Initial Report on TPE Program Suggests Positive Results

Noridian Healthcare Solutions, who serves as the Jurisdiction A and Jurisdiction D Durable Medical Equipment Medicare Administrative Contractor, has released results for its initial audits under the Target, Probe, and Educate (TPE) program in Jurisdiction D. The published results are only for four HCPCS codes selected for the TPE program, L4360, L4361, L4386, and L4387, which all describe walking boot style orthoses.

The results of the TPE audits are encouraging with an improper claim payment rate of 19%. This improper payment rate represents a vast improvement over error rates under the previous audit system which consisted of a probe review followed by widespread pre-payment review. Improper payment rates under this program ranged from 66% to 100% for walking boot style orthoses.

While the results did not discuss the reason for the significant reduction in the error rate, it is logical to conclude that the improvements are primarily due to the education efforts that are an integral part of the TPE program. The TPE program is designed to provide up to 3 rounds of audits with personalized provider education after each round that is designed to address the specific reasons for claim denial.

The results published by Noridian are certainly encouraging and AOPA will be monitoring the DME MAC websites for additional results from the TPE program.

The Noridian publication may be viewed at the following link.

https://med.noridianmedicare.com/web/jddme/cert-review/mr/review-results/afo-kafo-quarterly-results-of-tpe-review

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AOPA Secures Advocacy Victory on Direct Milled Diabetic Inserts

AOPA is very pleased to announce an advocacy win regarding the fee structure for K0903/A5513. AOPA has confirmed with the Centers for Medicare and Medicaid Services (CMS) that the Medicare fee schedule for K0903, a temporary HCPCS code effective April 1, 208, that describes custom fabricated, direct milled diabetic inserts has been set at the same amount as the current Medicare fee schedule for A5513 ($43.56 for most states).  A5513 describes custom fabricated diabetic inserts that are fabricated over a positive model of the patient’s foot.

This has been a very long battle, one in which AOPA partnered with the American Podiatric Medical Association, the O&P Alliance and the Amputee Coalition. AOPA is also greatly indebted to Rep. Brad Wenstrup and his excellent staffers—Derek Harley, Nick Uehlecke (Ways & Means Committee) and Greg Brooks for their help—as well as Joe McTernan, Devon Bernard, Ashlie White and others on AOPA’s lobbying team . Believe it or not, this battle started in August, 2017, when we set our strategy, began outreach to podiatrists, and to key Hill players! This is VERY important because A5513 is not the only code where scanning processes have evolved—this hopefully sets the right precedent for the agency.

This battle included a decision, first highlighted by PDAC, that diabetic shoes inserts that were fabricated using scanning devices and direct milling did not meet the precise words of the A5513 code, which referenced the process as molded over a model of the patient’s foot. A coding verification notification was initiated by PDAC to focus on the process used. It should be noted that this code, vital to protecting diabetic patients, had declined in utilization by 14% in the prior 3 years, largely because of unreasonable reimbursement cuts. At an Open Door Forum, CMS announced that they agreed that the processes were equivalent, but also said that the scanned device required less work, and they expected to reduce the fee by about $7 for direct milled inserts. A long battle has ensued, where as a result of Congressional pressure, the fee decision was shifted to the very highest levels in CMS. Ultimately, CMS reached the right decision that as the processes were essentially equivalent, the fee needed to also be identical (one of the several arguments AOPA mounted was the CMS’ own manuals say that when one code is “exploded” into two parallel codes both new codes must retain the same fee), as provided in CMS’s own Medicare Claims Processing Manual.

AOPA is proud of this advocacy victory, not only for what it represents for providers of diabetic inserts but also for the precedent that it sets for future issues involving the use of scanning and other technology to create alternate manufacturing processes in orthotics and prosthetics.

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AOPA Secures Legislative Victory on Prosthetist and Orthotist Documentation

After years of work and countless hours fighting to validate the role of orthotists and prosthetists as true medical professionals, AOPA has finally secured legislative language that recognizes documentation created by orthotists and prosthestists as part of the medical record for purposes of determining medical necessity. On February 9, 2018, President Trump signed a spending bill passed in both the House and the Senate that contained the following clause.

SEC. 50402. ORTHOTIST’S AND PROSTHETIST’S CLINICAL NOTES AS PART OF THE PATIENT’S MEDICAL RECORD.
13 Section 1834(h) of the Social Security Act (42 U.S.C. 1395m(h)) is amended by adding at the end the following new paragraph:”
(5) DOCUMENTATION CREATED BY ORTHOTISTS AND PROSTHETISTS. – For purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual’s medical record to support documentation created by eligible professionals described in section 1848(k)(3)(B).”.

This addition to section 1834(h) of the Social Security Act finally acknowledges that clinical documentation created by orthotists and prosthetists does have value when determining the medical necessity of services they provide.  This has been a legislative goal of AOPA for many years and we are excited that O&P professionals will finally receive the long awaited recognition as medical health professionals that they deserve.

While there is much work still to be done to translate this newly enacted law into real world practice, the passage of this legislation is a major step in the process.  AOPA will continue to work diligently to ensure that our members are treated with the respect and recognition that they have earned while providing the highest level of clinical care to their patients.  As this legislative change moves through the regulatory process and eventual implementation, AOPA will be there to make sure that role of the orthotist and prosthetist as an integral part of the rehabilitation team continues to be recognized and valued.

The complete announcement regarding this important legislative victory may be found on the AOPA website by clicking on the following link.

A Legislative win for O&P

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OIG Work Plan Targets OTS Spinal Orthoses and OTS Knee Orthoses

As part of its update to its 2018 work plan, the Department of Health and Human Services Office of Inspector General (OIG) announced that, based on abnormally high utilization and unusually high improper payment rates, two off the shelf (OTS) HCPCS codes that describe lumbar sacral orthoses (L0648 and L0650) and one OTS knee orthosis code (L1833) will be added as an area of focus for investigation by the OIG. All three codes identified by the OIG are part of the split code set created by CMS in 2014 that differentiated OTS orthoses from those that require the expertise of a certified orthotist or an equivalently trained professional.

In its announcement the OIG reported that, since 2014, claims for the three OTS codes have grown by 97% with allowed charges rising to $349 million in 2016.  The OIG plans to explore questionable billing practices for these three codes including the lack of medical necessity documentation from referring providers and instances where no patient/physician encounter occurred within the 12 months prior to provision of the orthosis.

Based on Medicare utilization data from 2014 until 2016 AOPA has determined that less than 10% of the OTS devices described by L0648, L0650, and L1833 were provided by traditional O&P companies. The vast majority of these devices, over 65%, were provided by DME suppliers without certified O&P professionals on staff.

While traditional O&P providers represent a small percentage of the overall utilization of these three codes, it remains wise to make sure that, when providing OTS orthoses described by these codes and any other codes, proper medical necessity documentation is maintained by the ordering physician and all Medicare policy requirements have been met.  While L0648, L0650, and L1833 have not previously been identified as approved for RAC review, the outcome of the OIG review may possibly lead to additional audit activity by the RAC and other contractors.

The OIG report may be viewed by clicking on the following link:

https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000271.asp

AOPA will be conducting additional data analysis that will identify trends in the utilization of these three codes from 2014 through 2016 based on provider type.

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

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!!!