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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.

2016 Medicare DMEPOS Fee Schedule Released

On November 23, 2015, the Centers for Medicare and Medicaid Services (CMS) released the 2016 Medicare DMEPOS fee schedule. As expected, Medicare fees for orthotic and prosthetic devices will be slightly lower in 2016 than they were in 2015.

The annual update to the Medicare O&P fee schedule is based on a combination of the increase in the Consumer Pricing Index for urban areas (CPI-U) from June to June of the previous year, and the annual Mutli-factor Productivity Adjustment. The CPI-U increased by a total of 0.1% from June 2014 to June 2015 and the 2016 Productivity Adjustment was calculated as -0.5%. The combination of these two factors will result in an overall decrease of 0.4% in the 2016 Medicare O&P fee schedule.

While a decrease in the fee schedule is not unprecedented, the 2016 decrease is the first one since 2011, when the Productivity Adjustment was first introduced as a result of the passage of the Patient Protection and Affordable Care Act (ACA) in 2010.

AOPA members are reminded that in addition to the 0.4% decrease in the 2016 O&P fee schedule, sequestration remains in effect for Medicare claims. Sequestration will result in a 2% reduction in Medicare reimbursement but as this reduction is not cumulative year over year, it should not be reflected in the net decrease in the 2016 fee schedule.

RAC Contractors Have Been Authorized to Re-Start Audit Activity

It has been remarkably quiet on the Recovery Audit Contractor (RAC) front for the last 18 months or so. As a result of the original RAC contracts coming to an end and new RAC contract proposals being submitted and reviewed, the number of additional documentation requests (ADRs) has been reduced significantly. CMS advised its original RAC contractors to essentially hold off on issuing new ADRs until new contracts were finalized and implemented. One of these new contracts would establish a single, national RAC contractor who would be responsible for RAC audits on all Medicare DMEPOS, Home Health, and Hospice claims. This contract was initially awarded to Connolly Healthcare who currently serves as the Jurisdiction C RAC contractor for all Medicare claims.  While the contract award was issued in December 2014, a subsequent protest of the award initially delayed its implementation and eventually led to a CMS decision to issue new bids for all of the RAC contracts, including the national contract for DMEPOS, Home Health, and Hospice claims.

On November 16, 2015, CMS announced that while new bids for RAC contracts are being accepted and reviewed, the existing four RACs may continue to perform RAC reviews and may begin to issue additional ADR requests.  This signals an effective end to the moratorium that was placed on new RAC activity in February of 2014.  While it may take a few weeks for the current RACs to put in place the resources to re-start full scale activities, there is no reason to expect that they will not do so as soon as possible.

While this announcement is not an encouraging development, RAC audits are not new to the O&P community and hopefully we have learned some lessons from previous experiences with RAC auditors.  When RAC audits began several years ago, O&P providers faced a new reality as far as what documentation was expected in order for claims to be paid and stay paid.  Hopefully this education has not been forgotten as a result of the slowdown in RAC audits and the impact of the RACs becoming more active will be significantly lower.

RAC audits for O&P providers are still limited to a maximum of 10 audits per Tax ID every 45 days.  AOPA encourages everyone to make sure you are aware of these limits and to challenge any requests that exceed the limits.  While nobody is happy to hear that the RACs are back in business, at least temporarily, the lessons of the past should make for a less stressful future. The CMS announcement regarding RAC audits may be found on the CMS website.

2016 HCPCS Codes Released

The Centers for Medicare and Medicaid Services (CMS) has released the new HCPCS codes for 2016. There were no L-codes added or deleted for 2016. There were two minor verbiage changes for codes L1902 and L1904, which describe pre-fabricated and custom fabricated ankle gauntlet style devices respectively. Below is a breakdown of the code descriptor changes which will be effective for claims with a date of service on or after January 1, 2016.
Code Descriptor Changes
Two L-codes had their official descriptors changed.
Code
New Descriptor
Old Descriptor
L1902
Ankle orthosis, ankle gauntlet or similar, with or without joints, prefabricated, off-the-shelf
AFO, ankle gauntlet, prefabricated, off-the-shelf
L1904
Ankle orthosis, ankle gauntlet or similar, with or without joints, custom fabricated
Ankle orthosis, ankle gauntlet, custom fabricated

Data, Hard Work, and Unified O&P/Amputee Community Response Yield PARTIAL WIN on Troublesome, Draft LCD for Lower Limb Prosthetics

The White House just announced that CMS “will not finalize” the July 16, 2015 Draft LCD. That may be clarified further when comparable announcement text from both CMS and from the DME MACs are released and can be analyzed.  The White House report appears to confirm the information that AOPA shared at the recent San Antonio National Assembly that O&P could be confident that the July 16 proposed LCD for Lower Limb Prosthetics would not be enacted in anything close to its proposed form.

Unfortunately, there are aspects of this document which raise concerns.  The announcement on the CMS website reports that CMS is going to convene “…a multi-disciplinary Lower Limb Prostheses Interagency Workgroup in 2016…the Workgroup will be comprised of clinicians, researchers, policy specialists, and patient advocates from different federal agencies.”

A “working group” that would include both government officials as well as stakeholders from the public would have been more promising.  The immediate concern is that this is NOT a rescission of the Draft LCD.  Some might see this as following a too frequent government step of “kicking the can down the road.”  AOPA, the O&P Alliance, the Amputee Coalition and others had made clear that complete rescission was necessary because the draft was so completely out-of-touch with patient needs AND because there was no scientific data in the medical literature to support the draft. But the medical literature actually supports the present LCD—not a revision and tightening of requirements for beneficiaries to secure a prosthesis.

We recognize and believe it is a positive step that the draft LCD will not be implemented at this time.  However, we continue to believe that the draft LCD should be rescinded by the Medicare Contractors and that CMS should provide patient and provider stakeholders with a meaningful role in the development of future coverage policies for lower limb prostheses.

There is a principle “if it ain’t broke, don’t fix it.”  Prosthetic spend for Medicare has declined for each of the past 4 years, by a total of 14% since the 2010 high.  Looks like even though they are shelving the LCD, they want to convene a special committee, presumably to craft either a new, or revised LCD.

The foundation and structure within the current LCD is sound but there is an opportunity to improve upon it; there remains a need to establish recognition of the prosthetist’s notes when considering medical necessity. That issue and similar additional requirements to care require continuing efforts to improve beneficiary access.

So, the announcement is a partial win—it means that we will not see the July 16, 2015 draft LCD enacted in its current form. AOPA urges caution in that beyond a White House email, we will need to take the time to examine carefully what the CMS announcement means, to assess any longer term issues/threats, beyond what appears, the near-term assurance that Medicare amputees will not see the kind of immediate degradation in the quality of prosthetic care that the draft LCD would have enforced on them, at least not in the near-term.

AOPA’s leadership and regulatory specialists will review ALL government and contractor communications as they arise, and provide a further analysis once that in-depth review is complete.

The report at this juncture would not be complete without acknowledging with appreciation the hard work of amputees and their O&P providers who supported AOPA, the O&P Alliance and the Amputee Coalition in the all-out effort to stop this LCD from reverting amputees to a 1970’s standard of care.

Read the White House statement.

Obama White House Disappoints With Interim Response to “We the People” Petition on LCD

AOPA Reacts
Over 100,000 people took President Obama at his word when they shared their names, email addresses and trust in/commitment to government, signing on in 17 days to surpass the 100,000 signatures required to prompt direct White House intervention and action on the draft lower prosthetic LCD. Others were skeptical, seeing the We the People process as 90% public relations and only 10% substance. Well, the first response from the White House did nothing to dissuade the PR skeptics.

On Friday evening that report did not represent any action by the White House on the petition as had been promised. Rather, it did precisely what the President frequently criticizes Congress for doing–the White House report simply kicks the can down the road. It engages in a pious promise to eventually do what’s right, without giving either a hint of what the substantive action might entail, or when a final substantive decision will be rendered.

The interim We the People report came:

  • exactly 3 months after the LCD was released as a proposal;
  • exactly 60 days after the 100,000th signature on the White House petition;
  • exactly 50 days after the DME MAC public meeting, the amputee rally at HHS HQ, and the date when top CMS and HHS senior officials met with O&P stakeholder representatives and promised a prompt, fair solution that would assure that all Medicare amputees will receive appropriate replacement limbs;
  • it occurs 15 days after the first of an expected stream of commercial payers began embracing this very deficient draft as if gospel, as a premise to invoke the misguided draft’s content as an excuse to cut costs, ramp up profits, and downgrade amputee care. That’s too long! Inaction and failure to rescind this deficient policy now allows it to disenfranchise amputees, sadly in the year when the Administration touted the 25th anniversary of the Americans with Disabilities Act!

While we remain confident that the final resolution of this draft LCD will be a favorable one for the O&P professional and the patients we serve, the question remains… Is the ‘We the People’ promise merely PR fluff, or will it ultimately proves more substantive? Whichever, it clearly does not reflect timely, fairness and responsiveness.

The O&P Alliance and the Amputee Coalition Issue a Joint Statement
The O&P Alliance (AAOP, ABC, AOPA, BOC, NAAOP) and the Amputee Coalition issued a joint statement. Read the entire statement, with excerpts below.

“Rescission of this draft LCD is critical due to the fact that it is out of sync with contemporary prosthetic practice and because private payers like United Healthcare are already adopting elements of this draft LCD as if it were final Medicare policy, inappropriately restricting coverage for amputees covered by private plans.”

“We take CMS and its contractors at their word that they will meaningfully consult with stakeholders before issuing any final coverage policy in this area—including another formal comment period—and we look forward to continuing to work with them to ensure that all individuals with limb loss have access to appropriate prosthetic care.”

Other Reactions
AOPA members and O&P are responding to the interim, non-substantive response from the White House to the We the People petition. Here’s what one member wrote in a letter to his members of Congress:

“Wow! We received overwhelming support to raise awareness and collected 100,000 signatures in 17 days to get a response from President Obama’s administration… and this is what we received… I’m disappointed and concerned! We need your help and influence to ensure that 110,000+ Americans that signed in 17 days and the 200+ demonstrators are heard!”

“People talk about Congress being at a stand-off, but seems like there is a bipartisan consensus in the US House and US Senate and media in opposition to this proposed CMS LCD, both showing more interest and timeliness of response than the current Presidential Administration.”

Read the White House’s response below or on their website:

An initial response to your petition on a Medicare local coverage determination:

Thanks for using We the People, and for sharing your concerns about the local coverage determination for lower limb prostheses proposed by Medicare contractors. In order to get the most up-to-date information concerning your petition, we’ve gone to the Department of Health and Human Services (HHS) — specifically, the Centers for Medicare and Medicaid Services (CMS), and the Administration for Community Living (ACL).

You can learn more about LCDs and how they’re determined here.

The coverage determination process is still ongoing, but CMS wants to make clear that they’re committed to providing high quality care to all Medicare beneficiaries. They also wanted to make sure you know that HHS has met with stakeholders on this important issue, and both CMS and its contractors understand the questions that have been raised about access to the right prosthetic care — including related technologies — for Medicare beneficiaries.

We will be in touch with another update.

–The We the People Team

Tell us what you think about this response and We the People.

Former CFI director Ret. Lieutenant Col. Donald Gajewski, MD Returns to San Antonio for AOPA National Assembly

WASHINGTON, D.C. – Retired Lieutenant Colonel Donald Gajewski, MD, former director of the Center for the Intrepid and renowned orthopedic surgeon is returning to San Antonio to address attendees of the 98th Annual American Orthotic & Prosthetic Association (AOPA) National Assembly, October 7-10.

The Annual Assembly is the highlight of the year for the more than 2,200 orthotic, prosthetic and pedorthic professionals expected in attendance – because of its expansive educational opportunities, massive exhibit hall, and engaging events.

This year’s Assembly continues its tradition of top-notch educational programming kicked off by Dr. Gajewski’s address, featuring the Fort Sam Houston Memorial Services Honor Guard. Eight other experts from the Center for the Intrepid at the Brooke Army Medical Center will be featured in the dazzling line-up of clinicians, researchers, and business gurus. The Brave New World of 3-D Printing, The Next Global Pandemic [Diabetes], and the Prosthetic Sports Symposium are some of this year’s most anticipated sessions.

The 100,000 square ft. exhibit hall features 165 of the most innovative companies showcasing their latest and most cutting edge prosthetic hands, legs, and feet; orthotic braces; and other services. Attendees will be challenged to ride Triton the Mechanical Bull in an ALSchallenge-style fundraiser at the AOPA booth. Attendees will wind down in the evenings with exciting events – the Texas-Style Welcome and Ribbon Cutting Ceremony, Happy Hour in the Exhibit Hall, and the Topgolf and Wine Auction Fundraisers.