RadioMedix & Curium Announce Permanent HCPCS Code for Detectnet™ (copper Cu 64 dotatate injection)

——— Download as PDF: English ——— (St. Louis, MO – January 26, 2021) – RadioMedix Inc. and its commercial partner Curium announced today that the Centers for Medicare & Medicaid Services (CMS) has granted Detectnet a permanent Healthcare Common Procedure Coding System (HCPCS) code – A9592 – effective April 1, 2021. The descriptor for this product specific A code will be: Copper Cu-64, dotatate, diagnostic, 1 millicurie. Beginning on April 1, 2021, this code will be available to bill claims for Medicare patients in non-hospital imaging centers and for private insurance patients in all imaging facilities. This information follows the recent news that Detectnet was granted Transitional Pass-Through Status by CMS (C9068) effective January 1, 2021. C9068 is used to bill Detectnet for Medicare patients seen in the hospital outpatient department. “Once in effect, having both a permanent HCPCS code and Transitional Pass-Through Status will simplify the reimbursement process for all imaging centers that desire to use Detectnet,” said Curium CEO, North America, Dan Brague. “We remain focused on helping physicians and patients in the neuroendocrine community and anticipate the simplified reimbursement process may increase access to the product. We would like to thank CMS for their timely release of both codes, especially in light of the current COVID-19 pandemic.” “The response to Detectnet from the neuroendocrine community is outstanding,” said Ebrahim Delpassand, MD, CEO of RadioMedix. “The Phase III results demonstrate the clinical sensitivity, specificity, and accuracy of Detectnet. Further, the 12.7 hour half-life of Detectnet enables it to be produced centrally and shipped to sites throughout the U.S. The HCPCS code and Transitional Pass-Through Status should now provide access to patients nationwide.” About Detectnet INDICATIONS Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients. IMPORTANT RISK INFORMATION WARNINGS AND PRECAUTIONS Radiation Risk Diagnostic radiopharmaceuticals, including Detectnet, contribute to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration. Risk for Image Misinterpretation The uptake of copper Cu 64 dotatate reflects the level of somatostatin receptor density in NETs, however, uptake can also be seen in a variety of other tumors that also express somatostatin receptors. Increased uptake might also be seen in other non-cancerous pathologic conditions that express somatostatin receptors including thyroid disease or in subacute inflammation, or might occur as a normal physiologic variant (e.g. uncinate process of the pancreas). A negative scan after the administration of Detectnet in patients who do not have a history of NET disease does not rule out disease. ADVERSE REACTIONS In clinical trials, adverse reactions occurred at a rate of < 2% and included nausea, vomiting and flushing. In published trials nausea immediately after injection was observed. DRUG INTERACTIONS Somatostatin Analogs Non-radioactive somatostatin analogs and copper Cu 64 dotatate competitively bind to somatostatin receptors (SSTR2). Image patients just prior to dosing with somatostatin analogs. For patients on long-acting somatostatin analogs, a wash-out period of 28 days is recommended prior to imaging. For patients on short-acting somatostatin analogs, a washout period of 2 days is recommended prior to imaging. USE IN SPECIFIC POPULATIONS Pregnancy All radiopharmaceuticals, including Detectnet, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. Advise a pregnant woman of the potential risks of fetal exposure to radiation from administration of Detectnet. Lactation Advise a lactating woman to interrupt breastfeeding for 12 hours after Detectnet administration in order to minimize radiation exposure to a breastfed infant. Pediatric use The safety and effectiveness of Detectnet have not been established in pediatric patients. Geriatric use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. OVERDOSAGE In the event of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by reinforced hydration and frequent bladder voiding. A diuretic might also be considered. Please see Full prescribing information by clicking here . About RadioMedix

The release as fetched from its publisher. curiumpharma.com ↗