Year: 2016

The Agency for Healthcare Research and Quality (AHRQ), the “government agency tasked with producing evidence to improve the quality of healthcare while working with partners to ensure that the evidence is understood and used” recently announced that it will be initiating a systematic review for lower limb prostheses.  The systematic review will be performed through the Evidence Based Practice Center Program of the AHRQ and the stated purpose of the systematic review is “to examine the available clinical evidence that defines practices in the care of beneficiaries who require lower limb prostheses (LLP).”

While the announcement does not tie the systematic review to the work of the inter-agency taskforce assigned to review the delayed draft Local Coverage Determination (LCD) that was released by the DME MACs in the summer of 2015, it is clear that the initiation of the systematic review for lower limb prostheses is directly related to the work of this taskforce.

AOPA will be requesting a meeting with representatives of the AHRQ in order to discuss existing systematic reviews for lower limb prostheses that have recently been completed through AOPA funding as well as the previous and current cost effectiveness studies that have been developed by Dobson DaVanzo.  In addition, AOPA will discuss the ongoing work of the RAND Corporation to determine the cost effectiveness of prosthetic intervention.

AOPA will continue to inform its membership of any developments in the status of the AHRQ initiated systematic review.

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

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 discusses 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.

Design for All Showcase

AOPA has submitted comments on the publication entitled Technical Considerations for Additive Manufactured Devices: Draft Guidance for Industry and Food and Drug Administration Staff which was published in the Federal Register on May 10, 2016.

AOPA submitted comments pertaining to additive manufacturing in the design and fabrication of external prosthetic components and orthotic devices, specifically through the use of 3-D printing. The comments submitted reflect that AOPA does not believe that either additional or lesser regulatory burdens should be placed on manufacturers of prosthetic components and orthotic devices solely based on the decision to utilize an additive manufacturing process into their fabrication protocols.

An excerpt of the comments:

“AOPA firmly believes that the manufacture of a prosthetic component or orthotic device is only a small part of the creation of an artificial limb or orthoses that meets the individual needs of a particular patient. The components that are included in the completed prosthesis or orthosis must be adjusted, and aligned by a properly educated, trained, and certified or licensed healthcare professional such as an orthotist or prosthetist. 

AOPA fully supports the role of the FDA in ensuring that medical devices, including prosthetic and orthotic devices remain safe and effective, but believes the current direction of the FDA, as outlined in the draft guidance document, to not alter regulatory requirements solely as a result of the use of additive manufacturing is appropriate…. (FDA’s stated position) will encourage the development of technology while assuring that devices created through additive manufacturing remain safe and effective for use by the general public, and maintaining consistency and a level regulatory playing field for the devices without regard to the specific method of fabrication employed by the manufacturer.”

Read the comments submitted.

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!

The Centers for Medicare and Medicaid Services have notified the four existing RAC contractors that as a result of the upcoming award of new RAC contracts, current RAC audit activity will be placed on hiatus to allow the RACs to complete their open audits prior to the completion of their contracts.  CMS has provided the following dates to the RAC contractors regarding current audits.

• May 16, 2016 – the last day that a Recovery Auditor could send Additional Documentation Request (ADR) letters or semi-automated notification letters.
• July 29, 2016 – the last day that a Recovery Auditor may send notification of an improper payment to providers. This includes sending a review results letter or no findings letter, and/or providing a portal notification to each provider.
• August 28, 2016 – Recovery Auditors will complete all discussion periods that are in process by this date. Recovery Auditors continue to be required to hold claims for 30 days, starting with the date of the improper payment notification (via letter or portal) to the provider, to allow for discussion period requests.
• October 1, 2016 – the last day a Recovery Auditor may send claim adjustment files to the MACs.

While this is good news for O&P providers in the short term, it is not a signal that the RACs are going away any time soon.  It is simply a pause to allow for a smooth transition to new RAC contractors, including the single, national RAC contractor that will focus on claims for DMEPOS, Home Health, and Hospice services.  While this announcement may result in a temporary slowdown of RAC activity, it is important to remember that claims that are submitted today may be selected for audit by RAC contractors in the future.