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AOPA Submits Comments on the Inclusion of the Term “Orthotics and Prosthetics” in The Uniform Glossary of Medical Terms

Update:  Just 10 days after the March 28th deadline for submission of comments regarding the Uniform Glossary of Medical Terms, CMS finalized an update to the glossary that included the revision to the definition of the term “orthotics and prosthetics” that were suggested by both AOPA and the O&P Alliance.  Both groups suggested that the definition no longer include the term “due to breast cancer” when defining external breast prosthesis as part of the larger definition of the term “orthotics and prosthetics.”  AOPA is pleased that its suggested revision was considered and accepted by CMS and the other federal agencies tasked with maintain the Uniform Glossary of medical Terms.

AOPA recently submitted comments applauding the decision to include a separate and distinct definition of the term “Orthotics and Prosthetics” as part of the Uniform Glossary of Medical Terms.  This document, which was established through provisions of the Affordable Care Act, is intended to provide guidance to private insurance companies when defining and establishing coverage for essential health benefits.

Recently, the Department of Labor, in conjunction with the Centers for Medicare and Medicaid Services (CMS), requested public comment on the latest revision to the Uniform Glossary of Medical Terms, which, for the first time, included a proposed definition of the term Orthotics and Prosthetics.  The Uniform Glossary proposed the following definition, which matched the suggested definition that was submitted for consideration by AOPA and the O&P Alliance as part of their previous comments:

Leg, arm, back, and neck braces, and artificial legs, arms, and eyes, and external breast prostheses incident to mastectomy resulting from breast cancer. These services include: adjustments, repairs, and replacements required because of breakage, wear, loss, or a change in the patient’s physical condition. 

AOPA’s comments applauded the decision to include a separate definition of the term Orthotics and Prosthetics as part of the Uniform Glossary and suggested a minor change to eliminate the requirement of breast cancer as the sole cause for mastectomy in the definition of a breast prostheses.  AOPA’s suggested revision to the definition reads as follows:

Leg, arm, back, and neck braces, and artificial legs, arms, and eyes, and external breast prostheses incident to mastectomy. These services include: adjustments, repairs, and replacements required because of breakage, wear, loss, or a change in the patient’s physical condition.

AOPA and its partners, such as the O&P Alliance will continue to advocate for fair and equitable treatment of O&P providers.  The inclusion of the separate definition of the term orthotics and prosthetics in the Uniform Glossary provides additional distinction of O&P services from the universe of Durable Medical Equipment and represents a significant advancement in acknowledging the unique skill set that properly trained and educated O&P practitioners offer to patients.

AOPA’s comments may be viewed here.

Questions regarding this issue may be directed to Joe McTernan at jmcternan@aopanet.org or Devon Bernard at dbernard@aopanet.org.

Bipartisan Bill That Would Delay Bundled Payments for Joint Replacements Introduced

On Wednesday, March 23, 2106, Rep. Price (R-GA) and Rep. Scott (D-GA) introduced a bipartisan bill that would delay implementation of a Medicare bundled payment program that would pay hospitals a single payment for joint replacement surgeries and any related follow up care for a period of 90 days post-surgery.  This program, known as the Comprehensive Care for Joint Replacement (CCJR) payment model was finalized in the Federal Register on November 16, 2015 and is scheduled for implementation on April 1, 2016 — despite significant concerns about the payment model that were submitted by various medical groups and allied healthcare groups such as AOPA through the official notice and comment period.

According to Rep. Price, the bipartisan bill seeks to delay implementation of the CCJR program until January 2018.  In an interview, Rep Price stated, “at the very least, a delay in implementation is warranted to give all involved time to better assess, review, and weigh the impact and consequences of this proposal and more adequately prepare so patients are protected.”

AOPA believes a delay in implementation is warranted to allow for more analysis of the potential impact of this payment model on all parties involved, especially patients.  AOPA’s comments on the CCJR payment model may be found here.

AOPA will continue to monitor the progress of this bill and report any information on a potential delay in implementation of the CCJR payment model as it becomes available.

Questions regarding this issue may be directed to Joe McTernan at jmcternan@aopanet.org.

Proof of Delivery Requirements: AOPA’s Efforts Pay Dividends

As you may recall, last year the four Durable Medical Equipment Medicare Administrative Contractors (DME MACs) released a clarification on the type of information which must be included on a valid Proof of Delivery (POD).  The DME MACs stated that the inclusion of the official L-code descriptor, which had been the accepted norm for years, was not sufficient enough and that suppliers/providers had to include narrative descriptions and/or manufacturer information (serial number, part number, model number, manufacturer name, brand name, etc.).  As a result of this sudden shift in policy numerous providers/suppliers began to have their claims denied due to invalid PODs, which were valid prior to the DME MAC clarification.

AOPA challenged the excessive specificity of that new proof of delivery policy and the problems it posed for O&P patient care providers almost immediately and sent a letter to CMS’ Laurence Wilson, Director of Chronic Care Policy Group and Dr. Shantanu Agrawal, CMS’ Deputy Administrator and Director of Center for Program Integrity. AOPA’s letter argued that only FDA received authority from Congress to require serial numbers and other unique device identifiers, and that CMS could not enforce such a ‘de facto’ serial number requirement in the absence of explicit Congressional authority.  AOPA also took the opportunity to address the issue of the new POD requirements with the comments submitted in regard to the Draft Lower Limb Prostheses Policy released in July 2015.

All of this work has paid off, as AOPA has recently learned that CMS has reversed course and will now accept the official L-code descriptors on PODs.  Effective March 4, 2016 the Program Integrity Manual, specifically Chapter 4; Section 4.26.1- Proof of Delivery and Delivery Methods, has been updated and includes the following statement:

The long description of the HCPCS code, for example, may be used as a means to provide a detailed description of the item being delivered; though suppliers are encouraged to include as much information as necessary to adequately describe the delivered item.

You may view the official Change Request published by CMS here and the revised Program Integrity Manual here.

While the complete PIM indicates that “suppliers are encouraged to include as much information as necessary to adequately describe the delivered item,” PODs that include the complete HCPCS code descriptors can no longer be considered invalid resulting in a denial of the claim.

AOPA is very pleased to see a direct result of its communication efforts with top CMS officials regarding POD requirements and will continue to advocate for the equitable treatment of its members.

Questions? Contact Joe McTernan at jmcternan@AOPAnet.org or Devon Bernard at dbernard@AOPAnet.org.

AOPA and the O&P Alliance Meet with CMS Officials about Prosthetic LCD Workgroup

On February 26, AOPA Executive Director Thomas Fise joined other representatives of the O&P Alliance for a meeting with CMS Deputy Administrator/Chief Medical Officer, Patrick Conway, M.D., Kate Goodrich, M.D., the Director of the Center for Clinical Standards & Quality, Susan Miller, M.D. who has responsibility for the planned Prosthetic LCD-related Interagency Committee comprised of Government Employees and other CMS staff in Baltimore to discuss the Prosthetic LCD.  O&P reps were informed that the participants in the Inter-agency Committee have been identified. They are expected to generate a Consensus statement, likely to take about a year before it is complete, and that Consensus document is expected to be made available for public comment.  Dr. Miller noted that the Consensus Statement, while spawned in the wake of the 2015 Prosthetic LCD, is really not about the LCD, but about Best Practices in the care of Medicare amputee beneficiaries.  A question was raised about whether the public would be allowed the access, thus far denied, to be able to see the comments on the LCD, but it appears that that information may be made available to the Interagency Committee, but not to the public.

After inquiry, CMS reps stated that they would not be releasing the names of the persons comprising the Interagency Committee until that group’s work was complete about a year hence, and the participants may then be identified in the Consensus Statement.  While CMS officials said they would take suitable input, especially new scientific articles, that there was not means by which public/stakeholder input from non-government individuals—Medicare amputees or others– could be incorporated into the Interagency Committee work until after release of the Consensus document.

O&P reps raised questions about the lack of transparency of this proposed approach.  It was noted especially that one of the perceived difficulties with the draft LCD was that it came as a surprise without any stakeholder input, and that there was the possibility that the intended Interagency Consensus document might be perceived in the same light.  CMS officials noted that to open the process to one meant opening the process to all, which would likely necessitate shifting to a Federal Advisory Committee process, which would mean the process would take longer.

O&P reps raised the issue of the continued presence of the draft LCD on the CMS and DME MAC websites.  We were told that the draft LCD was an essential part of the record, and that it would be highly unusual for that to be removed from the website.  It was noted that since none of the thousands of submitted comments were not available to the public, it would mean that really the draft LCD would be the only document, among thousands of comments and other materials in the record that was deemed as of sufficient critical importance to be available for website viewing under CMS/DME MAC’s masthead.

The O&P reps presented data on the reduction in Medicare spending for prosthetics in each of the past four years, 2010-14, a cumulative -15% reduction, as well as Medicare’s data showing that spending on advanced prosthetic devices for Medicare beneficiaries (K3 and K4) had dropped 41.6% over that 4 year period, while the Medicare spending on the cheaper less advanced (K1-K2) technology prosthetics had increased 49.9% over that same four-year period, clear evidence of a change in the standard of care for Medicare amputees, as well as that patients who have K3/K4 technology will now face an uphill battle in securing a comparable replacement when their current device wears out. Dr. Miller said that dollars are irrelevant to the Consensus statement, while O&P reps maintained that the evidence of a downshift in Medicare prosthetic standard of care is very germane to Best Practices. O&P reps also distributed a recent article outlining that a very substantial number of amputees never receive a prescription for a prosthetic device, and that with each advancing ten years of age, the prospect that an amputee receives such a prescription drops -50%, an especially relevant point for Best Practices since Medicare beneficiaries fall into those older patient age levels least likely to receive a prescription for a prosthesis, and thereby significantly reduced access to any prosthetic care.

Time will tell, but all reports are that it will take a year or so before we get a resolution to the question of whether (a) CMS takes the policy for lower limb prosthetics away from the DME MACs and pursues instead a National Coverage Determination; or (b) they decide after the Consensus Statement, to release the matter back to the DME MACs for them to resolve as they wish via one or more LCDs.  AOPA, in its communications with legislators, has encouraged consideration both for Congressional oversight and potential clarification to assure that the HHS statutes and rules clearly allow CMS to properly manage the activities of its contractors on LCD and all other issues, as well as supporting the concept of a moratorium to assure clarity through the end of the Obama Administration and into 2017 and beyond the inauguration of the next President.