As a radioactive drug that emits positrons, Pylarify can be imaged by PET to indicate the presence of PSMA-positive prostate cancer lesions in the tissues of the body. Claims reviewed for cardiac blood pool imaging/gated Equilibrium studies (78472, 78473, 78494, and 78496) were submitted with incorrect radiopharmaceutical codes. Please visit the. 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. Documentation RequirementsThe procedure note/medical record should document the findings supportive of the diagnosis stated on the claim. End Users do not act for or on behalf of the CMS. The responsibility for the content of this file/product is with CMS and no endorsement by the AMA is intended or implied. Applicable FARS\DFARS Restrictions Apply to Government Use. 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. You shall not remove, alter, or obscure any ADA copyright notices or other proprietary rights notices included in the materials. Applicable Federal Acquisition Regulation Clauses (FARS)/Department of Defense Federal Acquisition Regulation supplement (DFARS) Restrictions Apply to Government Use. If you do not indicate the availability of the additional documentation, or the information is not returned timely, the claim will be returned as unprocessable. Updated CMS Manual Explanations URL(s). Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. A9521-Technetium tc-99m exametazine, diagnostic, per study dose, up to 25 millicuries Brain perfusion (CPT 78600-78606, 78610, 78803), 8. with suspected metastasis who are candidates for initial definitive therapy. Similarly, agent codes (e.g., A4641, A4642, A9500-A9507, A9600) administered in an inpatient or outpatient hospital are billed by the hospital to MAC A. These materials contain Current Dental Terminology (CDTTM), copyright© 2022 American Dental Association (ADA). The record should also indicate the radiopharmaceutical name and amount administered and be made available to the Contractor upon request. A9550 Technetium tc-99m sodium gluceptate, diagnostic, per study dose, up to 25 millicure, 5. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. A9505-Thallous chloride tl-201, diagnostic, per millicurieCardiac imaging (CPT 78451-78454)Parathyroid imaging (CPT 78070, 78071, 78072)Tumor imaging (CPT 78800-78804)Brain imaging (CPT 78803), 8. The CMS.gov Web site currently does not fully support browsers with If you do not agree with all terms and conditions set forth herein, click below on the button labeled "I do not accept" and exit from this computer screen. Pylarify PET scan - Why the long wait by Medicare - CMS ? Per study dose, up to 30 millicuries is one unit of service. Medicare Coverage for Pylarify PSMA PET Scan. The SNMMI communicated this change to its membership . Format changes completed with no change in coverage. The AMA is a third party beneficiary to this Agreement. The Veterans Administration in Charlotte will be . The license granted herein is expressly conditioned upon your acceptance of all terms and conditions contained in this agreement. Providers are to bill G0235 for non-covered indications. Do not use HCPCS A9538 when administering "non-radioactive" Pyrophosphate with saline followed by a second administration of Tc99m pertechnetate. Are you sure you want to block this member? The AMA assumes no liability for data contained or not contained herein. The AMA does not directly or indirectly practice medicine or dispense medical services. Sign up to get the latest information about your choice of CMS topics in your inbox. However, determination of insurance coverage is specific to your individual history, needs, coverage, and insurance plan. Next Generation of Energy Based Targeted Therapies The code lists in the article help explain which services (procedures) the related LCD applies to, the diagnosis codes for which the service is covered, or for which the service is not considered reasonable and necessary and therefore not covered. An official website of the United States government. Removed the agents listed under #9 A. 05/01/2017 Annual review done 03/31/2017. CPT Code Descriptio n 78429 0000001456 00000 n 0000003982 00000 n If the provider administers one to 30mCi of this agent for a study, it should be billed as one unit of service. PYLARIFY PATIENT BROCHURE The PYLARIFY patient brochure includes information on prostate cancer, an overview of how PYLARIFY can help you and your doctor create an optimal treatment plan, as well as what to expect when having a PET/CT scan. The reason it doesn't make much sense for an active surveillance patient is that it is useful for detecting lymph node involvement and metastatic spread. 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. The FDA indication and usage for Pylarify are: PSMA positive lesions in men with prostate cancer: The page could not be loaded. 1 millicurie (Pylarify) 15. Some radiopharmaceutical code descriptions are defined as per millicurie (mCi). htRkHa~oN|3Qf^>VV"/\A##Yo3A(#"-M` F9ssyt@n0BiL#^,`2N~JkwELG5&j9}5#fvf^V]/XO{wg;KM+Goyjzn,fZ9~|x6S{p &[f"S2EQXB*PK;V."R)SKi(z7%_;cPnT`@%|?f>A!e'-:/a6HNI5z|u.B)D7TT7I4A.YPQcYjpA@. Delivery time and delivery area may vary. FDA granted approval to Progenics Pharmaceuticals, Inc. An official website of the United States government, : 0000010874 00000 n The ordering and referring providers name and NPI (National Provider Identifier) must be on the claim. A9588Fluciclovine f-18, diagnostic, 1 millicurie, 10. In April I will be having a Transperineal biopsy with the Precisionpoint Transperineal Access System, and have a question to anyone who has gone through such a procedure. Q9982 Flutemetamol f-18, diagnostic, per study dose, up to 5 millicuries, 6. This code is used for Pyrophosphate (PYP) compounded /prepared with technetium tc-99m pertechnetate. WASHINGTON (AP) If you get health care coverage through Medicaid, you might be at risk of losing that coverage over the next year. Please note that if you choose to continue without enabling "JavaScript" certain functionalities on this website may not be available. 01/01/2017- Code update- removed deleted codes A9544 & A9545. Another option is to use the Download button at the top right of the document view pages (for certain document types). Codes were being billed per mCi. Pylarify received priority review designation for this approval. Some older versions have been archived. 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. 0000010355 00000 n Up to 2 units of service will be allowed for A9500 and A9502.One unit of service will be allowed for A9503. There are several kits that can be used for both myocardial infarct imaging and blood pool imaging tests. Added A9513 and A9589 to Miscellaneous Radiopharmaceuticals section. 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. 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. 0000016465 00000 n CPT codes, descriptions and other data only are copyright 2022 American Medical Association. Prior to surgery the psma showed 1 lymph node had cancer and it and 21 other lymph nodes, I have just been diagnosed with prostate cancer. A9542 Indium in-111 ibritumomab tiuxetan, diagnostic, per study dose, up to 5 millicuries. Pass the word. Use this page to view details for the Local Coverage Article for billing and coding: radiopharmaceutical agents. F. The following agents are no longer marketed in the United States and will be denied. Cardiac blood pool imaging, There are two types of studies: first pass studies and equilibrium studies. You can use the Contents side panel to help navigate the various sections. Absence of a Bill Type does not guarantee that the It should be used for both the in vitro (Ultratag) and in vivo (non-radioactive cold pyrophosphate (PYP) followed by an injection of 99m technetium) methods. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions. I have had an MRI, a CT scan, a bone scan and a 12 point biopsy. 0000084402 00000 n Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Federal government websites often end in .gov or .mil. End User License Agreement: 0000007575 00000 n GOVERNMENT AND ITS EMPLOYEES ARE NOT LIABLE FOR ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION, PRODUCT, OR PROCESSES However, these imaging techniques have limitations in the detection of prostate cancer lesions. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The views and/or positions presented in the material do not necessarily represent the views of the AHA. ARA to offer prostate cancer imaging agent Pylarify pending CMS approval, Precisionpoint Transperineal access system, I am questioning my pre diagnosis treatment, Univ.of Toronto: TULSA-PRO-Next Generation Prostate Cancer Treatment, Visit and Like ZERO - The End of Prostate Cancer on Facebook, Sign up to receive emails and news from ZERO - The End of Prostate Cancer, Search prostate cancer clinical trials and studies. 0000084363 00000 n Food and Drug Administration. Posted 12/29/2022: Due to CR 10901, this article is being retired effective 12/29/2022 due to no accompanying LCD. 0000036847 00000 n 0000009697 00000 n A4642 Indium-in-111 satumomab pendetide, diagnostic, per study dose, up to 6 millicuriesAgent for imaging colorectal or ovarian cancers (CPT 78800-78804), 7. Finally, jumped from 11 to 16 in one 6 month period. 04/29/2021-Added new code A9592 Copper Cu 64 dotatate, diagnostic, 1 millicurie to section F. Pet Scan radiopharmaceuticals #12. used to report this service. LEARN MORE. Radiation exposure is associated with a dose-dependent increased risk of cancer. 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. (CPT 78191, 78199). A9560 will be allowed for these procedure codes. Before sharing sensitive information, make sure you're on a federal government site. Complete absence of all Bill Types indicates A9560 Technetium tc-99m Labeled Red Blood Cells (RBCs), Diagnostic, per study dose, up to 30 mCi's. Added A9509 into the coding table-code in policy-no change in coverage. When PET Scans are performed in conjunction with a CMS-approved clinical trial or for an indication reimbursed under "Coverage with Evidence Development" (CED), providers must append the Q0 or Q1 modifier to the appropriate CPT code. Article document IDs begin with the letter "A" (e.g., A12345). A9567-Technetium tc-99m pentetate, diagnostic, aerosol, per study dose, up to 75 millicuriesLung ventilation (CPT 78579, 78580, 78582, 78597, 78598), 6. 0000017512 00000 n CPT is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. Draft articles are articles written in support of a Proposed LCD. {IB _e|X@`Vy m'20N&OqcAyhiwiEdQCd]C2Je Ns endstream endobj 162 0 obj <>>> endobj 163 0 obj >/PageUIDList<0 2033>>/PageWidthList<0 612.0>>>>>>/Resources<>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC]/Properties<>/Shading<>/XObject<>>>/Rotate 0/Tabs/W/Thumb 150 0 R/TrimBox[0.0 0.0 612.0 792.0]/Type/Page>> endobj 164 0 obj <> endobj 165 0 obj <> endobj 166 0 obj <> endobj 167 0 obj [/ICCBased 198 0 R] endobj 168 0 obj <>stream The injection of the radiopharmaceutical agent should only be billed when it is accompanied by the agent and the procedure. First pass Studies (CPT codes 78481 and 78483)First pass studies utilize rapidly acquired images of a bolus of a radiopharmaceutical agent as it moves through the heart. It is prepared external to the patient and is then administered intravenously for cardiac hot spot imaging. Applications are available at the AMA Web site, http://www.ama-assn.org/go/cpt. Other Policies and Guidelines may apply. %PDF-1.7 % |&#EL":!S-Q$)rJG~n76kT,GR~U;* )x`#++0yL9,ir@ .`n~D=uMp137fFeY^2Y)7n3_0cFGye('yhY Q^=wNn&vw] L $eS^.x~DHqsC\l !_} (TJu08DP'!CZ|xsRK7eUB8X/a~lR -yzHR=|l4?6(}-A>E9I!IvEb*f*^ 90JH(H&>U, \XCuW2sI%EFuqXkND3( Ja^&oQ#2g;KTw[Gwiw wyVA sOB6b.. descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work A9547 Indium-in-111 Oxyquinoline, Diagnostic, per 0.5 mCi,Leukocyte labeling (CPT 78185, 78800, 78803)Platelet labeling. preparation of this material, or the analysis of information provided in the material. 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