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Medicare PET/CT Reimbursement for Oncology: What’s covered, what’s not

Posted on: 08.16.18

PET/CT is a vital diagnostic imaging tool and is especially effective in revealing conditions such as cancer and brain disorders. When it comes to Medicare coverage, there are a number of misconceptions about PET/CT reimbursements.

In the majority of cases, PET/CT imaging is covered when clinically necessary, either as an initial treatment strategy or a subsequent treatment strategy.

Few exceptions apply to specific breast and cervical cancer, and melanoma diagnoses. The initial treatment of prostate cancer is the only non-covered event. Below is a consolidated reference chart that details PET/CT insurance reimbursement for specific conditions.

Tumor Type Initial Treatment Strategy Subsequent Treatment Strategy
Brain Cancer
Breast Cancer (female & male) *CWE
Cervical Cancer *CWE
Colorectal Cancer
Esophageal Cancer
Head & Neck Cancer (not thyroid or CNS)
Lymphoma
Melanoma *CWE
Myeloma
Non-Small Cell Lung Cancer
Pancreatic Cancer
Prostate Cancer Non-covered
Ovarian Cancer
Small Cell Lung Cancer
Soft Tissue Sarcoma
Testicular Cancer
Thyroid Cancer
All other solid tumors
All other cancers not listed


Why you should rethink PET/CT imaging for prostate cancer

Posted on: 06.28.18

The large majority of the nuclear imaging community would be quick to point out that PET/CT imaging with either 18Fluorodeoxyglucose (18FDG), or Sodium 18Fluoride (NaF18), is not effective in prostate cancer diagnosis. In fact, it’s not even approved for initial prostate treatment strategy.

With oncology imaging, most other cancers are green-lighted for both initial and subsequent treatment strategies. Prostate imaging, however, is only approved in the latter.

Radiopharmaceuticals and diagnosis

Because prostate cancer is a slow growing, less aggressive disease, the common sugar-based FDG is not an effective agent for diagnosis, but it can be used appropriately to identify metastasis in the body during subsequent treatment.

Sodium 18Fluoride (NaF18), has been used in bone imaging and was previously covered through the National Oncologic Pet Registry (NOPR). However, when the radiopharmaceutical reimbursement was discontinued in December 2017, it lost some of its popularity among physicians. Based on the NOPR study results, coverage is expected to be addressed in the future.

While prostate cancer is consistently one of the top three cancers in the nation, there are very few effective imaging solutions. Blood work, specifically through monitoring the prostate-specific antigen (PSA) level, delivers the majority of diagnoses. Any deviation from normal is an indicator, and may lead to surgery, cryotherapy, or radiation, as necessary.

One new radiopharmaceutical, two benefits

The relative newcomer to prostate cancer detection is Axumin (18F-Fluciclovine), which is indicated for PET imaging in men with suspected prostate cancer recurrence based on elevated PSA levels following prior treatment (chemical recurrence). By continuously monitoring PSA levels following treatment, Axumin can be used as soon as PSA levels begin trending upward leading to quicker detection.

Other imaging methods rely on physical changes in the body, whereas Axumin detects changes on the physiological level, which can develop weeks, even months earlier than physical changes. It ultimately presents a huge opportunity to fill the void in prostate imaging solutions.

An Axumin PET scan accurately identifies the cellular activity and location of a reoccurrence. While 18FDG is ideal for soft tissue, and NaF18 for bone imaging, Axumin offers the best of both worlds. Imaging studies show skeletal mass and metastasis throughout the body, including the prostate bed. When using Axumin, the imaging process begins right away and there is little to no bladder uptake visualized, whereas the traditional method of imaging with 18FDG typically has a great deal of bladder uptake. This bladder uptake, in some cases, obscures residual prostate cancer that may be in the prostate bed or regional lymph nodes.

The challenge with Axumin is its availability. It is currently available from only a handful of radiopharmacies throughout the U.S. and is only produced on certain days, with doses available during a short window of time. However, additional manufacturing sites are planned for 2018.



The role of PET/CT with pulmonary nodule workups: what you need to know

Posted on: 05.25.18

The two most common approaches after identifying a solitary pulmonary nodule are the wait-and-see approach, or to move straight to a biopsy. While medically sound, both of these paths present risks for the patient that could be solved with a PET/CT scan.

It’s a common misconception in nuclear medicine that a patient must have a cancer diagnosis before a PET/CT scan can be ordered. While this is generally true, many physicians are not aware that a solitary pulmonary nodule that measures less than 4cm qualifies for a PET scan without a prior cancer-confirming biopsy.

Avoiding Unnecessary Risks

Lung nodules are typically discovered via chest x-ray or CT and available guidelines for nodule management are generally based on nodule size or changes.

The wait-and-see approach is a standard recommendation for nodules under 4cm. The patient is given CT scan and then rescanned on a pre-determined schedule (every six or 12 months). This approach works well if the risk is in-fact low, but for patients who do have metabolically active nodules, this approach can have serious consequences. Properly identifying and diagnosing the cancer early can have a far-reaching impact on their long-term prognosis. Waiting to see if the nodule gets worse costs valuable time.

However, the reason most physicians chose the wait-and-see approach is that the alternative, a lung biopsy, also presents risks. For small nodules that may or may not be growing, many doctors decide that waiting is safer than subjecting the patient to a potentially unnecessary invasive medical procedure. Lung biopsies are a vital diagnostic tool, but they bring with them the risk of infection, collapsed lungs, bleeding in the lung, etc.

Gaining Clarity with PET/CT

The central issue physicians deal with in these situations is how to deal with the unknown and juggle the risks associated with both paths. With PET/CT imaging, you have a much clearer picture of what is actually happening within the nodules. Having this vital information makes the decision much easier and drastically reduces the risk for the patient.

For nodules that are not metabolically active during the PET/CT scan, it’s not recommended to follow up with a biopsy. So patients avoid the risks of an unnecessary procedure. However, if the nodule positively reacts to the radiotracer, further investigation and a biopsy are strongly recommended. Knowing this sooner, rather than later, saves the patient valuable time.

Additionally, in the new “value-based” culture we operate in, investing in a single PET/CT scan could save the healthcare system tens of thousands of dollars in unnecessary scans, biopsies, or advanced cancer treatments. It’s the right thing for the patient, and the system. That is precisely why Medicare covers it.

PET/CT vs. CT

In the wait-and-see approach, most physicians recommend having a series of follow-up CT scans. While CT scans are effective, PET/CT is more accurate than CT alone for characterizing pulmonary nodules, resulting in fewer equivocal findings and higher specificity. Low to intermediate risk nodules ≥ 8 mm should be evaluated by PET/CT, whereas high-risk nodules should be biopsied or excised.

In over 80% of indeterminate CT scans, PET/CT correctly characterizes lung nodules. Statistically speaking, PET/CT is far superior to CT in terms of diagnostic accuracy in solitary pulmonary nodule characterization. PET/CT is 97% sensitive, has an 85% specificity value, a 92% negative predictive value (NPV) and a 93% positive predictive value (PPV). Overall, PET/CT imaging provides 92% accuracy when diagnosing SPNs.

Industry Recommendations

The Society of Nuclear Medicine recommends that FDG PET/CT exams should be routinely obtained in the diagnostic work-up of solitary pulmonary nodules. Imaging will improve health care outcomes, mostly by avoiding futile surgeries in low-risk patients and enabling curative surgeries in high-risk patients.

PET/CT is approved by CMS for characterization of solitary pulmonary nodules not exceeding 4 cm to determine the likelihood of malignancy. Claims should include evidence of the initial detection of a primary lung nodule, usually by computed tomography. SPNs recommended with a PET/CT follow up using ICD 10 code R91.1

Although the Fleischner Society generally recommends a wait-and-see approach for nodules under 8cm, the under 4cm requirement for PET scan approval is causing many physicians to reevaluate their care strategy. PET/CT scans are a useful screening tool that clarifies where the patient actually stands.



PET/CT Imaging New Tracer Guide

Posted on: 03.30.18

The landscape of PET/CT imaging is rapidly changing. Traditionally, physicians have used a sugar based radiopharmaceutical, 18Fluorodeoxyglucose or 18FDG, to perform the majority of PET/CT imaging. Over the past 20 years, this imaging agent was the only option available to many facilities across the United States.

Recent breakthroughs in research, reimbursement, and radiopharmaceutical manufacturing have made it so that physicians and patients will begin to have access to medicine that is designed for their unique situations.

RECENTLY APPROVED TRACERS

Prostate Cancer

Indication

Axumin (18F-Fluciclovine) is indicated for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

Mechanism of localization

It has been found that there is an over expression of amino acid transporters in certain cancer cells. This overabundance of amino acid transporters is typically easier to identify among normal, healthy tissue than traditional imaging methods. The body recognizes this drug as an amino acid and actively transports it to potential areas of concern.

Why look into this radiopharmaceutical?

  • Axumin allows healthcare providers to pinpoint the overexpression of amino acids associated with prostate cancer.
  • Increased visualization of the prostate bed— no bladder interference during imaging, as with traditional 18FDG.
  • PET imaging with Axumin can lead to quicker detectionof tumors. Other imaging methods rely on physical (structural) changes in the body for tumor detection, whereas Axumin detects changes on the physiological (cellular) level, which can occur weeks, even months quicker than physical changes.

Prescribing information and use

  • A standard 10 mCi dose of 18F-Fluciclovine is provided
  • Patient is injected and imaged immediately
  • Exam takes less than 30 minutes from start to finish

Axumin is a great tool for visualizing the prostate bed which can be challenging using traditional methods.

 

Neuroendocrine Tumors

Indication

NETSPOT (68Ga-Dotatate) is indicated for use withPET for localization of somatostatin neureceptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.

Mechanism of localization

68Ga-Dotatate binds to somatostatin receptors, with highest affinity for subtype 2 receptors (sstr2). It binds to cells that express somatostatin receptors including malignant cells, which overexpress sstr2 receptors.

Why look into this radiopharmaceutical?

Improved image quality over the traditional Gold Standard

The Gold Standard method of imaging NETs has traditionally been an Octreotide scan

  • Often times leaves physicians without answers
  • Takes up to a week to acquire the entire exam
  • Results are only qualitative

NETSPOT imaging

  • Results are conclusive
  • Improved patient satisfaction: no bowel prep needed or dietary restrictions, 3 hours to complete examination
  • Results are quantitative and qualitative

The FDA has recently approved a therapy for NETs that uses the same Dotatate as the PET imaging agent and replaces the 68Ga with 177Lu. The theranostic (see it,  treat it) approach to treatment has finally become a reality!

Prescribing information and use

  • A patient specific, weight based dose of 68Ga- Dotatate is provided
  • Patient is injected and imaged at 40-90 minutes post administration
  • Must be off somatostatin receptor blocking agents

Same Patient— Different Outcome

A) Standard imaging using Octreotide

B) Improved tumor visualization and treatment planning using 68Ga-Dotatate

 

Alzheimer’s Disease

Indication

  • Adults with cognitive impairment who are being evaluated for Alzheimer’s disease and other possible causes of cognitive decline
  • Currently 3 approved PET/CT imaging agents areavailable: Neuraceq (18F-Florbetaben), Amyvid (18F-Florbetapir), Vizamyl (18F-Flutemetamol)

Mechanism of localization

  • There are many studies that demonstrate a relationship between increased β-amyloid plaque and Alzheimer’s disease.
  • The radiopharmaceuticals bind to this β-amyloid plaque.

Why look into this radiopharmaceutical?

  • Until recently, there was no way to image the presence of the physiological changes associated with Alzheimer’s disease:
  • A positive scan indicates an increase β-amyloid plaque which is consistent with AD and other cognitive disorders: To be used in conjunction with other neurological testing to establish a diagnosis
  • A negative scan indicates that there is a low amountof β- amyloid plaque which is inconsistent with a neuropathological diagnosis of AD
  • Helps to rule out the possibility of AD

Prescribing information and use

  • Each radiopharmaceutical has its own prescribing and dosing information
  • Patient is injected and imaged
  • Entire exam takes less than 90 minutes from start to finish

 

TRADITIONAL TRACERS

18FDG

Indications

  • Cancer—most common
  • Infection & inflammation
  • Viable myocardium (cardiac)
  • Brain – seizure, epilepsy, Alzheimer’s disease, dementia, tumors

Mechanism of localization

18Fluorodeoxyglucose (18FDG) is a sugar molecule that concentrates in areas of high glucose metabolism. Healthcare providers are seeking to determine whether there is an abnormal amount of uptake of this tracer in a particular area of the body which may be indicative of a particular health concern.

Why look into this radiopharmaceutical?

This is the most widely used imaging agent in the world of oncology. Many referring physicians are familiar with this drug and its applications for oncologic purposes. It is generally accepted as the drug to use for most cancers.

Many physicians and facilities are not familiar with the other indications and usages of this imaging agent. Examples include: Viable myocardium—this drug can be used to determine what sections of the heart are still viable and have living, functioning cells.

Brain – Many times, 18FDG can add valuable information that a neurosurgeon needs prior to surgery. Functional changes occur much earlier than physical changes—PET/CT images often compliment CT or MRI images.

 

NaF18

Indication

This radiopharmaceutical is most commonly used to identify cancers of the bone or cancers that have metastasized (spread) into the bone. The Sodium 18Fluoride (NaF18) ions are deposited directly into the bone matrix and bone surface. Common sites are newly mineralized bone, such as during growth, infection, malignancy (primary or secondary), after trauma, or during inflammation.

Why look into this radiopharmaceutical?

This drug is much better at targeting skeletal activity than FDG and provides a much clearer image than traditional nuclear medicine bone scans. These 3D images are also quantitative which allows physicians to precisely measure the activity within a lesion – allows for a more accurate interpretation of the response to treatment.

Prescribing information and use

  • The imaging agent is ordered and delivered for each specific patient
  • There is no patient prep
  • Patient is injected and imaged
  • Entire exam takes roughly 90-120 minutes


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