NCD 240.6, Transvenous (Catheter) Pulmonary Embolectomy, DAB No. 3047 (2021)

DECISION DISMISSING UNACCEPTABLE AMENDED COMPLAINT

On June 2, 2021, Medicare beneficiary B.B., through counsel, submitted a “Beneficiary Amended Complaint” (Amended Complaint) seeking review of National Coverage Determination (NCD) 240.6, “Transvenous (Catheter) Pulmonary Embolectomy.”  NCD 240.6 provides that a transvenous (catheter) pulmonary embolectomy, a procedure for removing pulmonary emboli by passing a catheter through the femoral vein, is not covered by Medicare because the procedure is considered experimental.  For the reasons explained below, the Departmental Appeals Board (Board) dismisses the Amended Complaint because it was not submitted by an aggrieved party and fails to comply with the requirements of 42 C.F.R. § 426.500.

Procedural History

On April 8, 2021, Medicare beneficiary B.B., through counsel, initiated this matter by submitting a “Beneficiary Complaint” (Complaint)to the Board seeking review of NCD 240.6.  On May 12, 2021, the Board sent the beneficiary a notice specifying that her Complaint was unacceptable and providing her with an opportunity to amend pursuant to 42 C.F.R. § 426.510(c).  Notice of Unacceptable NCD Complaint and Opportunity to Amend.  The Board determined that the Complaint was unacceptable, in part, because it did not establish that the beneficiary met the definition of an “aggrieved party.”  Id. at 2 (citing 42 C.F.R. § 426.110).  The Board explained that a Medicare beneficiary who had already received the service that was the subject of an NCD could be an “aggrieved party,” “so long as payment for the claim was denied based on the NCD at issue.”  Id. (citing 42 C.F.R. §§ 426.110, 426.500(b)(2)).1

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In determining that the Complaint was unacceptable, the Board noted that the Complaint contained conflicting statements regarding the status of the beneficiary’s claim for a transvenous pulmonary embolectomy.  Notice of Unacceptable NCD Complaint and Opportunity to Amend at 2.  Specifically, the Board highlighted that the Complaint alleged “the claims will be denied,” whereas the treating physician statement attached to the Complaint asserted that the claims were denied without specifying the basis.  Id. (citing Complaint ¶ 10; Treating Physician Statement ¶ 13).  The Board further informed the beneficiary that if she submitted an amended complaint that was still unacceptable, section 426.510(c)(3) would preclude her from filing another challenge to the NCD for six months.  Id.

Analysis

On June 2, 2021, the beneficiary, through counsel, submitted an Amended Complaint with attachments, including an amended treating physician statement.  The Amended Complaint and the amended treating physician statement clarify that the beneficiary is challenging NCD 240.6 based on a service she has not yet received, not the denial of a Medicare coverage claim for a service already received.  See Amended Complaint ¶ 11; Amended Treating Physician Statement ¶ 13.  The Board has reviewed the Amended Complaint and has determined that it does not meet the requirements of an acceptable complaint under 42 C.F.R. § 426.500.  The Board, therefore, dismisses the Amended Complaint for the reasons explained below.  See 42 C.F.R. §§ 426.505(c)(2), 426.510(c)(2), 426.544(b)(3), (4).

The regulations implementing the NCD review process provide that only an “aggrieved party” may initiate a review of an NCD.  42 C.F.R. § 426.320(a).  Thus, an acceptable NCD complaint must be filed by an “aggrieved party.”  Id. § 426.500(a); see also Social Security Act (Act) § 1869(f)(1)(A)(iii) (explaining that the Board reviews an NCD “[u]pon the filing of a complaint by an aggrieved party”); 42 C.F.R. § 426.544(b)(3) (requiring the Board to dismiss an NCD complaint if the complaint “is not filed by an aggrieved party”).  The regulations define an “aggrieved party,” in part, as a Medicare beneficiary who “[i]s in need of coverage for a service that is denied based on an applicable . . . NCD, regardless of whether the service was received.”  42 C.F.R. § 426.110 (emphasis added) (definitions); see also Act § 1869(f)(5) (providing that only Medicare beneficiaries “who are in need of the items or services that are the subject of the coverage determination” have standing to seek review of an NCD). 

The regulations further require that, to be valid, an acceptable NCD complaint must include a “written statement from the treating physician that the beneficiary needs the service that is the subject of the NCD.”  42 C.F.R. § 426.500(c)(3) (emphasis added).  This written statement “may be in the form of a written order . . . or other documentation from the beneficiary’s medical record . . . indicating that the beneficiary needs the service.”  Id. (emphasis added).  An acceptable NCD complaint must also include a

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statement from the aggrieved party “explaining what service is needed.”  Id. § 426.500(c)(5) (emphasis added).  The Board must dismiss an NCD complaint “filed by an individual who fails to provide an adequate statement of need for the service from the treating physician.”  Id. § 426.544(b)(4).

The Board evaluates the acceptability of an NCD complaint by confirming, among other things, that the complaint (1) “is being submitted by an aggrieved party,” and (2) “meets the requirements for a valid complaint in § 426.500.”  42 C.F.R. §§ 426.510(b)(1), (2).  A beneficiary has a single opportunity to amend a complaint that the Board has determined to be unacceptable.  Id. § 426.510(c)(1).  The Board must dismiss a complaint that is still unacceptable following an amendment.  Id. §§ 426.505(c)(2), 426.510(c)(2), 426.544(b)(3), (4).  The submission of an unacceptable amended complaint to the Board also precludes the beneficiary from filing another challenge to the NCD for six months after being informed that the amended complaint is unacceptable.  Id. § 426.510(c)(3).

The Amended Complaint does not establish that the beneficiary is an “aggrieved party” who is “in need of coverage for a service.”  See 42 C.F.R. § 426.110 (emphasis added).  Instead, the beneficiary is challenging NCD 240.6 because the beneficiary and her physician “expect claims for a future pulmonary embolectomy will be denied.”  Amended Complaint ¶ 11 (emphasis added).  The Amended Complaint explains that, “[b]ecause [the beneficiary] has had pulmonary emboli [in the past], she is at greater risk of having additional pulmonary emboli and will need to have a pulmonary embolectomy in the future.”  Id. ¶ 10.  In addition, the treating physician’s amended statement provides that, “[b]ecause [the beneficiary] has had pulmonary emboli, she is at greater risk for additional pulmonary emboli in the future,” and “will need a pulmonary embolectomy to resolve future pulmonary emboli.”  Amended Treating Physician Statement ¶ 13.  There is no allegation in the Amended Complaint that the beneficiary “is in need of coverage” for a transvenous pulmonary embolectomy.  Similarly, the amended statement of the treating physician includes no assertion that the beneficiary “needs” a transvenous pulmonary embolectomy.  Moreover, the Amended Complaint includes no documentation, such as a physician order or other medical record, indicating that the beneficiary “needs” a transvenous pulmonary embolectomy.  Cf. 42 C.F.R. § 426.500(c)(3). 

The assertions made in the Amended Complaint and amended treating physician statement about a possible future pulmonary embolism and the potential need for a transvenous pulmonary embolectomy are plainly inadequate.  The regulations do not permit a Medicare beneficiary to challenge an NCD based on speculative statements about a possible future need for a service that is not covered by Medicare.  We conclude that the Amended Complaint is unacceptable because it does not demonstrate that B.B. “[i]s in need of coverage for a service that is denied” by NCD 240.6.  See 42 C.F.R. § 426.110 (defining “aggrieved party”).  And, the Amended Complaint is unacceptable because there is no attached treating physician statement, physician’s order, or other

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medical record indicating that B.B. “needs” a transvenous pulmonary embolectomy.  See id. § 426.500(c)(3) (necessitating a “written statement from the treating physician that the beneficiary needs the service that is the subject of the NCD”).  Still further, the beneficiary does not assert that a transvenous pulmonary embolectomy “is needed.”  See id. § 426.500(c)(5) (requiring a statement by the aggrieved party “explaining what service is needed”); see also Act § 1869(f)(5) (only Medicare beneficiaries “who are in need of the . . . services that are the subject of the coverage determination” have standing to seek review of an NCD).2

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Conclusion

For all of these reasons, the Board dismisses the Amended Complaint pursuant to 42 C.F.R. §§ 426.505(c)(2), 426.510(c)(2), and 426.544(b)(3), (4).  Because the Board has determined that the beneficiary’s Amended Complaint is unacceptable, the beneficiary is precluded from filing another challenge to NCD 240.6 for six months.  See 42 C.F.R. § 426.510(c)(3).3

1. The Board also concluded that the Complaint was unacceptable because it did not establish that it was timely filed within 120 days of the initial denial notice.  Notice of Unacceptable NCD Complaint and Opportunity to Amend at 2 (citing 42 C.F.R. § 426.500(b)(2)).  Because the Amended Complaint clarifies that the beneficiary’s NCD challenge is based on “claims for a future pulmonary embolectomy,” Amended Complaint ¶ 11, the timeliness of the NCD challenge is no longer at issue.
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2. To be clear, we are not deciding that a Medicare beneficiary can never challenge an NCD precluding coverage for an item or service the beneficiary needs in the future.  We can imagine scenarios where, for example, a treating physician certifies that a beneficiary has an existing medical condition that requires a non-covered medical procedure within a certain time period.  Such evidence may be sufficient to satisfy the requirements of section 426.500(c)(3) and establish that the beneficiary is an “aggrieved party.”  We do not decide the outer limits of what is required for an acceptable NCD complaint, but conclude only that the speculative assertions in this case about possible future medical conditions requiring a non-covered treatment are inadequate.
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3. The Board’s May 12, 2021 notice highlighted the potential availability of other kinds of review processes, such as a request for the Centers for Medicare & Medicaid Services (CMS) to reconsider the NCD.  Notice of Unacceptable NCD Complaint and Opportunity to Amend at 3.  We note that CMS has initiated and is currently conducting a national coverage analysis of NCD 240.6.  CMS, National Coverage Analysis (NCA) Tracking Sheet for Transvenous (Catheter) Pulmonary Embolectomy (CAG-00457R), (last visited August 11, 2021), https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.  Further information is available on CMS’s website at https://www.cms.gov/Medicare/Coverage/DeterminationProcess.
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