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Monday, October 8, 2018

Burton: Systemic Therapy For Skin Disabilities (Johnson v. Shulkin Continued)


Burton v. Wilkie, Opinion Number 16-2037, decided September 28, 2018 addresses and helps define systemic therapy for skin disabilities.  It is essentially an explanation of Johnson v. Shulkin, 862 F.3d 1351 (Fed. Cir. 2017). 

DC 7806, which impacts certain skin conditions, asks whether the treatment is systemic therapy.  The Court noted:

In Johnson, the Federal Circuit reversed this Court's decision that under DC 7806 topical
corticosteroids categorically constituted systemic therapy. 862 F.3d at 1352. Instead, the Federal Circuit held that the DC contemplated two types of therapy: systemic and topical. Id. at 1354. The court referenced Dorland's Illustrated Medical Dictionary in defining "systemic therapy." Id. at 1354-55. The court noted that "systemic" is defined as "pertaining to or affecting the body as a whole" and "therapy" is defined as "treatment of diseases." Id. at 1355. We will rely on these definitions to guide our analysis.

Although the Federal Circuit found a distinction between topical and systemic therapies, it made clear that sometimes a topical treatment can be systemic therapy. Id. at 1355-56. The Federal Circuit stated that "a topical corticosteroid could be considered either a systemic therapy or topical therapy based on the factual circumstances of each case." Id. at 1356. The court went on to opine that a topical therapy could be systemic if it was applied on a large enough scale.

Id. at *5.

The Court first rejected any argument that the key to systemic therapy required large scale topical application and held “large scale application is merely an example of a factual circumstance that can convert topical treatment into a systemic therapy.” Id. at *6.
The Court then stated “to qualify as a systemic therapy it is not enough that the
treatment standing alone affects the entire body. Rather, it must affect the entire body in its treatment of the condition at issue.”  Id.  The Court then concluded that

the Board must determine whether a topical treatment operates by affecting the body as a whole in treating the veteran's skin condition. Stated a different way, the Board must decide how the topical treatment works – not by its contact with the affected location of the condition on the body, but instead in some other way that affects the body more broadly. For example, a topical treatment may affect the body as a whole if it circulates through the bloodstream. Thus, in affecting the body as a whole, it essentially would not
matter whether the topical treatment was applied where the condition was located or some other part of the body, as the body in its entirety would be involved in the treatment.

How a topical treatment works is a factual question that may, but not necessarily, require
a medical opinion for its resolution.

Id. at *6-7.

While discussing this line of reasoning, the Court took time to attack the VA’s failure to update the M21-1 (the VA Adjudication Procedures Manual).  It noted the manual conflicts with Federal Circuit case by stating topical treatments are not considered systemic.  Id. at *7.  It then went further and stated “The Secretary's delay of a year and counting in updating VA's materials to comply with a Federal Circuit decision is unacceptable and especially egregious because it is not the first time that VA has delayed in implementing a court directive.”  Id. at *8.

The Court then noted the VA has changed the skin disordered diagnostic code to state topically applied treatment cannot qualify as systemic therapy, though the rule does not apply to claims made prior to August 13, 2018.  It then seemed to fire a warning shot at the VA in terms of a continued failure to implement court directives stating:

As noted above, after continued delay in updating the M21-1 to reflect Johnson, VA
published a final rule and changed DC 7806, effective August 13, 2018. There is nothing wrong with an administrative agency engaging in rulemaking, as VA has done, when it disagrees with a judicial interpretation of a regulation. Provided the agency follows the appropriate procedures, such rulemaking is a prime example of how separation of powers operates in American Government. An agency can change the law going forward. But  what an agency may not do is refuse to implement a court's decision while the agency seeks to change a regulation to conform to its view. Such refusal is antithetical to separation of powers. It is not acceptable in a country governed by the rule of law. VA should stop these actions of its own accord. Otherwise, the courts will have to act to preserve the constitutional separation of powers.

Id. at *8.
The Court then considered the impact of side effects from medication and determined:

It is simply not enough under DC 7806 for something to be systemic; it must also be treatment for the condition.  Therefore, if a treatment does not affect the body as a whole in the way in which it treats a skin condition, it cannot be considered systemic therapy for that skin condition, regardless of whether side effects result.

As the Secretary pointed out at oral argument, side effects can raise the possibility of
secondary service connection.

Id. at *9.

The Court also considered the veteran’s use of Benadryl and argument that if its use was systemic it might entitle the veteran to a higher rating, and determined

In Warren, this Court held that "systemic therapy" in DC 7806 was not limited to corticosteroids or immunosuppressive drugs. 28 Vet.App. at 197. Rather, the use of the phrase "such as" in DC 7806 before "corticosteroids or other immunosuppressive drugs" means that "those drug types do not constitute an exhaustive list of all compensable systemic therapies, but rather serve as examples of the kind and degrees of treatments used to justify a particular disability rating." Id. Therefore, the Board must determine whether a given treatment is "like" a corticosteroid or other immunosuppressive drug in determining whether the treatment constituted a systemic therapy to warrant a higher rating.

Id. at *10.

This case reveals the depths the VA will go to avoid a judicial decision they disagree with—they will simply change the regulation to make a less pro-veteran friendly regulation and refuse to change its manual (which gives guidance to VA decision-makers). It was heartening to see the Court especially take issue with the refusal to change the manual to conform with court directives. 

Decision by Judge Allen and joined in by Judges Schoelen and Greenberg.


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