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                              In Re LCD Complaint: Enteral Nutrition (L33783), DAB CR5276 (2019)
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In Re LCD Complaint: Enteral Nutrition (L33783), DAB CR5276 (2019)








  
  
    

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





*In Re LCD Complaint*: Enteral Nutrition (L33783)
Docket No. C-19-385Decision No. CR5276March 20, 2019

        
              
    

      DECISION DISMISSING LCD COMPLAINT
The complaint of a Medicare beneficiary1
 (Complainant) dated January 15, 2019, challenging a Local Coverage Determination (LCD) titled Enteral Nutrition is dismissed as unacceptable pursuant to 42 C.F.R. § 426.410(c)(2).  The Complainant, who purports to be an aggrieved party, is entitled to request further review by the Appellate Division of the Departmental Appeals Board (the Board) as explained hereafter.
I. Background
On January 15, 2019, counsel filed a letter on behalf of Complainant in which counsel requested Medicare coverage for an enteral feeding supply kit and enteral formula.  The case was assigned to me on January 31, 2019.  I treated the letter as a LCD complaint challenging a LCD titled Enteral Nutrition.
I advised Complainant by letter dated January 31, 2019, that I had evaluated his complaint pursuant to 42 C.F.R. § 426.410 and concluded that it was unacceptable.  Therefore, I granted Complainant until March 4, 2019, to file an acceptable amended complaint.  As of the date of this decision, Complainant has filed no response and no amended complaint.
Page 2
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 illnesses 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.
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 (NCD) and LCDs.  Act § 1869(f)(1)(B) and (2)(B) (42 U.S.C. § 1395ff(f)(1)(B) and (2)(B)).  A 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 a NCD or a LCD, individual claims 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)(1), 426.460(b)(1), 426.488(b).
An aggrieved Medicare beneficiary who has been denied coverage for an item or service based on a LCD may challenge that LCD before an administrative law judge (ALJ).  The aggrieved party initiates the review by filing a written complaint that meets 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)(1).  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 beneficiary is precluded from filing again for six months after being informed that it is unacceptable.  42 C.F.R. § 426.410(c)(3).
Page 3
**B. Findings of Fact, Conclusions of Law, and Analysis**
**1. Complainant failed to file an amended complaint within the allotted time and dismissal is required by 42 C.F.R. § 426.410(c)(2).**
In my letter to Complainant dated January 31, 2019, I advised him that he did not submit any physician statement with his letter.  42 C.F.R. § 426.400(c)(3).  Therefore, it is not possible to determine that Complainant is actually an aggrieved party within the meaning of 42 C.F.R. § 426.110 and eligible to file a LCD complaint.  I advised Complainant that he did not identify or provide a copy of any LCD that was cited by a Medicare contractor as a basis for denying a claim for Medicare payment, 42 C.F.R. § 426.400(c)(4)(i), (ii), although I inferred that he was seeking to challenge the LCD identified in the case caption.  I further advised Complainant that his complaint was unacceptable because he did not:  identify which provision(s) of the LCD adversely affected him, explain why he thought the challenged LCD provision(s) is (are) not valid under the reasonableness standard, or submit any clinical or scientific evidence in support of the complaint (much less an explanation of why that evidence shows that the challenged LCD is not reasonable).  42 C.F.R. § 426.400(c)(4)(iii), (5), (6).
I gave Complainant a reasonable time until March 4, 2019 to amend his complaint.  I advised Complainant that his amended complaint must satisfy all the requirements for an acceptable complaint specified at 42 C.F.R. § 426.400.  I advised him that if the amended complaint did not contain all the required information, I would dismiss his case.
No amended complaint has been received and dismissal is mandated by 42 C.F.R. § 426.410(c)(2).
**2. Appeal rights. 42 C.F.R. §§ 426.462, 426.465.**
Pursuant to 42 C.F.R. § 426.465(a), an aggrieved party may request review by 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. § 426.465(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.


          /s/
        Keith W. Sickendick

                      Administrative Law Judge
      1. The names of Medicare beneficiaries are not listed in published decisions to protect their privacy. 68 Fed. Reg. 63,691, 63,708, 63,711 (Nov. 7, 2003). back to note 1 Back to top
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