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                              LCD Complaint:  Knee Orthoses, DAB No. 3005 (2020)
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LCD Complaint:  Knee Orthoses, DAB No. 3005 (2020)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Appellate Division





LCD Complaint:  Knee Orthoses
	(LCD L33318)
Docket No. A-20-34Decision No. 3005June 25, 2020

        
              
    

      FINAL DECISION ON REVIEW OF ADMINISTRATIVE LAW JUDGE DECISION
Complainant, a Medicare beneficiary, challenged a Medicare coverage policy, called a Local Coverage Determination (LCD), under 42 C.F.R. Part 426, which authorizes the Departmental Appeals Board and its administrative law judges (ALJs) to review the validity of LCDs issued by Medicare program contractors.  Complainant seeks review of the ALJ's decision to dismiss his amended complaint challenging LCD L33318, Knee Orthoses.  *Acknowledgment of Receipt of Acceptable Complaint as to LCD L35427, Order to File Record for LCD L35427, and Briefing Schedule; and Dismissal of Complaint as to LCD L33318*, CRD Docket No. C-20-2431
 (Dec. 12, 2019) (ALJ Dismissal).  The ALJ dismissed as unacceptable the amended complaint as to LCD L33318 based on his determination that it did not contain a treating physician's statement that demonstrates the medical necessity of new custom-fabricated bilateral knee orthoses (knee braces).  For the reasons set forth below, we affirm the ALJ's dismissal.
Legal Background
Section 1869(f)(2) of the Social Security Act and the regulations at 42 C.F.R. Part 426 permit Medicare beneficiaries denied coverage for items or services on the basis of an LCD to challenge the validity of the LCD by filing an "LCD complaint" before an ALJ.  42 C.F.R. §§ 426.110, 426.320, 426.400; *see generally* 42 C.F.R. Part 426, subparts C, D. After an LCD complaint is docketed, the ALJ evaluates whether the complaint is "acceptable."  *Id*. § 426.410(b).  In order to be acceptable, an LCD complaint must meet
**Page 2**
the requirements for a valid complaint in section 426.400 (*id.* § 426.410(b)(2)), which include, among other things, a "copy of a written statement from the treating physician that the beneficiary needs the service that is the subject of the LCD."  *Id*. § 426.400(c)(3).  The statement "may be in the form of a written order for the service or other documentation from the beneficiary's medical record (such as progress notes or discharge summary) indicating that the beneficiary needs the service."  *Id*.
If the ALJ determines that the complaint is unacceptable, the ALJ must provide the beneficiary an opportunity to amend the complaint "within a reasonable timeframe as determined by the ALJ."  *Id*. § 426.410(c)(1), (c)(2).  If the ALJ later determines that the amended complaint is unacceptable, the ALJ must issue a decision dismissing that complaint.  *Id*. § 426.410(c)(2).  The beneficiary may then appeal the dismissal to the Board within 30 days of the date of the dismissal.  *Id*. § 426.465(a)(2), (e).  The standard of review that the Board applies is "whether the ALJ decision [dismissing the complaint] contains any material error."  *Id*. § 426.476(b)(1).
Case Background
Complainant2
 requested ALJ review of two LCDs, Knee Orthoses (LCD L33318) and Hyaluronan Acid Therapies for Osteoarthritis of the Knee (LCD L35427), pursuant to 42 C.F.R. Part 426.  ALJ Dismissal at 2; Request for LCD review at 1.  Complainant also requested review regarding the availability of platelet rich plasma injections, which he acknowledged were not covered under any LCD.  ALJ Dismissal at 2; Request for LCD review at 1.  Regarding LCD L33318, Complainant stated that he was "requesting replacement of [his] existing custom fabricated Bi Lateral orthosis braces every three years for both knees."  *Id*.  Complainant also stated that he was no longer qualified to receive new knee braces because the challenged LCD requires a beneficiary "to have a recent injury to or surgical procedure on the knees."  *Id*.  Complainant explained that he does not have a recent injury and that he cannot have surgery on both knees due to comorbidities.  *Id*.
The ALJ issued an acknowledgment letter in which he stated that Complainant's request was "not an acceptable complaint."  Acknowledgment Letter at 2.  The ALJ explained that Complainant "must be an aggrieved party within the meaning of the regulations."  *Id*. at 3.  As the ALJ also explained, to be an "aggrieved party," Complainant must be entitled to Medicare benefits, in need of the service or equipment denied based on an applicable LCD, and have documentation of need by the Complainant's (beneficiary's) treating physician.  *Id.*; 42 C.F.R. § 426.110 (defining "Aggrieved party").  The ALJ
**Page 3**
found that Complainant "failed to submit documents showing that a Medicare contractor denied coverage or would deny coverage for the necessary equipment based on an LCD within the 120 days preceding" the filing of the complaint.  Acknowledgment Letter at 3.  The ALJ also found that Complainant "failed to submit any clinical or scientific evidence that shows why [Complainant] believe[d] that a determination not to provide coverage is unreasonable."  *Id*. (citing 42 C.F.R. § 426.400(c)(6)).  The ALJ explained that section 426.410(c) permits a single opportunity to "correct [the] unacceptable complaint," and that section 426.410(c) "required" him to dismiss the case if Complainant failed to do so.  *Id*.  The ALJ informed Complainant that his "amended complaint must satisfy all the requirements for an acceptable complaint specified at 42 C.F.R. § 426.400."  *Id*.
In response, Complainant filed an amended complaint and eight exhibits (P. Exs. 1-8), which included a July 30, 2019 letter from his treating physician, Dr. T.W., stating that Complainant needs hyaluronic acid injections every three months (P. Ex. 1).  ALJ Dismissal at 4.  The ALJ subsequently issued the dismissal, determining that the complaint as to LCD L35427 was acceptable.  *Id*. at 3.  The ALJ also determined that the complaint as to the platelet rich plasma injections had been withdrawn.  *Id*.  However, the ALJ determined that the amended complaint as to LCD L33318 must be dismissed as unacceptable because it did not include a treating physician's statement of medical necessity in accordance with section 426.400(c)(3).  *Id*. at 4.  The ALJ found that the July 30, 2019 physician statement, P. Ex. 1, related to the need of hyaluronic acid injections and, while it mentioned the use of bracing as part of "management strategies," it did not state that Complainant was "in need of new braces."  *Id*.  The ALJ explained that he gave Complainant an opportunity to submit an acceptable (amended) complaint,3
 which Complainant did not do, and he was therefore required to dismiss the complaint pursuant to section 426.410(c)(2).  *Id*.  The ALJ notified Complainant that he was precluded from filing a new complaint regarding LCD L33318 for six months.  *Id*. (citing 42 C.F.R. § 426.410(c)(3)).
Complainant timely filed this appeal.
Discussion
Before the Board, Complainant argues that the ALJ committed a material error in determining that he had not submitted an acceptable amended complaint that included the requisite treating physician's statement of medical necessity of new braces.  Complainant
**Page 4**
points to a July 3, 2019 email from an individual at the office of Complainant's treating physician (Dr. T.W.) to Complainant as evidence of a doctor's determination of medical necessity.  Complainant's Appeal (CA)4
 at 15, 18; P. Ex. 2, at 1.  In the email, the individual stated that she wrote to the supplier's representative "regarding the bilateral knee braces," but had not yet received a response.  P. Ex. 2, at 1.  We see nothing in the July 3, 2019 email or elsewhere in the record on which the ALJ issued his dismissal that the author of the email is a physician.  That aside, the email says nothing about medical necessity.  It merely indicates that the author of the email contacted the supplier about the braces.5
Moreover, Complainant does not raise any argument concerning the ALJ's finding that the July 30, 2019 physician statement, P. Ex. 1, did not prove that Complainant required new knee braces because it mentioned "management strategies" that included the use of bracing, but did not state that Complainant was "in need of new braces."  ALJ Dismissal at 4.  Nor does the record on which the ALJ issued his dismissal include any medical records, such as progress notes, that demonstrate the medical necessity of new bracing.  *See* 42 C.F.R. § 426.400(c)(3) (requisite evidence of medical necessity may be established based on "documentation from the beneficiary's medical record" indicating medical need).  We therefore find no error in the ALJ's conclusion, *based on the record before the ALJ*, that Complainant had failed to submit a valid, acceptable complaint.6
**Page 5**
Complainant now offers the Board a January 7, 2020 letter from Dr. T.W., who wrote that, although "recent guidelines to [M]edicare disqualifies [Complainant] for bracing," Complainant has been wearing braces for some time and should have "replacement" braces every three years beginning in 2020.  CA at 14.  This letter – written two months after the date the ALJ permitted for submittal of a valid amended complaint, November 4, 2019 – comes too late.  As the ALJ explained, he was *required* to dismiss a complaint as unacceptable if, after *one* opportunity to amend it "within a reasonable timeframe as determined by the ALJ" (42 C.F.R. § 426.410(c)(2)), Complainant failed to amend it to make the complaint an acceptable one.  Acknowledgment Letter at 3.  The ALJ also explained that the amended complaint must satisfy 42 C.F.R. § 426.400 (*id.*), which states that requisite evidence of medical necessity is one of several requirements of a valid, acceptable complaint.
Complainant does not assert that the time period the ALJ gave him to amend his complaint to make it a valid, acceptable one – almost one month from the date of the ALJ's Acknowledgment Letter – was unreasonable.  He does not state that he was unable to obtain a letter from Dr. T.W., his treating physician, before November 4, 2019, for any reason.7
  Nor do we see anything in the record of the ALJ proceedings or in Complainant's submission to the Board that causes us to question whether Complainant was aware of what he needed to submit to the ALJ and when he must do so.  The ALJ did not err in dismissing the amended complaint as unacceptable for failure to include the requisite evidence of medical necessity despite the opportunity to correct the complaint.  By regulation, the ALJ was required to do so under the circumstances.
Lastly, we note that the ALJ informed Complainant that he had not established that he is an "aggrieved party" consistent with the definition in 42 C.F.R. § 426.110 because he "failed to submit documents showing that a Medicare contractor denied coverage or would deny coverage for the necessary equipment based on an LCD[.]"  Acknowledgment Letter at 3.  The ALJ Dismissal did not address whether the amended complaint established that Complainant met the regulatory definition of an "aggrieved party" as it relates to his challenge of LCD L33318.  But we find no material error based on the ALJ's not having addressed specifically whether Complainant met the regulatory definition of an "aggrieved party" because the basis on which the ALJ dismissed the
**Page 6**
amended complaint was itself legally sound.  42 C.F.R. § 426.476(b)(1).  We observe that one element of the regulatory definition of an "aggrieved party" is that the beneficiary "[h]as obtained documentation of need by the beneficiary's treating physician" (42 C.F.R. § 426.110) – the very evidence Complainant failed to submit to the ALJ by November 4, 2019 to support a valid, amended complaint.
Conclusion
We uphold the ALJ's dismissal of the amended complaint as to LCD L33318.  Pursuant to 42 C.F.R. § 426.410(c)(3), Complainant may file another complaint "6 months after being informed" that his complaint was unacceptable.


          /s/
        Christopher S. Randolph

                      Board Member
          /s/
        Constance B. Tobias

                      Board Member
          /s/
        Susan S. Yim

                      Presiding Board Member
      1. Complainant challenged LCD L33318, the subject of this appeal, and LCD L35427 in a single complaint, which was docketed under CRD Docket No. C-19-1132.  The ALJ subsequently dismissed the complaint as to LCD L33318 but accepted the complaint as to LCD L35427.  On January 16, 2020, the ALJ issued an order severing the dismissed complaint as to LCD L33318 "[i]n order to minimize confusion and to facilitate the processing of the appeal before the Board and any possible disposition by the Board[.]"  Order Severing Dismissed Complaint as to LCD L33318, at 2.  The severed case and all documents filed as of December 12, 2019 – the date of dismissal – were made available to the parties and to the Board for review under CRD Docket No. C-20-243.  Id. back to note 1
                      2. In his dismissal, the ALJ referred to the party requesting LCD review as the "Aggrieved Party."  We refer to that party as "Complainant" or "beneficiary" in this decision, depending on the context and as dictated by controlling authority. back to note 2
                      3. The ALJ's October 7, 2019 Acknowledgment Letter, page 3, stated that November 4, 2019 is the date by which the amended complaint must be filed electronically (or postmarked by that date if mailed as permitted by waiver of electronic filing). back to note 3
                      4. Complainant filed his appeal with the Medicare Operations Division of the Departmental Appeals Board via DAB E-File.  The Medicare Operations Division delivered the misfiled appeal to the Appellate Division, which uploaded the cover sheet identifying Complainant's submission to the Medicare Operations Division along with Complaint's submissions as a single PDF document (19 pages).  Complainant's submissions include items that duplicate those submitted to the ALJ and the ALJ's dismissal.  We cite to the PDF page numbers of the 19-page document. back to note 4
                      5. If, for instance, the individual had referred to a physician ordering the braces about which the individual had contacted the supplier, that could at least suggest the possibility that a physician had determined Complainant needed or should have the braces, even though the email itself would not suffice as a (treating) physician's order.  See 42 C.F.R. § 426.400(c)(3) (stating that the requisite evidence of medical necessity "may be in the form of a written order for the service").  But the email merely indicates that the individual, who apparently is not a doctor, contacted the supplier about the braces. back to note 5
                      6. Among the items Complainant submitted to the ALJ was a 2019 letter from Dr. C.P., an orthopedic specialist.  See P. Ex. 5.  C.P. stated that he treated Complainant between 1996 and 2015, and had not seen Complainant "in over 4 years."  Id. at 1.  Based on these statements, we are unable to determine that C.P. had an ongoing treating relationship with Complainant at the time the amended complaint was submitted.  See In re CMS LCD Complaint: Posterior Tibial Nerve Stimulation PTNS (L28457), DAB No. 2503, at 8 (2013) (finding that a urologist had an "ongoing treating relationship with the beneficiary," thus satisfying the "treating physician" requirement).  In any case, Complainant does not assert that C.P. is his treating physician or otherwise rely on C.P.'s statements to satisfy section 426.400(c)(3). back to note 6
                      7. The ALJ indicated that he had considered the July 30, 2019 physician statement, as we discussed above, supra at 4, but determined that it did not actually indicate that Complainant needed new braces.  ALJ Dismissal at 4.  We note that, although the ALJ did not expressly state as much, the physician who wrote the July 30, 2019 statement was Dr. T.W., Complainant's treating physician.  We agree with the ALJ's reading of that statement inasmuch as almost all of its contents concern knee injections, as opposed to the medical necessity of knee braces.  Moreover, if Dr. T.W., as the treating physician, was available to prepare such a letter for Complainant on July 30, 2019, it is not unreasonable for us to think that he could have directly addressed the medical necessity of knee braces in that letter or prepared another letter specifically addressing the medical necessity of knee braces a few months later, before November 4, 2019, if in his opinion Complainant needed the braces. back to note 7 Back to top
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