August 31, 2015 Mr. Andy Slavitt Acting Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS- 1633- P P.O. Box 8013 7500 Security Boulevard Baltimore, MD 21244-8013 Submitted electronically: http://www.regulations.gov Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Short Inpatient Hospital Stays; Transition for Certain Medicare- Dependent, Small Rural Hospitals under the Hospital Inpatient Prospective Payment System Dear Acting Administrator Slavitt: The Society of Interventional Radiology (SIR) is a physician association of over 6,100 members that represents the majority of practicing vascular and interventional radiologists in the United States. Our goal is to improve public health through disease management and minimally invasive, image- guided therapeutic interventions. The SIR appreciates the opportunity to provide written comments on the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Short Inpatient Hospital Stays; Transition for Certain Medicare- Dependent, Small Rural Hospitals under the Hospital Inpatient Prospective Payment System (HOPPS), published in the Federal Register as a proposed rule on July 7, 2015. Restructuring of Ambulatory Payment Classifications (APCs) and Comprehensive (C- APCs) CMS is in the process of restructuring and renumbering many of the HOPPS APC groupings. CMS is proposing changes to these groups based on the following principles: (1) improved clinical homogeneity; (2) improved resource homogeneity; (3) reduced resource overlap and (4) greater simplicity and improved understandability. While we applaud CMS efforts to create a more intuitive system, the methodology to create these new groupings needs further refinement before it is implemented. The changes proposed for next year are not ready to be implemented.
Page 2 The assignments are not clinically coherent and there are many violations of the two times rule throughout the payment system. SIR has several specific concerns regarding proposed clinical APC assignments for CY2016. For example, CMS is proposing to assign our new genitourinary (GU) family of codes to clinical APCs as well as our new percutaneous biliary family of codes. However, when we reviewed all the proposed assignments (see below) we do not follow the logic behind the assignments. Based on CMS restructuring initiative we would have expected to see the new biliary family in varying levels of the Percutaneous Abdominal/Biliary Procedures & Related Procedures APCs and the GU codes in varying levels of Urology & Related Services APCs. However, we see these families broken up and assigned to many different families of APCs. APC HCPCS Group Title Short Descriptor 5073 Level 3 Excision/ Biopsy/ Incision & Drainage 5073 4918A Sclerotx fluid collection SI Relative Weight Payment Rate Minimum Unadjusted Copayment T 13.4494 $994.30 $198.86 5122 Level 2 Musculoskeletal Procedures T 33.3017 $2,461.96 $492.40 5122 20982 Ablate bone tumor(s) perq 5122 22510 Perq cervicothoracic inject 5122 22511 Perq lumbosacral injection 5123 Level 3 Musculoskeletal Procedures J1 71.0459 $5,252.35 $1,050.47 5123 22513 5123 22514 Perq vertebral augmentation Perq vertebral augmentation 5192 Level 2 Endovascular Procedures J1 130.4388 $9,643.21 $1,928.65 5192 37241 5192 37242 5192 37243 5192 37244 5351 venous artery organ bleed Level 1 Percutaneous Abdominal/Biliary Procedures & Related Procedures 5351 4753C Plmt biliary drainage cath 5351 4753D Plmt biliary drainage cath T 29.7291 $2,197.84 $439.57
Page 3 5352 Level 2 Percutaneous Abdominal/Biliary Procedures & Related Procedures 5352 47383 Perq abltj lvr cryoablation 5352 4753H Perq plmt bile duct stent 5352 50593 Perc cryo ablate renal tum T 56.1638 $4,152.13 $830.43 5373 Level 3 Urology & Related Services T 18.2122 $1,346.41 $269.29 5373 5039C 5373 5039D 5391 Plmt nephrostomy catheter Plmt nephroureteral catheter Level 1 Tube/Catheter Changes/Thoracentesis/Lavage 5391 4753G Removal biliary drg cath 5392 Level 2 Tube/Catheter Changes/Thoracentesis/Lavage 5392 4753E Conversion ext bil drg cath 5392 4753F Exchange biliary drg cath 5392 5039E Exchange nephrostomy cath 5392 5039M Convert nephrostomy catheter T 6.6321 $490.30 $98.06 T 16.3393 $1,207.95 $241.59 5524 Level 4 X- Ray & Related Services S 4.9130 $363.21 $72.65 5524 4753A Injection for cholangiogram 5524 5039A Njx px nfrosgrm &/urtrgrm 5524 5039B Njx px nfrosgrm &/urtrgrm 5525 Level 5 X- Ray & Related Services S 9.0213 $666.94 $133.39 5525 4753B Injection for cholangiogram 5526 Level 6 X- Ray & Related Services S 37.0651 $2,740.19 $548.04 5526 75726 Artery x- rays abdomen Our concerns surrounding the restructuring initiative are exacerbated by the comprehensive APC methodology. Under the C- APC policy, CMS provides a single payment for all services on the claim regardless of the span of the date(s) of service. Conceptually, the C- APC is designed so there is a single primary service on the claim, identified by the status indicator (SI) of J1. All
Page 4 adjunctive services provided to support the delivery of the primary service are included on the claim. The payment is calculated to capture the costs associated with all of these services. The APCs will count all items on the same claim (across multiple days) to be part of the service package and will thus not render separate payment for conditionally packaged codes or other services (with the exception of preventative care) that appear anywhere on the same claim. CMS believes this will improve the validity of payments to more accurately reflect true costs, reduce the administrative burden, and improve transparency for the beneficiary, physicians, and hospitals. SIR believes there are serious operational issues with the C- APC methodology. CMS has not defined adjunctive services which is a serious problem for hospitals and needs to be specifically defined for subsets of many codes. Hospitals are also under tremendous pressure to get clean claims filed shortly after a service is rendered. CMS is proposing to establish a HCPCS modifier to be reported with every code that is adjunctive to a comprehensive service, but is billed on a different claim. CMS C- APC linking policy will require hospitals to hold claims in fear of having to affix this modifier to future related services or more likely have to re- file claims in order to affix a modifier to link procedures together. SIR believes CMS has recognized room for improvement in the C- APC methodology but are in a some data is better than no data mentality. We do not believe that is a responsible approach to data collection. It perpetuates establishing APC payment rates on bad data. We recognize that Medicare funds are limited but this approach to such a far- reaching Medicare payment system is not an acceptable management of funds. SIR appreciates the agency s efforts to develop a more accurate payment system. However, SIR strongly believes the agency should not expand the C- APC methodology for CY2106. We also believe that CMS should only implement the non- controversial re- structured APCs. We have two specific recommendations. First, SIR recommends CMS outline a request for information in the Final Rule (or a separate Notice) regarding the restructuring initiative and then allow specialty societies/stakeholders to work over the next year to analyze the HOPPS data (which just became available through the limited number of consultants in town that can reconstruct the HOPPS payment system) and make recommendations next summer, in time for CY2017 PR. We think this approach should be embraced by CMS since it transfers the burden from CMS to stakeholders, who will have to spend a tremendous amount of their already limited resources on this initiative, through consultants, staff and volunteers. SIR s second recommendation relates specifically to C- APCs. We believe CMS should work not propose any new C- APCs for CY2016. SIR recommends CMS work with stakeholders to establish coding criteria for one C- APC/family of codes per specialty per year. This will allow the Agency to move in a judicious fashion to ensure the data collected is relatively reliable.
Page 5 Proposed Treatment of New and Revised CY 2016 Category I and III CPT Codes CMS received the CY 2016 CPT codes from AMA in time for inclusion in this CY 2016 OPPS/ASC proposed rule. The new and revised CY 2016 Category I and III CPT codes can be found in OPPS Addendum B and assigned to new comment indicator NP to indicate that the code is new for the next calendar year or the code is an existing code with substantial revision to its code descriptor in the next calendar year as compared to current calendar year with a proposed APC assignment and that comments will be accepted on the proposed APC assignment and status indicator. SIR discussed several of our concerns regarding the new interventional radiology codes above. There are three other interventional radiology codes/families in which we request CMS to make changes to their proposed CY2016 APC assignments. The first family of concern is Vertebral Augmentation. The reported incidence of osteoporotic vertebral compression fractures in the United States is estimated to be more than 700,000. The majority of these patients are Medicare beneficiaries. In a recent prospective, multi- center, randomized control trial published in SPINE (Tutton et al. KAST Study: The KIVA System as a Vertebral Augmentation Treatment- A Safety and Effectiveness Trial. SPINE, 2015, #40, (12), 865-875), vertebral augmentation was proven to be safe, effective and durable. CMS is proposing payment cuts to CPT codes 22510, 22511, 22513 and 22514 for CY2016 while the mean data (for the predecessor codes 22520, 22521, 22523 and 22524) continues to rise. As we outlined above, SIR does not believe that CMS should move forward with the re- structuring project. We do not believe APC 5123 Level #3 Musculoskeletal Procedures is clinically homogeneous. Orthopedic procedures, such as rotator cuff (CPT 23410), reconstruction of knee (CPT 27427), laminotomy (CPT 63040), etc. should be separated from Interventional Radiology Procedures, such as vertebral augmentation. We also believe CMS should maintain five levels of musculoskeletal APCs in 2016, which will provide the Agency the opportunity to group this family of services more appropriately. SIR requests CPT Codes 22513 and 22514 remain in level IV Musculoskeletal Procedures and CPT codes 22510 and 22511 be placed in level III Musculoskeletal Procedures. Our next area of concern is CPT code 75726 Angiography, visceral, selective or supraselective (with or without flush aortogram), radiological supervision and interpretation. This service is assigned to Level 6 X- Ray & Related Services and while that makes clinical sense, the resource consumption does not make sense. APC 5526 is too widespread. The services included in this APC are not cohesive and there are significant violations of the two times rule. As outlined above, SIR does not believe CMS should move forward with the restructuring initiative. SIR requests CPT Code 75726 maintain the CY 2015 payment rate of $5322. Our final area of immediate concern is CPT Code 20982 Ablation therapy for reduction or eradication of 1 or more bone tumors (eg, metastasis) including adjacent soft tissue when involved by tumor extension, percutaneous, including imaging guidance when performed; radiofrequency. In the CPT restructuring initiative CMS proposed to move this from a level III
Page 6 Musculoskeletal Procedures to level II Musculoskeletal Procedures. SIR recommends this code stay in a level III Musculoskeletal Procedures APC. Thank you for your consideration of SIR s comments on the Hospital Outpatient Perspective Payment System (HOPPS) Proposed Rule for calendar year (CY) 2016. If you have any questions, please contact Trisha Crishock at (703) 934-8272. Sincerely, Alan H. Matsumoto, MD, FSIR President Gerald Niedzwiecki, MD, FSIR Chair, Health Policy and Economics Committee cc: Susan E. Sedory Holzer, M.A., CAE