By Melody W. Mulaik
Positron emission tomography (PET) is a nuclear medicine study that creates cross-sectional tomographic (3D) images of the metabolic activity in the patient’s tissues. Cancers can cause abnormalities of blood flow or metabolism before structural changes are visible, and for this reason PET can often detect cancer at an earlier stage than CT or MRI. Even though there have not been many coding changes for PET scans imaging studies over the last few years, there have been new radiopharmaceuticals that have been granted approval and assigned Healthcare Procedure Coding System (HCPCS) codes. This expansion of radiopharmaceuticals may offer an opportunity to expand your services and subsequently your revenue.
As a reminder, Medicare’s National Coverage Determination (NCD 220.6.17 ¹) classifies oncologic scans as either initial treatment strategy or subsequent treatment strategy. A scan falls into the initial treatment strategy category when it is performed to determine the physician’s initial treatment strategy for a patient who has a cancer that is “biopsy proven or strongly suspected based on other diagnostic testing.” Scans performed for diagnosis and staging of cancer are considered initial treatment strategy scans. (“Staging” refers to the diagnostic work-up the physician performs to determine the extent of the patient’s cancer). Initial treatment strategy does not include scans performed for screening, which is the preventive evaluation of a patient without signs or symptoms of disease. Medicare and other payers do not cover PET for screening.
According to the NCD, the patient’s physician must order the initial treatment strategy study for one of the following purposes: To determine whether the patient is a candidate for an invasive diagnostic or therapeutic procedure; To determine the optimal anatomic location for an invasive procedure; or To determine the anatomic extent of the tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor.
The NCD allows for coverage of only one initial treatment strategy scan per cancer per patient. For example, if a patient has an initial treatment strategy scan for lung cancer, and several years later the patient is found to have colon cancer, an initial treatment strategy scan can be billed for the colon cancer. CMS Decision Memo CAG-00181R4 ² states watchful waiting is not considered an initial treatment regimen. This means a scan performed after a period of watchful waiting would be considered an initial treatment strategy scan rather than a subsequent treatment strategy scan.
The Medicare NCD defines subsequent treatment strategy scans as those that are performed to guide subsequent management of anti-tumor treatment strategy after completion of initial anticancer therapy. Clinicians often refer to this as “restaging,” which is a re-evaluation of the cancer stage following completion of a course of treatment. Medicare does not cover studies performed for surveillance purposes in a patient with previously treated cancer who has no clinical evidence to suggest active disease. These studies are considered to be screening rather than subsequent treatment strategy scans.
The NCD allows for coverage of no more than 3 subsequent treatment strategy scans. In addition to the 3 subsequent treatment strategy scans covered under the NCD, Medicare Administrative Contractors (MACs) and Medicare Advantage plans have the authority to cover additional scans if desired.
The table below reflects the most frequently utilized HCPCS Level II codes for PET tracers. Several PET radiopharmaceuticals (A9591, A9595, A9596, A9602, and A9800) have pass-through status under the Outpatient Prospective Payment System. The facility specific HCPCS codes (e.g., A9593 – UCSF) are not included in the list.
C-11 choline is used to evaluate patients with biochemical recurrence of prostate cancer. This agent has a half-life of only 20 minutes, which means it must be produced at the same location where it is used rather than being transported from an off-site supplier. Medicare coverage of scans performed using choline C-11 is at the discretion of the individual MAC.
Gallium-68 dotatate (NETSPOT) is an oncologic radiopharmaceutical that received FDA approval in June 2016. It is used for evaluation of somatostatin receptor-positive neuroendocrine tumors. Fluciclovine F-18 (Axumin) is an oncologic radiopharmaceutical that received FDA approval in May 2016. It is used for patients with recurrent prostate cancer. Fluoroestradiol F18 (Cerianna) diagnostic agent used for the detection of estrogen receptor (ER) positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer. Copper CU 64 dotatate (Detectnet) is an oncologic radiopharmaceutical that received FDA approval in September 2020. It is used for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.
PET scans are an excellent imaging tool to identify and stage most types of cancers and there is no indication this technology will be replaced with something new anytime soon. Continuing to look at your current offering and how it may be expanded could benefit your organization and the patients in your community.
REFERENCES
1. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/ncd103c1_Part4.pdf
2. https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=263
