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                              In re LCD Complaint: Rituximab, DAB CR6149 (2022)
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*In re LCD Complaint:* Rituximab, DAB CR6149 (2022)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





*In re LCD Complaint:* Rituximab (LCD No. L33394)
Docket No. C-22-469Decision No. CR6149September 1, 2022

        
              
    

      DECISION DISMISSING COMPLAINT

On April 11, 2022, the Civil Remedies Division (CRD) of the Departmental Appeals Board (the Board) received a letter from physicians, on behalf of an Aggrieved Party (AP), a Medicare beneficiary, challenging a Local Coverage Determination (LCD) related to the use of Rituximab infusions to treat atypical demyelinating disorder.  The AP failed to respond to an Order to Show Cause issued on July 6, 2022. As a result, this matter will be dismissed.  The AP is entitled to request further review by the Appellate Division of the Board as explained hereafter.

I.    Background

By letter dated April 11, 2022, two physicians, on behalf of an AP, filed a complaint alleging that Medicare does not cover the use of Rituximab to treat atypical demyelinating disorder.  According to the physicians, the AP requires biannual infusions of Rituximab due to its success in stabilizing her condition.

On May 3, 2022, the CRD acknowledged receipt of the letter and issued an Acknowledgment of Receipt and Order to Aggrieved Party to Amend Unacceptable Complaint (Acknowledgment).  The CRD treated the physicians’ letter as a request for review of an LCD.  The Acknowledgment noted that neither the title1 of the LCD being

**Page 2**

challenged nor the specific provision of the LCD adversely affecting the AP was provided.  The Acknowledgment explained the requirements for filing a valid complaint challenging an LCD and determined that the physicians’ submission did not meet those requirements.  Citing the requirements of 42 C.F.R. § 426.410(c)(1), the Acknowledgment directed the AP to file a valid amended complaint no later than June 2, 2022.

On June 2, 2022, the AP filed an amended complaint in response to the Acknowledgment.  The amended complaint did not include the information required by 42 C.F.R. § 426.400(c)(4).  The Order issued on June 8, 2022, offered the AP an opportunity to provide clarifying information to meet the requirements for filing a valid complaint challenging an LCD.  The AP was directed to file the clarifying information and documents or a statement indicating that she does not have the information no later than June 22, 2022.

The AP did not file the clarifying information and documents by the deadline.  Therefore, an Order to Show Cause was issued on July 6, 2022, directing the AP to file the clarifying information and documents no later than July 18, 2022.  The AP was informed that failure to submit an acceptable amended complaint by July 18, 2022, may result in the dismissal of this case.  As of the date of this decision, the AP has not responded to the Order to Show Cause or filed a valid amended complaint.

II.   Discussion

**A.  Applicable Law**

Section 1862 of the Social Security Act (the Act) (42 U.S.C. § 1395y), which is applicable to both Medicare Part A and Part B, provides that no payment may be made for items or services “which . . . are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member . . . .”  The Secretary of the Department of Health and Human Services (the Secretary) has provided, by regulation, that any services not reasonable and necessary for one of the purposes listed in the regulations are excluded from coverage under Medicare.  42 C.F.R. § 411.15(k).  The Medicare Benefit Policy Manual, CMS pub. 100-02, ch.16, §§ 10 and 20, provides that no payment may be made for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

**Page 3**

The Centers for Medicare and Medicaid Services (CMS) administers the Medicare program (Act §§ 1102, 1871, 1874 (42 U.S.C. §§ 1302, 1395hh, 1395kk)) and contracts with carriers and intermediaries (Medicare contractors) to act on its behalf in determining and making payments to providers and suppliers of Medicare items and services.  Act §§ 1816, 1842 (42 U.S.C. §§ 1395h, 1395u).  The Act provides for both National Coverage Determinations (NCDs) and LCDs.  Act § 1869(f)(l)(B) and (2)(8) (42 U.S.C. § 1395ff(f)(l)(B) and (2)(B)).  An LCD, as defined by the Act, is “a determination by a fiscal intermediary or a carrier . . . respecting whether or not a particular item or service is covered” within the area covered by the contractor.  Act § 1869(f)(2)(B) (42 U.S.C. § 1395ff(f)(2)(B)); 42 C.F.R. § 400.202.  In the absence of an NCD or an LCD, individual claim determinations are made based upon an individual beneficiary's particular factual situation.  68 Fed. Reg. at 63,693 (citing *Heckler v. Ringer,*466 U.S. 602, 617 (1984) (recognizing that the Secretary has discretion to either establish a generally applicable rule or to allow individual adjudication)); 42 C.F.R. §§ 426.420(a), (b), (e)(l), 426.460(b)(1), 426.488(b).

An aggrieved Medicare beneficiary (i.e., an aggrieved party) who has been denied coverage for an item or service based on an LCD may challenge that LCD before an administrative law judge (ALJ).  The aggrieved party initiates the review by filing a written complaint that must meet the criteria specified in the governing regulations.  42 C.F.R. §§ 426.400; 426.410(b)(2).  If an ALJ determines that the complaint is unacceptable, the ALJ must provide the aggrieved party one opportunity to amend the unacceptable complaint.  42 C.F.R. § 426.410(c)(l).  If the aggrieved party fails to submit an acceptable amended complaint within a reasonable timeframe as determined by the ALJ, the ALJ must issue a decision dismissing the unacceptable complaint.  42 C.F.R. § 426.410(c)(2).  If a complaint is determined unacceptable after one amendment, the aggrieved party is precluded from filing again for six months after being informed that it is unacceptable.  42 C.F.R. § 426.410(c)(3).

**B.  Findings of Fact, Conclusion of Law, and Analysis**

**The AP failed to file an amended complaint within the allotted timeframe, and dismissal is required by 42 C.F.R. § 426.410(c)(2).**On May 3, 2022, the AP was advised that her treating physicians were not aggrieved parties within the meaning of the regulations, that the LCD challenge did not include the information needed to determine the timeliness of the complaint, and that the name of the contractor using the LCD was required to find the complaint was acceptable.  The AP was directed to submit both a copy of the LCD and a statement explaining 1) what service was needed; 2) why the AP thinks the LCD is not valid under the reasonableness standard; and 3) additional information needed to determine the timeliness of the complaint.

**Page 4**

On June 2, 2022, the AP filed an amended complaint in response to the Acknowledgment.  The amended complaint still did not include the information required by 42 C.F.R. § 426.400(c)(4).  The AP was offered a second opportunity to provide clarifying information to meet the requirements for filing a valid complaint challenging an LCD.  The AP was directed to file the clarifying information and a copy of the LCD or a statement that she did not receive a copy of the LCD no later than June 22, 2022.

The AP did not file the clarifying information and documents by the deadline.  As a result, an Order to Show Cause was issued on July 6, 2022, directing the AP to file the clarifying information and documents no later than July 18, 2022.  The AP was informed that failure to submit an acceptable amended complaint by July 18, 2022, may result in dismissal of the hearing request.

The AP was also advised that her amended complaint must satisfy all the requirements for an acceptable complaint specified at 42 C.F.R. § 426.400.  Finally, the AP was advised that if the amended complaint did not contain all of the required information her case would be dismissed.  Because the AP has not, within the timeframe established, submitted an acceptable amended complaint, this action must be dismissed pursuant to 42 C.F.R. § 426.410(c)(2).

**Appeal rights.  42 C.F.R. §§ 426.462, 426.465.**Pursuant to 42 C.F.R. § 426.465(a), an AP may request review by the Appellate Division of the Board.  Except upon a showing of good cause, a request for review by the Board must be filed within 30 days of the date of this decision (42 C.F.R. § 426.365(e)) and must comply with the requirements of 42 C.F.R. § 426.465(f).

III.  Conclusion

For the foregoing reasons, the complaint is dismissed.

Endnote

1  The Acknowledgment noted that the CRD docketed this matter as *In re LCD Complaint*:  Rituximab (LCD No. L33394) because preliminary searches for LCDs Drugs and Biologicals, Coverage of, for Label and Off-Label Uses for Rituximab and for services performed on or after August 1, 2016, returned results for two LCDs:  L33394 and L35026.  LCD No. L35026 does not include a contractor with jurisdiction in the location where the AP received treatment.  LCD No. L33394 does include a contractor with jurisdiction in the AP’s treatment location.  As a result, the CRD docketed this matter as *In re LCD Complaint:*  Rituximab (LCD No. L33394).  The AP was directed to include the LCD number and the contractor’s name in her amended complaint.
  
          /s/
        Tannisha D. Bell

                      Administrative Law Judge Back to top
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