1. CMS Proposed Rule For Off The Shelf Orthoses
What Does it Mean For You?

2. CMS Proposed Rule for OTS Orthoses
Proposed Rule published on July 11, 2014
Included in larger proposed rule
End Stage Renal Disease Prospective Payment System
Quality Incentive Program
DMEPOS Competitive Bidding
Relevant Section of proposed rule further defines the definition of the term “minimal self adjustment” as it relates to the provision of custom fitted orthoses

3. CMS Proposed Rule for OTS Orthoses
Comment Period Ends on September 2, 2014
AOPA will submit detailed comments
A template for AOPA members to submit comments is available at
Template must be completed by August 27, 2014 to ensure adequate time for AOPA to coordinate delivery to CMS
Similar process as the recent proposed rule on prior authorization for certain prosthetic codes

4. CMS Proposed Rule for OTS Orthoses
Comment Period Ends on September 2, 2014
AOPA members are also encouraged to submit comments directly to CMS
Comments submitted directly to CMS may be submitted in addition to using the template on the AOPAvotes site

5. History of OTS Orthoses and Competitive Bidding
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
Authorized competitive bidding for OTS orthoses
OTS orthoses defined as those that can be fit with “minimal self adjustment”
Required demonstration of significant savings through implementation of competitive bidding
Round one and two of competitive bidding did not include OTS orthoses as a product category for competitive bidding

6. History of OTS Orthoses and Competitive Bidding
Expanded Regulatory Definition of “Minimal Self Adjustment”
Regulation published on April 1, 2007
Defined minimal self adjustment
An adjustment that the beneficiary, caretaker for the beneficiary, or supplier of the device can perform and does not require the services of a certified orthotist or an individual who has specialized training

7. History of OTS Orthoses and Competitive Bidding
Expanded Regulatory Definition of “Minimal Self Adjustment”
AOPA disagrees with the regulatory expansion of the statutory definition of minimal self adjustment
CMS has chosen to ignore the presence of the word “self”
Multiple letters, meetings, and discussions with CMS have resulted in no change to the regulatory definition of minimal self adjustment

8. History of OTS Orthoses and Competitive Bidding
Publication of Initial OTS Orthosis list
On February 9, 2012 CMS published a list of 62 L-codes considered OTS for purposes of inclusion in competitive bidding
AOPA submitted 479 pages of code specific comments w/ clinical literature supporting the need for proper fitting

9. History of OTS Orthoses and Competitive Bidding
Final OTS List
Published/Released in August 2013
What did the final list contain?
Responses to the comments made about the initial list
CMS rejected or ignored AOPA comments and literature on 85-90% of initial codes
55 HCPCS codes to be considered OTS
Final list continued to use the regulatory definition of minimal self adjustment to justify OTS classification

10. History of OTS Orthoses and Competitive Bidding
“Split” Codes
Split codes divided into custom fitted versions and OTS versions
“Exploding” the code set resulted in 80+ changes
Existing codes were used to describe versions that require custom fitting
“by an individual w/ expertise”
New codes were developed for versions that can be delivered off the shelf
Minimal self-adjustment

11. History of OTS Orthoses and Competitive Bidding
2014 HCPCS Code Changes
32 existing codes were changed to OTS only
“prefabricated, off the shelf”
29 existing codes were changed to custom fit only
“prefabricated, item that has been trimmed, bent, molded, assembled, or otherwise customized to fit a specific patient by an individual with expertise”
23 new codes, to represent OTS versions of current codes

12. History of OTS Orthoses and Competitive Bidding
2014 Medicare Fee Schedule
Medicare allowables for custom fitted codes cross walked to OTS codes
Same reimbursement for now regardless of OTS or custom fit
CMS bound by Medicare Claims Processing Manual
Chapter 23, Section
“related but similar” provision
OTS fees may be reduced through future implementation of competitive bidding or other means

13. History of OTS Orthoses and Competitive Bidding
DME MAC OTS Orthosis Policy Bulletin
Issued March 27, 2014
Joint publication by all 4 DME MACS and PDAC
Introduced the term “substantial modification”
Relative to custom fitted orthoses
Lack of substantial modification results in classification as OTS
No recognition of certified orthotic fitter as qualified provider

14. History of OTS Orthoses and Competitive Bidding
DME MAC OTS Orthosis Policy Bulletin
Use of CAD/CAM does not change classification as OTS or custom fitted
“Kits” requiring some assembly may be considered OTS
Requires physician order to specify OTS or custom fitted
Documentation requirements to justify coding

15. History of OTS Orthoses and Competitive Bidding
LCD and Policy Article Updates
Coding bulletin incorporated into DME MAC medical policies
AFO/KAFO
Knee Orthoses
Spinal Orthoses
Effective for Claims on or after January 1, 2014
Retroactive effective date for policy revisions

16. History of OTS Orthoses and Competitive Bidding
Advanced Notice of Proposed Rulemaking
Published by CMS in Federal Register on February 26, 2014
Solicited public comment on different methodologies to adjust Medicare fees based on current DMEPOS competitive bidding programs
Round 1
Round 2
Round 1 re-compete
Deadline for comments was March 28, 2014

17. History of OTS Orthoses and Competitive Bidding
AOPA Comments on ANPRM
OTS orthoses were not included in previous rounds of competitive bidding
No authority to apply data from other product categories
Continued concern regarding expansion of definition of minimal self adjustment
Regulatory expansion
LCD/Policy Article expansion

18. AOPA Concerns Regarding Proposed Rule
Improper Regulatory Definition of “Minimal Self Adjustment”
Statutory language limits OTS devices to those which can be adjusted by the patient
No reference to supplier adjustment
AOPA believes that CMS has improperly expanded this definition through regulation and policy clarification by its contractors
CMS must revise its regulatory definition so that it is consistent with the statutory language

19. AOPA Concerns Regarding Proposed Rule
Intent of the Proposed Rule
CMS claims the purpose of the proposed rule is to clarify the definition of the term “minimal self adjustment”
Proposed rule goes beyond this and establishes who is qualified to fit OTS and custom fitted orthoses
Process to develop OTS lists did not follow Administrative Procedure Act (APA) requirements

20. AOPA Concerns Regarding Proposed Rule
Failure to Recognize Role of Appropriate Auxiliary Personnel
Proposed rule recognizes the following as “individuals with specialized training”:
Certified Orthotists
Physicians
Treating Practitioners (PA, NP, CNS)
Physical Therapists
Occupational Therapists

21. AOPA Concerns Regarding Proposed Rule
Failure to Recognize Role of Appropriate Auxiliary Personnel
Proposed rule does not recognize the following as “individuals with specialized training”:
Certified Orthotic Fitters
Certified Orthotic Assistants
Manufacturer’s Representatives

22. AOPA Concerns Regarding Proposed Rule
Failure to Recognize Role of Appropriate Auxiliary Personnel
AOPA believes the final rule must acknowledge the role of appropriate certified or licensed individuals who are fitting orthoses under the direct supervision of a recognized individual with expertise
Certified Orthotic Fitters
Certified Orthotic Assistants
Licensed Nurses

23. AOPA Concerns Regarding Proposed Rule
Failure to Recognize State Licensure Statutes
Proposed rule states that not all of the 17 states that currently require licensure in Prosthetics & Orthotics also license Certified Orthotic Fitters
Failure to recognize state laws that do license these individuals is a potential violation of the Constitution
9 states currently license fitters/assistants in some way

24. AOPA Concerns Regarding Proposed Rule
Flaws in the List of OTS Orthoses Subject to Competitive Bidding
CMS ignored or disregarded AOPA comments regarding the need for custom fitting of most devices described by the HCPCS codes on the final OTS list
This error has been compounded by subsequent policy changes by the DME MACs
No opportunity for stakeholder input

25. What Must Be Done
CMS must make the following changes in the final rule:
Revise its regulatory position on the definition of “minimal self adjustment”
Recognize flaws in the current OTS orthosis list and make revisions to ensure that safe and effective orthotic care is available for Medicare beneficiaries

26. What Must Be Done
CMS must make the following changes in the final rule:
Recognize the use of appropriate support personnel under the direct supervision of a certified/licensed provider
Allow for appropriate stakeholder input prior to the publication of significant changes to Medicare coverage policy

27. What Can You Do to Help? Make sure your voice is heard
Submit comments on the proposed rule
Use the template at to submit comments no later than August 28, 2014
Develop and submit your own comments independently
Comments must be submitted to CMS by September 2, 2014
Get patient’s involved
Encourage patients to take an active role in the provision of their healthcare
AOPA postcard campaign

28. Questions? Go to: www.aopavotes.org/comments/
OTS Orthoses: Shape Your Future
Click here to send comments to CMS
✔ AOPA will provide a pre-written letter for you to quickly submit comments to CMS via AOPAvotes listing ways that the proposed rule on OTS orthoses will negatively impact your business. All letters generated through AOPAvotes.org will be hand-delivered to CMS prior to the comment submission deadline.
Submit Comments to CMS on OTS Orthoses:
Go to:

29. Thank You!