It’s hard to believe that the integration of Part A and Part B Medicare payers is in the last procurement cycle for choosing administrative contractors. Within the structure, 15 primary Regional MAC A/B contracts will be awarded. These Regions are also called Jurisdictions. It is expected that all Regional contracts will be awarded by the end of 2008, with the transfer of the current workload to occur in 2009. The actual transition and implementation will take longer to accomplish, perhaps as long as 18 months, once the awards are announced.

The primary objectives for the MACs, as mandated in the Medicare Modernization Act (MMA) of 2003, are: 1) financial management and administrative cost savings; 2) improved allocation of the claims processing workload; 3) consistency in claims processing activities and decisions; and 4) delivering better service through open competition. CMS’ vision is to create a premier health plan that allows for comprehensive, quality care and first-rate provider and beneficiary service.

MACs are expected to interface with existing CMS contracted entities that perform medical review or benefit integrity work including agreements with beneficiary contract centers (BCC), qualified independent contractors (QIC), quality improvement organizations (QIO), and recovery audit contractors (RAC).

CMS will evaluate the performance of each MAC by setting up operational standards. Standards will focus on enhanced provider customer service, increased payment accuracy, and improved provider education and training. Specifically, the standards will measure accuracy, consistency, and timeliness. If the standards are not met, CMS will be allowed to terminate and/or transfer functions from one MAC to another at any time during the 5 year contract period.

To date the following Regional contracts have been awarded:

• Region 1 – Palmetto GBA
• Region 2 – National Heritage Insurance Corporation (under protest)
• Region 3 – Noridian Administrative Services
• Region 4 – Trailblazer Health Enterprises
• Region 5 – Wisconsin Physicians Services Health Insurance Corporation
• Region 7 – Pinnacle Business Solutions (under protest)
• Region 12 – Highmark Medical Services, Inc.
• Region 13 – National Government Services

The oncology community is fortunate to have the invaluable support and partnership of many of the pharmaceutical companies who have joined state oncology societies as annual corporate members. State societies want these companies to be engaged, involved and committed. Their generous resources provide significant revenue streams for state societies to use in providing and expanding their educational programs and legislative/economic efforts.

In its partnership with pharmaceutical companies, state society leaders and members have a responsibility to interact, discover, and explore companies’ information and displays at state society conferences. Pharmaceutical representatives want the opportunity to dialogue with physicians, practice managers, and other providers outside the purview of medical offices and hospitals.

In this ever changing world, there are new restraints on pharmaceutical companies’ interaction with physicians, other cancer care providers, and leaders in oncology. In particular, access to providers in the workplace--offices and hospitals—is being severely scaled back.

Conferences and meetings, therefore, provide neutral arenas for providers to explore and learn about new drugs, clinical trials, and research in the pharmaceutical arena. State society conferences are an ideal opportunity to mingle and learn about the latest oncology updates. Please attend the state societies’ 2008 fall conferences and visit the pharmaceutical companies’ displays.

See you in the Exhibit Hall!

The summer time is a time of major change in the field of healthcare reimbursement and policy. Even though Congress may be on recess for the month of August, the Centers for Medicare and Medicaid Services (CMS) and other Federal agencies are busy getting ready for 2009.

One major change that occurred in June was the addition of three new compendia to the approved list for Medicare reimbursement. The new additions are: NCCN's Drugs & Biologics Compendium™, Thomson Micromedex's DrugDex®, and Elsevier Gold Standard’s Clinical Pharmacology. The American Hospital Formulary Service Drug Information (AHFS-DI), published by the American Society of Health-System Pharmacists, also is a recognized compendium. As we know from a recently completed survey of ACCC members, off-label use is a large component of oncology care in the physician office setting. ACCC will continue to monitor these changes and report on how CMS and local carriers are going to implement these changes.

In addition this summer saw the announcement of the proposed changes in both the CMS 2009 Physician Fee Schedule and the 2009 Hospital Outpatient Prospective Payment System. For more information on the proposals, click here. Release of the final rules is to occur at the end of October 2008.

Finally, in July, Congress acted to stop the potential 10.6% cut to physicians treating Medicare patients. This cut, due to the flawed SGR formula, was delayed for 18 months and replaced with another 0.5 percent update for the remainder of 2008 and a 0.6 percent cut for 2009. For more information, click here.

Zoledronic acid (Zometa) has been accepted by the American Hospital Formulary Service Drug Information (AHFS-DI) drug compendium as treatment for prevention of aromatase inhibitor-associated bone loss (AIBL) in postmenopausal women. The oncology determination table is available online. AHFS-DI is published by the American Society of Health-System Pharmacists (ASHP).

Nplate (romiplostim). Amgen Inc. announced on Aug. 22 that the U.S. Food and Drug Administration (FDA) has approved Nplate (romiplostim), the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate, the first FDA-approved peptibody protein, works by raising and sustaining platelet counts, representing a novel approach for the long-term treatment of this chronic disease.

The FDA approval of Nplate was based on efficacy and safety results from two pivotal Phase 3 studies of adult patients with chronic ITP, including both splenectomized and non-splenectomized patients. The overall response rate for Nplate was 83 percent (n=69/83, p less than 0.0001) of treated splenectomized and non-splenectomized patients, and platelet counts were raised and sustained in these six month studies. Additionally, patients treated with Nplate were able to reduce or discontinue their use of concomitant ITP medications and emergency medications (i.e., corticosteroids, IVIG, Win-Rho, Anti-D therapy).

On August 6, 2008, the Epogen/Procrit (epoetin alfa) and Aranesp (darbepoetin alfa) labeling were revised to strengthen the safety information for healthcare professionals and patients. The changes are summarized as follows:

• Safety-related labeling changes for cancer patients receiving chemotherapy. The prescribing information has been revised to clarify the FDA-approved conditions for use of erythropoiesis-stimulating agents (ESAs) in patients with cancer and revised directions for dosing to state the hemoglobin level (≥ 10 g/dL) at which treatment with an ESA should not be initiated. The new label states that ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
• Medication Guide and Patient Instructions for use for all indications. The new Medication Guide contains information that FDA has determined is necessary for patients’ safe and effective use of ESAs, and that could affect patients’ decision to take this drug. Federal regulations require that the Medication Guide be distributed to patients.

Vidaza (azacitidine for injection). Celgene Corporation announced that Vidaza (azacitidine for injection) has received approval from the FDA to include survival data for patients with higher-risk myelodysplastic syndromes (MDS) in its prescribing information. A PDF file of the updated Vidaza prescribing information is attached to this message. For more information, please visit www.vidaza.com.

Aloxi (palonosetron HCl). Eisai Corporation of North America and its partner Helsinn Healthcare SA announced that the FDA has approved a new oral formulation of Aloxi (palonosetron hydrochloride) for the prevention of chemotherapy-induced nausea and vomiting (CINV). Aloxi capsules 0.5 mg for oral administration is indicated for the prevention of acute nausea and vomiting following initial and repeat courses of moderately emetogenic chemotherapy. A single 0.5 mg Aloxi capsule is administered approximately one hour prior to the start of chemotherapy.