Final CMS OTS List Released


AOPA Responds to Jurisdiction D announcement relating to AFO/KAFO physician documentation (corroboration) with Letter to All Four DME MAC Medical Directors on Deficiencies of Process Used to Modify LCD

Within the past two weeks, Jurisdiction D released a report which highlighted a 99 per cent error rate relating to AFO/KAFO claims. A very significant new factor with the evaluation of these claims has been the DME MACs interposing a stringent physician documentation (corroboration) requirement.

Click here to review the report.

Current Review Results
The Jurisdiction D DME MAC Medical Review Department is conducting a widespread complex review of HCPCS code L1960. The second quarter edit effectiveness results from March 2013 through June 2013 are as follows:

The L1960 review involved 225 claims of which 221 were denied. This resulted in an overall error rate of 99%.

Historical Data of the Error Rate for L1960 Review

 

Primary documentation errors that resulted in denial of claims
  • 27% of L1960 claims received a denial as the treating physician’s records don’t provide detailed documentation to support medical necessity of custom rather than prefabricated orthosis.
For custom-fabricated orthoses, there must be detailed documentation in the treating physician’s records to support the medical necessity of custom-fabricated rather than a prefab orthosis. This information will be corroborated by the functional evaluation in the orthotist or prosthetist’s records. This information must be available upon request.
  • 21% of L1960 claims received a denial as criteria 1–5 were not met.
AFO’s and KAFO’s that are custom-fabricated are covered for ambulatory beneficiaries when the basic coverage criteria and one of the following criteria are met:
1. The beneficiary could not be fit with a prefabricated AFO; or,
2. The condition necessitating the orthosis is expected to be permanent or of longstanding duration (more than 6 months); or,
3. There is a need to control the knee, ankle or foot in more than one plane; or,
4. The beneficiary has a documented neurological, circulatory, or orthopedic status that requires custom fabricating over a model to prevent tissue injury; or,
5. The beneficiary has a healing fracture which lacks anatomical integrity or anthropometric proportions.
If a custom-fabricated orthosis is provided but basic coverage criteria and the additional criteria 1-5 for a custom-fabricated orthosis are not met, the custom-fabricated orthosis will be denied as not reasonable and necessary.
  • 16% of L1960 claims received a denial as the documentation was insufficient to support basic coverage criteria.
Ankle-foot orthoses (AFO) described by codes L1900, L1902–L1990, L2106–L2116, L4350, L4360, L4386 and L4631 are covered for ambulatory beneficiaries with weakness or deformity of the foot and ankle, who require stabilization for medical reasons, and have the potential to benefit functionally.
  • 7% of L1960 claims received a denial as no documentation was provided to support the reason for replacing the item.
Replacement of a complete orthosis or component of an orthosis due to loss, significant change in the beneficiary’s condition, or irreparable accidental damage is covered if the device is still reasonable and necessary. The reason for the replacement must be documented in the supplier’s record.
Replacement components (e.g., soft interfaces) that are provided on a routine basis, without regard to whether the original item is worn out, are denied as not reasonable.
Going Forward
Based on high error rate, Noridian will continue with the Prepayment Widespread Review.
Education resources
It is important for suppliers to be familiar with the documentation requirements and utilization parameters as outlined in the Ankle-Foot/Ankle-Knee-Foot Local Coverage Determination (LCD) L142 and Policy Article A19800.
Noridian provides educational offerings by scheduling for supplier workshops, training opportunities, and presentations. Educational training and events are located at https://www.noridianmedicare.com/dme/train/.
Information about probe/error validation reviews may be found in CMS Publication 100-8, Program Integrity Manual (PIM), Chapter 3 located at: http://www.cms.gov/manuals/downloads/pim83c03.pdf
This is a new requirement introduced by the DME MACs into the Local Coverage Determination requirements and elsewhere in July, 2012. That change was initiated via a unilateral step taken by the DME MACs without any consultation with stakeholders—physicians, certified orthotists, patients or others.  There was no publication in the Federal Register, no notice of proposed rulemaking or opportunity for notice and comments, and no scientific justification rendered in support of these unilateral changes.
Today, AOPA filed a letter to the four DME MAC Medical Directors, as well as to leading public officials of the Centers for Medicare and Medicaid Services, challenging the validity of this process, and claiming that both the unilateral LCD changes announced by the DME MACs in July, 2012, and subsequent claims rejections based on that LCD are inappropriate, and contrary to the requirements of the Administrative Procedure and the Medicare Act.
CMS Issues Announcement of Its Final List of Off-the-Shelf O&P Devices, Together with Surprise “Exploding” of Codes for Orthotic Devices, with Ramifications for Competitive Bidding

 

Last week, AOPA members received a preliminary notification underscoring rumors and reports on communications from a CMS official to certain third parties pointing toward an expected announcement of the final OTS (off-the-shelf) list of orthotic devices, as well as toward plans for a bifurcated fee schedule separating the payment for the device only, from the payment for the clinical services of fitting, adjusting, trimming, etc. that accompany the vast majority of orthotic devices. See the prior AOPA Announcement here.
This is a very important announcement both for certified orthotists and for Medicare patients depending on customized bracing to maintain their stability and mobility.  It culminates a very important statutory history, as well as a long, substantially internal “shadow process” within CMS and by others to try to ‘enlarge the envelope’ of what constitutes an ‘off-the-shelf’ orthotic device.  One benchmark in that process occurred in August, 2011 when the O&P Alliance had a meeting on another topic with the Deputy Director of CMS within two weeks before Round II competitive bidding was initiated. The CMS leader asked what harm would be done if CMS enlarged the envelope of off-the-shelf orthotics a bit beyond the limits of the minimal self adjustment statutory definition. AOPA responded that this would be wrong for two reasons: (1) it would be harmful to Medicare beneficiaries and (2) that it would violate the law.
CMS has moved in almost exactly the expected direction regarding the OTS list on competitive bidding. AOPA believes that the following comment on p. 3 of the recent CMS announcement violates the statute. When Congress defined OTS as devices which could be used by the patient with “minimal self-adjustment” they did not contemplate a “sometimes they are and sometimes they are not” category. The only devices that meet the OTS definition are those that can “always” be used with minimal self-adjustment.
Here is the CMS response to stakeholder comments on the “minimal self-adjustment” issue:
Response: After considering all comments received on the initial OTS list, we have identified HCPCS codes that describe items that are never furnished OTS, HCPCS codes that describe items that are always furnished OTS, and HCPCS codes that describe items that may or may not be furnished OTS, depending on whether more than minimal fitting and adjustment of the device by experts is necessary for the individual patient. We are therefore exploding the HCPCS codes for items that may or may not be custom fitted, depending on each individual patient’s needs, into separate codes that describe the item when it has been furnished OTS and when it has been custom fitted (i.e., when more than minimal fitting and adjustment of the device by experts is necessary) for the individual patient.
Congress recognized that grave patient harm could result from overly expansive competitive bidding of orthotics, and they set very clear restrictions, granting CMS only very limited competitive bidding authority confined to true “off-the-shelf” orthotic devices. Congress did this in the statute by setting two hurdles, both of which CMS is compelled to abide by before it could institute any competitive bidding of orthotic devices. Congress prohibited competitive bidding as to all orthotic devices except for these true “off-the-shelf” orthotics, and it established a strict statutory definition which limits OTS only to devices which can be used by the patient with ‘minimal self-adjustment,’ and ‘…do not require expertise in trimming, bending, molding, assembling, or customizing to fit the individuals.’ CMS took its first attempt at substituting its view for what Congress had established firmly in the statute when the agency published its regulatory definition of ‘off-the shelf orthotics’ which ventured far beyond the narrow definition Congress prescribed in the law. CMS would prefer the following definition, which it wishes it could substitute for what the statute actually says: “the device does not require modifications and requires ‘minimal self-adjustment’ performed by the beneficiary, caregiver for the beneficiary, or supplier.” Make no mistake, this broad CMS definition is logically and linguistically incompatible with the much more limited definition Congress set as the law of the land.
The potential adverse impact on Medicare beneficiaries from CMS over-stepping the boundaries on trying to incorporate an excessive number of orthotic devices in the competitive-bidding eligible ‘off-the-shelf’ category seems to have been overlooked by CMS.  In December, 2012, the Amputee Coalition and AOPA joined forces in generating a letter to every Member of Congress underscoring that serious adverse impact (to see a copy of the AC/AOPA joint communication, please click here).
AOPA participated very actively when CMS announced in February, 2012 via a website posting that it was announcing a draft OTS list, and inviting feedback on the list.  We did that despite the fact that the CMS process was deficient in not going through the required steps for actual promulgation of a legitimate agency rule. AOPA submitted comments spanning approximately 500 pages, including scientific literature (as scientific rationale was conspicuously absent both in the February, 2012 CMS announcement, as it is in this week’s website “final list” posting/rationale). (See comments filed by AOPA here). The O&P Alliance similarly met with CMS and issued comments on the draft list. The AOPA filing included a letter from AOPA outside counsel, Thomas Mills, Esquire, underscoring both the deviation from the limits of the statute, as well as the procedural deficiencies of the path CMS was taking (see a copy of that letter here).
Obviously AOPA is disheartened that the 500 pages of comments didn’t yield a greater result, as the new OTS list still contains 55 codes, far more than the 17 AOPA recommended, but less than the original 62 codes on the first OTS list. AOPA does not agree with the final list, and we want to make that clear. Is there a potential threat at some time down the line? Yes. Is it imminent? No.  At this juncture OTS orthotics are not part of the competitive bidding program, and CMS has not broached either a plan or a timetable to do so, and we will provide comments and address our issues with this new list with CMS.
Some very noteworthy and potentially controversial CMS statements are made in the comment analysis, response and rationale that accompanies the ‘final list.’
a. Response: After considering all comments received on the initial OTS list, we have identified HCPCS codes that describe items that are never furnished OTS, HCPCS codes that describe items that are always furnished OTS, and HCPCS codes that describe items that may or may not be furnished OTS, depending on whether more than minimal fitting and adjustment of the device by experts is necessary for the individual patient. We are therefore exploding the HCPCS codes for items that may or may not be custom fitted, depending on each individual patient’s needs, into separate codes that describe the item when it has been furnished OTS and when it has been custom fitted (i.e., when more than minimal fitting and adjustment of the device by experts is necessary) for the individual patient.
CMS wishes that by developing some differential way to pay for devices which the agency construes as “HCPCS codes that describe items that may or may not be furnished OTS” it can expand the OTS category.  But the single fact is that this would violate the statutory definition which very clearly does not contemplate CMS “having it both ways.”  Congress clearly intended a decision by which devices in specific codes, as a group, either do, or do not meet the critical statute’s defining test—‘minimal self-adjustment’.  The only orthotic devices which might possibly meet that legal definition are those HCPCS codes that CMS recognizes as describing items that are always furnished OTS. (Emphasis added)
 
b. Response: The term “includes fitting and adjustment” indicates that any fitting and adjustment that is provided when furnishing the item is included in the procedure code and corresponding allowed payment amount. Items being billed under HCPCS codes with this term, such as HCPCS code L0631, may only require minimal self-adjustment or may not be fitted or adjusted at all. For example, as part of a report issued in December 2012, titled Medicare Supplier Acquisition Costs for L0631 Back Braces (OEI-03-11-0600), the Office of Inspector General in the Department of Health and Human Services found that for one-third of Medicare claims for HCPCS code L0631 that they sampled, suppliers did not report providing fitting and adjustment services. As indicated above, to resolve this matter, we are exploding codes such as L0631 into two codes so that the items furnished OTS and for which custom fitting is not necessary can be billed under one code while items for which custom fitting by individuals with appropriate expertise is medically necessary and is furnished can be billed under a second, separate code.
What CMS fails to recognize in its reference to what the OIG said in this report is that the assertion “ that for one-third of Medicare claims for HCPCS code L0631 that they sampled, suppliers did not report providing fitting and adjustment services” is essentially conjecture by the OIG.  AOPA challenged this in subsequent communications directly with the OIG (You may view the OIG Report and subsequent AOPA responses here), and we were told the following by Stuart Wright of OIG in a letter of April 3, 2013: 
“Fitting and Adjustment Services and Followup Visits:
The data regarding fitting and adjustment services were self-reported by suppliers. The report’s “one-third estimate” – i.e., its estimate that for one-third of claims, suppliers did not provide fitting and adjustment services – is based on suppliers’ answers to our survey question as to whether they provided these services. We requested documentation regarding fitting and adjustment services. However, documentation for these services (or the lack thereof) was not considered when reporting the estimate. Therefore, the one-third estimate reflects what suppliers reported to be their practices and not what suppliers were able to document; we have no reason to believe that suppliers underreported their fitting and adjustment practices.
c. Comment: One commenter stated that many of the codes in the OTS list are reserved for licensed dispensation in certain states.   Response: We have reviewed all comments from individual states and their licensed dispensation requirements. There was no consistent agreement among the states regarding which HCPCS codes should be deemed OTS. However, we took into consideration their differing perspectives. Individual states have the authority to exercise regulatory authority over their respective professional licenses. These standards in no way preclude CMS from establishing Medicare policy.
d. Response: We have evaluated each HCPCS code thoroughly and identified each of the codes which appropriately fit the OTS definition. For those devices we have found can be modified, we are creating new HCPCS codes that will be available for use in those instances when these items require custom fitting for a specific individual.
e. Response: In reviewing the products and items classified under the codes on the initial OTS list and the comments received on the initial list, we have identified several codes that include a variety of items, some of which are dispensed to patients with no modifications or fitting necessary, and some for which custom fitting by certified orthotists or other individuals with specialized training may be necessary. Therefore, for those devices we have determined can be modified and are modified for specific individuals who require expertise in fitting, we are creating new HCPCS codes that will be available for use in those instances when these items require custom fitting for a specific individual.
We promise to keep members informed of any changes or progress made on this new OTS list.
Competitive Bidding – Storm Clouds Gather – A Special Session at the AOPA World Congress in Orlando on Friday, September 20th
We’ve seen how overly aggressive CMS activities have decimated the care you can provide to Medicare amputees. Now, just when we have hard economic data demonstrating that orthotic intervention saves Medicare money, ill-advised, short-term thinkers show signs of turning their draconian, money grabbing tactics toward similar desolation in orthotics, denying Medicare beneficiaries the synergy of the quality devices AND clinical care they deserve. Attending this session will give you the inside picture–so you can be both forewarned and forearmed.
Competitive Bidding: Devastation to Orthotic Patient Care OR Just a Passing Storm?
1. What Authorities Has Congress Given to Medicare for CB in O&P, and What Boundaries Have Been Set to Protect Patient Care?
 
2. Tangible CMS Steps Toward CB for Orthotics, Demonstration Projects & Publication of Draft Off-the-Shelf List
 
3. Signals from CMS of Possible Rogue Overreach on Orthotics
 
4. What Is AOPA’s Plan–What Should You Be Doing?
This course will be scheduled on Friday, September 20th, between 11 AM and 2 PM at the O&P World Congress – Don’t miss it, register now!