Blessed Home Health Services, Inc., DAB CR5614 (2020)

DECISION

Palmetto GBA (Palmetto), an administrative contractor acting on behalf of the Centers for Medicare & Medicaid Services (CMS), revoked the Medicare enrollment and billing privileges of Petitioner, Blessed Home Health Services, Inc., pursuant to 42 C.F.R. § 424.535(a)(8)(ii) because Petitioner had a pattern or practice of submitting Medicare claims for home health services that lacked a valid physician signature as required by 42 C.F.R. § 424.22(a)(2).  For the reasons stated herein, I affirm the revocation of Petitioner’s Medicare enrollment and billing privileges.

I.  Background and Procedural History

Petitioner is a provider that was enrolled as a home health agency in the Medicare program.  See CMS Ex. 1 at 1; see 42 U.S.C. § 1395x(u) (classifying home health agencies as “providers” in the Medicare program).

Agnes Anyalebechi is a nurse practitioner who practices in the State of Texas.  See CMS Exs. 9 at 1; 10 at 1.  According to CMS, Ms. Anyalebechi is the “owner” of Kindle Clinic, and Petitioner provided home health services to Kindle Clinic’s patients.  CMS Ex. 2 at 3.  Ms. Anyalebechi “work[ed] in collaboration with” a physician, Dr. Lynn

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Gibbs.  Petitioner’s Motion for Summary Judgment and Pre-Hearing Brief (P. Motion) at 5.  On February 1, 2016, Dr. Gibbs signed a letter that stated the following:  “To whom it may concern: This is [to] certify that I Lynn R. Gibbs MD authorized Agnes C. Anyalebechi NP of Kindle [C]linic Inc. to sign all Home Health orders on my behalf as his [sic] supervising physician.”1  CMS Ex. 9 at 1.

On June 12, 2018, Qlarant, a Medicare program integrity contractor, conducted a records review with Dr. Gibbs, at which time he denied that 13 Medicare beneficiaries were his patients or that he had authorized home health services for those 13 patients that resulted in 38 Medicare claims.  CMS Ex. 5; see CMS Ex. 7 at 1-2 (CMS’s spreadsheet listing claims for home health services that were reported to have been ordered by Dr. Gibbs).

In a February 1, 2019 initial determination, Palmetto revoked Petitioner’s Medicare enrollment and billing privileges effective March 3, 2019, pursuant to 42 C.F.R. § 424.535(a)(8)(ii), based on Petitioner’s abuse of its billing privileges.  CMS Ex. 1.  In support of its determination, Palmetto explained the following:

The Centers for Medicare & Medicaid Services (CMS) has determined that [Petitioner] has engaged in a pattern or practice of submitting claims that fail to meet Medicare requirements, in violation of 42 C.F.R[.] § 424.535(a)(8)(ii).  [Petitioner] has failed to meet Medicare requirements by submitting claims for home health services that were provided in violation of 42 C.F.R. § 424.22, for reasons including, but not limited to, the fact that the home health services were provided without a valid certification of eligibility.

Dr. Lynn Gibbs is listed as the ordering/certifying physician on thirty-eight (38) home health service claims for thirteen (13) Medicare beneficiaries,

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submitted by [Petitioner], with episodes of care starting August 16, 2016 and continuing through November 22, 2017.  See Enclosure A for a sample set of ten claims.  Dr. Gibbs reviewed a list of beneficiaries for whom [Petitioner] submitted claims listing Dr. Gibbs as the ordering/certifying physician.  Dr. Gibbs attested that, for all beneficiaries listed, he did not order home health services.  Furthermore, claims data analysis revealed that Dr. Gibbs did not have a prior Part B relationship with those beneficiaries.  Therefore, Dr. Gibbs was not involved in the care, treatment, or monitoring of the beneficiaries whose medical records he reviewed.

CMS Ex. 1 at 1; see CMS Ex. 1 at 3 (Enclosure A; listing, inter alia, the following 10 beneficiaries and the corresponding claim submission dates:2 A.S.A., S.L., C.J., J.H., H.S., C.L., C.E., J.P., M.D., and A.S.).  Palmetto also barred Petitioner from re-enrolling in the Medicare program for a period of three years.  CMS Ex. at 1 at 2.  Palmetto explained that Petitioner could seek reconsideration of its determination, and informed Petitioner that if it had “additional information that you would like a hearing officer to consider during the reconsideration, or if necessary, an administrative law judge to consider during a hearing, you must submit that information with your request for reconsideration.”  CMS Ex. 1 at 1-2.  Palmetto cautioned that “[t]his is your only opportunity to submit information during the administrative appeals process; you will not have another opportunity to do so unless an administrative law judge specifically allows you to do so under 42 [C.F.R. §] 498.56(e).”  CMS Ex. 1 at 2.

Petitioner, through its current counsel, submitted a six-page letter, dated March 27, 2019, in which it requested reconsideration of the initial determination and provided 52 additional pages of supporting patient records.  CMS Exs. 3, 4.  Each page of Petitioner’s combined 58-page submission contains a mark of “BH” in the lower right hand corner, along with sequential pagination from pages 1 through 58, with “BH1” through “BH6” marked on each page of the six-page letter requesting reconsideration, and “BH7” through “BH58” marked on each page of the “related records reflecting the relevant orders and communications between the respective patients, physicians, nurse practitioner and [Petitioner]” that Petitioner referenced in its letter as “Exhibit A.”  CMS Ex. 4; see CMS Ex. 3 at 2.  The supporting patient records pertain only to the nine specific patients Petitioner identified by name in its letter requesting reconsideration.  CMS Exs. 3 at 3; 4.  For unknown reasons, Petitioner addressed only two of the ten beneficiaries listed in Enclosure A to the initial determination, J.H. and S.L., in its letter and submission of supporting records.  CMS Exs. 3 at 3; 4 at 21-35; see CMS Ex. 1 at 3.3

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Among its arguments against the revocation of its enrollment and billing privileges, Petitioner stated the following in its letter requesting reconsideration:  “A careful review of Dr. Gibbs and his relationship with Agnes Anyalebechi of Kindle Clinic will show that Kindle Clinic had an ongoing relationship with Dr. Gibbs during the entire period at issue and all related orders were signed and submitted by Dr. Gibbs and/or Agnes Anyalebechi of Kindle Clinic.”  CMS Ex. 3 at 4.

CMS, through its Provider Enrollment & Oversight Group, issued a reconsidered determination on May 16, 2019, in which it upheld the revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(8)(ii).  CMS Ex. 2.  In upholding the revocation of Petitioner’s enrollment and billing privileges, CMS explained:

Under § 424.535(a)(8)(ii), CMS may revoke a currently enrolled provider’s Medicare billing privileges and any corresponding provider agreement when CMS determines that the provider has a pattern or practice of submitting claims that fail to meet Medicare requirements. [Petitioner] is a provider of home health services and as such, is required to provide services and submit claims for payment in accordance with § 424.22. . . .

* * * *

[I]n addition to the lack of the requisite treating relationship between the nine beneficiaries and Dr. Gibbs, [Petitioner] acknowledges in its reconsideration request that claims where Dr. Gibbs was the ordering/certifying physician were noncompliant because there was an impermissible delegation of his authority to sign home health certification documents to Agnes Anyalebechi – who is not a physician.  This signature delegation is in violation of § 424.22 and any claims arising out of the delegation are noncompliant.

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CMS Ex. 2 at 4.  CMS determined that Petitioner “blindly relied on Kindle in ensuring that the orders and certifications it received were Medicare compliant.”  CMS Ex. 2 at 5.  CMS found that Petitioner “engaged in a pattern and practice of abuse of billing privileges” and that the revocation of Petitioner’s Medicare enrollment and billing privileges was appropriate.  CMS Ex. 2 at 5.

On July 12, 2019, Petitioner electronically filed a request for an ALJ hearing, along with various supporting documents, to include 127 pages of records pertaining to eight beneficiaries.4  Petitioner also submitted a document with the file name “392047_Reconsideration_Letter_3.27.19,” which is a complete copy of its 58-page request for reconsideration with supporting documents.

The Civil Remedies Division acknowledged receipt of Petitioner’s request for hearing and issued my Standing Pre-Hearing Order (Pre-Hearing Order) directing the parties to file pre-hearing exchanges in accordance with specific requirements and deadlines.  CMS filed a motion for summary judgment and pre-hearing brief (CMS Br.), along with 9 proposed exhibits (CMS Exs. 1-5 and 7-10).  Petitioner filed a response to CMS’s motion for summary judgment (P. Br.) and six proposed exhibits (P. Exs. 1-6); nearly a month later, Petitioner filed a motion for summary judgment and pre-hearing brief, at which time it re‑submitted its proposed exhibits.  CMS filed a reply to Petitioner’s motion for summary judgment.  CMS also filed objections5 (CMS Objections) to Petitioner’s evidentiary exhibits, at which time it filed proposed supporting exhibit CMS Ex. 11 (testimony of Minisha Hicks, Director of CMS’s Division of Compliance and Appeals within CMS’s Provider Enrollment & Oversight Group).  Petitioner filed a response to CMS’s evidentiary objections (P. Response to Objections), along with objections to CMS Ex. 11 (P. Objections).

Both parties’ objections are premised on 42 C.F.R. § 498.56(e), which requires that I examine whether good cause exists for a provider or supplier to submit new documentary

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evidence for the first time at the ALJ hearing level.6  42 C.F.R. § 498.56(e)(1).  I must exclude any new documentary evidence if I do not find good cause for its submission for the first time at the ALJ level.  42 C.F.R. § 498.56(e)(2)(ii); Care Pro Home Health, Inc., DAB No. 2723 at 11 (2016) (“In enrollment revocation cases, an ALJ must exclude ‘new documentary evidence’ – that is, documentary evidence that a provider did not previously submit to CMS at the reconsideration stage (or earlier) – unless the ALJ determines that ‘the provider or supplier has good cause for submitting the evidence for the first time at the ALJ level.’  42 C.F.R. § 498.56(e)(1).”); see Pre-Hearing Order § 10 (directing Petitioner to contemporaneously file with its pre-hearing exchange a statement of good cause regarding the submission of any new documentary evidence).  While “good cause” is not defined in the regulations, the Departmental Appeals Board (DAB) has explained that, in showing good cause in such a situation, a party must explain its “failure to submit [evidence] at the reconsideration stage (or earlier).”  Care Pro, DAB No. 2723 at 13.

Petitioner objects to CMS’s submission of CMS Ex. 11 because CMS did not file Ms. Hicks’s declaration with its pre-hearing exchange or provide good cause, pursuant to 42 C.F.R. § 498.56(e), for its submission of this declaration.  P. Objections.  In her declaration, Ms. Hicks explained that she had “reviewed the documents in P. Ex. 1 and P. Ex. 2 and these records were not previously submitted by Petitioner for CMS’s consideration on reconsideration.”  CMS Ex. 11 at 2.  Ms. Hicks further explained that the only evidence Petitioner submitted in support of its request for reconsideration consisted of a document containing 52 pages of records involving 9 specific Medicare beneficiaries (B.B., T.B., J.D., J.H., S.L., G.O., E.R., P.S., and T.T.).  CMS Ex. 11 at 1-2.

I overrule Petitioner’s objections to CMS Ex. 11.  First, 42 C.F.R. § 498.56(e) is inapplicable to CMS Ex. 11 because the plain language of 42 C.F.R. § 498.56(e) states that the good cause requirement applies to a provider or supplier; CMS is not a provider or supplier that is bound by that provision.  I additionally note that CMS did not submit CMS Ex. 11 as evidence in support of its arguments with respect to the revocation of Petitioner’s enrollment and billing privileges, but rather submitted CMS Ex. 11 to refute Petitioner’s unsupported allegation that it “should not be required to show good cause for submitting P. Ex. 1 and P. Ex. 2 because this evidence was submitted prior to and during the ‘reconsideration stage.’”  See P. Response to Objections.  Ms. Hicks’s testimony is limited to a narrow procedural issue regarding the admissibility of proposed exhibits,7 and CMS could not have anticipated that Petitioner would make such a claim when it

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filed its pre-hearing exchange.  In fact, when Petitioner submitted its request for hearing, it did not argue that CMS had failed to consider any evidence.  See CMS Ex. 2 at 1-2 (CMS’s listing of the evidence it considered at the time it issued the reconsidered determination); see 42 C.F.R. § 498.40(b)(1) (directing a party filing a request for hearing to identify the specific issues, findings of fact, and conclusions of law with which it disagrees).  Although I admit CMS Ex. 11, it was not necessary to rely upon this evidence in determining that P. Exs. 1 and 2 must be excluded from the evidentiary record.

CMS opposes the admission of five of Petitioner’s six proposed exhibits (P. Exs. 1, 2, 4, 5 and 6) because Petitioner did not submit these documents with its request for reconsideration and did not allege good cause, as required by section 498.56(e), for their initial submission at the ALJ hearing level.  CMS Objections. 

• P. Ex. 1, which Petitioner describes as “Original Certification Documents,” is identical to the 127-page document it submitted with its request for hearing that contains documents pertaining to CJ., C.L., H.S., J.P., M.D., P.J., S.G., and S.L. 8  See Docket Entry 1d, “392045_Additional_ Evidence.”  
• P. Ex. 2, which Petitioner describes as “Re-Certification Documents with Physician signature,” is an 81-page document containing records for the following beneficiaries:  J.H., S.G., M.D., J.P., C.J., H.S., C.L., and P.J.9
• P. Ex. 4, which Petitioner describes as “Blessed Home Health Services, Inc. Website,” appears to be a printout from another website, https://www.carepathways.com, that reports various “quality of care” percentile ranking scores ranging from 11% to 100%. 
• P. Ex. 5 is a July 15, 2019 printout of the American Medical Association website’s “DoctorFinder” entry for Dr. Lynn Gibbs. 
• P. Ex. 6 is a July 15, 2019 printout from the Texas Board of Nursing website reporting that Agnes Chinenye Anyalebechi is licensed as a registered nurse.

I reiterate that Palmetto, in its February 1, 2019 determination, informed Petitioner that it needed to submit any supporting evidence with its request for reconsideration and warned Petitioner that it may not have another opportunity to do so, stating:

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[I]f you have additional information that you would like a hearing officer to consider during the reconsideration or, if necessary, an administrative law judge to consider during a hearing, you must submit that information with your request for reconsideration.  This is your only opportunity to submit information during the administrative appeals process; you will not have another opportunity to do so unless an administrative law judge specifically allows you to do so under 42 CFR § 498.56(e).

CMS Ex. 1 at 1-2.  Petitioner, through its counsel and in response to CMS’s objections, makes an unsupported allegation that “the records in P. Ex. 1 were made available to CMS as an attachment to Petitioner’s Request for Reconsideration dated March 27, 2019” and “this evidence was submitted prior to and during the ‘reconsideration stage.’”  P. Response to Objections at 1-2.  I exclude this evidence because Petitioner submitted it for the first time during the hearing stage of the administrative appeals process and has not alleged, much less shown, good cause for its late submission.

As I previously discussed, Petitioner, which continues to be represented by the same counsel who filed its request for reconsideration, submitted a six-page letter requesting reconsideration in March 2019, along with 52 pages of supporting patient records for nine of its patients (B.B., T.B., J.D., J.H., S.L., G.O., E.R., P.S., and T.T.).  CMS submitted these documents as CMS Exs. 3 and 4.  See also DAB E-File Docket Entry 1f.  The pages of Petitioner’s reconsideration request bear the previously mentioned sequential markings from BH1 through BH58.  CMS Exs. 3 at 1‑6 (letter marked “BH1” through “BH6”), 4 at 1-52 (supporting patient records marked “BH7” through “BH58”).

In its reconsidered determination, CMS listed the six exhibits that constituted the evidentiary record at the time of its determination.  CMS Ex. 2 at 1-2.  CMS described Exhibit 1 as a “Reconsideration request, dated March 27, 2019, from Wayne E. Revack of Gill, Revack, Samaan & Muller, LLP, on behalf of [Petitioner] to CMS” and Exhibit 2 as “(Provider’s Exhibit A):  Patient medical records, physician orders, face-to-face encounter forms, and home health certification forms, submitted by [Petitioner] for Medicare beneficiaries [B.B.], [T.B.], [J.D.], [J.H.], [S.L.], [G.O.], [E.R.], [P.S.], and [T.T.].”).  CMS Ex. 2 at 1.

Petitioner, which has not disputed this characterization of the evidentiary record in either its request for hearing or its pre-hearing exchange filings, stated in its request for hearing that it had enclosed a copy of the “March 27th, 2019, Reconsideration Letter.”  Request for Hearing at 2; see CMS Ex. 2 at 1.  Consistent with this statement, Petitioner uploaded a file, “392047_Reconsideration_Letter_3.27.19,” that is identical to CMS Exs. 3 and 4, including the same sequential page markings on each of the 58 pages.  Compare DAB E‑File Docket Entry 1f with CMS Exs. 3, 4.

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The additional records Petitioner submitted with its request for reconsideration align with the names Petitioner listed on the third page of its letter; in fact, Petitioner submitted the supporting patient records in the same order that it listed the names of its patients in its letter.  See DAB E-File Docket Entry 1f (“March 27th, 2019, Reconsideration Letter”); CMS Exs. 3 at 3 (list of names in Petitioner’s letter (B.B., T.B., J.D., J.H., S.L., G.O., E.R., P.S., and T.T.)); 4 at 1-6 (records for B.B. (“BH7”-“BH12”)); 7-14 (records for T.B. (“BH13”-“BH20”)); 15-20 (records for J.D. (“BH21”-“BH26”)); 21-27 (records for J.H. (“BH27”-“BH33”)); 28-35 (records for S.L. (“BH34”-“BH41”)); 36-39 (records for G.O. (“BH42”-“BH45”)); 40-43 (records for E.R. (“BH46”-“BH49”)); 44-48 (records for P.S. (“BH50”-“BH54”)); 49-52 (records for T.T. (“BH55”-“BH58”)).  Petitioner did not identify any other beneficiaries by name in its request for reconsideration, nor did it submit any records for any other beneficiaries.  DAB E-File Docket Entry 1f; CMS Exs. 3, 4.

It is noteworthy that, with respect to the ten beneficiaries whom Palmetto identified in Enclosure A, a “sample set of ten claims” to its initial determination (CMS Ex. 1 at 1, 3, listing claims involving A.S.A., S.L., C.J., J.H., H.S., C.L., C.E., J.P., M.D., and A.S.), Petitioner addressed and submitted records for only two of those beneficiaries, J.H. and S.L., when it submitted its request for reconsideration.  DAB E-File Docket Entry 1f; CMS Ex. 4 at 21-35; see CMS Exs. 1 at 3; 3 at 3 (Petitioner’s list of nine specific beneficiaries, with only two of those beneficiaries, J.H. and S.L., being listed on Palmetto’s sample set of claims).  The other seven beneficiaries Petitioner listed in its request for reconsideration, and for whom it furnished records, were not listed in Enclosure A to the initial determination.10  CMS Exs. 1 at 1, 3; 3 at 3; 4 at 1-20, 36-52.  In fact, Petitioner argued that other physicians had ordered home health services for most of these patients, which naturally explains why Palmetto did not list these beneficiaries in the sample set of claims involving beneficiaries for whom Dr. Gibbs had purportedly ordered home health services.  CMS Ex. 3 at 3.

Petitioner changed course when it filed its request for hearing, in that it specifically identified seven new beneficiaries that it had not previously referenced in its request for reconsideration.  Compare Request for Hearing at 2 (listing S.L., C.J., J.H., J.P., S.G., P.J., H.S., M.D., and C.L.) with Request for Reconsideration (CMS Ex. 3 at 3) (listing B.B., T.B., J.D., J.H., S.L., G.O., E.R., P.S., and T.T.).  The list Petitioner provided in its request for hearing mirrors the nine beneficiaries that CMS listed in a footnote in the reconsidered determination (CMS Ex. 2 at 4), five of whom had already been listed in Enclosure A to the initial determination, but for whom Petitioner did not previously submit any records (C.J., J.P., H.S., M.D., and C.L.)  CMS Exs. 1 at 3; 4.  Further,

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Petitioner had not previously submitted any records for beneficiaries S.G. and P.J.11  CMS Exs. 3 at 3; 4.

With its request for hearing, Petitioner submitted a 127-page document, with the file name “392045_Additional_Evidence.pdf,” that appears at Entry 1d of the DAB E-File electronic docket for this case.  That filing contains records for eight beneficiaries Petitioner specifically identified in its request for hearing (C.J. (pages 1-12), C.L. (pages 13-30), H.S. (pages 31-43), J.P (pages 44-55), M.D. (pages 56-85), P.J. (pages 86-96), S.G. (pages 97-114), and S.L. (pages 115-127)).  See Request for Hearing at 2 (Petitioner’s statement that it submitted “Treatment records for the nine (9)[12] beneficiaries at issue”).  Based on a comparison with Petitioner’s reconsideration submission, Petitioner’s submission of records for C.J., C.L., H.S., J.P., and M.D. with the hearing request was new, and it submitted additional records for S.L. that it had not previously submitted.  See CMS Ex. 4 at 28-35.  Petitioner re-submitted an identical copy of this 127-page document as a proposed exhibit, P. Ex. 1, when it filed its pre-hearing exchange.  See Petitioner’s Proposed Exhibit List (describing P. Ex. 1 as “Original Certification Documents”).

Petitioner also filed another proposed exhibit, P. Ex. 2, that is a compilation of beneficiary records for J.H., S.G., M.D., J.P., C.J., H.S., C.L., and P.J., totaling 81 pages, that it had not previously submitted with either its request for reconsideration or its request for hearing.  See Petitioner’s Proposed Exhibit List (describing P. Ex. 2 as “Re‑Certification Documents with Physician signature).   DAB E-File Docket Entry 10a.

Other than Petitioner’s cursory and bald assertion that it had, in fact, submitted P. Exs. 1 and 2 with its request for reconsideration, Petitioner has not submitted any evidence, such as witness testimony or documentary evidence, in an effort to demonstrate that it had submitted those records with its request for reconsideration.  To the contrary, the record supports that the only evidence Petitioner submitted with its reconsideration request was the 52-page submission of records pertaining to B.B., T.B., J.D., J.H., S.L., G.O., E.R., P.S., and T.T.  See CMS Exs. 3 at 2-3 (request for reconsideration, marked “BH1” through “BH6”, referencing B.B., T.B., J.D., J.H., S.L., G.O., E.R., P.S., and T.T., and explaining that it had submitted an exhibit that contained “related records.”); 4 (records supporting request for reconsideration, marked “BH7” through “BH58”); DAB E-File Docket Entry 1f (“March 27, 2019, Reconsideration Letter,” to include supporting

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exhibits, marked “BH1” through “BH58” and mirroring CMS Exs. 3 and 4); CMS Ex. 2 at 1 (reconsidered determination listing the evidence Petitioner had submitted, to include the names of the nine beneficiaries for whom Petitioner had submitted records); Request for Hearing (failing to identify any purported error of fact or law relating to CMS’s identification of the evidence submitted with its reconsideration request and its consideration of that evidence).

Petitioner has not alleged good cause for submitting P. Exs. 1 and 2 at the ALJ hearing level for the first time, nor has it shown that it previously submitted those documents.  Therefore, this evidence is inadmissible.  42 C.F.R. § 498.56(e)(2)(ii) (stating that “[i]f the ALJ determines that there was not good cause for submitting the evidence for the first time at the ALJ level, the ALJ must exclude the evidence from the proceeding and may not consider it in reaching a decision”); Care Pro, DAB No. 2723 at 11 (“In enrollment revocation cases, an ALJ must exclude ‘new documentary evidence’ – that is, documentary evidence that a provider did not previously submit to CMS at the reconsideration stage (or earlier) – unless the ALJ determines that ‘the provider or supplier has good cause for submitting the evidence for the first time at the ALJ level.’  42 C.F.R. § 498.56(e)(1).”).

With respect to P. Exs. 4, 5, and 6, Petitioner has not provided good cause for its failure to submit these documents with its request for reconsideration.  Therefore, these documents are not admissible.  42 C.F.R. § 498.56(e)(1).  Further, with respect to P. Ex. 4, the source of the reported information is unknown, and Petitioner has made no effort to establish the veracity of the information reported on the https://www.carepathways.com website.13  With respect to P. Exs. 5 and 6 (reports that Dr. Gibbs is a physician and Ms. Anyalebechi is licensed as a nurse), the parties mutually agree that Dr. Gibbs is a physician and Ms. Anyalebechi is a nurse practitioner.  CMS Exs. 2 at 2-3; 4 at 3.  This new evidence is simply unnecessary.

Finally, it is not lost on me that, at best case, Petitioner was grossly mistaken when it stated that it had previously submitted the documents contained in P. Exs. 1 and 2, or at worst case, it misrepresented that it had previously submitted this evidence with its request for reconsideration.  CMS has not sought sanctions against Petitioner or its counsel for making such misrepresentations and, therefore, I will not sua sponte address whether such conduct warrants the imposition of sanctions.  See Civil Remedies Division Procedures § 23.

I admit CMS Exs. 1-5 and 7-11 and P. Ex. 3 into the evidentiary record.  Because a hearing is unnecessary for the purpose of cross-examination of any witnesses, this case is

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ready for a decision on the written record.  Pre‑Hearing Order §§ 12-14.  Although each party has filed a motion for summary judgment, I will issue a decision on the merits.

II.  Issue

Whether CMS has the authority to revoke Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(8)(ii).

III.  Jurisdiction

I have jurisdiction to hear and decide this case.  42 C.F.R. §§ 498.1(g), 498.3(b)(17), 498.5(l)(2); see also 42 U.S.C. § 1395cc(j)(8).

IV.  Findings of Fact, Conclusions of Law, and Analysis14

1. Petitioner is a home health agency that has been in operation since 2008.
2. Pursuant to 42 U.S.C. § 1395f(a)(2)(C) as it existed at the time of the revocation, only a physician may certify the need for home health services, and 42 C.F.R § 424.22(a)(2), 15 requires that the certifying physician sign and date the certification of need for home health services.
3. Ms. Agnes Anyalebechi, a nurse practitioner affiliated with Kindle Clinic, worked in collaboration with Dr. Lynn Gibbs.
4. Petitioner does not dispute that Dr. Gibbs authorized “Agnes C. Anyalebechi NP of Kindle [C]linic Inc. to sign all Home Health orders on [his] behalf.”
5. Petitioner concedes that “all related orders were signed and submitted by Dr. Gibbs and/or Agnes Anyalebechi of Kindle Clinic.”

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6. Petitioner provided home health services to S.L., C.J., J.H., H.S., C.L., J.P., and M.D., and submitted claims for Medicare reimbursement for those services between January 18 and December 4, 2017.
7. Dr. Gibbs is listed as the ordering physician on the claims for home health services provided to S.L., C.J., J.H., H.S., C.L., J.P., and M.D.
8. On June 9, 2018, Dr. Lynn Gibbs signed a statement, witnessed by two Qlarant representatives, in which he certified that he had not ordered home health services for a number of Medicare beneficiaries, to include S.L., C.J., J.H., H.S., C.L., J.P., and M.D.
9. S.L., C.J., J.H., H.S., C.L., J.P., and M.D. are listed in Exhibit A to the initial determination, which is a sample set of home health services claims for whom Dr. Gibbs is listed as the ordering physician but had reported that he did not order those services.
10. Petitioner has not submitted any admissible evidence regarding the claims it submitted for the services it provided to C.J., H.S., C.L., J.P., and M.D.
11. Petitioner has submitted admissible evidence relating to the home health services it provided to S.L. and J.H., to include orders it received from Kindle Clinic and copies of face-to-face encounters conducted by Ms. Anyalebechi.
12. Petitioner has not demonstrated that Dr. Gibbs signed the orders certifying the need for home health services for S.L., C.J., J.H., H.S., C.L., J.P., and M.D.
13. Because, over a considerable period of approximately 11 months, from January 18 through December 4, 2017, Petitioner submitted multiple claims for Medicare services involving at least seven beneficiaries for whom a physician had not signed the order certifying the need for home health services, it engaged in a pattern or practice of submitting improper claims to Medicare.
14. Palmetto and CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(8)(ii).

Pursuant to 42 U.S.C. § 1395cc(j)(1)(A), CMS has promulgated enrollment regulations.  See 42 C.F.R. § 424.500 et seq.  These regulations give CMS the authority to revoke the billing privileges of an enrolled provider if CMS determines that certain circumstances

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exist.  42 C.F.R. § 424.535(a).  Relevant to this case, CMS may revoke a provider’s billing privileges when it determines that billing privileges have been abused as follows:

(ii)  CMS determines that the provider or supplier has a pattern or practice of submitting claims that fail to meet Medicare requirements.  In making this determination, CMS considers, as appropriate or applicable, the following:

(A)  The percentage of submitted claims that were denied.
(B)  The reason(s) for the claim denials.
(C)  Whether the provider or supplier has any history of final adverse actions (as that term is defined under § 424.502) and the nature of any such actions.
(D)  The length of time over which the pattern has continued.
(E)  How long the provider or supplier has been enrolled in Medicare.
(F)  Any other information regarding the provider or supplier’s specific circumstances that CMS deems relevant to its determination as to whether the provider or supplier has or has not engaged in the pattern or practice described in this paragraph.

42 C.F.R. § 424.535(a)(8)(ii).16  At the time of the initial determination, CMS could impose a bar on re‑enrollment for a minimum of one year, but no more than three years.  42 C.F.R. § 424.535(c)17; see CMS Ex. 1 at 2 (initial determination imposing a three-year re‑enrollment bar).

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Medicare requirements for home health services are addressed in 42 C.F.R. § 424.22.18  As relevant here, a physician must certify a beneficiary’s eligibility for home health services.  42 C.F.R. § 424.22(a)(2); see 42 U.S.C. § 1395f(a)(2)(C).  A certification that home health services are necessary “must be signed and dated by the physician who establishes the plan.”19  42 C.F.R. § 424.22(a)(2).  Pursuant to 42 C.F.R. § 424.22(a)(1)(v), a “face-to-face encounter” with the beneficiary for whom home health services are being certified must be performed by the certifying physician or an authorized non-physician practitioner.  See 42 U.S.C. § 1395f(a)(2)(C).  A nurse practitioner, as a non-physician practitioner, is authorized to perform the face‑to‑face encounter if he or she “is working in accordance with State law and in collaboration with the certifying physician . . . .”20  42 C.F.R. § 424.22(a)(1)(v)(A)(3).  Medicare Part B covers nurse practitioner services under certain circumstances, to include, but not limited to, when the services are performed “while working in collaboration with a physician,” as described below:

(i)  Collaboration is a process in which a nurse practitioner works with one or more physicians to deliver health care services within the scope of

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the practitioner’s expertise, with medical direction and appropriate supervision as provided for in jointly developed guidelines or other mechanisms as provided by the law of the State in which the services are performed;

(ii)  In the absence of State law governing collaboration, collaboration is a process in which a nurse practitioner has a relationship with one or more physicians to deliver health care services.  Such collaboration is to be evidenced by nurse practitioners documenting the nurse practitioners’ scope of practice and indicating the relationships that they have with physicians to deal with issues outside their scope of practice.  Nurse practitioners must document this collaborative practice with physicians.

(iii)  The collaborating physician does not need to be present with the nurse practitioner when the services are furnished or to make an independent evaluation of each patient who is seen by a nurse practitioner.

42 C.F.R. § 410.75(c)(3); see Medicare Benefit Policy Manual, Pub. 100-02, Ch. 15, § 200(D) (eff. Nov. 19, 2007) (containing substantially similar guidance).

CMS has demonstrated that revocation of Petitioner’s enrollment and billing privileges is warranted based on Petitioner’s pattern or practice of submitting claims for home health services that were not compliant with Medicare requirements.  42 C.F.R. § 424.535(a)(8)(ii).  Specifically, Petitioner failed to ensure that the claims it submitted contained the signature of the certifying physician, as required by 42 C.F.R. § 424.22(a)(2).  CMS identified a number of instances in which Petitioner submitted claims for home health services for beneficiaries for whom Dr. Gibbs is listed as the ordering physician, to include the claims for services provided to S.L., C.J., J.H., J.P., H.S., M.D., and C.L.21  CMS Ex. 7 at 1-2.  On June 9, 2018, Dr. Gibbs certified, in the presence of two witnesses, that he had not ordered home health services for any of those beneficiaries.  CMS Ex. 5 at 1-2.  When given an opportunity to respond to these allegations, Petitioner did not submit evidence showing that Dr. Gibbs had actually certified the need for home health services or signed the orders for those claims.  CMS Exs. 3, 4.  Rather, Petitioner acknowledged that the orders were signed by Dr. Gibbs and/or Ms. Anyalebechi, which it argued was permissible based on Kindle Clinic’s

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“ongoing relationship with Dr. Gibbs.”  CMS Ex. 3 at 4.  Petitioner contends that “orders “bared [sic] the signature of Dr. Gibbs and/or his Nurse Practitioner, Agnes Anyalebechi, whom Dr. Gibbs previously authorized to sign all Home Health orders on his behalf.”  P. Br. at 2.  Petitioner concedes that it was aware that Dr. Gibbs may not have signed the orders or certified the need for home health services, as mandated by 42 C.F.R. § 424.22(a), and therefore, Petitioner engaged in a pattern or practice of submitting multiple invalid claims for no fewer than seven Medicare beneficiaries over a span of at least 11 months.  See CMS Exs. 1 at 3; 7 at 1-2.  Revocation is warranted pursuant to 42 C.F.R. § 424.535(a)(8)(ii) because Petitioner had a pattern or practice of submitting claims that failed to meet Medicare requirements.

Petitioner contends that revocation is not warranted, arguing that “orders, certifications, and re-certifications” were properly signed by Dr. Gibbs and/or Ms. Anyalebechi.  P. Br. at 2.  Petitioner further argues that CMS has not proven that the signatures on the physician orders were not provided by Dr. Gibbs.  P. Br. at 4-5.  However, CMS does not need to prove that the actual signatures on the orders are not those of Dr. Gibbs; it has provided an attestation by Dr. Gibbs that he did not order home health services for any of the beneficiaries at issue (CMS Ex. 5), and it has provided evidence that Dr. Gibbs improperly delegated his signature authority to a nurse practitioner.  CMS Ex. 9 at 1.  Further, Petitioner has repeatedly conceded that the physician orders may have been signed by Ms. Anyalebechi rather than a physician.  See CMS Ex. 3 at 4 (Petitioner’s recognition that, based on an “ongoing relationship” between Dr. Gibbs and Ms. Anyalebechi, the orders it received from Kindle Clinic were signed by Dr. Gibbs and/or Ms. Anyalebechi); P. Br. at 2 (arguing that Dr. Gibbs had authorized Ms. Anyalebechi to sign home health orders and that it received orders that were signed by Dr. Gibbs and/or Ms. Anyalebechi); P. Motion at 8 (arguing that because Ms. Anyalebechi had a collaboration agreement with Dr. Gibbs, it was permissible for her “to sign Dr. Gibbs’ signature.”).  CMS has offered compelling evidence that Dr. Gibbs did not sign the orders and physician certifications, as required by 42 C.F.R. § 424.22(a)(2), and Petitioner, as a home health agency, should have known that certifications for home health eligibility must be signed by a physician, as required by 42 C.F.R. § 424.22(a)(2).  Petitioner understood that Ms. Anyalebechi may be the signatory on physician certifications for the need for home health services, yet it did not exercise due diligence to ensure that orders or certifications received from Kindle Clinic had actually been signed by a physician.  Revocation is warranted based on Petitioner’s pattern and practice of submitting improper claims purportedly ordered by Dr. Gibbs.  42 C.F.R. § 424.535(a)(8)(ii).

With respect to Petitioner’s allegation that CMS should have proven that the signatures on the claims were not those of Dr. Gibbs, I note that Petitioner has not submitted admissible evidence regarding five of the seven claims I have focused on in this decision.  Therefore, there is no evidence that, with respect to C.J., J.P., H.S., M.D., and C.L., Dr. Gibbs signed the required physician orders.  And although Petitioner submitted admissible evidence regarding S.L. and J.H., Petitioner’s submissions do not establish

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that Dr. Gibbs, himself, signed the orders or certified the need for home health services, as required by 42 C.F.R. § 424.22(a)(2).  For example, the records Petitioner provided for S.L. and J.H. both include a pre-printed form on Kindle Clinic letterhead, entitled “Home Health Care Services Physician Order,” that shows a pre-printed signature on the line corresponding to the “Physician’s Signature” and purports to be a physician’s order to, inter alia, “Admit [patient] to home health services.”22  CMS Ex. 4 at 21, 28.  Petitioner’s submissions also show that Kindle Clinic, through Ms. Anyalebechi, conducted the face‑to-face encounter for both S.L. and J.H.  CMS Ex. 4 at 22-24, 30-33.  Likewise, Petitioner’s submissions purport to show that a signature appears on the line adjacent to “Physician Signature” on a face-to-face visit attestation on Kindle Clinic letterhead.  CMS Ex. 4 at 25, 29.  Petitioner’s submissions further show that an individual signed and dated the Home Health Certification and Plan of Care (Form CMS-495).  CMS Ex. 4 at 26, 34.  Despite these submissions of evidence pertaining to S.L. and J.H., Petitioner has

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not submitted evidence that Dr. Gibbs signed the physician orders and certified the need for home health services.   42 C.F.R. § 424.22(a)(2).

Petitioner argues that “CMS has not proven a prima facie case that [Petitioner] was not in substantial compliance with Medicare billing requirements.”  P. Br. at 6 (emphasis omitted).  However, it appears that Petitioner misunderstands the relatively low burden that CMS must meet to establish a prima facie case.  The DAB has explained that “CMS has the burden of coming forward with evidence related to disputed findings that is sufficient (together with any undisputed findings and relevant legal authority) to establish a prima facie case of noncompliance with a regulatory requirement.”  Evergreene Nursing Care Ctr., DAB No. 2069 at 7 (2007).  The DAB has further applied this burden to enrollment cases such as the instant case, explaining:

The [DAB] applies to provider and supplier enrollment appeals the same burden of proof that it applies to other cases subject to the appeal procedures in Part 498.  [Internal citations omitted.]  Applying that burden to appeals of enrollment revocations, CMS has the burden of coming forward with evidence that establishes a prima facie case that the cited basis for the revocation exists.  If CMS meets this burden, a petitioning provider then has the burden to prove its case, that is, to rebut the basis for the revocation, by a preponderance of the evidence.

Adora Healthcare Services, Inc., DAB No. 2714 at 4-5 (2016), citing Promptcare New England Respiratory, LLC, DAB No. 2673 at 7-8 (2016); Ronald J. Grason, M.D., DAB No. 2592 at 5 (2014).  The DAB also explained that for CMS to establish its prima facie case, it “needed to point to evidence in the record developed before the ALJ showing” the basis for revocation.  Adora, DAB No. 2714 at 5.  Similarly, in a matter involving revocation pursuant to 42 C.F.R. § 424.535(a)(8)(i), the DAB explained, with respect to CMS’s burden, that CMS “need only provide evidence of three or more instances of [abusive] billing,” whereas “Petitioner must furnish evidence disputing CMS’s prima facie case of a pattern of abusive billing.”  Med-Care Diabetic & Medical Supplies, Inc., DAB No. 2764 at 17 (2017).

Contrary to Petitioner’s vague and unsupported allegation that CMS has not established a prima facie case, CMS has undoubtedly satisfied this burden of proof.  Palmetto initially explained that Dr. Gibbs certified that he had not ordered home health services for numerous beneficiaries for whom Petitioner submitted claims, and it issued a list of representative claims and beneficiaries that include the seven beneficiaries that I have focused on for purposes of this decision.  CMS Ex. 1 at 1, 3.  To establish a prima facie case, as relevant here, CMS needed to establish that Petitioner had a pattern or practice of submitting claims for services that had not been certified by a physician; CMS met this burden by identifying a number of claims for services that Petitioner submitted for reimbursement for which the physician listed on the claims had certified that he had not

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ordered those services.  CMS Exs. 1 at 3; 5 at 1-2.  CMS presented further evidence that Dr. Gibbs had authorized Ms. Anyalebechi to sign all home health orders on his behalf.  CMS Ex. 9.

In order to rebut CMS’s prima facie case that revocation is warranted based on a pattern and practice of submitting claims for reimbursement that had not been certified or signed by a physician, Petitioner was required to rebut, by a preponderance of the evidence, the evidence showing that Dr. Gibbs did not authorize the home health services at issue (i.e., that he actually certified and signed the orders as required by 42 C.F.R. § 424.22(a)(2)).  Petitioner does not deny that it provided home health services to the beneficiaries on this list.  Further, despite the fact that CMS offered evidence that Dr. Gibbs attested that he did not order home health services for the listed beneficiaries (CMS Ex. 5 at 1-2), Petitioner has not asserted that Dr. Gibbs personally signed each of those orders himself, nor has it submitted evidence of such.  Rather, Petitioner acknowledges that Dr. Gibbs may not have signed those orders.  CMS Ex. 3 at 2-3 (Petitioner’s acknowledgment that Kindle Clinic “initiated” the “formal written orders” for cases involving Dr. Gibbs, and that “all orders [were] forwarded by both the Nurse Practitioner, Agnes Anyalebechi, DNP, ACNP, BC . . . and/or . . . Dr. Lynn Gibbs.”), 4 (stating that “[a] careful review of Dr. Gibbs and his relationship with Agnes Anyalebechi of Kindle Clinic will show that Kindle Clinic had an ongoing relationship with Dr. Gibbs during the entire period at issue and all related orders were signed and submitted by Dr. Gibbs and/or Agnes Anyalebechi for Kindle Clinic.”); P. Br. at 2 (“Each of the beneficiaries’ orders, certifications, and re‑certifications received by Blessed Home bared [sic] the signature of Dr. Gibbs and/or his Nurse Practitioner, Agnes Anyalebechi, whom Dr. Gibbs previously authorized to sign all Home Health orders on his behalf.”).  Even though Petitioner must submit evidence showing that Dr. Gibbs actually certified the need for home health services for these beneficiaries and signed the orders, Petitioner has submitted admissible evidence for only two of the seven beneficiaries I have focused on in this decision, and this evidence does not established that Dr. Gibbs signed the orders for home health services.  Despite having the opportunity to do so, Petitioner has not submitted documentary evidence or witness testimony demonstrating that Dr. Gibbs signed the orders.23  Nor did Petitioner request the issuance of a subpoena to compel the production of any documents or testimony.  See 42 C.F.R. § 498.58(c); Pre-Hearing Order § 9.

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Petitioner has not presented evidence that Dr. Gibbs personally signed the orders for home health services or the physician certifications for those services.  To the contrary, Petitioner argued that any orders and certifications signed by Ms. Anyalebechi are valid, even without a signature by Dr. Gibbs, stating:

Each of the beneficiaries’ orders, certifications, and re-certifications received by [Petitioner] bared [sic] the signature of Dr. Gibbs and/or his Nurse Practitioner, Agnes Anyalebechi, whom Dr. Gibbs previously authorized to sign all Home Health Orders on his behalf.

[Petitioner] thus, in full compliance with 42 C.F.R. § 424.22, reasonably relied on the orders, certifications, and re-certifications baring [sic] Dr. Gibbs’ and/or Agnes Anyalebechi’s signature from Kindle Clinic, Inc.  [Petitioner] properly believed that the prerequisite prior relationship between Dr. Gibbs and the beneficiaries had been established and the treatment was ordered by Dr. Gibbs prior to [Petitioner’s] treatment of each such beneficiary.

P. Br. at 2.  Petitioner added that “[a]s illustrated by Ms. Anyalebechi’s affidavit and Dr. Gibb’s [sic] personal statement of giving Kindle Clinic authority, it is clear” that Ms. Anyalebechi was working in collaboration with Dr. Gibbs under state law.24  P. Br. at 8.  Petitioner has not come forward with any evidence, much less evidence meeting the standard of a preponderance of the evidence, that Dr. Gibbs signed the orders or certifications for the home health services.

CMS has submitted evidence that Petitioner submitted multiple claims for home health services involving seven beneficiaries for which Dr. Gibbs certified that he did not sign the orders for home health services.  CMS Ex. 5; see CMS Ex. 2 at 5.  CMS has also presented evidence that Dr. Gibbs had authorized Ms. Anyalebechi to sign orders on his behalf.  CMS Ex. 9 at 1.  Therefore, and contrary to Petitioner’s claims, CMS has established a prima facie case.  As such, Petitioner was required to show, by a

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preponderance of the evidence, that Dr. Gibbs authorized and signed the orders for home health services.  Petitioner submitted no such evidence.  To the contrary, Petitioner concedes that “Dr. Gibbs and/or Agnes Anyalebechi of Kindle Clinic” signed the physician orders.  CMS Ex. 3 at 4; see P. Br. at 2.

Petitioner argues that “the facts of this case are parallel to those” in TEHC, LLC, DAB No. CR4371 (2015) and Proteam Healthcare, Inc., DAB No. 2658 (2015), which are cases in which an ALJ and the DAB, respectively, reversed a revocation.25  P. Br. at 4.  Neither TEHC nor Proteam involved the regulation at issue in this case, 42 C.F.R. § 424.535(a)(8)(ii).  Rather, the revocations in both TEHC and Proteam were premised on 42 C.F.R. § 424.535(a)(1).  At the time of TEHC’s revocation in December 2014 and Proteam’s revocation in June 2013, the basis for revocation CMS applied in the present case did not yet exist; section 424.535(a)(8)(ii), which allows CMS to revoke enrollment based on a pattern or practice of submitting claims that do not meet Medicare requirements, did not become effective until February 3, 2015.  79 Fed. Reg. at 72,513 (adding paragraph (ii) to 42 C.F.R. § 424.535(a)(8)); see TEHC, DAB No. CR4371 at 1; Proteam, DAB No. 2658 at 2.  The addition of this new regulatory provision at 42 C.F.R. § 424.535(a)(8)(ii) is significant because, in both TEHC and Proteam, the revocations were reversed based on the inapplicability of 424.535(a)(1) as a basis for revocation to instances of inaccurate billing and noncompliance with Medicare requirements.  TEHC, DAB No. CR4371 at 11; Proteam, DAB No. 2658 at 7.  However, with the addition of section 424.535(a)(8)(ii) in February 2015, there is a clear regulatory basis for revocation that addresses circumstances in which a provider’s billing fails to comply with Medicare requirements (i.e., billing for services that were based on orders not signed by physicians).  See Rural Metro Corporation of Florida, Inc., DAB No. 2977 at 8 (2019) (stating that “revocation under [section 424.535(a)(8)(ii) depends on showing a pattern or practice of claims that are not compliant with requirements”).

Petitioner also references Access Foot Care, Inc., and Robert Metnick, D.P.M., DAB No. 2752 at 8 (2016), without any explanation of why it cited to that decision.  P. Motion at 8.  I note that Access Foot Care explains that neither 42 C.F.R. § 424.535(a)(8)(i) or language in that regulation’s rulemaking “establishes a strict liability standard for improper billing or creates an exception for accidental billing.”  Access Foot Care, DAB No. 2752 at 8.  However, I reiterate that the regulatory provision at issue here is 42 C.F.R. § 424.535(a)(8)(ii), and section 424.535(a)(8)(ii) allows for revocation when a provider such as Petitioner engages in a pattern or practice of submitting claims that do not comply with Medicare requirements.  Petitioner also cites to InFocus Health, LLC,

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DAB No. CR5435 (2019), in support of its claim that “Dr. Gibbs is the subject of multiple Medicare revocation cases currently pending before this tribunal.”  P. Br. at 10.  I observe that both Dr. Gibbs and Ms. Anyalebechi are recurring figures in a line of home health agency cases involving revocation pursuant to 42 C.F.R. § 424.535(a)(8)(ii).  See, e.g., InFocus Health, LLC, DAB No. CR5435; Skyview Home Health Agency, DAB No. CR5607; K&G Home Health Services, DAB No. CR5596.  Dr. Gibbs, along with other physicians, improperly delegated to Ms. Anyalebechi the authority to sign physician names on orders.  Likewise, Ms. Anyalebechi signed orders for physicians when she clearly should not have done so.  See InFocus Health, DAB No. CR5435 at 3 (testimony by Ms. Anyalebechi in which she “admitted that she signed” certification forms on a physician’s behalf).  Regardless of whether there was any wrongdoing by Dr. Gibbs, Ms. Anyalebechi, and the other physicians who have been involved in a number of cases involving Kindle Clinic, home health agencies such as Petitioner cannot deflect fault for their own failures.  Petitioner was aware that Ms. Anyalebechi had been authorized by a physician to sign orders on his behalf, even though section 424.22(a)(2) unambiguously states that only a physician may sign orders certifying the need for home health services.  42 C.F.R. § 424.22(a)(2); 42 U.S.C. § 1395f(a)(2)(C).  Similar to what occurred in InFocus, Petitioner acknowledges that Dr. Gibbs and/or Ms. Anyalebechi signed the necessary physician orders.  Regardless of any fault by Dr. Gibbs or Ms. Anyalebechi, revocation is warranted based on Petitioner’s pattern and practice of submitting claims that did not meet Medicare requirements.  See CMS Ex. 2 at 5 (CMS’s statement that Petitioner “blindly relied on Kindle in ensuring that the orders and certifications it received were Medicare compliant,” even when it was on notice that it should have conducted “a deeper investigation [into] its own and Kindle’s Medicare compliance.”).

If Petitioner conducted the requisite amount of due diligence necessary to ensure that it submitted valid Medicare claims, it is simply implausible that it did not recognize that Ms. Anyalebechi, as a nurse practitioner, could not have properly been delegated the authority to sign orders certifying the need for home health services on behalf of a physician.  42 C.F.R. §§ 424.22(a)(2) (“The certification of need for home health services . . . must be signed and dated by the physician who establishes the plan.”), 489.21(b)(1) (making providers responsible for having in its files required physician certifications related to services furnished to Medicare beneficiaries).  The requirement for actual and non-delegable physician authorization is clearly stated in the regulation setting requirements for home health services, and it is simply inexcusable that Petitioner would be ignorant of such a critical requirement.  Therefore, with the knowledge that Ms. Anyalebechi was authorized to sign orders on behalf of Dr. Gibbs, Petitioner was on notice that orders certifying the need for home health services may lack the necessary physician signature and that it should verify that a physician had actually signed those orders and certifications.

The evidence must merely establish that Petitioner had a pattern or practice of submitting claims that fail to meet Medicare requirements.  42 C.F.R. § 424.535(a)(8)(ii); 79 Fed.

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Reg. at 72,515 (“The term ‘abusive,’ as used in the context of § 424.535(a)(8)(ii), is meant to capture a variety of situations in which a provider or supplier regularly and repeatedly submits non-compliant claims over a period of time.”).  Further, the plain language of 42 C.F.R. § 424.535(a)(8)(ii) contains no reference to the culpability of the supplier or any requirement of fraudulent intent.  Likewise, there is no knowledge requirement.  79 Fed. Reg. at 72,516, 72,520.  As the preamble to the final rule stated:  “We explained that a provider or supplier should be responsible for submitting valid claims at all times and that the provider or supplier’s repeated failure to do so poses a risk to the Medicare Trust Funds.”  79 Fed. Reg. at 72,513.

The evidence establishes that over an approximately 11-month period, Petitioner submitted multiple claims involving seven beneficiaries for whom home health services were not certified by a physician.   42 C.F.R. § 424.535(a)(8)(ii)(A),(B), (D).26  Petitioner claims that it has been enrolled in Medicare since 2008, and with that amount of experience with the Medicare program, it is implausible that Petitioner was uninformed about Medicare requirements such that it did not recognize that physician orders certifying the need for home health services mustbe signed by a physician.  42 C.F.R. § 424.535(a)(8)(ii)(E).  Petitioner acknowledges that physician orders were signed by Dr. Gibbs and/or Ms. Anyalebechi (CMS Ex. 3 at 4; P. Br. at 2), and even with this knowledge, Petitioner did not attempt to determine whether Ms. Anyalebechi had signed the orders certifying the need for home health services.  CMS Ex. 3 at 4; see 42 C.F.R. § 424.22(a)(2).  I need only determine whether Petitioner had a “pattern or practice of submitting claims that fail to meet Medicare requirements.”  Petitioner submitted multiple claims for at least seven beneficiaries that it should have known were based on orders and certifications that may not have been signed by a physician, and it failed to undertake any effort to determine whether Dr. Gibbs, rather than Ms. Anyalebechi, had actually signed the orders and certifications.  Pursuant to section 424.535(a)(8)(ii), Petitioner had a pattern or practice of submitting claims that failed to meet Medicare requirements.

Petitioner has not addressed the effective date of the revocation or the duration of the reenrollment bar.  Therefore, I need not address these issues.  See 42 C.F.R.  §§ 424.535(c), 498.3(b)(17).

To the extent that Petitioner may be requesting equitable relief, I am unable to grant equitable relief.  See US Ultrasound, DAB No. 2302 at 8 (2010) (stating that an ALJ may not grant equitable relief in an instance where statutory or regulatory requirements are not met).  Petitioner points to no authority by which I may grant it relief from the applicable regulatory requirements.  1866ICPayday.com, L.L.C., DAB No. 2289 at 14 (2009) (“An

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ALJ is bound by applicable laws and regulations and may not invalidate either a law or regulation on any ground . . . .”).

V.  Conclusion

I affirm the determinations revoking Petitioner’s Medicare enrollment and billing privileges.

• 1. Curiously, Dr. Gibbs did not specify a termination date for this delegation of signature authority to Ms. Anyalebechi.  Although Petitioner argues that Ms. Anyalebechi worked in collaboration with Dr. Gibbs, it did not submit a copy of a collaborative practice agreement.  See, e.g., 42 C.F.R. § 410.75(c).  Another recent administrative law judge (ALJ) decision references a collaborative practice agreement between Ms. Anyalebechi and Dr. Gibbs, in which Ms. Anyalebechi agreed to compensate Dr. Gibbs at a rate of $1,000 per month for period of twelve months that concluded in January 2017.  Skyview Home Health Agency, Inc., DAB No. CR5607 at 5 (2020).  Likewise, I recently addressed another collaborative practice agreement that Ms. Anyalebechi entered into with a different physician, Dr. Grace Varas, wherein Ms. Anyalebechi agreed to compensate Dr. Varas at the same $1,000 monthly rate, effective September 2017.  K&G Home Health Services, DAB CR5596 at 2 (2020).  Dr. Varas, like Dr. Gibbs, had authorized Ms. Anyalebechi “to sig[n] all [her] [h]ome health care orders on [her] behalf as her [s]upervising physician.”  Id.
• 2. All beneficiary names are redacted to protect the privacy of those individuals.
• 3. Even though the initial determination clearly explained that the revocation of Petitioner’s enrollment and billing privileges was based upon abusive billing related to beneficiaries for whom Dr. Gibbs purportedly certified the need for home health services (CMS Ex. 1 at 1), Petitioner’s request for reconsideration contains a substantial amount of discussion regarding irrelevant matters such as claims Petitioner submitted for a number of beneficiaries for whom Dr. Gibbs was not the ordering physician.  CMS Ex. 3 at 2-3.  Petitioner also inexplicably referenced “written and direct testimony” (which is not part of the reconsideration process), argued about claims with dates of service that were well outside range of dates cited in the initial determination, and disputed an “inaccurate finding” regarding a $319,706.62 overpayment, despite the fact that there was no such finding in the initial determination.  CMS Ex. 3 at 1-5.  Petitioner also requested “a hearing with the appropriate ALJ office to reconsider its termination and reconsideration of each prior stated findings,” even though the submission of a request for hearing prior to the issuance of a reconsidered determination was premature and contrary to regulatory requirements.  CMS Ex. 3 at 5; see 42 C.F.R. § 498.5(l)(2).
• 4. This submission has the file name, “392045_Additional_Evidence” and contains records for C.J., C.L., H.S., J.P., M.D., P.J., S.G., and S.L.  See Departmental Appeals Board Electronic Filing System (DAB E-File) Case Record, Docket Entry 1d.
• 5. Because Petitioner filed what appeared to be its complete pre-hearing exchange nearly a month before filing its motion for summary judgment and pre-hearing brief, CMS had previously filed its objections before Petitioner later submitted its motion for summary judgment and pre‑hearing brief.  CMS thereafter renewed its objections.  My references herein are to CMS’s latter filing, dated November 4, 2019.
• 6. Specifically, section 498.56(e)(1) states that the ALJ “will examine any new documentary evidence submitted to the ALJ by a provider or supplier . . . .”
• 7. Petitioner argues that “CMS Ex. 11 does not provide any additional insight on whether Petitioner was in substantial compliance with Medicare regulations . . . .”  P. Objections.  I agree.
• 8. Petitioner submitted eight pages of records for S.L. with its request for reconsideration (CMS Ex. 4 at 28-35), whereas it submitted 13 pages of records for S.L. with its request for hearing.
• 9. Although Petitioner had previously submitted documents pertaining to J.H., the documents pertaining to J.H. in P. Ex. 2 are not duplicative of the records contained in CMS Ex. 4.  Compare CMS Ex. 4 at 21-27 with P. Ex. 2 at 1-5.
• 10. I reiterate that Petitioner, in its request for reconsideration, disputed matters that were irrelevant to the revocation of its enrollment and billing privileges, such as a $319,706.62 overpayment that had not been cited in the initial determination.  CMS Ex. 3 at 5.
• 11. S.G. and P.J. are not listed in Enclosure A to the initial determination.  CMS Ex. 1 at 3.  I have determined that revocation is warranted without consideration of the claims involving S.G. and P.J.
• 12. Petitioner did not submit any records for J.H. with its request for hearing.  However, it previously submitted records for J.H. with its request for reconsideration.  CMS Ex. 4 at 21-27.
• 13. In fact, the website indicates that it is a family-owned “e-store” that generates its revenue through advertising and online store sales.  https://www.carepathways.com/aboutus.cfm#money (last visited May 14, 2020).
• 14. Findings of fact and conclusions of law are in italics and bold font.
• 15. I refer to these provisions as they were previously in effect.  Section 3708 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, P.L. 116-136, enacted March 27, 2020, authorizes, inter alia, nurse practitioners to certify the need for home health services for Medicare beneficiaries.  CMS issued an interim final rule implementing these statutory revisions.  85 Fed. Reg. 27,550, 27,625 (May 8, 2020).
• 16. Section 424.535(a)(8)(ii) is a relatively new basis for the revocation of enrollment and billing privileges that became effective in February 2015.  During the rulemaking process to add section 424.535(a)(8)(ii), CMS stated:  “We explained that a provider or supplier should be responsible for submitting valid claims at all times and that the provider or supplier’s repeated failure to do so poses a risk to the Medicare Trust Funds.”  79 Fed. Reg. 72,500, 72,513 (Dec. 5, 2014).  CMS further explained that its intention was not to revoke billing privileges based on a “misunderstanding of these policies,” but cautioned that “Medicare billing privileges come with a responsibility for the provider to diligently seek and obtain clarification of Medicare policies should there be a misunderstanding or confusion.”  79 Fed. Reg. at 72,514.  CMS also discussed that “[t]he term ‘abusive,’ as used in the context of § 424.535(a)(8)(ii), is meant to capture a variety of situations in which a provider or supplier regularly and repeatedly submits non-compliant claims over a period of time.”  79 Fed. Reg. at 72,515.
• 17. The regulation was amended after Petitioner filed its request for hearing.  See 84 Fed. Reg. 47,794, 47,854-56 (Sept. 10, 2019).
• 18. CMS, citing to the version of “42 C.F.R. § 424.22” (without listing a pinpoint subsection) that was purportedly in effect between January 1, 2016, and December 31, 2018, argues that the certifying physician “must certify that the home health services will be or were furnished while the individual is under his/her care.”  CMS Br. at 6 n.2 (emphasis added).  However, I was unable to locate such a provision in hard copy editions of the U.S. Government Publishing Office publication of the Code of Federal Regulations from the timeframe identified by CMS.  Rather, section 424.22(a)(1)(iv) has consistently referenced that a physician must certify that home health services are furnished while the beneficiary was under the care of a physician.  Although the Medicare Benefit Policy Manual (Ch. 7, § 30.3 (eff. Jan. 1, 2015)) similarly states that “[a] patient is expected to be under the care of the physician who signs the plan of care,” this manual provision relies exclusively on 42 C.F.R. § 424.22.  Regardless, it is unnecessary to address whether the home health services were provided while the beneficiaries were under the care of Dr. Gibbs, nor is it necessary to address whether Dr. Gibbs had a prior relationship with those beneficiaries.
• 19. “Physician certification/recertification claims are Part B physician claims paid for under the Physician Fee Schedule.”  Medicare Benefit Policy Manual, Ch. 7, § 30.5.4 (eff. Jan. 1, 2015).
• 20. Under Texas law, a physician “may delegate to a qualified and properly trained” nurse practitioner certain acts such as prescribing and ordering drugs and devices.  Tex. Occ. Code Ann.  §§ 157.001(a), 157.051.  In order to delegate such authority, a physician and nurse practitioner must enter into a prescriptive authority agreement.  Tex. Occ. Code Ann.  § 157.0512.
• 21. I focus on these seven beneficiaries and the corresponding claims that were submitted between January 18 and December 4, 2017.  Palmetto specifically identified these claims in the initial determination, and Petitioner had an opportunity to submit evidence demonstrating that Dr. Gibbs had certified and ordered home health services for these beneficiaries.  CMS Exs. 1 at 1; 3; see CMS Ex. 2 at 4.  As previously discussed at length, despite being given an opportunity to do so, Petitioner addressed only two of the ten claims (i.e., J.H. and S.L.) in its request for reconsideration and failed to produce evidence showing that Dr. Gibbs signed any of the physician orders.  CMS Ex. 4 at 21‑35; see CMS Ex. 3 at 3.
• 22. While I refuse to accept CMS’s invitation to assess whether various signatures purported to be those of Dr. Gibbs “match” (CMS Br. at 8-9), I recognize the obvious fact that Kindle Clinic’s “Home Health Care Services Physician Order” that lists Dr. Gibbs as the ordering physician is actually a pre-printed form that includes a pre-printed physician signature.  Compare CMS Ex. 4 at 21 (physician order for J.H.) with CMS Ex. 4 at 28 (physician order for S.L.).  By virtue of the fact that the signature and other handwritten information is pre-printed on each of these Kindle Clinic physician orders, Petitioner’s submission of these purported orders weighs against a finding that Dr. Gibbs signed each certification, as required by 42 C.F.R. § 424.22(a)(2).  The pre-printed nature of the Kindle Clinic orders is readily apparent to any lay observer through a comparison of the identical markings and lines on both forms (that were presumably created though the photocopying process), along with identical handwritten notations and the pre‑printed signatures.  My observation can be easily replicated by printing out both forms, lining them up (one on top of the other), stapling them together, and then holding them against a light source; one can see that there is no deviation between both forms with respect to several markings and handwritten notations.  CMS Ex. 4 at 21, 28.  Further, the signatures on the line adjacent to “Physician’s Signature” line up precisely, as if one signature had had been traced directly over the other, with absolutely no deviation, to include the placement of the signature with respect to the signature line.  CMS Ex. 4 at 21, 28.  While I am not competent to conduct the analysis necessary to establish who signed the order on Kindle Clinic’s pre-printed physician order for Dr. Gibbs, I can easily determine that these orders are on pre-printed forms based on this precision in the overlap of markings, print, and signatures on those forms.  CMS Ex. 4 at 21, 28.  Although I need not reach the question of who signed the pre-printed signature on these orders, I nonetheless caution CMS that handwriting analysis is best left to someone with the appropriate expertise.  See CMS Br. at 8-9 (incorporating images of various purported signatures for Dr. Gibbs, and arguing, in support of summary judgment, that the signatures “clearly do not match”).
• 23. For instance, Petitioner could have submitted documentation establishing that Dr. Gibbs actually signed the orders, or it could have submitted the testimony of an expert witness who is qualified to analyze handwritten signatures.  Petitioner also could have submitted the written testimony of one of its managers or employees explaining any processes utilized to verify that Dr. Gibbs had signed all physician orders, or it could have asked Dr. Gibbs to provide testimony that he did, in fact, authorize home health service for the beneficiaries at issue and has signed the physician orders and certifications.
• 24. Although Petitioner argues that Ms. Anyalebechi and Dr. Gibbs had a collaborative practice agreement, it has not provided evidentiary support for this assertion.  I note that Dr. Gibbs improperly authorized Ms. Anyalebechi to sign orders on his behalf in a letter dated February 1, 2016; this letter does not specify a termination date and the record does not indicate the duration of any collaborative practice agreement(s).  Therefore, the record does not establish that Dr. Gibbs and Ms. Anyalebechi remained in a collaborative practice agreement during the relevant time period, between January and December 2017.  In fact, another ALJ decision reports that Ms. Anyalebechi entered into a collaborative practice agreement with a different physician, Dr. Varas, in September 2017, which overlaps the time period at issue in this case.  K&G Quality Healthcare Service, DAB No. CR5596 at 2.
• 25. The ALJ decision in TEHC extensively cited to the DAB’s decision in Proteam.   TEHC, DAB No. CR4371 at 11-13.  Further, the TEHC decision is an ALJ decision, and I am not bound by the decisions or rulings of other ALJs.  See, e.g., Vamet Consulting & Medical Servs.,DAB No. 2778 at (2017) (discussing that an ALJ decision is “not binding precedent on another ALJ or on the [DAB]”).
• 26. Petitioner, without any elaboration or supporting evidence, contends that “the percentage of submitted claims denied by Medicare is miniscule.”  P. Br. at 10; see 42 C.F.R. § 424.535(a)(8)(ii)(A).  I lack a meaningful basis to address this allegation.