Allen Care Inc., DAB CR5615 (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, Allen Care Inc., pursuant to 42 C.F.R. § 424.535(a)(8)(ii) because Petitioner submitted claims for home health services that failed to meet Medicare requirements.  Upon reconsideration, CMS upheld that determination.  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 42 U.S.C. § 1395x(u) (classifying home health agencies as "providers" in the Medicare program).

On April 9, 2018, Qlarant, a Medicare program integrity contractor, interviewed H. Spangler, M.D.  CMS Ex. 3 at 1-2.  A contact report summarizing the interview

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explained that Dr. Spangler's National Provider Identifier (NPI)The National Plan & Provider Enumeration System maintains the NPI system, which assigns a single, unique NPI to health care providers.  45 C.F.R. § 162.408.  A provider need not be enrolled in Medicare to have an NPI.  See 45 C.F.R. §§ 162.408, 162.410, 162.412, 162.414. had been listed on claims for home health services submitted by nine different home health agencies, and Dr. Spangler "stated he did not order home health for any of the beneficiaries and he was not the attending physician for any of the beneficiaries."  CMS Ex. 3 at 1.  The contact report further explained:

Dr. Spangler related he has been employed by GO Imaging since 2008 and his medical specialty is Radiology and Nuclear Medicine.  His primary duties include reading and interpretation of images and preparing detailed reports associated with the images.  He stated he has never ordered home health for any beneficiaries and has never been attending physician for any beneficiaries receiving home health services.

CMS Ex. 3 at 1.  Dr. Spangler signed a "Physician Statement" in which he denied that three specific Medicare beneficiaries, C.D., L.J., and R.T., were his patients, or that he had ordered home health services for those three beneficiaries during specific dates of service.For purposes of reference throughout this decision, I identify the five claims as follows:  Claim # 1, submitted August 27, 2015, involving care for R.T. from June 26 through August 24, 2015; Claim # 2, submitted August 7, 2015, involving care for L.J. from June 5 through August 3, 2015; Claim # 3, submitted September 18, 2015, involving care for C.D. from July 19 through September 16, 2015; Claim # 4, submitted November 2, 2015, involving care for R.T. from August 25 through  October 23, 2015; and, Claim # 5, submitted October 6, 2015, involving care for L.J. from August 4 through October 2, 2015.  CMS Ex. 2 at 3.  CMS Ex. 4 at 1; see CMS Ex. 7 at 1 (spreadsheet listing claims for home health services provided by Petitioner that were reported to have been ordered by Dr. Spangler).  At that time, Dr. Spangler authorized an "auto-deny edit be placed on [his] NPI in order to stop home health and hospice billing under [his] NPI."  CMS Ex. 4 at 2.

In an April 4, 2019 initial determination, Palmetto revoked Petitioner's Medicare enrollment and billing privileges effective May 4, 2019, pursuant to 42 C.F.R. § 424.535(a)(8)(ii).  CMS Ex. 2 at 1-2.  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[.]

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§ 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. Henry Spangler is listed as the ordering/certifying physician on five (5) home health service claims for three (3) Medicare beneficiaries, submitted by [Petitioner], with episodes of care starting June 5, 2015 and continuing through October 23, 2015.  See Enclosure A for a list of these claims.  Dr. Spangler reviewed a list of beneficiaries for whom [Petitioner] submitted claims listing Dr. Spangler as the ordering/certifying physician.  Dr. Spangler attested that, for all beneficiaries listed, he did not order home health services and those beneficiaries were not his.  Furthermore, claims data analysis revealed that Dr. Spangler did not have a prior Part B relationship with those beneficiaries.  Therefore, Dr. Spangler was not involved in the care, treatment, or monitoring of the listed beneficiaries.

CMS Ex. 2 at 1 (emphasis in original); see CMS Ex. 2 at 3 (Enclosure A).  Palmetto also barred Petitioner from re-enrolling in the Medicare program for a period of three years.  CMS Ex. 2 at 2.  Palmetto explained that Petitioner could seek reconsideration of its determination and informed it that if it had "additional information that [it] would like a hearing officer to consider during the reconsideration, or if necessary, an administrative law judge to consider during a hearing, [it] must submit that information with [its] request for reconsideration."  CMS Ex. 2 at 1-2.

Petitioner, through counsel, submitted an undated request for reconsideration that was received on June 25, 2019.CMS reported that U.S. Postal Service tracking information indicates that it took several weeks for CMS to receive Petitioner's submission by mail.  CMS Ex. 1 at 1 n.1.  CMS Exs. 5, 6; see CMS Ex. 1 at 1.  Petitioner explained that "all orders for services provided to [Petitioner] came directly from, Amex Medical Clinic, the facility in which Dr. Spangler initiated and maintained a contractual relationship."  CMS Ex. 5 at 2.  Petitioner reported that it enclosed "a copy of the orders and face-to-face as attached to this correspondence to substantiate validity of Allen Care, Inc. compliance to 424.535(a)(8)(ii)."  CMS Ex. 5 at 2 (bold font omitted).  Petitioner further explained that "orders attached substantiate the appropriate billing for services in compliance with 424.22(1) [sic] and 424.535(a)(8)(ii) performed by Allen Care, Inc., and refute any and all physician attestation."  CMS Ex. 5 at 2 (bold font omitted).  Petitioner's submission included the following documents:

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Claim # 1See Footnote 2. (CMS Ex. 6 at 23-28):  various documents listing Dr. A.,It is unnecessary to identify this physician by his full name. and not Dr. Spangler, as the ordering physician, with several documents lacking a date in the section designated for the physician to date his signature (CMS Ex. 6 at 23, 25, 28).

Claim # 2 (CMS Ex. 6 at 7-10):  various documents listing Dr. A., and not Dr. Spangler, as the ordering physician, with two documents lacking a date in the section designated for the physician to date his signature (CMS Ex. 6 at 7, 8).

Claim # 3 (CMS Ex. 6 at 1-6):  various documents listing Dr. A., and not Dr. Spangler, as the ordering physician, with four documents lacking a date in the section designated for the physician to date his signature (CMS Ex. 6 at 1, 2, 3, 4).

Claim # 4 (CMS Ex. 6 at 29-33):  various documents listing Dr. Spangler as the ordering physician, with all five of the documents lacking a date in the section designated for the physician to date his signature.

Claim # 5 (CMS Ex. 6 at 11-13):  three pages of documents listing Dr. Spangler as the ordering physician, with all three documents lacking a date in the section designated for the physician to date his signature.Petitioner submitted documentation for three consecutive 60-day periods of home health services provided to L.J., with a series of three different physicians certifying the need for home health services and that L.J. was under that particular physician's care.  CMS Ex. 6 at 7-22.

Thus, even though Palmetto had revoked Petitioner's enrollment and billing privileges based on its submission of claims listing Dr. Spangler as the ordering physician, when Dr. Spangler had denied being the ordering physician, Petitioner submitted evidence that Dr. Spangler did not order the services that were the subject of three of those five claims.  CMS Ex. 6 at 1-6 (Claim # 3), 7-10 (Claim # 2), and 23-28 (Claim # 1).

CMS, through its Provider Enrollment & Oversight Group, issued a reconsidered determination on August 14, 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. 1.  CMS explained that Petitioner submitted evidence showing that its Medicare claims failed to comply with Medicare requirements, stating:

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[T]his billing behavior is an act of noncompliance as [Petitioner] submitted claims containing inaccurate information.  Though [Petitioner] provided medical records in an effort to demonstrate its compliance with § 424.22, it has done the opposite.  Based on the submission of these medical records alone, [Petitioner] has demonstrated that it did not submit home health claims in line with Medicare requirements because the claims did not list the correct ordering/certifying physician.  The physician that ordered/certified the home health services is the ordering physician that should appear on the claim.  [Petitioner's] documentation demonstrates that this did not occur on at least three of the five claims that form the basis of this revocation.

CMS Ex. 1 at 4.  In upholding the revocation of Petitioner's enrollment and billing privileges, CMS explained that it may revoke a provider's enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(8)(ii) when it determines "the provider has a pattern or practice of submitting claims that fail to meet Medicare requirements."  CMS Ex. 1 at 3.  CMS further explained that Petitioner is required to provide services and submit claims for payment that comply with 42 C.F.R. § 424.22, and that "Dr. Spangler has attested that he did not order or refer home health services for the beneficiaries in question."  CMS Ex. 1 at 3.  CMS determined that Petitioner "engaged in a pattern or practice of abusive billing when it . . . submitted claims to the Medicare program for payment that failed to meet Medicare requirements."  CMS Ex. 1 at 4-5.  CMS explained that Petitioner "submitted claims listing an ordering/referring physician who did not have any prior relationships treating or caring for the Medicare beneficiaries for whom home health services were certified and ordered," and "in several instances these claims were submit[ted] under the name of a different physician than that of the physician whose name appears on and signed the associated medical records."  CMS Ex. 1 at 5.

Petitioner filed a request for an administrative law judge (ALJ) hearing on October 12, 2019.When it filed its request for hearing, Petitioner submitted a copy of a September 13, 2019 letter notifying it that it had been added to CMS's preclusion list.  See 42 C.F.R. §§ 422.2, 423.100.  Petitioner did not raise its inclusion on the preclusion list in its request for hearing, nor did it raise this issue in its brief.  Therefore, I do not address Petitioner's inclusion on the preclusion list.  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 seven proposed exhibits (CMS Exs. 1-7).  Petitioner filed a pre-hearing brief (P. Br.), along with two exhibits (P. Exs. 1-2).

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Petitioner has submitted the written direct testimony of Shawnika Blake (P. Ex. 1), and CMS has not requested an opportunity to cross-examine Ms. Blake.  Therefore, a hearing for the purpose of cross-examination of any 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.As an in-person hearing to cross-examine witnesses is not necessary, it is unnecessary to further address CMS's motion for summary judgment.

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 AnalysisMy findings of fact and conclusions of law are set forth in italics and bold font.

1. Petitioner does not dispute that it submitted the five claims for reimbursement for services rendered to three beneficiaries, R.T., L.J., and C.D., that are listed in Enclosure A to the initial determination.

2. Petitioner does not dispute that each of these five claims for reimbursement listed Dr. Spangler as the ordering/certifying physician.

3. Dr. Spangler attested that the R.T., L.J., and C.D. were not his patients and that he had not authorized home health services for these three beneficiaries on the dates of service listed in aforementioned five claims.

4. Palmetto revoked Petitioner's enrollment and billing privileges because Petitioner had abused its billing privileges by submitting claims for home health services that had not been ordered by the physician listed on those claims.

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5. In requesting reconsideration of Palmetto's determination revoking its enrollment and billing privileges, Petitioner submitted copies of records pertaining to the five claims at issue.

6. Petitioner's records show that Dr. Spangler was not the ordering and certifying physician for services provided between June and August 2015 for Medicare beneficiary R.T., even though Petitioner had listed Dr. Spangler as the ordering physician when it submitted a claim for reimbursement in August 2015.

7. Petitioner's records show that Dr. Spangler was not the ordering and certifying physician for services provided between June and August 2015 for Medicare beneficiary L.J., even though it had listed Dr. Spangler as the ordering physician when it submitted a claim for reimbursement in August 2015.

8. Petitioner's records show that Dr. Spangler was not the ordering and certifying physician for services provided between July and September 2015 for Medicare beneficiary C.D., even though it had listed Dr. Spangler as the ordering physician when it submitted a claim for reimbursement in September 2015.

9. Pursuant to 42 U.S.C. § 1395f(a)(2)(C), a physician must certify the need for home health services, and 42 C.F.R § 424.22(a)(2) I refer to these provisions as they were in effect until very recently.  Section 3708 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, P.L. 116-136, enacted March 27, 2020, authorizes, inter alia, certain non-physician practitioners, in addition to physicians, 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, 27,624-25 (May 8, 2020). requires that the certifying physician sign and date the certification of need for home health services.

10. Petitioner engaged in a pattern or practice of submitting claims that fail to meet Medicare requirements when it repeatedly listed on its claims a physician who did not order or certify the need for the home health services listed in those claims.

11. 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).

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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.
(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).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.  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

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health services are necessary "must be signed and dated by the physician who establishes the plan.""Physician certification/recertification claims are Part B physician claims paid for under the Physician Fee Schedule."  Medicare Benefit Policy Manual, CMS Pub, 100-02, Ch. 7, § 30.5.4 (eff. Jan. 1, 2015).  42 C.F.R. § 424.22(a)(2).  When a home health agency submits a claim for reimbursement for services provided to a Medicare beneficiary, it certifies its compliance with the aforementioned requirements, in that it identifies "the name and [NPI] of the attending physician who signed the plan of care . . . [and] who certified/re-certified the patient's eligibility for home health services."The listing of the ordering physician on a Medicare claim assists CMS and its contractors in determining whether home health services are valid and necessary (i.e., that a physician who is a doctor of medicine, osteopathy, or podiatric medicine has determined that the services are necessary, and that the beneficiary was under the care of such a physician).  See 42 C.F.R. § 424.22(a)(1).  Medicare Claims Processing Manual, CMS Pub. 100-4, Ch. 10, § 40.2; see CMS Pub. 100-4, Transmittal 2833, § I(B) (addressing that the aforementioned reporting requirements became effective July 1, 2014).

Palmetto informed Petitioner that it had revoked its enrollment and billing privileges based on a pattern and practice of abusive billing, as evidenced by the fact that Dr. Spangler had attested that he did not order home health services for three beneficiaries, R.T., L.J., and C.D.  CMS Ex. 2 at 1, 3.  Palmetto identified five claims for services provided to R.T., L.J. and C.D. in which Petitioner listed Dr. Spangler as the certifying physician.  CMS Ex. 2 at 3.  In response to Palmetto's allegations, Petitioner stunningly submitted evidence that wholly supported Palmetto's allegation that Dr. Spangler had not ordered home health services for all three beneficiaries on specific dates of service in 2015.  CMS Ex. 6 at 1-10, 23-28.  Therefore, the evidence submitted by Petitioner shows that it submitted at least three claims (Claims # 1, # 2, and # 3) that did not meet Medicare requirements when it listed a physician on each claim who had not ordered and certified the home health services at issue.Because I have determined that, based on these three claims alone, CMS had a legitimate basis pursuant to 42 C.F.R. § 424.535(a)(8)(ii) to revoke Petitioner's enrollment and billing privileges, it is unnecessary to address whether revocation is warranted based on the other two claims (Claims # 4 and # 5).  However, I note that Petitioner has not established, with respect to those two claims, that Dr. Spangler actually certified those home health services.  CMS presented evidence that Dr. Spangler attested that he did not order the services listed in those two claims.  CMS Ex. 4 at 1-2.  Petitioner offered documents that list Dr. Spangler's name and include his purported signature, but it has not offered any evidence demonstrating that Dr. Spangler actually signed those orders, such as the testimony of Dr. Spangler or the beneficiaries who Dr. Spangler certified were under his care.  Further, I note that 42 C.F.R. § 489.21(b)(1) requires that a home health agency maintain in its files the required physician certifications related to the services furnished to beneficiaries, yet the certifications Petitioner produced each lack a date accompanying the signature.  CMS Ex. 6 at 11-13, 29-33; see 42 C.F.R. § 424.22(a)(2) (requiring that a certification of need "must be signed and dated by the physician who established the plan").  Thus, these claims fail to meet Medicare requirements because the physician orders are not dated as required by section 424.22(a)(2).

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Petitioner argues that "its privileges were revoked based on self-serving statements of Dr. Spangler in an attempt to avoid criminal liability."  P. Br. at 2.  Petitioner has not submitted any evidence in support of this statement, and it premises this bald allegation on an apparent belief that Dr. Spangler was somehow affiliated with Amex Medical Clinic,Even if Dr. Spangler was affiliated with Amex Medical Clinic, which the evidence of record does not establish, such an affiliation, without specific evidence of the nature of the relationship, is of little value without specific information defining the parameters of the relationship.  For instance, Dr. Spangler could have been affiliated with Amex Medical Clinic to provide radiological consultation services for its patients; such an affiliation would not necessarily evidence that Dr. Spangler, as a radiologist, ordered and certified home health services or served as an attending physician. which is a medical practice that referred home health patients to Petitioner.  P. Br. at 4-5; see P. Ex. 1 (written declaration by Ms. Blake reporting that Dr. Spangler told her that "he left the company because he did not like their practices" and that it "was owned and operated by two women who were crooks").  Petitioner argues that the owners of Amex Medical Clinic were convicted of Medicare fraud, yet it has produced no evidence Dr. Spangler had any involvement in this activity.  More significantly, Petitioner has not drawn any connection between Dr. Spangler and its own failure to list the correct ordering and certifying physician on at least three Medicare claims.  P. Br. at 5; see P. Ex. 2 (Department of Justice press release announcing that three individuals associated with Amex Medical Clinic had been convicted of Medicare fraud).  Any illegal activity by Amex Medical Clinic is simply immaterial to the fact that Petitioner repeatedly submitted erroneous claims for services that listed Dr. Spangler as the certifying physician when Dr. Spangler did not order those services.  The simple fact is that Petitioner repeatedly submitted claims that failed to meet Medicare requirements when it listed a physician on those claims who had not certified the need for the services that were the subject of those claims.  Petitioner's revocation is not due to any criminal activity by Amex Medical Clinic, but rather, its own failures.

Petitioner argues that CMS "has failed to show that [it] purposely submitted fraudulent bills."  P. Br. at 5.  However, it is unnecessary for CMS to make such a showing.  "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

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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.

Petitioner limits its arguments to factual matters, and it has not argued that Palmetto or CMS misapplied any of the factors outlined in 42 C.F.R. § 424.535(a)(8)(ii).  The evidence establishes that Petitioner submitted at least three separate claims for services it provided to three beneficiaries over span of more than two months for whom home health services were not certified by the physician it reported on those claims.  See 42 C.F.R. § 424.535(a)(8)(ii)(B), (D).  I need not find that Petitioner engaged in any "fraudulent" activity to sustain revocation based on section 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."  Pursuant to section 424.535(a)(8)(ii), the submission of multiple claims for multiple beneficiaries over the span of a number of weeks establishes a pattern or practice of submitting claims that failed to meet Medicare requirements.  Therefore, Palmetto and CMS had a legitimate basis to revoke Petitioner's enrollment and billing privileges.

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

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 . . . .").

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V.  Conclusion

I affirm the determination revoking Petitioner's Medicare enrollment and billing privileges.