Image Source: Siemens Healthcare

Although the imaging community scored a big win last Friday when the Centers for Medicare & Medicaid Services (CMS) expanded the reimbursement coverage for PET to include 11 cancers, in many respects, "it is not mission accomplished," Johannes Czernin, MD, told Health Imaging News.

The new national coverage determination (NCD) expands coverage for all nine oncologic conditions under consideration, along with two additional cancers--ovarian and myeloma--to allow initial PET diagnostic testing for Medicare beneficiaries. This decision was based on clinical evidence supporting the effectiveness of PET for cancer management and treatment from the National Oncologic PET Registry (NOPR).

Czernin, director of the nuclear medicine clinic and a professor of molecular and medical pharmacology at David Geffen School of Medicine in Los Angeles,  said that while the decision is clear progress, some of the protocols outlined by CMS are still a bit awkward.

"The idea that you will have one PET-CT scan for patients for post-diagnostic assessment does not make sense. How will you know if the treatment is working if you cannot use the same test to monitor the effect?" he said.

CMS will cover one FDG-PET study for patients who have solid tumors that are biopsy proven or strongly suspected based on diagnostic testing when the patient's physician determines FDG-PET is essential for determining the location and/or extent of the tumor. This is an expansion of coverage for FDG-PET scans for all cancer types, with a few exceptions, beyond those currently covered--breast, cervix, colorectal, esophageal, head and neck, lymphoma, melanoma and non-small cell lung.

The agency also has adopted a coverage framework that differentiates FDG-PET imaging used to inform the initial antitumor treatment strategy from other uses related to guiding subsequent antitumor treatment strategies after the completion of initial treatment.

"So we now have 11 cancers for which we can do everything--the initial assessment and subsequent assessment--without any limitations," Czernin said. And because NOPR meets the model for coverage with evidence development, this model can be applied to new imaging probes if CMS is consistent with its own model, he added.

Czernin stressed the importance of giving credit where credit is due. "The imaging community needs to give credit to the NOPR group for setting it up and for analyzing the data and getting it published since this data provided CMS the evidence it needed. Also, the CMS approach deserves credit because that is the model for new imaging modalities that forces us to provide evidence that imaging is beneficial to patients and NOPR has met that challenge. Lastly, the Academy of Molecular Imaging deserves credit for funding the study."

Billing and coding implications

According to the SNM, CMS also mentions in the final policy that there will be two new modifiers accompanying the revised coverage parameters. While information has not been published yet, the SNM said it will have further details on these modifiers well before the July 2009 implementation date.

Furthermore, the SNM said it plans to clarify new billing instructions for those cancers that are specifically not covered for the initial treatment strategy evaluation.

For the following cancer types/indications, there are specific codes for some. G0219 PET imaging whole body; melanoma for non-covered indications should be for assessing regional lymph nodes in melanoma. Submit G0235 PET imaging, any site, not otherwise specified for the diagnosis of prostate cancer and initial staging of newly diagnosed prostate cancer.

Finally, G0252 PET imaging, full and partial-ring PET scanner only, for initial diagnosis of breast cancer and/or surgical planning for breast cancer (e.g., initial staging of axillary lymph nodes) should be coded when diagnosing and axillary nodal staging breast cancer.