAC) meeting on radiation therapy for localized prostate cancer. ACCC believes that each cancer patient should have access to the most appropriate treatment options for his condition, including various forms of radiation therapy for localized cancer.

On April 21, 2010, MEDCAC will consider the currently available evidence regarding the risks, benefits, and outcomes of radiation therapy, inclusive of external beam radiotherapy and brachytherapy, for the treatment of localized prostate cancer.

ACCC urged the agency "to recognize that each form of radiation therapy presents unique benefits and risks for patients with prostate cancer. . . Medicare's coverage policies must continue to allow beneficiaries access to the full range of treatment options so that each patient diagnosed with cancer has the best chance of survival."

ACCC also urged CMS to consider the effect of its coverage policies on access to future improvements in care. “Unduly restrictive Medicare coverage and uncertainty about Medicare coverage could discourage such investment, restrict treatment options, and deny patients the benefits of emerging technology.”

Read more.

Posted 03/23/2010

Historic HealthCare Bill Passes House of Representatives:
How Will Oncology Care Fare?

On March 21, the House of Representatives passed a landmark healthcare bill that seeks to extend health coverage to most Americans. An estimated 24 million people who lack access to affordable coverage through the workplace will be eligible for tax credits to buy insurance on new state-based exchanges. Medicaid, the federal-state program that provides health insurance to the poor and disabled, will be expanded to cover all adults earning less than 133 percent of the federal poverty level.

Bill sponsors predict that all but about 5 percent of non-elderly Americans will ultimately be covered. Half of those currently uninsured will receive coverage through the expansion of Medicaid and half through private insurance through the exchanges — often with subsidies that make up the bulk of the legislation's projected costs.

How will oncology care fare? Under the healthcare legislation, oncology comes out without cuts to its core businesses of medical oncology, radiation oncology, office administered drugs, or PET/PET-CT imaging.

Among the provisions that directly affect oncology care:

1. Voluntary participation in accountable care organizations (ACOs). ACOs will manage and coordinate care across settings. Here, the concept is to improve value and control costs by aligning provider incentives toward integration, quality, and efficiency. Coordinating patient care across settings and using lower cost/equally effective regimens will be rewarded. ACOs can include physician groups, networks of physician groups, joint ventures between a hospital and physicians, hospitals with employed physicians, and integrated delivery systems.
2. CMS Innovation Center. The new legislation funds $10 billion to test new innovative payment models within the Medicare system. It specifies 13 models that CMS must consider. One model is specific to oncology: Align nationally recognized, evidence-based guidelines of cancer care with Medicare payment incentives in the areas of treatment planning and follow-up care planning for Medicare beneficiaries with cancer.
3. Generic incentives. The healthcare reform legislation will pay biosimilars at the average sales price of the biosimilar plus 6 percent of the ASP of the reference/innovator biologic. The goal: to remove the incentive for using the higher cost drugs.
4. Clinical trials. The legislation requires insurance company coverage of routine care costs associated with a patient’s participation in a clinical trial. Bottom line: perhaps increased trial participation.
5. New fees on medical device manufacturers. This will mean, for example, higher costs for such equipment as linear accelerators.
6. Payment Advisory Board. The Senate version of the legislation creates an independent payment advisory board to make recommendations to Congress. The goal: reduce Medicare spending by $28 billion.

ACCC will update members about specific measures within the bill.

Although the bill has been passed by the House and will be signed into law by the President, most of the provisions do not take effect right away. The elimination of pre-existing conditions rules for adults does not take effect until 2014, as do some of the new taxes and fees. There are some provisions that will start this year, including the elimination of pre-existing conditions for children and the expansion of coverage of young adults on their parents’ insurance until age 26.

Note that the healthcare debate is far from over. The Senate still needs to pass the reconciliation, or fixes, bill in order to implement some of the changes the President and members of the House of Representatives wanted in the final bill.

ACCC expects the Senate to take up the fixes bill soon, but it may be some time before it is passed. There continues to be strong opposition from the Republican Party, and there are a number of tactics at their disposal to slow the process.

Posted 03/22/2010

Al B. Benson III, MD, FACP, Becomes President of the Association of Community Cancer Centers

Al B. Benson III, MD, FACP, became President of the Association of Community Cancer Centers at its 36th Annual Meeting on March 19, 2010. Dr. Benson is a professor of medicine in the Division of Hematology/Oncology at Northwestern University Feinberg School of Medicine in Chicago, Ill. He is also associate director for clinical investigations, Robert H. Lurie Comprehensive Cancer Center, at Northwestern.

“I am honored to serve as President of the Association of Community Cancer Centers,” said Dr. Benson. “During my year as ACCC President, I hope to give voice to the importance of putting comparative effectiveness research and evidence-based medicine into practice. ACCC needs to be at the table with other oncology organizations. Oncology must have a definitive voice in the comparative effectiveness debate and how it evolves.”

Dr. Benson has served on ACCC’s Board of Directors since 2003 and has been active on ACCC’s Strategic Planning Committee, Editorial Committee, New Technology Committee, Corporate Development Committee, Awards Committee, Bylaws Committee, Program Committee, and Membership Committee.

Dr. Benson was an assistant professor of medicine at the University of Illinois and co-medical director for the National Public Health Service in Champaign, Ill. He then served as a clinical oncology fellow at the University of Wisconsin Clinical Cancer Center, where he received an American Cancer Society Fellowship Award, prior to joining the faculty at Northwestern.

Dr. Benson’s research is primarily in the areas of gastrointestinal cancer clinical trials, cancer clinical trials, biologic therapies, Phase I cancer clinical trials, and cancer guideline development. He has authored or co-authored numerous reports, reviews, and book chapters focusing on these topics. His research in biologics, cancer therapy, and cancer prevention has been awarded funding from a variety of sources including the NIH. Dr. Benson has been honored with a number of awards, including most recently the ASCO Statesman Award and the Woman’s Board of Northwestern Memorial Hospital Compassionate Care Award.

Dr. Benson has served on a number of committees for the American Society of Clinical Oncology (ASCO) and is currently a member of the Task Force on Quality of Cancer Care, and the co-chair of ASCO’s Colorectal Cancer Surveillance Guidelines Panel, the Stage II Colon Cancer Guidelines Panel and the RFA for colorectal cancer liver metastases panel. He is also the chair of the Eastern Cooperative Oncology Group Gastrointestinal and Data Monitoring Committees. In addition, he is a member of several medical societies, and serves as past-president of the Illinois Medical Oncology Society, past-president of the International Society of GI Oncology, and is a member and immediate past-chair of the board of directors of the National Comprehensive Cancer Network (NCCN). He was recently appointed as a Scientific Advisory Board member of both the Patient Advocacy Foundation and the National Patient Advocacy Foundation.

He earned his medical degree at the State University of New York at Buffalo, following which he completed an internal medicine residency at the University of Wisconsin Hospitals.

Posted 03/22/2010

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

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 02/8/2009

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

ACCC Submits Comments to CMS on Proposed NCD on PET to Identify Bone Metastasis

On Dec. 29, 2009, the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare and Medicaid Services (CMS) regarding the proposed national coverage decision (NCD) on positron emission tomography (PET) (NaF-18) to identify bone metastasis of cancer.

CMS concluded that NaF-18 PET is "promising," but "the evidence of clinical benefit is not yet conclusive and is not generalizable to the Medicare patient population."

ACCC agreed with CMS that the evidence is promising, but ACCC suggested "that the evidence is sufficient to cover the test as prescribed by physicians, however, without coverage with evidence development (CED). ACCC believes that Medicare should allow patients and physicians to select the most appropriate imaging methods for each patient." ACCC encouraged CMS to cover NaF-18 PET to ensure that patients have a choice of effective imaging modalities.

In its proposed NCD, CMS states, "there is inconsistent evidence that the results of NaF-18 PET scans are used to alter recommended treatment strategy." CMS also reports that it found "no conclusive evidence of improved patient oriented health outcomes related to NaF-18 PET studies for routine follow-up or monitoring of suspected bone metastases, except for the diagnosis of bone metastases in patients with symptomatic evidence of bone pain and with no other imaging findings of bone metastasis."

Posted 12/30/2009

CMS to Hold Claims for Services Paid Under the 2010 Medicare Physician Fee Schedule, Waits Action by Congress on SGR

The Centers for Medicare & Medicaid Services (CMS) has instructed its contractors to hold claims containing services paid under the Medicare Physician Fee Schedule (MPFS) for the first 10 business days of January (January 1 through January 15) for 2010 dates of service.

After 10 business days, contractors will begin releasing held claims into processing under the fee schedule, which implements current law. This, of course, could result in claims being processed with the 21.2 percent payment reduction. If a new law is enacted that changes the negative update effective January 1, CMS will correctly process claims under the new law and, if necessary, CMS is prepared to automatically reprocess most of those claims that have already been processed at the lower rate.

Note: The President has signed the Department of Defense Appropriations Act of 2010, which provides for a zero percent update to the 2010 Medicare Physician Fee Schedule for a two-month period, January 1, 2010, through February 28, 2010. So, unless Congress acts, physicians will be reimbursed at 2009 conversation factor until Feb 28.

To the extent possible, providers may hold claims in-house until it becomes clearer as to whether new legislation regarding sustainable growth rate (SGR) methodology will be enacted or until cash flow becomes problematic. This will reduce the need for providers to reconcile two payments (i.e., the initial claim and the reprocessed claim), and it will simplify provider billings of beneficiary coinsurance and payment calculations for payers which are secondary to Medicare.

CMS has extended the 2010 Annual Participation Enrollment Program end date from January 31, 2010, to March 17, 2010. Therefore, the enrollment period now runs from November 13, 2009, through March 17, 2010. The effective date for any Participation status change during the extension, however, remains January 1, 2010, and will be in force for the entire year.

Posted 12/19/2009

CMS Special Open Door Forum for PQRI

The Centers for Medicare & Medicaid Services (CMS) hosted a Special Open Door Forum on the 2010 PQRI and eRx Incentive programs. This discussion focused on a new reporting option, available for the 2010 PQRI and eRx Incentive Program, known as the Group Practice Reporting Option (GPRO.

Click here for archive material of this call beginning on or around 1/27/2010.

Click here to view 2010 PFS final rule (Statute/Regulations/Program Instructions page), or click here for eRX Incentive Program information.

Posted 12/18/2009

New 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. The ASP pricing files for October 2009 and January 2009 have also been updated.

Click here.

Posted 12/18/2009

Contact Your Senators: Urge Them to Pass "Stop Gap" Measure

The Association of Community Cancer Centers (ACCC) urges its members to call their U.S. Senators to urge them to pass the "stop gap" measure that will temporarily suspend Medicare cuts to physicians. Ensure that any health system reform legislation passed by Congress includes provisions to replace the flawed sustainable growth rate (SGR) formula with a new Medicare physician payment system. A vote is scheduled for December 17, 2009, which will temporarily suspend for two months the 21 percent Medicare physician payment cut that is scheduled to begin January 1, 2010.

Please join us by contacting your Senator and urge them to vote YES to this temporary suspension. To locate your Senator's contact information, click here.

Posted 12/17/2009

CMS Releases Revisions to 2010 Consultation Services Payment Policy

On December 14, 2009, the Centers for Medicare & Medicaid Services (CMS) released Change Request (CR) 6740, which alerts physicians and non-physician practitioners that effective January 1, 2010, the Current Procedural Terminology (CPT) consultation codes (ranges 99241-99245 and 99251-99255) are no longer recognized for Medicare Part B payment. Effective for services furnished on or after January 1, 2010, physicians and non-physician practitioners should code a patient evaluation and management visit with E/M codes that represent where the visit occurs and that identify the complexity of the visit performed.

Click here to view key points of the CMS policy changes.

Click here to view CR 6740.

Posted 12/17/2009

2010 Physician Quality Reporting Initiative Educational Products Now Available

The Centers for Medicare & Medicaid Services (CMS) posted online its 2010 Physician Quality Reporting Initiative (PQRI) educational products. You'll find the 2010 PQRI Quality Measure List, which identifies the 179 quality measures. Included are Hormonal Therapy for Stage IC-IIIC Estrogen Receptor/Progesterone Receptor (ER/PR) Positive Breast Cancer; Chemotherapy for Stage III Colon Cancer Patients; Avoidance of Overuse of Bone Scan for Staging Low-Risk Prostate Cancer Patients; and Adjuvant Hormonal Therapy for High-Risk Prostate Cancer Patients, among others.

Click here to view the PQRI web page.

Posted 12/16/2009

Several New HCPCS Codes to Take Effect in 2010

A number of agents have new HCPCS codes that will take effect on January 1, 2010.

• C9257, Injection, bevacizumab, 0.25 mg (Replaces deleted code Q2024, Injection, bevacizumab, 0.25 mg
• J2562, Injection, plerixafor, 1 mg (Replaces deleted code C9252, Injection, plerixafor, 1 mg
• J2796, Injection, romiplostim, 10 mcg (Replaces C9245, Injection, romiplostim, 10 mcg)
• J7185, Injection, Factor VIII (antihemophilic factor, recombinant) (Xyntha), per I.U. (Replaces Q2023, Injection, Factor VIII (antihemophilic factor, recombinant) (Xyntha), per I.U.
• J9171, Injection, docetaxel, 1 mg (Replaces J9170, Injection, docetaxel, 20 mg)
• J9328, Injection, temozolomide, 1 mg (Replaces C9253, Injection, temozolomide, 1 mg)

Look for a comprehensive coding and regulatory update in the January 2010 Oncology Issues.

Posted 12/16/2009

Infusion Nurses Society Releases Updated Reference Text, Includes FDA-approved Treatment for Anthracycline Extravasation

The Infusion Nurses Society has released the third edition of its "Infusion Nursing: An Evidence-Based Approach." This authoritative reference covers every aspect of infusion therapy, including advances in equipment, technology, best practices, guidelines, and patient safety. Other key topics include quality management, ethical and legal issues, patient education, and financial considerations.

The third edition includes Totect®, the only FDA-approved treatment for anthracycline extravasation. Anthracyclines are a group of chemotherapy medications including daunorubicin, doxorubicin, idarubicin and epirubicin. During a patient's chemotherapy treatment, whether peripheral or central venous catheter, anthracyclines can leak out of the vein or central line into surrounding healthy tissue causing a serious complication known as extravasation. Anthracycline extravasations cause extreme damage to skin and tissue if left untreated.

For more information, click here.

Posted 12/16/2009

U.S. Cancer Cases and Deaths Continued to Decline

The overall rate of new cancer cases diagnosed and deaths from cancer continued to decline significantly in the United States through 2006, due largely to lower lung, prostate, and colorectal cancer rates in men and lower breast and colorectal cancer rates in women. New diagnoses for all cancers decreased, on average, almost 1 percent per year between 1999 and 2006. Cancer deaths decreased 1.6 percent per year between 2001 and 2006. Researchers from NCI, CDC, American Cancer Society, and the North American Association of Central Cancer Registries reported these findings in the "Annual Report to the Nation on the Status of Cancer (1976-2006)," published online December 7 in Cancer.

Click here to read the report.

Posted 12/8/2009

Schering-Plough Archives Webcast on Intron A

Schering-Plough has an archived webcast intended for healthcare professionals that provides a response to the recent information that has emerged regarding the administration of INTRON® A.

The presentation is available on-demand at https://www.accessedgeweb.com/webcast.

Posted 11/19/2009

ACCC Submits Comments to CMS About AHRQ Draft Technology Assessment and Off-Label Indications for Targeted Therapies

The Association of Community Cancer Centers (ACCC) submitted comments Nov. 16, 2009, to the Centers for Medicare & Medicaid Services about the Agency for Healthcare Research and Quality’s (AHRQ) draft "Technology Assessment: Report on the Evidence Regarding Off-Label Indications for Targeted Therapies Used in Cancer Treatment." In its comments ACCC "strongly supports" efforts to improve the quality of clinical evidence available to support treatment and policy decisions. "We also acknowledge that treatment decisions must be made today with the information available now. Until any new research models are developed and implemented, CMS and other payers must continue to cover off-label treatments supported by the compendia or other published peer-reviewed research."

In its comments ACCC recognized the important and challenging role the compendia play in clinical decision-making and coverage policy. The Draft Report notes that the compendia function as a “stepping stone” between drug development and research and FDA approval. ACCC agreed with this observation. "The compendia perform a critical service to patients, physicians, and policy-makers by collecting, analyzing, and disseminating the constantly-growing body of clinical research on cancer therapies."

According to ACCC's comments, "as CMS considers the evidence on off-label uses of FDA-approved therapies, it must recognize that patients and physicians must make treatment decisions under extremely difficult circumstances, and applying unduly strict standards to the clinical evidence will deny patients access to potentially life-saving care."

Click here to read ACCC's comment letter.

Posted 11/16/2009

CMS Releases Final NCD on PET for Cervical Cancer

The Centers for Medicare & Medicaid Services (CMS) released the final National Coverage Determination (NCD) on positron emission tomography (PET) for cervical cancer on Tuesday, November 10, 2009. It's available at on the CMS website.

In brief, CMS will cover only one FDG PET for staging for beneficiaries who have biopsy proven cervical cancer when the beneficiary’s treating physician determines that the FDG PET study is needed to determine the location and/or extent of the tumor for the following therapeutic purposes related to the initial treatment strategy:

• To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or
• To determine the optimal anatomic location for an invasive procedure; or
• To determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor.

The NCD notes that "CMS may find it appropriate to exclude coverage for diagnosis of cervical cancer since this disorder is initially diagnosed by biopsy." CMS agrees that there is no credible evidence that the results of FDG PET imaging are useful to make the initial diagnosis of cervical cancer, and therefore do not improve health outcomes, and thus are not reasonable and necessary under §1862(a)(1)(A) of the Act. Therefore, CMS will not cover FDG PET for this indication.

Posted 11/11/2009

Medicare 2010 Physician Fee Schedule Removes Part B Drugs, Cuts Fees 21.2 Percent

The Centers for Medicare & Medicaid Services (CMS) Oct. 30 finalized the 2010 physician fee schedule that removes office-administered Part B drugs from the calculation of reimbursements and terminates payments for consultation services. The rule, slated to be published in the Nov. 25 Federal Register and effective Jan. 1, 2010, also finalizes a 21.2 percent reduction in the fee schedule amounts as a result of the sustainable growth rate (SGR) formula, a slight change from the proposal (21.5 percent) published this summer. In previous years, Congress has erased the reductions through temporary fixes.

Click here to read the final Physician Fee Schedule.

ACCC has assembled an in-depth analysis for members only. Log onto the Members-Only section of the website. Click on Publications and Tools.

House Democrats Oct. 29 introduced legislation (H.R. 3961) that would replace the SGR with a new formula that removes items such as drugs and laboratory services not paid directly to practitioners from spending targets; allows the volume of most services to grow at the rate of the gross domestic product plus 1 percentage point per year; and allows the volume of primary and preventive care services to grow at GDP plus 2 percent per year. The Senate Finance Committee health care reform bill (S. 1796) would increase doctors' pay by 0.5 percent in 2010.

In a redistribution of fees, consultation codes will be eliminated and work relative value units increased for new and established office visits and for initial hospital and nursing facility visits.

As reported in the Nov. 2 BNA Health Care Daily Report, CMS said that one of the changes from its earlier proposal concerns the increase of the equipment utilization percentage that is assumed for purposes of setting practice expensive relative value units (PE RVUs). In the proposal, CMS adopted a recommendation of the Medicare Payment Advisory Commission to change the equipment usage assumption for machines priced over $1 million to 90 percent—or 45 hours a week—from the current 50 percent standard—or 25 hours a week.

In the final rule, CMS will increase the rate assumption to 90 percent but will phase in this change over a four-year period. CMS also will not apply this change to expensive therapeutic equipment.

Also concerning the PE RVUs, CMS said it will use the results of a survey on practice expenses that was conducted by the AMA and other medical professional organizations. The Physician Practice Information Survey data will replace the existing data used on practice costs for establishing the PE RVUs. CMS said it will phase it in over a four-year period and will not use the Physician Practice Information data to determine the PE for medical oncology.

The final rule adds measures under the Physician Quality Reporting Initiative that allow eligible professionals to earn extra money; enable payments to groups, rather just individual practitioners; and add an electronic health records reporting mechanism.

The rule was published as final with a comment period. CMS said that comments are due by Dec. 29 on issues including the interim relative value units (RVUs) for selected codes, physician self-referral designated health services (DHS) codes, and services for consideration for the five-year review of work RVUs for certain services.

Posted 11/2/2009

CMS Adopts 2.1 Percent Payment Increase, Policy Changes for Hospital Outpatient Care

The Centers for Medicare & Medicaid Services Oct. 30 announced that most hospitals will receive an inflation update of 2.1 percent in their payment rates for services furnished to Medicare beneficiaries in hospital outpatient departments (HOPDs) under the outpatient prospective payment system (OPPS) for 2010. The final rule, scheduled to be published in the Nov. 20 Federal Register, updates payment policies and rates for both hospital outpatient departments and ambulatory surgical centers (ASCs) for next year.

Click here to read the final hospital outpatient department rule.

ACCC as assembled an in-depth analysis for members. Log onto the Members-Only section of the website. Click on Publications and Tools.

According to CMS and as reported in the Nov. 2 BNA Health Care Daily Report, total payments for services furnished to Medicare beneficiaries in HOPDs during calendar year 2010 will be $32.2 billion, a $1.9 billion increase over projected payments in CY 2009. The total projected CY 2010 payments under the ASC payment system will be approximately $3.4 billion, CMS said.

According to a fact sheet issued by the agency, the final rule contains a number of significant provisions to strengthen ties between payment and quality in hospital outpatient departments. Many were included in the proposed rule. The quality initiatives include:

• Payment reduction for failure to report quality measures. As required by law, CMS said it will reduce the CY 2010 annual inflation update factor by 2 percentage points for most services furnished by hospitals that failed to meet the CY 2009 reporting requirements of the Hospital Outpatient Department Quality Data Reporting Program (HOP QDRP). Those hospitals will see a net update of 0.1 percent. The reduction will not apply to payments for separately payable pass-through drugs, biologicals and devices, separately payable non-pass-through drugs and non-implantable biologicals, separately payable therapeutic radiopharmaceuticals, and services assigned to new technology ambulatory payment classifications (APCs).
• Quality measures to be reported. CMS said it will continue to require hospitals subject to HOP QDRP requirements to provide quality data for the current seven chart-abstracted emergency department and surgical care measures and four claims-based imaging efficiency measures for CY 2011 payment determinations.
• Validation of quality reporting. CMS said it will implement a new HOP QDRP validation requirement to ensure that hospitals are accurately reporting measures using chart-abstracted data.
• Public reporting of quality data. CMS said it is establishing procedures to make HOP QDRP quality measure data publicly available as early as June 2010.

Physician Supervision. CMS also said it is implementing a number of significant payment provisions, including physician supervision requirements. In particular, CMS said it will allow certain nonphysician practitioners—specifically physician assistants, nurse practitioners, clinical nurse specialists, certified nurse-midwives, and licensed clinical social workers—to provide direct supervision for all hospital outpatient therapeutic services that they are authorized to personally perform according to their state scope of practice rules and hospital-granted privileges. Under current policy, only physicians may provide the direct supervision of these services.

In addition, as reported in the BNA Health Care Daily Report, CMS said it is defining “direct supervision” for on-campus hospital outpatient services to mean that the physician or nonphysician practitioner must be present in the hospital or on-campus provider-based department of the hospital and immediately available to furnish assistance and direction throughout the performance of the procedure, in contrast to the current definition which requires the physician only to be present in the on-campus provider-based department.

For services furnished in an off-campus provider-based department, "direct supervision" would continue to mean that the physician or nonphysician practitioner must be present in the off-campus provider-based department and immediately available to furnish assistance and direction throughout the performance of the procedure, CMS said.

The agency also said it will require that all hospital outpatient diagnostic services furnished directly or under arrangement, whether provided in the hospital, in a provider-based department, or at a nonhospital location, follow the Medicare physician fee schedule's physician supervision requirements for individual tests.

Other payment changes listed by the agency address drugs and pharmacy overhead, pass-through implantable biologicals, partial hospitalization services, kidney disease education, pulmonary and cardiac rehabilitation, therapeutic radiopharmaceuticals, and brachytherapy sources.

Posted 11/2/2009

House Reform Bill Includes Sweeping Budget Cuts for Medicare Plans, Strips Physician Pay Fix From Health Reform

Revised health reform legislation (H.R. 3962) introduced by House Democratic leaders Oct. 29 would make sweeping changes to Medicare, including cuts of $170 billion to Medicare Advantage plans and $229 billion in savings from reductions in annual payment updates to Medicare fee-for-service providers. According to the October 30,2009, BNA Health Care Daily Report, under the bill, overall Medicare and Medicaid spending would be reduced by $426 billion over 10 years, compared with current law, according to a Congressional Budget Office analysis of the measure released Oct. 29. The bill includes a three-year reduction in payments to Medicare managed care plans to fee-for-service payment levels that would begin in 2013. Health insurers criticized the provision, saying the cuts to Medicare Advantage plans would negatively affect the health care of millions of seniors. House Democrats said the bill would cover 96 percent of Americans.

House Democratic leaders have stripped an expensive, permanent fix to Medicare's physician payment system from healthcare reform legislation (H.R. 3962) introduced Oct. 29, and instead introduced separate legislation (H.R. 3961) to fix the system. In removing the physician payment fix from the legislation, House leaders were able to lower the cost of healthcare reform legislation by about $245 billion, keeping the cost of the reform bill below $900 billion.

As reported in the October 30, 2009, BNA Health Care Daily Report, under H.R. 3961, the sustainable growth rate (SGR) formula of Medicare's physician payment system would be replaced with a new formula that removes items such as drugs and laboratory services not paid directly to practitioners from spending targets; allows the volume of most services to grow at the rate of the Gross Domestic Product plus 1 percentage point per year; and allows the volume of primary and preventive care services to grow at GDP plus 2 percent per year, according to a press released issued by the House Ways and Means and Energy and Commerce Committees.

H.R. 3961, the Medicare Physician Payment Reform Act of 2009, will be considered in the House under a procedure that will add the text of H.R. 2920, the Statutory PAYGO Act of 2009, as passed by the House on July 22 before being sent to the Senate.

House Majority Leader Steny Hoyer (D-Md.) has said a separate physician payment bill, which likely will cost at least as much as the provision removed from the reform bill, would not be acted on in the House unless it does not add to the budget deficit or was enacted along with a legislative package reinstating a pay-as-you-go budget law.

A $247 billion, unpaid-for bill canceling a 21 percent Medicare payment cut for physicians in 2010 and freezing their pay for 10 years failed to clear an initial Senate hurdle Oct. 21. Senate Majority Leader Harry Reid (D-Nev.) has said the Senate will return to the issue after healthcare reform legislation is finished. The Senate Finance Committee healthcare reform bill would increase doctors’ pay by 0.5 percent in 2010 at a cost of $10.9 billion, reports the BNA Health Care Daily Report.

Posted 10/30/2009

Senate Rejects Bid to Freeze Medicare Pay to Docs for 10 Years

A bill to cancel a 21 percent Medicare payment cut for physicians in 2010 and freeze their pay for 10 years failed to clear an initial vote hurdle Oct. 21, likely ensuring doctors again will have their payments increased for only one year before the issue is again revisited.

By a 47-53 vote, the Senate Oct. 21 failed to invoke cloture on a bill (S. 1776) to cancel the pay cut and replace it with a payment freeze. The bill, introduced by Sen. Debbie Stabenow (D-Mich.), would cost $247 billion and was not paid for, producing objections from Republicans and some fiscally conservative Democrats. The motion to invoke cloture—which would allow debate on the bill to proceed—needed to attract 60 votes to succeed. The Senate Finance Committee health care reform bill (S. 1796) would cancel the 21 percent cut and replace it with a 0.5 percent increase in 2010 at a cost of $10.9 billion.

Posted 10/22/2009

Onmark Enhances Online Physician Resources

Onmark, has enhanced its portfolio of online clinical and practice management tools for community-based practices. These resources are exclusively available to Onmark’s more than 3,000 member practices, which represent over 4,800 physicians nationwide. Onmark is a leading national group purchasing organization (GPO) for community-based practices and a McKesson Specialty Care Solutions company.

Onmark's suite of online resources encompasses four key elements of patient care. New and enhanced offerings for each phase include:

• Treatment Decision-Making: Enhanced care pathways provide guidance and references for specific episodes of care. Pathways can easily be incorporated into an electronic medical record (EMR) for treatment decision support or can be used standalone.
• Regimen Selection: New drug treatment order forms, including chemotherapy order forms, improve clinical efficiency and reduce errors by documenting all regimen components including supportive care and monitoring parameters.
• Therapy Administration: The IV Compatibility Chart, a new chemotherapy mixing and compatibility tool, helps staff understand how to handle, mix and administer drugs to support drug safety. New Risk Evaluation & Mitigation Strategy (REMS) tools are available for the practice to use to manage physician and patient compliance to REMS program requirements.
• Patient Education: 328 downloadable patient education handouts are written at the drug and regimen level for practices to provide to patients that undergo treatment. Patient financial responsibility reports in Onmark Regimen Profiler™ help patients understand the potential out-of-pocket costs for different therapeutic options and make informed treatment decisions.

Read more.

Posted 10/20/2009

FDA Approves Elitek for Management of PUA Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy

Sanofi-aventis U.S. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Elitek (rasburicase) to be used for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid.

The FDA approval was based on Phase 3 trial results that demonstrated that Elitek significantly reduced PUA levels when compared to the current standard of care (oral allopurinol) in adults with hematologic cancers at risk for the potentially life-threatening complication of TLS. Patients considered at high risk for TLS either had an elevated level of PUA (hyperuricemia) due to a malignancy, or were diagnosed with a very aggressive hematologic malignancy (leukemia or lymphoma).

Posted 10/19/2009

Prometheus Laboratories Launches Three New Diagnostic Tests

Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, announced the nationwide commercial launch of three new cancer diagnostic products: ProOnc TumorSource^Dx, ProOnc Squamous^Dx and ProOnc Mesothelioma^Dx. Each of these tests is based on recently developed, highly sensitive microRNA technology.

ProOnc TumorSource^Dx identifies the tissue-of-origin of a metastatic tumor. The test identifies 25 different tumor types, including colon, liver, brain, breast, kidney, lung, ovary, pancreas, prostate and testis, and measures the expression level of 48 microRNA biomarkers. The test uses a proprietary classifier to assign a primary site to the cancer sample based on the microRNA expression in the tumor and may become a critical tool in the detection of cancer of unknown primary (CUP).

ProOnc Squamous^Dx classifies non-small cell lung carcinoma tumors into two histological groups: cancers of squamous histology and non-squamous cancers. The test measures the expression level of a squamous microRNA biomarker to differentiate patients that have squamous cell carcinoma of the lung from patients that have non-squamous non-small cell lung cancer.

ProOnc Mesothelioma^Dx is a cutting-edge molecular diagnostic test that uses microRNA to differentiate malignant pleural mesothelioma from peripheral adenocarcinoma of the lung and metastatic carcinomas involving the lung and pleura.

Posted 10/19/2009

New Benchmarking Resource Available to Hospitals

The Oncology Business Institute (TOBI) was recently launched as a collaboration of the Oncology Management Consulting Group and Oncology Metrics and is a resource for productivity, staffing and financial benchmarks, education, and professional networking for hospital cancer centers. Hospital cancer centers will have access to applicable information and resources designed specifically to answer their most frequent and most challenging questions about their financial and operational performance. TOBI supports hospital cancer centers in making sound operational, financial, and strategic decisions to become true centers of excellence.

TOBI benchmarks include staffing for infusion, radiation, registry, and clinical trials, as well as productivity metrics and financial benchmarks.

Click here to read the press release.

Posted 10/13/2009

Reach Out to Congress: Stop Payment Cuts to Oncology Care

Members of the House of Representatives are circulating a "Dear Colleague” letter to stop Medicare payment cuts for cancer care.

ACCC asks that you reach out to your Representative and ask him or her to sign on to the letter to HHS Secretary Sebelius. The deadline is Friday, October 10 at 12:00 PM/EDT. Call their offices and email. Contacts for all House members can be found on the ACCC website under Contact Washington.

The Centers for Medicare & Medicaid Services (CMS) is planning severe Medicare payment cuts for cancer care effective January 1, 2010. These cuts are to services associated with drug administration, consultation services, diagnostic imaging, and radiation treatment. If the awareness level of the negative impact of these cuts is not raised among members of Congress and the Administration, these drastic cuts may go through as planned.

Congressman Steve Israel (D-NY) is leading the effort along with Representatives Artur Davis (D-AL), Debbie Wasserman Schultz (D-FL), Bart Gordon (D-TN), John Tanner (D-TN), Danny Davis (D-IL), and Steve Cohen (D-TN) to ask HHS Secretary Kathleen Sebelius to forestall making the Medicare payment cuts for cancer care.

Posted 10/7/2009

NCI Announces New NCCCP Sites Funding Opportunity

The National Cancer Institute (NCI) plans to add approximately 14 competitively chosen NCI Community Cancer Centers Program (NCCCP) sites. To explore how NCI-designated cancer centers can implement partnerships with hospital-based community cancer centers using the NCCCP model, approximately half of the awards will be made to NCI-designated cancer centers in partnership with freestanding community hospital cancer centers, and half will be made to freestanding facilities.

The funds will be made available under the American Recovery and Reinvestment Act to enhance and expand the NCCCP, according to a press release from NCI’s Director John E. Niederhuber, MD.

Please see the Request for Proposal posted to FedBizOpps.gov.

Started in 2007, the NCCCP involves 16 community hospitals located primarily in rural, small-town, and underserved urban areas in 14 states. The NCCCP goals are to: 1) reduce cancer healthcare disparities; 2) recruit more patients into clinical trials; 3) standardize the collection of tissue and other biospecimens for research purposes; 4) improve information technology capabilities, including instituting electronic health records; 5) improve quality of care; and 6) enhance cancer survivorship and palliative care.

According to Dr. Niederhuber, the 16 pilot hospitals have made considerable progress toward achieving the major program goals and are defining for NCI what it takes to build a national network of community hospitals that are fully engaged in cancer research and offer the latest evidence-based, multidisciplinary care to diverse populations in their home communities.

NCI is also allocating funds to current NCCCP hospitals for two years, again competitively awarded, for 18 specific projects encompassing clinical trials, disparities, community outreach, biospecimen collection, electronic health records, quality of care, partnerships with state cancer plans, communications, survivorship and palliative care. SAIC-Frederick is coordinating the announcements for these Requests for Proposals advertised in FedBizOps.

These new sites – and new tasks for existing sites – will further help NCI better understand how to deliver the most advanced cancer care to patients in their local communities, while allowing NCI to actively participate in cancer research.

Posted 10/5/2009

The Long and Winding Road to Healthcare Reform

Chairman of the Senate Finance Committee, Max Baucus (D-MT), released the long anticipated healthcare reform bill, America's Healthy Future Act of 2009, the morning of Wednesday, September 16. The bill took over three months to construct.

Now that the Senate Finance version of the healthcare reform bill has finally been introduced, the next step in the process is markup. The bill will sit in committee where it will face debate and amendments to its current state by members of the Senate Finance Committee, who may want to, for example, preserve high-cost Medicare Advantage plans and the Children’s Health Insurance Program (CHIP).

Senator Bill Nelson (D-FL) is concerned that many of his constituents would lose their benefits and pay higher costs under Baucus’ plan. He has a proposal to "grandfather" people in who have Medicare Advantage plans now so they do not have to give up their benefits. America's Health Insurance Plans (AHIP) issued a report that stated seniors with Medicare Advantage plans spent fewer days in the hospitals and were subject to less hospital re-admissions than those in fee-for-service Medicare. Senator Nelson’s concern is to ensure that Baucus' plan does not cause people to lose access to elective Medicare plans that seemingly keep them healthier.

Senator Ron Wyden (D-OR) fears that the cost people will have to pay for insurance will be too high of a percentage of their income and will put an economic strain on their lives. Due to the requirement to buy insurance in the new healthcare reform bill, people would have no choice, but Senator Wyden believes that there needs to be more done to make coverage more affordable for more people.

In addition, Senator Olympia Snowe (R-ME) has been long prepared to introduce her public option as an amendment. If this amendment makes it into the final bill and services are reimbursed at the Medicare rate, it could prove to put on a tight strain at the physician level.

America’s Healthy Future Act of 2009 is scheduled to begin markup September 22. ACCC will continue to monitor the situation.

Posted 9/17/2009

CMS Posts October 2009 ASP Pricing and Crosswalks

The Centers for Medicare & Medicaid Services (CMS) has posted the October 2009 ASP pricing files and crosswalks.

Click here to download.

Posted 9/17/2009

CDC Awards $22 Million for Colorectal Cancer Screening Program

The Centers for Disease Control and Prevention (CDC) has awarded a total of $22 million to 26 states and tribal organizations to provide colorectal cancer screening services for low–income people aged 50–64 years, who are underinsured or uninsured. Colorectal cancer is the second leading cause of cancer deaths among men and women aged 50 and older in the United States. The awards range from $358,283 to $1.1 million. The awardees are expected to begin screening patients for colorectal cancer within six months.

Click here to read more.

Posted 9/17/2009

Prometheus Laboratories Inc. Joins ACCC's Technical Advisory Council

Prometheus Laboratories Inc. has joined the Association of Community Cancer Centers' Technical Advisory Council. Prometheus is a specialty pharmaceutical company committed to improving the lives of patients and to personalized medicine. ACCC's Technical Advisory Council is designed to provide healthcare service, equipment, and technology companies with access to up-to-the-minute news and insight into cancer care issues not available through any other professional association.

Prometheus primarily focuses on the treatment, diagnosis and detection of gastrointestinal, autoimmune and inflammatory diseases and disorders. Prometheus' strategy includes the marketing and delivery of pharmaceutical products complemented by its proprietary and patented high-value diagnostic testing services. By integrating therapeutics and diagnostics, Prometheus provides physicians with a comprehensive approach to diagnosis and treatment for acute and chronic diseases. Our commitment to personalized medicine helps physicians to make better decisions for “the person in every patient.”

Prometheus diagnostic tests may help healthcare professionals manage their oncology patients more effectively.

• ProOnc TumorSource^DXTM identifies the tissue-of-origin of a metastatic tumor. The test identifies 25 different tumor types, including, but not limited to, tumors with the following tissue origins: colon, liver, brain, breast, kidney, lung, ovary, pancreas, prostate and testis. The test leverages proprietary microRNA technology developed by Rosetta Genomics, and measures the expression level of 48 microRNA biomarkers. The test uses a proprietary classifier to assign a primary site to the cancer sample based on the microRNA expression in the tumor.
• ProOnc Squamous^DXTM classifies non-small cell lung carcinoma tumors into two histological groups: cancers of squamous histology, and non-squamous cancers. The test leverages proprietary microRNA technology developed and validated by Rosetta Genomics, and measures the expression level of a squamous microRNA biomarker to differentiate patients that have squamous cell carcinoma of the lung from patients that have non-squamous non-small cell lung cancer.
• ProOnc Mesothelioma^DXTM is a cutting-edge molecular diagnostic test that uses microRNA to differentiate malignant pleural mesothelioma from peripheral adenocarcinoma of the lung and metastatic carcinomas involving the lung and pleura.

Posted 9/11/2009

ACCC Submits Comments to CMS on FDG PET

On September 11, 2009, the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare and Medicaid Services (CMS) about its proposed national coverage decision (NCD) on positron emission tomography (FDG PET) to guide initial management of cervical cancer. ACCC urged the agency to finalize its proposal to cover the use of FDG PET to help determine the appropriate initial treatment strategy for beneficiaries who have biopsy proven cervical cancer.

ACCC believes that the proposal to cover FDG PET only for biopsy proven cervical cancer is a valid proposal and agrees that this procedure can be effective in the following areas:

• To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or
• To determine the optimal anatomic location for an invasive procedure; or
• To determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor.

Read ACCC's comments.

Posted 9/9/2009

Sanofi-aventis Receives Cancer Gold Standard for Encouraging Cancer Prevention with Employees

Sanofi-aventis announced that it has received CEO Cancer Gold Standard accreditation from the non-profit organization CEO Roundtable on Cancer, in recognition of the company's extensive efforts to encourage employees at all U.S. facilities (sanofi-aventis U.S. and sanofi pasteur) to take an active role in their health and reduce their risks of developing cancer. The CEO Cancer Gold Standard is awarded to companies that have met exceptionally high standards of cancer prevention, screening and care in the workplace through concrete action in five defined areas. With this accreditation, sanofi-aventis becomes the 34th company to be granted this honor since the program's inception in 2006.

To earn Gold Standard accreditation, an organization must establish programs to reduce cancer through: 1) discouraging tobacco use; 2) encouraging physical activity; 3) encouraging healthy diet and nutrition; 4) detecting cancer at its earliest stages; and 5) providing access to quality care and clinical trials. Programs established under the guidance of the CEO Roundtable on Cancer help reduce cancer mortality, and statistics show that the efforts recognized by the Gold Standard have a tangible impact on the cost of treating cancer, which totaled nearly $210 billion in 2005 in the U.S., according to the Centers for Disease Control and Prevention.

Click here to learn more.

Posted 8/5/2009

Lilly USA Adjusts Income Eligibility for Some Patient Assistance Programs

On Aug. 1, 2009, Lilly USA adjusted the income eligibility for its most widely used patient assistance programs to allow enrollment of eligible patients with incomes at or less than 300 percent of the U.S. Federal Poverty Level. This is an income eligibility increase from the previous 200 percent Federal Poverty Level. With this change, the income eligibility limit for all Lilly owned or supported patient assistance programs is set at, or above, 300 percent of the current Federal Poverty Level. As an example, the new yearly eligible income limit for a family of two corresponds to approximately $44,000.

The income eligibility adjustment is a long-term change for the programs, which over the past three years have assisted more than 580,000 patients in the United States and distributed medications valued at over $784 million.

Click here to learn more.

Posted 8/5/2009

FDA Approves Bevacizumab to Treat Advanced Renal Cell Carcinoma

The U.S. Food and Drug Administration (FDA) has approved Avastin (bevacizumab) plus interferon alfa for people with metastatic renal cell carcinoma, the most common type of kidney cancer. The approval is based on data from a Phase III study that showed that patients who received the Avastin combo lived nearly twice as long without their disease getting worse compared to those on interferon alfa alone – 10.2 months versus 5.4 months. Combination therapy decreased tumor size by 30 percent compared with 12 percent who received interferon-alfa alone.

Posted 8/3/2009

Analysis of HOPPS and Physician Proposed Rules: Available NOW for ACCC Members

ACCC has assembled an in-depth analysis of the Medicare Hospital Outpatient Prospective Payment System Proposed Rule for Calendar Year 2010 and the Medicare Physician Fee Schedule Proposed Rule for Calendar Year 2010.

These reports are available only to ACCC members. To access them, please log into the Members-Only web section. Once inside, click on PUBLICATIONS AND TOOLS. The Public Policy section contains the links to:

• ACCC Analysis of Proposed 2010 Hospital Outpatient Department Rule
• ACCC Analysis of Proposed 2010 Hospital Outpatient Department Rule

• Overview (Available to members and nonmembers): CMS Releases 2010 Proposed Hospital Outpatient Department Rule, Clarifies "Physician Supervision"
• Overview (Availble to members and nonmembers): CMS Releases Proposed 2010 Physician Fee Schedule

Posted 7/23/2009

Florida Oncologists Voice Concerns About Payer Restraints

Back in April 2009 the Blues rolled out of a new statewide contract through ICORE Healthcare, a subsidiary of Magellan Health Services, in which payments were drastically reduced from previous contracts. ICORE promised Blue Cross significant savings—from pre-certifications on such big-ticket anti-cancer drugs as Herception, Avastin, and Erbitux to a switch to average sales price reimbursement.

Florida oncologists voiced concerns.

“If we sign this contract, we’d take a substantial hit to our practice,” said Thomas A. Marsland, MD, of Florida Oncology Associates, A Division of Integrated Community Oncology Network, in Orange Park, Fla.

Soon after the roll-out, the Florida Society of Clinical Oncology (FLASO) met with the Blues for a heart-to-heart conversation. The message: FLASCO understands the need to control costs, but believe there are other ways that are less draconian in their potential restriction of access to care.

“Pathways and adherence to those pathways can hold down costs,” said Dr. Marsland.

Recently, the Blue Cross/Blue Shield responded. And the news was not entirely favorable. Though the Blues indicated they “understood” the impact on oncology practices, they were committed to the ICORE program and were not about to change the contracts.

FLASCO is planning a strategic retreat to discuss the issue and have set up a subcommittee to reach out to other payers to discuss ways to help to control costs and maintain access and quality.

At this point, how the new BCBS contract will be received is still open to debate.

Posted 7/23/2009

Label Change to Erbitux and Vectibix

New label information on the cancer treatment Erbitux will state there is no evidence the drug works on a minority of colon cancer patients with a specific genetic mutation. Eli Lilly & Co. and Bristol-Myers Squibb Company announced that the addition to the drug's label will state that studies have not shown that Erbitux helps patients whose tumors have a mutated gene, or biomarker, called K-Ras. Amgen Inc. announced a similar label change for its cancer drug Vectibix. Both Erbitux and Vectibix block the epidermal growth factor receptor, preventing cells from growing and expanding.

Posted 7/23/2009

ACCC Co-sponsors Congressional Educational Forum on Off-Label Use of Cancer Drugs

More than 50 people, including Congressional staff and members of the oncology community, attended an educational forum on July 21, 2009, sponsored by the Association of Community Cancer Centers, US Oncology, and the Community Oncology Alliance. The issue: Medicare coverage for novel and emerging therapies in cancer care, particularly the importance of off-label drug indications and the compendia process.

"Cancer medicine is an off-label specialty," said J. Leonard Lichtenfeld, MD, MACP, deputy chief medical officer, American Cancer Society.

"Off-label" use of cancer drugs—in which drugs are prescribed for uses other than those for which they have been specifically approved by the Food and Drug Administration (FDA)—is a frequent practice in oncology, reflecting up to 75 percent of all anti-cancer prescriptions. Dr. Lichtenfeld stressed the need for a more accessible and consistent structure to get therapies to patients. "We are blessed with many new drugs, many combinations, targeted therapies, and oral drugs… [but] the realities are that not all information is readily accessible, and it is certainly not well organized."

That "information" comes from a steadily increasing number of clinical trials, a rapidly changing evidence base, and a small number of approved treatment "guides," also known as drug compendia. Currently, Medicare allows reimbursement for off-label chemotherapy drugs listed in the National Comprehensive Cancer Network’s (NCCN) Drugs and Biologics Compendium, Thomson Micromedex's DrugDex, Elsevier Gold Standard’s Clinical Pharmacology, and the American Society of Health-System Pharmacist’s American Hospital Formulary Service Drug Information.

Recently, the current compendia process has been an area of debate, particularly as Medicare's costs for cancer drugs and overall healthcare system costs have continued to rise. Cited benefits of the existing process have included flexibility for physicians in choosing the right treatments—rather than waiting for the lengthy FDA approval process for cancer drugs, and expanded access to treatments shown to be effective for rare types of cancer but that have not completed the formal FDA approval process.

Presenter Amy P. Abernethy, MD, associate director of Duke Comprehensive Cancer Center, discussed drawbacks of the compendia process, which have included a lack of transparency and differing levels of evidence, detail, and referencing among some listed drugs. Dr. Abernethy conducts studies related to quality of care, the clinical trials system, and evidence review.

Among her recommendations for examining and potentially amending the current compendia process are introducing greater transparency in the process for evaluating drug therapies, including disclosing any potential conflicts of interest; identifying and reducing unnecessary duplication and waste in review methods; and applying comparative effectiveness research to more thoroughly assess the clinical and cost-effectiveness of off-label therapies to aid in coverage decisions.

"Although off-label drug use is applied in a variety of medical situations, having access to the latest emerging therapies is often critical in oncology, in which life-threatening treatment scenarios with shorter windows for decision-making are more commonly experienced," said Matt Farber, MA, ACCC Manager of Provider Economics and Public Policy.

Mr. Farber and other presenters agreed that particularly with a new era of healthcare reform upon us, there is an opportunity for additional attention on and improvement to the off-label compendia process that provides access to safe, effective, proven therapies for cancer patients.

Posted 7/22/2009

Seven ACCC-Member Cancer Programs Make Honor Roll of America's Best Medical Centers

Congratulations! Seven ACCC Cancer Program Members made the annual "honor roll" of America's best medical centers, published by U.S. News & World Report. ACCC member Johns Hopkins Hospital in Baltimore is at the top of the list for the 19th straight year.

Other honor roll members include the Cleveland Clinic; New York-Presbyterian University Hospital of Columbia and Cornell; Barnes-Jewish Hospital/Washington University; Duke University Medical Center; UPMC-University of Pittsburgh Medical Center; and Ohio State University Hospital, Columbus.

Posted 7/22/2009

Alimta Receives FDA Approval for Maintenance Therapy for Nonsquamous Non-Small Cell Lung Cancer

Eli Lilly and Company announced July 5, 2009, it received a new approval from the U.S. Food and Drug Administration (FDA) for Alimta® (pemetrexed for injection). The latest approval is for Alimta as a maintenance therapy for locally advanced or metastatic non-small cell lung cancer (NSCLC), specifically for patients with a nonsquamous histology whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. Alimta is not indicated for treatment of patients with squamous cell non-small cell lung cancer.

Results from a global, multicenter, double-blind Phase III trial were presented as an oral presentation at the American Society of Clinical Oncology (ASCO) annual meeting in Orlando, Fla. on May 31, 2009, (Abstract # CRA8000) by Chandra Belani, MD, Miriam Beckner distinguished professor of medicine and deputy director of Penn State Cancer Institute at Penn State Milton S. Hershey Medical Center. The trial compared efficacy with respect to overall survival of Alimta plus best supportive care versus placebo plus best supportive care in 663 patients with stage IIIB/IV NSCLC whose disease had not progressed after four cycles of platinum-based induction chemotherapy. The trial supported previous studies looking at the use of histology to tailor treatment for patients with advanced nonsquamous NSCLC. Patients in the trial were treated with Alimta (500 mg/m2 on day one of each 21-day cycle) plus best supportive care or placebo plus best supportive care. All patients were supplemented with vitamin B12, folic acid, and dexamethasone.

Read Eli Lilly press release in full.

Click here for full prescribing information.

Posted 7/7/2009

CMS Issues Proposed Hospital Outpatient Department Rule for 2010

On July 1, 2009, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would update payment policies and rates for services provided in hospital outpatient departments for 2010 under the Outpatient Prospective Payment System (OPPS). The proposed rule also clarifies “physician supervision” as it relates to hospital outpatient therapeutic services, and seeks to promote higher quality, efficient services for Medicare beneficiaries by proposing improvements to the Hospital Outpatient Quality Data Reporting Program.

The Association of Community Cancer Centers (ACCC) is analyzing the CMS proposed OPPS rule and will report to membership soon, as well as submit comments to CMS. CMS will accept comments on the proposed rule until August 31, 2009, and will respond to comments in a final rule to be issued by November 1, 2009.

Physician supervision requirements. CMS is proposing to revise or further define several current policies for the physician supervision of outpatient services. First, CMS is proposing that nonphysician practitioners, specifically physician assistants, nurse practitioners, certified nurse specialists, and certified nurse-midwives, may directly supervise all hospital outpatient therapeutic services that they are able to personally perform within their state scope of practice and hospital-granted privileges. Under current policy, only physicians may provide the direct supervision of these services.

In addition, CMS is proposing to define “direct supervision” for on-campus hospital outpatient services to mean that the physician or nonphysician practitioner must be present in the hospital or on-campus provider-based department of the hospital and immediately available to furnish assistance and direction throughout the performance of the procedure, in contrast to the current definition which requires the physician to be present in the on-campus provider-based department. For services furnished in an off-campus provider-based department, “direct supervision” would continue to mean that the physician or nonphysician practitioner must be present in the off-campus provider-based department and immediately available to furnish assistance and direction throughout the performance of the procedure.

CMS is also proposing to require that all hospital outpatient diagnostic services furnished directly or under arrangement, whether provided in the hospital, in a provider-based department, or at a nonhospital location, follow the Medicare Physician Fee Schedule physician supervision requirements for individual tests.

Drugs and pharmacy overhead. CMS is proposing to pay for the acquisition and pharmacy overhead costs of separately payable drugs and biologicals without pass-through status at the average sales price (ASP) plus 4 percent in 2010. The proposed payment rate of ASP plus 4 percent is based upon the cost of separately payable drugs and biologicals calculated from hospital claims and cost reports (ASP minus 2 percent), with an adjustment for pharmacy overhead cost that reflects the redistribution of $150 million of the pharmacy overhead cost currently attributed to packaged drugs and biologicals to separately payable drugs and biologicals without pass-through status.

Therapeutic radiopharmaceuticals. CMS is proposing to provide payment for separately payable therapeutic radiopharmaceuticals that have ASP information submitted through the existing ASP process at ASP plus 4 percent. If ASP information is not available, CMS is proposing that payment would be based upon mean unit cost from hospital claims data.

Brachytherapy sources. CMS is proposing to pay for brachytherapy sources based on median unit costs, as calculated from claims data according to the standard OPPS rate setting methodology. In 2009, the payment methodology for brachytherapy sources was based on each hospital’s charges adjusted to cost through January 1, 2010.

Proposals to strengthen ties between payment and quality: Payment reduction for failure to report quality measures. As required by law, the proposed rule includes a reduction to the projected CY 2010 annual payment update factor of two percentage points for most services furnished by hospitals that failed to meet the requirements of the Hospital Outpatient Quality Data Reporting Program for the 2010 payment update. The reduction would not apply to payments for separately payable pass-through drugs and biologicals and devices, separately payable non-pass-through drugs and non-implantable biologicals, separately payable therapeutic radiopharmaceuticals, and services assigned to New Technology APCs.

CMS is proposing to implement a new Hospital Outpatient Quality Data Reporting Program (HOP QDRP) validation requirement to ensure that hospitals are accurately reporting measures using HOP QDRP chart-abstracted data. Under this requirement, CMS would take a sample of actual patient records, determine how the chart-abstracted measures should have been reported, and compare the results with the measures reported by the hospital. CMS will begin validating hospital submitted data for purposes of the 2011 update, but the validation results will not affect a hospital’s OPPS payment until 2012. This timeline will give hospitals sufficient advance notice to become familiar with the process.

Click here to read the proposed CMS rule.

Posted 7/2/2009

Cancer Figures Prominently in IOM Comparative Effectiveness Research Report

The Institute of Medicine (IOM) provided a road map June 1, 2009, for a new U.S.-backed effort to compare medical treatments and give healthcare providers and patients better information to guide care. In its new report entitled “Initial National Priorities for Comparative Effectiveness Research,” IOM defines comparative effectiveness research and puts forth a portfolio of 100 high-priority research priorities from about 2,600 suggestions submitted from professional groups, policy makers, and the public.

Cancer figures prominently in the IOM report with four priority topics in the first quartile.

• Compare the effectiveness of management strategies for localized prostate cancer (e.g., active surveillance, radical prostatectomy [conventional, robotic, and laparoscopic], radiotherapy [conformal, brachytherapy, proton-beam, and intensity-modulated radiotherapy]) on survival, recurrence, side effects, quality of life, and costs.
• Compare the effectiveness of management strategies for ductal carcinoma in situ (DCIS).
• Compare the effectiveness of imaging technologies in diagnosing, staging, and monitoring patients with cancer including positron emission tomography (PET), magnetic resonance imaging (MRI), and computed tomography (CT).
• Compare the effectiveness of genetic and biomarker testing and usual care in preventing and treating breast, colorectal, prostate, lung, and ovarian cancer, and possibly other clinical conditions for which promising biomarkers exist.

In the second quartile, three priority topics relate to cancer.

• Compare the effectiveness of robotic assistance surgery and conventional surgery for common operations, such as prostatectomies.
• Compare the effectiveness of film-screen or digital mammography alone and mammography plus magnetic resonance imaging (MRI) in community practice-based screening for breast cancer in high-risk women of different ages, risk factors, and race or ethnicity.
• Compare the effectiveness of new screening technologies (such as fecal immunochemical tests and computed tomography [CT] colonography) and usual care (fecal occult blood tests and colonoscopy) in preventing colorectal cancer.

The Association of Community Cancer Centers (ACCC) welcomes the report and supports comparative effectiveness research. At the same time ACCC has expressed concerns that comparative effectiveness research may ultimately lead to treatment decisions based on price and has urged that any guidance on comparative effectiveness research include explicit language preventing cost from being considered. ACCC has also noted the importance of recognizing that all patients with the same disease may not benefit from the same treatment option, which is especially important in oncology, where the most effective treatment for one person may not be the same for another person with the same diagnosis. According to ACCC, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations. Click here for more information.

Congress, in the American Recovery and Reinvestment Act (ARRA) of 2009, appropriated $1.1 billion to jump-start the nation’s efforts to accelerate comparative effectiveness research.

Comparative effectiveness research as defined by IOM “is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of comparative effectiveness research is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels.”

The key elements of this definition are the direct comparison of effective interventions, the study of patients in typical day-to-day clinical care, and the aim of tailoring decisions to the needs of individual patients.

Click here to read the Report Brief.

Posted 7/1/2009

CMS Proposes Payment, Policy Changes for Physicians' Services in 2010

The Centers for Medicare & Medicaid Services (CMS) announced July 1, 2009, proposed changes to policies and payment rates for services to be furnished during 2010) by over 1 million physicians and nonphysician practitioners who are paid under the Medicare Physician Fee Schedule (MPFS). The MPFS sets payment rates for more than 7,000 types of services in physician offices, hospitals, and other settings. the proposed rule includes a general 21.5 percent reduction to all physicians and elimination of consultation codes.

ACCC is analyzing the proposed changes and will report shortly to membership.

Click here to read the proposed Physician Fee Schedule. 

Medicare requires CMS to adjust the MPFS payment rates annually based on an update formula which includes application of the Sustainable Growth Rate or SGR that was adopted in the Balanced Budget Act of 1997. This formula has yielded negative updates every year beginning in 2002, although CMS was able to take administrative steps to avert a reduction in 2003, and Congress has taken a series of legislative actions to prevent reductions in 2004-2009. Based on current data, CMS is projecting a rate reduction of -21.5 percent for 2010.

As part of healthcare reform, the Administration supports comprehensive, but fiscally responsible, reforms to the physician payment formula. Consistent with this goal, the Administration announced in the 2010 President’s Budget that it would explore the breadth of options available under current authority to facilitate such reforms, including an assessment of whether the cost of physician-administered drugs should continue to be included in the payment formula. Thus, while working with Congress to develop a more appropriate mechanism for updating physician payment rates, CMS is proposing to remove physician-administered drugs from the definition of “physician services” for purposes of computing the physician update formula in anticipation of enactment of legislation to provide fundamental reforms to Medicare physician payments. While the proposal will not change the projected update for services during 2010, CMS projects that it would reduce the number of years in which physicians are projected to experience a negative update.

CMS is also proposing to stop making payment for consultation codes, which are typically billed by specialists and are paid at a higher rate than equivalent evaluation and management (E/M) services. Practitioners will use existing E/M service codes when providing these services instead. Resulting savings would be redistributed to increase payments for the existing E/M services.

Imaging. CMS is proposing to implement a requirement that suppliers of the technical component of advanced imaging services be accredited beginning January 1, 2012, by designating accrediting organizations (AOs) for these suppliers and utilizing the imaging quality standards that have been developed by the AOs. The accreditation requirement would apply to mobile units, physicians’ offices, and independent diagnostic testing facilities that create the images, but would not apply to the physician who interprets them. According to the GAO, spending on advanced imaging services, such as computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET), is growing almost twice as fast as spending on other types of imaging services, and is a significant contributor to the rapid growth in health care spending in recent years, but there is little administrative oversight to ensure the quality of care.

E-Prescribing and PQRI. The proposed rule contains a number of provisions to promote improvement in quality of care and patient outcomes through revisions to the Electronic Prescribing Incentive Program (e-Prescribing Program) and the Physician Quality Reporting Initiative (PQRI). Eligible professionals or group practices that meet the requirements of each program in CY 2010 will be eligible for incentive payments for each program equal to 2.0 percent of their total estimated allowed charges for the reporting periods. CMS is proposing to simplify the reporting requirements for the electronic prescribing measure and to provide eligible professionals with more reporting options. CMS is also proposing a new process for group practices to be considered successful electronic prescribers.

In addition, CMS is proposing to add more measures and more measures groups for eligible professionals to report under the PQRI, to provide a mechanism for participants to submit quality measure data from a qualified electronic health record and to create a process for group practices to use for reporting the quality measures.

Posted 07/1/2009

Non-Small Cell Lung Cancer Trial Seeks Study Sites

Accelerated Community Oncology Research Network, Inc. (ACORN) is seeking study sites to accrue patients to a multi-center randomized phase 2b study of Cetuximab (Erbitux®) in combination with platinum-based chemotherapy as first-line treatment of patients with recurrent or advanced non-small cell lung cancer (NSCLC). The primary objective is to evaluate overall survival with three different regimens of chemotherapy and cetuximab. Key eligibility: Stage IIIb, IV or recurrent NSCLC; all histologies allowed; ECOG PS 0-1; no prior chemotherapy for advanced NSCLC. Patients will be treated with combination chemotherapy/study drug for up to 6 cycles and then continue with maintenance study drug every other week until progression or unacceptable toxicity (estimated to be approximately 5 months).

Contact Heidi Vosseler at 215.801.4017, or email: heidi.vosseler@actsolutions.org

Posted 06/17/2009

Support the Bill to Remove the Prompt Pay Discount from ASP

Senators Arlen Specter (D-PA) and Pat Roberts (R-KS) introduced a bill (S. 1221) June 11, 2009, in the Senate to address the Average Sales Price (ASP) issue with Part B drugs by removing prompt pay discounts extended to wholesalers from the ASP calculation. Including prompt pay discounts in the ASP calculation threatens community oncology practices by artificially lowering the reimbursement rate for chemotherapy treatments.

The Association of Community Cancer Centers (ACCC) strongly endorses S. 1221 and looks forward to working with Senators Specter and Roberts, the other Congressional champions of community cancer care and the broader community oncology and specialty distribution coalition, to move this important legislation forward in Congress.

This bill is a companion to H.R. 1392, introduced in the House of Representatives earlier this year, which ACCC also supports. H.R. 1392 was introduced by Reps. Gene Green (D-TX), Ed Whitfield (R-KY), Diana DeGette (D-CO), Mike Ross (D-AR), Edolphus Towns (D-NY), Mike Rogers (R-MI), Betty Sutton (D-OH), Bart Gordon (D-TN), Lee Terry (R-NE), and Ralph Hall (R-TX) and currently has 46 co-sponsors. That bill would also change the ASP methodology used by Medicare to set prices for Part B drugs and biologicals to better align drug reimbursement with actual cost.

Drug manufacturers are currently required to net out prompt pay discounts paid to wholesale distributors before reporting ASP figures to the Centers for Medicare and Medicaid Services (CMS), even though the wholesaler prompt pay discount is not passed along to physicians. Physician drug reimbursements are lowered by approximately two percent by this provision in the ASP calculation, which is the customary amount of the wholesale distributor prompt pay discount.

  Click here to send an email to your Congressman in support of S. 1221 and H.R. 1392.

Posted 06/15/2009

CMS Issues Clarification for Billing Part B versus Part D for the Anti-emetic Aprepitant (Emend)

The Centers for Medicare & Medicaid Services (CMS) has issued a clarification of policy distinguishing Part B versus Part D billing for the anti-emetic medication aprepitant (Emend®) for chemotherapy induced nausea-vomiting (CINV). Be sure your billing staff is aware of this information.

Medicare Part B covers Emend when used as part of the following regimen:

• IV Emend provided on day 1 would be covered under B. (Payment for Oral Emend on days 2 and 3 would not be made under Part B but should be billed under Part D.)
• Days 1-3 of the oral anti-emetic 3-drug combination of Emend, a 5-HT3 antagonist, and dexamethasone. This regimen acts as a full replacement for IV anti-emetic therapy for patients receiving one or more of the following anti-cancer chemotherapeutic agents: Carmustine, Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin, Epirubicin, Lomustine, Mechlorethamine, Streptozocin.

Coverage of Emend Under the Part D Program
The Part D program will generally cover Emend when it is not prescribed in accordance with the above Medicare Part B coverage guidelines. If Emend IV is given on Day 1, then oral Emend is given on days 2-3, the oral Emend must be billed to Part D. To assist in billing of Emend, CMS recommends physicians indicate on a prescription that the Emend is being used as part of a CINV chemotherapeutic drug regimen, what day of treatment the patient is on (e.g. Post chemo Day 2) and whether the IV or oral form of the drug was given on Day 1.

  Click here to learn more.

Posted 06/15/2009

ACCC Submits Comments About Comparative Effectiveness Research

The Association of Community Cancer Centers (ACCC) submitted comments on June 9, 2009, to the Federal Coordinating Council (Council) about its Draft Definition of Comparative Effectiveness Research (CER), Draft Prioritization Criteria, and Draft Strategic Framework. ACCC expressed agreement with the Threshold Minimal Criteria and also with the Prioritization Criteria in the draft document. ACCC also agreed with the basic framework and cross-cutting priorities, such as cancer, announced by Council, and appreciated the Council’s transparency and willingness to seek stakeholder input to this important process.

Still, ACCC expressed concerns that cost effectiveness may be included in future CER. “Although the Draft Definition does not refer to cost effectiveness, there still could be opportunities for cost effectiveness to be taken into account in CER.” ACCC requested that any guidance on CER include explicit language preventing cost from being considered.

In addition, ACCC was concerned that the Draft Definition’s reference to “decision-makers,” along with patients and providers, as the users of CER could be construed as support for the use of CER in payers’ coverage decisions. “This would be contrary to the American Reinvestment and Recovery Act’s (ARRA) express prohibition against the Council mandating coverage, reimbursement, or other policies for any public or private payer. The ARRA conference report also notes that Congress did not intend for CER funding to be used for such purposes.”

ACCC asked that the definition of CER include explicit language preventing coverage decisions from being based on CER. “The Council should clarify that ‘decision-makers’ refers to patients’ advocates, including a patient’s parents, guardians, and family members who may be involved in making health care decisions.”

ACCC was pleased that the Draft Definition appeared to recognize that all patients with the same disease may not benefit from the same treatment option, which is especially important in oncology, where the most effective treatment for one person, may not be the same for another person with the same diagnosis. To further clarify that CER "must assess a comprehensive array of health-related outcomes for diverse patient populations," ACCC suggested that the word "subpopulations" be added to the end of this sentence.

ACCC also expressed concerns with some of the aspects of comparative effectiveness that were not included in the Draft Definition, Prioritization Criteria, or Strategic Framework. ACCC remains concerned that there is still some confusion as to where this research will take place. The Agency for Healthcare Research and Quality (AHRQ) already is conducting some CER, and the National Institutes of Health (NIH) is also in line to conduct research. ACCC asked the Council to clarify whether other agencies will be involved in CER. “We also ask for clarification about the application of the Draft Definition, Prioritization Criteria, and Strategic Framework. Will these terms and structures apply to research already underway, or will they apply only to new research?”

Posted 06/9/2009

Policy Change on Supervising Physicians Makes Hospitals Vulnerable, Groups Tell CMS; ACCC Agrees

In a June 1, 2009, letter to the Centers for Medicare & Medicaid Services (CMS), a number of hospital groups, including the American Hospital Association, encouraged the agency to withdraw the 2009 policy clarification that imposes physician supervision of outpatient therapeutic services.

"Our members remain very concerned about certain CMS statements from the 2009 OPPS rulemaking that have the potential to subject hospitals to substantially heightened and unwarranted enforcement scrutiny," the groups said in the letter. "As the agency considers next steps related to its policy, we strongly urge CMS to take immediate steps to mitigate the new and inappropriate enforcement risks that the troubling CMS statements have created."

As reported in the BNA Healthcare Daily, the hospital groups said that a policy clarification in the 2009 Outpatient Prospective Payment System (OPPS) final rule actually was a policy change that now requires physicians that supervise therapeutic outpatient services to be present physically, even if the services are rendered in an on-campus hospital department.

Furthermore, the groups said that CMS's clarification in the 2009 OPPS was different from the policy on supervising physicians articulated in the 2001 OPPS, which stated that physicians supervising outpatient therapeutic services in an on-campus hospital outpatient department were not required to be present physically. The hospital organizations said they understood the policy as of 2001 to require that supervising doctors be present physically only for services provided in off-campus departments.

The Association of Community Cancer Centers supports the statement. On February 25, 2009, Matt Farber, ACCC Manager, Provider Economics and Public Policy, met with CMS representatives to discuss the policy and express concerns.

  Click here to learn more.

Posted 06/8/2009

ACCC Launches Cancer Care Patient Navigation Website

The Association of Community Cancer Centers is pleased to announce the launch of its new Cancer Care Patient Navigation resource. You'll find:

• Model patient navigation efforts underway at ACCC member programs and articles from a supplement published in Oncology Issues
• Sample forms, including pre-assessment forms, intake summaries, referrals forms, patient satisfaction surveys, and outcomes measures
• An update to ACCC's "Cancer Program Guidelines" to include patient navigation services
• A full array of tools, including navigator job descriptions, tracking forms, and discharge tools.

The project is a joint effort by ACCC and the Meniscus Educational Institute in West Conshohocken, Pa. The project is made possible by an educational grant from sanofi-aventis U.S.

  Click here to learn more.

  Click here to register for ACCC's Cancer Care Patient Navigation: A Call to Action webinar. ACCC and the Meniscus Educational Institute have teamed up to present a free webinar about cancer care patient navigation. The live web presentation will take place on June 10, 2009, at 12:00 pm to 1:30 pm ET. Supported by an educational grant from sanofi-aventis U.S.

Can't attend? Come back later for the archived webinar on ACCC's Continuing Education Blackboard.

Posted 06/1/2009

FDA Grants Full Approval to Sprycel for CML

Bristol-Myers Squibb Company announced May 26, 2009, that the U.S. Food and Drug Administration (FDA) has granted full approval for Sprycel® (dasatinib) for the treatment of adults in all phases of chronic myeloid leukemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including Gleevec® (imatinib mesylate).

Sprycel, an oral tyrosine kinase inhibitor, was originally approved under the accelerated approval regulations of Subpart H for new drugs for serious or life-threatening illnesses of the Food, Drug and Cosmetic Act, based on its effectiveness on hematologic and cytogenetic response rates in CML. The full approval was based in part on results from a Phase 3 randomized, open-label dose optimization study that enrolled 670 chronic phase CML patients with resistance or intolerance to Gleevec. The primary endpoint of this study was major cytogenetic response (MCyR) (0-35 percent Ph+metaphases, which combines both complete and partial responses), in Gleevec-resistant patients. The data included a minimum of two years of follow up after the start of treatment with SPRYCEL 100 mg once daily, which is the recommended starting dose of SPRYCEL for chronic phase CML patients resistant or intolerant to Gleevec. A summary of results from the 167 patients who received Sprycel 100 mg once daily include:

• 80 percent progression-free survival (95% CI: 73%-87%) estimated rate at two years, based on Kaplan-Meier estimates
• 91 percent overall survival (95% CI: 86%-96%) estimated rate at two years, based on Kaplan-Meier estimates
• 63 percent of patients achieved MCyR (95% CI: 56%-71%; median duration of treatment was 22 months)
• 93 percent of patients who achieved MCyR maintained that response for 18 months (95% CI: 88%-98%), based on Kaplan-Meier estimates.

Posted 05/26/2009

ACCC's 2009 Cancer Program Administrator Survey, Salaries and Programmatic Challenges

In February and March 2009, ACCC sent email surveys to cancer program administrators employed at ACCC-Member Cancer Programs. Slightly more than 19 percent (130 programs) responded to ACCC’s survey. Survey results are now available to ACCC members.

  Click here to read survey results.

In this year of widespread economic distress, cancer program administrators, too, face a challenge: keeping their cancer service lines financially viable while still offering the best care to their patients. Sixty-four percent of respondents indicate that the economy is affecting their ability to access the capital needed to acquire new technologies or expand services. Of those respondents, 62 percent said upgrades to current radiation therapy equipment have been put on hold, including replacing outdated linear accelerators and HDRs or upgrading to IGRT, for example. Eight percent note that physical expansion plans have been put on hold.

All is not bad news, however. Although a majority of respondents report the economy is affecting their ability to access the capital needed to acquire new technologies or expand services, more than one in five (23 percent) report they are making upgrades to radiation oncology equipment and equipment for diagnostic imaging. A few report moving forward on building expansion.

The majority of the cancer program administrators remain happy in their positions. In fact, almost half report they are “very satisfied.” Just 3 percent express dissatisfaction, a sharp decline from 16 percent expressing dissatisfaction in 2006.

Posted 05/4/2009

State Oncology Society Presidents Gather to Discuss Outlook for Cancer Care in 2009

Leaders from the nation’s state medical oncology societies gathered in Alexandria, Va., January 16-17, 2009, for the 17th Annual Oncology Presidents’ Retreat, sponsored by the Association of Community Cancer Centers (ACCC) and the American Society of Clinical Oncology (ASCO). On the eve of the inauguration of President Barack Obama, the focus was on the new Administration’s plans for healthcare reform.

"What can Democrats and Republicans agree on now?” asked opening speaker Amy Holmes, CNN political analyst. Her answer: “Bringing down healthcare costs.” On that front, she predicted, “Americans will give Obama wide latitude.” Although she did not go into specifics, Ms. Holmes said the new Administration will give priority to disease prevention and enhanced electronic medical records.

Oncology professionals in attendance were particularly interested in sessions that explored emerging coverage trends from the Centers for Medicare & Medicaid Services (CMS), as well as e-prescribing, and the future of clinical trials.

Emerging Coverage Trends. "There is real push from the MACs [Medicare Administrative Contractors] to have Medicare develop more and more NCDs [National Coverage Decisions]," said Joseph S. Bailes, MD, chair of ASCO’s Government Relations Council. Medicare generally covers the use of an FDA-approved drug if the use conforms to the FDA-approved labeling. However, Medicare has stated that it may initiate a review of coverage of a newly approved drug if the drug is 1) novel, complex, or a controversial treatment; 2) costly to the Medicare program; or 3) subject to overutilization. CMS has released more than 300 NCDs and has more than 150 National Coverage Analyses in its active docket, many of them cancer related. Contractors have little or no discretion to do anything different in areas covered under NCDs, such as ESAs, PET (FDG), and screenings for such cancers as colorectal, prostate, cervical, and vaginal, said Bailes. “It is incumbent upon. . . those who work with the contractors to watch these NCDs and be engaged."

Click here to read more.

Posted 01/20/2009

ACCC Annual Meeting Highlights: Congressmen Price and Sarbanes Note Consensus and Contention on Healthcare Reform

“There is absolutely no question that healthcare reform is finally here,” said Congressman John Sarbanes (D-MD) at the 35th Annual National Meeting of the Association of Community Cancer Centers (ACCC), held March 18-21, 2009, at the National Harbor just outside Washington, D.C. He and Representative Tom Price (R-GA), as well as other policy experts, spoke to more than 400 cancer care professionals who had come to learn how politics and regulations may change cancer care.

"Consensus has emerged in recent years that the [healthcare] system is broken and that we need to move to a system of universal coverage," said Rep. Sarbanes. His Republican colleague Tom Price agreed. Both expect an aggressive timetable, with a comprehensive healthcare bill by August 2009—one that meets the expectations of the various House and Senate committees involved in the discussions. Hearings on Capitol Hill are already underway.

"Given the decades of inaction on healthcare, that is obviously a breakneck pace," said Rep. Sarbanes, who expects a "huge debate" and "a fair amount of contention among the different players in this game." However, he does anticipate a transformative system that "aligns incentives in a way that really makes sense—one that puts patients and providers in the driver seat when it comes to deciding healthcare in this country."

Primary care, prevention, fitness, and “fixing reimbursement in a sensible way” are what Rep. Sarbanes calls universally accepted principles. He noted that poor government reimbursement models lead to bad behavior in the private sector as well with commercial payers who simply follow suit. “The reimbursement structures have to be looked at very carefully. And we have to think hard about the kinds of services and kind of care we want to reimburse and incentivize.”

Rep. Price expects that the coming reform will change healthcare for at least a generation. He calls for health insurance for everyone in a system that ensures the five principles of access, affordability, quality, innovation, and responsiveness. "An increase in governmental intervention is detrimental to each principle," he said. His solution relies heavily on changes to the tax code, tax deductions, refundable tax credits, and "huge pools to ensure purchasing power." Rep. Price urges a "patient-centered" healthcare system where everyone owns and controls his or her own insurance policy, and where a "robust peer-review process"—not the government—ensures quality.

Both congressmen provided few details on what exactly the finished healthcare reform product might look like. Rep. Sarbanes noted that most people want to see a single payer system, but he cautioned that putting such a system into practice will be a "very difficult place to get to. We have to be practical and recognize that certain design elements in the system we already have, we will have for a while." He envisions that lawmakers will "enhance and expand," finding good things that work and that are part of our system, then "figuring out how to make them better." Rep. Sarbanes described a system of "place-based" healthcare, where, for example, school-based health clinics would be placed in every school or local clinics would serve the healthcare needs of retirement communities. "I believe there will be a new, expanded, and very exciting role for community health centers across this country."

In closing, both congressmen urged meeting attendees to make their needs heard by emailing or calling their representatives on Capitol Hill. “Your input is vital,” said Rep. Price.

Posted 3/23/2009

Idaho Nurse, Administrator Becomes New ACCC President

Luana Lamkin, RN, MPH, became President of the Association of Community Cancer Centers at its 35th Annual National Meeting on March 20, 2009. She is the administrator for St. Luke’s Mountain States Tumor Institute (MSTI) at St. Luke's Boise Medical Center in Boise, Idaho, which serves patients at 12 different locations in southwest Idaho and eastern Oregon. Ms. Lamkin has more than 25 years of oncology experience. She succeeds Ernest R. Anderson, Jr., MS, RPh, ACCC President 2008-2009.

"As the population ages and the number of cancer patients grows, there will be a concomitant increase in the need for oncology health professionals to care for them," said Ms. Lamkin. "The need for highly educated professionals to care for these patients will far outstrip the number of professionals available. During my year as ACCC President, I hope to shine a light on this need and use the forums of the ACCC national meetings to begin exploring ways that we can prepare for this inevitability via developing new staffing strategies, encouraging young people to go into oncology careers, and advocating for greater federal funding to meet the educational needs."

Ms. Lamkin has served on ACCC’s Board of Directors since 2002 and has been active on ACCC’s Bylaws Committee, Program Committee, and Membership Committee.

She served as the national treasurer of the Oncology Nursing Society from 1998-2002 and a six-year term as a member of the American College of Surgeons’ Commission on Cancer. She has been a volunteer for the American Cancer Society, Sigma Theta Tau, and the Big Brothers/Big Sisters of America.

Ms. Lamkin has published numerous articles about the delivery of oncology care in the community setting and has presented at national and international conferences. Her areas of expertise include trends in national oncology care, strategic planning, cancer program development, and nurse staffing issues, including the nursing shortage. She has received numerous awards, including the ACS Lane Adams Award and the Excellence in Nursing Administration from ONS.

Ms. Lamkin received her master’s of public health degree in health administration from the University of Hawaii in Honolulu, Hawaii, after receiving her bachelor's of science degree in nursing at the University of Illinois in Chicago.

Ms. Lamkin succeeds Ernest R. Anderson, Jr., MS, RPh, ACCC President 2008-2009. Mr. Anderson is director of pharmacy at the Lahey Clinic in Burlington, Mass., as well as the Lahey Clinic North in Peabody. Mr. Anderson is also associate clinical professor of pharmacy at Northeastern University College of Pharmacy and Allied Health Professions and adjunct associate professor of pharmacy at Massachusetts College of Pharmacy and Health Sciences in Boston.

Posted 3/23/2009

ACCC Annual National Meeting Attendees Voice Concerns About Private Payers

At a special session during ACCC’s recent Annual National Meeting, attendees voiced concerns about increasing denials and difficulties associated with private payers.

“We are seeing prior authorizations on both on- and off-label indications for many commonly used oncology drugs," said one attendee at the “Private Payer Prognosis: Identifying the Problems and Potential Solutions” presentation.

Meeting attendees gave many other examples of increasing friction with private payers, which include:

• “Voluntary” prior authorization that is actually mandatory (If pre-authorizations are not submitted, with every dose the practice has to submit medical records.)
• Refusal to pay for related routine and customary care costs of clinical trials
• Uncertain and random payments
• Disclaimers that stated authorization is no guarantee of payment, despite the pre-authorization
• Mandates for specialty pharmacy reimbursement
• Diagnostic imaging denials or delays in authorization
• Difficulties with contract negotiations.

Nearly half of patients seen in oncology practices have private insurance, and many private payers follow Medicare’s lead on numerous issues, including adoption of Medicare rates for drug reimbursement.

ACCC will be working with legislators and policy makers to discuss these private payer concerns.

Are you having difficulties with private payers? Please send your comments and concerns to ACCC's Matt Farber, Manager, Provider Economics and Public Policy, at mfarber@accc-cancer.org

Posted 3/23/2009

Arizona Nurse and Cancer Survivorship Advocate Susan Leigh Honored with ACCC’s Annual Achievement Award

Susan Leigh, RN, BSN, was honored with ACCC’s Annual Achievement Award for her long-standing advocacy, dedication, and commitment to quality cancer survivorship services and education. The award was presented to Ms. Leigh on Friday, March 20, 2009, at the Awards Luncheon during ACCC’s 35th Annual National Meeting at the Potomac National Harbor, Md.

“I’m taking this wonderful, wonderful award for all cancer survivors across the country, whether they have just been diagnosed or at end of life,” said Ms. Leigh, who is a founding member and past president of the National Coalition for Cancer Survivorship (NCCS). She also initiated the formation of both the Nurse Survivors Focus Group and the Survivorship Special Interest Group within the Oncology Nursing Society.

Ms. Leigh urged meeting attendees to enhance and expand their survivorship care plans and programs. “Help your cancer survivors help you,” she said, encouraging providers, particularly small practices with limited resources, to “bring back your cancer survivors to help those newly diagnosed.” She also stressed the importance of survivorship guidelines as well as treatment and care plan summaries that cancer survivors can take with them.

Currently, Ms. Leigh works as a cancer survivorship consultant, and focuses on long-term and late effects of disease and therapy. Besides surviving Hodgkin's lymphoma, she has also been treated for breast and bladder cancers.

Ms. Leigh is an advocate for cancer clinical research studies at both local and national levels. Locally, she serves as a consumer advocate at the Arizona Cancer Center in Tucson. Nationally, she sits on committees at the National Cancer Institute (NCI), and has been a member of CARRA (Consumer Advocates in Research Related Activities) since its inception. Her current work with NCI includes co-chairing the newly formed Patient Advocate Steering Committee.

“Our challenge as survivors is not rather how do we die with cancer, but how do we live with cancer—and how do we help patients on whatever their journey.”

Ms. Leigh has been actively involved with Sunstone Cancer Support Centers, a community-based outreach program in Southern Arizona. She also coordinates Life Beyond Cancer, a national women’s retreat at Miraval Life in Balance outside Tucson.

After receiving her degree in nursing from the University of Arizona in Tucson, Ms. Leigh served as a Lieutenant in the U.S. Army and completed a tour of duty in the Mekong Delta, Vietnam, in 1971. Soon after her return from Vietnam, she was diagnosed and treated for Hodgkin’s lymphoma. This experience influenced her decision to enter oncology nursing where she worked with various clinical research teams at the University of Arizona from 1976 to 1989.

Posted 3/23/2009

ACCC Honors Community Oncologist and Researcher James E. Radford, Jr., for Outstanding Service

James E. Radford, Jr., MD, was honored March 19, 2009, with ACCC’s annual David King Community Clinical Scientist Award for his outstanding service, leadership, and commitment to the oncology community. Dr. Radford leads the Cancer Research Program at the Margaret R. Pardee Memorial Hospital in Hendersonville, N.C. He is also a medical oncologist in private practice with Hendersonville Hematology and Oncology, PLLC.

Dr. Radford expressed his thanks and appreciation to ACCC for the award and to those who participate in clinical research. “ACCC deserves a lot of credit for using its resources to recognize the work done by thousands of physicians and tens of thousands of research nurses and CRAs and IRB administrators and data managers who struggle every day against inadequate reimbursement and defective computer log in screens and case report forms and 22-page consent forms to do the work that will hopefully make life better for all of our children.”

Dr. Radford has led efforts at the Margaret R. Pardee Memorial Hospital Cancer Research Program to improve access to clinical trials for older cancer patients. Through his efforts the program has been highly successful in recruiting older patients to clinical trials. Dr. Radford is Hendersonville Community Leader, Southeast Cancer Control Consortium. Under Dr. Radford’s leadership—and with help from his team, Pardee’s Cancer Research Program has achieved an exceptional record of cancer clinical trial participation. In 2008, a record 64 new patients were enrolled in 17 different studies. These patients represent 11 percent of the number of new cancer patients (582) diagnosed and treated at Pardee Hospital. At present, 50 separate national (and, in some cases, international) clinical trials are open locally to patients with 14 different types of cancer.

The David King Community Clinical Scientist Award recognizes active community clinical research leaders and is named after former ACCC President David K. King, MD, FACP, who spent his entire life caring for individuals with cancer and advocating for access to quality care. He passed away after a brief battle with cancer.

Posted 3/23/2009

ACCC Supports HR 1392, Fair Drug Reimbursement

On March 9, 2009, Representatives Gene Green (D-TX) and Ed Whitfield (R-KY), senior members of the House Energy & Commerce Committee, introduced HR 1392, a bill to change the Average Sales Price (ASP) methodology used by Medicare to set prices for Part B drugs and biologicals to better align drug reimbursement with actual cost.

The Association of Community Cancer Centers (ACCC) strongly endorses HR 1392 and looks forward to working with Representatives Green and Whitfield, and other congressional champions of community cancer care and the broader community oncology and specialty distribution coalition to move this important legislation forward in the 111th Congress. This bipartisan effort will allow for more accurate reimbursement for physicians.

You can help. ACCC requests your support for HR 1392 by sending an email to your congressman.

  Go to ACCC's Legislative Action Center and select the ISSUES AND LEGISLATION tab to send your email to Congress.

HR 1392 removes the customary prompt-pay discount extended to wholesalers from ASP. Drug manufacturers are currently required to net out prompt-pay discounts paid to wholesale distributors before reporting ASP figures to the Centers for Medicare and Medicaid Services (CMS), even though the wholesaler prompt-pay discount is not passed along to physicians. Physician drug reimbursements are lowered by approximately 2 percent by this provision in the ASP calculation.

HR 1392 clarifies this statute by removing "customary prompt-pay discounts extended to wholesalers" from the list of price concessions that reduce ASP. The legislation also conforms prompt-pay discount treatment in the ASP methodology to the Average Manufacturer Price (AMP) methodology used to set reimbursement for pharmacies in the Medicaid program. The broader coalition of community oncology and specialty distribution organizations is working together to advance HR 1392.

Posted 3/17/2009

UnitedHealthcare Announces Change to Herceptin Coverage Policy

UnitedHealthcare has removed the requirement to submit a pathology report to obtain coverage for Hercepin (trastuzumab). This change is effective for claims submitted after January 1, 2009. Herceptin claims that were submitted in 2008 that are pending payment will require the submission of the pathology report showing over expression of the HER2 gene. The pathology reports should be faxed to 915.231.1970 and should use the dedicated fax cover sheet, available on the UnitedHealthcare website.

Herceptin claims submitted after January 1, 2009, will continue to be subjected to two reimbursement policies that may impact the reimbursement: the National Comprehensive Cancer Network (NCCN) policy and the Maximum Dosage Edit policy. Both of these policies address Herceptin claims and are posted on the UnitedHealthcare website.

UnitedHealthcare launched the Herceptin policy requiring submission of pathology reports in early 2006 based on an audit showing that 12 percent of the patients being treated with trastuzumab did not have over–expression of the HER2 gene. Its last audit in September 2008, demonstrated that less than 1 percent of the submissions failed to show over– expression.

"Our medical policy hasn't changed," writes UnitedHealthcare in a press release, "treatment of patients with under-expression is still inappropriate. We believe the recent audit demonstrates that this quality parameter is being followed and no longer requires the quality check."

According to UnitedHealthcare, there are other critical issues with HER2 gene expression testing. "Studies show that concordance between local laboratories and a central laboratory with quality controls can be poor. The College of American Pathology has established accreditation for HER2 gene testing, but participation in the accreditation process is voluntary. UnitedHealthcare contracts with two national laboratories that meet the ASCO / CAP guideline recommendations and proficiency testing for HER2, Genezyme and Laboratory Corporation of America (LabCorp). We encourage the use of laboratories that meet these standards. If you don’t know the accreditation status of your current lab for HER2, we would encourage retesting, or a second opinion, from either of these laboratories for your patients who are UnitedHealthcare enrollees."

Posted 2/25/2009

ACCC Testifies at APC Panel Meeting, Panel Makes Recommendations for 2010

At a meeting of the Ambulatory Payment Classification (APC) Panel last week at the headquarters of the Centers for Medicare & Medicaid Services (CMS) in Baltimore, Md., the Association of Community Cancer Centers (ACCC) testified on a range of hospital outpatient prospective payment system (HOPPS) issues, including drug reimbursement, pharmacy overhead services, and 340B hospitals. ACCC President Ernest R. Anderson, Jr., MS, RPh, testified on behalf of the Association, and ACCC was joined in the testimony by other groups, including the American Society of Health System Pharmacists (ASHP), the Biotechnology Industry Organization (BIO), the Plasma Protein Therapeutics Association (PPTA), and the Alliance of Dedicated Cancer Centers.

After testimony was concluded, the APC Panel made the following recommendations to CMS for 2010 rulemaking:

• CMS should reimburse all separately paid drugs at no less than ASP+6 percent. (It is currently at ASP+4 percent.)
• CMS should package payment for all drugs that are not separately paid at ASP+6 percent, and should use the difference between those rates and CMS's costs derived from charges to create a pool that is used to fund payment for pharmacy service costs more appropriately.
• CMS should reimburse hospitals for pharmacy service costs using this pool by making payments based on a tiered approach of drug complexity.
• CMS should exclude data from hospitals that participate in the 340B program from its rate-setting calculations for drugs. CMS should not, however, adjust payments for separately paid drugs to 340B hospitals.

These recommendations are almost word for word the recommendations that ACCC and the other stakeholders requested of the panel in testimony. It is important to remember, however, that CMS is under no obligation to abide by the recommendations of the Panel.

Posted 2/23/2009

Economic Stimulus Legislation Includes Funds for Healthcare IT, Prevention

On Feb. 17, President Obama signed into law a $787 billion economic stimulus bill, H.R. 1, the American Recovery and Reinvestment Act. The bill includes $87 billion in additional Medicaid funding for states; $20 billion in federal funds to help physicians and hospitals adopt healthcare information technology; and $24.7 billion to help workers who lost their jobs keep their healthcare insurance under the Consolidated Omnibus Budget Reconciliation Act (COBRA). An additional $650 million is set aside for evidence-based clinical and community-based prevention and wellness strategies that deliver specific, measurable health outcomes that address chronic disease rates. In addition, $50 million is reserved for grants to the states to implement healthcare-associated infection reduction strategies.

The Act has two major sections. Division A-Appropriates Provisions, which includes new funding for the National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), and the Health Resources Administration (HRSA) as well as part of the funding for new health information technology and comparative effectiveness research.

ACCC is currently reviewing the bill and will provide more information shortly.

 Click here to read a detailed summary.

Posted 2/23/2009

CMS's RAC Program Reinstated

The Centers for Medicare & Medicaid Services (CMS) announced that on February 4, 2009, the parties involved in the protest of the award of the Recovery Audit Contractor (RAC) contracts settled the protests. The settlement means that the stop work order has been lifted and CMS will now continue with the implementation of the RAC program.

Under the program, the four RACs will contract with subcontractors to supplement their efforts. PRG-Schultz, Inc. will serve as subcontractor to HDI, DCS, and CGI in regions A, B, and D. Viant Payment Systems, Inc., will serve as a subcontractor to Connolly Consulting in region C. Each subcontractor has negotiated different responsibilities in each region, including some claim review.

The RAC in each jurisdiction is as follows:

Region A: Diversified Collection Services (DCS)

Region B: CGI

Region C: Connolly Consulting, Inc.

Region D: HealthDataInsights, Inc.

For more information go to http://www.cms.hhs.gov/RAC.

Posted 2/18/2009

ACCC Submits Comments to CMS Regarding NCD on FDG PET for Solid Tumors

On Feb. 4, 2009, the Association of Community Cancer Centers (ACCC) submitted comments supporting the Centers for Medicare and Medicaid Services’ (CMS) proposed national coverage decision (NCD) on positron emission tomography (FDG PET) for solid tumors that are biopsy proven or strongly suspected based on other diagnostic testing. At the same time, ACCC requested additional coverage enhancements that reflect the current standard of care for patients with cancer.

ACCC believes that CMS should finalize its proposal to cover the use of FDG PET, without Coverage with Evidence Development (CED), in the determination of subsequent treatment strategy for patients with breast, cervix, colorectal, esophagus, head and neck, lymphoma, melanoma, non-small cell lung, and thyroid cancer. Further, ACCC urged CMS to carefully monitor the results of the upcoming CED on the use of FDG PET for the subsequent treatment strategy for brain, ovary, pancreas, prostate, small cell lung, soft tissue sarcoma, testes, and all other solid tumors.

"Our members constantly search for tools to appropriately treat and manage cancer and should the clinical benefits of FDG PET continue to evolve, we hope the agency would act quickly to remove the CED coverage restrictions to afford broader access to this important technology."

ACCC asks the agency to provide greater detail regarding its plans to implement CED in a way that preserves continuity of care. ACCC believes that the NCD proposed coverage framework affords physicians and patients with another state-of-the-art tool to fight cancer more effectively.

Under the proposed decision, CMS would provide coverage for FDG PET to guide "subsequent treatment strategies" only if the beneficiary is enrolled in a clinical study pursuant to a CED framework that meets certain listed criteria. ACCC urged CMS to detail in its final decision a clear pathway for Medicare beneficiaries to continue to access FDG PET. This pathway should include practical and specific information to guide beneficiaries and their physicians to access these clinical trials and obtain Medicare coverage.

On January 6, 2009, CMS posted a proposed decision memorandum (PDM) for PET that would expand its standard coverage of a number of tumors for certain indications, while maintaining other indications under the CED category. All patients scanned under the auspices of CED must either be enrolled in the National Oncologic PET Registry (NOPR) database, as has been the case for the past several years, or be enrolled in another evidence-gathering clinical trial, as outlined in the PDM. CMS would now routinely cover PET or PET/CT imaging for the initial diagnosis or the initial staging of primary brain tumors, ovarian cancer, pancreatic cancer, small-cell lung carcinoma, soft-tissue sarcomas, thyroid cancer, and testicular cancer, as well as all other solid tumors. All subsequent studies (for restaging or therapy monitoring) in these tumors will still be in the CED category. The one exception is that prostate carcinoma, which had been covered under the CED category for diagnosis, staging, restaging and therapy monitoring will no longer be covered (with or without evidence development) for diagnosis and initial staging, but it would still be covered under CED for restaging and therapy monitoring.

CMS is expected to issue a Final NCD in April 2009.

Click here to read ACCC's complete comments.

Posted 2/5/2009

ACCC Submits Comments on AHRQ Draft Comparative Effectiveness Review

The Association of Community Cancer Centers (ACCC) submitted comments to the Agency for Healthcare Research and Quality (AHRQ) on its Draft Comparative Effectiveness Review: Comparative Effectiveness of Chemotherapy Agents in the Prevention of Primary Breast Cancer in Women. ACCC understands the importance of such research for helping physicians and patients make well-informed decisions about diagnosis and treatment. The Association is concerned about the implications of such research if it could be used to limit access to the care determined to be most appropriate for each patient by his or her physician.

The Draft Review notes that it “may be used, in whole or in part, . . as a basis for reimbursement and coverage policies.” ACCC believes that research like this study, and other studies that may be performed in the future, should not necessarily be linked to coverage and reimbursement. If this practice would be adopted by payers like the Centers for Medicare and Medicaid Services (CMS), physicians could be limited in what therapies they can provide to their patients, regardless of their professional clinical judgment. This system of payer-controlled treatment options would become very similar to the model used in some European countries, like the United Kingdom, where patients may be denied timely access to appropriate, innovative therapies.

ACCC has always supported policies that lead to increased patient access to innovative therapies. This is especially important in a specialty such as oncology, where the standard of care is constantly evolving and more personalized treatment options are being developed. The Association expressed fear that narrow application of comparative effectiveness research could halt the development of these new treatments, and also could tie the hands of physicians when it comes to clinical decision making.

Click here to read ACCC's complete comments.

Posted 1/26/2009

HHS Pushes Back Compliance Deadline for ICD-10-CM Codes to Oct. 1, 2013

The U.S. Department of Health and Human Services (HHS) on Jan. 14, 2009, released two final rules that will facilitate the United States’ ongoing transition to an electronic healthcare environment through adoption of a new generation of diagnosis and procedure codes and updated standards for electronic health care and pharmacy transactions.

The first final rule replaces the ICD-9-CM code sets now used to report healthcare diagnoses and procedures with greatly expanded ICD-10 code sets, with a compliance date of Oct. 1, 2013, instead of Oct. 1, 2011. For the ICD-10 code sets, the final rule sets the compliance date at Oct. 1, 2013, providing nearly five years from the date of publication for the industry to implement the new code sets. The Oct. 1 compliance date also corresponds with the effective date for annual changes to Medicare payment systems.

The ICD-10 code sets final rule concurrently adopts the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) for diagnosis coding, and the International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS) for inpatient hospital procedure coding. The new codes replace the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) Volumes 1 and 2, and the International Classification of Diseases, Ninth Revision, Clinical Modification (CM) Volume 3 for diagnosis and procedure codes, respectively.

The second final rule adopts an updated X12 standard, Version 5010, for certain electronic health care transactions, an updated version of the National Council for Prescription Drug Programs (NCPDP) standard, Version D.0, for electronic pharmacy-related transactions, and a standard for Medicaid pharmacy subrogation transactions. Version 5010 includes updated standards for claims, remittance advice, eligibility inquiries, referral authorization, and other administrative transactions. Version 5010 also accommodates the use of the ICD-10 code sets, which are not supported by Version 4010/4010A1, the current X12 standard.

Click here to read more.

Posted 01/14/2009

CMS Proposes Expansion of PET Scans as Cancer Diagnostic Tool

The Centers for Medicare & Medicaid Services (CMS) proposed Jan. 5, 2009, a national coverage determination (NCD) to expand coverage for initial diagnostic testing with positron emission tomography (PET) for many Medicare beneficiaries who are being treated for cancer.

Under the Coverage with Evidence Development (CED) program, CMS had issued a national coverage determination in 2005 that tied Medicare coverage of PET scans to the collection of clinical information about the effect of the test on the beneficiary’s cancer care. This information was obtained through the National Oncologic PET Registry (NOPR) observational study. Without CED, these tests would not have been covered by Medicare. The purpose of CED is to develop evidence on the utilization and impact of the item or service evaluated in an NCD, so that Medicare can a) document the appropriateness of use of that item or service in Medicare beneficiaries under current coverage; b) consider future changes in coverage for the item or service; c) generate clinical information that will improve the evidence base on which providers base their recommendations to Medicare beneficiaries regarding the item or service.

The sponsors of NOPR submitted a formal written request to reconsider the 2005 coverage determination to CMS, based on the evidence they had collected and published. Medicare uses a formal evidence based process when it reconsiders past NCDs. This proposed expansion in coverage is the first time that CMS has reviewed medical evidence arising from its CED program. CMS proposes some cancer-specific exceptions to these broad requirements, which are listed in the proposed decision memorandum.

CMS will accept public comments on the entire proposed decision through February 5, 2009, and will issue a final national coverage determination in April 2009. CMS invites public comments on its proposed decision, which is available on its website.

Posted 01/6/2009

ACCC Submits Comments to CMS on HOPPS Final Rule

On Dec. 29, 2008, the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare and Medicaid Services’ (CMS) regarding the 2009 hospital outpatient prospective payment system (HOPPS) final rule. ACCC addressed three areas of concern for its membership: 1) reimbursement for separately paid drugs; 2) reimbursement for pharmacy services and overhead; and 3) inclusion of data from 340B hospitals in OPPS rate-setting calculations. In its 2009 OPPS final rule, CMS rejected calls by ACCC and other stakeholders to reimburse all separately paid drugs at ASP +6 percent and make additional payments for pharmacy services. CMS contends that its proposed rates appropriately reflect both drug acquisition and pharmacy service costs.

Reimbursement for separately paid drugs. In its comments to CMS, ACCC expressed "grave" concern over the reduction in reimbursement from average sales price (ASP) +5 percent in 2008 to ASP +4 percent in 2009 and the indication of future reductions in the following years. ACCC, along with the pharmacy stakeholder group, has commented on numerous occasions and testified before numerous Ambulatory Payment Classification (APC) Panel meetings that reimbursement at less than the physician office rate of ASP +6 percent is based on flawed calculations and could harm hospitals’ ability to provide important cancer therapies. An analysis of CMS’s rate-setting methodology for separately paid drugs shows that CMS’s methodology is fundamentally flawed due to the effects of charge compression and the inclusion of claims data from 340B hospitals. "It is imperative for the agency to fix the fundamental flaws in its rate-setting methodology for separately paid drugs in order for our members to continue to deliver high quality cancer care," according to ACCC's comments. "ACCC is extremely disappointed by CMS’s decision to reduce reimbursement for separately paid drugs to ASP +4 percent for 2009. We urge CMS to reconsider this decision."

Reimbursement for pharmacy services and overhead. ACCC also expressed disappointment that CMS did not implement the pharmacy stakeholder proposal for 2009. After much work and careful consideration, ACCC believes that the stakeholder proposal is the best option to begin reimbursing hospitals appropriately for the costs of providing drugs safely. The proposal, which is budget neutral and is supported by the APC Panel and a number of stakeholders, would allow more appropriate payment for drug acquisition and pharmacy services costs immediately. ACCC urges the agency to act now to ensure that payments for drug acquisition and pharmacy service costs are appropriate in 2010 and beyond.

340B hospital reimbursement rates and data. ACCC does not believe that there should be two separate reimbursement rates: one for 340B hospitals and one for non-340B hospitals. "We believe that all hospitals should be paid at the same rates. We do believe that 340B drug acquisition data should not be included in the calculation of drug reimbursement rates under the OPPS, however, as sales under the 340B program are excluded from the calculation of ASP." To include data from 340B hospitals, according to the comments, as CMS currently does, unfairly penalizes non-340B hospitals by artificially lowering drug reimbursement rates.

 Click here to read ACCC's comment letter to CMS.

Posted 01/5/2009