News

Marine Vet, Quadruple Amputee, gets Double Arm Transplant

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A Marine veteran who lost all four limbs after stepping on an explosive device in Afghanistan in 2010 is celebrating after successfully undergoing surgery for a double arm transplant.

John Peck, 31, underwent a 14-hour transplant surgery in August. His body rejected the transplant for the first few weeks, but the immune response was managed with medication. He will undergo weeks to months of physical therapy to encourage the nerves to grow and keep the muscles from withering. Sensation in the transplanted arms may take months to develop, as the nerves grow.

“My dream job since I was 12 is to become a chef,” he told reporters, and hopes to have a shot at his dream career with his new arms.

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White House Design For All Showcase

White House Fashion Show celebrates inclusive design, assistive technology, and prostheses. #DesignForAll

See a video of the fashion show, provided by the White House, as well as a recording of the closing remarks by Alison Cernich, Director of NICHD National Center for Medical Rehabilitation Research, below.

Alison Cernich discussed an ambitious research plan mapped by 17 institutes and centers at the National Institutes of Health during her closing statement at the White House Design for All Showcase.

See the full Design for All Fashion Show below.

Update on the Youngest Hand Transplant Patient

Congress Being Urged by Some in “Big Medicine” and CMS, to Downgrade or Eliminate Stark Laws/Rules That Preclude Self-Referral

Earlier this year, Medicare implemented a new policy on Comprehensive Care of Joint Replacement.  While positioned as a pilot test, all hospitals were forced to be involved.  Under this new program, hospitals are given financial incentives to reduce the total cost for hip and knee replacements.  If hospitals succeed in driving down the total costs, the hospitals keep a portion of the savings. If the hospitals fail to drive down the total costs, the hospitals will have to pay a portion of the tab.  If you are a Medicare patient, do you think this means you will receive the best quality of care or the cheapest?  If you said “cheapest”, keep reading to find out how Stark Rules could protect you from these “risk-sharing” deals.

The Stark Rules, also known as the Stark Laws, were created to help control conflicts of interest in medical care.  For example, they limit certain aspects of physician ownership of facilities to which physicians refer patients, including those facilities that provide blood tests and X-rays. In addition, they restrict other actions which could compromise the fundamental principle that patients can always look to their health care providers, first and foremost, to advocate for what is best for them as patients – not what makes them the most money.

As CMS/Medicare and other payers try to move aggressively toward “valued-based purchasing” and provider risk-sharing, CMS, private payers, and hospitals—all of whom stand to profit if others, namely providers, can be enticed to shoulder some of the risk and uncertainty that goes along with risk sharing—have found the Stark rules inconvenient and have beseeched their friends in Congress to do away with or, at least, substantially reduce the ‘teeth’ in the Stark Rules’ prohibitions on provider conflict of interest.  It is a game of big medicine vs. the little guys—patients and providers.  What we talk about as risk sharing today is very similar to what we used to call capitation, managed care, or HMOs.  If you think those things made things better for patients, then sure, do away with the Stark Rules and allow the system to create deals that operate to incentivize reductions in care to patients.

There is one aspect of how CMS has interpreted the Stark Rules that has proven particularly controversial, that being the in-office ancillary services (IOAS) exception, which among a number of other instances where it has permitted a measure of physician self-referral that the Stark Rules would NOT permit, this IOAS exemption granted by CMS has been used by some physicians to themselves deliver and bill to patients for prosthetics and/or orthotic devices supplies within the physician’s office or a related physically adjacent facility.  While AOPA and others oppose these broad interpretations of the in-office ancillary services exemption, it is important to recognize that eliminating the Stark Rules would open the door to even wider, essentially unlimited self-referral by hospitals, rehab facilities, as well as physician offices.  If you oppose the exemption CMS has granted in the in office ancillary services exemption, you very likely favor the underlying broad prohibition on self-referral (by physicians and other providers) that is embodied in the Stark Rules.  The bottom line, after all, is assuring the highest possible level and quality of patient care for prosthetic and orthotics patients.

However, if the Stark Rules are eliminated, Payers could set mechanisms to award all the business to the lowest bidder…again, patient beware.  Keep your eyes open, and let your voices be heard—with Congress, with your state legislators and others—it’s important!

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The VA has Changed Reimbursement Rules for Prosthetics

The Department of Veterans Affairs has unilaterally decided to assign reimbursement amounts to prosthetic feet that are not consistent with the Center for Medicare Services. As a result of their action, veterans do not have the same access to certain prosthetic feet that those with Medicare, Medicaid, and private insurance receive.

Read the letter from five Congressional members to the Secretary of the VA.

Take action now! Take a few minutes to send a prewritten letter to your representatives in Congress.

Veterans – use this letter.

Practitioners – use this letter.

Anyone else can click on one of the links above and customize the letter to your own circumstances.

 

 

2016 Draft LCD Updates

The July 2015 LCD Draft proposal that would have limited access to prosthetic care for Medicare patients generated a flurry of activity by organizations serving the prosthetic community, patients, and other advocates. The LCD was not enacted but CMS began the process of  convening a workgroup of clinicians, researchers, and policy specialists to develop a consensus statement. The effects of the LCD have already been felt in the private sector, as several insurers removed coverage for vacuum pumps (as in the LCD) following the proposal. For this reason, an official rescission of the LCD remains a high priority for the O&P community.

In June 2016, as a result of the series of actions taken by the American Orthotic & Prosthetic Association (AOPA), important language 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.”

One of the events leading to this inclusion in the report was a series of meetings between Prosthetist Tom Watson and Sen. Majority Leader Mitch McConnell. Read the letter sent from Sen. McConnell to CMS’ Acting Director Andy Slavitt.

On April 21, 2016, AOPA held a press conference call to discuss the impact that CMS’ proposed Lower Limb LCD is having in the private sector. Media participants heard from AOPA President Elect Michael Oros, CPO, FAAOP and two amputees who have been affected by the new policies. Listen to the audio from the call and the press release summarizing the call.

On April 25, Rep. Renee Ellmers (R-NC) and Rep. Jan Schakowsky (D-IL) introduced H.R. 5045, a bill that would establish a moratorium on any action on the LCD through Spring 2017 and remove the withdrawn LCD from the CMS and DME MAC websites and establishing that, contrary to some legal interpretations at HHS, CMS indeed can, and is obliged to manage and instruct its contractors what to do across topics including LCD issues.

The next day, the first fruits of a months-long effort spearheaded by AOPA appeared as the House Oversight and Government Reform Committee released a letter it has initiated to HHS Secretary Sylvia Mathews Burwell, criticizing the prosthetic LCD efforts of CMS and its contractors, and launching an oversight inquiry with a request for a substantial collection of documents.
We will keep everyone updated on any further developments.

Prosthetist Speaks to United Nations, Highlighting Value and Potential of 3-D Printing Technology in Third World Environments Where Access to Traditional Components is Limited, and in Mass Injuries

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Jeff Erenstone, CPO

Jeff Erenstone, CPO, President of Create Prosthetics and member of the eNABLE Advisory Boards, addressed the United Nations, during a panel headed by the UN ambassador of Iraq and sponsored by UN Mine Action Service (UNMAS) about the value and potential of 3D printed prosthetics in Third World Environments and conflict zones.  He discussed the evolution of 3D printed prosthetics from “over hyped” plastic toys to devices that, when properly constructed in accordance with all FDA regulatory controls may be considered medical grade.  He shared his experience with recent efforts in Haiti and how his team focused on educating the local prosthetists on this technology and giving them the control over deciding if a 3D printed device is appropriate or to stick with a more conventional device.

Part of his address included one of the great benefits of 3D printed devices – that the components can be fabricated on-site.  This is especially valuable in conflict zones where shipping supplies is especially difficult. He plans continue to talk with UNMAS about their efforts to deploy relatively low cost 3D printed devices in Iraq and Syria.
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Other panelists included the Ambassador of Iraq, who spoke about the great need for long term care of IED victims in north Iraq.  The UNMAS representative supported the information provided by the Ambassador and explained the actions that UNMAS are taking to deal with this area and other areas around the map.  Ned Norton of the Hercules Project also addressed the UN, as he has been working to supply people in conflict zones physical therapy free to people with disabilities.

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Cutting Edge Lower Limb Prosthetics

Touching Video of Girl Receiving Doll with Matching Prosthetic Leg

Update on CMS’ Lower Limb Prosthetics Policy

The July 16, 2015 Local Coverage Determination (LCD) Lower Limb Prostheses policy that was proposed would have reverted patient care to a 1970’s standard. O&P organizations and patients joined to object to the policy, in the form of a White House petition, comments submitted to CMS, testimony at the hearing, letters from researchers whose work was cited, a rally in front of the HHS headquarters, meetings with CMS, etc. (Read all the actions taken.)

The policy was not enacted but it has not been removed from the website of CMS and its contractors, so O&P advocates have continued to voice their objections. On April 28, after efforts from the American Orthotic & Prosthetic Association, the House Oversight and Government Reform Committee released a letter to HHS Secretary Sylvia Mathews Burwell, criticizing the prosthetic LCD efforts of CMS and its contractors, and launching an oversight inquiry with a request for a substantial collection of documents. We will post updates of progress.

On April 26-27, O&P professionals, students, and patients visited Capitol Hill to meet with legislators to advocate for fair treatment of O&P providers and patients. One clinician met with Senate Majority Leader, Mitch McConnell (R-KY), who then authorized a letter to CMS Acting Administrator, Andy Slavitt regarding the 2015 LCD Policy, its status, and the workgroup that has been assembled to evaluate CMS’ O&P policy. Read the letter from Sen. McConnell to Andy Slavitt. AOPA will post any further correspondence.

 

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