Park Avenue Endocrinology & Nutrition, PLLC, DAB CR6851 (2026)

DECISION

The Medicare enrollment and billing privileges of Petitioner, Park Avenue Endocrinology & Nutrition, PLLC, are revoked pursuant to 42 C.F.R. § 424.535(a)(8)(ii),1  effective August 23, 2023.  There is a basis for listing Petitioner on the Centers for Medicare & Medicaid Services (CMS) preclusion list for the duration of its 10-year reenrollment bar. 

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I.  Background

National Government Services, a CMS Medicare administrative contractor (MAC), notified Petitioner by letter dated July 24, 2023, that its Medicare enrollment and billing privileges were revoked pursuant to 42 C.F.R. § 424.535(a)(8)(ii)2  effective August 23, 2023.  CMS advised Petitioner that the revocation was based on Petitioner’s abuse of billing privileges by submitting Medicare claims without sufficient documentation that care or services ordered were reasonable or necessary.  CMS advised Petitioner that it was subject to a 10-year reenrollment bar pursuant to 42 C.F.R. § 424.535(c) to begin 30 days after the date of CMS’s letter.  CMS also advised Petitioner that its name was being added to the CMS preclusion list.  CMS Exhibit (Ex.) 13 at 1-4. 

Petitioner requested reconsideration on August 1, 2023.  CMS Ex. 12.  On January 12, 2024, a CMS hearing officer issued a reconsidered determination.3   The hearing officer upheld revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(8)(ii), a reenrollment bar of 10 years, and placing Petitioner’s name on the CMS preclusion list.  The hearing officer concluded that Petitioner engaged in a pattern or practice of submitting claims that did not meet Medicare requirements over a period of more than four years.  The hearing officer upheld placing Petitioner on the

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preclusion list concluding that the conduct that caused revocation was detrimental to the best interests of the Medicare program.  Ct. Ex. 1 at 1, 3, 7-8. 

Petitioner requested a hearing before an administrative law judge (ALJ) on March 7, 2024.  On March 8, 2024, the case was assigned to Judge Jacinta L. Alves for hearing and decision and her Standing Order was issued.  The case was reassigned to me on December 23, 2025, in anticipation of Judge Alves’ retirement. 

On May 24, 2024, CMS filed a combined prehearing brief and motion for summary judgment (CMS Br.).  CMS also filed CMS Exs. 1 through 14.  On July 28, 2024, Petitioner filed its combined prehearing brief and response in opposition to the CMS motion for summary judgment (P. Br.).  Petitioner also filed the declaration of Clifton M. Jackness, MD, the physician-owner of Petitioner (DAB E-File # 12a).4   CMS waived the filing of a reply brief on August 16, 2024.5 

No objection has been filed to my consideration of CMS Exs. 1 through 14,6  which are admitted as evidence.  No objection has been filed to my consideration of P. Ex. 1.  P. Ex. 1 contains some irrelevant evidence that will be discussed in greater detail later in this

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decision.  Ct. Ex. 1 is important to establish my jurisdiction in this case and no grounds exist for its exclusion, and it is also admitted. 

II.  Discussion

A.  Medicare Enrollment and Billing Privileges and Preclusion List

Section 1831 of the Social Security Act (Act) (42 U.S.C. § 1395j) establishes the supplementary medical insurance benefits program for the aged and disabled known as Medicare Part B.  Payment under the program for services rendered to Medicare-eligible beneficiaries may only be made to eligible providers of services and suppliers.7   Act §§ 1835(a) (42 U.S.C. § 1395n(a)), 1842(h)(1) (42 U.S.C. § 1395u(h)(1)).  Petitioner, a physician practitioner group, is a supplier. 

The Act requires that the Secretary of Health and Human Services (Secretary) issue regulations that establish a process for the enrollment in Medicare of providers and suppliers, including the right to a hearing and judicial review of certain enrollment determinations, such as revocation of enrollment and billing privileges.  Act § 1866(j) (42 U.S.C. § 1395cc(j)).  Pursuant to 42 C.F.R. § 424.505, a supplier must be enrolled in the Medicare program and be issued a billing number to have billing privileges and to be eligible to receive payment for services rendered to a Medicare-eligible beneficiary. 

The Secretary has delegated the authority to revoke enrollment and billing privileges to CMS.  42 C.F.R. § 424.535.  CMS or its Medicare contractor may revoke an enrolled supplier’s Medicare enrollment and billing privileges and supplier agreement for any of the reasons listed in 42 C.F.R. § 424.535.  If CMS revokes a supplier’s Medicare billing privileges, the revocation becomes effective 30 days after CMS or one of its contractors mails the revocation notice to the supplier, subject to some exceptions not applicable in this case.  42 C.F.R. § 424.535(g).  After a supplier’s Medicare enrollment and billing privileges are revoked, the supplier is barred from reenrolling in the Medicare program

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for a minimum of one year, but no more than 10 years, with exceptions not applicable in this case.  42 C.F.R. § 424.535(c)(1)(i). 

Effective June 15, 2018, CMS was required to establish a preclusion list as defined by 42 C.F.R. §§ 422.2 and 423.100 (2018).  There is only one preclusion list.  83 Fed. Reg. 16,440, 16,641-67 (Apr. 16, 2018).  CMS adds to the preclusion list suppliers whose Medicare enrollment and billing privileges are revoked pursuant to 42 C.F.R. § 424.535; who are currently subject to a reenrollment bar under 42 C.F.R. § 424.535(c); and whose conduct that is the basis for revocation CMS determines is detrimental to the best interests of the Medicare program.  In deciding whether conduct is detrimental to Medicare, CMS considers the seriousness of the conduct; the degree to which the conduct could affect the integrity of the Medicare program; and other evidence CMS considers relevant.  Suppliers not enrolled in Medicare may be added to the preclusion list if CMS determines that their conduct would have provided a basis for revocation of Medicare enrollment and after consideration of the other factors listed above.  42 C.F.R. §§ 422.2, 423.100 (2018).  No payment under Medicare Parts C and D may be made to anyone on the preclusion list.  42 C.F.R. §§ 422.222-.224, 422.504(i)(2)(v), 423.120(c)(6).  CMS must notify a supplier in writing that the supplier is being added to the preclusion list, the basis for the action, and inform the supplier of the right to ALJ review and appeal pursuant to 42 C.F.R. pt. 498.  42 C.F.R. §§ 422.222(a)(2), 423.120(c)(6)(v) (2018). 

A supplier whose enrollment and billing privileges have been revoked or who has been placed on the preclusion list may request reconsideration and review as provided by 42 C.F.R. pt. 498.  42 C.F.R. §§ 424.545(a), 422.222(a)(2), 423.120(c)(6)(v).  A supplier submits a written request for reconsideration to CMS or its contractor.  42 C.F.R. § 498.22(a).  CMS or its contractor must give notice of its reconsidered determination to the supplier, giving the reasons for its determination and specifying the conditions or requirements the supplier failed to meet, and the right to an ALJ hearing.  42 C.F.R. § 498.25.  If the decision on reconsideration is unfavorable to the supplier, the supplier has the right to request a hearing by an ALJ and further review by the Departmental Appeals Board (Board).  Act § 1866(j)(8) (42 U.S.C. § 1395cc(j)(8)); 42 C.F.R. §§ 424.545, 498.3(b)(17), (20) (2018), 498.5.  A hearing on the record, also known as an oral hearing, is required under the Act, unless waived.  Crestview Parke Care Ctr. v. Thompson, 373 F.3d 743, 748-51 (6th Cir. 2004).  CMS is also granted the right to request ALJ review of a reconsidered determination with which it is dissatisfied.  42 C.F.R. § 498.5(l)(2).  The supplier bears the burden to demonstrate that it meets enrollment requirements with documents and records.  42 C.F.R. § 424.545(c).  Preclusion list review is strictly limited to whether there is a basis for adding the supplier to the preclusion list.  83 Fed. Reg. at 16,642. 

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B.  Issues

Whether there was a basis for the revocation of Petitioner’s billing privileges and enrollment in Medicare; and

Whether there is a basis to list Petitioner on the CMS preclusion list. 

C.  Findings of Fact, Conclusions of Law, and Analysis

My conclusions of law are set forth in bold followed by the undisputed facts and analysis. 

1.  Summary judgment is appropriate. 

Judge Alves advised the parties in her Standing Order that summary judgment following the principles of Fed. R. Civ. Pro. 56 was an available procedural device in this case.  She also advised them that oral argument would not generally be granted on a motion for summary judgment.  Standing Order ¶ 8.  The Civil Remedies Division Procedures (CRDP) also provide for the availability of summary judgment akin to the procedure described by Fed. R. Civ. Pro. 56 and the federal courts applying that rule or ALJ order.  CRDP § 19a. 

CMS has moved for summary judgment.  Petitioner opposes summary judgment for CMS. 

A supplier whose enrollment has been revoked and/or who has been placed on the preclusion list has a right to a hearing and judicial review, and a hearing on the record is required under the Act.  Act §§ 205(b), 1866(h)(1), (j); 42 C.F.R. §§ 498.3(b)(17)(i), (20), 498.5(l), (n); Crestview, 373 F.3d at 748-51.  A party may waive appearance at an oral hearing but must do so affirmatively in writing.  42 C.F.R. § 498.66.  In this case, Petitioner has not waived the right to oral hearing or otherwise consented to a decision based only upon the documentary evidence or pleadings.  Accordingly, disposition on the written record alone is not permissible, unless summary judgment is appropriate as I conclude it is in this case. 

Summary judgment is not automatic upon request but is limited to certain specific conditions.  The Secretary’s regulations at 42 C.F.R. pt. 498 that establish the procedures to be followed in adjudicating Petitioner’s case do not establish a summary judgment procedure or recognize such a procedure.  However, the Board has long accepted that summary judgment is an acceptable procedural device in cases adjudicated pursuant to 42 C.F.R. pt. 498.  See, e.g., Ill. Knights Templar Home, DAB No. 2274 at 3-4 (2009); Garden City Med. Clinic, DAB No. 1763 (2001); Everett Rehab. & Med. Ctr., DAB No. 1628 at 3 (1997).  The Board also has recognized that the Federal Rules of Civil

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Procedure do not apply in administrative adjudications such as this, but the Board has accepted that Fed. R. Civ. Pro. 56 and related cases provide useful guidance for determining whether summary judgment is appropriate. 

Summary judgment is appropriate and no hearing is required where either: there are no disputed issues of material fact and the only questions that must be decided involve application of law to the undisputed facts; or, the moving party must prevail as a matter of law even if all disputed facts are resolved in favor of the party against whom the motion is made.  The Board follows the general approach of the federal courts in evaluating whether summary judgment in lieu of a hearing is appropriate.  The movant bears the initial burden of demonstrating that there are no genuine issues of material fact for trial and that the movant is entitled to judgment as a matter of law.  When confronted with a properly supported motion for summary judgment, the nonmoving party “may not rest upon the mere allegations or denials of his pleading, but . . . must set forth specific facts showing that there is a genuine issue for trial.”  Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986) (quoting First Nat’l Bank of Az. v. Cities Serv. Co., 391 U.S. 253, 249 (1968)); see also, Fed. R. Civ. P. 56(c); Ill. Knights Templar Home, DAB No. 2274, at 3-4 (2009); Garden City Med. Clinic, DAB No. 1763 (2001), Everett Rehab. & Med. Ctr., DAB No. 1628 at 3 (1997) (in-person hearing required where nonmovant shows there are material facts in dispute that require testimony); Big Bend Hosp. Corp., DAB No. 1814 at 13 (2002) (in some cases, any factual issue is resolved on the face of the written record because the proffered testimony, even if accepted as true, would not make a difference).  In opposing the motion for summary judgment, the nonmovant bears the burden of showing that there are material facts that are disputed either affecting the movant’s prima facie case or that might establish a defense.  It is insufficient for the nonmovant to rely upon mere allegations or denials to defeat the motion and proceed to hearing.  The nonmovant must, by affidavits or other evidence that sets forth specific facts, show that there is a genuine issue for trial.  If the nonmovant cannot show by some credible evidence that there exists some genuine issue for trial, then summary judgment is appropriate and the movant prevails as a matter of law.  Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247 (1986).  A test for whether an issue is regarded as genuine is if “the evidence [as to that issue] is such that a reasonable jury could return a verdict for the nonmoving party.”  Id. at 248.  In evaluating whether there is a genuine issue as to a material fact, an ALJ must view the facts and the inferences to be drawn from the facts in the light most favorable to the nonmoving party.  Pollock v. Am. Tel. & Tel. Long Lines, 794 F.2d 860, 864 (3rd Cir. 1986). 

The Board has explained that the ALJ’s role in deciding summary judgment is different from deciding a case on the merits after a hearing.  On summary judgment, credibility determinations are not made, the evidence is not weighed, and the ALJ does not decide which inferences to draw from the facts.  Rather, the evidence of record is construed in a light most favorable to the nonmovant without determining which version of the facts is

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more likely true.  Venetian Gardens, DAB No. 2286 at 10-11 (2009); Ill. Knights Templar Home, DAB No. 2274 at 8 (2009).  

The Secretary has not provided in 42 C.F.R. pt. 498 for the allocation of the burden of persuasion or the quantum of evidence required to satisfy the burden of persuasion.  However, the Board has provided some persuasive analysis regarding the allocation of the burden of persuasion in cases subject to 42 C.F.R. pt. 498.  Batavia Nursing & Convalescent Ctr., DAB No. 1904 (2004), aff’d, Batavia Nursing & Convalescent Ctr. v. Thompson, 129 F. App’x 181 (6th Cir. 2005). 

Petitioner opposes summary judgment arguing that there is a need for me to receive testimony related to the claims that are the basis for the CMS determination that Petitioner engaged in a pattern or practice of filing claims that did not meet Medicare requirements.  P. Br. at 2.  Based on Petitioner’s request for a reconsidered determination (CMS Ex. 12) and the declaration of Dr. Clifton M. Jackness, MD (P. Ex. 1), I construe Petitioner’s argument to be that I need to determine whether Petitioner’s Medicare claims involved in the two post-payment reviews and the one prepayment review were appropriately denied by the MAC and CMS.  I disagree.  As explained in greater detail in my discussion of the relevance of P. Ex. 1 in my Findings of Fact, Petitioner’s right to challenge claims denials from the post-payment and prepayment reviews was triggered when Petitioner was notified of the denials and the due process procedure was then available under 42 C.F.R. pt. 405.  Petitioner does not argue or allege that any of the claims from the post-payment reviews and the prepayment review are still pending redetermination, reconsideration, ALJ or attorney adjudicator review, before the Medicare Appeals Council, or in any federal court.  Therefore, the initial determinations and any subsequent determinations as to those claims are now administratively final and binding on Petitioner and CMS as a matter of law under 42 C.F.R. pt. 405, subpt. I.  I have no authority to grant Petitioner another bite at the apple by now reviewing the merits of the individual claims.  Rather, I consider the undisputed evidence before me in the form of Investigator Sherry Knickerbocker’s undisputed and unrebutted testimony that either no appeal was made by Petitioner under 42 C.F.R. pt. 405 related to the post-payment reviews and the resulting declaration of overpayments based on those claims denials or as to the results of Petitioner’s appeals related to the prepayment reviews and claims denials.  CMS Ex. 1 at 3-7 ¶¶ 23, 32, 40-44. 

Viewing the evidence before me in a light most favorable to Petitioner and drawing all inferences in Petitioner’s favor, I conclude that there are no genuine disputes as to any relevant material facts pertinent to revocation under 42 C.F.R. § 424.535(a)(8)(ii) or the addition of Petitioner to the preclusion list that require a hearing in this case.  The undisputed relevant and material facts in this case establish as a matter of law a basis for the revocation of Petitioner’s Medicare enrollment and billing privileges.  Petitioner’s asserted defenses must also be resolved against Petitioner as matters of law.  Having

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determined that there is a basis for revocation, whether there is a basis for adding Petitioner to the CMS preclusion list must also be resolved against Petitioner as a matter of law.  CMS is entitled to judgment as a matter of law.  Accordingly, summary judgment is appropriate. 

2.  Billing privileges are abused within the meaning of 42 C.F.R. § 424.535(a)(8)(ii) when a provider or supplier engages in a pattern or practice of submitting claims that do not meet Medicare requirements. 

3.  Based on post-payment and prepayment reviews, CMS determined that Petitioner engaged in a pattern or practice of submitting claims to Medicare that did not meet Medicare requirements. 

4.  There is a basis for revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(8)(ii). 

5.  The effective date of revocation in this case was August 23, 2023, 30 days after the date of the notice of initial determination to revoke.  42 C.F.R. § 424.535(g). 

6.  The duration of the 10-year bar to reenrollment is not subject to my review. 

7.  There is a basis for adding Petitioner to the CMS preclusion list for the duration of its bar to reenrollment. 

Providers and Suppliers Agree to Comply with Medicare Requirements

The requirements for a provider or supplier to establish and maintain the right to file claims with Medicare, known as Medicare billing privileges, are established by 42 C.F.R. pt. 424 subpt. P.  Pursuant to 42 C.F.R. §§ 424.500 and 424.505, a supplier must be enrolled in the Medicare program and be issued a billing number to have billing privileges and to be eligible to receive payment for Medicare covered services or supplies provided to a Medicare beneficiary, either from Medicare or the beneficiary.  A prospective provider or supplier must file the appropriate enrollment application.  42 C.F.R. § 424.510(a).  The enrollment application must be signed by an individual who has authority to bind a provider or supplier legally and financially to comply with Medicare program requirements.  The signature “attests that the information submitted [in the enrollment application] is accurate and that the provider or supplier is aware of, and abides by, all applicable statutes, regulations, and program instructions.  42 C.F.R. § 424.510(d)(3).  An enrolled provider or supplier must periodically certify to CMS that

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it continues to comply with Title XVIII of the Act and Medicare regulations.  42 C.F.R. § 424.516(a)(1). 

Medicare Claims

A claim is the transmission of a request for payment for the provision of health care with necessary information from a health care provider to a health plan.  45 C.F.R. § 162.1101(a).  The requirements for all claims are established by 42 C.F.R. pt. 424, subpt. C.  The CMS-1500, Health Insurance Claim Form is required for use by physicians and other suppliers to request payments for medical services.  42 C.F.R. § 424.32(b).  The CMS-1500 permits filing a claim for multiple services.  Claims for items or services provided to Medicare beneficiaries must be filed with the correct fiscal intermediary or carrier electronically.  42 C.F.R. § 424.32(d)(2).  Subject to the limitation on assignment and reassignment of claims under 42 C.F.R. pt. 424 subpt. F, Medicare pays directly the supplier, such as Petitioner, for covered services when the Medicare beneficiary who received covered services assigns the right to claim reimbursement from Medicare to the supplier and the supplier accepts the reassignment.  42 C.F.R. § 424.55(a). 

a.  Undisputed Facts

Judge Alves advised the parties regarding summary judgment “that a fact alleged and not specifically denied, may be accepted as true for purposes of a motion or cross-motion for summary judgment.  Any evidence will be considered admissible and true unless specific objection is made to its admissibility and accuracy.”  Standing Order ¶ 8.  The relevant material facts are undisputed, or for purposes of summary judgment, Petitioner’s averred facts are accepted as true and all favorable inferences are drawn in favor of Petitioner. 

Petitioner’s Medicare Enrollment

According to an Enrollment Record Summary for Petitioner dated March 13, 2024, Petitioner was enrolled in Medicare as a clinic or group practice.  The record indicates Petitioner’s Medicare enrollment and billing privileges were revoked August 23, 2023.  CMS Ex. 2 at 1.  The Enrollment Record Summary indicates that Petitioner is subject to a 10-year bar to enrollment from August 23, 2023 through August 22, 2033.  CMS Ex. 2 at 2.  Clifton Jackness, MD was listed in Medicare records as Petitioner’s owner, president, director, authorized agent, and managing employee.  CMS Ex. 2 at 4-5.  These facts are not disputed. 

Two Post-Payment Reviews and One Prepayment Review

September 5, 2019 Post-Payment Review.  It is not disputed by Petitioner that the Northeastern Unified Program Integrity Contractor, SafeGuard Services (SGS),

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conducted a post-payment review of some of Petitioner’s claims.  Petitioner was advised of the results of the post-payment review by letter from SGS dated September 5, 2019. 

SGS requested on June 26, 2019 that Petitioner submit for review the records for 10 Medicare beneficiaries with claims for dates of service from January 3, 2018 to December 11, 2018.  It is not disputed that Petitioner was paid a total of $8,012.43 for the claims.  Based on its review, SGS determined that all 102 claims involved should be denied for lack of sufficient documentary support for frequent or uncommon laboratory tests and insufficient documentation to support medical necessity for the testing.  CMS Ex. 3 at 2-3.8   By letters dated September 16, 18, and 19, 2019, CMS demanded payment of the overpayment determined based on the 2019 post-payment review.  CMS advised Petitioner that if it disputed the overpayment determination, appeal processes were found in section 1870(b) of the Act, 42 C.F.R. §§ 405.350-.359, and 20 C.F.R. §§ 404.506-.509, 404.510a, and 404.512.9   CMS advised Petitioner that it could appeal the overpayment decision by requesting redetermination within 120 days of the date of the demand for payment or within 30 days to stop recoupment of the overpayment.  CMS also advised Petitioner that if the redetermination was unfavorable, Petitioner would be informed of the right to request reconsideration.  CMS Ex. 10 at 1-6, 10-15, 26-31. 

July 2, 2021 Post-Payment Review.  It is undisputed that SGS did a second post-payment review of Petitioner’s claims in 2021.  Petitioner was advised of the results of the post-payment review by SGS letter dated July 2, 2021. 

On April 13 and 28, 2021, SGS requested records for 11 Medicare beneficiaries for whom Petitioner submitted Medicare claims with dates of service from October 13, 2020

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to February 23, 2021, and for which Petitioner was paid $3,730.92.  Petitioner provided records for the 11 Medicare beneficiaries.  SGS determined based on its review that 186 of 188 services for which claims were filed by Petitioner should be denied Medicare coverage, because documentation submitted by Petitioner did not support medical necessity for the service claimed or required documents were not received from Petitioner.  CMS Ex. 5 at 2-3.10   By letters dated August 2, 3, and 6, 2021, CMS demanded payment of the overpayment determined based on the 2021 post-payment review.  CMS advised Petitioner that if it disputed the overpayment determination, appeal processes were found in section 1870(b) of the Act, 42 C.F.R. §§ 405.350-.359, and 20 C.F.R. §§ 404.506-.509, 404.510a, and 404.512.  CMS advised Petitioner that it could appeal the overpayment decision by requesting redetermination within 120 days of the date of the demand for payment or within 30 days to stop recoupment of the overpayment.  CMS also advised Petitioner that if the redetermination was unfavorable, Petitioner would be informed of the right to request reconsideration.  CMS Ex. 11 at 1-6, 8-13, 15-20. 

November 23, 2022 Prepayment Review.  It is undisputed that on November 23, 2022, SGS informed Petitioner that it would be conducting prepayment review of Petitioner’s Medicare claims.  Prepayment review involved SGS reviewing medical records for claims before payment of the claims by Medicare.  SGS informed Petitioner in its November 23, 2022 notice of prepayment review that any dispute related to a denied claim would need to follow the MAC appeals process described on the MAC website.  CMS Ex. 7 at 2-3.  2022 prepayment review electronic remittances, which provide details, advised Petitioner of the right to appeal.  CMS Ex. 9 at 3, 11, 16, 20, 24.  In the November 23, 2022 notice of prepayment review, SGS also advised Petitioner that CMS was authorized to revoked Medicare billing privileges pursuant to 42 C.F.R. § 424.535(a)(8)(ii) if CMS determined that Petitioner had a pattern or practice of submitting claims that failed to meet Medicare requirements.  CMS Ex. 7 at 3. 

On June 6, 2023, SGS informed Petitioner of the results of the prepayment review.  SGS reviewed 29 claims with 569 services.  SGS determined that 526 services out of 569 services should be denied.  SGS denied all 29 claims with 33 service units allowed, 10 service units reduced, and 526 services denied.  SGS found Petitioner’s documentation of claims was insufficient to support that services were medically reasonable and necessary and other requirements specific to certain services.  CMS Ex. 8.11 

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Investigator Sherry Knickerbocker’s Declaration

CMS filed the declaration of Sherry Knickerbocker, an SGS fraud investigator.  Investigator Knickerbocker testified that the MAC determined based on the 2019 post-payment review that Petitioner was overpaid for Medicare claims.  She testified that SGS reviewed 102 claims for 302 services provided to10 Medicare beneficiaries with dates of service from January 3 through December 11, 2018.  SGS determined that all 102 claims and 302 services were denied because documentation submitted by Petitioner did not show medical necessity or how the services were used in the management of specific medical problems.  The MAC demanded that Petitioner repay the overpayments.  CMS Ex. 1 at 3-4 ¶¶ 17, 21-22; CMS Ex. 10.  In its demand, the MAC advised Petitioner of the right to file a rebuttal and an administrative appeal.  But no appeal was received.  CMS Ex. 1 at 4 ¶ 23.  Petitioner has not disputed this testimony of Investigator Knickerbocker. 

Investigator Knickerbocker testified that the MAC determined based on the 2021 post-payment review that Petitioner was overpaid for claims made to Medicare.  She testified that SGS reviewed 32 claims for 186 services to 11 Medicare beneficiaries with dates of service from October 13, 2020 to February 23, 2021.  She testified that SGS determined that all claims should be denied but that two of the 185 services for which claims were made were allowed.  She testified that the denials were generally due to insufficient documentation by Petitioner of medical necessity or how the services were used in the management of specific medical problems.  CMS Ex. 1 at 4 ¶¶ 24, 26, 30.  The MAC demanded repayment of the overpayments.  CMS Ex. 1 at 4 ¶ 31; CMS Ex. 11.  In its demand, the MAC advised Petitioner of the right to file a rebuttal and an administrative appeal.  But no appeal was received.  CMS Ex. 1 at 4 ¶ 32.  Petitioner has not disputed this testimony of Investigator Knickerbocker. 

Regarding the 2022 prepayment reviews, Investigator Knickerbocker testified that the MAC gave Petitioner notice of the prepayment review on November 23, 2022.  The prepayment review continued until about February 2, 2023.  SGS reviewed 29 claims for 569 services for 29 Medicare beneficiaries with dates of service from November 4, 2022 through December 12, 2022.  CMS Ex. 1 at 5 ¶¶ 33-35.  Investigator Knickerbocker testified that SGS determined that all 29 claims should be denied and 526 of the 569 services for which Petitioner submitted claims should be denied because the medical records submitted by Petitioner did not show medical necessity or indicate how the services would be used to manage medical problems.  CMS Ex. 1 at 6 ¶¶ 37-38.  Investigator Knickerbocker testified that Petitioner was notified of the denials and the right to request redetermination.  CMS Ex. 1 at 6 ¶ 40.  She testified Petitioner requested redetermination as to 11 of the 29 reviewed claims; one denial was overturned; and Petitioner was informed of the right to request reconsideration by a Qualified Independent Contractor (QIC).  But Petitioner made no requests for further review.

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CMS Ex. 1 at 6-7 ¶¶ 43-44.  Petitioner does not dispute this testimony of Investigator Knickerbocker. 

Declaration of Clifton M. Jackness, MD

Petitioner provided the declaration of Dr. Jackness, Petitioner’s physician owner.  P. Ex. 1 at 1 ¶ 1.  The entire declaration is admitted as evidence.  But Dr. Jackness’ testimony related to whether individual claims were properly denied by the MAC is not relevant to the issues within my authority to decide.  The issue I must decide is whether the claims previously denied are a basis for revocation of Petitioner’s Medicare enrollment and billing privilege pursuant to 42 C.F.R. § 424.535(a)(8)(ii).  I must also decide whether CMS had a basis for adding Petitioner’s name to the CMS preclusion list.  But I have no authority to examine the prior claims denials as the prior determinations of the individual claims are binding in this forum upon Petitioner and CMS as a matter of fact and law. 

A.  Dr. Jackness’ Relevant Testimony

Dr. Jackness testified that he reviewed Petitioner’s records and determined Petitioner filed the following claims: 

3009 Medicare Part B claims from January through December 2018, the first period of post-payment review;

1336 Medicare Part B claims from October 2020 to February 2021, the second period of post-payment review; and

461 Medicare Part B claims during the period of the prepayment review.  

P. Ex. 1 at 2 ¶ 8.  I accept these numbers as true for purposes of summary judgment.  Dr. Jackness also did the math and found that the 102 claims denied by the MAC during the first post-payment review was 3.3 percent of the total claims filed during that period.  Dr. Jackness found that the 30 claims denied during the second post-payment review constituted 2.2 percent of the total claims filed during the period.  And the 29 claims subject to prepayment review constituted 6.2 percent of the total claims filed during that period.  P. Ex. 1 at 2 ¶ 8.  I accept Dr. Jackness calculations as true and correct for purposes of summary judgment.  I also accept as true Dr. Jackness’ testimony that following the first post-payment review Petitioner revised its practices and stopped ordering autonomic function tests.  P. Ex. 1 at 2 ¶ 9.  I do not consider for purposes of summary judgment that the change of practice is an admission by Petitioner that its prior procedure violated Medicare requirements. 

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B.  Dr. Jackness’ Testimony Regarding Individual Claims Is Not Relevant

Dr. Jackness testified that he reviewed each of the patients’ medical records that he sent to SGS.  He testified that for each patient “there are multiple reasons why the treatment furnished to each Medicare beneficiary was consistent with the patient’s needs, accepted medical practice, and Medicare program requirements.”  P. Ex. 1 at 1 ¶ 7.  Dr. Jackness testified to his opinion as to the reasons specific tests were necessary for his patients.  The tests included complete blood counts, serum iron studies, blood glucose testing, glycated hemoglobin/glycated protein testing, thyroid studies, lipid testing, and vitamin D assay testing.  P. Ex. 1 at 2-3 ¶¶ 11-18.  Dr. Jackness also testified regarding the medical situation of specific beneficiaries, opining that all testing and treatments were medically necessary and consistent with accepted medical practice.  Dr. Jackness opined that had the MAC reviewer considered the entire medical record of some of the patients, the reviewer would have reached different conclusions.  Dr. Jackness cited learned articles to support his opinions.  P. Ex. 1 at 3-23 ¶¶ 20-100. 

I conclude that Dr. Jackness’ testimony regarding the merits of individual claims is not relevant because I have no authority to review the individual claims as such review was only available to Petitioner in another forum.  Therefore, I do not consider this testimony. 

Pursuant to 42 C.F.R. § 498.60(b)(1), I am to receive as evidence any evidence that is relevant and material to the issues before me.  Relevant evidence is any evidence that has a tendency to make a fact of consequence to an issue I may decide more or less probable than without the evidence.  Fed. R. Evid. 401.  The issues before me are whether there is a basis for revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(8)(ii), and whether there is a basis for adding Petitioner’s name to the CMS preclusion list.  Whether tests ordered and care and services delivered to Medicare beneficiaries by Petitioner are reasonable and necessary is not an issue before me as a matter of fact and law in this case. 

My authority or jurisdiction, i.e., the scope of review, is limited by Congress and the Secretary.  A limitation important in this case is that claim denials and the recovery of overpayments by Medicare are subject to an entirely different administrative appeals procedure before different adjudicators under different regulations than those applicable to proceedings before me.  The regulations applicable to the claims appeals process provide that each determination in that process are final and binding upon the parties unless further appealed.  Devine Sols. Grp. LLC, DAB No. 3159 at 3 (2024).  Denial of individual Medicare claims are not subject to my review or Board review but are subject to the review procedures established by 42 C.F.R. pt. 405.  Id. at 17 (citing Ronald J. Grason, M.D., DAB No. 2592 at 8 (2014), aff’d sub nom. Grason v. Burwell, No. 14-2267 (C.D. Ill. Feb. 23, 2016), aff’d, 659 F. App’x. 899 (7th Cir. 2016), cert. denied, 583 U.S. 842 (2017)). 

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In section 1869(a)(1) of the Act, Congress required the Secretary to issue regulations and make initial determinations regarding benefits under Medicare Parts A and B, including entitlement to benefits and claims for benefits.  Section 1870(b) of the Act requires the Secretary recover or otherwise resolve overpayments by Medicare to any provider or supplier for items or services furnished to an individual under the Act.  Congress established deadlines for initial determinations and redeterminations for claims and provided that no initial determination was subject to reconsideration or appeal until there was a redetermination by the fiscal intermediary or MAC.  Act § 1869(a)(2)-(3).  Congress provided for reconsideration of the redetermined initial determination by a QIC, a hearing before an ALJ or attorney adjudicator, and the Medicare Appeals Council, and subsequent judicial review.  Act § 1869(b)(1), (c), (d)(1)-(2). 

Regulations the Secretary promulgated to satisfy the requirements imposed by Congress in section 1869 of the Act related to processing claims and in sections 1870(b) and (c) and 1893(f)(2) (which incorporates the appeals procedure required by section 1869(b)(1))  of the Act for the waiver of adjustment or recovery of overpayments of Medicare benefits to providers and suppliers for claims on behalf of Medicare beneficiaries, are found in 42 C.F.R. pt. 405, subpt. I.  Pursuant to 42 C.F.R. § 405.924(b), a MAC makes an initial determination regarding claims for benefits under Medicare Parts A and B made by or on behalf of Medicare beneficiaries or the overpayment of such benefits.  Pursuant to 42 C.F.R. § 405.928, an initial determination is binding upon all parties to the initial determination unless there is a redetermination or reopening.  Under 42 C.F.R. § 405.978, a reconsideration determination is final and binding on all parties unless there is an ALJ or attorney adjudicator decision issued, there is a request for expediated judicial review, or the reconsidered determination is reopened and revised.  Pursuant to 42 C.F.R. § 405.984, revised determinations or initial determinations, redeterminations, reconsiderations, the Office of Medicare Hearings and Appeals (OMHA) ALJ/attorney adjudicator decisions, or the Medicare Appeals Council decisions become final and binding on the parties unless there is higher level appeal or reopening.  Pursuant to 42 C.F.R. § 405.1048(a), an ALJ or attorney adjudicator’s decision becomes final and binding on the parties unless there is an appeal to the Medicare Appeals Council or for expedited judicial review, or the decision is only a recommended decision.  A Medicare Appeals Council decision is final and binding on the parties unless a federal district court issues a decision modifying the Medicare Appeals Council decision or the decision is reopened.  42 C.F.R. § 405.1130.  The procedural due process afforded in 42 C.F.R. pt. 405, subpt. I was established by the Secretary to satisfy Congress’ requirements in section 1869 of the Act.  Under the process, a right to review is accorded after the initial determination denying a claim for Medicare payment, and after redetermination, reconsideration, ALJ/attorney adjudicator, and Medicare Appeals Council reviews.  If the next higher level of review or appeal is not requested, the decision issued becomes final

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and binding upon the parties.  OMHA provides the ALJ hearings required by section 1869(b)(1) of the Act and accorded in 42 C.F.R. pt. 405, subpt. I, §§ 405.1000-.1058. 

The process for enrollment of providers and suppliers is different from the process for handling claims they file to recover from Medicare for items or services they provide to Medicare beneficiaries.  Congress required that the Secretary establish by regulation the process for enrollment of providers and suppliers.  Act § 1866(j).  The Secretary was required by Congress to provide a right to hearing in cases of denial or non-renewal of Medicare enrollment.  Act § 1866(j)(8).  The Secretary promulgated regulations at 42 C.F.R. pt. 424 for enrolling providers and suppliers who can file claims and be paid by Medicare for care or services delivered to Medicare beneficiaries.  42 C.F.R. § 424.1(b).  Medicare enrollment requirements and enrollment procedures are specified in 42 C.F.R. pt. 424, subpt. P.  The rules for revocation of enrollment are established by 42 C.F.R. § 424.535.  Under 42 C.F.R. § 424.545(a), a provider or supplier denied Medicare enrollment or whose enrollment is revoked is granted the right to appeal under the procedures established by 42 C.F.R. pt. 498.  Hearings under 42 C.F.R. pt. 498 are provided by ALJs of the Board, not OMHA, and appeals of those decisions are to the Board not the Medicare Appeals Council.  42 C.F.R. §§ 498.1, 498.5, 498.44(c).  In the case of revocation of Medicare enrollment and billing privileges, the issue for appeal and review is whether CMS had one or more of the reasons to revoke authorized in 42 C.F.R. § 424.535.  The Board has consistently held that ALJ and Board review of a revocation determination is limited to determining whether the elements of one of the bases for revocation authorized by 42 C.F.R. § 424.535(a) are satisfied.  Letantia Bussell, M.D., DAB No. 2196 at 13 (2008); John Hartman, D.O., DAB No. 2564 at 6 (2014); Stanley Beekman, D.P.M., DAB No. 2650 at 10 (2015). 

I find as fact that the process available for Petitioner to challenge the basis for denial of its claims in the post-payment reviews and the resulting allegations of overpayment and denial of its claims in the prepayment review was the procedural process provided by 42 C.F.R. pt. 405, subpt. I.  Investigator Knickerbocker’s undisputed and unrebutted testimony was that all review of Petitioner’s claims under 42 C.F.R. pt. 405, subpt. I was completed as requested or no review was requested.  Therefore, under the provisions of 42 C.F.R. pt. 405, the determinations as to the basis for denials of the claims were final and binding upon Petitioner.  42 C.F.R. §§ 405.928, 405.978, 405.1048(a), 405.1130. 

I conclude that the MAC’s claims determinations are final and binding on Petitioner.  There is no statutory or regulatory authority for me to review the basis for denial of the claims from the post-payment and prepayment reviews in this case.  I cannot conduct a second review of the claims to determine whether the tests or other care and services underlying the claims filed by Petitioner with Medicare were reasonable and necessary and met other Medicare requirements. 

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Accordingly, Dr. Jackness’ testimony regarding the reasonableness or medical necessity of the service provided for his patients for which claims were denied is simply not relevant to an issue I may decide.  Petitioner is bound as a matter of law by the determinations under the claims review process provided by 42 C.F.R. pt. 405, subpt. I, and the issue is whether those claims permit a CMS determination that Petitioner engaged in a pattern or practice of submitting claims that failed to meet Medicare requirements and are a basis for revocation under 42 C.F.R. § 424.535(a)(8)(ii). 

MAC Initial Determination

The MAC notified Petitioner by letter dated July 24, 2023, that Petitioner’s Medicare billing privileges were revoked effective August 23, 2023.  The MAC cited 42 C.F.R. § 424.535(a)(8)(ii) as the basis for revocation.  The MAC alleged that 102 Medicare claims submitted by Petitioner with dates of service from January 3 to December 11, 2018, were denied for insufficient documentation to support frequent and/or uncommon laboratory testing.  The MAC alleged 32 Medicare claims submitted by Petitioner with dates of service from October 12, 2020 to February 23, 2021, were denied for insufficient documentation of medical necessity for the billed services.  Finally, the MAC alleged that 29 of Petitioner’s Medicare claims with dates of service from November 4 to December 12, 2022, were denied for insufficient documentation of medical necessity for the services billed.  The MAC stated CMS determined that Petitioner’s denied bills for the three periods show that Petitioner had a pattern or practice of submitting claims that failed to meet Medicare requirements.  The MAC also advised Petitioner its name was being added to the CMS preclusion list and that a 10-year reenrollment bar was imposed.  CMS Ex. 13 at 1-4.  

Petitioner timely requested a reconsidered determination by letters dated August 1, 2023 and September 22, 2023.  CMS Ex. 12 at 1, 18. 

CMS Reconsidered Determination

A CMS hearing officer issued a reconsidered determination on January 12, 2024.  The hearing officer upheld revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(8)(ii), the 10-year reenrollment bar, and placing Petitioner’s name on the CMS preclusion list.  Ct. Ex. 1. 

The hearing officer based her determination on the two post-payment reviews, the prepayment review, and the fact Petitioner was educated regarding the proper submission of claims in the notices of the findings of the post-payment reviews.  Ct. Ex. 1 at 3. 

The hearing officer declined to review the issue raised by Petitioner on reconsideration of whether the claims involved in the post-payment reviews and prepayment review were

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properly denied, noting that whether claims were properly denied had to be addressed through the separate individual claim appeals process.  Ct. Ex. 1 at 4. 

The hearing officer limited her determination to the specific determination that Petitioner’s submission of noncompliant claims constituted a pattern or practice of abusive billing that authorized revocation pursuant to 42 C.F.R. § 424.535(a)(8)(ii).  The hearing officer stated that “CMS considers a pattern or practice to exist where a supplier submits claims that repeatedly fail to meet Medicare requirements.”  Ct. Ex. 1 at 4.  The hearing officer listed some of the criteria CMS uses to determine whether a claim fails to meet Medicare requirements, including:  whether the claims are for items or services reasonable and necessary to diagnosis or treat illness or injury or to improve function of a malformed body member; whether a claim includes necessary information to process the claim; and whether the MAC receives sufficient information to decide whether a payment is due and the amount of the payment.  Ct. Ex. 1 at 4.  The hearing officer noted that the regulatory history for 42 C.F.R. § 424.535(a)(8)(ii), states that CMS would not define the terms “pattern or practice,” but would implement a revocation if:  (1) the submission of incorrect claims could not be considered sporadic, and (2) after the careful and thorough consideration of the relevant factors, i.e., those listed in the regulation.  79 Fed. Reg. 72,500, 72,519 (Dec. 5, 2014).  Ct. Ex. 1 at 4-5.  The hearing officer found that Petitioner was provided education on billing requirements in September 2019 and July 2021, but noncompliant billing continued.  Because the noncompliant billing continued after education, the hearing officer concluded that Petitioner’s noncompliant billing was not sporadic but systematic and routine.  The hearing officer also discussed her analysis of each of the four regulatory factors established by 42 C.F.R. § 424.535(a)(8)(ii).  The hearing officer considered the regulatory factors as follows:  

A.  The percentage of submitted claims that were denied during the period under consideration. 

The hearing officer identified the periods under consideration as the periods of the dates of service for the post-payment and prepayment reviews – January 3 to December 11, 2018; October 13, 2020 to February 23, 2021; and November 4 to December 12, 2022.  She found that 100 percent of claims services with dates of service from January 3 to December 11, 2018, were denied.  She found that 98.9 percent of claims for services filed for dates of service from October 13, 2020 to February 23, 2021, were denied.  She found that 92 percent of claims for services filed for dates of service from November 4 to December 12, 2022, were denied.  The hearing officer concluded that the denial rates were extremely high considering that they recurred in three distinct periods over four years showing a pattern or practice of submitting claims not meeting Medicare requirements.  Ct. Ex. 1 at 5.

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B.  Whether the provider or supplier has any history of final adverse actions and the nature of any such actions.

The hearing officer found no evidence of any other adverse actions against Petitioner.  Ct. Ex. 1 at 5.

C.  The type of billing non-compliance and the specific facts surrounding the noncompliance. 

The hearing officer found that Petitioner’s noncompliance with Medicare billing requirements was consistent through all three periods under consideration.  The hearing officer found Petitioner repeatedly billed for frequent and/or uncommon laboratory tests that Petitioner’s medical records did not show were medically necessary.  The reasons for tests were not listed in the medical evidence, and many laboratory requisitions were not dated or signed.  Ct. Ex. 1 at 5-6.  She found that the repeated billing for the same tests without documentation the tests were medically reasonable and necessary despite education shows that Petitioner engaged in a pattern of practice of submitting noncompliant claims to Medicare.  Ct. Ex. 1 at 5-6.

D.  Any other information regarding the provider’s or supplier’s specific circumstance that CMS deems relevant.

The hearing officer identified two factors she considered as showing a pattern or practice of noncompliant billing:  (1) noncompliant billing occurred for four years, and (2) noncompliant billing occurred while Petitioner was under the administration of two different physicians.  Ct. Ex. 1 at 6. 

Based on her analysis of the regulatory factors, the hearing officer concluded that Petitioner engaged in a pattern or practice of submitting claims that failed to meet Medicare requirements.  Ct. Ex. 1 at 7. 

The hearing officer upheld the 10-year bar to reenrollment.  Ct. Ex. 1 at 7. 

The hearing officer also determined that Petitioner’s name should be added to the CMS preclusion list.  The hearing officer determined that Petitioner was revoked pursuant to 42 C.F.R. § 424.535(a)(8)(ii); Petitioner was subject to a 10-year reenrollment bar; and Petitioner’s conduct that caused the revocation was detrimental to the best interests of Medicare based on consideration of the regulatory factors.  Ct. Ex. 1 at 7-8. 

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b.  Analysis

Revocation Under 42 C.F.R. § 424.535(a)(8)(ii)

CMS may revoke the Medicare enrollment and billing privileges of a provider or supplier for any of the reasons authorized by 42 C.F.R. § 424.535(a).  Revocation for abuse of billing privileges is authorized by 42 C.F.R. § 424.535(a)(8).  In this case, CMS revoked pursuant to the authority of 42 C.F.R. § 424.535(a)(8)(ii), which provides: 

(8)  Abuse of billing privileges.  Abuse of billing privileges includes either of the following: 

* * * *

(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 during the period under consideration. 

(B) Whether the provider or supplier has any history of final adverse actions and the nature of any such actions. 

(C) The type of billing non-compliance and the specific facts surrounding said non-compliance (to the extent this can be determined). 

(D) Any other information regarding the provider or supplier’s specific circumstances that CMS deems relevant to its determination. 

42 C.F.R. § 424.535(a)(8)(ii). 

CMS was granted authority to revoke for abuse of billing privileges by the addition of 42 C.F.R. § 424.535(a)(8)(ii) in 2014.  When the regulation was adopted, CMS was clear that CMS and not its contractors would make all determinations under 42 C.F.R. § 424.535(a)(8)(ii).  CMS was also clear that the authority would only be used when the filing of claims that did not meet Medicare requirements was not sporadic and when there was a pattern of filing noncompliant claims.  79 Fed. Reg. 72,500, 72,515 (Dec. 5, 2014). 

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CMS stated: 

We believe it is the responsibility of the provider submitting the claim to ensure that all requirements—including, as necessary, proper and compliant supporting documentation—have been met prior to the claim’s submission.  Repeated denials due to improper documentation are an indication to a provider or supplier that its billing behavior must change in order to become compliant with Medicare requirements—including documentation requirements. 

Id. at 72,516. 

CMS determined not to include an intent or knowledge element due to the burden of attempting to determine intent, and if a provider or supplier submits a claim with the specific or actual knowledge the claim does not meet Medicare requirements or with reckless disregard of whether the claim meets Medicare requirements, that situation could be handled under various other authorities such as the False Claims Act.  Id.  CMS declined to define pattern or practice to maintain flexibility to address various fact scenarios.  Id. at 72,519.  CMS identified factors to be considered in determining whether there was a pattern or practice.  CMS determined not to give certain factors greater weight than others because the importance of each factor could vary based on the situation.  CMS also determined not to establish a minimum percentage of claims denials to ensure flexibility in addressing different scenarios.  79 Fed. Reg. 72,514, 72,517, 72,519.  The number of factors for CMS to consider was reduced from six to the four quoted above in 2021, with an effective date of January 1, 2022.  86 Fed. Reg. 64,996, 65,683 (Nov. 19, 2021).  CMS explained that its intent was to make clear it could consider shorter periods of noncompliant billing during the period under consideration and that it was not limited to longer periods of a provider’s or supplier’s billing or the entire period of enrollment, as even a short period of noncompliant billing can threaten the Medicare program and Trust Funds.  CMS commented that it removed consideration of the length of the provider’s or supplier’s enrollment which should have no bearing on whether 42 C.F.R. § 424.535(a)(8)(ii) applies because it is the behavior itself in issue and not the period of enrollment.  CMS also stated that the reason for claim denials is not particularly germane in applying 42 C.F.R. § 424.535(a)(8)(ii) because, even if there was no evidence of nefarious intent on the part of a provider or supplier, the failure to comply with Medicare billing requirements presents a risk to the Medicare program.  Intent is irrelevant because the purpose is deterring noncompliant billing.  It exists regardless of the reason it occurred.  Id. at 65,334-65,336.  In 2023, CMS considered providing a definition of pattern or practice under 42 C.F.R. § 424.535(a)(8)(ii) to be at least three submitted noncompliant claims.  But after considering comments, CMS decided not to

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finalize the proposed definition but held open the possibility of adding a definition through future rule-making.  88 Fed. Reg. 78,818, 79,275-79,276 (Nov. 16, 2023).  

In Devine Solutions, DAB No. 3159, the Board considered and upheld revocation of a supplier’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(8)(ii).  The Board commented upon the scope of review as follows: 

We repeat that by governing regulation, CMS has discretionary authority to revoke or not revoke in a particular case, and the role of the ALJ and the Board “is limited to determining whether CMS’s action is legally authorized and does not extend to second-guessing whether CMS properly exercised its discretion.”  Acute Care Homenursing Servs., Inc., DAB No. 2837, at 9 (2017).  “ALJs and this Board may review only whether CMS had a valid legal basis to revoke billing privileges, and, if it did, may not address whether it properly exercised its discretion to do so.”  Wendell Foo, M.D., DAB No. 2904, at 25 (2018), aff’d, 420 F. Supp. 3d 1100 (D. Haw. 2019); see also George M. Young, M.D., DAB No. 2750, at 11 (2016) (“To the extent CMS exercised its discretion in ultimately deciding to go forward with revocation in Petitioner’s case, it is not for the ALJ and the Board to look behind that exercise of discretion to ask whether [the ALJ], or the Board, standing in CMS’s shoes, would reach the same decision to revoke.”).  In short, we determine whether CMS could revoke, not whether it should revoke, and in this case we conclude that CMS lawfully could revoke and had ample basis to do so. 

Devine Sols., DAB No. 3159 at 22. 

I conclude that the undisputed facts establish a prima facie case of abuse of billing privileges under 42 C.F.R. § 424.535(a)(8)(ii).  For purposes of 42 C.F.R. § 424.535(a)(8)(ii), an abuse of billing privileged occurs when CMS determines, after consideration of whichever of the four specified factors CMS deems appropriate, that Petitioner engaged in a pattern or practice of submitting claims that fail to meet Medicare requirements.  The intent of Petitioner is irrelevant.  The period considered is the period under consideration and not a longer period or the entire period of enrollment.  The number of claims involved is also not determinative. 

The only determination of CMS that is subject to my review is the reconsidered determination.  Neb Grp. of Ariz. LLC, DAB No. 2573 at 7.  The reconsidered

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determination in this case was issued by a CMS hearing officer.  Ct. Ex. 1.  The fact that the reconsidered determination was by a CMS hearing officer is consistent with the CMS statements in promulgating 42 C.F.R. § 424.535(a)(8)(ii) that only CMS would make the decision to revoke under that provision. 

The CMS hearing officer carefully and clearly articulated her evaluation of each of the four factors established by 42 C.F.R. § 424.535(a)(8)(ii) that guided her conclusion that Petitioner engaged in a pattern or practice of submitting claims that failed to meet Medicare requirements and that the submission of such claims was not merely sporadic. 

Regarding the factor under 42 C.F.R. § 424.535(a)(8)(ii)(A), the hearing officer identified the periods under consideration as the periods of the dates of service for the post-payment and prepayment reviews – January 3 to December 11, 2018; October 13, 2020 to February 23, 2021; and November 4 to December 12, 2022.  She found that 100 percent of claims services with dates of service from January 3 to December 11, 2018, were denied.  She found that 98.9 percent of claims for services filed for dates of service from October 13, 202 to February 23, 2021, were denied.  She found that 92 percent of claims for services filed for dates of service from November 4 to December 12, 2022, were denied.  The hearing officer concluded that the denial rates were extremely high considering that they recurred in three distinct periods over four years showing a pattern or practice of submitting claims not meeting Medicare requirements.  Ct. Ex. 1 at 5. 

Considering 42 C.F.R. § 424.535(a)(8)(ii)(B), the hearing officer found no evidence of any other adverse actions against Petitioner.  Ct. Ex. 1 at 5. 

Under 42 C.F.R. § 424.535(a)(8)(ii)(C), the hearing officer found that Petitioner’s noncompliance with Medicare billing requirements was consistent through all three periods under consideration.  The hearing officer found Petitioner repeatedly billed for frequent and/or uncommon laboratory tests that Petitioner’s medical records did not show were medically necessary.  The reasons for tests were not listed in the medical evidence, and many laboratory requisitions were not dated or signed.  Ct. Ex. 1 at 5-6.  She found that the repeated billing for the same tests without documentation that the tests were medically reasonable and necessary despite education shows that Petitioner engaged in a pattern of practice of submitting noncompliant claims to Medicare.  Ct. Ex. 1 at 5-6.

CMS has discretion under 42 C.F.R. § 424.535(a)(8)(ii)(D) to consider other information it deems relevant.  The hearing officer identified two factors she considered as showing a pattern or practice of noncompliant billing:  (1) noncompliant billing occurred during a period of four years, and (2) noncompliant billing occurred while Petitioner was under the administration of two different physicians.  Ct. Ex. 1 at 6. 

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The hearing officer’s findings are consistent with my findings of fact.  The claims denials are final and binding upon Petitioner in this forum.  Petitioner’s attempts to relitigate the merits of the claims are unavailing.  CMS indicated in rule-making that the exact reason for the claims denials is not relevant in the revocation determination under 42 C.F.R. § 424.535(a)(8)(ii).  Although I may not substitute my discretion for CMS, I would also conclude that the rate of denials was high particularly given that they occurred during three distinct periods over a period of four years; the denials were based on the same kind of failures to meet Medicare requirements; and the failures to meet Medicare requirements recurred despite the education on Medicare requirements provided in notices in evidence that SGS sent to Petitioner.  The conclusion that Petitioner engaged in a pattern or practice of submitting claims not meeting Medicare requirements is clearly supported in this case. 

Petitioner’s Arguments

Petitioner argues that there is no basis for revocation under 42 C.F.R. § 424.535(a)(8)(ii) because Petitioner has shown its claims were consistent with accepted medical practices and peer-reviewed studies.  P. Br. at 1-2, 7-8, 12-18.  Petitioner’s argument is unavailing because it is bound by the claims denials that are not subject to review in this forum.  Petitioner’s argument it was deprived of due process because the CMS hearing officer refused to review individual claims is without merit.  The denial of the individual claims that are the basis for the finding of a pattern or practice of submitting claims that do not meet Medicare requirements were subject to review pursuant to 42 C.F.R. pt. 405, subpt. I – which accorded the procedural process due to Petitioner related to the denials of those claims.  The process provided for appeal and review of claim denials and declaration of an overpayment under 42 C.F.R. pt. 405 subpt. I was the opportunity for Petitioner to challenge the denials of its claims on which the CMS revocation determination was based.  Petitioner has not denied or disputed that it had the opportunity to seek review of its denied claims or the declaration of overpayments based on the claims and it either did not seek review or its appeal of 10 of 11 claims from the prepayment review was unsuccessful except for one claim determined favorably to Petitioner and eight claims decided partially favorably to Petitioner as testified to by Investigator Knickerbocker (CMS Ex. 1 at 4-7 ¶¶ 23, 32, 40-44).  The evidence shows the denials are final and binding on Petitioner and CMS in this forum.  The CMS hearing officer had no authority under 42 C.F.R. pts. 424 and 498 to conduct any review of the underlying claims in deciding to revoke Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(8)(ii). 

Petitioner argues that CMS’s brief exceeded the 25-page limit established under Judge Alves’ Standing Order para. 5.e.i.  Petitioner requested leave to file an equally length brief.  P. Br. at 2 n.1.  The CMS brief was 28 pages, including the certificate of service.

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CMS Br.  To ensure no prejudice to Petitioner and to avoid further delay in this case, I simply do not consider pages 26, 27, and 28 of the CMS brief. 

Petitioner complains about the adequacy of the MAC’s initial determination, including the failure of the MAC to state how the factors established by 42 C.F.R. § 424.535(a)(8)(ii)(A) through (D) were considered.  P. Br. at 3-7.  However, only the reconsidered determination is subject to my review.  Neb Grp. of Ariz., DAB No. 2573 at 7.  Petitioner does not allege the initial determination did not adequately inform Petitioner of the right to request a reconsidered determination.  The July 24, 2023 initial determination (CMS Ex. 13) did not specifically discuss consideration of the four factors under 42 C.F.R. § 424.535(a)(8)(ii)(A)-(D).  But CMS made clear in rule-making that only CMS, not one of its contractors, makes the decision to revoke under 42 C.F.R. § 424.535(a)(8)(ii).  Therefore, it is the CMS hearing officer’s consideration of the four factors that is important to my decision.  Petitioner does not deny that the CMS hearing officer specifically discussed the four factors in her reconsidered determination.  Ct. Ex. 1.  But Petitioner complains that the CMS hearing officer had no authority to add the substantive basis for the revocation and asserts that the hearing officer is limited to considering the initial determination and its findings.  P. Br. at 6-7.  Petitioner overlooks the fact that CMS specifically reserved the revocation determination to CMS and not its contractor, the MAC.  Petitioner also overlooks in its narrow reading of 42 C.F.R. § 498.24(b) that on reconsideration under 42 C.F.R. § 498.24(c) CMS has authority to affirm or modify the initial determination and the findings on which it was based. 

Petitioner argues that the number of claims denied during the two post-payment reviews and the prepayment review should be compared to the total number of claims submitted by Petitioner resulting in a dramatic reduction in the error rate.  P. Br. at 8-12, 18.  I accepted Dr. Jackness assertions of total claims filed and his calculations as true for purposes of summary judgment.  But CMS made clear in rule-making that for revocation under 42 C.F.R. § 424.535(a)(8)(ii), it considers only claims during the period under consideration and it does not consider the total number of claims filed over a longer period such as the period of enrollment.  Petitioner also argues that CMS failed to engage in proper random statistical sampling.  P. Br. at 3, 9-10.  However, the CMS action in this case is based on specific claims denials for claims filed during a specific period and not on statistical sampling.  CMS does not purport in this case to draw any inferences about the total universe of claims filed by Petitioner during its Medicare enrollment and no such inference is cited by the CMS hearing officer as a basis for revocation.  Ct. Ex. 1. 

Petitioner argues that CMS failed to establish what documentation and other Medicare requirements Petitioner failed to satisfy with the claims that underlie the revocation.  P. Br. at 3-4, 12-14, 19-20.  Petitioner’s opportunity to challenge the basis for the claim denials was under the procedures of 42 C.F.R. pt. 405, subpt. I not in this forum.  However, I note that when enrolling in Medicare, Petitioner agreed to be bound and to

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abide by all “applicable statutes, regulations and program instructions.”  42 C.F.R. § 424.510(d)(3).  In the September 5, 2019 post-payment review letter (CMS Ex. 3 at 3-5) and the July 2, 2021 post-payment review letter (CMS Ex. 5 at 3-6), SGS explained the basis for claims denials that caused the overpayments.  SGS explained the basis for prepayment review denials in its June 6, 2023 letter informing Petitioner of the results of the prepayment review.  CMS Ex. 8 at 2-7. 

Petitioner argues that CMS cannot substantiate any allegation of fraud.  P. Br. at 20.  I find that there is no allegation of fraud by CMS in this proceeding.  I reiterate that CMS made clear in rule-making that a provider’s or supplier’s intent when submitting claims that do not satisfy Medicare requirements is not an issue and, therefore, irrelevant to a determination to revoke pursuant to 42 C.F.R. § 424.535(a)(8)(ii).  Any allegation of fraud would be addressed in a different forum. 

I conclude that CMS had a basis to revoke Petitioner’s Medicare enrollment and billing privileges and the discretion to do so after consideration of the factors established by 42 C.F.R. § 424.535(a)(8)(ii) that CMS deemed applicable and appropriate. 

The only determination of CMS or the MAC that is subject to my review in a provider and supplier enrollment case is the reconsidered determination.  42 C.F.R. § 498.5(l)(1)-(2); Neb Grp. of Ariz., DAB No. 2573 at 7.  Only CMS not the MAC makes the revocation decision under 42 C.F.R. § 424.535(a)(8)(ii).  79 Fed. Reg. at 72,515.  Based on my review of the CMS hearing officer’s decision, it is clear she considered the four factors listed in 42 C.F.R. § 424.535(a)(8)(ii), and the factors considered are consistent with and supported by the undisputed facts.  The undisputed evidence shows that there is a basis for revocation pursuant to 42 C.F.R. § 424.535(a)(8)(ii). 

I have no authority to review the exercise of discretion by CMS or its contractor to revoke enrollment where there is a basis for such action.  Abdul Razzaque Ahmed, M.D., DAB No. 2261 at 19 (2009), aff’d, Ahmed v. Sebelius, 710 F. Supp. 2d 167 (D. Mass. 2010). 

Petitioner is ultimately responsible as a matter of law for ensuring that its claims for Medicare reimbursement are accurate and for any errors in those claims.  Louis J. Gaefke, D.P.M., DAB No. 2554 at 5-6 (2013) (citing 73 Fed. Reg. 36,448, 36,455 (June 27, 2008)).  Petitioner, as the enrolled supplier, is responsible to ensure compliance with Medicare requirements.  42 C.F.R. §§ 424.510(d)(3), 424.516. 

To the extent Petitioner’s arguments may be construed as a request that I grant equitable relief, I have no authority to do so.  US Ultrasound, DAB No. 2302 at 8 (2010).  Furthermore, I am required to follow the Act and regulations and have no authority to

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declare statutes or regulations invalid.  1866ICPayday.com, L.L.C., DAB No. 2289 at 14 (2009). 

Reenrollment Bar

CMS imposed a reenrollment bar of 10 years in this case.  Under the regulations, the reenrollment bar after a revocation is a minimum of one year and a maximum of 10 years.  42 C.F.R. § 424.535(c).  There is no statutory or regulatory language establishing a right to review of the duration of the reenrollment bar CMS imposes.  Act § 1866(j)(8); 42 C.F.R. §§ 424.535(c), 424.545, 498.3(b); and 498.5.  The Board has held that the duration of a revoked supplier’s reenrollment bar is not an appealable initial determination listed in 42 C.F.R. § 498.3(b) and, thus, is not subject to ALJ review.  Vijendra Dave, M.D., DAB No. 2672 at 11 (2016). 

Preclusion List

Petitioner argues there is no basis for adding Petitioner to the CMS preclusion list as there is no basis for revocation of Petitioner’s Medicare enrollment and billing privileges.  P. Br. at 2, 22.  But because I have found that there is a basis for revocation, CMS has a basis for adding Petitioner to the CMS preclusion list for the duration of his reenrollment bar.  42 C.F.R. §§ 422.222, 423.120.  I find no authority to conduct review of the CMS exercise of discretion in determining that Petitioner’s underlying conduct was detrimental to Medicare and in adding Petitioner to the preclusion list where, as here, I determine that there is a basis for such action.  42 C.F.R. §§ 422.2, 423.100 (2018); 83 Fed. Reg. 16,440, 16,641-67. 

III.  Conclusion

For the foregoing reasons, the Medicare enrollment and billing privileges of Petitioner are revoked pursuant to 42 C.F.R. § 424.535(a)(8)(ii) effective August 23, 2023.  There is a basis for listing Petitioner on the CMS preclusion list for the duration of its ten-year bar to reenrollment.