In re CMS LCD Complaint: Glucose Monitor, DAB CR5058 (2018)

Department of Health and Human Services
Civil Remedies Division

Docket No. C-18-461
Decision No. CR5058


Ronald Geraci, purportedly on behalf of his wife Tricia Geraci (Aggrieved Party), submitted correspondence dated January 10, 2018, which the Civil Remedies Division treated as a challenge to a local coverage determination (LCD); docketed as styled above, C-18-461; and assigned to me for review.

The regulations at 42 C.F.R. § 426.410(b) require that I determine whether an aggrieved party has filed an “acceptable” and “valid” complaint.  After reviewing Mr. Geraci’s filing, I was unable to determine whether the filing was submitted by an aggrieved party or a legal representative of an aggrieved party, as required by regulation.  See 42 C.F.R. §§ 426.400(c)(2), 426.410(b), 426.110.  Even assuming the January 10 correspondence was submitted by an aggrieved party, I concluded that it was not an acceptable and valid LCD complaint under the applicable regulations.  Therefore, in an Acknowledgment of Receipt and Order to Aggrieved Party to Amend Unacceptable Complaint (Order), dated January 29, 2018, I informed the Aggrieved Party that she had one opportunity to submit an acceptable complaint.  See 42 C.F.R. § 426.410(c)(1).

My January 29 Order listed the information that is required to be included in an LCD complaint to make it acceptable.  I specifically directed the Aggrieved Party to provide all of the following information:

  • LCD-identifying information:  As I explained in detail in my January 29 Order, it did not appear that the unacceptable complaint was challenging an LCD, but was instead challenging a CMS ruling that was not an LCD.  I therefore directed the

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      Aggrieved Party to provide (i) the name of the contractor using the LCD; (ii) the title of the LCD;
      and (iii) the specific provision of the LCD that adversely affects the Aggrieved Party.

  • Aggrieved Party statement:  The unacceptable complaint explained what service the Aggrieved Party needs, but it did not explain why the Aggrieved Party contends that the provision(s) of the LCD is (are) not valid under the reasonableness standard.  I therefore directed the Aggrieved Party to submit a statement explaining her position.
  • Clinical or scientific evidence:  The Aggrieved Party did not provide copies of clinical or scientific evidence in support of her complaint.  Nor did she explain why she believes that this evidence shows that the LCD is not reasonable.  I therefore directed the Aggrieved Party to submit such evidence and argument.
  • If the beneficiary has a representative:  The Aggrieved Party did not provide sufficient identifying information for her purported representative or a copy of a written authorization for the purported representative to represent her in this proceeding.  I therefore directed the Aggrieved Party to submit this information, along with a written authorization for her purported representative to represent her.

My Order directed the Aggrieved Party to file the amended complaint within 30 days of the date of the Order.  I advised the Aggrieved Party that if she did not submit an acceptable amended complaint, then I must issue a decision dismissing the unacceptable complaint.  42 C.F.R. § 426.410(c)(2).

The Aggrieved Party failed to file a response to my January 29 Order.  Therefore, for the reasons explained in that Order, the January 10, 2018 complaint submitted by the Aggrieved Party remains unacceptable under 42 C.F.R. § 426.410(b).  I am required to dismiss the unacceptable complaint.  42 C.F.R. § 426.410(c)(2).  Accordingly, I order that the complaint be dismissed.