September 26, 2019 
VIA ELECTRONIC SUBMISSION 
The Honorable Seema Verma 
Administrator 
Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1715-P P.O. Box 8016 Baltimore, MD 21244-8016 
Re: CMS-1715-P: Medicare Program; CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies 
Dear Administrator Verma: 
We appreciate the opportunity to 'conunent on the proposed CY 2020 Medicare Physician Fee Schedule ("PFS"). In the preamble to the proposed rule, CMS stated it would consider comments from stakeholders and invoice submissions regarding potentially rnisvalued services as part of the rulemaking process.1 Based on evidence reported in the field, we believe CPT code 364752 may continue to be rnisvalued and write to bring the circumstance to CMS's attention. We respectfully request that CMS review the enclosed materials to evaluate CPT 36475 and ensure the practice expense inputs accurately reflect the procedure's cost. 

BACKGROUND 
CMS has made several attempts in recent years to correct the fee schedule rate for endovenous ablation procedures. In the CY 2015 PFS proposed rule, CMS identified CPTcode 36475 using one of its screening processes as a code that accounted for significant spending under the PFS yet had not been reviewed since CY 2009. As a result, the_ service underwent a review as potentially misvalued, but only minor adjustments were made to its practice expense ("PE") inputs. 3 
In the CY 2019 PFS rulernaking cycle, CMS commissioned a market-based supply update that produced revised estimates of the supply costs associated with a range of services. RF ablation catheters (supply code SD155) are a significant cost input for CPT 36475, and these catheters were included in the market-based supply update. CMS reduced the assigned costs for RF catheters from $725 to $550 to reflect more accurate invoice prices observed during the 
1 CMS, Medicare Prcigram; Medicare Program; CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies, 84 Fed. Reg. 40,482, 40,504, 40,565 (Aug. 14, 2019). 
2 Descriptor for 36475: Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; first vein treated. 
3 CMS, Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for CY 2015, 79 Fed. Reg. 40,318, 40,337 (July 11, 2014). 
1 
marketwbased survey. In addition, CMS made the following changes to the costs of other supplies that are individually listed as supply costs in the value of the procedure reported with CPT 36475: 
• 
An increase in costs for the vascular sheaths (supply code SD136) from 2018 cost of $20.50 to new cost of $52.80; 

• 
An increase in costs for the hydrophilic guidewire (supply code SD089) from 2018 cost of$35.50 to $43.37; and 

• 
A decrease in costs for the RF introducer (supply code SA026) from 2018 cost of $50 to $24.16.4 


Recent evidence from the field, per the attached invoices, suggests the following: 
1. 
When sold individually, the costs of the RF ablation catheter, vascular sheaths, and hydrophilic guidewire are all lower than CMS's estimated costs; and 

2. 
In many cases, if the price of an RF ablation catheters approaches the $550 estimated by CMS, it is being sold as a kit containing other supplies that are listed (and valued) as separate supplies and expenses in the PE calculation for code 36475. 


Attached are invoices and order fonns that suggest-based on the two observations above----the current PE calculation may be overvalued for CPT 36475 due to overpriced items and separately paid items that are in fact bundled into a kit priced at the $550 estimated by CMS (or less). As CMS has recognized, an overvaluation not only constitutes a potential source of waste by the Medicare program, but may also distort medical decision making. 
REQUEST TO REVIEW PRACTICE EXPENSE INPUTS FOR CPT 36475 
The ten (10) attachments to this letter contain invoices, obtained from end users,5 which demonstrate that RF ablation supplies are often purchased at prices substantially lower than the cost inputs taken into account in the marketwbased supply update. Based on our analysis, these invoices demonstrate that the combined cost of typical RF ablation supplies can be 45% lower than the PE inputs used to calculate payment rates (see Table 1): 
• 
Attachment 1 shows the purchase of a single ClosureFast Catheter at a unit price of $325 rather than $550; 

• 
Attaclunent 2 shows an order of Micro Introducer Sheaths of various sizes-all at a unit price of $20, rather than CMS's estimate of $52.80; 


4 See CY 2020 PFS Proposed Rule Rule Market-Based Supply and Equipment Pricing Update, https://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/Downloads/CY2019wPFS­
w
FR-Market-Based-Supp1y.zip. 
5 These attachments have been redacted to protect sensitive infonnation. 
2 
• Attachment 3 shows an order containing two forms of guidewire (item numbers "GW-025-150-DEI.SJ" and "GW-018-45-SS") priced at $13.35 and $14.55 per unit, respectively, rather than CMS's estimate of $43.37 per unit. 
Table 1. CMS Assigned Costs Compared to Actual Costs of Individual Supplies 
CMS Assigned Invoice-Supported 
Item (CMS PE Code) Df[ference (%) 
Unit Cost Unit Cost 
RF Catheter (SD155) 
$325 -$225 (41%) 
Vascular Sheath (SD 136)  $52.80  $20  -$32.80 (62%)  
Guidewire, Hydrophilic (SD089)  $43.37  $13.35  -$30.02 (69%)  
Totals:  $646.17  $358.35  -$287.82 (45%>)  

In addition to marketing individual supplies at prices below the recommended price finalized by CMS just last year, key supply components are now being bundled into consolidated kits that are also sold at comparatively low prices. This bundling was not reflected in CMS's updated pricing for these inputs. 6 The invoices in Attachments 4-10 contain product numbers ranging from CPKS0-07 to CPK85-1 l-all of which are kits that bundle one or more items (see Table 2). Many of these kits include both the RF catheter and vascular sheath (referred to as the Introducer Sheath). The content of each kit is demonstrated by the product numbers referenced in the "Description" columns of the invoices: For example, in Attachment 4, kit "CPK64-07" includes two items: (1) the "ClosureFast catheter 60 cm" (the RF catheter described by supply code SD155); and (2) product number "MIS-7F07" (a 7-French vascular sheath described by supply code SD136). The invoice prices of these kits never exceed the $550 assigned by CMS for RF catheters, and most prices are substantially lower. 
Similar to Attachment 4, the invoices in Attachments 5-10 identify kits that include the RF Catheter, vascular sheath, and a "ClosureFast Procedure Pack" (identified by product identifier "CFP"). This procedure pack is regularly sold in kits marketed by the manufacturer, and it appears to include numerous items that are currently reflected as separate cost items by CMS, such as needles, syringes, scalpels, and gowns. The bundling of such a large number of products into a single kit was not considered in the market-based supply update, and the consolidation of products into relatively low-cost kits suggests that the current valuation of CPT 36475 greatly exceeds the cost estimates finalized by CMS. 
6 StrategyGen utilized specialized methodologies to account for the costs of"Kits, Packs, and Trays." Because the RF catheter was not analyzed as a kit or pack, there is a strong chance that costs are being double-counted in CMS's current estimate of practice expenses for CPT 36475. 
3 
Table 2. Items Currently Bundled into Kits  
Document  Items Currently Included in Kits  CMS-Assigned Cost*  Invoice-Supported Cost per Kit  Difference (%)  
RF catheter (Product#: CF7-7-60, CF7-7-100,  

CF7-3-60); ClosureFast Procedure Pack (CFP); 
$623.90 
-$148.90 
(24%) 
Attachment 4 
vascular sheath (MIS-7F07, MIS-7F 11, IS-7F07, 
IS-7FI 1)  
Attachment 5  RF catheter (CF7-7-100); vascular sheath (MIS­7F07)  $602.80  $520  -$82.80 (14%)  
Attachment 6  RF catheter (CF7-7-60); ClosureFast Procedure Pack (CFP); vascular sheath (MIS-7F07)  $623.90  $550  -$73.90 (12%)  

RF catheter (CF7-7-60); ClosureFast Procedure 
-$73.90 
(12%) 
-$198.90 
$623.90 
Attachment 7 
Pack (CFP); vascular sheath (MIS-7F07) 
RF catheter (CF7-7-60, CF7-7-100, CF7-3-60); $425 
(32%) 
Attachment 8 ClosureFast Procedure Pack (CFP); vascular sheath $623.90 
-$173.90 
(28%) 
-$323.90 
(M1S-7F07, MIS-7Fl 1, IS-7F07, 1S-7Fl 1) 
RF catheter (CF?-7-100; CF?-3-60); ClosureFast 
Attachment 9 $623.90 $300 
Procedure Pack (CFP); vascular sheath (MIS-7F07) 
(52%) 
RF catheter (CF7-7-100); ClosureFast Procedure -$323.90 
Attachment I 0 $623.90 $300 
Pack (CFP); vascular sheath (M1S-7F07) (52%) 
* Because CMS did not calculate pricing for such kits, the CMS-assigned cost used in these calculations is the sum of the individual unit costs for separate items included in each kit. 
Finally, we believe that the RF catheter and other supplies used in furnishing CPT 36475 are being re-sterilized by a third party company and sold back to users at discounted prices. Therefore, the true pricing discrepancies prevalent throughout the market are likely to be greater than what the attached invoices demonstrate. 
* * * 
We respectfully request that CMS review the PE inputs and related pricing applicable to CPT 36475 at the Agency's earliest convenience to ensure they accurately reflect current practice and pricing. As described above, recent observations from the field suggest that: (1) the cost of individual units has fallen dramatically from the costs CMS previously assigned; and (2) when products do approach their CMS-assigned cost, further inspection reveals they are sold in kits containing multiple items for which CMS assigned separate values. 
We believe this appropriate revision will bring spending for the procedure in line with the procedure's typical costs and eliminate any inappropriate financial motivation to offer the procedure. We appreciate CMS' s continued attention to assessing misvalued codes and would 
4 
welcome the opportunity to provide further input as needed. Please do not hesitate to contact me­at STrowbridge@AngioDynamics.com. 
Respectfully submitted, 
u . ./. I ..------0 
./Y' 1(pl--{ ,<-Cn,..,{')1 • 
Stephen Trowbridge SVP, General Counsel AngioDynamics, Inc. 7 
Enclosures 
7 Founded in 1988, AngioDynamics designs, manufactures, and sells a wide range ofmedical, surgical and diagnostic devices used by professional healthcare providers for the treatment of peripheral vascular disease, vascular access and for use in oncology and surgical settings. We are committed to improving patient outcomes by focusing on the development of innovative technologies to address unmet patient needs and ihat facilitate the delivery ofhigh.quality patient care. 
5 
Attachment 1 


Attachment 2 

Attachment 3 

Attachment 4 


Attachment 5 
Archive Information

*** REPRINT *** INVOICE 
PAGE  INVOICE DATE  INVOICE NUMBER  
1  of  1  2016  
 

RH 
Sold To: 

Ship To : 






CPK65-07 
1,040.00 
92.30 

accordance with all applicable laws and regulations, including without limitation 42 USC § 1320a-7b(b)(3)(A) and 42 CFR § 1001.952(h). 
Inquiries: 

REV 3.00  09/15/15 
Attachment 6 



Attachment 7 


Attachment 8 

Attachment 9 



Thank You for your order. Please review your Order Details. 

Shipping Address: 

Order/Confirmation #: 

PO #: 

Order Type: Standard Order Order Date: 

2019 
Order Total Excluding Tax: 15525.00 
Comments: Item Details: 
Line #  Item #  Description  Status  UOM  Quantity  Unit Price  Pricing UOM  Extended Price  Contract Pricing  

 
 
 
 
 
2.000  CPK55-07  KIT: CF7-7-100, CFP, MIS-7F07  In-Process  Each  40  $ 300.00  Each  $ 12000.00  
 
Description  Qty  UnitPrice  
 
 
CLOSURE FAST CATH 100CM  40  0.00  
 
 
CLF PROCEDURE PACK  40  0.00  
 
 
MICRO INTRODUCER 7F 7CM 7FX7CM  40  0.00  
 
 
3.000  CPK83-07  KIT: CF7-3-60, CFP, MIS-7F07  In-Process  Each  10  $ 300.00  Each  $ 3000.00  
 
Description  Qty  UnitPrice  
 
 
CLOSURE CATH 3CM COIL  10  0.00  
 
 
CLF PROCEDURE PACK  10  0.00  
 
 
MICRO INTRODUCER 7F 7CM 7FX7CM  10  0.00  
 
 

Thank you again for your order. We appreciate your business. 
Thank you for using 

Contact Information 

Attachment 10 


Thank You for your order. Please review your Order Details. 

Shipping Address: 

Order/Confirmation #: 

PO #: 

Order Type: Standard Order Order Date: 

/2019 
Order Total Excluding Tax: 48843.00 
Comments: Item Details: 
Line #  Item #  Description  Status  UOM  Quantity  Unit Price  Pricing UOM  Extended Price  Contract Pricing  

 
 
2.000  RFS2-6-12  CLOSURERFS CATHETER 6F 12CM  In-Process  Each  6  $ 378.00  Each  $ 2268.00  
 
3.000  CPK55-07  KIT: CF7-7-100, CFP, MIS-7F07  In-Process  Each  150  $ 300.00  Each  $ 45000.00  
 
Description  Qty  UnitPrice  
CLOSURE FAST CATH 100CM  150  0.00  
CLF PROCEDURE PACK  150  0.00  
MICRO INTRODUCER 7F 7CM 7FX7CM  150  0.00  

Thank you again for your order. We appreciate your business. 
Thank you for using 

Contact Information 






