FDA has approved Pylarify (piflufolastat F 18) a drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. The patient is then injected with labeled RBCs. Does anyone have a list of PSMA locations that are not clinical trials? This can be added to the manufacturers invoice and must be signed or initialed to indicate information was added. Should the foregoing terms and conditions be acceptable to you, please indicate your agreement and acceptance by clicking below on the button labeled "I Accept". A9580 will be denied effective 12/15/2017 based on Decision Memo for Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer (CAG-00065R2). No change in coverage. Codes effective for claims with dates of service on or after 07/01/2016 (CR 9636) & corrected typos. It would be unusual to have more than 2 units of service for most of the agents with a per study dose or per treatment in its description. Radiation exposure is associated with a dose-dependent increased risk of cancer. Established in 1985, Merlin Law Group is a leading insurance litigation law firm committed to assisting policyholders receive fair and just outcomes from their insurance companies. A9588Fluciclovine f-18, diagnostic, 1 millicurie, 10. Please refer to your Membership Agreement, Certificate of Coverage, Benefit Summary, or other plan documents for specific information about your benefits coverage. A9594 Gallium ga-68 psma-11, diagnostic, (ucla), 1 millicurie, 17. In vivo- Pt is injected with non-radioactive cold Pyrophosphate (PYP) reconstituted with normal saline followed 20 minutes later by an injection of Tc 99m Pertechnetate. With the approval of Pylarify, certain men with prostate cancer will have greater access to PSMA-targeted PET imaging that can aid health care providers in assessing prostate cancer. 16. These partners develop clinical coverage guidelines that will determine what procedures will be approvedwe can provide support to establish coverage and assist in pre-authorization of claims with the RBMs you deal with, Benefit Investigation: The Hotline will verify patient insurance benefits, including deductible and copayments, any prior authorization requirements, and determine any possible coverage restrictions such as to network or place of service, Prior Authorization (PA) Assistance: If PA is required, we will work with providers on submitting a request for prior authorization and assist in appealing a denied request for approval, Appeal/Peer-to-Peer Assistance: When a claim is denied, we offer assistance on appealing the denial with the payer, PYLARIFY Coding and Billing Guide: Includes PYLARIFY billing codes (NDC, Diagnosis/ICD 10 code[s], CPT, HCPCS [J-code, A-code]), as well as details about PYLARIFY access and reimbursement support services, PYLARIFY Access & Reimbursement Best Practices Guide: Includes recommendations for inquiring with a patients payer prior to administration, managing expectations for cost and coverage, steps to take upon potential denials, and reimbursement scenarios/cases, Patient Brochure: Includes information on prostate cancer, an overview on how PYLARIFY can help create an optimal treatment plan as well as what to expect when having a PET scan. You can use the Contents side panel to help navigate the various sections. Other Policies and Guidelines may apply. A9558-Xenon xe-133 gas, diagnostic, per 10 millicuries Lung study (CPT 78579, 78580, 78582, 78597, 78598), 9. CDT is a trademark of the ADA. Side effects are rare and temporary and may include headache and a change in taste. Coverage will be added if the agent(s) become available in the future. Reactions may be delayed. For purpose of this exclusion, "the term 'usually' means more than 50 percent of the time for all Medicare beneficiaries who use the drug. and 3.a., and Section C Number 2 and 7. 0000076071 00000 n CMS WILL NOT BE LIABLE FOR ANY CLAIMS ATTRIBUTABLE TO ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION OR MATERIAL CONTAINED ON THIS PAGE. The availability of this information prior to treatment is expected to have important implications for patient care. This Agreement will terminate upon notice if you violate its terms. The most common adverse reactions to Pylarify were headache, altered taste, and fatigue. It is not appropriate to bill per mCi for the codes that include per study dose in its HCPCS description. My 6 week post surgery PSA .09, 3 month post .055 and now at 4.5 months it is back to .094. 0000018338 00000 n Regardless of the method used to tag the red blood cells, in vitro or in vivo, the correct code to use is A9560. "JavaScript" disabled. CMS has defined "not usually self-administered" according to how the Medicare population as a whole uses the drug, not how an individual patient or physician may choose to use a particular drug. of every MCD page. New Codes are effective 07/01/2021. 0000003982 00000 n Finally, jumped from 11 to 16 in one 6 month period. Policy. Medicaid and the State Children's Health Insurance Programs, contracts with certain organizations to assist in the administration 3. Post Administration Instructions Follow the PYLARIFY injection with an intravenous flush of 0.9% Sodium Chloride Injection USP. Medicare contractors are required to develop and disseminate Articles. When multiple studies (rest and stress) nuclear medicine procedures are performed using this agent for two studies it would be appropriate to bill for 2 units. PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. 0000003714 00000 n Pylarify PET scan - Why the long wait by Medicare - CMS ? I will be having a PSMA PET scan on January 19. A9536 Technetium tc-99m depreotide, diagnostic, per study dose, up to 35 millicuries, 4. Medicare Coverage for Pylarify PSMA PET Scan. Please visit the. Myocardial Infarct Imaging - CPT codes 78466-78469.A9538 Technetium tc-99m pyrophosphate, diagnostic, per study dose up to 25 mCi's is used for these procedures. Absence of a Bill Type does not guarantee that the an effective method to share Articles that Medicare contractors develop. A9539-Technetium tc-99m pentetate, diagnostic, per study dose, up to 25 millicuries Lung ventilation (CPT 78579, 78580, 78582, 78597, 78598)Testicular imaging with vascular flow (CPT 78761)GFR renal scan (CPT 78700 78709, 78725, 78803)Urinary bladder residual (CPT 78730)Ureteral reflux (CPT 78740)CSF study (CPT 78630 78645, 78650, 78803)Brain study (CPT 78600- 78606, 78610,78803) Shunt patency agent. An official website of the United States government. 0000042026 00000 n The CMS.gov Web site currently does not fully support browsers with A9592 Copper Cu 64 dotatate, diagnostic, 1 millicurie (Detectnet), 13. Piflufolastat is a radionuclide dye, so it contains a small amount of radiation. A9537-Technetium tc-99m mebrofenin, diagnostic, per study dose, up to 15 millicuries Hepatobiliary scan agent (CPT 78226, 78227), 13. Articles often contain coding or other guidelines that are related to a Local Coverage Determination (LCD). As of January 1, 2022, CMS provided PSMA PET Scan (Pylarify) with a dedicated billing code, which in turn facilitated Medicare creating a consistent reimbursement schedule, making PSMA PET Scan reimbursable. 78483 is a multiple first pass study at rest and stress, and requires two injections of appropriate radiopharmaceutical agent(s). Next Generation of Energy Based Targeted Therapies The second trial enrolled 208 patients who had rising serum PSA levels after initial prostate surgery or other definitive therapy, and thus had biochemical evidence of recurrent prostate cancer. Will be having mine at *Partners Imaging* in Sarasota for this 7 year (this month) GL10 guy, here's a locater for it: https://www.pylarify.com/site-locator, My husband had his last month in Arizona at MD Anderson on Medicare. Reproduced with permission. Please report 78800 or 78803.Added to Group 1 range 78012 79999: CPT Codes: 78429, 78430, 78431, 78432, 78433, 78434, 78830, 78831, 78832, and 78835. By clicking below on the button labeled "I accept", you hereby acknowledge that you have read, understood and agreed to all terms and conditions set forth in this agreement. If the provider administers one to 25mCi of this agent for a study, it should be billed as one unit of service. Also, you can decide how often you want to get updates. resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; CMS believes that the Internet is Instead my treatment would be ADT starting. CPT Long Description Change: 78130. PYLARIFY is a sterile, non-pyrogenic, clear, colorless solution for intravenous injection. If you are acting on behalf of an organization, you represent that you are authorized to act on behalf of such organization and that your acceptance of the terms of this agreement creates a legally enforceable obligation of the organization. 0000006337 00000 n recommending their use. The claim must include the name and total dosage of the agent in item 19 of the CMS 1500 form, or the electronic equivalent for EMC. 0000016225 00000 n 1 millicurie (Pylarify) 15. PYLARIFY AI is FDA cleared for automated quantification and reporting for PSMA PET/CT images, including PYLARIFY images1, Looking for a PYLARIFY imaging site near your postal code? Do not use HCPCS A9538 when administering "non-radioactive" Pyrophosphate with saline followed by a second administration of Tc99m pertechnetate. A9550 Technetium tc-99m sodium gluceptate, diagnostic, per study dose, up to 25 millicure, 5. Any questions pertaining to the license or use of the CPT should be addressed to the AMA. Review completed 10/08/2019. A9589 Instillation, hexaminolevulinate hydrochloride, 100 mgA diagnostic agent instilled into the bladder for detection of carcinoma of the bladder. WASHINGTON (AP) If you get health care coverage through Medicaid, you might be at risk of losing that coverage over the next year. The radiopharmaceutical and the procedure code should be billed on the same claim. Assay the dose in a suitable dose calibrator prior to administration. Please report CPT 78803. However, these imaging techniques have limitations in the detection of prostate cancer lesions. The invoice must indicate the number of mCi in a dose. My PSA elevated to 4.9 over the last year and a half. Myocardial Perfusion imaging studies (78451-78454)Radiopharmaceuticals commonly used for these studies include A9500 and A9502. The AMA does not directly or indirectly practice medicine or dispense medical services. descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work Sometimes, a large group can make scrolling thru a document unwieldy. I am in Ohio and have been waiting two months for a Pylarify PET scan but it's still not getting a go by cancer institutes in this state that I am aware of. If two (2) per study doses of these agents are used, one for rest and one for the stress portion of the study, it would be billed as two (2) units. apply equally to all claims. Non Medicare patients will rely on the . A9586-Florbetapir f-18, diagnostic, per study dose, up to 10 millicuries, 5. 0000014686 00000 n For the last 12 years before my surgery in feb 22, my uro followed me every 6 months after a 7.7 PSA. The Centers for Medicare & Medicaid Services (CMS), the federal agency responsible for administration of the Medicare, A9513 Lutetium lu 177, dotatate, therapeutic, 1 millicurieFor the treatment of adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Added A9513 and A9589 to Miscellaneous Radiopharmaceuticals section. 0000075294 00000 n Is Medicare covering these scans now. PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. Radiopharmaceutical Agents are isotopes, frequently attached to carrier molecules, used as adjuncts to nuclear medicine diagnostic or therapeutic procedures. On May 27, 2021, Lantheus Holdings announced that the U.S. Food and Drug Administration (FDA) had approved Pylarify, an F 18-labeled prostate-specific membrane antigen (PSMA) PET imaging agent targeted to identify suspected metastasis or recurrence of prostate cancer. The listing of the radiopharmaceutical agent and procedure code do not imply coverage. 9. Food and Drug Administration. Providers are to bill G0235 for non-covered indications. 0000009697 00000 n The FDA approved the F 18-labeled prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent 18F-DCFPyL (Pylarify) for use in prostate cancer, according to an announcement from the company responsible for the agent, Lantheus Holdings, Inc. 18F-DCFPyL is now the first commercially available PSMA PET . Pylarify is indicated for patients with suspected prostate cancer metastasis (when cancer cells spread from the place where they first formed to another part of the body) who are potentially curable by surgery or other therapy. Effective on FDA approval date 05/26/2021. PYLARIFY will be available immediately to imaging centers in parts of the mid-Atlantic and southern regions and is expected to be broadly available throughout the U.S. by year end May 27, 2021 07: . 3. This code includes the physician service, which includes counseling the patient and family, setting up and infusing the radiopharmaceutical and post-procedure time reviewing the appropriate blood work. Draft articles have document IDs that begin with "DA" (e.g., DA12345). For information about ordering PYLARIFY for your imaging site, and how to get started, contact PYLARIFY Customer Support at 1-800-964-0446 1-800-964-0446 M-F 8:30 am-8:00 pm ET, or email cspyl@lantheus.com. 0000833559 00000 n 09/30/2021- 03Q21 CPT/HCPCS Code Update: Added A9593 & A9594 to Section E. PET Scan radiopharmaceuticals. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816. Applicable FARS/HHSARS apply. Enroll in health insurance. PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans San Francisco, CA (UroToday.com) -- Lantheus Holdings, Inc., an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics, and artificial intelligence solutions to find, fight and follow serious medical . A9571-Indium in -111 labeled autologous platelets, diagnostic, per study dosePlatelet labeling (CPT 78191, 78199), 1. A9600-Strontium sr-89 chloride, therapeutic, per millicurie Therapeutic for treatment of bone pain due to skeletal metastases. Neither the United States Government nor its employees represent that use of such information, product, or processes with suspected metastasis who are candidates for initial definitive therapy. Six weeks later, PSMA show cancer mets so I am told no radiation for me. Newly diagnosed.63 years oldPSA went from 4.5 to 7 in 2 years.Did TRUS biopsy . . 0000016349 00000 n 0000084363 00000 n The radiotracer piflufolastat, also known as Pylarify, is safe and FDA-approved. House Bill 2177 now moves to the state Senate after the House passed the measure with an 80-18 vote. Some articles contain a large number of codes. 11/28/2019 Returned the Radiopharmaceutical names that were inadvertently removed from the following sections: Section A - Number 9 and 10; Section B 1.a. In patients with positive Pylarify PET readings who had correlative tissue pathology from biopsies, results from baseline or follow-up imaging by conventional methods, or serial PSA levels available for comparison, local recurrence or metastasis of prostate cancer was confirmed in an estimated 85% to 87% of cases, depending on the reader. The views and/or positions I am 56 years old, had my prostate removed in March 2022. 0000015087 00000 n Gleason of 9, Decipher score of .93 and seminal vesicle invasion all point to high risk of return. There are several kits that can be used for both myocardial infarct imaging and blood pool imaging tests. 0000007575 00000 n 0000008838 00000 n License to use CDT for any use not authorized herein must be obtained through the American Dental Association, 211 East Chicago Avenue, Chicago, IL 60611.