PET Medicare reimbursement -- narrow but widening

Jun 16, 2004

Reimbursement for PET procedures in the U.S. has improved incrementally over the past few years. Most recently, PET proponents scored a big victory this week when the Center for Medicare and Medicaid Services (CMS) reversed its earlier denial of coverage for the use of the modality in the diagnosis of suspected Alzheimer's disease (AD).

In addition to PET imaging coverage for patients who do not have a specific AD diagnosis despite a thorough clinical evaluation, Medicare also covers the use of PET in patients with early dementia or unexpected memory loss who are enrolled in clinical trials. A 30-day comment period is open to the public before CMS issues its final ruling in 90 days.

But coverage can still be problematic. In an effort to hold down costs, the CMS has tightly controlled payments for the use of PET in diagnostic imaging. The best bet for practitioners to receive payment for services rendered is to be aware of the specifics for Medicare reimbursement for PET.

Coverage guidelines for the modality in the U.S. are defined by CMS. Currently, carriers and intermediaries cannot provide coverage beyond what is specified.

"In fact, Medicare contractors can only define ICD codes eligible for payment, set frequency limits if not specified in national policy, determine implementation guidelines for national policy, and set technical and global payments under the Physician Fee Schedule," said Jennifer Keppler, a principal consultant with KE Solutions of Silverado, CA, and a PET reimbursement expert with CTI Molecular Imaging (Knoxville, TN).

Keppler shared her expertise on the vagaries of PET reimbursement in a presentation at the 2004 Academy of Molecular Imaging conference in Orlando, FL.

Medicare currently reimburses physicians for the use of PET with ¹⁸FDG in patients with certain types of cancer, epilepsy, and heart disease. Providers are also reimbursed for use of the radioisotopes rubidium-82 or ¹³N ammonia for rest/stress perfusion imaging of the heart.

FDG-PET is covered for diagnosis, initial staging, and restaging of patients with:

Non-small cell lung cancer

Esophageal cancer

Colorectal cancer

Lymphoma

Melanoma

Head and neck cancer (with the exception of thyroid cancer, which is covered elsewhere, and central nervous system (CNS) cancers, which are not covered).

Medicare also covers FDG-PET for the characterization of a solitary pulmonary nodule that is 4 cm or smaller in diameter and considered indeterminate by conventional imaging, as well as for the presurgical evaluation of epilepsy, she said.

Because CMS holds the power of the purse, it defines the coverage and terminology under which reimbursement can take place, Keppler said.

"'Diagnosis' scans are those that are done before tissue confirmation and are only covered when PET may help avoid another procedure or determine the optimal location for biopsy," she said. "'Staging' is an initial staging scan that is done after tissue confirmation but before any treatment. It is only covered when the stage is in doubt after a standard work-up including conventional MR, CT, or ultrasound imaging; or if PET replaces a test in the workup, and if the clinical management of the patient will differ depending on the stage by PET."

Restaging scans can be performed at any time after a patient diagnosis or stage has been determined.

"Restaging can be covered for detecting residual disease, suspected recurrence, or to determine the extent of a known recurrence, if it occurs only after a treatment course is finished," she said.

FDG-PET scans for breast cancer are also eligible for Medicare reimbursement, with certain restrictions. Patients with distant metastases can be staged or restaged. Patients with local or regional recurrence can be restaged. Keppler noted that PET scans for the evaluation of response to treatment during the course of therapy or when a change in therapy is contemplated are also reimbursable.

"Monitoring tumor response to therapy, which is a PET scan during the course of treatment, is only covered in breast cancer and only when a change in therapy is contemplated," she said.

The restaging of thyroid cancer of follicular cell origin is also covered under Medicare, but only under the following three conditions, Keppler said:

When a patient has been previously treated by thyroidectomy and radioablation;

When a patient presents with elevated serum thyroglobulin greater than 10mg/ml;

The patient has a current negative 131-iodine whole-body scan.

Medicare also covers the use of FDG-PET for myocardial viability in a primary or initial diagnostic study for determining myocardial viability prior to revascularization following an inconclusive SPECT study. The other reimbursable cardiac PET study utilizes the radioisotopes rubidium-82 or ¹³N ammonia for rest and stress imaging.

"This (application) can be in lieu of or following an inconclusive SPECT myocardial perfusion imaging study," she said.

Keppler advised the audience of several noteworthy limitations to Medicare coverage for PET imaging:

Only non-small cell lung cancer is covered;

Lymphoma scans can be repeated only at or after 50 days to ascertain patient response to therapy;

CNS brain tumors aren't covered in head and neck cancer coverage;

Thyroid cancer coverage includes follicular cell origin only and excludes medullary cancer;

Melanoma coverage excludes lymph node mapping with FDG;

Breast cancer coverage does not include initial diagnosis or pre-surgical staging.

Although CMS has slowly relented on expanding the use of PET and the variety of radioisotopes available for imaging, pressure from both inside and outside the medical community could nearly double the procedures available for reimbursement in the future.

For example, the National Institute on Aging, the Alzheimer's Association, and the Academy of Molecular Imaging (AMI) were instrumental in submitting scientific evidence in support of the request for reimbursement. Dr. Edward Coleman, president of the AMI, called the announcement of CMS' intention to provide limited Medicare coverage of PET scans for Alzheimer's patients and the announcement of a clinical trials demonstration project "an historic step in the right direction."

In addition, on April 29 a bipartisan group of 37 U.S. senators sent a letter to U.S. Health and Human Services Secretary Tommy Thompson requesting a national coverage determination on PET for use in seven additional cancer indications. The letter asked for reimbursement consideration for pancreatic, brain, cervical, ovarian, testicular, and small-cell lung cancer, as well as multiple myeloma.

By Jonathan S. Batchelor
AuntMinnie.com staff writer
June 17, 2004

Medicare to decide soon on Alzheimer's imaging, June 8, 2004

PET procedures surge 70%, April 23, 2003

U.S. PET backers win some, lose some, April 17, 2003

PET/CT growth sparks gains in U.S. PET market, April 15, 2003