February 7, 2017 Arthur Lurvey, MD 900 42nd Street S, PO Box 6781 Fargo, ND 58108-6781 Charles E. Haley, MD 900 42nd Street S, P.O. Box 6740 Fargo, ND 58108-6740 Gary Oakes, MD 900 42nd Street S, P.O. Box 6740 Fargo, ND 58108-6740 Richard Whitten, MD 900 42nd Street South Fargo, ND 58103-6747 dick.whitten@noridian.com Eileen Moynihan, M.D. 900 42nd Street South Fargo, ND 58103-6747 eileen.moynihan@noridian.com Re: Request to Retire Article (A54072) Restricting Medicare Coverage of Treatment with Yttrium-90 Microspheres Dear Drs Moynihan, Lurvey, Haley, Oakes & Whitten: The Society of Interventional Radiology is a 6,600-member specialty physician organization that represents the majority of Interventional Radiologists practicing in the United States. As a
professional society, we strive to treat our patients compassionately, with the most up to date evidence-based procedures we can offer. The Society and its membership are dedicated to improving public health through pioneering advances in minimally-invasive, image-guided therapies. Our members are at the forefront of innovative and minimally invasive therapies to treat an array of diseases and conditions without surgery. Our society is writing to you to respectfully urge Noridian Healthcare Solutions (Jurisdictions E and F) to retire the Medicare Coverage Article entitled, Treatment with Yttrium-90 Microspheres, which inappropriately restricts Medicare beneficiary access to a well-established and clinically-proven treatment for tumors affecting the liver, Y-90 radioembolization (using microspheres commercially marketed by two sources known as SIR-Spheres or TheraSphere ). Y-90 microspheres are microscopic resin or glass beads that contain the isotope yttrium-90 which emits beta radiation. During a radioembolization procedure, interventional radiologists inject microspheres into the liver tumor s arterial supply through an angiographic microcatheter. The spheres selectively implant in the microvasculature of the tumor where they become lodged, and emit beta radiation for a period of about two weeks, killing tumor cells and slowing the progression of the tumor. The procedure can be performed concurrently with chemotherapy or as monotherapy. Y-90 radioembolization therapy is currently being offered at more than 1000 medical centers around the world, including more than 300 centers in the U.S. In 1999, radioembolization was given a humanitarian device exemption (HDE) by the FDA to treat unresectable hepatocellular carcinoma, including tumors with segmental or lobar portal venous tumor invasion. In 2002, radioembolization was also approved by the FDA to treat unresectable metastatic liver tumors from primary colorectal cancer, when given with adjuvant intra-hepatic artery chemoinfusion using Floxuridine. Since that time, interventional radiologists have successfully used radioembolization to treat not only unresectable liver metastases of primary colorectal cancer, but also unresectable liver tumors of other origins, including liver metastases of neuroendocrine tumors (NET) and primary intrahepatic cholangiocarcinoma (ICC). Although Noridian s Medicare Coverage Article affirmatively provides coverage for radioembolization when used to treat liver metastases of primary colorectal cancer, the Medicare Coverage Article effectively denies coverage for the procedure when used to treat any other liver cancers, including liver metastases from NET and ICC. Given the robust body of clinical evidence supporting the use of Y-90 microspheres to treat unresectable liver metastases from NET and ICC, which has led a number of other payers to issue policies affirmatively covering Y- 90 for these indications, Noridian s Medicare Coverage Article is contrary to both clinical evidence and clinical practice, and does not offer patients optimal care.
The clinical evidence supports the medical necessity of Y-90 spheres to treat unresectable liver metastases from NET. For example, in a 2010 prospective study on 48 patients who underwent SIRT procedures with Y-90 spheres for unresectable neuroendocrine tumor liver metastases, the median survival was 35 months, and a majority of patients responded to the treatment (15% of patients had a full response to treatment and 40% had a partial response to treatment). 1 In a 2012 study of 42 patients with treatment-refractory unresectable liver metastases from neuroendocrine tumors, the authors concluded that radioembolization with Y-90 spheres is a safe and effective treatment option, based on results that demonstrated good tumor control, decreased tumor-marker levels, and improved clinical symptoms. 2 A number of other peer-reviewed, published studies support the use of Y-90 to reduce tumor progression in patients with unresectable liver metastases from NET. 3 Similarly, the medical necessity of Y-90 spheres to treat ICC has also been established in peer-reviewed clinical literature. In a prospective study of Y-90 spheres in 25 patients with unresectable nodular ICC, 24% demonstrated an objective response rate, and 48% had stable disease. The authors concluded that the study provided preliminary evidence that radioembolization is a safe and effective treatment option for unresectable ICC. 4 Another retrospective study of 33 patients with unresectable or chemotherapy-refractory liver-dominant cholangiocarcinoma demonstrated 36.4% partial response and 51.5% stable disease following treatment with Y-90. The authors concluded that radioembolization is an efficacious and safe 1 Saxena A, Chua TC, Bester L et al. Factors predicting response and survival after yttrium-90 radioembolization of unresectable neuroendocrine tumor liver metastases: a critical appraisal of 48 cases. Annals of Surgery 2010; 251: 910-916. 2 Paprottka, PM, Hoffmann RT, Haug A et al. Radioembolization of symptomatic, unresectable neuroendocrine hepatic metastases using yttrium-90 microspheres. Cardiovascular and Interventional Radiology 2012; 35: 334-342. 3 See (1) Kennedy AS, Dezarn W, McNeillie P et al. Radioembolization for unresectable neuroendocrine hepatic metastases using resin 90 Y-microspheres: Early results in 148 patients. American Journal of Clinical Oncology 2008; 30: 271-279. (2) Rhee TK, Lewandowski RJ, Liu DM et al. 90 Y Radioembolization for metastatic neuroendocrine liver tumors: preliminary results from a multi-institutional experience. Annals of Surgery 2008; 247: 1029-1035. (3) King J, Quinn R, Glenn D et al. Radioembolization with selective internal radiation microspheres for neuroendocrine liver metastases. Cancer 2008; 113: 921-929. (4) Murthy R, Kamat P, Nunez R et al. Yttrium-90 microsphere radioembolotherapy of hepatic metastatic meuroendocrine carcinomas after hepatic arterial embolization. Journal of Vascular and Interventional Radiology 2008; 19: 145-151. (5) Kalinowski M. Dessler M, Konig A, et al. Selective Internal Radiotherapy with Yttrium-90 Microspheres for Hepatic Metastatic Neuroendocrine Tumors: A Prospective Single Center Study. Digestion 2009; 79: 137-142. (6) Peker A, Cicek O. Soydal C et al. Radioembolization with yttrium-90 resin microspheres for neuroendocrine tumor liver metastases. Diagnostic and Interventional Radiology 2015; 21: 54-59. (7) Barbier CE, Garske-Román U, Sandström M et al. Selective internal radiation therapy in patients with progressive neuroendocrine liver metastases. European Journal of Nuclear Medicine and Molecular Imaging 2015 Dec 3; epub doi: 10.1007/s00259-015-3264-6. 4 Saxena A, Bester L, Chua TC et al. Yttrium-90 radiotherapy for unresectable intrahepatic cholangiocarcinoma: A preliminary assessment of this novel treatment option. Annals of Surgical Oncology 2010; 17: 484-491.
treatment for unresectable ICC. 5 Other studies also support the clinical value of treatment with SIRT for patients with unresectable ICC. 6 This robust body of clinical evidence led the National Comprehensive Cancer Network (NCCN) to assign locoregional therapy for liver metastases of NET and ICC 2B recommendations in the NCCN Clinical Practice Guidelines in Oncology, which means that [b]ased upon lower-level evidence, there is NCCN consensus that the intervention is appropriate. 7 These 2B recommendations by NCCN are evidence that radioembolization is generally accepted by the medical community and established in clinical practice standards as an appropriate treatment for liver metastases of NET and ICC, and further support the medical necessity of the treatment. Indeed, major payers have recognized the peer-reviewed clinical studies that support the use of radioembolization to treat liver metastases of NET and ICC, as well as the general acceptance of the treatment in the medical community, and have issued policies that provide coverage for Y-90 for these liver tumors. These payers include Aetna, 8 Anthem, 9 Humana, 10 and United Healthcare. 11 Notably, we believe that no other Medicare Administrative Contractor currently has a coverage policy or article denying coverage for SIRT for certain types of liver tumors. 5 Hoffmann RT, Paprottka PM, Schön A et al. Transarterial hepatic yttium-90 radioembolization in patients with unresectable intrahepatic cholangiocarcinoma: factors associated with prolonged survival. Cardiovascular and Interventional Radiology 2012; 35: 105-116. 6 See (1) Rafi S, Piduru SM, El-Rayes B et al. Yttrium-90 radioembolization for unresectable standardchemorefractory intrahepatic cholangiocarcinoma: Survival, efficacy, and safety study. Cardiovascular and Interventional Radiology 2013; 36: 440-448. (2) Haug AR, Heinemann V, Bruns CJ et al. 18 F-FDG PET independently predicts survival in patients with cholangiocellular carcinoma treated with 90 Y microspheres. European Journal of Nuclear Medicine and Molecular Imaging 2011; 38: 1037-1045. (3) Camacho JC, Kokabi N, Xing M et al. Modified response evaluation criteria in solid tumors and European Association for the Study of the Liver criteria using delayed-phase imaging at an early time point predict survival in patients with unresectable intrahepatic cholangiocarcinoma following yttrium-90 radioembolization. Journal of Vascular and Interventional Radiology 2014; 25: 256-265. (4) Filippi L, Pelle G, Cianni R et al. Change in total lesion glycolysis and clinical outcome after 90Y radioembolization in intrahepatic cholangiocarcinoma. Nuclear Medicine and Biology 2015; 42: 59-64. (5) Soydal C, Kucuk ON, Bilgic S, Ibis E. Radioembolization with 90Y resin microspheres for intrahepatic cholangiocellular carcinoma: prognostic factors. Annals of Nuclear Medicine 2015 Sep 14. 7 NCCN Guidelines for Neuroendocrine Tumors, Version 2.2016; NCCN Guidelines for Hepatobiliary Cancers, Version 2.2016. 8 Aetna Coverage Policy 0268, Liver and Other Neoplasms Treatment Approaches, eff. Jun. 18, 1998 (rev. May 27, 2016). 9 Anthem Medical Policy #THER-RAD.00006, Selective Internal Radiation Therapy (SIRT) of Primary or Metastatic Liver Tumors, eff. Jan. 5. 2016. 10 Humana Medical Coverage Policy No. HGO-0348-017, Brachytherapy, eff. Apr. 26, 2016. 11 United Healthcare Medical Policy No. 2016T0445M, Implantable Beta-Emitting Microspheres for Treatment of Malignant Tumors, eff. Jan. 1, 2016.
As a result, Medicare beneficiaries in Noridian s Medicare jurisdictions with unresectable liver tumors that are not the result of primary colorectal cancer are placed at a significant disadvantage compared to Medicare beneficiaries throughout the rest of the United States, and compared to the privately insured. SIR members are concerned that providers in Noridian jurisdictions are requiring their Medicare patients to sign Advanced Beneficiary Notices before treatment with Y-90 for liver metastases of NET and ICC, which place great financial burdens on these beneficiaries a relatively small population of severely ill patients. Moreover, where providers are able to timely file appeals of coverage denials, it is our understanding that, in most cases, Noridian overturns the denial because it determines that treatment with radioembolization is medically necessary. The present inefficient system of initial denial followed by coverage on appeal is an unnecessary and administratively burdensome exercise for parties involved providers, beneficiaries and Noridian. If Noridian has concerns about overutilization of treatment with Y-90 (which seems unlikely given the small and seriously ill patient population in which it is used), there are other options to monitor claims for the treatment that do not inappropriately hinder Medicare beneficiary access, such as claims reviews or audits. Noridian has taken an unusual position in issuing a Medicare Coverage Article denying coverage for a treatment that is supported by peer-reviewed literature and clinical practice standards. In summary, the medical necessity of treatment of liver metastases of NET and ICC using radioembolization is established in the peer-reviewed literature, recognized by the NCCN as appropriate, and is widely accepted in the oncology and interventional radiology community. The medical necessity of Y-90 with for Medicare beneficiaries suffering from liver tumors should be determined by the clinicians taking care of these complicated and severely ill patients, and not by a Medicare Coverage Article that effectively denies coverage of medically necessary treatments. SIR strongly urges Noridian to retire its Medicare Coverage Article so that Medicare beneficiaries have access to this clinically crucial treatment. Thank you for your consideration of this request. Should you have questions or wish to speak with several SIR members who treat these patients, meet in person, or need additional information, please contact the SIR via Susan Sedory Holzer, Executive Director, at sholzer@sirweb.org or 703-691-1805. With very best regards, Charles E. Ray Jr., MD, PhD, FSIR 2016-2017 SIR President
cc: Tom McGraw President and CEO Noridian Healthcare Solutions 900 42nd Street S. Fargo, ND 58103