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# In re LCA Complaint: Home PT/INR Monitoring for Anticoagulation Management (LCA A55754), DAB CR5965 (2021)

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

## *In re LCA Complaint:*Home PT/INR Monitoring for Anticoagulation Management (LCA A55754)

### Docket No. C-21-970Decision No. CR5965October 21, 2021

### DECISION DISMISSING UNACCEPTABLE COMPLAINT

John Teige, purportedly on behalf of Emma Didyk (Aggrieved Party), submitted correspondence dated July 26, 2021, which the Civil Remedies Division treated as a challenge to a local coverage determination (LCD); docketed as styled above, C-21-970; 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. Teige’s filing, I was unable to determine whether the Aggrieved Party had appointed Mr. Teige as her legal representative, as required by regulation.  *See* 42 C.F.R. §§ 426.400(c)(2), 426.410(b), 426.110.  Even assuming the July 26 correspondence was submitted by the legal representative of 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 August 3, 2021, 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 August 3 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 August 3 Order, it did not appear that the unacceptable complaint was challenging an LCD, but was instead challenging a contractor policy that was not an LCD.  I therefore directed

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                            - the 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 a copy of a written authorization for the purported representative to represent her in this proceeding.  I therefore directed the Aggrieved Party to submit 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).

On September 1, 2021, Mr. Teige, on behalf of the Aggrieved Party, filed an amended complaint and supporting exhibits.  Among the exhibits is a copy of an appointment of representative form, signed by the Aggrieved Party and by Mr. Teige.  Aggrieved Party Exhibit (A.P. Ex.) 3 (Docket Entry #3a at 6 in DAB E-File).1  I accept the appointment of representative form as proof that Mr. Teige is the legal representative of the Aggrieved Party and, accordingly, is authorized to file an LCD complaint on her behalf.

I have considered the Aggrieved Party’s amended complaint and supporting exhibits.  However, as I explain in greater detail below, I conclude that the amended complaint remains unacceptable.  I therefore dismiss the complaint.

***The Aggrieved Party’s amended complaint is unacceptable because it does not challenge an LCD.***

The Aggrieved Party’s amended complaint states that it is challenging “LCA 55754.”  Amended Complaint at 1.  I take administrative notice that this is the identifier for Local Coverage Article (LCA) A55754 issued by Noridian Healthcare Solutions, LLC (Noridian), the Medicare Administrative Contractor for Jurisdiction E, which includes

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California.2  LCA A55754 is entitled “Home PT/INR Monitoring (G0249) Billing and Coding.”  The article states:

Noridian is issuing this coding and billing guidance as it relates to the National Coverage Determination for Home Prothrombin Time/International Normalized Ratio[] (PT/INR) Monitoring for Anticoagulation Monitoring (NCD 190.11) and is in no way a change in coverage as outlined in the NCD and MLN Matters articles.

This NCD provides coverage for home testing of the PT/INR for those beneficiaries who meet the criteria for coverage in the NCD language.

For the purpose of billing and coding the following guidelines are promulgated and are effective immediately.
                            - The coverage is for one home test per week. For the purpose of this direction a week is considered a calendar week, Sunday through Saturday.

Providers may only bill Noridian for this service when the fourth test is completed and the results submitted to the treating physician . . . . [U]se of this code G0249 is for completion of four INR services[.]

The NCD to which LCA A55754 refers provides:

For services furnished on or after March 19, 2008, Medicare will cover the use of home PT/INR monitoring for chronic, oral anticoagulation management for patients with mechanical heart valves, chronic atrial fibrillation, or venous thromboembolism (inclusive of deep venous thrombosis and pulmonary embolism) on warfarin.  The monitor and the home testing must be prescribed by a treating physician as provided at 42 CFR 410.32(a), and all of the following requirements must be met:
                            - The patient must have been anticoagulated for at least 3 months prior to use of the home INR device; and,

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                            - The patient must undergo a face-to-face educational program on anticoagulation management and must have demonstrated the correct use of the device prior to its use in the home; and,
                            - The patient continues to correctly use the device in the context of the management of the anticoagulation therapy following the initiation of home monitoring; and,
                            - Self-testing with the device should not occur more frequently than once a week.

Medicare National Coverage Determinations Manual, Ch.1, Part 3, § 190.11 (emphasis added).3

Notwithstanding the fact that LCA A55754 states unequivocally that it concerns billing and coding and defers to NCD § 190.11 for coverage policy, the Aggrieved Party argues that the article represents a “de facto LCD.”  Amended Complaint at 2.  The Aggrieved Party takes this position because the coverage article limits the number of tests per month that will be reimbursed by Medicare.  The Aggrieved Party asserts that the billing frequency provision in LCA A55754 conflicts with Section 1871(a)(2) of the Social Security Act (Act), NCD § 190.11, and the Medicare Claims Processing Manual Chapter 32, § 60.5.

Importantly, even if LCA A55754 were in conflict with the authorities cited by the Aggrieved Party – a finding I do not make4 – if its provisions concern only coding and billing, then I have no authority to review it.  The regulations governing administrative law judge review of LCDs place strict limits on that review.  The regulations provide that “[o]nly LCDs” that are currently effective may be challenged, and forbid review of “[c]ontractor decisions that are not based on section 1862(a)(1)(A) of the Act,” i.e., the medical necessity standard.  42 C.F.R. § 426.325(a), (b)(5).  They also forbid review of “[a]ny other policy that is not an LCD . . . as set forth in § 400.202 of this chapter.”  42 C.F.R. § 426.325(b)(12).  Section 400.202 defines an LCD as a contractor

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determination “whether to cover a particular service on a [contractor-wide] basis in accordance with section 1862(a)(1)(A) of the Act.”  The regulations also state that an administrative law judge “does not have authority to . . . [c]onduct a review of any policy that is not an LCD, as defined in § 400.202 of this chapter.”  42 C.F.R. § 426.405(d)(5).

Further, the preamble to the final rule implementing the LCD appeal process emphasized the limited nature of the available review, stating that “[p]rovisions of contractor policies that are based on things *other than the reasonable and necessary provision*of section 1862(a)(1)(A) of the Act, such as benefit category determinations, statutory exclusion determinations, statutory exclusion determinations, and *HCPCS/Revenue Code coding determinations*, would not be subject to review under this part [Part 426].”  68 Fed. Reg. 63692, 63,707 (Nov. 7, 2003) (emphasis added); *see also In re CMS LCD Complaint:  Wheelchair Options/Accessories (L11451)*, DAB No. 2370 at 6-7 (2011).

LCA A55754 states on its face that it contains “coding and billing guidance” and that home testing of PT/INR is covered (i.e. is medically reasonable and necessary) in accordance with NCD § 190.11.  None of the Aggrieved Party’s arguments convinces me that the article is a coverage determination rather than an instruction for billing and coding.  I therefore conclude that LCA A55754 is not an LCD.  Because the Aggrieved Party’s amended complaint seeks to challenge a policy that is not an LCD, I have no authority to review it.  42 C.F.R. § 426.405(d)(5).

For the reasons stated, the complaint remains unacceptable and I dismiss it pursuant to 42 C.F.R. § 426.410(c)(2).

Leslie A. WeynAdministrative Law Judge

                                              1. The Aggrieved Party’s exhibits were uploaded to the electronic file as a single document.  I cite to the PDF page number as it appears when opened in DAB E-File. 
                            - back to note 1
                                                  2. The Aggrieved Party’s representative, Mr. Teige, is affiliated with Alternative Health Care, Inc., a Medicare supplier located in California.  The company submitted claims to Noridian for reimbursement of PT/INR testing supplies furnished to the Aggrieved Party.  See A.P. Ex. 1 (Docket Entry #3a at 1-4). 
                            - back to note 2
                                                  3. The National Coverage Determinations Manual may be accessed via the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/ncd103c1_Part3.pdf (last visited October 14, 2021). 
                            - back to note 3
                                                  4. The coding information in LCA A55754 to which the Aggrieved Party objects provides that a “unit of service” for HCPCS code G0429 is “four tests, which have been completed and reported to the provider over a period of four weeks or greater.”  I do not find this provision inconsistent with NCD § 190.11.  As I have quoted above, the NCD states that self-testing using a home monitoring device “should not occur more frequently than once a week.”  Ordinarily, then, billing for four tests in one month (i.e. four weeks) aligns with the NCD provision. 
                            - back to note 4