On November 1, 2018, the Centers for Medicare and Medicaid Services (CMS) announced that it is soliciting comments on its proposed inclusion of off-the-shelf spinal orthoses and off-the-shelf knee orthoses as product categories in the next round of Medicare competitive bidding. This announcement came on the same day that the final rule on changes to the competitive bidding program was announced. Ironically, a provision of the final rule was the announcement of a delay in the implementation of future rounds of competitive bidding until at least January 1, 2021. While the impact of inclusion of OTS spinal and knee orthoses will not be felt for at least two years, the recent CMS announcement represents the first indication that OTS orthoses of any kind will be included in competitive bidding.

There are a total of 16 OTS spinal orthoses and 8 OTS knee orthoses that have been identified for inclusion in the competitive bidding program. AOPA has performed preliminary analysis on the codes included in the proposal and traditional O&P providers are responsible for less than 15{b3e9dd6b2a2b9b0b8877c781f3059c6a19b65fa453cdc02b99584f3fd07dbcf4} of overall claims submitted to Medicare for the codes in question. While these codes do not represent a large portion of a typical O&P practices business, AOPA continues to believe that no orthoses should be subject to competitive bidding and will be submitting comments to CMS indicating that competitive bidding for OTS orthoses is not in the best interest of patients or the Medicare program.

The CMS announcement may be viewed here.

Comments must be submitted by December 3, 2018.

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

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

On November 1, 2018, the four Durable Medical Equipment Medicare Administrative Contractors (DME MACs) released an updated Local Coverage Determination (LCD) for lower limb prostheses. Since the changes to the LCD were minimal and do not restrict coverage, the notice and comment period required by the 21st Century Cures Act does not apply to this revision.

The only change to the LCD was the removal of the patient weight range (110 lbs to 275 lbs) for coverage of L5859–Addition to lower extremity prosthesis, endoskeletal knee shin system, powered and programmable flexion/extension assist control, includes any type motor(s). All other requirements for coverage of L5859 remain the same.

AOPA continually reviews the Medicare LCDs and Policy Articles for changes such as this and will keep you informed when they occur.

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

The four Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have recently released a revised version of the “Dear Physician” letter that addresses the need for prescribing physicians to support the medical necessity of the DMEPOS services they prescribe through proper clinical documentation in the patient’s medical record.  While the revisions to the Dear Physician letter were not significant from previous versions of the long-standing letter, the revision provides a reminder that for DMEPOS items or services to be covered, they must always be supported by physician documentation.

 

O&P won a battle in February 2018, with the enactment of Section 50402, which recognized the clinical notes of orthotists and prosthetists as part of the medical record for purposes of medical necessity determinations.  While the legislative change essentially reset the clock back to 2011 and reversed the now retired Dear Physician letter for lower limb prostheses that said that O&P notes were not considered part of the medical record, Section 50402 DID NOT convey to O&P prescribing rights and DID NOT eliminate the need for physician notes supporting the medical need for O&P services they prescribe.  Section 50402 specifically indicates that while orthotist and prosthetist notes are now part of the medical record, they are corroborative, and cannot, standing alone, trigger a finding of medical necessity.

 

The recognition of orthotist and prosthetist notes as part of the medical record is a long sought-after result, and one of great pride for AOPA but it is important to remember the crucial role of physician partners in documenting the medical need for O&P services they prescribe.

 

The revised Dear Physician letter regarding general documentation was just one of many minor revisions made to the Dear Physician letters.  Most of the revised Dear Physician letters do not apply to O&P services.  This includes the recently revised Dear Physician letter regarding face-to-face visit and written orders prior to delivery for certain DMEPOS items.  It is important to remember that these specific requirements do not apply to O&P services as O&P services are specifically exempt from these requirements.

 

AOPA continually monitors the DME MAC websites for substantive changes to the Dear Physician letters that affect O&P providers and will communicate them to AOPA members immediately.

 

The revised Dear Physician letter on general documentation requirements may be viewed by clicking HERE.

Recently, AOPA reported that the report of the Inter Agency Work group that was formed to provide a consensus statement to inform Medicare coverage of lower limb prostheses had been published. As part of the consensus statement, the Inter Agency Work group recommended, and CMS concurred, that the draft LCD and Policy Article for Lower Limb Prostheses, that was initially released on July 16, 2015, should be removed from the DME MAC websites and that the current LCD and Policy Article should remain in force for the immediate future.
On June 21, 2018, the DME MACs released a joint publication announcing the retirement of both the draft LCD and Policy Article. AOPA is continuing to evaluate the full consensus statement of the Inter Agency Workgroup and will provide comments in the near future.
The announcement of the draft LCD and Policy Article may be viewed by clicking here.

AOPA and its lobbying team have been pressing CMS from all levels, most recently including consultation with Trump Administration officials at the Office of Management and Budget, to formally implement the provisions of Section 50402 of the Bipartisan Budget Act of 2018 (Public Law 115-123) as it related to the prosthetist’s and orthotist’s clinical notes.

AOPA was encouraged bythe DME MAC notification 2-3 weeks ago where the DME MAC Medical Directors announced that they were ‘retiring’ the August 2011 “Dear Physician” letter on Lower Limb Prosthetics.

AOPA would like to share a recent letter from Alec Alexander, CMS’ Director of Program Integrity, that indicates that CMS “has issued instruction to the Durable Medical Equipment (DME) Medicare Administrative Contractors (MAC) to implement Section 50402 immediately.”

Section 50402 states:
‘‘(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).’’.

Mr. Alexander’s letter is a clear assertion of CMS’ commitment to acknowledge immediate implementation of the new statutory provisions in Section 50402, accepting the orthotist and prosthetist clinical notes as part of the individual’s medical record as to “determining the reasonableness and medical necessity of orthotics and prosthetics” e.g., functional levels, identification of broken, damaged parts and their repair, and identifying components in a category included in a physician approved detailed written order. We also suggest that AOPA members consider including a copy of the letter with all claims they file.

We will continue to keep you informed of any developments in this important area.

The letter from Mr. Alexander and the DME MAC announcement regarding the retirement of the Dear Physician letter for lower limb prostheses may be viewed on AOPA’s website at http://www.aopanet.org

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

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{b3e9dd6b2a2b9b0b8877c781f3059c6a19b65fa453cdc02b99584f3fd07dbcf4}. 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{b3e9dd6b2a2b9b0b8877c781f3059c6a19b65fa453cdc02b99584f3fd07dbcf4} to 100{b3e9dd6b2a2b9b0b8877c781f3059c6a19b65fa453cdc02b99584f3fd07dbcf4} 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

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

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{b3e9dd6b2a2b9b0b8877c781f3059c6a19b65fa453cdc02b99584f3fd07dbcf4} 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.

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

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

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

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{b3e9dd6b2a2b9b0b8877c781f3059c6a19b65fa453cdc02b99584f3fd07dbcf4} 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{b3e9dd6b2a2b9b0b8877c781f3059c6a19b65fa453cdc02b99584f3fd07dbcf4} 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{b3e9dd6b2a2b9b0b8877c781f3059c6a19b65fa453cdc02b99584f3fd07dbcf4}, 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!!!

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

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