June 24, 2014 Dr. Bernice Hecker, MD, MHA, FACC Contractor Medical Director Noridian Healthcare Solutions, LLC 900 42nd Street S. P.O. Box 6740 Fargo, ND 58108-6740 Re: LCD DL35236- Draft LCD for Stereotactic Radiation Therapy: Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT) Dear Dr. Hecker: The American Society for Radiation Oncology* (ASTRO) appreciates the opportunity to review and provide comments on the Noridian Healthcare Solutions, LLC Jurisdiction E, draft LCD DL35236 on Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT). Noridian accepted some of ASTRO’s previous recommendations sent on April 17, 2012, but in light of recently published data, ASTRO respectfully submits the following comments. Stereotactic Radiosurgery (SRS) Indications The draft LCD states that patients with more than three primary or metastatic brain lesions must be enrolled in an IRB-approved clinical trial or appropriate clinical registry for coverage. ASTRO recommends the removal of the limit on the number of primary or metastatic lesions to determine medical necessity. We recommend a more nuanced approach in which the number of intracranial lesions is not the essential consideration in making a determination to use SRS. A large body of published literature shows that patients presenting with greater than three lesions and excellent performance status also benefit from SRS1-5. Recent studies found Karnofsky Performance Status (KPS) score, not the number of brain metastases, significantly correlated with overall survival2-4. The total intracranial volume rather than the number of metastases has been demonstrated to be an important predictor of survival in two major series4,5. While ASTRO supports the accrual of additional data and research, including the creation of a national SRS * ASTRO is the premier radiation oncology society in the world, with more than 10,000 members who are physicians, nurses, biologist, physicists, radiation therapists, dosimetrists and other health care professionals that specialize in treating patients with radiation therapies. As the leading organization in radiation oncology, the Society is dedicated to improving patient care through professional education and training, support for clinical practice and health policy standards, advancement of science and research, and advocacy. ASTRO publishes two medical journals, International Journal of Radiation Oncology, Biology, Physics (www.redjournal.org) and Practical Radiation Oncology (www.practicalradonc.org); developed and maintains an extensive patient website, www.rtanswers.org; and created the Radiation Oncology Institute (www.roinstitute.com), a non-profit foundation to support research and education efforts around the world that enhance and confirm the critical role of radiation therapy in improving cancer treatment. To learn more about ASTRO, visit www.astro.org. ASTRO Comments – Noridian Draft LCD (DL35236) for SRS and SBRT Page 2 registry, which we anticipate joining with another professional society, we believe that the limiting criteria listed in items 7,8,and 9 under “Indications for SRS/SBRT (for Cranial Lesions only)” to be unnecessary and overly restrictive. Likewise, item #3 should be deleted. Additionally, the draft policy declares cobalt-60 pallidotomy a non-covered service. In Chapter 13 of the “ASTRO/ACR Guide to Radiation Oncology Coding 2010” under Common Clinical Indications, ASTRO states that SRS may be used as a course of treatment in movement disorders such as Parkinson’s disease, essential tremor, and other disabling tremors when open neurosurgical thalamotomy cannot be performed and medical therapy is unsatisfactory. Several studies support this approach6-8. The draft policy also does not include ICD-9-CM code 333.1 (Essential and Other Specified Forms of Tremor) in the list of codes that support medical necessity. ASTRO’s SRS Model Policy recommends coverage for ICD-9-CM code 333.1 “be limited to the patient who cannot be controlled with medications, has major systemic disease or coagulopathy, and who is unwilling or unsuited for open surgery. Coverage should further be limited to unilateral thalamotomy.” While ASTRO agrees that SRS is not the primary treatment for all patients suffering from functional disorders, stereotactic radiotherapy offers an appropriate alternative for select cases. Thus, we recommend removing the cobalt-60 pallidotomy non- coverage statement and adding ICD-9-CM code 333.1 to the final policy. Stereotactic Body Radiation Therapy (SBRT) Indications ASTRO proposes Noridian remove the requirement that prostate cancer patients be enrolled in an IRB-approved clinical trial or registry. ASTRO updated its SBRT Model Policy in April 2013 to reflect the many clinical studies now supporting SBRT in the treatment of prostate cancer. The clinical data has matured to a point where SBRT represents an appropriate alternative for select patients with low to intermediate risk prostate cancer. A recently published pooled analysis of 1100 patients enrolled on prospective trials of SBRT for prostate cancer demonstrates biochemical relapse-free survival rates and quality of life outcomes that compare favorably with other definitive treatments for prostate cancer 9,10. After a median dose of 36.25 Gy in 4-5 fractions, the 5-year biochemical relapse free survival rate was 93% for all patients; 95%, 83% and 78% for GS 6, 7 and 8, respectively; and 95%, 84% and 81% for low-, intermediate- and high-risk patients, respectively. A transient decline in the urinary and bowel domains was observed within the⩽ first 3 months⩾ after SBRT which returned to baseline status or better within 6 months and remained so beyond 5 years. In addition, SBRT’s cost effectiveness relative to other forms of radiation therapy of prostate cancer11,12 in this is appealing in this setting. Additionally, the draft policy lacks crucial ICD-9-CM codes indicated for SBRT including those for “recurrent pelvic and head and neck tumors that have recurred after primary irradiation”, listed on page seven of the LCD. SBRT may also treat patients with recurrent nodal metastasis who have already undergone prior conventionally fractionated radiotherapy and thus the corresponding diagnosis codes should be included in the policy. ASTRO recommends the following ICD-9-CM codes be added to the final LCD: • 147.0-149.9 Malignant neoplasms of the pharynx ASTRO Comments – Noridian Draft LCD (DL35236) for SRS and SBRT Page 3 • 160.0-161.9 Malignant neoplasms of the nasal cavities, accessory sinuses, and larynx • 154.0-154.8 Malignant neoplasms of the rectum and anus • 179-184.9 Malignant neoplasms of the female reproductive system • 195.2 Malignant neoplasm of abdomen • 195.3 Malignant neoplasm of pelvis • 196.0-196.9 Secondary and unspecified malignant nodal neoplasms Stereotactic Radiotherapy Coding Historically, in the hospital outpatient environment, CMS utilized G-codes to distinguish between robotic and non-robotic SBRT and SRS. The agency recently reviewed current radiotherapy equipment technology and found that most linac-based treatment platforms incorporate some type of robotic capability. CMS therefore concluded that it is no longer necessary to continue distinguishing robotic and non-robotic linear accelerators. Beginning January 1, 2014, CMS replaced the existing four HCPCS codes: G0173, G0251, G0339, and G0340 with the SRS CPT® code 77372 and SBRT code 77373. The chart below provides a summary of these changes: 2013 Descriptor 2014 Descriptor ® CPT CPT Code Code G0173 Linear accelerator stereotactic Radiation treatment delivery, radiosurgery, complete course of therapy in stereotactic radiosurgery (SRS), one session. 77372 complete course of treatment of cranial lesion(s) consisting of 1 session; linear accelerator based. G0251 Linear accelerator based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per session, maximum five sessions per course of treatment. G0339 Image-guided robotic linear accelerator- Stereotactic body radiation therapy, based stereotactic radiosurgery, course of treatment delivery, per fraction to 1 therapy in one session, or first session of 77373 or more lesions, including image fractionated treatment guidance, entire course not to G0340 Image-guided robotic linear accelerator- exceed 5 fractions. based stereotactic radiosurgery, delivery including collimator changes and custom plugging, fractionated treatment, all lesions, per session, second through fifth sessions, maximum five sessions per course of treatment ASTRO Comments – Noridian Draft LCD (DL35236) for SRS and SBRT Page 4 The draft coverage policy lists G-codes in the “CPT/HCPCS Code” section. In order to avoid any confusion, ASTRO recommends Noridian remove all G-codes from the final LCD. Enclosed for your reference are the current version of ASTRO’s SRS and SBRT Model Coverage Policies. ASTRO recently mailed Noridian complimentary copies of the ASTRO/ACR Guide to Radiation Oncology Coding 2010: 2014 Supplement. Chapters 13 and 14 provide extensive coding information for these technologies including the codes integral to the process of care. Since no specific codes for SRS planning or for the professional component of SBRT planning exist, other codes such as CPT code 77295 (3-dimensional radiotherapy plan, including dose-volume histograms) or IMRT CPT code 77301 (Intensity modulated radiotherapy plan, including dose-volume histograms for target and critical