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                              K&G Quality Healthcare Service, DAB CR5596 (2020)
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K&G Quality Healthcare Service, DAB CR5596 (2020)








  
  
    

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





K&G Quality Healthcare Service
	(NPI: 1164451811; PTAN: 679566),
	Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-19-1066Decision No. CR5596April 24, 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, K&G Quality Healthcare Service, pursuant to 42 C.F.R. § 424.535(a)(8)(ii) because, over a combined period of eight months, Petitioner submitted dozens of 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 based on a pattern or practice of submitting claims that fail to meet Medicare requirements.
I.  Background and Procedural History
Petitioner is a provider that was enrolled as a home health agency in the Medicare program.  CMS Exhibit (Ex.) 8 at 2; *see*42 U.S.C. § 1395x(u) (classifying home health agencies as “providers” in the Medicare program).
Agnes Anyalebechi is a nurse practitioner who is licensed in the State of Texas.  CMS Ex. 6 at 1.  According to Petitioner, Ms. Anyalebechi “operated” Kindle Clinic, and
Page 2
Petitioner provided home health services to Kindle Clinic’s patients.  Petitioner (P.) Brief (Br.)1
; CMS Ex. 1 at 1.
On September 6, 2017, Ms. Anyalebechi entered into a Collaborative Practice Agreement with Grace Varas, DO.  CMS Ex. 6 at 1-3.  The agreement addressed such topics as the scope of practice (to include the prescribing of medications), practice protocols, physician consultation, and record review.  CMS Ex. 6 at 1-3.  The agreement also reported that Dr. Varas would be compensated at a rate of $1,000 per month.  CMS Ex. 6 at 3.  Ms. Anyalebechi and Dr. Varas jointly signed a letter, dated September 6, 2017, that stated the following:  “To whom it may concern: This is to certify that I Dr. Grace Varas DO authorized NP Agnes Anyalebechi of Kindle Clinic to sig[n] all my Home health care orders on my behalf as her Supervising physician.”  CMS Ex. 6 at 4.  On September 6, 2017, Ms. Anyalebechi and Dr. Varas jointly signed another letter, which is dated January 27, 2016, that stated the following:  I Agnes C. Anyalebechi, ACNP, have Dr. Grace Varas DO. [sic] as my Supervising physician . . . effective date 09/06/2017.”2
  CMS Ex. 6 at 5.  The letter provided a telephone number for Dr. Varas, and that telephone number is different (to include a different area code) than the telephone number listed on Kindle Clinic’s letterhead.  CMS Ex. 6 at 5.
Qlarant, a Medicare program integrity contractor, conducted an investigation of Petitioner’s billing practices.  On August 31, 2018, Qlarant conducted a records review with Dr. Varas, at which time she denied that 16 Medicare beneficiaries were her patients or that she had authorized home health services for those 16 beneficiaries that resulted in 29 Medicare claims.  CMS Ex. 4; *see*CMS Ex. 9 at 1 (spreadsheet listing claims for home health services that were reported to have been ordered by Dr. Varas).  Similarly, on November 30, 2018, another physician, Maryam Qayum, denied that 13 Medicare beneficiaries were her patients or that she had authorized home health services for those 13 beneficiaries that resulted in 13 Medicare claims.3
  CMS Ex. 5; *see*CMS Ex. 9 at 2 (spreadsheet listing claims for home health services that were reported to have been ordered by Dr. Qayum).
Page 3
In an April 3, 2019 initial determination, Palmetto revoked Petitioner’s Medicare enrollment and billing privileges effective May 3, 2019, pursuant to 42 C.F.R.
	§ 424.535(a)(8)(ii), based on Petitioner’s abuse of its billing privileges.  CMS Ex. 2.  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. Grace Varas is listed as the ordering/certifying physician on twenty‐nine (29) home health service claims for seventeen (17)[4
] Medicare beneficiaries, submitted by [Petitioner], with episodes of care starting November 4, 2017 and continuing through May 4, 2018.  See ***Enclosure A*** *for a sample set of ten of these claims*.  Dr. Varas reviewed a list of beneficiaries for whom [Petitioner] submitted claims listing Dr. Varas as the ordering/certifying physician.  Dr. Varas attested that she did not order home health services for any of the beneficiaries listed and none of them were her beneficiaries.  Furthermore, claims data analysis revealed that Dr. Varas did not have a prior Part B relationship with those beneficiaries.  Therefore, Dr. Varas was not involved in the care, treatment, or monitoring of the listed beneficiaries.
Dr. Maryam Qayum is listed as the ordering/certifying physician on thirteen (13) home health service claims for thirteen (13) Medicare beneficiaries, submitted by [Petitioner], with episodes of care starting July 29, 2016 and continuing through September 27, 2016.  See ***Enclosure B*** *for a list of these claims*.  Dr. Qayum reviewed a list of beneficiaries for whom [Petitioner] submitted claims listing Dr. Qayum as the ordering/certifying physician.  Dr. Qayum attested that she did not order home health services for any of the beneficiaries listed and none of them were her beneficiaries.  Furthermore, claims data analysis revealed that Dr. Qayum did not have a prior Part B relationship with those beneficiaries.  Therefore, Dr. Qayum was not involved in the care, treatment, or monitoring of the listed beneficiaries.
Page 4
CMS Ex. 2 at 1 (emphasis in original); *see*CMS Ex. 3 at 1-2 (Enclosures A and B).  Palmetto also barred Petitioner from re-enrolling for a period of three years.  CMS Ex. 2 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 2.
Petitioner, through its current counsel, submitted a request for reconsideration dated April 23, 2019.  CMS Ex. 1.  Petitioner did not submit any evidence regarding the specific claims for services that had been listed in the two enclosures to the initial determination.  CMS Ex. 1; *see*CMS Ex. 3 at 1-2.  Rather, Petitioner argued that it was an “unwitting victim” and had not knowingly engaged in any fraudulent practices.  CMS Ex. 1 at 1.  Petitioner stated the following in support of its request that Palmetto reverse the revocation:
The referenced claims were as a result of referrals and services rendered pursuant to a physician’s order from a Clinic in which a Nurse Practitioner (NP) operated.  The NP represented to [Petitioner] that she had a signed agreement with the physician who was her supervising and covering physician.  The NP made [Petitioner] to believe that the physician practiced from the Clinic and signed all orders.  All referrals and orders bore the physician’s signature which the NP claimed was signed by the physician.  [Petitioner] relied on the representations of the NP and [Kindle] Clinic and did not intend to nor did it knowingly accept referrals without valid physicians’ orders.  [Petitioner] did not conspire with the NP to defraud Medicare.  Please see enclosed copy of the NP’s Collaborative Practice Agreement with one of the physicians.
There is no allegation that [Petitioner] failed to render needed services or that the beneficiaries did not need the services.  The provider had no incentive to spend its resources to service beneficiaries that were not properly referred to it.  The clinics provided documents ‘signed’ by the physicians and represented to [Petitioner] that they were signed by the physicians.  [Petitioner] did not knowingly engage in a pattern or practice of submitting claims for services provided without valid certification of eligibility.  It has severed all ties with the clinics and the NPs and has put in place a verification process to ensure that its orders and plans of care are actually signed by eligible physicians.
CMS Ex. 1 at 1, 3.  In support of its request for reconsideration, Petitioner submitted a copy of the Collaborative Practice Agreement between Agnes Anyalebechi and Dr. Varas, a copy of the letter in which Dr. Varas “authorized NP Agnes Anyalebechi of
Page 5
Kindle Clinic to sign all my Home health care orders on my behalf as her Supervising physician,” and a copy of the letter on Kindle Clinic letterhead stating that Dr. Varas is Ms. Anyalebechi’s supervising physician.  CMS Exs. 1 at 1; 6 at 1-5.
CMS, through its Provider Enrollment & Oversight Group, issued a reconsidered determination on July 2, 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. 8.  By way of background, CMS explained:
Data analysis was conducted on claims submitted by [Petitioner] with dates of service from November 4, 2017 through May 4, 2018.  The analysis revealed 29 home health service claims for 17 Medicare beneficiaries listing Dr. Grace Varas, (Dr. Varas) as the ordering/certifying physician for home health services.  Investigators from Qlarant, the Unified Program Integrity Contractor for CMS, interviewed Dr. Varas regarding home health service claims on which she is listed as the ordering/certifying physician for the 29 claims, for 17 Medicare beneficiaries, submitted by [Petitioner].  Dr. Varas reviewed the list of 29 claims, for 17 Medicare beneficiaries for whom [Petitioner] submitted home health service claims and attested that [neither] she, nor anyone associated with her office acted as the referring or attending physician for any of the 17 Medicare beneficiaries identified. Furthermore, data analysis revealed that Dr. Varas did not have a prior relationship treating some of the Medicare beneficiaries in question or rendering Medicare Part B services to them.
Similarly, data analysis was conducted on claims submitted by [Petitioner] with dates of service from July 29 through September 27, 2016.  The analysis revealed 13 home health service claims for 13 Medicare beneficiaries listing Dr. Maryam Qayum, (Dr. Qayum) as the ordering/certifying physician for home health services.  Investigators from Qlarant interviewed Dr. Qayum regarding home health service claims on which she is listed as the ordering/certifying physician for the 13 claims, for 13 Medicare beneficiaries, submitted by [Petitioner].  Dr. Qayum reviewed the list of 13 claims, for 13 Medicare beneficiaries for whom [Petitioner] submitted home health service claims and attested that [neither] she, nor anyone associated with her office acted as the referring or attending physician for any of the 13 Medicare beneficiaries identified.  Furthermore, data analysis revealed that Dr. Qayum did not have a prior relationship treating any of the Medicare beneficiaries in question or rendering Medicare Part B services to them.
CMS Ex. 8 at 2-3 (internal citations omitted).  In upholding the revocation of Petitioner’s enrollment and billing privileges, CMS further stated:
Page 6
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. . . . CMS finds a pattern of abusive billing where three or more claims were submitted to Medicare for services that fail to meet Medicare requirements. 73 Fed. Reg. 36455 (June 27, 2008).  [Petitioner] submitted a total of 42 noncompliant claims, allegedly ordered by Drs. Varas and Qayum, which failed to meet Medicare requirements to the Medicare program for payment.  The submission of 42 noncompliant claims surpasses CMS’s threshold of three noncompliant claims and establishes a pattern of abusive billing.
[Petitioner] listed the ordering physicians Drs. Varas and Qayum for the claims at issue.  The reconsideration states that [Petitioner] initiated home health services based on orders it received from Kindle Clinic and nurse practitioner Agnes Anyalebechi.  [Petitioner] admits in its reconsideration request that it submitted claims for services ordered by the clinic and nurse practitioner, while listing the ordering physician as Dr. Varas.  The relationship Dr. Varas has with the clinic or nurse practitioner does not establish her as having a prior relationship treating the Medicare beneficiaries at issue.  As stated above, Dr. Varas must have a prior relationship treating the Medicare beneficiaries whose claims form the basis of this revocation.  There is no documentation to establish a prior, independent relationship with Drs. Varas and Qayum treating the Medicare beneficiaries for whom home health services were ordered.  The submission of claims listing Drs. Varas and Qayum as the ordering physicians who did not have a prior relationship treating the Medicare beneficiaries makes the associated claims noncompliant.  Therefore, [Petitioner] has submitted 42 claims to Medicare for payment that fail to meet Medicare requirements.
Further, in addition to the lack of the requisite treating relationship between the listed Medicare beneficiaries and Drs. Varas and Qayum, the submission of 42 [sic] claims where Dr. Varas was the ordering/certifying physician [was] noncompliant because there was an impermissible delegation of her authority to sign home health certification documents to nurse practitioner Agnes Anyalebechi – who is not a physician.  This signature delegation is in violation of § 424.22 and any claims arising out of that delegation are noncompliant.
Page 7
CMS Ex. 8 at 4.  CMS determined that Petitioner “engaged in a pattern or practice of abusive billing when it, for nearly eight months collectively, submitted claims to Medicare for payment that failed to meet Medicare requirements” and that the revocation of Petitioner’s Medicare enrollment and billing privileges was appropriate.  CMS Ex. 8 at 5.
Petitioner filed a request for an administrative law judge hearing (ALJ) on August 28, 2019.5
  Thereafter, 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, along with nine proposed exhibits (CMS Exs. 1-9).  Petitioner filed a pre-hearing brief and response to CMS’s motion for summary judgment.
Neither party has submitted the written direct testimony of any witnesses, and therefore, a hearing for the purpose of cross-examination of witnesses is unnecessary.  Pre‐Hearing Order §§ 12-14.  I consider the record to be closed and the matter ready for a decision on the merits.6
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 Analysis
***1. Petitioner concedes that it “relied on the representation” of Agnes Anyalebechi that orders certifying the need for home health services had been “signed by physicians.”***
Page 8
***2. Petitioner does not dispute that Dr. Varas and Dr. Qayum did not order home health services for a combined 29 beneficiaries and that it submitted claims for services provided to those beneficiaries.***
***3.******Petitioner does not dispute that it submitted a total of 42 claims without an order or certification from the physician listed on the claims.***
***4. Pursuant to 42 U.S.C. § 1395f(a)(2)(C), only a physician may certify the need for home health services, and 42 C.F.R § 424.22(a)(2) requires that the certifying physician sign and date the certification of need for home health services.***
***5. Petitioner had written notice that at least one physician had authorized Ms. Anyalebechi to sign home health certification orders on her behalf.***
***6. As a long-term participant in the Medicare program, Petitioner should have known that a physician’s signature was required on orders certifying the need for home health services.***
***7. Because, over a combined period of approximately eight months, from July 29 through September 27, 2016, and November 4, 2017 through May 4, 2018, Petitioner submitted 42 claims for Medicare services involving 29 beneficiaries that had not been certified by a physician, it engaged in a pattern or practice of submitting improper claims to Medicare.***
***8. Palmetto and CMS had a legitimate basis to revoke Petitioner’s Medicare enrollment and billing privileges 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 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.
Page 9
(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).7
  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); *see*CMS Ex. 2 at 2 (initial determination imposing a three-year re‐enrollment bar).
Medicare requirements for home health services are addressed in 42 C.F.R. § 424.22.  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.”8
  42 C.F.R. § 424.22(a)(1)(v)(B)(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
Page 10
in accordance with State law and in collaboration with the certifying physician.”9
  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 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, Ch. 15, § 200(D) (eff. Nov. 19, 2007) (containing substantially similar guidance).
Petitioner does not dispute CMS’s determination that, over an approximately eight-month period, it submitted a total of 42 claims for services involving 3010
 beneficiaries that had not been certified or signed by physicians.  P. Br.  Petitioner claims that it “relied on the representation of the [nurse practitioner] in her clinic that documents were signed by [p]hysicians.”  P. Br.  Petitioner argues that Ms. Anyalebechi “represented to the Petitioner at all times that she had a signed agreement with the physician who was her supervising and covering physician” and that it “had no knowledge whatsoever that the
Page 11
certification was being done by [Ms. Anyalebechi] instead of the certifying [p]hysicians themselves.”  P. Br.
Petitioner was not an “unwitting victim of the conducts of clinics and the Nurse Practitioner . . . that practiced in those clinics,” as it claimed in its request for hearing.  Petitioner has acknowledged that it was aware that Kindle Clinic, through Ms. Anyalebechi, had been “authorized” to sign all of the home health care orders on “behalf” of her supervising physician.11
  CMS Exs. 1 at 1; 6 at 4.  In fact, Petitioner submitted a copy of the letter purportedly delegating Ms. Anyalebechi the authority to sign orders on behalf of a physician.  CMS Ex. 6 at 5.  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, was improperly given 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 their files required physician certifications related to the services furnished to 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.  In fact, Petitioner acknowledged that Kindle Clinic is operated by Ms. Anyalebechi, and it has not pointed to any evidence that either Dr. Varas or Dr. Qayum were employees of Kindle Clinic.  CMS Ex. 1 at 1; *see*CMS Ex. 6 at 5 (Kindle Clinic, Inc. letterhead listing only the name of Ms. Anyalebechi on its letterhead, and listing a telephone number that is different than the contact telephone number listed for Dr. Varas); CMS Ex. 6 at 3 (collaboration agreement between Ms. Anyalebechi and Dr. Varas ).12
  Therefore, with the knowledge that “Dr. Grace Varas DO authorized [nurse practitioner] Agnes Anyalebechi of Kindle Clinic to sign all [her] home
Page 12
health care orders on [her] behalf as her Supervising physician,” Petitioner was on notice that orders certifying the need for home health services may not contain the requisite physician signatures and that it would need to verify that a physician had actually signed those orders.13
  CMS Ex. 6 at 4.
Petitioner argues in its request for hearing that “the revocation was predicated on the allegation that [Petitioner] had engaged in fraudulent practices” and that its practices were not fraudulent because it lacked intent to commit fraud when it engaged in a pattern or practice of abusive billing.  However, “fraud” is not a necessary element of any determination that a home health agency engaged in a pattern of abusive billing pursuant to section 424.535(a)(8)(ii).  Rather, 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. Reg. 72,500, 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 provider or 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 a lengthy and combined period of approximately eight months (from July 29 through September 27, 2016, and from November 4, 2017 through May 4, 2018), Petitioner submitted a large number of claims – at least 42 claims involving 29 beneficiaries –  for whom home health services were not certified by a physician.  *See*42 C.F.R. § 424.535(a)(8)(ii)(B), (D).  Petitioner claims that it has been enrolled in Medicare for 15 years (P. Br.), and with that amount of experience with the Medicare program, it is difficult to fathom how Petitioner could be unaware of the basic requirement that physician orders certifying the need for home health services *must*be signed by a physician.  *See*42 C.F.R. § 424.535(a)(8)(ii)(E).  Petitioner has presented evidence that it was aware that Ms. Anyalebechi had purportedly been delegated to sign home health orders on behalf of physicians (CMS Exs. 1 at 1; 6 at 1-5), yet Petitioner made no effort to ascertain whether she improperly signed the orders certifying the need for home health services.  42 C.F.R. § 424.22(a)(2).  I need not find that Petitioner engaged in any “fraudulent” activity to sustain revocation based on section
Page 13
424.535(a)(8)(ii), but rather, need only look to whether Petitioner had a “pattern or practice of submitting claims that fail to meet Medicare requirements.”  Petitioner submitted dozens of improper claims 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 Ms. Anyalebechi, rather than a physician, had signed the orders and certifications even though it knew she had improperly been delegated this authority.  Pursuant to section 424.535(a)(8)(ii), Petitioner had a pattern or practice of submitting claims that failed to meet Medicare requirements.
Petitioner argues in its brief that revocation is “too punitive and extreme.”  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 ALJ is bound by applicable laws and regulations and may not invalidate either a law or regulation on any ground . . . .”).
***9.  The three-year length of the re-enrollment bar is not reviewable.***
The Departmental Appeals Board (DAB) has explained that “CMS’s determination regarding the duration of the re-enrollment bar is not reviewable.”  *Vijendra Dave, M.D.*, DAB No. 2672 at 11 (2016).  The DAB explained that “the only CMS actions subject to appeal under Part 498 are the types of initial determinations specified in section 498.3(b).”  *Id.*The DAB further explained that “[t]he determinations specified in section 498.3(b) do not, under any reasonable interpretation of the regulation’s text, include CMS decisions regarding the severity of the basis for revocation or the duration of a revoked supplier’s re-enrollment bar.”  *Id.*The DAB discussed that a review of the rulemaking history showed that CMS did not intend to “permit administrative appeals of the length of a re-enrollment bar.”  *Id.*I have no authority to review this issue, and I do not disturb the three-year re-enrollment bar.  *See*CMS Ex. 2 at 2.
V.  Conclusion
I affirm the determination revoking Petitioner’s Medicare enrollment and billing privileges.


          /s/
        Leslie C. Rogall

                      Administrative Law Judge
      1. Because Petitioner did not paginate its brief, I do not reference page numbers when citing to its brief. back to note 1
                      2. The letter is on Kindle Clinic letterhead listing only Ms. Anyalebechi by name. CMS Ex. 6 at 5. The letter appears to be a “form letter,” in that it is not addressed to a particular person or entity. back to note 2
                      3. Although Petitioner did not submit a copy of a collaboration agreement between Ms. Anyalebechi and Dr. Qayum, it explained in its reconsideration request that Ms. Anyalebechi “represented to [it] that she had a signed agreement with the physician who was her supervising and covering physician.”  CMS Ex. 1 at 1. back to note 3
                      4. By my count, Dr. Varas is listed as the ordering/certifying physician on 29 claims for home health services for 16 beneficiaries. back to note 4
                      5. Because Petitioner did not paginate its request for hearing, I do not reference page numbers when citing to the request for hearing. back to note 5
                      6. As an in-person hearing to cross-examine witnesses is not necessary, it is unnecessary to further address CMS’s motion for summary judgment. back to note 6
                      7. Section 424.535(a)(8)(ii) is a relatively new basis for the revocation of enrollment and billing privileges.  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. back to note 7
                      8. “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). back to note 8
                      9. 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, 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. back to note 9
                      10. As previously noted, Petitioner provided home health services to 29 beneficiaries for whom a physician did not sign a certification of the need for home health services. CMS Exs. 4, 5. back to note 10
                      11. I note that this is not the first case involving the revocation of a home health agency’s enrollment and billing privileges based on a home health agency’s submission of claims for home health services that had been signed by Ms. Anyalebechi rather than a physician.  In testimony before another administrative law judge, Ms. Anyalebechi “admitted that she signed” certification forms on a physician’s behalf.  In Focus Health, LLC, DAB CR5435 at 3 (2019). back to note 11
                      12. The fact that Ms. Anyalebechi’s collaborative practice agreement reports that she, as a nurse practitioner,compensates a physician $1,000 per month is inconsistent with an expectation that they would be co-workers at the same medical practice.  Rather, it appears that Ms. Anyalebechi owns and/or operates Kindle Clinic and compensates physicians to enter into collaborative practice agreements so that she can bill for services provided to Medicare beneficiaries.  See P. Br. (Petitioner’s statement that a “Nurse Practitioner . . . operated” Kindle Clinic); see also 42 C.F.R. § 410.75(c). back to note 12
                      13. Petitioner has not claimed that it attempted to verify that a physician actually signed the orders, nor has it submitted evidence, such as written direct testimony from its own representatives or the testimony of Dr. Varas, Dr. Qayum, or Ms. Anyalebechi. back to note 13 Back to top
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