PET Possibilities Proliferate Under New CMS Ruling

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The second quarter of 2009 may go down in history as the time when PET services and molecular imaging began their move into the mainstream of medicine. In case you haven’t heard, in early April, the Centers for Medicare & Medicaid Services (CMS) issued a final national coverage determination (NCD) to expand coverage for initial testing with PET for Medicare beneficiaries who are diagnosed with and treated for most solid tumor cancers.

R. Edward Coleman, professor of radiology and chief of the division of nuclear medicine at Duke University School of Medicine in Durham, N.C., and member of the National Oncologic PET Registry (NOPR) observational study, says that PET practitioners have had to work hard for reimbursement.

Unlike CT or MRI, CMS elected to approve coverage for PET scans on a cancer-by-cancer indication under the Coverage with Evidence Development (CED) program. 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.

“The road to coverage by Medicare has been long and complicated,” Coleman says. “For a great many patients, who would otherwise have to pay out-of-pocket for their PET scans, this CMS decision will save thousands of dollars. It also will allow more providers to offer this life-saving care to our nation’s seniors.”

The recent 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. 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.

“This expansion in coverage for PET scans shows that the CED program is a success,” says 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.”

James H. Thrall, MD, FACR, chair of the American College of Radiology (ACR) Board of Chancellors, radiologist-in-chief at Massachusetts General Hospital and professor of radiology at Harvard Medical School in Boston, agrees with Frizzera’s assessment.

“Expanded CMS coverage for PET is a tremendous step forward for cancer care in this country. The NOPR is a shining example of how the medical community can interact with government on research that can ultimately save and extend patients’ lives,” he says.

NOPR is sponsored by the Academy of Molecular Imaging (AMI) and managed by the ACR and the ACR Imaging Network (ACRIN); the American Society of Clinical Oncology (ASCO) and SNM also have played key roles in guiding the project’s development.

Barry A. Siegel, MD, FACR, chair of the ACRIN PET Imaging Core Laboratory, co-chair of the NOPR working group, and professor of radiology and chief of nuclear medicine at the Mallinckrodt Institute of Radiology at Washington University in St. Louis, cites the results from the NOPR as the tipping point in the coverage decision.

“NOPR data undoubtedly served a primary role in this CMS decision, which will allow seniors far greater access to PET imaging to guide their care. The registry provided undeniable evidence that PET scans can serve a vital role in diagnosing, staging, restaging and monitoring treatment for patients with many types of cancer. We are proud that NOPR efforts have enabled CMS take this very important step to help cancer patients nationwide.”

Oncologist and NOPR working group co-chair Anthony F. Shields, MD, professor of medicine and oncology at the Karmanos Cancer Institute at Wayne State University in Detroit and chair of ACRIN’s Oncology Committee says the CMS decision is welcome news.

“Certainly it makes the availability of PET much greater for our patients given that basically almost every tumor type is now covered for the initial staging and diagnosis under the CMS ruling. In addition, they’ve extended the use of PET in subsequent treatment strategy to additional tumors, so that will make it easier for clinicians to order and get a PET scan covered for most of our patients.” 

“This is a major victory for patients,” says Robert W. Atcher, PhD, 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.”

“We’re thrilled with the decision that has been made,” says AMI President Timothy McCarthy, PhD. “This is really opening up PET for use by many people across the board with many types of cancers. We’re very excited to have been part of this study [NOPR] with CMS. Our colleagues that have been running this trial have felt a very collaborative relationship with CMS as we’ve gone through this process, which was quite groundbreaking in its approach and the way in which data was collected.”

Good news, bad news

The CMS decision creates a new framework that differentiates PET imaging into use for initial treatment strategies (formerly diagnosis and initial staging) and subsequent treatment strategies (formerly treatment monitoring and restaging/detection of suspected recurrence).

“As part of the initial treatment evaluation, a single PET scan will be covered for all cancers with the exception of prostate cancer, breast cancer diagnosis and axillary nodal staging, and melanoma regional nodal staging,” Siegel says.

“For subsequent treatment evaluation, the expanded coverage for PET in legacy conditions [PET indications that had been reimbursed prior to the April decision] will include treatment monitoring, which represents a real substantial gain in coverage; as well as new coverage for subsequent treatment evaluation of cervical cancer, ovarian cancer and myeloma.” (see chart on page 27)

Siegel notes that PET scans for most of the other cancers originally included in the original NOPR eligibility criteria will still need to be conducted through the CED program.

“A CED is also required for initial treatment strategy of cervical cancer that doesn’t meet the current coverage requirements, such as a negative CT or MRI for extrapelvic metastasis, and for leukemia,” he says.

The NOPR has obtained CMS approval to continue its data collection to allow for coverage of PET scans performed for these cancers and indications under a successor CED program. In compliance with the new coverage policy, NOPR launched a new version of the registry on April 6.

Most of the data collection questions are the same or similar to the questions in the original registry, but there are some important differences, especially for PET studies being done for treatment monitoring. PET imaging facilities and physicians interested in participating in the new registry, NOPR 2009, can get detailed information through the NOPR web site, www.cancerpetregistry.org.

SNM’s Atcher notes 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,” he says.

Many questions remain

Siegel says that the expanded coverage is a significant gain, but there are some clinical workflow and treatment issues that are unclear in the recent CMS decision.

“One problem is the single-scan limit for initial treatment evaluation. I believe this is illogical in some respects and very problematic with respect to radiotherapy treatment planning. For example, a patient may have a whole-body scan thinking that he or she may be a surgical candidate, but then it turns out he or she needs radiotherapy. You’ll need to do a repeat scan with a flat-table insert and an alpha cradle that’s been molded specifically to that patient—according to the current rules that second scan, even though it’s a limited study, would not be covered.

“In addition, you can imagine a situation in which an evaluation was done for a solitary pulmonary nodule and the initial scan was negative. Six months later, the patient comes back and the nodule has doubled or tripled in size and is an obvious cancer. Can you get reimbursed for a scan to stage it for surgery? That’s a big question that still needs to be answered by CMS,” he says.

AMI President McCarthy says that coverage for monitoring response to therapy is the next coverage and reimbursement goal for molecular imaging proponents.

“We’d like to move into the area of monitoring therapy with PET imaging. There’s a component of that in the first NOPR (NOPR 2006), but we only collected some pilot data in that area. What we want to do now is show where we believe PET has enormous potential, which is showing how therapy is affecting a patient’s cancer. Hopefully, in the long run, we can use it to help predict outcome; but that, of course, is a long way off.”

Shields agrees with McCarthy there is still significant coverage and reimbursement work that remains to be accomplished by the PET community.

“There are certainly some indications that are not covered, particularly under subsequent treatment strategy—for instance, pancreatic cancer and soft-tissue sarcoma and testicular cancer. In addition, there are actually a couple different groups underlying that subsequent treatment strategy. One is basically restaging after initial treatment and the other is monitoring response to treatment. And those are really two very different questions that will require additional study.”

He is confident that the NOPR 2009 trial will provide data that will allow evidence-based medicine decisions to be made for the further coverage of PET imaging in additional areas of oncologic care.

“We’re continuing to collect data on those particular subgroups and we also are looking at extending the data. Previously, NOPR collected data about the intended management based on the survey of physicians taken just after the PET scan was completed. We also are looking into the actual management; this is being done by gathering data from the CMS records of what treatment was provided and charged to CMS. We hope this will give us a clinical endpoint in terms of care delivered.”

New coverage, new codes

“We have a new NCD, and an effective date of service of April 3, 2009, but we don’t have guidance how to bill just yet,” says Denise A. Merlino, CNMT, MBA president of Merlino Healthcare Consulting and coding adviser to SNM.

According to Merlino, there are two new PET tumor identifying CPT modifiers:
  • PI—PET or PET/CT to inform the initial treatment strategy of tumors that are biopsy proven or strongly suspected of being cancerous based on other diagnostic testing, one per cancer diagnosis. The effective date for this modifier is July 1, 2009; however, Merlino says the community is still waiting for a CMS transmittal to define the details of use and an implementation date.
  • PS—PET or PET/CT to inform the subsequent treatment strategy of cancerous tumors when the beneficiary’s treating physician determines that the PET study is needed to inform subsequent anti-tumor strategy. The effective date for this modifier is July 1, 2009; and the community is still waiting for a CMS transmittal to define the details of use and an implementation date.

“One of the questions I get is ‘can I continue to submit claims to my Medicare contractor for PET scans for the indications that are already covered prior to the release of the PET NCD?’ The answer is, absolutely yes,” Merlino says.

Until July, PET and PET/CT coding is sort of a mixed bag for reimbursement.

“The current guidelines for billing using the CPT codes and the Q0 modifier (for investigational clinical service provided in an approved clinical research study—i.e. NOPR-reported PET scans) are in effect right now, so you have to mix the two. You have to take the current NCD and follow that using the current rules until they come up with new policy,” she says.