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

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

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 www.aopavotes.org 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

CMS Proposed Rule for OTS Orthoses Comment Period Ends on September 2, 2014 AOPA members are also encouraged to submit comments directly to CMS http://www.regulations.gov/#!submitComment;D=CMS-2014-0092-0002 Comments submitted directly to CMS may be submitted in addition to using the template on the AOPAvotes site

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

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

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

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

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

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

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

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 60.3.1 “related but similar” provision OTS fees may be reduced through future implementation of competitive bidding or other means

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 http://www.medicarenhic.com/viewdoc.aspx?id=2645 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

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

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

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

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

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

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

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

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

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

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

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

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

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

What Can You Do to Help? Make sure your voice is heard Submit comments on the proposed rule Use the template at www.aopavotes.org 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

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: www.aopavotes.org/comments/

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