Final CMS OTS List Released

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

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.

A copy of the AOPA letter may be accessed here.
(https://www.aopanet.org/Custom_AFO-KAFO_Documentation_Letter.pdf)

 

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:

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.

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.“

We promise to keep members informed of any changes or progress made on this new OTS list.

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.

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!