Response to Comments: Surgical Treatment of Nails

In reviewing all the references listed for the proposed LCD, there are no findings that support the assumptions made by the authors of this proposal. The references support my following statements that nail regrowth after permanent matrixectomy can occur even when done properly.

Nails surgically treated with matrixectomy for the purpose of permanently removing and stopping regrowth can recur even when done properly. Nail deformity can continue and progress requiring more treatment on the same border previously treated even when done properly. Nails surgically treated for ingrown nail without matrixectomy can become ingrown again without the nail fully regrowing to its full length.

This proposed LCD for surgically treatment of nails puts Medicare beneficiaries at risk for unnecessary morbidity and mortality. These minor surgical procedures have proven to provide powerful relief for the suffering and reduction in the morbidity and mortality of the Medicare beneficiaries. These are procedures that should be encouraged when medically necessary and not have barriers in place that could dissuade a provider.

If there are providers that are not performing the procedure when submitting the CPT^® codes for surgically treatment of nails 11730 and 11750, then those providers are outliers and appropriate intervention is needed. This proposed LCD would be a significant burden on providers and beneficiaries who are using the codes appropriately.

Thank you for your comments. The LCD and related billing and coding article were modified to include the -KX modifier to allow for a medically reasonable and necessary repeat nail excision on the same finger or toe, consistent with the CPT^® codes 11750 recognizing that additional therapy may be required on the same nail.

In addition, the LCD and related billing and coding article was modified to include the -KX modifier to allow for a medically reasonable and necessary repeat nail avulsion of the same toenail or fingernail performed more often than every 32 weeks (8 months) for toenails or every 16 weeks (4 months) for fingernails consistent with the CPT^® code 11730 recognizing that additional therapy may be required on the same nail.

We respectfully submit the below support, concerns, and recommendations in response to Proposed Local Coverage Determination (LCD): Surgical Treatment of Nails (DL39258) and Proposed Local Coverage Article (LCA): Surgical Treatment of Nails (DA59028).

In the “Limitations” section of the proposed LCD, the following indications are listed as non-covered:

• Trimming, cutting, clipping or debridement of nails;
• Removing small chips or wedges of the nail or skin that does not require local anesthesia;
• Simple treatment of ingrown toenails (e.g., trimming, cutting, clipping of the distal unattached nail margins);
• Surgical treatment of asymptomatic conditions

We agree with the proposal to consider these indications to be non-covered. This is consistent with the education we already provide to our membership and plan to continue to provide should this proposal be finalized.

Problem #1

In the “Limitations” section of the proposed LCD, the following indication is proposed to be non-covered and not medically reasonable and necessary:

Repeat nail excision on the same toenail or fingernail following a complete nail excision for permanent removal

We do not agree with this proposal, and we list our reasons for this disagreement below.

Inability To Enforce

CPT^®1 11750 - Excision of nail and nail matrix, partial or complete (e.g., ingrown or deformed nail), for permanent removal

CPT^® 11750 does not differentiate between a partial nail permanent removal and a complete nail permanent removal. A partial nail permanent removal occurs when a single border of a toenail or fingernail, either medial or lateral, is permanently removed. A complete nail permanent removal occurs when an entire toenail or fingernail is permanently removed. Partial nail permanent removals are performed much more frequently than complete nail permanent removals. Under this proposal, as stated, any submission of CPT^® 11750 will disallow coverage of another CPT^® 11750 submitted for the same toe or finger indefinitely. This would be inappropriate as Palmetto providers have no way to indicate with CPT^® coding, including available CPT^® modifiers, whether CPT^® 11750 is being submitted for a partial nail permanent removal or a complete nail permanent removal. Likewise, Palmetto has no way of knowing whether a submitted CPT^® 11750 represents a partial nail permanent removal or a complete nail permanent removal. The only way for Palmetto to determine this would be manual record review, which would be terribly inefficient and introduce tremendous burden to both Palmetto providers and Palmetto staff. Worst of all, this inefficiency could delay care to Palmetto beneficiaries for a condition (ingrown toenail) which can cause infection, amputation, and even death.

Medial Versus Lateral Border Ingrown Nails

CPT^®1 11750 - Excision of nail and nail matrix, partial or complete (e.g., ingrown or deformed nail), for permanent removal

Ingrown toenails and fingernails typically occur along either a medial or lateral nail border. While it is possible for both medial and lateral borders to present ingrown at the same time, it is much more likely that only one border is ingrown on presentation. Pathology of one border of a nail is normally unrelated to pathology that exists on the other border of that same nail. When a permanent removal of either a medial or lateral border of a nail is performed, CPT^® 11750 does not differentiate between a medial or lateral border permanent removal. Furthermore, there are no CPT^® modifiers that allow providers to indicate which border was permanently removed when a medial or lateral nail border permanent removal is performed. The permanent removal of one border of a nail has no impact on the behavior of the other border of the same nail. For example, if a permanent removal of a medial border of a right hallux nail is performed, represented by CPT^® 11750 – T5 modifier, the lateral border of the same right hallux could require permanent removal one year later. This would result in another submission of CPT^® 11750 – T5 modifier. As proposed, Palmetto would have no way of knowing whether this second CPT^® 11750 was for the same medial border previously removed or for the unrelated lateral border without performing a manual record review, which would be terribly inefficient and introduce tremendous burden to both Palmetto providers and Palmetto staff. Worse, this inefficiency could delay care to Palmetto beneficiaries for a condition (ingrown toenail) which can cause infection, amputation, and even death.

Recurrence Happens

As shared in this Palmetto proposed LCD, a Cochrane systematic review found that one in 25 patients experience recurrence following nail avulsion with phenolization (permanent removal)². This is an incredibly high rate of recurrence. There is tremendous risk involved with limiting coverage for a pathology that occurs this frequently.

Inconsistency with Centers for Medicare and Medicaid Services (CMS) Precedent

Following nationwide implementation of an edit to require redetermination for repeat nail excisions, we engaged with staff across multiple centers within CMS, including the Center for Program Integrity (CPI), the Center for Clinical Standards and Quality (CCSQ), and the Center for Medicare (CM) over a period of several months to reverse the policy. As a result of this engagement, it is our understanding that CPI staff agreed that a requirement for redetermination was inappropriate and overly burdensome. To that end, CPI staff worked to revise the edit, effective April 3, 2023, thereby allowing medically reasonable and necessary repeat submissions of CPT^® 11750 for the same toe without the need to submit for redetermination. We believe that CMS’ revision of the nationwide edit to allow for repeat nail excisions without redetermination reflects an appropriate understanding of the costs versus benefits of restricting availability of repeat nail excisions. Therefore, we believe it should serve as a precedent that should be applied broadly across all jurisdictions.

The Solution

We ask that this limitation (Repeat nail excision on the same toenail or fingernail following a complete nail excision for permanent removal) be removed from this LCD when it is finalized for the reasons listed above.

Instead, Palmetto can address potential inappropriate utilization of CPT ^®11750 by mirroring the guidance of its colleagues at Novitas Solutions, Inc.³ and First Coast Services Options, Inc.⁴ by adding this guidance to this policy:

“For a medically reasonable and necessary repeat nail excision on the same finger or toe, report modifier KX (Requirements specified in the medical record have been met). The medical record documentation must be specific as to the indication, such as ingrown nail of the opposite border or new significant pathology on the same border recently treated.”

This commonsense solution allows providers to demonstrate the medical necessity of the procedure at the time of claim submission without the inefficiency that accompanies the redetermination process.

Problem #2

In the “Limitations” section of the proposed LCD, this indication is proposed to be non-covered and not medically reasonable and necessary:

When a complete nail avulsion is performed, a repeat nail avulsion of the same toenail or fingernail performed more often than every 32 weeks (8 months) for toenails or every 16 weeks (4 months) for fingernails

We do not agree with this proposal and list our reasons for this disagreement below.

Inability To Enforce

CPT^®1 11730 - Avulsion of nail plate, partial or complete, simple; single

CPT^® 11730 does not differentiate between a partial nail avulsion and a complete nail avulsion. A partial nail avulsion occurs when a single border of a nail, either medial or lateral, is avulsed. A complete nail avulsion occurs when an entire nail is removed. Partial nail avulsions are performed much more frequently than complete nail avulsions. We are concerned that any submission of CPT^® 11730 will trigger this 8-month (32 week) limitation should this limitation be finalized. This would be inappropriate as Palmetto providers have no way to indicate with CPT^® coding, including available CPT^® modifiers, whether CPT^® 11730 is being submitted for a partial nail avulsion or a complete nail avulsion. Likewise, Palmetto has no way of knowing whether a submitted CPT^® 11730 represents a partial nail avulsion or a complete nail avulsion. The only way for Palmetto to determine this would be manual record review, which would be terribly inefficient and introduce tremendous burden to both Palmetto providers and Palmetto staff. Worst of all, this inefficiency could delay care to Palmetto beneficiaries for a condition (ingrown toenail) which can cause infection, amputation, and even death.

Rate of Recurrence

In the proposed LCD, Palmetto provides multiple references that speak to how long it takes for an entire toenail to grow. This typically refers to how long it takes for a toenail to grow from the matrix to the distal aspect of the toe. However, ingrown and diseased toenails that require either complete or partial avulsion can occur without the toenail being fully grown to the distal edge of the toe. Ingrown toenails that can cause infection can occur anywhere proximal to distal along the medial and lateral nail grooves, including the most proximal aspect of the nail groove. While it may take 8 months for a toenail to grow from the matrix to the distal edge of the toe, it may take only one month for a toenail to grow 1/8 of the way from the matrix to the distal edge of the toe. With only this amount of nail growth, an ingrown toenail requiring avulsion may occur at the most proximal aspect of the medial or lateral nail border.

Therefore, there is grave danger in finalizing this proposed limitation. While the references in the proposed LCD speak to how long it may take a toenail to grow from the matrix to the distal tip of the toe, there is no peer-reviewed literature that speaks to how long it may take for an ingrown toenail to occur at the most proximal aspect of a medial or lateral nail border following complete nail avulsion. Recurrence of ingrown toenails following complete nail avulsion happens. If the recurrent ingrown toenail offends the skin at the most proximal aspect of the medial or lateral nail border, this can occur in much less than 8 months following complete nail avulsion. Denying Palmetto beneficiaries coverage for this needed service may lead beneficiaries to delay seeking care, increasing the risks of infection and amputation.

Medial Versus Lateral Border Ingrown Toenails

CPT^®1 11730 - Avulsion of nail plate, partial or complete, simple; single

Ingrown nails typically occur along either a medial or lateral border of a nail. While it is possible for both medial and lateral nail borders to present ingrown at the same time, it is much more likely that only one border is ingrown on presentation. Pathology of one border of a nail is normally unrelated to pathology that exists on the other border of that same nail. When a partial nail avulsion of either a medial or lateral border of a nail is performed, CPT^® 11730 does not differentiate between a medial or lateral border avulsion. Furthermore, there are no CPT^® Modifiers that allow providers to indicate which border was avulsed when a medial or lateral nail border avulsion is performed. The partial nail avulsion of one border of a toe has no impact on the behavior of the other border of the same toenail. For example, if an avulsion of a medial border of a right hallux nail is performed, represented by CPT^® 11730 – T5 modifier, the lateral border of the same right hallux could become ingrown three months later, requiring a partial nail avulsion. This would result in another submission of CPT^® 11730 – T5 modifier three months after the same CPT^® code with same modifier was submitted with submission representing a completely unrelated service. As proposed, Palmetto would have no way of knowing whether this second CPT^® 11730 was for the same medial border that was just performed three months ago or for an unrelated lateral border avulsion without performing a manual record review, which would be terribly inefficient and introduce tremendous burden to both Palmetto providers and Palmetto staff. Worst of all, this inefficiency could delay care to Palmetto beneficiaries for a condition (ingrown toenail) which can cause infection, amputation, and even death.

The Solution

We ask that this limitation (When a complete nail avulsion is performed, a repeat nail avulsion of the same toenail or fingernail performed more often than every 32 weeks (8 months) for toenails or every 16 weeks (4 months) for fingernails) be removed from this LCD when it is finalized for the three reasons listed above.

Instead, Palmetto can address potential overutilization of CPT^® 11730 by adding this guidance to this policy:

“For a medically reasonable and necessary repeat nail avulsion of the same toenail or fingernail performed more often than every 32 weeks (8 months) for toenails or every 16 weeks (4 months) for fingernails, report modifier KX (Requirements specified in the medical record have been met). The medical record documentation must be specific as to the indication, such as ingrown nail of the opposite border or new significant pathology on the same border recently treated.”

This commonsense solution allows providers to demonstrate the medical necessity of the procedure at the time of claim submission without the inefficiency that accompanies the redetermination process.

Alternate Solution

When communicating with multiple centers within CMS, including the Center for Program Integrity (CPI), the Center for Clinical Standards and Quality (CCSQ), and the Center for Medicare (CM) about these restrictions, it was shared that these came about in response to inappropriate submission of these repeat services by a small number of providers, identified as outliers. In response to this information, APMA and AADA launched an aggressive, nationwide campaign to educate our members regarding appropriate utilization of these services and provide guidance regarding what constitutes medical necessity when repeating these procedures. This education included in-person seminars, live webinars, recorded videos, social media posts, electronic mail communication, infographics, and more. We are confident the great majority of our members have received the guidance needed to appreciate when it is and when it is not medically necessary to repeat these two procedures.

The outliers can be identified. We suggest that another solution to this issue, aside from those listed above, is to identify the outliers and provide them with the proper guidance regarding use of these services, and even discipline if needed rather than inappropriately punishing every provider in the country with these burdensome requirements that are not rooted in science.

Conclusion

In summary, for the reasons listed herein, we support the four limitations listed on page 1 of this letter and ask that Palmetto not include the following under its list of limitations for the final LCD:

• Repeat nail excision on the same toenail or fingernail following a complete nail excision for permanent removal

• When a complete nail avulsion is performed, a repeat nail avulsion of the same toenail or fingernail performed more often than every 32 weeks (8 months) for toenails or every 16 weeks (4 months) for fingernails

Alternatively, Palmetto may allow these repeat procedures only with the submission of the KX Modifier as outlined above.

References and images were provided for review.

Thank you for your comments. The LCD and related billing and coding article were modified to include the -KX modifier to allow for a medically reasonable and necessary repeat nail excision on the same finger or toe, consistent with the CPT^® codes 11750 recognizing that additional therapy may be required on the same nail.

In addition, the LCD and related billing and coding article was modified to include the -KX modifier to allow for a medically reasonable and necessary repeat nail avulsion of the same toenail or fingernail performed more often than every 32 weeks (8 months) for toenails or every 16 weeks (4 months) for fingernails consistent with the CPT ^®code 11730 recognizing that additional therapy may be required on the same nail.