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CMS Issues Final Rule on Medicare Prior Authorization for Certain DMEPOS Including Most Lower Limb Prostheses

On December 29th, the Centers for Medicare and Medicaid Services (CMS) released the long anticipated final rule regarding Medicare prior authorization of certain DMEPOS, including most lower limb prostheses.  The final rule, which will be published in the December 30, 2015 Federal Register, will be implemented 60 days after it publication.

AOPA has reviewed the final rule, and offers the following preliminary thoughts and comments regarding the provisions of the final rule.

AOPA’s primary concern with prior authorization of prostheses is, and always has been, that it will critically delay timely access to the provision of prosthetic devices that are crucial to the rehabilitation needs of Medicare beneficiaries.  In the final rule, CMS acknowledged that proper access to medically necessary care is of the utmost importance, but indicated that it will use sub-regulatory processes to determine appropriate timelines for making prior authorization decisions.  These sub-regulatory processes are inherently arbitrary in that they do not allow for public input and or comment regarding their appropriateness.  AOPA remains concerned that prior authorization of any kind will only serve to hinder the delivery of medically necessary prosthetic care within reasonable timeframes.

Another concern that AOPA expressed in its comments on the proposed rule that was not sufficiently addressed in the final rule is that prior authorization does not equate to a guarantee of claim payment nor does it eliminate the exposure of the claim to additional audits.  While the final rule states that an affirmative prior authorization decision indicates that the required documentation for claim payment is present, it also reiterates that it is not an initial claim determination and the claim may ultimately be denied for technical reasons such as invalid proof of delivery documentation.

AOPA met with representatives from the Office of Management and Budget (OMB) in August while they were reviewing the proposed rule and registered concerns about the above issues.

The few seeming new wrinkles in the final rule is that implementation will not be immediate and universal, but there will be a Master List of 135 HCPCS codes eligible for inclusion in prior authorization.  It appears there will a phase-in process, meaning not all 135 codes will be subject to prior authorization immediately.  Rather, the final rule indicates that CMS will establish a subset of the master list that will determine which HCPCS codes require prior authorization as part of the initial implementation of the final rule.  While the master list includes lower limb prosthetic HCPCS codes that meet or exceed the $1,000 threshold, it remains to be seen which codes will be included in the initial list of codes that will be subject to prior authorization.

While the current list does not include any orthotic codes, AOPA remains concerned that future updates to the master list may include orthotic codes that meet the criteria for inclusion in prior authorization.

At first glance, the final rule does not recognize two key facts from Medicare’s own data:

  1. There is not a problem of unnecessary utilization of lower limb prosthetics, and the -14% reduction in prosthetics payments over the 2010-13 period proves that;
  2. Today, Medicare prosthetic patients are 35% LESS LIKELY to receive an advanced tech prosthetic device than they were just 5 years ago (2005-2009).

In addition, the final rule acknowledges AOPA’s concern regarding the need for a more timely response to prior authorization requests but elects to define these timeframes through sub regulatory processes that do not allow for public comment or input.

While AOPA will review the final rule more closely in the coming days, After its preliminary review,  AOPA believes that the final rule fails to address AOPA’s concerns regarding the implementation of a prior authorization program that:

  1. Does not appear to constitute a guarantee of payment; and
  2. Retains the payment threshold of $1,000 for inclusion in prior authorization
  3. Does not assure that providers would not be subject to post-payment/RAC audits on the very same issue of medical necessity; and
  4. Uses sub-regulatory processes to define appropriate timeframes for response to prior authorization requests; and
  5. Exceeds its authority to initiate a limited pilot on prior authorization, done only in selected areas (as was done with power mobility devices) to a national policy impacting all amputee beneficiaries nationwide.

AOPA will provide additional analysis of the final rule as it becomes available. Read the final rule.

Congress Close to a Deal on Funding of the Federal Government; Modest Potential Impact on O&P and Suspension of Medical Device Excise Tax for Non-O&P in Play

On Wednesday, December 16th, President Obama signed a short term spending measure that will allow the Federal government to continue to operate until December 22, allowing Congress to finalize its long anticipated Omnibus appropriations and tax break extender legislation that will fund the Federal government for the remainder of the 2016 fiscal year.  Two important provisions of this legislation that are of significance to O&P are the limitation of Medicaid reimbursement rates for Durable Medical Equipment to current Medicare rates and a 2 year moratorium of the 2.3% medical device excise tax.

The provisions that would limit Medicaid reimbursement for DME to current Medicare rates may result in significant reductions in Medicaid payments for DME due to significant reductions in Medicare payments as a result of competitive bidding.   This provision would not have an immediate impact on O&P services since they are not currently included in current competitive bidding programs,  If CMS eventually acts to exercise its sole competitive bidding authority as to O&P , i.e. if CMS were to incorporate off the shelf (OTS) orthoses into future competitive bidding programs, it would like result also  in a significant impact reducing also Medicaid payments for this limited category of OTS (only) orthotic devicesin the future.

The second provision would create a 2 year moratorium of the 2.3% medical device excise tax, a tax that AOPA has opposed since its inception.  While this would be good news for the DMEPOS industry in general,  it is important for AOPA members to recognize three facts relative to the pending deliberations on the omnibus bill, and the provision calling for a two-year moratorium of the 2.3% medical device excise tax:

  1. AOPA’s efforts with the Department of Treasury and the IRS secured a decision in 2012 that recognized, from the very inception of the medical device excise tax, that O&P devices are, and remain exempt from the tax at both the manufacturer and patient care facility levels.
  2. Nonetheless, AOPA has consistently advocated the complete elimination/repeal of the medical device excise tax as it is an unnecessary burden on all medical device companies, and thereby, upon all of American health care.
  3. Whether or not the pending omnibus spending bill is actually enacted in its current form and results in a two-year moratorium of the medical device excise tax or not, the long-standing, permanent exemption secured for O&P in 2012 remains fully in force and applicable without change.  The O&P exemption is completely distinct and independent of the current discussions on suspending the 2.3% tax that has been applicable to virtually all others selling medical devices.

AOPA will continue to monitor the status of the pending omnibus bill as it moves closer to passage, presumably next week.

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

AOPA Announces Mobility Saves Contest Winners

WASHINGTON, D.C. – The American Orthotic & Prosthetic Association (AOPA) has announced the winners of the Mobility Saves Testimonial Contest. Jeff Lewis of Mesa, AZ won the grand prize of $500 for his video describing his active life as a quadruple amputee, including bowling, dancing, and golfing. On the independence he achieves with the help of prosthetics, Jeff said “Certainly I have some restrictions, but I am not going to let the things I can’t do get in the way of the things I can.”

Ruth Frieboes of North Powder, OR submitted footage of her adventures zip lining, hiking, and enjoying the beach after becoming an above knee amputee in her mid-50s, inspiring her students and grandchildren to overcome their own obstacles. She won the 2nd place prize of $250. She said, “I wanted to get back into my life as I approached retirement. My dreams and goals would never have happened without a good prosthetic.”

The nationwide contest was open to all users of orthotic and prosthetic devices. The winning testimonials will be used as part of the Mobility Saves campaign. The primary objective of the Mobility Saves campaign is to spread the news that orthotic and prosthetic care saves lives and money, by promoting research on the cost effectiveness of O&P, and showing patients whose lives are improved with modern technology.

View the videos and learn more at www.MobilitySaves.org.

PDAC Announces Coding Verification Review for Ankle Gauntlets

The Pricing, Data Analysis and Coding contractor (PDAC) has announced that due to a change in the 2016 descriptor verbiage for L1902 and L1904, it will initiate a new coding verification for any ankle gauntlet style devices that contain joints that are currently listed on the PDAC site under L2999. Read the announcement.

It is important to note that PDAC coding verification for products described by L1902 and L1904 is not mandatory under current Medicare policy guidelines.  The coding verification review only applies to products that have been voluntarily submitted to the PDAC for coding verification in the past, and only applies to ankle gauntlet style devices that contain joints and were previously verified as L2999 through the PDAC coding verification process.  Ankle gauntlet style devices that do not contain joints and have been voluntarily submitted and verified by PDAC as coded as L1902 or L1904 in the past  should not be affected.

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