CMS Responds to AOPA Concerns Regarding Custom Fabricated Diabetic Inserts

AOPA is pleased to announce that the Centers for Medicare and Medicaid Services (CMS) has proposed a change to the DMEPOS Quality Standards that addresses AOPA’s concern regarding the recent DME MAC/PDAC interpretation of the term “molded to patient model” when used to describe custom fabricated diabetic shoe inserts.  The proposed change to the quality standards allows for the creation of a digital positive model of the patient’s foot using CAD/CAM technology that is then used to direct mill a custom fabricated insert based on the digital model.

In July, 2017, the DME MACs and PDAC issued a joint bulletin that stated that in order to meet the definition of “molded to patient model” contained in the descriptor for A5513, diabetic inserts must be fabricated over a physical model of the patient’s foot.  The bulletin went on to state that digital or virtual models that were used to direct mill custom inserts are not considered a positive model and inserts fabricated using this technique do not meet the code requirements of A5513 and therefore must be billed as A9270, a statutorily non-covered HCPCS code.  On September 28, 2017, AOPA and the American Podiatric Medical Association (APMA) submitted a joint letter to CMS expressing their concern over this bulletin as it represented a significant threat to the use of advanced technology to provide better clinical service.  In addition to working directly with the APMA, AOPA worked closely with the O&P Alliance, Representative Wenstrup’s (R-OH) office, his staff, and the House VA Subcommittee on Health to make sure that this issue remained at the forefront of the discussion.

On November 2, 2017, CMS announced a proposed change to the DMEPOS Quality standards that would include the use of digital or virtual models to direct mill custom diabetic inserts as an acceptable method to meet the definition of “molded to patient model” contained in the code language for A5513.  CMS will hold an Open Door Forum call on November 28, 2017 at 2:00 pm EST to allow experts to discuss the proposed changes to the DMEPOS Quality Standards and will accept comments on the proposed changes through December 11, 2017.  Comments on the proposed changes may be sent to CMS via e-mail at ReducingProviderBurden@cms.hhs.gov.  CMS has indicated that it intends to finalize the proposed changes by January 1, 2018.

AOPA will participate in the Open Door Forum call and will be preparing comments for submission to CMS.

The proposed changes to the DMEPOS Quality Standards may be viewed by clicking on the link below.

https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Downloads/Revised-Definitions-Only.pdf

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Agency for Healthcare Quality Research Publishes Its Draft Report on Systematic Review of Lower Limb Prosthesis Research

The Agency for Healthcare Quality Research (AHRQ), through its Evidence-based Practice Center contractor has released a draft systematic review of current scientific literature that address the use of lower limb prostheses in the United States.  The Systematic review was originally announced in September of 2016 with a request for additional comments on the “key questions” that would be used in the systematic review in December of 2016.  AOPA provided significant comments on the systematic review itself as well as on the key questions issue.

While the complete systematic review document is 440 pages and is currently under review by AOPA, the abstract of the systematic review indicates the following:

  • 92 studies were identified that assessed performance characteristics of lower limb prostheses
  • 29 of the 92 studies were deemed valid and reliable by the researchers
  • 19 of the 29 studies were generally applicable to Medicare aged populations
  • 11-22% of amputees abandon their lower limb prosthesis within one year of delivery
  • Unilateral trans-femoral amputees are twice as likely to abandon their prosthesis than unilateral trans-tibial amputees
  • Currently, there is not evidence to support the selection of specific components for patient subgroups to maximize ambulation, function, and quality of life or to minimize abandonment or limited use

While AOPA supports the need to review the current research that addresses lower limb prostheses, we do not agree with much in the conclusions, and particularly its final abstract conclusion noted above, as there is clear evidence, apparently not considered by AHRQ or its contractor to support specific components for patient subgroups for maximizing favorable patient outcomes.  It is important to recognize that the draft systematic review did not include recent research by the RAND Corporation and the health economics firm Dobson DaVanzo that specifically studied both the clinical and cost effectiveness of the provision of higher technology prosthetic limbs, despite AOPA’s having submitted BOTH preliminary findings of both studies before the December, 2016 AHRQ deadline, as well as the final study results of both being submitted to AHRQ as soon as the first became available seven (7) weeks ago.  It is particularly unfortunate to see a purportedly current literature review be deficient in not reflecting the latest determinative scientific findings.

AOPA will be preparing extensive comments on the draft systematic review and encourages its members to review the document and provide comments as appropriate.  The draft report may be viewed by clicking on the link below.

https://effectivehealthcare.ahrq.gov/topics/prosthesis/draft-report/

AOPA’s Take.  Where you go…..when you need to know!!!

 

 

 

 

AOPA’s Take is Back!!

 

 

 

 

After a bit of a hiatus, AOPA’s Take is back!!  Make sure you let folks know that the premiere blog for O&P professionals is active once again.  AOPA’s Take will continue to be the place to get all of the latest news and events occurring in the O&P Universe.

It has been a while but it feels great to be back.

AOPA’s Take.  Where you go….when you need to know!!!

AOPA Efforts on Proof of Delivery Requirements Pay Dividends!

CMSAs you may recall, last year the four Durable Medical Equipment Medicare Administrative Contractors (DME MAC) released a clarification on the type of information which must be included on a valid Proof of Delivery (POD). The DME MACs stated that the inclusion of the official L-code descriptor, which had been the accepted norm for years, was not sufficient enough and that suppliers/providers had to include narrative descriptions and/or manufacturer information (serial number, part number, model number, manufacturer name, brand name, etc.). As a result of this sudden shift in policy numerous providers/suppliers began to have their claims denied due to invalid PODs, which were valid prior to the DME MAC clarification.

AOPA challenged the excessive specificity of that new proof of delivery policy and the problems it posed for O&P patient care providers almost immediately and sent a letter to CMS’ Laurence Wilson, Director of Chronic Care Policy Group and Dr. Shantanu Agrawal, CMS’ Deputy Administrator and Director of Center for Program Integrity. AOPA’s letter argued that only FDA received authority from Congress to require serial numbers and other unique device identifiers, and that CMS could not enforce such a ‘de facto’ serial number requirement in the absence of explicit Congressional authority. AOPA also took the opportunity to address the issue of the new POD requirements with the comments submitted in regards to the Draft Lower Limb Prostheses Policy released in July 2015.

All of this work has paid off, as AOPA has recently learned that CMS has reversed course and will now accept the official L-code descriptors on PODs. Effective March 4, 2016 the Program Integrity Manual, specifically Chapter 4; Section 4.26.1- Proof of Delivery and Delivery Methods, has been updated and includes the following statement:

The long description of the HCPCS code, for example, may be used as a means to provide a detailed description of the item being delivered; though suppliers are encouraged to include as much information as necessary to adequately describe the delivered item.

While the complete PIM indicates that “suppliers are encouraged to include as much information as necessary to adequately describe the delivered item”, PODs that include the complete HCPCS code descriptors can no longer be considered invalid resulting in a denial of the claim.

AOPA is very pleased to see a direct result of its communication efforts with top CMS officials regarding POD requirements and will continue to advocate for the equitable treatment of its members. If you have additional questions, you may contact Joe Mcternan at jmcternan@AOPAnet.org or Devon Bernard a dbernard@AOPAnet.org.

AOPA’s Take. Where you go……When you need to know!!!

New Year…New Medicare Fee Schedule

CMSOn 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.

AOPA’s Take. Where you go……When you need to know!!!

RACs are Back!

RACIt 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) have 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 slow down 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.

AOPA’s Take.  Where You Go…..When You Need to Know!!!

Your Voices Were Heard!!!….Medicare Pulls Back from the Draft Lower Limb Prosthetic Policy

Protest PictureOn July 16, 2015, the four DME MACs simultaneously released a draft LCD and Policy Article that proposed major changes to Medicare coverage rules for lower limb prostheses. The proposed changes were so detrimental to the provision of quality prosthetic care for Medicare amputee beneficiaries that the response from all sides of the prosthetic community, from patients, to providers, to researchers and physicians, was instantaneous and unanimous. There was a broad consensus that the draft policy, as it was written, was simply unacceptable and must be rescinded immediately.

Since the release of the draft LCD and Policy Article, AOPA and its partners, including the O&P Alliance and the Amputee Coalition, have worked tirelessly to educate patients, referral sources, Congressional representatives, and CMS officials on the potentially devastating impact the proposed policy would have on the provision of clinically appropriate prosthetic care to Medicare beneficiaries. Highlights of these efforts included more than 1,000 comment letters from O&P facilities, more than 2,000 comment letters from Medicare beneficiaries, an extremely effective public demonstration at the headquarters of the Department of Health and Human Services, support from multiple Congressional offices, multiple meetings and correspondence with high ranking CMS officials, and a “We The People” White House petition that garnered more than 100,000 signatures in 17 days, requiring a formal response from the Obama administration.

Those efforts bore significant fruit yesterday when the White House and CMS simultaneously announced that the draft LCD and Policy Article would not be finalized “at this time.” The announcement went on to explain that an interagency, multi-disciplinary workgroup composed of federal employees would be formed in 2016 that will review existing research and evidence, identify gaps in knowledge, and develop a consensus statement that will be used to help develop future policy.

While AOPA continues to believe that a full rescission of the draft LCD and Policy Article is the most appropriate action to ensure that Medicare beneficiaries continue to have access to the highest quality of prosthetic care, the decision to not publish the draft LCD and Policy Article in final form shows that when many voices cry out in unison, they cannot be ignored.

Despite the fact that many questions regarding the future of Medicare policy governing coverage of lower limb prostheses, It was a good day for O&P!

AOPA’s Take. Where You Go…….When You Need to Know!!!

The Dominoes Begin to Fall

falling dominoesThe publication of the Medicare draft LCD and Policy Article for Lower Limb Prostheses obviously caused great concern within the O&P community as evidenced by the huge show of support during the August 26th public meeting and rally at DHHS headquarters.  A consistent question that has been heard since the release of the policy is: How long will it take to see the affects of this policy trickle down into the private insurance market.  The answer to that question, unfortunately, is not long at all.

In its most recent medical policy bulletin published in August of 2015 and effective for dates of service on or after October 1, 2015, United Healthcare, currently the largest insurer in the United States, issued a policy statement that states, “The use of vacuum pumps for residual limb volume management and moisture evacuation systems among amputees is unproven and not medically necessary due to insufficient clinical evidence of safety and/or efficacy in published peer-reviewed medical literature”.  A remarkably similar statement in the Medicare draft LCD and Policy Article states that claims for HCPCS codes L5781 and L5782 which describe vacuum based residual limb volume management and moisture evacuation systems will be denied as not medically necessary because there is “insufficient published clinical evidence to support these claims.”  While I try to never be pessimistic about things, the timing of this policy decision by United Healthcare, along with the similar language that appears in both policies forces me to question the genesis of the United Healthcare coverage decision.

During its meeting with high ranking CMS and HHS officials on the afternoon of August 26th, AOPA expressed its deep concern that while the policy published by Medicare was done so as a draft, with no bearing on current claims for lower limb prostheses, private insurers would be quick to use language in the draft to justify policy decisions regarding coverage of lower limb prostheses.  Unfortunately, It appears that AOPA’s concern was well founded.

AOPA has provided CMS and HHS with a copy of the recent United Healthcare policy bulletin to drive home the point that the language from the draft LCD and Policy Article is already being picked up by private insurers, and has also reached out to United Healthcare directly to discuss this policy decision.  As this issue progresses, AOPA will provide updates regarding the future coverage of vacuum based volume management and moisture evacuation systems by Medicare and private payers.

The decision by United Healthcare to declare vacuum based volume management and moisture evacuation systems will not be the last decision that is based on language in the Medicare draft LCD and Policy Article.  It is important that you review any policy bulletins you receive that appear to limit coverage of prosthetic services and notify AOPA immediately so we may address these issues promptly.

AOPA’s Take.  Where you go…..When you need to know!!!

Amputees Take Their Message to the Street!

Protest PictureLast Wednesday, I experienced one of my proudest moments as an employee of AOPA and a member of the O&P community. I witnessed the full power of the amputee community as they stood up and proclaimed enough is enough and demanded recognition as folks who, despite their missing limbs, must be treated fairly by the government and the Medicare program.

Wednesday morning began with the scheduled public meeting to provide input on the draft Local Coverage Determination (LCD) and Policy Article governing Medicare coverage of lower limb prostheses that was published simultaneously by the four DME MACs on July 16, 2015.  As those of you that are familiar with the draft LCD and Policy Article are aware, the proposed policy would severely limit access to clinically appropriate and medically necessary lower limb prostheses for Medicare beneficiaries.  I was honored to sit in the room with more than 400 people and 80 speakers who felt the need to express their concern over the potential ramifications of the draft policy on Medicare beneficiaries and amputees covered by private insurance.  While the draft policy is a Medicare only policy, many private insurers adopt Medicare policy as their own, greatly expanding the universe of amputees potentially affected by the proposed policy changes.  Speaker after speaker took the podium to discuss their very personal stories and express their grave concern regarding how the proposed policy may restrict their access to quality prosthetic care.  To say these stories were emotionally moving is an understatement.  The bravery and willingness to share very personal issues in order to influence the direction of the proposed policy was simply awe inspiring.

After the public meeting, more than 150 individuals boarded buses for a trip to Washington, DC to participate in a rally in front of the Department of Health and Human Services building.  Amputees and non-amputees joined together and made sure their voices were heard for almost 3 hours as they marched, rallied, gave speeches, and literally stood on a soap box to deliver the message to CMS that artificial limbs are not a luxury.  Toward the end of the rally, representatives from AOPA, the O&P Alliance, and the Amputee Coalition met with CMS Acting Administrator Andrew Slavitt as well as other high ranking CMS and DHHS officials to reiterate the concerns of the O&P community regarding the potential impact of the draft LCD and Policy Article.  Reports from this meeting indicate that it was extremely positive and that CMS will be discussing the draft LCD and Policy Article further with its DME MAC contractors.

As the rally ended and the folks that had dedicated their personal time and money to participate in the days events headed home, I took a moment to reflect on the day.  Never in my twenty years in the O&P industry have I seen such a coordinated effort of the amputee community, the O&P community, and the groups that represent them, to make sure their voices were heard.  I can truly say that on Wednesday, August 26, 2015, I have never been prouder to work for and be part of the O&P community.

AOPA’s Take.  Where You Go….When You Need to Know!

Proposed Medicare Lower Limb Prosthetic Policy-What Does It Mean For The Future of O&P?

CMSOn August 16th, the four DME MACs published a proposed Local Coverage Determination (LCD) and Policy Article that will govern the future provision of lower limb prosthetic service to Medicare beneficiaries.  To say that the proposed policy, in its current form is a “game changer” is an understatement.  The proposed policy represents the first major change to lower limb prosthetic policy in over 20 years and is almost a complete revision of the existing lower limb prosthetic policy.

AOPA has significant concerns regarding the potential impact this policy will have on AOPA members and, more importantly, Medicare beneficiaries who rely on Medicare to cover their artificial limbs.  A multi-level strategy for creating a professional, clinically based response to this proposed policy is being developed and will be communicated to AOPA members in the near future.  This strategy will include coordinated efforts among all industry groups to ensure that we are communicating with “one voice”, representing the entire O&P industry, not just the individual businesses or professionals each group separately represents.  The strategy will also include the education and mobilization of Medicare beneficiaries, who must be their own advocate in ensuring the continued access to high quality, medically appropriate prosthetic care.

As an initial step, AOPA has prepared an executive summary of its major concerns regarding the proposed policy along with a more comprehensive detailed analysis of the potential impact of the proposed policy along with opinion on how the policy can be improved to ensure continued access to medically necessary prosthetic care for Medicare beneficiaries as well as provision of that care at reasonable rates for providers.  Both the executive summary and the comprehensive analysis may be viewed on AOPA’s website at:

http://www.aopanet.org/wp-content/uploads/2015/07/Proposed-Lower-Limb-Prosthesis-LCD-Summary-and-AOPA-Executive-Summary-for-Distribution-to-AOPA-Members.pdf

AOPA will continue to post information and resources regarding how you can provide your own input regarding the proposed policy revision as they are developed.

AOPA’s take on this issue is that the proposed policy revision is one of the most important issues the O&P industry will face.  The proposed policy, if finalized in its current form, will have a profound impact on your ability to provide high quality, medically necessary prosthetic services to your patients.  Failure to take notice and participate in the public comment process would be a disservice to yourself and your colleagues in the O&P profession.

AOPA’s Take.  Where you go….when you need to know!