Marilyn B. Tavenner Acting Administrator Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS 1589 P, Mail Stop C4 26 05, 7500 Security Boulevard, Baltimore, MD 21244 1850 Submitted electronically to: http://www.regulations.gov RE: Notice of Proposed Rule Making: Hospital Outpatient Prospective and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Electronic Reporting Pilot; Inpatient Rehabilitation Facilities Quality Reporting Program; Quality Improvement Organization Regulations Dear Ms. Tavenner: The Society of Interventional Radiology (SIR) is a physician association of over 4,800 members that represents the majority of practicing vascular and interventional radiologists in the United States. SIR appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) Notice of Proposed Rule Making: Hospital Outpatient Prospective and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Electronic Reporting Pilot; Inpatient Rehabilitation Facilities Quality Reporting Program; Quality Improvement Organization Regulations published in the Federal Register. Endovascular Revascularization of the Lower Extremity (APCs 0083, 0229 and 0319) CMS is proposing to continue to assign the endovascular revascularization CPT codes to APCs 0083, 0229, and 0319, as listed in Table 4B. The endovascular revascularization of the lower extremity CPT codes were new for CY 2011, so CY 2013 is the first year of claims data that are available for rate setting for these specific CPT codes. SIR remains concerned that the APC assignments for CPT codes 37223, 37234 and 37235 are incorrect. 37223 Revascularization, endovascular, open or percutaneous, iliac artery, each additional ipsilateral iliac vessel; with transluminal stent placement(s), includes angioplasty within the same vessel, when performed.
Page 2 37234 peroneal artery, unilateral, each additional vessel; with transluminal stent placement(s), includes angioplasty within the same vessel, when performed (List separately in addition to code for primary procedure). 37235 peroneal artery, unilateral, each additional vessel; with transluminal stent placement(s) and atherectomy; includes angioplasty within the same vessel, when performed (List separately in addition to code for primary procedure). CPT Codes 37223, 37234 and 37235 describe services that involve not only angioplasty, but also stent placement. The cost of the stent device typically constitutes a significant portion of the cost of the entire procedure. APC 0083 does not reflect the resources used in the placement of a stent. APC 0229 contains procedures including stent procedure codes. As we outlined in our comment letters over the past year, the three services mentioned above would be more appropriately placed in APC 0029 (Transcatheter Placement of Intravascular Shunt and Stents). Appropriate valuation of procedures and services can impact access to care across the nation by Medicare beneficiaries. SIR strongly recommends that CMS reclassify CPT codes 37223, 37224 and 37235 into APC 0229 for CY 2013. Bypass List CMS is proposing to bypass 480 HCPCS codes that are identified in Addendum N. CMS is proposing to continue to bypass most of the HCPCS codes on the CY 2012 OPPS bypass list, with the exception of the HCPCS codes listed in Table 1. CPT Code 76880 (U/S exam extremity) is proposed for deletion. CMS is also proposing to add several codes to the bypass list including CPT codes 76881 Ultrasound, extremity, nonvascular, real-time with image documentation; complete and 76882 Ultrasound, extremity, nonvascular, real-time with image documentation; limited, anatomic specific. SIR agrees with CMS proposal to add these two codes to the bypass list. Payment Adjustment Policy for Radioisotopes Derived from Non-Highly Enriched Uranium Sources For CY 2013, CMS is proposing to make an additional payment of $10 for diagnostic radiopharmaceuticals that utilize the Tc-99m radioisotope produced by non-heu methods. SIR appreciates CMS proposal for a payment differential for the use of non-heu sources. SIR encourages CMS to work with stakeholders to assess whether the $10 payment differential is sufficient.
Page 3 AMBULATORY SURGICAL CENTER (ASC) PAYMENT SYSTEM Proposed Additions to the List of ASC Covered Surgical Procedures CMS conducted a review of all HCPCS codes that currently are paid under the OPPS, but not included on the ASC list of covered surgical procedures, to determine if changes in technology and/or medical practice changed the clinical appropriateness of these procedures for the ASC setting. CMS is proposing to update the list of ASC covered surgical procedures by adding 16 procedures to the list as they do not pose a significant safety risk to Medicare beneficiaries and would not be expected to require an overnight stay if performed in ASCs, included on Table 39. TABLE 39 - PROPOSED NEW ASC COVERED SURGICAL PROCEDURES FOR CY 2013 CY 2012 HCPCS Code 37205 37206 37224 37225 37226 37227 CY 2012 Long Descriptor Transcatheter placement of an intravascular stent(s) (except coronary, carotid, vertebral, iliac, and lower extremity arteries), percutaneous; initial vessel Transcatheter placement of an intravascular stent(s) (except coronary, carotid, vertebral, iliac, and lower extremity arteries), percutaneous; each additional vessel (list separately in addition to code for primary procedure) popliteal artery(s), unilateral; with transluminal angioplasty popliteal artery(s), unilateral; with atherectomy, includes angioplasty within the same vessel, when performed popliteal artery(s), unilateral; with transluminal stent placement(s), includes angioplasty within the same vessel, when performed popliteal artery(s), unilateral; with transluminal stent placement(s) and atherectomy, includes angioplasty within the same vessel, when performed Proposed CY 2013 ASC Payment Indicator** J8
Page 4 37228 37229 37230 37231 37232 37233 37234 37235 0299T 0300T artery, unilateral, initial vessel; with transluminal angioplasty artery, unilateral, initial vessel; with atherectomy, includes angioplasty within the same vessel, when performed artery, unilateral, initial vessel; with transluminal stent placement(s), includes angioplasty within the same vessel, when performed artery, unilateral, initial vessel; with transluminal stent placement(s) and atherectomy, includes angioplasty within the same vessel, when performed angioplasty (list separately in addition to code for primary procedure) peroneal artery, unilateral, each additional vessel; with atherectomy, includes angioplasty within the same vessel, when performed (list separately in addition to code for primary procedure) stent placement(s), includes angioplasty within the same vessel, when performed (list separately in addition to code for primary procedure) stent placement(s) and atherectomy, includes angioplasty within the same vessel, when performed (list separately in addition to code for primary procedure) Extracorporeal shock wave for integumentary wound healing, high energy, including topical application and dressing care; initial wound R2* Extracorporeal shock wave for integumentary wound healing, high energy, including topical application and dressing care R2* *If designation is temporary. **Proposed payment indicators are based on a comparison of the proposed rates according to the ASC standard rate setting methodology and the MPFS proposed rates. At the time this proposed rule is being developed for publication, current law authorizes a negative update to the MPFS payment rates for CY 2013. For a discussion of those rates, we refer readers to the CY 2013 MPFS proposed rule. J8
Page 5 SIR agrees with CMS proposal to include these interventional procedures on the ASC list. We believe these procedures would not pose a significant safety risk to Medicare beneficiaries nor would they require an overnight stay if performed in Ambulatory Surgery Centers. Proposed Changes for CY 2013 to Covered Surgical Procedures Designated as Office-Based CMS is proposing to designate HCPCS Code G0365 (Vessel mapping of vessels for hemodialysis access (services for preoperative vessel mapping prior to creation of hemodialysis access using an autogenous hemodialysis conduit, including arterial inflow and venous outflow)) as a covered surgical procedure designated as office-based for CY 2013. CMS performed their annual review of the surgical procedures for which ASC payment is made to identify new procedures that may be appropriate for ASC payment, including their potential designation as office-based. Their review of the CY 2011 volume and utilization data resulted in the identification of six covered surgical procedures that they believe meet the criteria for designation as office-based. The data indicate that the procedures are performed more than 50 percent of the time in physicians offices. The six CPT codes they are proposing to permanently designate as office-based are listed in Table 40. HCPCS Code G0365 is included in Table 40. SIR agrees with CMS proposal to designate G0365 as an office-based procedure in CY 2013. Thank you for your consideration of SIR s comments on the proposals for the CY 2013 Hospital Outpatient Prospective Payment System. If you have any questions, please contact Trisha Crishock at (703) 934-8272. Sincerely, Marshall Hicks, MD President Society of Interventional Radiology Gerald Niedzwiecki, MD Chair, Health Policy and Economics Committee Society of Interventional Radiology cc: Susan E. Sedory Holzer, M.A., CAE