CMS Decides "No Change" to Clinical Trial Policy

The Centers for Medicare & Medicare Sercices (CMS) issued its final Clinical Trial Policy on October 17. CMS has decided that "no change to the July 9, 2007, policy is appropriate at this time," and it will not impose any additional conditions of coverage.

On July 19, 2007, CMS opened a second reconsideration of the Clinical Trial Policy (CTP) National Coverage Determination (NCD) and issued a proposed decision memorandum. The proposed decision included standards that CMS believed were necessary for the protection of subjects in research studies and other standards, an approval process to determine if a study met those standards, and proposed to clarify the items and services that would be covered in approved trials.

CMS received numerous comments, including those from the Association of Community Cancer Centers (ACCC), that questioned the authority of CMS to establish standards and provide limitations to coverage within research studies. ACCC had asked CMS to withdraw the proposed clinical research policy and issue a notice of proposed rulemaking, or NPRM. ACCC was concerned that the proposed clinical research policy would undermine CMS' goal of increasing Medicare beneficiary access to clinical research studies by withdrawing coverage for reasonable and necessary items and services unless provided in the context of a qualifying clinical research study.

Following the expiration of the public comment period, Congress passed the Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85 (September 27, 2007). The new legislation establishes significant requirements for clinical trials and additional authority for other agencies in the Department of Health and Human Services. CMS is continuing to review this new legislation and will work with other HHS components in order to avoid imposing duplicative or inconsistent obligations.

Posted 10/18/2007

FDA Approves Ixempra for Advanced Breast Cancer

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has granted approval of IXEMPRA® (ixabepilone) as monotherapy for the treatment of patients with metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine. The FDA has also granted approval of IXEMPRA in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline, and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. IXEMPRA is a microtubule inhibitor belonging to a class of antineoplastic agents, the epothilones. Bristol-Myers Squibb anticipates that IXEMPRA will be available within days.

McKesson to Purchase OTN

McKesson Corporation announced Oct. 4 that it has signed a definitive agreement to purchase Oncology Therapeutics Network (OTN), a U.S. distributor of specialty pharmaceuticals. Sales of specialty drugs are increasing rapidly, especially oncology drugs, and OTN is one of the nation's largest distributors of specialty drug products, serving the needs of more than 3,500 oncologists, 1,500 rheumatologists and other providers. Its annualized revenues are approximately $3 billion. McKesson plans to combine the operations of OTN with the operations of McKesson Specialty, which is reported in the McKesson Distributions Solutions segment.

"The integration of these two businesses will enhance our position in one of the fastest-growing categories of drugs in the United States," said John H. Hammergren, chairman and chief executive officer.

More than 200 oncology drugs are in development across the pharmaceutical and biotechnology industry, representing more than 50 percent of the new drug pipeline. Between 2006 and 2010, sales of oncology drugs are forecast by IMS Health to increase from $30 billion to $60 billion.

"OTN and McKesson Specialty each have strong, value-based relationships with physicians and manufacturers based on high-quality service and technologies that align clinical outcomes with financial incentives," Hammergren continued. "McKesson has relationships across healthcare and a comprehensive product offering that includes healthcare claims processing and physician revenue cycle outsourcing. We plan to use all these capabilities to provide our customer and supplier partners with a unique specialty pharmaceutical distribution solution."

The acquisition is subject to customary closing conditions, including any necessary regulatory review.

CMS Decides "No Change" to Clinical Trial Policy

The Centers for Medicare & Medicare Sercices (CMS) issued its final Clinical Trial Policy on October 17. CMS has decided that "no change to the July 9, 2007, policy is appropriate at this time," and it will not impose any additional conditions of coverage.

On July 19, 2007, CMS opened a second reconsideration of the Clinical Trial Policy (CTP) National Coverage Determination (NCD) and issued a proposed decision memorandum. The proposed decision included standards that CMS believed were necessary for the protection of subjects in research studies and other standards, an approval process to determine if a study met those standards, and proposed to clarify the items and services that would be covered in approved trials.

CMS received numerous comments, including those from the Association of Community Cancer Centers (ACCC), that questioned the authority of CMS to establish standards and provide limitations to coverage within research studies. ACCC had asked CMS to withdraw the proposed clinical research policy and issue a notice of proposed rulemaking, or NPRM. ACCC was concerned that the proposed clinical research policy would undermine CMS' goal of increasing Medicare beneficiary access to clinical research studies by withdrawing coverage for reasonable and necessary items and services unless provided in the context of a qualifying clinical research study.

Following the expiration of the public comment period, Congress passed the Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85 (September 27, 2007). The new legislation establishes significant requirements for clinical trials and additional authority for other agencies in the Department of Health and Human Services. CMS is continuing to review this new legislation and will work with other HHS components in order to avoid imposing duplicative or inconsistent obligations.

Posted 10/18/2007

FDA Approves Ixempra for Advanced Breast Cancer

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has granted approval of IXEMPRA® (ixabepilone) as monotherapy for the treatment of patients with metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine. The FDA has also granted approval of IXEMPRA in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline, and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. IXEMPRA is a microtubule inhibitor belonging to a class of antineoplastic agents, the epothilones. Bristol-Myers Squibb anticipates that IXEMPRA will be available within days.

McKesson to Purchase OTN

McKesson Corporation announced Oct. 4 that it has signed a definitive agreement to purchase Oncology Therapeutics Network (OTN), a U.S. distributor of specialty pharmaceuticals. Sales of specialty drugs are increasing rapidly, especially oncology drugs, and OTN is one of the nation's largest distributors of specialty drug products, serving the needs of more than 3,500 oncologists, 1,500 rheumatologists and other providers. Its annualized revenues are approximately $3 billion. McKesson plans to combine the operations of OTN with the operations of McKesson Specialty, which is reported in the McKesson Distributions Solutions segment.

"The integration of these two businesses will enhance our position in one of the fastest-growing categories of drugs in the United States," said John H. Hammergren, chairman and chief executive officer.

More than 200 oncology drugs are in development across the pharmaceutical and biotechnology industry, representing more than 50 percent of the new drug pipeline. Between 2006 and 2010, sales of oncology drugs are forecast by IMS Health to increase from $30 billion to $60 billion.

"OTN and McKesson Specialty each have strong, value-based relationships with physicians and manufacturers based on high-quality service and technologies that align clinical outcomes with financial incentives," Hammergren continued. "McKesson has relationships across healthcare and a comprehensive product offering that includes healthcare claims processing and physician revenue cycle outsourcing. We plan to use all these capabilities to provide our customer and supplier partners with a unique specialty pharmaceutical distribution solution."

The acquisition is subject to customary closing conditions, including any necessary regulatory review.

New Erbitux Vial Approved by FDA

The FDA has approved a new 200 mg vial of Erbitux (cetuximab). The new 200 mg vial will offer a reduction in preparation time and effort, requiring the use of only three vials where previously 5 vials would have been required. Additionally, the 200 mg vial will require less storage space than that required for the equivalent mgs. quantity of the 100 mg vial. The 100 mg vial will continue to be available to provide convenience and minimization of waste. The new Erbitux vial will be priced on an equivalent basis to the 100 mg vial price. The price remains unchanged from the product launch price in 2004.

ACCC Responds to CMS Proposal for ESAs, Believes MDS Should Be in Covered Category

The Association of Community Cancer Centers (ACCC) has submitted comments to the Centers for Medicare & Medicaid Services regarding the agency’s proposed decision about the Medicare National Coverage Determination (NCD) for Erythropoiesis Stimulating Agents (ESAs). ACCC believes that CMS should not limit access to ESAs for proven Food and Drug Administration (FDA) indications and compendia listings. In addition, ACCC did not agree with CMS’ decision to enforce clinical limitations on ESA usage, both dosage and time limits, when that decision should be made by both the physicians and FDA. “When label indications are followed, ESAs can be very beneficial to patients, increasing their quality of life.”

ACCC indicated its belief that CMS made an error in including anemia of myelodysplastic syndrome (MDS) in the non-covered category. "As a result of the proposal by CMS, more patients with MDS and chemotherapy-induced anemia will require blood transfusions, which may take them out of the community setting where they are receiving chemotherapy. This will put a serious strain on the nation’s blood supply…It will also add an additional strain on hospital resources, with hospitals having to utilize more space and personnel to administer the transfusions.”

Read ACCC's comments.

CMS Issues Proposed National Coverage Decision for ESAs in Cancer

On Monday, May 14, 2007, the Centers for Medicare and Medicaid Services (CMS) issued a proposed National Coverage Decision (NCD) regarding the coverage of Erythropoiesis Stimulating Agents (ESAs) in cancer and related patients. Groups have until June 13, 2007, to comment on the proposal.

The proposed NCD limits the coverage of ESAs in a number of cancer-related treatments. The following is a list of non-covered indications:

• any anemia in cancer or cancer treatment patients due to folate deficiency, B-12 deficiency, hemolysis, bleeding, or bone marrow fibrosis;
• the anemia of myelodysplasia;
• the anemia of myeloid cancers;
• the anemia associated with the treatment of myeloid cancers or erythroid cancers;
• the anemia of cancer not related to cancer treatment;
• any anemia associated with radiotherapy;
• prophylactic use to prevent chemotherapy-induced anemia;
• prophylactic use to reduce tumor hypoxia;
• patients with erythropoietin-type resistance due to neutralizing antibodies;
• patients with treatment regimens including anti-angiogenic drugs such as Avastin® (bevacizumab);
• patients with treatment regimens including monoclonal/polyclonal antibodies directed against the epidermal growth factor (EGF) receptor (i.e., Erbitux® and Vectibix™);
• anemia due to cancer treatment if patients have uncontrolled hypertension; and
• patients with thrombotic episodes related to malignancy.

CMS is proposed to continue to cover ESA usage in certain cases; however, they are also adding stipulations and requirements for that coverage.

CMS proposes to allow ESA coverage for the treatment of anemia in those types of cancer in which the presence of erythropoietin receptors on either normal tissue/cell lines or malignant tissue/cell lines has been reported in the literature. These cancer types include but are not necessarily limited to bone (sarcoma), hepatic, pancreatic (exocrine), brain-neurologic, lung, prostate, breast, lymphoma, retinal, cervical, melanoma, uterine, colorectal, multiple myeloma, gastric, muscle including cardiac, head-and-neck (squamous cell), and ovarian.

The proposed reimbursement parameters in the covered indications would be as follows:

• the hemoglobin/hematocrit levels immediately prior to initiation of dosing for the month should be < 9 g/dl or 27 percent in patients without known cardiovascular disease and < 10 g/dl or 30 percent in patients with documented symptomatic ischemic disease that cannot be treated with blood transfusion (CMS suggests that patients, especially those in the latter category, be alerted to the increased potential for thrombosis and sequelae.);
• the maximum covered treatment duration is 12 weeks/year;
• the maximum covered 4 week treatment dose is 126,000 units for erythropoietin and 630 mcg for darbepoetin;
• continued use of the drug is not reasonable and necessary if there is evidence of poor drug response (hemoglobin/hematocrit rise < 1 g/dl or < 3%) after 4 weeks of treatment;
• continued administration of the drug is not reasonable and necessary if there is an increase in fluid retention or weight (5 kg) after 2 weeks of treatment; and
• continued administration of the drug is not reasonable and necessary if there is a rapid rise in hemoglobin/hematocrit > 1 g/dl or > 3% after 2 weeks of treatment.

For more information and the complete proposed NCD, go to the Decision Summary web page.

ACCC Submits Comments to CMS on Clinical Trial Policy

On May 4, 2007, the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare and Medicaid Services’ (CMS) on the agency’s proposed decision regarding Medicare National Clinical Trial Policy. ACCC noted that it shares CMS’ interest in developing better evidence for use by patients, physicians, and policymakers, and strongly supports efforts to increase the coverage of trials that may help in the treatment of cancer and other diseases.

“We believe that continued clinical research is essential to improving patient care and must be a priority for all stakeholders involved in cancer care, including CMS,” noted Edward L. Braud, MD, chair of ACCC’s Government Affairs Committee.

Among ACCC's specific recommendations on the proposed Clinical Research Policy (CRP):

• ACCC supports the decision to have all research studies subject to the CRP posted on a central website, so patients and providers alike will be able to better keep track of available trials.
• ACCC supports the proposal that sponsors consider the potential benefits to Medicare populations and other subpopulations in designing a research study. However, ACCC stresses that this requirement should be applied in a manner that reflects the broad range of research studies that may be covered by the CRP and should not limit any Medicare beneficiary from participation in a research study.
• ACCC urges CMS to continue to work closely with the FDA to resolve the many remaining questions regarding IND-exempt trials that take into account the many stakeholder comments received on the CRP. ACCC disagrees with the decision by CMS to no longer automatically cover IND-exempt trials as “deemed” to meet the standards of the CRP, since this type of research study has been critical to the development of innovative treatments, particularly in the area of oncology.

In its comments ACCC noted that it appreciates the need to expand research to enhance clinical decision-making.

Read ACCC's comment letter.

New CMS Administrator Chosen by President Bush

President Bush nominated Department of Health and Human Services deputy chief of staff Kerry N. Weems, a 24-year veteran of the department, to be the next administrator of the Centers for Medicare & Medicaid Services (CMS).

Weems's "wealth of experience as an advisor to several HHS secretaries and as a manager of large budgets and organizations will make him successful in the role of [CMS] Administrator," HHS Secretary Michael O. Leavitt said in a May 3 statement. "He understands the large fiscal challenges facing Medicare and Medicaid and what it will take to strengthen and sustain those programs for the future. Further, he has been a leader in this department's efforts to accelerate adoption of health information technology and better financial management systems, which will be a valuable asset to CMS."

As reported in the May 4 BNA Health Care Daily, in picking Weems, 50, Bush bypassed several other candidates rumored to be considered for the job, including current acting administrator Leslie V. Norwalk and current acting deputy administrator Herb Kuhn. Norwalk has been serving as acting administrator since the departure of Mark McClellan in October 2006. Weems must be confirmed by the Senate, and that may not take place for several months. If he is confirmed, he would have about 18 months at the helm of the agency.

Cancer Quality Measures Proposed within the Inpatient Payment System for 2009

The Centers for Medicare & Medicaid Services (CMS) is proposing to add new measures for quality reporting in the inpatient department of hospitals for 2009. The following are the oncology-related measures that may be included in the hospital inpatient prospective payment system (IPPS):

• Breast cancer: Patients with early stage breast cancer who have evaluation of the axilla
• Breast cancer: College of American Pathologists Breast Cancer Protocol
• Colon cancer: Surgical resection includes at least 12 nodes (ACOS-02)
• Colon cancer: College of American Pathologists colon and rectum protocol
• Completeness of pathologic reporting (CCO-04).

In addition to an expanded list of publicly reported quality measures and the provision of additional incentives for hospitals to engage in quality improvement efforts, CMS is proposing to take significant steps to improve the accuracy of Medicare's payment under the acute care IPPS. The payment reforms include a proposal to restructure the inpatient diagnosis-related groups (DRGs) to account more fully for the severity of the patient's condition. In addition, the proposed rule includes provisions to ensure that Medicare no longer pays hospitals for their additional costs of hospital-acquired conditions (including infections). The proposed rule would also reduce payment for a DRG involving the implantation of a device, when a hospital replaces a device and the replacement is supplied to the hospital at no or reduced cost.

ODAC to Meet, Discuss ESAs

The Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) is scheduled to meet on May 9-10, 2007. On May 9 the committee will discuss, among other topics, new drug application (NDA) 022-092, JUNOVAN™ (mifamurtide), proposed indication for the treatment of newly diagnosed resectable high-grade osteosarcoma following surgical resection in combination with multiple agent chemotherapy. On May 10, the committee will discuss updated information on risks of erythropoiesis-stimulating agents (ESAs) for use in the treatment of anemia due to cancer chemotherapy.

ACCC Submits Comments on ESAs to CMS

On April 11, 2007, the Association of Community Cancer Centers (ACCC) submitted comments regarding erythropoiesis stimulating agents (ESAs) for non-renal disease indications to the Centers for Medicare & Medicaid Services (CMS). In its letter ACCC expressed appreciation for CMS’s concerns for ensuring that these therapies are used appropriately by Medicare beneficiaries. ACCC asked that, if CMS decides to issue a new national coverage determination (NCD) for ESAs, the NCD be as clear as possible and continue to allow Medicare beneficiaries with cancer to receive ESAs for medically accepted indications, including those uses supported by the compendia or peer-reviewed medical literature. Furthermore, ACCC asked that any further questions regarding coverage for ESAs that are not explicitly addressed in the NCD be left to the local carriers’ discretion.

Click here to read ACCC’s comments.

NQF Endorses Commission on Cancer Measures for Quality of Cancer Care for Breast and Colon Cancer

The National Quality Forum (NQF) endorsement of Commission on Cancer quality of care measures for breast and colon cancer became effective April 12, 2007. These are the first nationally recognized hospital-based performance measures for quality of care for breast and colon cancer and include:

• Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 receiving breast conserving surgery for breast cancer. Combination chemotherapy is considered or administered within 4 months (120 days) of diagnosis for women under 70 with AJCC T1cN0M0, or Stage II or III hormone receptor negative breast cancer.
• Tamoxifen or third generation aromatase inhibitor is considered or administered within 1 year (365 days) of diagnosis for women with AJCC T1cN0M0, or Stage II or III hormone receptor positive breast cancer.
• Adjuvant chemotherapy is considered or administered within 4 months (120 days) of diagnosis for patients under the age of 80 with AJCC Stage III (lymph node positive) colon cancer.

Through a parallel process, the American Society for Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) developed a similar set of measures for breast and colon cancer. Facilitated by the NQF, the CoC, ASCO, and NCCN have synchronized their developed measures to ensure that a unified set are put forth to the public.

In addition to the measures endorsed by the NQF, the CoC, ASCO, and the NCCN have developed and agreed upon specifications for the following two colorectal cancer measures:

• At least 12 regional lymph nodes are removed and pathologically examined for resected colon cancer.
• Radiation therapy is considered or administered within 6 months (180 days) of diagnosis for patients under the age of 80 of with clinical or pathologic AJCC T4N0M0 or Stage III receiving surgical resection for rectal cancer.

Click here for more information.

CMS Releases Proposed 2008 Hospital Inpatient Rule

The Centers for Medicare & Medicaid Services on April 13 released a proposed rule that it said continues the transition to a more accurate payment system for hospital inpatient care, an effort begun last year. Overall, the proposed rule would increase payments to more than 3,500 acute care hospitals by $3.3 billion, according to CMS's press release. The agency also said that the inpatient rates for operating expenses will rise by 3.3 percent in fiscal 2008 for the hospitals that report quality data to the government.

As reported in the April 16 BNA Health Care Daily, payment reforms include a proposal to restructure the inpatient diagnosis related groups (DRGs) to account for the severity of a patient's condition. The proposed rule would create 745 new severity-adjusted DRGs, replacing the current 538 DRGs, with payments increasing for hospitals with sicker patients and decreasing for hospitals with less ill patients. These changes reflect recommendations from the Medicare Payment Advisory Commission.

The proposed rule would implement a provision of the Deficit Reduction Act of 2005, moving to end higher Medicare payments for care of hospital-acquired conditions, including infections. Further, the proposed rule would create five new quality measures, including 30-day mortality for Medicare patient with pneumonia and four measures related to surgical care improvement, bringing to 32 the total number of measures that hospitals would need to report in fiscal year 2008 to qualify for the full marketbasket (inflation index) pay update in 2009.

Comments on the proposed inpatient prospective payment system (IPPS) rule are due on June 12, and the final rule, which will be effective beginning Oct. 1, will be published later in the summer, CMS said.

Click here to read the Medicare proposed hospital payment rule.

CMS Proposes Changes to Clinical Trial Policy

On April 10, CMS released a proposal that will require more written protocols to cover the costs for Medicare patients in clinical trials. The proposal, renamed the clinical research policy, will require that the written protocols must show how the research will benefit the Medicare population, and it must also consider relevant subpopulations. In addition, all trials must be registered and published on the internet, and the protocol must state the potential impact of age-specific and other factors on outcomes. The comment period lasts for 30 days, and CMS expects a final rule in July, 2007.

"This new decision will signal our continued support to provide access to services for beneficiaries by facilitating participation in the full range of qualified, scientifically sound research projects," CMS Acting Administrator Leslie V. Norwalk said in a statement. CMS said that the new name reflects a broader policy. "Many researchers have a very narrow definition of 'clinical trial' and, as such, many studies that CMS would like to support may not be included" under the former title."

The seven "highly desirable characteristics" in the original policy have been continued but will be renamed "general standards for a scientifically and technically sound clinical research study."

To read more, click here.

More than 500 cancer care professionals attended the Association of Community Cancer Centers 33rd Annual National Meeting, March 28-31, in Baltimore, Md.

“This was the largest meeting in the Association’s 33-year history,” said ACCC Executive Director Christian Downs, JD, MHA. “We’re proud of our multidisciplinary sessions, which provide the cancer care team with practical strategies to deal with evolving restraints on the delivery of quality care, and provide insight into implementation of new technologies and treatments.”

The meeting also featured updates about the rapidly changing regulatory and reimbursement issues in oncology, including news from the Centers for Medicare & Medicaid Services (CMS). Terrence Kay, CMS Acting Director for the Hospital Ambulatory Payment Group provided insight into CMS’s in-progress transformation into a value-based purchasing (VBP) program. He emphasized the agency’s role as an “active purchaser of care for beneficiaries.”

Click here for more details about the meeting.

Part B ASP Rates Updated for Second Quarter

Medicare’s latest quarterly update of Part B average sales prices (second quarter 2007) is available. Effective April 2007 here are the latest Average Sales Prices for selected Part B oncology drugs:

• Bevacizumab (Avastin) 10 mg, $57.27 April 2007 vs. $57.48 Jan. 2007 
• Bortezomib (Velcade) 0.1 mg, $32.68, April 2007 vs. $32.68 Jan. 2007
• Cetuximab (Erbitux) 10 mg, $49.81 April 2007 vs. $49.83 Jan. 2007
• Epotein alfa, ESRD (Epogen) 1000 units, $9.577 April 2007 vs. $9.57 Jan. 2007
• Filgrastim (Neupogen) 300 mcg, $189.47 April 2007 vs. $188.29 Jan. 2007
• Goserelin acetate (Zolodex) 3.6 mg, $198.69 April 2007 vs. $200.43 Jan. 2007
• Leuprolide acetate (Lupron) 3.75 mg, $433.92 April 2007 vs. $431.95 in Jan. 2007
• Pegfilgrastim (Neulasta) 6 mg, $2,163.33 April 2007 vs. $2,152.34 Jan. 2007
• Rituximab (Rituxan) 100 mg, $496.22 April 2007 vs. $486.55 Jan. 2007
• Trastuzumab (Herceptin) 10 mg, $57.87 April 2007 vs. $56.76 Jan. 2007

Write Your Congressperson: Support Anti-Smoking Legislation

The Association of Community Cancer Centers (ACCC) would like you to support H.R. 1108 and S. 625, the Family Smoking Prevention and Tobacco Control Act of 2007. You can support this legislation by writing to your Congressperson though our website, or by calling the local or Washington, DC, office of your Congressperson. Click here to compose your email through ACCC's "Contact Washington" website.  Once there, look for our ACTION ALERT.

The legislation would give the FDA the necessary tools and resources to effectively regulate the manufacturing, marketing, labeling, distribution and sale of tobacco products. The FDA would have the authority to:

• Stop illegal sales of tobacco products to children and adolescents.
• Require changes in tobacco products, such as the reduction or elimination of harmful chemicals, to make them less harmful and less addictive.
• Restrict advertising and promotions that appeal to children and adolescents.
• Prohibit unsubstantiated health claims about so-called “reduced risk” tobacco products that discourage current tobacco users from quitting or encourage new users to start.
• Require the disclosure of tobacco product content and tobacco industry research about the health effects of their products.
• Require larger and more informative health warnings on tobacco products.

The bipartisan bill is sponsored by Senators Edward Kennedy (D-MA) and John Cornyn (R-TX), and Representatives Henry Waxman (D-CA) and Tom Davis (R-VA). It currently has more than 37 co-sponsors in the Senate, including 10 Republicans, and more than 100 co-sponsors in the House of Representatives, including 22 Republicans.

FDA Approves Tykerb for Advanced or Metastatic Breast Cancer

On March 12, 2007, the Food and Drug Administration (FDA) approved Tykerb (lapatinib), a new targeted anti-cancer treatment, to be used in combination with capectabine (Xeloda), for patients with advanced, metastatic breast cancer that is HER2 positive. The combination treatment is indicated for women who have received prior therapy with other cancer drugs, including an anthracycline, a taxane, and trastuzumab (Herceptin).

Tykerb is available in tablets of 250 mg. The dosing for Tykerb is continuous, while the dosing of capecitabine is based on a 21 day cycle. Therefore, a months' supply of 5 tabs daily for Tykerb should be written as 150 tabs for a 30 day supply. Additionally, Tykerb is to be given continuously until progression or unmanageable toxicity occurs. Tykerb will be distributed by GlaxoSmithKline, of Research Triangle Park, N.C.

Tykerb is a small molecule that is administered orally, inhibits the tyrosine kinase components of the EGFR (ErbB1) and HER2 (ErbB2) receptors. Stimulation of EGFR (ErbB1) and HER2 (ErbB2) is associated with cell proliferation and with multiple processes involved in tumor progression, invasion, and metastases. Overexpression of these receptors has been reported in a variety of human tumors and is associated with poor prognosis and reduced overall survival.

The approval of Tykerb was based on a randomized clinical trial in about 400 women with advanced or metastatic breast cancer that was also HER2 positive. In the trial, half the patients received Tykerb with capecitabine and half received capecitabine alone. Compared to patients receiving capecitabine alone, the group of patients receiving Tykerb with capecitabine had a statistically significant improvement in the time to tumor progression. In addition, the tumor response rate was higher in the group of patients receiving Tykerb with capecitabine (24 percent vs. 14 percent). The survival data are not yet mature.

APC Panel Recommends ACCC Plan

On Wednesday, March 7, 2007, the Association of Community Cancer Centers (ACCC) testified before the Ambulatory Payment Classification (APC) Panel on pharmacy overhead costs in the Hospital Outpatient Department. ACCC Secretary Ernie Anderson, MS, RPh, presented a three phased plan that would better reimburse for pharmacy services. The APC Panel agreed with ACCC's assessment and recommended to CMS that they meet with ACCC and other stakeholders in order to implement this plan. ACCC will be holding meetings with CMS to discuss the plan and hope to have part of it included in the 2008 Hospital Outpatient Prospective Payment System (HOPPS) rule. To see ACCC's testimony, click here.

ACCC Voices Support for New Bill to Address Nursing Shortage

The Association of Community Cancer Centers (ACCC) has voiced its support for S. 646, a bill to increase the nursing workforce. In a letter to Senator Norm Coleman, co-sponsor of the bill, ACCC acknowledged the severe shortage of nursing professionals and applauded the Senate's effort to help address this critical issue. ACCC expressed support for the "distance learning program," measures to expand opportunities for nursing faculty, and proper funding for nursing programs currently in place within the Department of Health and Human Services.

We will keep ACCC members up to date on further developments.

2006 a Good Year for New Oncology Drugs, Will 2007 Be Even Better?

Last year saw the FDA conducting fewer priority reviews than in 2004 and 2005 and slightly fewer drugs were given orphan designation. Oncology and infectious diseases were the main therapeutic areas to benefit from new drugs in 2006. As reported by Joanna Owens in Nature Reviews Drug Discovery (Feb. 2007), a growing understanding of signal transduction pathways and oncogenic factors supports the advancement of new therapies with novel mechanisms of action.

Indeed, 2006 saw Merck enter the oncology arena with the first vaccine developed to prevent cervical cancer (Gardasil), and the approval of its histone deacetylase inhibitor, Zolinza (vorinostat) for cutaneous T-cell lymphoma. Zolinza was the second of two epigenetics-based cancer therapies that were approved in 2006; MGI Pharma's Dacogen (decitabine), a demethylating agent, was also approved to treat myelodysplastic syndromes. The approval of Pfizer's Sutent (sunitinib malate) also heralds the continued roll-out of targeted treatments for cancer that work by interfering with a well-characterized molecular event known to cause a disease.

Similarly, Bristol–Myers Squibb's second-generation kinase inhibitor Sprycel (dasatinib) is another targeted therapy. It was approved last year after priority review to treat imatinib-resistant chronic myeloid leukemia. Like imatinib (Gleevec; Novartis), it targets the BCR–ABL kinase that causes chronic myeloid leukemia but retains activity against mutant kinases that confer resistance to imatinib. Its rapid launch shows how an understanding of the molecular basis of a disease can be used to accelerate the development of the next generation of drugs.

According to the Nature article, 2007 is likely to be another good year for cancer drugs. Following on quickly from Sprycel, Novartis is hoping to launch its own second-generation BCR–ABL kinase inhibitor, nilotinib (Tasigna), in 2007. Approval of several first-in-class cancer drugs, including Wyeth's mTOR (mammalian target of rapamycin) inhibitor, temsirolimus (Torisel), and the first small-molecule ERB1/2 inhibitor, lapatinib (Tykerb), developed by GlaxoSmithKline, is also anticipated. Another prospect is Dendreon's Provenge, the first therapeutic cancer vaccine, which has been shown to benefit patients with metastatic hormone-independent prostate cancer.

2006 a Good Year for New Oncology Drugs, Will 2007 Be Even Better?

Last year saw the FDA conducting fewer priority reviews than in 2004 and 2005 and slightly fewer drugs were given orphan designation. Oncology and infectious diseases were the main therapeutic areas to benefit from new drugs in 2006. As reported by Joanna Owens in Nature Reviews Drug Discovery (Feb. 2007), a growing understanding of signal transduction pathways and oncogenic factors supports the advancement of new therapies with novel mechanisms of action.

Indeed, 2006 saw Merck enter the oncology arena with the first vaccine developed to prevent cervical cancer (Gardasil), and the approval of its histone deacetylase inhibitor, Zolinza (vorinostat) for cutaneous T-cell lymphoma. Zolinza was the second of two epigenetics-based cancer therapies that were approved in 2006; MGI Pharma's Dacogen (decitabine), a demethylating agent, was also approved to treat myelodysplastic syndromes. The approval of Pfizer's Sutent (sunitinib malate) also heralds the continued roll-out of targeted treatments for cancer that work by interfering with a well-characterized molecular event known to cause a disease.

Similarly, Bristol–Myers Squibb's second-generation kinase inhibitor Sprycel (dasatinib) is another targeted therapy. It was approved last year after priority review to treat imatinib-resistant chronic myeloid leukemia. Like imatinib (Gleevec; Novartis), it targets the BCR–ABL kinase that causes chronic myeloid leukemia but retains activity against mutant kinases that confer resistance to imatinib. Its rapid launch shows how an understanding of the molecular basis of a disease can be used to accelerate the development of the next generation of drugs.

According to the Nature article, 2007 is likely to be another good year for cancer drugs. Following on quickly from Sprycel, Novartis is hoping to launch its own second-generation BCR–ABL kinase inhibitor, nilotinib (Tasigna), in 2007. Approval of several first-in-class cancer drugs, including Wyeth's mTOR (mammalian target of rapamycin) inhibitor, temsirolimus (Torisel), and the first small-molecule ERB1/2 inhibitor, lapatinib (Tykerb), developed by GlaxoSmithKline, is also anticipated. Another prospect is Dendreon's Provenge, the first therapeutic cancer vaccine, which has been shown to benefit patients with metastatic hormone-independent prostate cancer.

ACCC Member Elected to APC Panel

02.23.07.—The Association of Community Cancer Centers congruatulates Patricia Spencer-Cisek, MS, APRN-BC, AOCN, who has been appointed to serve a four-year term on the Ambulatory Payment Classification (APC) Panel beginning with its March 7-9, 2007, meeting. Ms. Spencer-Cisek has served on the Board of Trustees of the Association of Community Cancer Centers (ACCC). Currently, she is chair of ACCC’s Nominating Committee and co-chair of the Patient Advocacy Committee.

She is an active member of the Oncology Nursing Society at both local and national levels.

Ms. Spencer-Cisek is the clinical director of oncology services at Glens Falls Hospital in Glens Falls, N.Y. She has worked in advanced practice nurse roles in oncology since 1987, including experience at two NCI-designated cancer centers, MD Anderson Cancer Center in Houston, Tex., and Dana Farber Cancer Institute in Boston, Mass.

The main purpose of the APC Panel is to review the APC groups and their associated weights and to make recommendations to CMS. Since the APC groups and weights are major elements of the hospital outpatient prospective payment system (HOPPS), the panel's recommendations will be used by CMS to prepare their annual report on HOPPS. In her new role on the panel, Ms. Spencer-Cisek will work with the other members to assign new CPT (current procedural terminology) codes to APCs and address whether procedures are similar both clinically and in terms of resource use. In order to make the most appropriate recommendations, she will consult with entities, such as medical device and drug organizations, who have expert knowledge of APC components.

ACCC looks forward to working with Ms. Spencer-Cisek and other APC Panel members at their upcoming meetings.

CMS Confirms Plans to Prevent 5 Percent Physician 2007 Reimbursement Cut

CMS has confirmed that it will be ready to implement its plans to implement legislation preventing a scheduled 5 percent reduction in Medicare payments from going into effect in 2007. It is important to note that only the conversion factor and the geographic adjustments will be the same as in 2006. Payment rates for many services will be changing due to the revisions in work relative value units and practice expense, as well as the imaging provisions of the Deficit Reduction Act. Previously, 2007 payment rates were posted by the carriers to their websites in mid-November. The new rates will be posted to the CMS and carrier websites no later than December 31, 2006, and carriers will be prepared to process claims at the correct rates. As Medicare claims are held for 14 days before they are paid, physicians will start receiving payments based on the new rates in mid-January.

Congress Rolls Back 5 Percent Physician 2007 Reimbursement Cut

In the early hours on Saturday morning, Dec. 9, Congress passed a bill of tax break extenders and trade packages that also included a rollback of the 5 percent cut to the physician fee schedule that was scheduled to go into effect on January 1, 2007. Therefore, the conversation factor for 2007 will be the same as 2006. (See Table 1. Impact on High-Volume Oncology Services and Table 2. Comparison of 2007 to 2006 Payments). The Association of Community Cancer Centers had urged Congress to take action to prevent the expected cuts, and provided extensive comments to CMS.

Also included in the package was a bonus payment of 1.5 percent for quality reporting that will begin on July 1, 2007, and continue on to the end of the year. The exact quality reporting measures were not included in the bill.

Congress has decided to use part of the Medicare Stabilization Fund to offset the costs of the fix. The next Congress will once again most likely seek a permanent fix to the SGR formula.

Transitioning to the Medicare Administrative Contractor (MAC)

Transitioning to the Medicare Administrative Contractor (MAC) system is well underway. CMS contract reform under the MMA of 2003 for the administration of claims and billing activities for intermediary and carrier and outpatient services, which include physician care, will include 15 awards to contractors that submit proposals through three federal procurements. A RFP has been released for the jurisdictions in Cycle One that includes Colorado, New Mexico, Oklahoma, Texas, Iowa, Kansas, Missouri, Nebraska, Delaware, District of Columbia, Maryland, New Jersey, and Pennsylvania. These jurisdictions account for 23 percent of the fee-for-service claims workload. Contract awards for these jurisdictions are anticipated in July 2007. Another RFP was released for the jurisdictions in Cycle One that includes California, Hawaii, Nevada, Alaska, Idaho, Oregon, Washington, Arkansas, Louisiana, Mississippi, Connecticut, and New York. These jurisdictions also account for 23 percent of the fee-for-service workload. Contract awards for these jurisdictions are expected in late September 2007.

The competition in Cycle Two that includes the remaining states will not begin until September 2007 with contracts to be awarded in September 2008.

One major change in this process to note is that CMS has accelerated its schedule by two years to effectively transfer the current claims workload by 2009 rather than 2011.

Most physicians are aware of the jurisdiction in which they are located and the timeframe for transitioning to the MACs, but many are unaware that they are encouraged to comment if they believe they can impact change. The primary objectives for which CMS developed the RFPs are: 1) administrative cost savings, 2) improved allocation of the claims processing workload, 3) consistency across a wider service area, and 4) delivery of 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. The more input CMS gets from those who are directly affected by the change the more acceptable and less problematic the transition will be.

The agency does not want to operate in a vacuum and during the development process has solicited review from providers and other industry entities that would encourage specific feedback and suggested innovations to modernize business processes and the technology platform.

CMS had three comment periods during Cycle One, has encouraged participation in various Open Door Forum update conferences and is sending periodic emails to those who have signed onto the Open Door Forum listserv.

CMS is planning a pre-proposal teleconference on January 9, 2007 for jurisdictions 1, 2, 7, and 13 (Cycle One). Information on the teleconference will be posted on www.FedBizOpps.gov shortly. Additionally, the RFPs are available for viewing at www.FedBizOpps.gov. CMS wants to communicate information and decisions concerning the MACs as often as possible through its website. Any stakeholder who is interested in the CMS feedback forums should check the above websites for ways to receive and respond to information about the MAC initiative.

Part B ASP Rates Updated for New Quarter

Medicare’s latest quarterly update of Part B average sales prices indicates that the average reimbursement for all Part B drugs increases 1 percent from the previous quarter. Effective January 2007 here are the latest Average Sales Prices for selected Part B oncology drugs:

• Bevacizumab (Avastin) 10 mg, $57.48 Jan. 2007 vs. $56.88 Oct. 2006, +1%
• Bortezomib (Velcade) 0.1 mg, $32.68 Jan. 2007 vs. $31.87 Oct. 2006, 3%
• Cetuximab (Erbitux) 10 mg, $49.83 Jan. 2007 vs. $49.86 Oct. 2006, +0%
• Epotein alfa, ESRD (Epogen) 1000 units, $9.57 Jan. 2007 vs. $9.45 Oct. 2006, +1%
• Filgrastim (Neupogen) 300 mcg, $188.29 Jan. 2007 vs. $188.07 Oct. 2006, +0%
• Goserelin acetate (Zolodex) 3.6 mg, $200.43 Jan. 2007 vs. $199.12 Oct. 2006, +1%
• Leuprolide acetate (Lupron) 3.75 mg, $431.95 in Jan. 2007 vs. $437.58 in Oct. 2006, -1%
• Pegfilgrastim (Neulasta) 6 mg, $2,152.34 Jan. 2007 vs. $2,163.61 Oct. 2006, -1%
• Rituximab (Rituxan) 100 mg, $486.55 Jan. 2007 vs. $481.69 Oct. 2006, +1%
• Trastuzumab (Herceptin) 10 mg, $56.76 Jan. 2007 vs. $56.17 Oct. 2006, +1%

CMS Confirms Plans to Prevent 5 Percent Physician 2007 Reimbursement Cut

CMS has confirmed that it will be ready to implement its plans to implement legislation preventing a scheduled 5 percent reduction in Medicare payments from going into effect in 2007. It is important to note that only the conversion factor and the geographic adjustments will be the same as in 2006. Payment rates for many services will be changing due to the revisions in work relative value units and practice expense, as well as the imaging provisions of the Deficit Reduction Act. Previously, 2007 payment rates were posted by the carriers to their websites in mid-November. The new rates will be posted to the CMS and carrier websites no later than December 31, 2006, and carriers will be prepared to process claims at the correct rates. As Medicare claims are held for 14 days before they are paid, physicians will start receiving payments based on the new rates in mid-January.

Congress Rolls Back 5 Percent Physician 2007 Reimbursement Cut

In the early hours on Saturday morning, Dec. 9, Congress passed a bill of tax break extenders and trade packages that also included a rollback of the 5 percent cut to the physician fee schedule that was scheduled to go into effect on January 1, 2007. Therefore, the conversation factor for 2007 will be the same as 2006. (See Table 1. Impact on High-Volume Oncology Services and Table 2. Comparison of 2007 to 2006 Payments). The Association of Community Cancer Centers had urged Congress to take action to prevent the expected cuts, and provided extensive comments to CMS.

Also included in the package was a bonus payment of 1.5 percent for quality reporting that will begin on July 1, 2007, and continue on to the end of the year. The exact quality reporting measures were not included in the bill.

Congress has decided to use part of the Medicare Stabilization Fund to offset the costs of the fix. The next Congress will once again most likely seek a permanent fix to the SGR formula.

Transitioning to the Medicare Administrative Contractor (MAC)

Transitioning to the Medicare Administrative Contractor (MAC) system is well underway. CMS contract reform under the MMA of 2003 for the administration of claims and billing activities for intermediary and carrier and outpatient services, which include physician care, will include 15 awards to contractors that submit proposals through three federal procurements. A RFP has been released for the jurisdictions in Cycle One that includes Colorado, New Mexico, Oklahoma, Texas, Iowa, Kansas, Missouri, Nebraska, Delaware, District of Columbia, Maryland, New Jersey, and Pennsylvania. These jurisdictions account for 23 percent of the fee-for-service claims workload. Contract awards for these jurisdictions are anticipated in July 2007. Another RFP was released for the jurisdictions in Cycle One that includes California, Hawaii, Nevada, Alaska, Idaho, Oregon, Washington, Arkansas, Louisiana, Mississippi, Connecticut, and New York. These jurisdictions also account for 23 percent of the fee-for-service workload. Contract awards for these jurisdictions are expected in late September 2007.

The competition in Cycle Two that includes the remaining states will not begin until September 2007 with contracts to be awarded in September 2008.

One major change in this process to note is that CMS has accelerated its schedule by two years to effectively transfer the current claims workload by 2009 rather than 2011.

Most physicians are aware of the jurisdiction in which they are located and the timeframe for transitioning to the MACs, but many are unaware that they are encouraged to comment if they believe they can impact change. The primary objectives for which CMS developed the RFPs are: 1) administrative cost savings, 2) improved allocation of the claims processing workload, 3) consistency across a wider service area, and 4) delivery of 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. The more input CMS gets from those who are directly affected by the change the more acceptable and less problematic the transition will be.

The agency does not want to operate in a vacuum and during the development process has solicited review from providers and other industry entities that would encourage specific feedback and suggested innovations to modernize business processes and the technology platform.

CMS had three comment periods during Cycle One, has encouraged participation in various Open Door Forum update conferences and is sending periodic emails to those who have signed onto the Open Door Forum listserv.

CMS is planning a pre-proposal teleconference on January 9, 2007 for jurisdictions 1, 2, 7, and 13 (Cycle One). Information on the teleconference will be posted on www.FedBizOpps.gov. shortly. Additionally, the RFPs are available for viewing at www.FedBizOpps.gov. CMS wants to communicate information and decisions concerning the MACs as often as possible through its website. Any stakeholder who is interested in the CMS feedback forums should check the above websites for ways to receive and respond to information about the MAC initiative.

Medicare Posts Physician and Hospital Outpatient Information

To help consumers, providers, and payers make more informed healthcare decisions, CMS is making available Medicare payment information for physicians and hospital outpatient departments. The release includes data for common services provided in physicians’ offices, as well as services performed in a hospital outpatient department. This information complements the inpatient hospital and ambulatory surgery center data already posted to the CMS website.

The new information posted by CMS at www.cms.hhs.gov/HealthCareConInit will allow consumers and users of the data to compare the costs and procedures, which may vary depending upon the site of service, and to select the most appropriate setting in their city or state for the delivery of high quality, efficient care. The information includes payment rates for over 70 physician services rendered in non-office settings as well as 19 services usually performed in a physician’s office. The outpatient hospital payment data also provide information for commonly performed procedures., including calculation of radiation therapy dose; PET/CT scan of body to study tumors; and scope bladder and remove lesions, tumors.

FDA Approves Herceptin for the Adjuvant Treatment of HER2-Positive Node-Positive Breast Cancer

Genentech, Inc. announced Nov. 16, 2006, that the U.S. Food and Drug Administration (FDA) approved Herceptin® (Trastuzumab), as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel, for the adjuvant treatment of HER2-positive node-positive breast cancer. Adjuvant therapy is given to women with early-stage (localized) breast cancer who have had initial treatment surgery with or without radiation therapy with the goal of reducing the risk of cancer recurrence and/or the occurrence of metastatic disease.

The FDA approval was based on data from an interim joint analysis of more than 3,500 patients enrolled in two Phase III clinical trials. These results showed that the addition of Herceptin to standard adjuvant therapy significantly reduced the risk of breast cancer recurrence, the primary endpoint of the studies, by 52 percent (or a hazard ratio of 0.48) in women with HER2-positive breast cancer, compared to those patients who received standard adjuvant therapy alone.

CMS Releases Final Hospital Outpatient Rule, To Pay ASP +6 Percent, Require Quality Reporting

On Nov. 1, 2006, the Centers for Medicare & Medicaid Services (CMS) issued its final rule for Medicare payment for hospital outpatient services in calendar year (CY) 2007 that will implement new steps to make payments more accurate and to promote higher quality and value in outpatient care. Included in the final outpatient prospective payment system (OPPS) rule are provisions expanding quality reporting requirement for hospital inpatient services as well as expanding the list of services for which Medicare will make payment to ambulatory surgical centers in 2007. It will be effective for outpatient and ASC services furnished to Medicare beneficiaries on or after January 1, 2007.

The Association of Community Cancer Centers provided extensive comments and testimony to CMS, and is analyzing the final hospital outpatient rule and will report to its membership shortly.

CMS is revising the Ambulatory Payment Classification (APC) payment and coding structure for drug administration services, allowing hospitals to report the same CPT codes for drug administration used by physicians and other payers, and to be paid separately for additional hours of infusion, in addition to their payment for the initial hour of infusion. As a result, says CMS, hospitals will be paid more accurately for complex and lengthy drug administration services, while also receiving more appropriate payments for individual services when provided alone.
(See Table 1. Impact of 2007 Hospital Outpatient Prospective Payment Services Rule on Oncology Services by APC)

Under the final rule, Medicare will pay for drugs and biologicals at 106 percent of the average sales price (ASP), instead of the proposed ASP plus 5 percent. Radiopharmaceuticals will be paid at charges adjusted to cost, using hospital specific cost-to charge ratios. Payments for other drugs will continue to be bundled into payments for their associated procedures. In the final rule CMS finalizes its proposed policy to pay separately for drugs, biologicals, radiopharmaceuticals and the anti-nausea drugs costing $55 or more per day, consistent with the previous $50 threshold but updated for inflation. This is an increase of $5 from the current level of $50. CMS will continue to pay separately for anti-emetic drugs regardless of their daily cost.

Pharmacy Handling Costs
As in 2006, CMS concludes that ASP plus 6 percent is sufficient payment for both pharmacy acquisition and handling costs and will not make a separate payment for handling costs. CMS remains convinced that pharmacy handling costs are included in hospitals’ charges for drugs, and thus are included in Medicare’s payment rates, but the agency will continue to work with stakeholders to study these costs.

Drug Administration Services
For 2007, CMS will implement three significant changes to payment policies for drug administration services. First, CMS will make separate payment for second and subsequent hours of drug administration services. Up to now, CMS has packaged payment for additional hours into payment for the first hour. Second, CMS has organized the drug administration codes into new APCs with new payment rates. Although payments for the first hour administration codes have been reduced, payments for administrations lasting two hours or longer will be increased. Third, CMS will use all of the Current Procedural Terminology (CPT) codes for drug administration instead of the current mix of CPT codes and C-codes.
(See Table2. Drug Administration Codes)

CMS did not implement the APC Panel’s recommendations to pay for a second IV push of the same drug or to issue clarifications regarding billing for biologic response modifiers.

CMS will continue to make a $75 payment for pre-administration services associated with intravenous immune globulin.

Evaluation and Management Services
As proposed, CMS will implement new APCs for evaluation and management (E&M) services. For 2007, CMS replaces the three current APCs for hospital clinic visits with five new APCs. CMS did not finalize its proposal to create new G-codes for E&M services, but instead will use the current CPT codes for these services. CMS will continue to work on refining the draft American Hospital Association (AHA)/American Health Information Management Association (AHIMA) guidelines for billing for these services.

Imaging Procedures
As proposed, CMS will not reduce payment for second and subsequent imaging procedures in 2007. CMS will assign positron emissions tomography (PET) and PET/ computed tomography (CT) services to new, lower-paying APCs from their current new technology APCs. Concurrent PET/CT will be assigned to New Technology APC 1511 with a payment rate of $950, reduced from the current rate of $1250. PET will be assigned to APC 308, with a payment of $855.43.

Quality Measures. In order to promote greater value in the purchase of hospital outpatient services for Medicare beneficiaries, the final rule ties OPPS rate increases to the reporting of quality measures beginning in 2009. The final rule announces CMS’ plans to develop additional quality measures that are specifically appropriate for hospital outpatient care, and will require hospitals to report the outpatient-specific measures beginning in CY 2009. According to Herb Kuhn, CMS acting deputy director, the agency will use the two-year lead time to develop robust quality measures for outpatient services.

The final rule also includes an expansion of the hospital reporting of additional quality measures for inpatient services beginning in FY 2008, based on measures endorsed by the National Quality Forum (NQF) and supported by the privately-led Hospital Quality Alliance (HQA). Under the final rule, hospitals would, for the first time, be required to report consistent measures on patient satisfaction with hospital care to receive a full IPPS payment update. The survey instrument, called HCAHPS® (Hospital Consumer Assessment of Healthcare Providers and Systems), was developed jointly by the Agency for Healthcare Research and Quality and CMS, and is designed to gather information about patient perspectives on the care that they have received during an inpatient stay. Also for the first time, hospitals would report risk-adjusted outcome measures to receive the full payment update, including 30-day mortality measures for patients hospitalized with an acute myocardial infarction, or heart failure. The final rule also includes three new measures from the Surgical Care Improvement Project related to the process of care for beneficiaries undergoing surgical procedures.

Per Diem Payment. In the proposed rule, CMS proposed to reduce per diem payment for partial hospitalization services in both CMHCs and hospital outpatient departments by 15 percent to reflect decreases in costs reported by these programs. After further consideration, including review of public comments on the proposed rule, the final rule includes a per diem reduction of only 5 percent for CY 2007. "We believe this rate is appropriate to ensure access for the vulnerable population served by partial hospitalization programs, while still reflecting the downward trend in the cost data," noted CMS.

MACs. The rule will begin the transition from the current policies for administering hospital claims for outpatient services using entities called fiscal intermediaries and carriers to the new Medicare Administrative Contractors (MACs), authorized by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). Under the rule, hospitals will file their claims with the intermediary with jurisdiction over the hospital’s geographic location until a MAC which will handle not only hospital claims, but also Part B claims from physicians, laboratories and other suppliers replaces the intermediary. CMS is adopting a policy that all providers and suppliers generally be assigned to a MAC based on geographic location, but that a large qualified provider chain would be permitted to file all claims with the MAC that has jurisdiction over the chain’s home office.

Ambulatory Surgical Centers. Finally, the rule makes final two statutory mandates that will affect ambulatory surgical centers (ASCs) in CY 2007. First, in response to public comments, CMS is adding 19 procedures to the ASC list. The law requires that the ASC list be updated at least every two years; the last update through notice and comment rulemaking was implemented in July 2005. Two of the procedures for which Medicare will allow payment to ASCs beginning in CY 2007 are for surgical services furnished to maintain vascular access fistulas and grafts for hemodialysis patients. The procedures are consistent with the CMS “Fistula First” initiative and adding them to the ASC list of Medicare approved procedures will provide expanded access to these services, which can be of critical importance to patients receiving dialysis treatment.

In addition, CMS is implementing in CY 2007 a provision of the Deficit Reduction Act (DRA) which requires that Medicare payment for surgical procedures performed in ASCs not exceed the Medicare payment for the same procedures when they are performed in a hospital outpatient department subject to the OPPS. This provision will result in decreased payment for approximately 280 procedures on the ASC list beginning January 1, 2007.

According to CMS, hospitals would receive an estimated $32.5 billion in CY 2007 under the final rule that revises policies and payment rates under the OPPS for outpatient services provided to Medicare beneficiaries. As provided by statute, the rule includes a 3.4 percent market basket update to Medicare payment rates for services paid under the hospital OPPS for CY 2007. After taking into account other factors that affect the level of payments, CMS estimates that hospitals will receive an overall average increase of 3.0 percent in Medicare payments for outpatient department services in 2007 due to the changes in this final rule.

While the market basket update accounts for increases in the costs of providing a service, much of the growth in outpatient spending results from increases in utilization and complexity (volume and intensity). CMS estimates that between 2005 and 2006, hospital outpatient expenditures increased by nearly 12 percent, mainly due to growth in the volume and intensity of services. CMS projects that the expenditures under the OPPS in CY 2007 will be approximately 9.2 percent higher than the estimated CY 2006 expenditures. That rate of growth in expenditures is of great concern to CMS, not only because of its impact on all taxpayers, but especially on beneficiaries whose monthly premiums cover 25 percent of Part B expenditures.

Gleevec Receives New FDA Indications

The US Food and Drug Administration (FDA) has extended the approval of Gleevec (imatinib mesylate), an oral tyrosine kinase inhibitor, to five new indications, all rare life-threatening disorders. The new indications, all second-line, include dermatofibrosarcoma protuberans, a solid tumor that typically presents as a hard lump in the skin of the chest, abdomen, or leg. Others are for hematologic diseases. They are:

• Relapsed or refractory Philadelphia-chromosome-positive acute lymphoblastic leukemia (ALL), a rapidly progressive disease
• Myelodysplastic/myeloproliferative diseases
• Hypereosinophilic syndrome/chronic eosinophilic leukemia, which is characterized by persistent overproduction of eosinophils
• Aggressive systemic mastocytosis, also known as aggressive mast cell disease.

The FDA approvals are based on data from Novartis-sponsored clinical studies and clinical data from independent medical researchers showing the efficacy of Gleevec in the treatment of these diseases, in which there is a suggested connection between a Gleevec-sensitive pathway and a disease. Gleevec was approved in May 2001 for treating Philadelphia-chromosome-positive chronic myelogenous leukemia (CML) and later for gastrointestinal stromal tumor (GIST).

New NCI Director Sworn In

On Wednesday, October 18, 2006, Dr. John Niederhuber was officially sworn in as the 13th Director of the National Cancer Institute (NCI) at the National Institutes of Health (NIH). The Department of Health and Human Services Secretary, Michael Leavitt, was on hand to deliver the oath of office and to give remarks to the assembled audience. Dr. Elias Zerhouni, the Director of NIH was also on hand. After his swearing in, Dr. Niederhuber spoke of his continued desire to bring science to the people, which is the underlying theme behind his new Community Cancer Centers Initiative.

Dr. Niederhuber spoke of today's "post-genomic scientific environment," which heralds: "an entirely new era of risk determination, disease prevention, diagnosis, and highly targeted therapies. It is the era of genomically and proteomically characterized disease. As we move into this new era of personalized medicine, ideas, tactics, and techniques are coming from many sectors of science. The physical sciences and engineering are being applied to optimize the discovery, development, and, ultimately, the delivery of interventions to the patient. The once-futuristic tool of nanotechnology is being used to perform molecular classification of tumors to enable high-throughput screening and to predict therapeutic efficacy. Imaging is becoming a tool to ascertain just how much of a small molecule is reaching a targeted receptor and whether the therapeutic molecule changes cellular function. Computational biology - systems biology, if you will - is addressing issues such as information scale, modeling, simulations, and data interpretation."

CMS Releases 86 Quality Measures for Physician Voluntary Reporting Program

The Centers for Medicare & Medicaid Services (CMS) has published a list of 86 quality measures that the agency expects to have available at the beginning of 2007 for its Physician Voluntary Reporting Program (PVRP). None includes oncology specifically; four include hematology. CMS said it plans to select a subset of the measures for use in the reporting program for 2007 "in order to achieve an appropriate balance in measures to be reported by different specialties." The list of measures to be used in the program will be posted before Jan. 1, 2007, the agency said in a fact sheet released Oct. 17.

The list of quality measures released Oct. 17 covers 32 of 39 physician specialties, CMS said, adding that it continues working with specialties that have yet to develop quality measures. No quality measures are listed for oncology. Four quality measures are listed for hematology: myelodysplastic syndromes, erythropoietin therapy, chronic lymphocytic leukemia and multiple myeloma, and acute leukemia.

The fact sheet and quality measures are available at http://www.cms.hhs.gov/PVRP/Downloads/qualmeasures.pdf.

ACCC Submits Comments to CMS on Proposed 2007 Hospital Outpatient Prospective Payments System

On Friday, October 6, 2006, , the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) with regard to the proposed 2007 Hospital Outpatient Prospective Payments System. ACCC recommended the following:

• Recalculate its payment rates for separately paid drugs by including charges for all drugs with Healthcare Common Procedure Coding System (HCPCS) codes and setting rates at no less than ASP +6 percent.
   
• Continue to study mechanisms to reimburse hospitals for their pharmacy service costs.
   
• Pay separately for all drugs with HCPCS codes.
   
• Continue to pay separately for anti-emetics.
   
• Continue to reimburse separately paid radiopharmaceuticals based on the hospital’s charge adjusted to cost using hospital-specific cost to charge ratios.
   
• Implement the proposed new APCs for drug administration services and the changes recommended by the Advisory Panel on APC Groups to allow hospitals to be reimbursed appropriately for drug administration services.
   
• Continue to make payment for the preadministration services associated with providing intravenous immune globulin (IVIG).
   
• Implement the proposed new APCs and codes for evaluation and management services provided during clinic visits and continue to work to refine the draft guidelines for the use of those codes.
   
• Adopt codes, with appropriate reimbursement, to reflect coordinated care services provided by several professionals.
   
• Postpone the adoption of a policy to reduce payment for second and subsequent imaging procedures within the same family when performed in the same session.
   
• Implement the proposed payment rates for brachytherapy APCs.
   
• Delay the movement of positron emission tomography/computed tomography (PET/CT) scans to a clinical APC.
   
• Reevaluate its proposal to assign nonmyocardial PET scans to a clinical APC.

Click here for the full text of ACCC’s comments.

ACCC Submits Comments to CMS on Physician Fee Schedule Rule

On Friday October 6, 2006, the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the proposed 2007 Physician Fee Schedule Rule. ACCC recommended the following:

• Work with Congress and all interested parties to make changes to the Sustainable Growth Rate (SGR) or take other action to permanently stabilize physician payments at levels adequate to protect beneficiary access to care and work with the physician community to develop appropriate quality measures linked to payment incentives.
   
• Not implement the significant reductions in payment for drug administration services, as would occur under the proposed changes to the practice expense methodology, at least until the effect of these changes can be considered in conjunction with the expected reduction in the conversion factor and other changes mandated under the MMA and DRA and a determination can be made that beneficiary access to cancer care won’t be compromised.
   
• Ensure continued beneficiary access to essential IVIG services by continuing to pay physicians for preadministration-related services for standard and specialty IVIG. If CMS believes there is a basis for discontinuing payment for these services, the reasons must be articulated and interested parties must have an opportunity to comment.
   
• Not impose any further reduction in payment for second and subsequent imaging services in the same session and continue to study the resources used in combinations of imaging services and assess the interaction of the existing multiple imaging procedure policy with the imaging payment reductions also required by the Deficit Reduction Act.
   
• In order to ensure the accuracy and validity of the data used, and to protect beneficiary access to care, assure that adequate procedural and substantive safeguards are in place before using the widely available market price (WAMP) or average manufacturer price (AMP) for drugs instead of payment based on average sales price (ASP).
   
• Ensure that when compounded drugs are prescribed and provided, the costs associated with such compounding are included in the pricing, and instruct contractors accordingly in order to promote standardization in policies and pricing related to compounded drugs.

Click here for the full text of ACCC’s comments.

CMS Completes Additional MACs

The Centers for Medicare & Medicaid Services (CMS) released a Request for Proposal (RFP) for new Medicare Administrative Contractors (MACs) “that will streamline the processes to pay Medicare claims and answer providers’ questions about Medicare payments for services,” according to the CMS press release. This RFP is for three of 15 separate contracts that will be issued as part of the Medicare contracting reform created by the Medicare Modernization Act.

Under these improvements, Medicare will continue its move from a network of Part A fiscal intermediaries who process claims for hospitals and other institutional providers, and Part B carriers who process claims for physicians, laboratories, and other suppliers to one that will combine responsibility for both Part A and Part B claims. The goal is to provide a greater coordination of claims processing when a beneficiary receives services in different settings. For providers, this will also mean having one place to go for questions about claims.

CMS expects to award these contracts in July 2007. CMS intends to issue a separate RFP for four other MAC jurisdictions in December 2006, and additional RFPs will be issued in 2007 for the remainder of the 15 MAC jurisdictions. CMS previously awarded an A/B MAC contract for Jurisdiction 3, covering Arizona, Montana, North Dakota, South Dakota, Utah, and Wyoming, as well as four specialty contracts for the Durable Medical Equipment MACs.

Together these contractors will be responsible for 23 percent of the total Medicare fee-for-service workload, comprised of claims from the following jurisdictions:

• Jurisdiction 4 – Colorado, New Mexico, Oklahoma, and Texas
• Jurisdiction 5 – Iowa, Kansas, Missouri and Nebraska
• Jurisdiction 12 – Delaware, the District of Columbia, Maryland, New Jersey and Pennsylvania

The RFP also contains unique requirements for specific MACs. These include:

• Jurisdiction 4 has special requirements for Indian Health Services, the Veterans Affairs Medicare Equivalent Remittance Advice, centralized billing for mass immunizers, rural community hospitals, and a chiropractic demonstration.
• Jurisdiction 5 has special requirements for rural community hospitals, a chiropractic services demonstration, and a low vision demonstration.

The Government Accountability Office sustained a protest of the award for DME MAC Jurisdiction C. After that decision, CMS undertook corrective action. After evaluation of final proposal revisions under the corrective action, CMS today also announced that it had awarded the contract for DME MAC Jurisdiction C to CIGNA Government Services, LLC (CIGNA).

Fact sheets for Jurisdictions 4, 5, and 12 along with additional information on Medicare contracting reform can be found on the Medicare contracting reform webpage at http://www.cms.hhs.gov/MedicareContractingReform/

Medicare Posts Physician and Hospital Outpatient Information

To help consumers, providers, and payers make more informed healthcare decisions, CMS is making available Medicare payment information for physicians and hospital outpatient departments. The release includes data for common services provided in physicians’ offices, as well as services performed in a hospital outpatient department. This information complements the inpatient hospital and ambulatory surgery center data already posted to the CMS website.

The new information posted by CMS at www.cms.hhs.gov/HealthCareConInit will allow consumers and users of the data to compare the costs and procedures, which may vary depending upon the site of service, and to select the most appropriate setting in their city or state for the delivery of high quality, efficient care. The information includes payment rates for over 70 physician services rendered in non-office settings as well as 19 services usually performed in a physician’s office. The outpatient hospital payment data also provide information for commonly performed procedures., including calculation of radiation therapy dose; PET/CT scan of body to study tumors; and scope bladder and remove lesions, tumors.

FDA Approves Herceptin for the Adjuvant Treatment of HER2-Positive Node-Positive Breast Cancer

Genentech, Inc. announced Nov. 16, 2006, that the U.S. Food and Drug Administration (FDA) approved Herceptin® (Trastuzumab), as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel, for the adjuvant treatment of HER2-positive node-positive breast cancer. Adjuvant therapy is given to women with early-stage (localized) breast cancer who have had initial treatment surgery with or without radiation therapy with the goal of reducing the risk of cancer recurrence and/or the occurrence of metastatic disease.

The FDA approval was based on data from an interim joint analysis of more than 3,500 patients enrolled in two Phase III clinical trials. These results showed that the addition of Herceptin to standard adjuvant therapy significantly reduced the risk of breast cancer recurrence, the primary endpoint of the studies, by 52 percent (or a hazard ratio of 0.48) in women with HER2-positive breast cancer, compared to those patients who received standard adjuvant therapy alone.

New NCI Director Sworn In

On Wednesday, October 18, 2006, Dr. John Niederhuber was officially sworn in as the 13th Director of the National Cancer Institute (NCI) at the National Institutes of Health (NIH). The Department of Health and Human Services Secretary, Michael Leavitt, was on hand to deliver the oath of office and to give remarks to the assembled audience. Dr. Elias Zerhouni, the Director of NIH was also on hand. After his swearing in, Dr. Niederhuber spoke of his continued desire to bring science to the people, which is the underlying theme behind his new Community Cancer Centers Initiative.

Dr. Niederhuber spoke of today's "post-genomic scientific environment," which heralds: "an entirely new era of risk determination, disease prevention, diagnosis, and highly targeted therapies. It is the era of genomically and proteomically characterized disease. As we move into this new era of personalized medicine, ideas, tactics, and techniques are coming from many sectors of science. The physical sciences and engineering are being applied to optimize the discovery, development, and, ultimately, the delivery of interventions to the patient. The once-futuristic tool of nanotechnology is being used to perform molecular classification of tumors to enable high-throughput screening and to predict therapeutic efficacy. Imaging is becoming a tool to ascertain just how much of a small molecule is reaching a targeted receptor and whether the therapeutic molecule changes cellular function. Computational biology - systems biology, if you will - is addressing issues such as information scale, modeling, simulations, and data interpretation."

CMS Releases 86 Quality Measures for Physician Voluntary Reporting Program

The Centers for Medicare & Medicaid Services (CMS) has published a list of 86 quality measures that the agency expects to have available at the beginning of 2007 for its Physician Voluntary Reporting Program (PVRP). None includes oncology specifically; four include hematology. CMS said it plans to select a subset of the measures for use in the reporting program for 2007 "in order to achieve an appropriate balance in measures to be reported by different specialties." The list of measures to be used in the program will be posted before Jan. 1, 2007, the agency said in a fact sheet released Oct. 17.

The list of quality measures released Oct. 17 covers 32 of 39 physician specialties, CMS said, adding that it continues working with specialties that have yet to develop quality measures. No quality measures are listed for oncology. Four quality measures are listed for hematology: myelodysplastic syndromes, erythropoietin therapy, chronic lymphocytic leukemia and multiple myeloma, and acute leukemia.

The fact sheet and quality measures are available at http://www.cms.hhs.gov/PVRP/Downloads/qualmeasures.pdf.

ACCC Submits Comments to CMS on Proposed 2007 Hospital Outpatient Prospective Payments System

On Friday, October 6, 2006, , the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) with regard to the proposed 2007 Hospital Outpatient Prospective Payments System. ACCC recommended the following:

• Recalculate its payment rates for separately paid drugs by including charges for all drugs with Healthcare Common Procedure Coding System (HCPCS) codes and setting rates at no less than ASP +6 percent.
   
• Continue to study mechanisms to reimburse hospitals for their pharmacy service costs.
   
• Pay separately for all drugs with HCPCS codes.
   
• Continue to pay separately for anti-emetics.
   
• Continue to reimburse separately paid radiopharmaceuticals based on the hospital’s charge adjusted to cost using hospital-specific cost to charge ratios.
   
• Implement the proposed new APCs for drug administration services and the changes recommended by the Advisory Panel on APC Groups to allow hospitals to be reimbursed appropriately for drug administration services.
   
• Continue to make payment for the preadministration services associated with providing intravenous immune globulin (IVIG).
   
• Implement the proposed new APCs and codes for evaluation and management services provided during clinic visits and continue to work to refine the draft guidelines for the use of those codes.
   
• Adopt codes, with appropriate reimbursement, to reflect coordinated care services provided by several professionals.
   
• Postpone the adoption of a policy to reduce payment for second and subsequent imaging procedures within the same family when performed in the same session.
   
• Implement the proposed payment rates for brachytherapy APCs.
   
• Delay the movement of positron emission tomography/computed tomography (PET/CT) scans to a clinical APC.
   
• Reevaluate its proposal to assign nonmyocardial PET scans to a clinical APC.

Click here for the full text of ACCC’s comments.

ACCC Submits Comments to CMS on Physician Fee Schedule Rule

On Friday October 6, 2006, the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the proposed 2007 Physician Fee Schedule Rule. ACCC recommended the following:

• Work with Congress and all interested parties to make changes to the Sustainable Growth Rate (SGR) or take other action to permanently stabilize physician payments at levels adequate to protect beneficiary access to care and work with the physician community to develop appropriate quality measures linked to payment incentives.
   
• Not implement the significant reductions in payment for drug administration services, as would occur under the proposed changes to the practice expense methodology, at least until the effect of these changes can be considered in conjunction with the expected reduction in the conversion factor and other changes mandated under the MMA and DRA and a determination can be made that beneficiary access to cancer care won’t be compromised.
   
• Ensure continued beneficiary access to essential IVIG services by continuing to pay physicians for preadministration-related services for standard and specialty IVIG. If CMS believes there is a basis for discontinuing payment for these services, the reasons must be articulated and interested parties must have an opportunity to comment.
   
• Not impose any further reduction in payment for second and subsequent imaging services in the same session and continue to study the resources used in combinations of imaging services and assess the interaction of the existing multiple imaging procedure policy with the imaging payment reductions also required by the Deficit Reduction Act.
   
• In order to ensure the accuracy and validity of the data used, and to protect beneficiary access to care, assure that adequate procedural and substantive safeguards are in place before using the widely available market price (WAMP) or average manufacturer price (AMP) for drugs instead of payment based on average sales price (ASP).
   
• Ensure that when compounded drugs are prescribed and provided, the costs associated with such compounding are included in the pricing, and instruct contractors accordingly in order to promote standardization in policies and pricing related to compounded drugs.

Click here for the full text of ACCC’s comments.

CMS Completes Additional MACs

The Centers for Medicare & Medicaid Services (CMS) released a Request for Proposal (RFP) for new Medicare Administrative Contractors (MACs) “that will streamline the processes to pay Medicare claims and answer providers’ questions about Medicare payments for services,” according to the CMS press release. This RFP is for three of 15 separate contracts that will be issued as part of the Medicare contracting reform created by the Medicare Modernization Act.

Under these improvements, Medicare will continue its move from a network of Part A fiscal intermediaries who process claims for hospitals and other institutional providers, and Part B carriers who process claims for physicians, laboratories, and other suppliers to one that will combine responsibility for both Part A and Part B claims. The goal is to provide a greater coordination of claims processing when a beneficiary receives services in different settings. For providers, this will also mean having one place to go for questions about claims.

CMS expects to award these contracts in July 2007. CMS intends to issue a separate RFP for four other MAC jurisdictions in December 2006, and additional RFPs will be issued in 2007 for the remainder of the 15 MAC jurisdictions. CMS previously awarded an A/B MAC contract for Jurisdiction 3, covering Arizona, Montana, North Dakota, South Dakota, Utah, and Wyoming, as well as four specialty contracts for the Durable Medical Equipment MACs.

Together these contractors will be responsible for 23 percent of the total Medicare fee-for-service workload, comprised of claims from the following jurisdictions:

• Jurisdiction 4 – Colorado, New Mexico, Oklahoma, and Texas
• Jurisdiction 5 – Iowa, Kansas, Missouri and Nebraska
• Jurisdiction 12 – Delaware, the District of Columbia, Maryland, New Jersey and Pennsylvania

The RFP also contains unique requirements for specific MACs. These include:

• Jurisdiction 4 has special requirements for Indian Health Services, the Veterans Affairs Medicare Equivalent Remittance Advice, centralized billing for mass immunizers, rural community hospitals, and a chiropractic demonstration.
• Jurisdiction 5 has special requirements for rural community hospitals, a chiropractic services demonstration, and a low vision demonstration.

The Government Accountability Office sustained a protest of the award for DME MAC Jurisdiction C. After that decision, CMS undertook corrective action. After evaluation of final proposal revisions under the corrective action, CMS today also announced that it had awarded the contract for DME MAC Jurisdiction C to CIGNA Government Services, LLC (CIGNA).

Fact sheets for Jurisdictions 4, 5, and 12 along with additional information on Medicare contracting reform can be found on the Medicare contracting reform webpage at http://www.cms.hhs.gov/MedicareContractingReform/

Energy and Commerce Hearing on Physician Payment Fix

On Sept. 28 The Committee on Energy and Commerce held a hearing to discuss options for fixing the impending 5% cut to the physician fee schedule in 2007. While no action items emerged from the hearing, a promise from Committee Chairman Joe Barton (R-TX) promised legislation during a lame-duck session after the election in November. There is support from both parties on a fix, and the major questions that remain deal with the length of the fix, and increase for physicians, and the connection to quality reporting and pay for performance (P4P). Chairman Barton favors a multi-year solution, which would give lawmakers time to propose a replace system to the Sustainable Growth Rate (SGR) that is currently in place. Barton also cautioned his colleagues from passing another one-year fix, saying it will only make it more difficult and costly next year.

The Committee's Ranking Member John Dingell (D-MI) has proposed a bill, HR 5916, that would provide a two-year positive update while at the same time would not increase the Part B premiums that seniors have to pay. Many of the plans proposed involve some kind of payment freeze or increase, but they also have stipulations that would award a greater increase to physicians that participate in quality reporting. The physicians testifying before the panel stressed the importance for any P4P measures must be voluntary, and that physicians should not be penalized for not reporting. The plans cost anywhere from $3-6 billion dollars, and a replacement plan for the SGR would likely cost more than $200 billion. Some lawmakers on the panel suggested taking some money from payments to managed care organizations to help offset those costs.

FDA Approves Vectibix for Colorectal Cancer

Amgen Inc announced that the Food and Drug Administration approved its fully human monoclonal antibody Vectibix for the treatment of patients with metastatic colorectal cancer. The drug was developed in partnership with Abgenix until Amgen bought that company earlier this year. Vectibix was previously known as panitumumab. The FDA approved Vectibix for patients with colorectal cancer that has spread during or after chemotherapy and who are expressing epidermal growth factor receptors. Vectibix binds to EGF receptors and interferes with the signal that might otherwise stimulate growth of cancer cells.

Amgen expects Vectibix to go on sale in early-to-mid October and to cost approximately 20 percent less than the other anti-EGFr antibody now on the market.

Amgen is introducing its Amgen Oncology Assistance program for patients receiving Vectibix who are uninsured, underinsured, or unable to afford their insurance co-payments.  The program is a comprehensive, multifaceted financial assistance program that will include a cap on out-of-pocket co-payments for cancer patients receiving Vectibix. The program will be available in October. Amgen's current Reimbursement Connection ™ is available Monday–Friday, 9 am–8 pm, ET, at 800.272.9376.

Pearl Moore Honored with ACCC’s Progress Award

Pearl Moore, RN, MN, FAAN, was honored with ACCC’s Progress Award for her many contributions to the oncology nursing profession. Ms. Moore is chief executive officer of the Oncology Nursing Society (ONS), the ONS Foundation, the Oncology Nursing Certification Corporation, and Oncology Education Services, Inc. Additionally, she is an adjunct assistant professor at the University of Pittsburgh School of Nursing. Ms. Moore received the award on Friday afternoon, September 15, at ACCC's Oncology Economic Conference in St. Louis.

Ms. Moore is a prominent leader in the national and international cancer care communities. As a pioneer practitioner in the specialty, she served as one of the first oncology clinical nurse specialists in the nation at Montefiore Hospital in Pittsburgh. Later, she blended clinical practice with research as the first coordinator of the Brain Tumor Study Group, which was part of a groundbreaking national consortium conducting clinical trials. At the same time, Ms. Moore was a volunteer and pivotal leader in the historical development of the Oncology Nursing Society. In 1975, she joined 250 nursing peers as an ONS founding member and became an active volunteer serving on committees and holding office.

Cephalon Receives FDA approval for Fentora® for Breakthrough Pain in Patients with Cancer

The U.S. Food and Drug Administration announced it has approved Cephalon Inc.'s drug Fentora® to treat breakthrough pain in certain cancer patients. The drug, a dissolving tablet that aims to treat intense, rapid-onset pain in cases where other opioid-based drugs no longer work, won conditional approval from the FDA earlier this year. Cephalon expects Fentora to be available in the United States during the first week of October.

Fentora is a sugar-free tablet that contains fentanyl, the same active ingredient found in Actiq. Fentora is the first and only buccal tablet indicated for the management of breakthrough pain in opioid-tolerant patients with cancer, and the first tablet formulation of fentanyl approved for any use. Its proprietary OraVescent® drug delivery system was developed by Cephalon subsidiary CIMA.

OIG Report Faults Data from Quality-of-Care Demo

The data from the first year of a Medicare quality-of-care demonstration for cancer patients are incomplete and unreliable because of inconsistent practices among participating physicians and a lack of specified data collection methods from the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services Office of Inspector General said in a report released Aug. 30.

As reported in the August 31 BNA Health Care Daily, the OIG also found that Medicare overpaid $17 million in demonstration claims in 2005 because of duplicate billings, reimbursements for demonstration activities not performed concurrent with chemotherapy, and payments for services associated with patients not diagnosed with cancer.

The findings in Cost and Performance of Medicare's 2005 Chemotherapy Demonstration Project (OEI-09-05-00171) are similar to those in a September 2005 report to Senate Finance Committee Chairman Charles E. Grassley (R-Iowa), in which the OIG said it was concerned about the reliability and usefulness of the data generated in the demonstration and that billing errors had been identified.

Click here to read the report.

Among problems the OIG identified was lack of a mandated, consistent approach to collecting patient data, the report stated. "We identified numerous anomalies and gaps in the data and collection methods that demonstrate the unreliability and undermine the usefulness of the data," the OIG said in its report.

The OIG found that CMS allowed $275 million in claims for the demonstration, consistent with its expectations. Beneficiaries were responsible for the usual 20 percent coinsurance for codes billed to Medicare, meaning beneficiary liability for demonstration claims totaled about $55 million, the OIG noted. About 90 percent of chemotherapy practitioners participated in the first year of the demonstration, with about 85 percent billing the demonstration codes half the time. While the median amount allowed per physician was about $23,000, the top 10 billers were allowed more than $270,000 each, the report stated.

CMS began the one-year demonstration project in January 2005 and extended it for an additional year in 2006 with what the OIG called "significant modifications." The initial demonstration allowed physicians to bill Medicare $130 each time a chemotherapy patient's levels of nausea and vomiting, pain, and fatigue were assessed and logged via a claims system. The three conditions are those most commonly experienced by chemotherapy patients. The OIG evaluated only data from 2005--the first year of the demonstration.

ACCC Submits Comments to CMS on Practice Expense Methodology and Five-Year Review of Physician Work

On August 21, 2006, the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the proposed notice regarding the five-year review of work relative value units (RVUs) under the physician fee schedule and proposed changes to the practice expense methodology. Click here to read ACCC’s comments.

ACCC expressed deep concerns that the proposed changes to work and practice expense RVUs for drug administration and imaging services will harm beneficiary access to quality cancer care.

“Physicians will not be able to continue to provide quality care unless Medicare appropriately reimburses them for their services,” noted ACCC’s comments. “We urge CMS to not implement these changes until it can assure that beneficiaries’ access to quality cancer care will not be harmed. On the other hand, CMS should finalize the proposed work RVUs for radiation oncology services. Changes in the assumptions regarding equipment utilization should be delayed, and CMS should review the direct practice cost inputs for medical physics services.”

For 2007, CMS proposes to make substantial changes to the work and practice expense RVUs with the goal of making payments more accurate and improving the transparency of CMS’ rate-setting methodologies. With the exception of the proposed work RVUs for radiation oncology and evaluation and management services, these changes will undercut many of Medicare’s recent efforts to improve payment for cancer care, according to ACCC’s comments. If the new RVUs are implemented fully, the RVUs for many drug administration services would fall by 4 to 33 percent. The practice expense RVUs for administration of radioimmunotherapies, such as Bexxar® and Zevalin®, also would fall by 10 percent in 2007 and by 43 percent when fully implemented.

If implemented, these changes will have a significant effect on payments for cancer care. The proposed new practice expense methodology would produce cuts in 2007 of .5 to 8.4 percent in many drug administration codes. When fully implemented, payments for these codes would be reduced by .5 to 25 percent, before factoring in any changes to the conversion factor. Combining these changes with the anticipated cut in the conversion factor and the changes in payment for imaging services mandated by the Deficit Reduction Act creates considerable uncertainty about whether Medicare’s reimbursement will be adequate to protect beneficiaries’ access to cancer care.

Furthermore, these changes are contrary to Congress’ intent to protect beneficiary access to care by simultaneously adjusting payments for drugs and drug administration. To ensure that physicians can continue to provide Medicare beneficiaries with the critical therapies they need to fight their battles with cancer, ACCC recommends that CMS postpone any changes to the RVUs that would reduce reimbursement for drug administration services, including administration of radioimmunotherapies, until the agency can ensure that beneficiary access to care will not be harmed.

ACCC also recommends that CMS not implement any reductions to the RVUs for imaging services until CMS has measured the effects of the current multiple service payment reduction policy for certain imaging services. ACCC would like CMS to finalize the proposed work RVUs for radiation oncology services, delay changes in the assumptions regarding equipment utilization, and review the direct practice cost inputs for medical physics services.

MedImmune and Infinity Pharmaceuticals Announce Cancer Drug Development Agreement

MedImmune, Inc., and Infinity Pharmaceuticals, Inc., announced that they have entered into an agreement to jointly develop and commercialize novel small molecule cancer drugs targeting Heat Shock Protein 90 (Hsp90) and the Hedgehog cell-signaling pathway. In pre-clinical studies, Hsp90 and the Hedgehog pathway appear to be implicated in the growth and survival of a broad range of blood-related and solid tumor types. IPI-504, the most advanced of the drug candidates included in the agreement, is an Hsp90 inhibitor that has thus far been studied in two disease-focused phase I trials.

In collaboration with Infinity, MedImmune plans to accelerate development of the intravenous formulation of IPI-504, as well as to expand into additional tumor types. In addition, the company expects to be able to commence clinical testing of the next generation oral formulation of IPI-504, as well as an oral formulation of a hedgehog inhibitor within the next 12 to 18 months.

NCI Looking For Community Cancer Programs to Participate in Pilot Research Initiative

SAIC-Frederick, Inc., under its prime contract in support of the National Cancer Institute (NCI) has issued a request for information, interest, and/or comment to explore the development of community-based cancer centers under the NCI pilot research initiative. The NCI pilot research initiative will explore ways to increase accruals to NCI-sponsored clinical trials especially for minorities by increasing community outreach to reduce cancer health disparities, expanding the use of NCI IT capability (the Cancer Bioinformatics Grid) to support clinical research, and advancing NCI biospecimen initiatives to support clinical research.

Respondents should be community hospital cancer programs in a discrete center that incorporates medical, surgical, and radiation oncology. It is anticipated that subcontracts totaling $9,000,000 will be issued to six pilot sites covering a three-year period. SAIC-Frederick will be seeking a subset of the pilot sites to be health systems/corporations with a track record of success in utilizing knowledge transfer strategies and methods for clinical program development, quality initiatives, and community outreach to the underserved in multiple markets. Statements of interest and comments must be provided in writing to the point of contact listed in the request not later than September 15, 2006, at 12:00 noon ET. To access the complete request, click here.

New NCI Director Named

On August 15 President George W. Bush announced his intent to appoint of John E. Niederhuber, M.D. as Director of the National Cancer Institute (NCI). Look up the details at http://www.whitehouse.gov/news/releases/2006/08/20060815-1.html.
A nationally renowned surgeon and researcher, Dr. Niederhuber has dedicated his entire academic career to the treatment and study of cancer - as a professor, cancer center director, National Cancer Advisory Board chair, external advisor to the NCI, grant reviewer, and laboratory investigator supported by NCI and the National Institutes of Health.

Dr. Niederhuber joined NCI in September 2005 as NCI's Chief Operating Officer and Deputy Director for Translational and Clinical Sciences, and was appointed Acting Director in June 2006. Additional information on Dr. Niederhuber can be found at http://www.cancer.gov/aboutnci/directorscorner/jen.

Cephalon Oncology Launches CORE, Cephalon Oncology Reimbursement Expertise

Cephalon Oncology has launched a new reimbursement support program called CORE, Cephalon Oncology Reimbursement Expertise. CORE supports Cephalon Oncology’s product TRISENOX® (arsenic trioxide). Assistance from CORE can be accessed by calling toll free at 1.866.261.7730 or by using the CORE website found at www.cephalononcologycore.com. CORE services are provided to both healthcare professionals and patients. For oncology practices, CORE can provide benefit verifications, coding and claims support, letter of medical necessity templates, assistance in locating relevant medical literature, access to the Cephalon Oncology Patient Assistance Program and appeals support.

CMS Proposes Changes to Policies and Payment for Hospital Outpatient Services and Proposes Update to Physician Fee Schedule

On August 8, 2006, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule for Medicare payment for hospital outpatient services in calendar year 2007 that would implement new steps to make payments more accurate and to promote higher quality and value in outpatient care. CMS Administrator Mark B. McClellan, MD, PhD, said “Our current payment systems for outpatient services must be improved, and we are seeking public input on the most effective way to address this challenge.”

According to CMS, the proposed rule would improve payments to hospitals for costs associated with administering drugs to beneficiaries in the outpatient department. Currently, there are six ambulatory payment classification (APC) groupings for most drug administration services. The hospital receives the same payment for each type of drug infusion, whether it takes an hour or five hours to administer. CMS is proposing to revise the APC payment structure for drug administration services, allowing hospitals to be paid separately for additional hours of infusion, in addition to their payment for the initial hour of infusion. Under the proposed policy, hospitals would be paid “more accurately for complex and lengthy drug administration services, while also receiving more appropriate payments for individual services when provided alone,” according to CMS. This may prove to be especially important given the fact that the rule sets the payment for acquisition and overhead costs of certain separately payable drugs and biologicals at the manufacturer’s average sales price (ASP) plus 5 percent, a reduction from the current rate of ASP plus 6 percent. Drugs and biologicals with pass-through status would be paid at the rate established under the Competitive Acquisition Program (CAP), if the drug is covered by the CAP, or ASP plus 6 percent.  The CAP rates vary by drug, but often are less than ASP plus 6 percent.  Therefore, the proposed hospital outpatient rates are significantly reduced from the current rates.

The Association of Community Cancer Centers is studying the rule and will report shortly to our members.

Currently, the Medicare statute requires CMS to pay separately for drugs and biologicals that cost $50 or more per administration and to bundle those costing less than $50 per administration into payments for the procedures with which they are associated. Medicare has made an exception to the bundling policy for certain anti-nausea drugs often used by cancer patients to counteract side effects of treatment. CMS is proposing to pay separately for drugs, biologicals, and radiopharmaceuticals costing $55 or more per day, consistent with the previous $50 threshold but updated for inflation, as well as for the anti-nausea drugs. Payments for other drugs would continue to be bundled into payments for their associated procedures.

Also on the topic of reimbursement, the rule calls for Medicare to continue to pay separately for brachytherapy sources, basing payment on the source-specific median costs for brachytherapy sources, as reflected in claims data. Payment would be on a per unit source basis rather than on a per day basis, to recognize the high variability of treatment costs.

Hospitals would receive $32.5 billion in CY 2007 under the proposed rule that would revise policies and payment rates under the outpatient prospective payment system (OPPS) for outpatient services provided to Medicare beneficiaries. The rule includes a 3.4 percent inflation update in Medicare payment rates for services paid under the OPPS for 2007. After taking into account other factors that affect the level of payments, CMS estimates that hospitals will receive an overall average increase of 3.0 percent in Medicare payments for outpatient department services in 2007 due to the changes in this proposed rule.