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AOPA Offers 2 RAC Audit Webinars

AOPA has recently received reports of increased RAC activity (details here) and has scheduled several educational webinars to help you prepare. The first webinar will cover the basics of what the renewed RAC audits mean for O&P providers and how to be prepared to respond to an audit request when it is received. The second webinar will focus on the details of preparing your practice to do the things today that will protect you from RAC audits when they are received.

Understanding the Basics of RAC Audits and How to Prepare for Them; July 14th, 1:00 PM EDT, Free for AOPA Members.

Don’t Let the RACs Catch You Unprepared: Working Today to Protect Tomorrow; July 21st, 1:00 PM EDT, $99 Members; $199 Non-Members.

audit

Submit Comments on Proposed Assistive Technology Standards

AOPA members should be aware of proposed education standards by the Assistive Technology Professional (ATP) that could potentially encroach on the O&P profession.

AOPA encourages members to make public comments about a proposed set of Assistive Technology education standards that are currently being advanced by the Rehabilitation Engineering and Assistive Technology Society of North American (RESNA). The concern is that the new standards could be interpreted to qualify those certified as an ATP to evaluate, fit and/or deliver orthotic or prosthetic devices. Read the proposed standards.

AOPA has prepared a statement for members to use, and below are directions on how to submit comments by July 1, 2016.

Survey for Assistive Technology

    1. Click on Survey link above / Click Next
    2. Select Appendix B-Curriculum / Click Next
    3. Type 493 in the box (that is the line number)
    4. Paste in comment box:

The accreditation and  scope of practice issues relating to orthotics and prosthetics are well-established under (a) Section 427 of the Benefits Improvement and Protection Act, enacted in 2000, (b) the two accreditation bodies referenced in that federal legislation, and (c) the deemed accrediting organizations identified and recognized by the Centers for Medicare and Medicaid Services (CMS).  Therefore, any action by RESNA relating to defining the qualifications needed for orthotics and prosthetics would be at best redundant, and at worst, potentially conflicting and disruptive, and so we request the document resulting from this process not include content relating to defining the qualifications for those providing orthotic and/or prosthetic services.

5. Click Next – This returns you to the previous page
6. Replace 493 in the box with 566 (that is the line number)
7. Paste in comment box:

The accreditation and  scope of practice issues relating to orthotics and prosthetics are well-established under (a) Section 427 of the Benefits Improvement and Protection Act, enacted in 2000, (b) the two accreditation bodies referenced in that federal legislation, and (c) the deemed accrediting organizations identified and recognized by the Centers for Medicare and Medicaid Services (CMS).  Therefore, any action by RESNA relating to defining the qualifications needed for orthotics and prosthetics would be at best redundant, and at worst, potentially conflicting and disruptive, and so we request the document resulting from this process not include content relating to defining the qualifications for those providing orthotic and/or prosthetic services.

8. Click Next – I have completed my comments – Click Next – Click Done

See more information in the alert issued by NCOPE, ABC and the Academy.

 

Senate Appropriations Committee Report Incorporates Recommendations to CMS on Draft LCD

Capitol rectangleAs a result of the series of meetings during the Policy Forum involving Senator Kerrey and top members of the Senate and the Finance Committee, and particularly through AOPA Past President Tom Watson’s intercession with Senate Majority Leader McConnell, important language relating to the July 2015 draft LCD was inserted into the Committee report which has been prepared to explain the 2017 Senate Labor/HHS Appropriations Bill.  This is an important directive to CMS, essentially that in light of reductions in Medicare prosthetic spend over 2012-2014, there seems no necessity for intervention to change the LCD, and instructing CMS to consult with clinicians, patients and prosthetist groups before releasing any new or revised version of the LCD.

The language included in the report is as follows:

“The Committee recognizes that Medicare payments for all prosthetics, and especially the newer advanced technologies, have declined over each of the years 2010-2014.  The committee encourages CMS to consult broadly with clinicians, patient groups, and the prosthetics field regarding revisions to the draft Local Coverage Determination, prior to publishing an updated draft policy for public comment.”

AOPA Updates its Joint Statement on Physical Characteristics of Orthopedic Shoe Inserts

In 2013, AOPA, in conjunction with the American Podiatric Medical Association (APMA) and the Pedorthic Footcare Association (PFA), developed a joint statement on the interpretation of HCPCS codes L3000, L3010, L3020, and L3030.  The joint statement was presented to AOPA leadership at the time and was approved for publication.  On May 13, 2016 a follow up meeting of the three organizations was held and a slight revision to the joint statement was proposed with the understanding that the leadership of the three organizations would have the opportunity to review and approve the revised document.  The revised statement has been reviewed and approved by AOPA leadership.

Read the statement.

Renewed RAC Activity Reported

AOPA has recently received reports of increased Recovery Audit Contractor (RAC) activity focusing on the provision of ankle foot orthoses, especially in Jurisdiction A and Jurisdiction D. While the existing RAC contractors have been authorized to begin new audits for some time now, pending the competition for and award of the single, national DMEPOS RAC contract, these reports represent the first significant RAC activity focused on O&P providers since the re-authorization took place.

It is important for AOPA members to ensure that the RAC contractors are playing by the rules, especially when it comes to the limits to the number of Additional Documentation Requests (ADRs) that can be made against a single tax identification number.

Current regulations limit the number of ADR requests for suppliers to 10% of all claims submitted for the previous calendar year, divided into eight periods, each period representing 45 days. In addition, for suppliers who bill under specialty codes identifying them as O&P providers (51, 52, 53, 55, 56, or 57) the limit on ADR requests is capped at 10 ADR requests every 45 days, per Tax ID. AOPA is preparing educational resources to help prepare its members for continuing challenges of RAC audits.

In the meantime, if you have received ADRs related to RAC audits, it is imperative that you challenge any ADR requests that exceed the limits discussed above. Questions regarding this issue may be directed to Joe McTernan at jmcternan@aopanet.org or Devon Bernard at dbernard@aopanet.org.

The FDA and 3-D Printing: What Potential Regulatory Action Means for O&P

On May 10, 2016, the Food and Drug Administration (FDA) released a document entitled, Technical Considerations for Additive Manufactured Devices: Draft Guidance for Industry and Food and Drug Administration Staff.  The publication of this document marks the first foray of the FDA into potential regulation of devices that use additive manufacturing as a means of fabrication of medical devices.  Additive manufacturing is a broad term that encompasses 3-D printing as a means of creating functional medical devices.  The guidance document has been published in order to solicit public comment regarding the FDA’s current thinking on the topic of 3-D printing and “is not intended to be a binding document on either the FDA or the public.”

The bulk of the document relates to specific considerations that Additive Manufacturing devices need to address in order to assure that they meet the Quality System requirements of 21 CFR section 820.198 (good manufacturing practices).  The document, which specifically mentioned the conference on 3D devices FDA conducted on October, 2014, does make a few important things clear:

  1. Standard FDA requirements, e.g. 510(k), premarket approval, and investigational device exemption requirements apply to additive manufactured devices.  Likewise the classification regulations for products are referenced as specifically applicable.
  2. If the device classification provides for exemption from either 510(k) or 21 CFR Section 820.198; quality standards, those exemptions would appear to apply when the device is fabricated using an AM process.  However, it is noted that some aspects of 21 CFR Section 820.198 quality system requirements, e.g., maintenance of complaint records apply to virtually all devices, even those exempted (via published classification regs) from some other aspects of 21 CFR section 820.198.
  3. The document mentions apparently more stringent requirements which may be applicable to AM devices that are, for instance, used as implants, or which are load-bearing.

The draft guidance may ultimately not have a very substantial impact on all O&P devices.  FDA places medical devices into one of three regulatory categories: Classes I, II, and III. While medical devices (including most O&P devices) that are manufactured using 3-D printing processes will be subject to the same exemption from most FDA regulation as Class I devices manufactured in a more traditional manner, AOPA believes that the publication of this document remains a significant development.  The publication of the document clearly indicates the intent of the FDA to ultimately regulate the 3-D printing process in regards to its use in the manufacture of medical devices.

Some Class I O&P devices have been designated by FDA as exempt from either premarket notification [section 510(k)], or many aspects of GMPs, i.e., Quality Systems rules, or both.  It is clear from this FDA notice that whatever rules apply to traditional O&P devices will also apply to similar devices fabricated using 3-D techniques and introduced for sale/commerce.  So, while one or both of these specific exemptions may have been identified for a specific 3-D fabricated O&P device, it is important to note that the FDA continues to require manufacturers of all Class I devices to register with the FDA through its device establishment registration process.  In addition, Class I device manufacturers are almost never exempted from FDA general requirements on record keeping and maintenance of complaint files.  While some Class I O&P devices have been designated as not being subject to more rigid regulation such as the 510(k) pre-market notification process and complete compliance with all aspects of Good Manufacturing Processes (GMPs), in addition virtually no one is exempted from complaint record rules under the GMPs, and failure to comply with the record keeping and complaint file requirements could lead to trouble for both traditional O&P manufacturers as well as those that incorporate 3-D printing into their manufacturing process.

The FDA guidance document is a total of 28 pages, most of which focus on suggested quality systems and basic manufacturing processes that should be followed when using 3-D printing as a means to manufacture completed medical devices.  While this guidance is more relevant to ALL Class II and Class III devices, and to some Class I O&P devices, it is a valuable resource regarding the intent of the FDA to ensure that 3-D printed medical devices do not pose a danger to the public. Even though FDA has couched this as a guidance document and non-binding, no one could read this document and conclude that all aspects of FDA’s medical device regulation and structure are not seen by the agency as applicable to Additive Manufacturing Devices that are offered for sale to patients/consumers/public.

Individual manufacturers of O&P devices that currently use, or intend to use additive manufacturing as part of their manufacturing process should familiarize themselves with the specifics of the guidance document.  Areas of focus of the guidance document include sections on device design, software workflow, material controls, process validation and acceptance, quality data, device testing including both mechanical and material testing, cleaning and sterilization, biocompatibility, and labeling considerations.

The guidance document discusses, in detail, the differences between the manufacture of standard size devices and patient matched devices and the design alterations that must be made to accomplish both manufacturing styles.  The document also highlights the need to ensure that the software that is used to convert a digital design into a physical device is efficient and not subject to error through file conversion.  The guidance document then provides information on making sure that the materials used to create the medical device are appropriate both in material and structure, especially regarding implantable or load bearing devices.  The guidance document continues by discussing the importance of process validity to ensure that using different machines to fabricate the devices will not result in significant alteration of the device itself.  The document closes by discussing the need to not only assure the quality of the finished device, but also to ensure that the device is properly tested to confirm its effectiveness.

The complete document may be viewed here.

The FDA will accept public comment on the draft guidance document until August 8, 2016 (90 days from the publication date of May 10, 2016.  Electronic comments may be submitted through http://www.regulations.gov and written comments may be submitted to the following address:

Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane
Room 1061
Rockville, Maryland 20852

AOPA will be preparing comments and will share them with AOPA members prior to submission.

Medicare Participation and Competitive Bidding: How Your Status Affects Your Reimbursement

In January of 2016, new authority granted to CMS to build on DME competitive bidding to set pricing more broadly and nationally took effect. This authority allows CMS to use pricing established as a result of competitive bidding programs for specific DME products in certain parts of the country to be applied more broadly to those same DME products in non-competitive bid areas.  On May 19, 2016, the AOPA SmartBrief included an article highlighting reports from CMS underscoring the success of these efforts, essentially concluding that since DME providers accepted this reduced pricing, everything must be fine at these rates.  This contention could prove very important in the future as CMS continues to look for ways to reduce spending by cutting reimbursement.

The May 24, 2016 SmartBrief contained a link to an article in HME News citing feedback from leaders in the DME world stating that the analysis by CMS was simplistic, inappropriately using one or two small bits of isolated information, as the basis for reaching a broad generalized conclusion about the effectiveness of applying competitive bid rates to non-bid areas relative to both market-based and patient care based impacts.

This matter is NOT directly germane to either orthotics or prosthetics because the authority Congress has granted to CMS with respect to competitive bidding for prosthetics and orthotics is limited to a very small subset, i.e., off-the-shelf (OTS) orthotics, and CMS has, to date, never competitively bid any such OTS orthotics devices.  The changes in Medicare reimbursement referenced in this notice does not currently have a direct impact on prosthetics and/or orthotics.  That said, AOPA tends to agree with DME industry sources quoted by HME News that the analysis seems to rest on a somewhat questionable assumption that if the nation’s largest health care payer unilaterally, and seemingly without any rulemaking process, reduces its payment for devices, and if the impacted provider community largely continues to deliver those devices, that one can assume both that the reduced payment is fair, and that the impacted providers will be able to remain as viable, operating businesses in the long term, and that neither the quality of care, nor the access to care for the patient community will be adversely impacted.

The circumstance above has prompted some in the O&P industry to ask the question, what options does a provider have if they decide that Medicare payment is not enough?  Or stated differently, if in the future, Medicare precipitously cuts O&P reimbursement, similar to what was outlined in its recent announcements about major cuts in DME fee schedule pricing, what could you do?  While entirely theoretical, this article will take a few minutes to outline reversion to being a non-participating Medicare provider as a potential alternative to simply accepting unsustainable reimbursement rates.

Be a Participating or a Non-Participating Medicare Provider—It’s Your Choice, and What That Means
The term “participation” is often misunderstood in the context of the Medicare program.  Rather than the traditional meaning of the term, which implies that by participating you have the ability to provide services to Medicare patients, “participation” in the Medicare program only relates to how you submit claims and receive reimbursement under the Medicare program.  The ability to provide services to Medicare beneficiaries is established when you enroll in the Medicare program as a DMEPOS supplier, regardless of whether you decide to be a participating provider or not.  When you submit your initial application to the National Supplier Clearinghouse to become a DMEPOS supplier, you have the option to complete and submit a Medicare Participation Agreement (Form CMS-460). If you do not complete the participation agreement, you will automatically be enrolled as a non-participating supplier. If you choose to complete this form and become a Medicare participating supplier, you are bound by the terms of the participation agreement for at least the remainder of the current calendar year.  It is very important that you make an informed decision as to whether becoming a participating provider is in the best interest of your organization.

If you enroll as a Medicare participating provider, you agree in advance, to accept assignment on all Medicare claims submitted during the term of the participation agreement.  What this means is that for every Medicare claim you submit that is approved for payment, you will receive 80% of the Medicare published allowed amount directly from the Medicare program. It is your responsibility to collect the remaining 20% from the patient directly or by submitting a claim to their secondary or supplemental insurance carrier.  Alternatively, providers who elect a non-participating status are free to make an individual decision, on a claim by claim basis, whether or not to accept assignment.  Theoretically you can elect to be a non-participating provider and still accept assignment on all of your Medicare claims.  Non-participating status allows you the freedom to accept assignment on some claims but not others.  In the context of the potential impact of any future decision to apply competitive bidding rates to OTS orthoses in non-bid areas, non-participating status allows suppliers to not be tied to the reduced rates by choosing to not accept assignment on the claim.  When submitting a non-assigned claim, suppliers may collect their full usual and customary charge from the Medicare beneficiary at the time of delivery of the completed device.  Non-assigned claims must still be submitted to Medicare by the supplier and, if approved, Medicare will send payment of 80% of the Medicare allowed amount directly to the patient.  It is important to note that not accepting assignment on a claim does not change the supplier’s financial liability for services that are deemed not medically necessary by Medicare.  If a non-assigned claim is deemed not medically necessary, the supplier is required to immediately refund any money collected from the patient at the time of delivery unless a properly executed Advanced Beneficiary Notice (ABN) is in the supplier’s files.

The obvious question that remains is, how can non-participation status help my business should Medicare decide to apply competitive bidding rates to OTS orthoses in non-competitive bidding areas?  While this discussion remains hypothetical as OTS orthoses have yet to be included in any Medicare competitive bidding program, let’s take a look at a potential scenario where non-participation status may be to your benefit.  Again, this is a hypothetical scenario for illustration purpose only.

Let’s assume that the Medicare allowed amount for an OTS walking boot is $150 and your company’s usual and customary charge for this item is $200.  Let’s also assume that through application of competitive bidding rates, Medicare reduces the allowed amount for a walking boot to $100.  If you have elected to be a participating Medicare supplier and you submit a claim for a walking boot in this scenario, Medicare would reimburse you $80 and you could collect an additional $20 from the patient or their secondary/supplemental insurance.  Total reimbursement in this scenario would be limited to $100.  If you have elected to be a non-participating provider, you could choose not to accept assignment on the claim and charge the patient up to $200 at the time of delivery.  You would still be required to submit a non-assigned claim to Medicare and Medicare would send a payment of $80 directly to the patient, representing 80% of the reduced allowed amount as a result of the application of competitive bidding prices.

While this scenario may present some business challenges relative to your patient’s willingness to pay more for the device than Medicare is willing to reimburse them, it remains a viable alternative to simply accepting reduced reimbursement should Medicare ultimately decide to bring OTS orthoses into the competitive bidding environment.

While the inclusion of competitive bidding pricing does not appear to be imminent for OTS orthoses, since the decision to be a Medicare participating provider is applicable for a full calendar year, it may be prudent to review your current Medicare participation status and decide whether Medicare participation is in your company’s best  interest.  If you are currently a participating supplier your next opportunity to change your status is effective January 1, 2017.  To change your status from participating to non-participating you must submit a written notification on your company letterhead to the National Supplier Clearinghouse during the annual open enrollment period which spans from mid-November until December 31st of each year.  This letter must be signed by the authorized official for your company on file with the NSC.  It is important to note that the participation decision applies to all locations under a single Tax ID.

Your Patients May Be Your Best Advocates—Keep Them Informed!
Beyond a provider’s option to choose Medicare participating vs. non-participating status, another option that AOPA members should consider is assuring optimal communication with your Medicare patients on any changes in Medicare’s payment policies.  For example, in the recent CMS announcement on the ‘success’ of its payment reduction policies in the DME arena, it was noted that the measuring stick they used did not include any confirmation ‘that neither the quality of care, nor the access to care for the patient community will be adversely impacted.’  Medicare may not take the initiative to speak to its beneficiaries about changes, and that may be all the more reason why you may want to strengthen your own outreach to your Medicare patients.  If Medicare takes steps which make it harder for you to deliver what the patient expects, poses additional steps which delay your ability to make timely delivery, cuts payments which in turn force you to scale back services—those are all things you likely want to tell your patients about.  If patients are unhappy or unsatisfied because Medicare belt-tightening results in less options or quality/timeliness limitations in the care they receive, by having alerted them in advance, they will know that it is Medicare to whom they should voice their disappointment, rather than thinking you have somehow shortchanged them.  Your patients are your best advocates—Medicare listens to them much more closely than they listen to any providers.  So, it is very much in your interest to take steps to assure your patients are ‘in the loop’ on how new Medicare changes may be impacting them.

AOPA hopes that the information in this article has been helpful, especially in the context of the recent announcement by CMS regarding the perceived effectiveness of applying competitive bidding rates for DME in non-competitive bidding areas.  While the decision to become a Medicare participating provider must be made according to the individual needs of your company, it is important to consider the impact of this decision carefully.

 

Jurisdiction D DME MAC Publishes Results of Pre-Payment Review of Ankle Foot Orthoses, Knee Orthoses, and Spinal Orthoses

Noridian, who serves as the Jurisdiction D Durable Medical Equipment Medicare Administrative Contractor (DME MAC), has released the most recent quarterly results of its ongoing pre-payment review of claims for several codes.

For AFOs described by HCPCS codes L1960, L1970 and L4360: from December 2015 through March 2016, a total of 1008 claims were reviewed; 855 of which were denied. This error rate varied for each code. The L1960 had an error rate of 69%, the L1970 had an error rate of 70%, and the L4360 had an error rate of 99% (484 out of 488 claims were denied). Based on these results Noridian will continue its pre-payment reviews for codes L1960, L1970 and L4360.

The DME MAC noted that common denial reasons included a lack of proof of delivery documentation, failure to include documentation to show “substantial” modifications were made to the custom fitted item (L4360), documentation was not received in response to the ADR, and insufficient documentation to establish a need for a custom fabricated item (L1960 and L1970). You may view the full results of the quarterly review here.

Noridian has also released the most recent results of its ongoing pre-payment review of claims for L1833 (knee orthosis, adjustable knee joints (unicentric or polycentric), positional orthosis, rigid support, prefabricated, off-the-shelf). From September 2015 through December 2015, a total of 627 claims were reviewed, 607 of which were denied for an overall claim error rate of 96%. Noridian noted that claims were denied due to a failure to respond or a late response to additional documentation requests (which will result in an automatic denial), the submission of an invalid proof of delivery, a missing/incorrect ICD-10 code, and documentation that did indicate the patient is ambulatory (as sometimes required by policy). You may view the full results of the review here. Based on the results, Noridian will continue its pre-payment review for code L1833.

For spinal orthoses described by HCPCS codes L0631 and L0637, from December 2015 through March 2016, a total of 291 claims were reviewed and 492 were denied, a denial rate of 99% for L0631 and 94% for L0637.

The DME MAC provided the following five top reasons for why the claims were denied: Submitted documentation didn’t identify the modifications made for the custom fitted brace; Documentation was not submitted in response to the ADR request; Missing or invalid proof of delivery; Documentation didn’t meet basic coverage criteria; Brace provided didn’t have a PDAC coding verification (required by policy). Based on the results Noridian will continue its pre-payment review for codes L0631 and L0637. You may view the full results of the review here.

DME MACs Revise Knee Orthosis Policy

The DME MACs have recently published a revision to the Knee Othosis Local Coverage Determination (LCD) and Policy Article (PA) that will be effective for dates of service on or after June 2, 2016.

The primary revisions to the LCD and Policy article include the addition of ICD-10 diagnosis codes that allow providers to indicate whether the encounter was considered an initial, subsequent, or sequela encounter; and incorporation of language from the DMEPOS quality standards regarding the definition of custom fabricated orthoses. The revision also incorporates standard documentation language found in other O&P policies.

Review the revised knee orthosis LCD and Policy Article.

AOPA Announces 2016 Thranhardt Award Contenders

WASHINGTON, D.C. – The American Orthotic & Prosthetic Association (AOPA) has announced the contenders for the 2016 Thranhardt Award.  The award, launched by a gift from J.E. Hanger in memory of Howard R. Thranhardt, CP in 1996 has become one of the most distinguished honors in the orthotics and prosthetics profession.

The contenders of the Thranhardt Award will present their research at the 2016 AOPA National Assembly in Boston, Massachusetts on Friday, September 9.  “The Thranhardt Lectures are always one of the highlights of the National Assembly – it brings together some of the brightest O&P researchers and clinicians.  This year’s applicants were especially impressive and we look forward to announcing the winner,” remarked Chris Nolan, Chairman of the 2016 Assembly Planning Committee.  The contenders are Beatrice Janka, MPO, CPO; Gordon Stevens, CPO, LPO; Kenton Kaufman, PhD, PE; and Lauren White, PT, DPT, PCS.

Beatrice Janka, MPO, CPO, is a clinical prosthetist-orthotist within Becker Orthopedic’s Patient Care Division as well as a product development engineer on Becker’s Research and Product Development team, and will present “The Effects of AFO Stiffness and Alignment on Lower Extremity Kinematics in Stroke and Multiple Sclerosis”.

Gordon Stevens, CPO, LPO is the President of Baker O&P in Texas, and a previous Thranhardt award winner, who will present “Increasing Functional Independence through Prosthetic Rehabilitation”.

Kenton Kaufman, PhD, PE is the W. Hall Wendel Jr. Musculoskeletal Research Professor, Biomedical Engineering Professor, and Director of the Biomechanics-Motion Analysis Laboratory at the Mayo Clinic and will present “Functional Assessment and Satisfaction in K2 Transfemoral Amputees Receiving MPK Knees–Initial Findings”.

Lauren White, PT, DPT, PCS is a physical therapist with the International Center for Spinal Cord Injury(ICSCI) and manages the Interdisciplinary Orthotic Clinic at Kennedy Krieger Institute.  She will present “Development and Implementation of a Clinical Decision Making Algorithm for Aiding Orthotic Prescription for Patients with Neurological Impairments”.

More information about the 2016 National Assembly is available at www.AOPAnet.org or bit.ly/2016assembly. 

Questions? Please contact Lauren Anderson, AOPA’s Manager of Communications, Policy, and Strategic Initiatives at 571/431-0843 or landerson@aopanet.org.