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Senate Introduces Bill To Boost Participation In Clinical Trials For Rare Diseases

September 17, 2009

Senate Introduces Bill To Boost Participation In Clinical Trials For Rare Diseases

CMS PET Scan Decision a Major Benefit for Cancer Patients

MEDICARE EXPANDS COVERAGE OF PET SCANS AS CANCER DIAGNOSTIC TOOL

CMS' Coverage with Evidence Development Project Shows PET Scans as "Reasonable and Necessary" for Initial Treatment Decisions of Most Solid Tumor Cancers

The Centers for Medicare & Medicaid Services (CMS) issued a final national coverage determination (NCD) to expand coverage for initial testing with positron emission tomography (PET) for Medicare beneficiaries who are diagnosed with and treated for most solid tumor cancers.

This NCD removes a clinical study requirement for PET scan use in these patients.

Since 2005, Medicare coverage of PET scans for diagnosing some forms of cancer and guiding treatment has been tied to a requirement that providers collect clinical information about how the scans have affected doctors’ treatment decisions. This information was gathered through the National Oncologic PET Registry (NOPR) observational study. Today's decision removes the requirement to report data to the NOPR when the PET scan is used to support initial treatment (or diagnosis and "staging") of most solid tumor cancers.

Medicare collects data from the NOPR under CMS’ Coverage with Evidence Development (CED) program. CED allows Medicare to develop evidence about how a medical technology is used in clinical practice so that Medicare can do the following:

This decision is based, in part, on the information generated as a result of CMS' 2005 decision to require NOPR reporting for many cancer PET scans. As a result of this evidence from NOPR, CMS reconsidered its 2005 coverage policy. This decision is the first time that CMS has reconsidered a coverage policy based on new evidence developed under the CED program.

"This expansion in coverage for PET scans shows that the Coverage with Evidence Development program is a success," said CMS Acting Administrator Charlene Frizzera. "CED allowed us to cover an emerging technology, learn more about its usage in clinical practice, and adjust our coverage policies accordingly. Thanks to CED, Medicare beneficiaries have greater access to cutting edge medical technologies and treatments."

This decision applies to PET scans used to support initial diagnosis and treatment for most types of solid tumor cancers. It also expands coverage of PET scans for subsequent follow up testing in beneficiaries who have cervical or ovarian cancer, or who are being treated for myeloma, a cancer that affects white blood cells. For these cancers, NOPR data collection will no longer be required.

It is important to note that today's decision still requires clinicians to report data to the NOPR when using PET scans to monitor the progress of treatment or remission of cancer in some cases. Although the evidence generated by the NOPR study helped CMS determine that PET scans are useful in helping guide treatment when cancer is first diagnosed, scientific evidence is not as strong in showing that PET scans are as useful in making subsequent treatment decisions for some types of cancer.

A minimally invasive diagnostic imaging procedure, PET uses a radioactive tracer to evaluate glucose metabolism in tumors and in normal tissue. The test may provide important clinical information to guide the initial treatment approach (e.g., diagnosis and "staging") for many cancers.

This additional information may help physicians to distinguish benign from cancerous lesions and better determine the extent of a tumor’s growth or metastasis. PET scans have also been used in subsequent testing for cancer patients, e.g., to monitor cancer progression or remission after cancer treatment has begun.

More information about the types of cancer covered by this new policy is available in CMS' final decision memorandum. Read the final decision on the CMS Web site at http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=218.

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April 3, 2009

SNM Calls CMS PET Scan Decision a Major Benefit for Cancer Patients

National Oncologic PET Registry Provided Overwhelming Evidence of PET's Value

Reston, Va.—SNM applauds today's decision by the Centers for Medicare and Medicaid Services (CMS) to expand coverage of positron emission tomography (PET) scans in the initial treatment strategy of patients with cancer. This decision was based, in large part, on compelling clinical evidence of the effectiveness of PET for cancer management and treatment contained in a comprehensive study known as the National Oncologic PET Registry (NOPR).

"This is a major victory for patients," said Robert W. Atcher, Ph.D., M.B.A., president of SNM and University of New Mexico/Los Alamos National Laboratory professor of pharmacy. "CMS' decision to cover PET scans for cancer demonstrates the intrinsic medical value of PET and important role of these scans in diagnosing, staging, restaging and monitoring treatment for many cancers."

Previously, PET scans for many cancers would be reimbursed only if the PET facility submitted data to the NOPR. Now, all Medicare beneficiaries with certain cancers will be able to receive Medicare coverage for at least one PET scan, as prescribed by their physicians. The nine currently covered cancers— breast, cervix, colorectal, esophageal, head and neck, lymphoma, melanoma, non-small cell lung and thyroid—have all been expanded to cover the subsequent treatment strategy, in addition to initial diagnosis. Additionally, Medicare is now expanding coverage to include ovarian cancer and myeloma, making a total of eleven indications now covered for both the initial diagnosis and subsequent treatment strategy for patients. For all other cancers, PET coverage for subsequent treatment strategy evaluation requires participation in an approved Coverage with Evidence Development (CED) program, such as a modified NOPR.

The new CMS decision will save patients thousands of dollars who would otherwise have to pay out-of-pocket for their PET scans. Additionally, this decision increases the likelihood that private insurers will eventually follow CMS' lead.

"For years, physicians and researchers around the world have known that PET is an invaluable diagnostic tool for guiding management of patients with a wide range of cancers," said Barry Siegel, M.D., co-chair of the NOPR Working Group and chief of the nuclear medicine at the Mallinckrodt Institute of Radiology, St. Louis, Mo. "The evidence contained in the NOPR study proves the effectiveness of PET as an essential part of a cancer patient's treatment planning."

To help PET providers better understand the repercussions of the new CMS policy and navigate the new NOPR system effectively, SNM will host a live audio conference, Monday, April 27, 1 p.m. to 2:30 p.m. EDT. For more information or to register for the audio conference, visit www.snm.org/PETChanges.

SNM's Atcher also noted that the organization will continue to work with partner medical and professional organizations to seek coverage for other types of cancers for which PET has a proven medical and therapeutic value. "Our goal is to continue to work tirelessly on behalf of our patients to ensure that all individuals whom physicians believe would benefit from these advanced imaging procedures receive the coverage they need for care," Atcher added.

NOPR was established in 2006 to track the utility of PET in patients with cancer. Studies, which analyzed data from more than 41,000 patients and were published in the Journal of Clinical Oncology and Journal of Nuclear Medicine, showed that the use of PET scanning led to an intended change in cancer management in more than one out of three cases.

NOPR is sponsored by the Academy of Molecular Imaging (AMI) and managed by the American College of Radiology (ACR) and ACR Imaging Network (ACRIN). The registry received input from—and is endorsed by—ACR, the American Society for Clinical Oncology (ASCO) and SNM. The NOPR Working Group was chaired by Bruce Hillner, M.D., of Virginia Commonwealth University and co-chaired by Barry Siegel, M.D., Washington University; R. Edward Coleman, M.D., Duke University; and Anthony Shields, M.D., Wayne State University.

Members of the press should contact Amy Shaw at (703) 652-6773 or ashaw@snm.org or Kathryn Wiley at (703) 326-1184 or kwiley@snm.org for more information or to schedule an interview with SNM leadership.

 

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