Update on LCD Policy – What is AOPA Doing?

August 18, 2015

Dear AOPA Member,

Everyone throughout the orthotics and prosthetics world has pulled together and gone “all in” on the effort to fight back the DME MAC proposed revisions to the Local Coverage Determination (LCD) for Lower Limb Prosthetics, and hopefully restore some sanity to delivery of prosthetic limbs to Medicare amputee beneficiaries in the future. We are more than halfway through the short 45 day comment period which ends August 31. The meeting where the DME MACs will hear from interested stakeholders is August 26^th — eight days from now. We owe every AOPA member a report, in summary form, of the things we have been doing, and will be doing in the coming days.

Your One-Pager…The Low-Down on the Dozen Essentials You Shouldn’t Miss

AOPA has activated communications to members, and placed explanatory content on both the AOPA website for members and on the Mobility Saves website for patients– we had recorded about 1,175 O&P/AOPA members comment letters, as well as 2,075 patient comment letters.
NAAOP President (and AOPA Board Member) Dave McGill has initiated and provided excellent promotion for a “We the People” petition to the White House which achieved its 100,000 mark this past weekend reaching 102,770.
AOPA is partnering with the Amputee Coalition on Postcards that have been distributed to O&P facilities for distribution to patients.
AOPA has registered at least 4 participants, including AOPA President Charlie Dankmeyer, and AOPA Member Tom Watson, to appear and provide statements at the DME MAC meeting in Linthicum, Maryland on August 26 from 8-12 noon.
AOPA has activated plans to hold an amputee patient demonstration at the HHS building in DC on August 26 from 2 to 5 pm—know an amputee who would like to attend? Email landerson@aopanet.org for details.
AOPA has initiated PR efforts focusing on The “Glass Ceiling of Prosthetics” concept, and is being transformed into (i) broadcast and print ads to run in the DC area August 23-26 and (ii) placement on the Mobility Saves website. Print advertising is slated over the next 3 weeks, and TV broadcast advertising, starting with two messages that will appear in the Washington DC market on ABC’s Sunday morning News programs, “This Week with George Stephanopoulus,” on August 23, and continuing with morning programs all week on CNN, Fox News, CSNBC and other media outlets.
AOPA has worked on challenging the absence of scientific/medical/literature support for the LCD, having generated a request to the DME MACs for such information in light of its absence from the proposal.
AOPA has generated a series of true to life Patient Vignettes in cooperation with the Amputee Coalition that capture the very specific impact of the proposed LCDs on patient care.
AOPA, in consultation with former CMS Administrator, Tom Scully and other AOPA lobbyists scheduled one and possibly more meetings with CMS officials to discuss the LCDs. The first meeting took place on August 11 with Sean Cavanaugh, the Deputy Director of CMS.
Input from physicians–three past presidents of the American Academy of Orthopedic Surgeons, plus communications from a President of the Association of Bone & Joint Surgeons, the American Orthopaedic Foot and Ankle Society, and the International Federation of Foot and Ankle Societies. A draft letter is in the works from a couple of Past Presidents of the American Academy of Physical Medicine and Rehabilitation, and the American Medical Rehabilitation Providers Association has started its own sign-on letter.
AOPA Analysis of Data Since 2010 Shows Steady Decline in Medicare Prosthetics Payments–OIG Report has dictated CMS and contractors behaviors for the past five years. Medicare’s determination to squelch that progression as ‘fraudulent (in some unknown way)’ pushed the number of all types of K3s down, resulting in an increase in K2s AND reduction in the total dollars Medicare spends on prosthetics each of the past 4 years. CMS and the DME MACs have succeeded in practicing medicine and changing the prevailing standard of amputee care for the worse. You’ll want to take a look at this, which demonstrates that data shows no reason for the LCD. Medicare prosthetic costs DOWN 13.8% in past 4 years.
If you go to the mobilitysaves.org home page, you’ll find: (a) list of amputee talking points; and (b) you’ll be able to link to the remarkable letter authored by former U.S. Senator Bob Kerrey. (website update in progress)

A. Things AOPA has done…

The pace of activities regarding the LCD proposal has been incredible, and this is a very brief summary of how we are doing in implementing the AOPA Action Plan that was approved by the AOPA Board less than a month ago, on July 21. Attached are a fair number of items to help you get the larger picture and we will give a sentence or two synopsis.

The AOPA Coding and Reimbursement Committee met on August 3 and provided great assistance in framing both AOPA’s comments as well as those of the O&P Alliance.
AOPA has prepared and circulated an extensive summary of the proposal, along with an Executive Summary.
AOPA has activated communications to members, and placed explanatory content on both the AOPA website for members and on the Mobility Saves website for patients. The sites contain links to AOPAVotes.org where folks can generate comment letters to the DME MACs on the proposed revisions. As of yesterday, we had recorded about 1,175 O&P/AOPA members comment letters, as well as 2,075 patient comment letters. Every comment letter goes not just to the DME MACs, but also to the writer’s two Senators and their one Representative.
AOPA has drafted Physician Talking Points.
AOPA has participated in outreach to Congress, including joining in the O& P Alliance letter to CMS Administrator Andy Slavitt, consulting with offices of Reps. Duckworth and Guthrie and prepared a draft letter from Rep. Guthrie to HHS Secretary Burwell, and worked with Hanger attorney former Rep. Scott Klug on a proposed letter for the Chairs of three Congressional Committees to consider forwarding to Mr. Slavitt seeking rescission of the policy. Contacts with a dozen proven O&P Congressional champions are proceeding to urge them to communicate directly to the HHS Secretary and to participate in press on the LCD. More such contacts will continue even though the timing for this LCD action has managed to occur over the period of Congress’ summer recess. They are out until after Labor Day, a week past the August 31 deadline for comments on the proposed LCD.
The O&P Alliance has held 7 meetings (another set for tomorrow) to work on Comments for the Alliance.
NAAOP President (and AOPA Board Member) Dave McGill has initiated and provided excellent promotion for a “We the People” petition to the White House with objective of securing 100,000 signatures challenging the LCD by August 31. The petition achieved its 100,000 mark this past weekend reaching 102,770. The White House promises response to any petition which includes 100,000 signatures.
AOPA has convened the Prosthetics 2020 Physician Medical Advisory Board (August 3) and several contacts for follow-up action have been initiated.
AOPA is partnering with the Amputee Coalition on postcards that have been distributed to O&P facilities for distribution to patients.
AOPA has registered at least 4 participants, including AOPA President Charlie Dankmeyer, and AOPA Member Tom Watson, to appear and provide statements at the DME MAC meeting in Linthicum, Maryland on August 26 from 8-12 noon.
AOPA has activated plans, and received necessary permit to hold an amputee patient demonstration at the HHS building on August 26 from 2 to 5 pm. We are expecting 100 amputees as well as a substantial number of non-amputee participants.
AOPA has initiated PR efforts.
The “Glass Ceiling of Prosthetics” concept is being transformed into (i) broadcast and print ads to run in the DC area August 23-26 and (ii) placement on the Mobility Saves website;
PR promotion of both a press advisory session sometime before August 23, as well as promotion of the Patient Demonstration on August 26 at HHS.
AOPA has worked on challenging the absence of scientific/medical/literature support for the LCD, having generated a request to the DME MACs for such information in light of its absence from the proposal. This resulted in a response from the MACs pointing to a 31 item bibliography which was woefully weak in providing any scientific evidence to support the proposed changes. Some of the authors cited in the bibliography acknowledge their work cited by the DME MACs does not provide any support for proposed changes.
AOPA staff, with strong assistance from members of the AOPA Executive Committee, has generated a series of true to life Patient Vignettes in cooperation with the Amputee Coalition that capture the very specific impact of the proposed LCDs on patient care, eligibility for advanced prosthetics and overall patient welfare.
AOPA, in consultation with former CMS Administrator, Tom Scully and other AOPA lobbyists scheduled one and possibly more meetings with CMS officials to discuss the LCDs. The first meeting took place on August 11 with Sean Cavanaugh, the Deputy Director of CMS with responsibility for the Medicare program. Efforts continue to arrange a meeting with both the CCSQ, as well as with CMS Acting Administrator Andrew Slavitt.

B. Where we stand right now?

I’m pleased to report that 2,075 patients and 1,175 practitioners and other O&P professionals have used the AOPAVotes mechanism to generate letters for inclusion in the official record for the LCD rulemaking.

Input from physicians and patients is probably going to count more than input from O&P professionals. So, additionally, we have, with strong assistance from AOPA Board member Don Shurr, a group letter from three past presidents of the American Academy of Orthopedic Surgeons, plus communications from a President of the Association of Bone & Joint Surgeons, the American Orthopaedic Foot and Ankle Society, and the International Federation of Foot and Ankle Societies. A draft letter is in the works from a couple of Past Presidents of the American Academy of Physical Medicine and Rehabilitation, and the American Medical Rehabilitation Providers Association has started its own sign-on letter. Suffice it to say we are gaining some traction!

Data is always king in payment related discussions, and AOPA has spent some time and money to capture the current state of Medicare payments for prosthetics.

You’ll want to take a look at this, which demonstrates that data shows no reason for the LCD. Medicare prosthetic costs DOWN 13.8% in past 4 years.

What does this information mean and how does it interact with the proposed LCD?

Data Since 2010 Shows Steady Decline in Prosthetics–OIG Report has dictated CMS and contractors behaviors for the past five years. The data in that report was used to reach an errant conclusion. Moreover, CMS is locked into that 5-year old data—if the agency looked at its own data it would see that the 2015 picture is the exact opposite of the 2010 data.

What we have in terms of data is an over-reaction to where things were between 2005-10. In that period the number of Medicare beneficiaries was flat, but costs rose because more amputees were getting their first crack at recently available new technologies–MPKs, energy-storing feet–that triggered higher per capita cost but delivered better results in terms of amputee mobility and independence. Medicare’s determination to squelch that progression as ‘fraudulent (in some unknown way)’ pushed the number of all types of K3s down, resulting in an increase in K2s AND reduction in the total dollars Medicare spends on prosthetics each of the past 4 years.

CMS and the DME MACs have succeeded in practicing medicine and changing the prevailing standard of amputee care for the worse, and they have missed the last four years of data and don’t know that 2005-10 data is outdated and is really no longer relevant.

One of the topics raised in the DME MAC proposal related to their wanting to institutionalize the Proof of Delivery requirements that have vexed O&P providers since February. AOPA’s research indicates that these requirements are inappropriate since it is FDA, not CMS, that has been given the authority by Congress to prescribe what appears in medical device labeling. So, we have provided a request to CMS challenging the entire Proof of Delivery rule.

AOPA Meets with Deputy Administrator of CMS Regarding the Proposed LCD for Lower Limb Prosthetics:

On Tuesday afternoon, August 11, AOPA had a meeting with the Deputy Director of CMS, Sean Cavanaugh, to discuss the DME MACs LCD Lower Extremity Prosthetics Policy Article published July 16, 2015. The AOPA delegation included: Charlie Dankmeyer, CPO, Dr. Paul Pasquina (AOPA Prosthetics 2020 Medical Advisory Board Member), Sam Liang (Hanger Clinics), Brad Ruhl (Ottobock), Michael Park (Alston & Bird), Peter Thomas (Powers Pyles), and AOPA Executive Director Thomas Fise.

This meeting was to the best of our knowledge the first opportunity for anyone from the O&P community to alert and present our serious concerns about the LCD to the top leadership at CMS.

We started by asserting our patient-centric objective and outlined the fact that this errant policy could potentially impact ALL 2 million amputees in America (as private payers follow Medicare’s lead) and their roughly 10 million services per year, reverting amputees to the standard of care and limb technology of the 1970s. We informed Mr. Cavanaugh that if enacted this policy would dramatically and adversely impact patient standards of care.

We challenged the dearth of scientific support for the policy, and provided an overview of the prevailing CMS/DME MAC perception driven by the 2011 OIG report that showed substantial increases in dollars expended for prosthetics from 2005-10. During this same period we experienced a quantum leap into the advanced technologies spawned by Iraq/Afghanistan. CMS interpreted the OIG report as suggestive of fraudulent activity which in turn triggered the massive audits. Starting with 2010-13 the converse picture is clear from Medicare data—incremental DECREASES in total Medicare payment for prosthetics every year, and an even steeper downward slope each year in payments for K3 technologies, accompanied by a steady increase in payments for K1 and K2 technologies.

We explained to Mr. Cavanaugh that the behavior of CMS officials and their contractors tells us that they are still living the 2005-10 data and seem to be behind in recognizing that the entire trend line from Medicare’s own data shows a 180 degree reversal of direction. We concluded by reiterating the O&P Alliance request for rescission of this policy and we pledged to work in earnest with CMS, the DME MACs and other stakeholders around a new direction, starting with a proposed demonstration project through the CMS Center for Innovation that would update coding, that would be evidence-based, benefit patients and be value-based– all of the things that this proposal is not. Dr. Pasquina completed the session with a comprehensive overview of improvements in patient care over the past 10-15 years, and a plea not to allow this progress to be further reversed by a misguided new policy.

Mr. Cavanaugh appeared to understand the points we made. He recommended we also meet with the CMS Office of Clinical Standards and Quality, a suggestion we had expected and plan to pursue as this group also has a key role on these issues. He offered that we should feel free to come back to him as needed. It was a good start to a dialogue that must continue toward putting aside this proposed LCD revision and moving forward with a sounder approach to any updating of the LCD on lower extremity prosthetics.

What does the LCD proposal mean for patients? If you go to the www.mobilitysaves.org home page, you’ll find two things. There is a list of amputee talking points that highlight the real world terrible impact this proposal, if enacted, would have in denying Medicare amputee beneficiaries access to the higher quality prosthetic devices and care. Secondly, you’ll be able to link to the remarkable letter authored by former U.S. Senator Bob Kerrey. Can just one letter make a difference?

Yes, it certainly can. Recently, former U.S. Senator, and former Nebraska Governor Bob Kerrey, and a lower limb amputee, contacted NAAOP to say he had heard about the DME MAC LCD proposal, and how it would limit availability of advanced technology prosthetics to Medicare amputee beneficiaries. Read the letter he wrote to HHS Secretary Burwell to explain just how detrimental implementation would be for himself and other amputees! And then send a letter yourself and assure that your voice will be heard.

C. What Will Happen in the Next Week?

AOPA has a full-fledged PR effort underway which will start with a press release to all health media within the next couple of days, and culminating with the Teleconference Press Conference to be held next Tuesday, August 25, the day before two big events—the DME MAC open meeting in Linthicum, Maryland in the morning on August 26, and the Amputee Demonstration which AOPA is sponsoring in front of the HHS/Medicare headquarters at 200 Independence Avenue, SW from 2- 5 pm on the afternoon of 8/26.

Starting this weekend, AOPA will begin an advertising campaign around the LCD issue to appear primarily in the Washington DC area. There will be print advertising over the next 3 weeks, and TV broadcast advertising, starting with two messages that will appear in the Washington DC market on ABC’s Sunday morning News programs, “This Week with George Stephanopoulus,” on August 23, and continuing with morning programs all week on CNN, Fox News, CSNBC and other media outlets.
As noted above, Wednesday, August 26 will be a big day. A large group of people will appear at the DME MAC open meeting in Linthicum—AOPA President Charlie Dankmeyer, Past President Tom Watson, Executive Director Tom Fise and Boston Marathon Survivor Adrianne Haslet-Davis are among the many who have requested the opportunity to speak at that open forum. In the afternoon, we expect well over 100 amputees to converge at the HHS/Medicare headquarters building at the base of Capitol Hill. All amputees are welcome—we plan to carry signs, speak with press, and some legislators who are national champions for amputee patients have been invited to stop by to pass on some words of encouragement!
August 31 is the official deadline to submit your comments. You can go to AOPAvotes.org to send a standard letter which will only take a minute or two, and/or you can write your own letter.