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                              Ajay Sonogram Inc., DAB CR6049 (2022)
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Ajay Sonogram Inc., DAB CR6049 (2022)








  
  
    

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





Ajay Sonogram Inc.,
(PTAN: FDCV07 / NPI: 1447361225),
Petitioner,

v.

Centers for Medicare & Medicaid Services,
Respondent.
Docket No. C-19-874Decision No. CR6049March 21, 2022

        
              
    

      DECISION

Novitas Solutions, Inc. (Novitas), an administrative contractor acting on behalf of Respondent, the Centers for Medicare & Medicaid Services (CMS), revoked the Medicare billing privileges and provider agreement of Ajay Sonogram, Inc. (Petitioner), pursuant to 42 C.F.R. § 424.535(a)(2) for a period of three years, effective September 20, 2018.  Novitas revoked Petitioner's enrollment as a supplier to the Medicare program because its enrollment record showed RR1
 to be a supervising physician at the time RR was excluded from participation in federal health care programs by the Department of Health and Human Services' Office of Inspector General (OIG).  As explained herein, I affirm CMS's revocation action.

I.  Background and Procedural History

Petitioner was incorporated in the state of Maryland in 2004.  CMS Exhibit (Ex.) 5 at 13.  NC, the owner and president of Ajay Sonogram, Inc., is a licensed cardiovascular sonographer, not a physician.  CMS Ex. 5 at 73; P. Req. for Hearing (RFH) at 8.  Sometime before February 2008, NC filed an initial Form CMS-855B enrollment

Page 2

application to enroll his company as an Independent Diagnostic Testing Facility (IDTF) in the Medicare program.  Petitioner was assigned a provider number and approved for electronic billing privileges on or about February 1, 2008.  CMS Ex. 5 at 19, 71.  An IDTF is considered a supplier in the Medicare program.  42 C.F.R § 498.2 (definition of *Supplier*); *see also* 42 C.F.R. § 424.502.

IDTFs are required to have one or more supervising physicians who are responsible for the direct and ongoing oversight of the quality of the testing performed, the proper operation and calibration of equipment used to perform tests, and the qualification of non-physician IDTF personnel who use the equipment.  42 C.F.R. § 410.33(b); Medicare Program Integrity Manual (MPIM), CMS Pub. 100-08, Ch. 10, § 10.2.2.4.  Petitioner's initial enrollment application identified SS as its supervising physician.  RFH Supporting Doc. at 8.

On February 7, 2016, Petitioner submitted a second Form CMS-855B enrollment application to add a new supervising physician, RR, to its enrollment record.  CMS Ex. 5 at 53.  Petitioner indicated RR would provide general supervision and sought an effective date of February 1, 2016 for recognition of his status as a supervising physician.  *Id.* at 59.

On April 1, 2016, Petitioner submitted a third Form CMS-855B enrollment application to add another supervising physician, PL, effective April 1, 2016.  CMS Ex. 6 at 7.  Though this document is not in the record before me, Petitioner's owner NC declares he received a letter from Novitas on May 10, 2016 confirming PL was added to Petitioner's enrollment record as a supervisor.  RFH Supporting Doc. at 9; P. Ex. 1 at ¶ 10.

On February 27, 2019, Novitas notified Petitioner that it would revoke Petitioner's Medicare privileges retroactively from September 20, 2018, pursuant to 42 C.F.R. § 424.535(a)(2).  CMS Ex. 2.  Novitas explained that Petitioner's billing privileges were revoked because on "September 20, 2018, RR was excluded by the OIG, pursuant to Section 1128(b)(4) of the Act.  [And at the time of RR's exclusion] RR [was] listed as a supervising physician on [Petitioner's] Medicare 855 enrollment record."  *Id.* at 1.

Petitioner asked CMS to reconsider the revocation determination, arguing RR was only "on [Petitioner's] board from mid-February 2016 [until the] end of April 2016," and it "totally forgot about notifying removal of RR from [Ajay Sonogram, Inc.] as a supervisory physician . . . ."  CMS Ex. 1 at 1-2.  On May 11, 2019, CMS issued a reconsidered determination upholding the revocation determination, finding Petitioner failed to provide any documentation to support its claim that it terminated its business relationship with RR prior to his exclusion by the OIG on September 20, 2018.  CMS Ex. 7 at 3-4.

Page 3

Petitioner timely requested a hearing before an Administrative Law Judge in the Civil Remedies Division and I was designated to hear and decide this case.  On June 20, 2019, I issued an Acknowledgment and Pre-hearing Order (Pre-hearing Order) setting forth a schedule for the parties to submit arguments and proposed evidence.  On July 24, 2019, CMS submitted a pre-hearing brief and motion for summary judgment (CMS Br.) and CMS Exhibits 1 through 7.  Petitioner filed its brief (P. Br.) on September 16, 2019 and included one exhibit, Petitioner Exhibit 1.  There being no objection from either party to the opposing party's proposed exhibits, I admit CMS Exhibits 1 through 7 and Petitioner Exhibit 1 into the record.

II.  Decision on the Record

My Pre-hearing Order in this case required the parties to submit written direct testimony for any proposed witness and advised an in‐person hearing would only be necessary if a party requested an opportunity to cross‐examine the opposing party's witness.  Pre‐hearing Order ¶¶ 8, 10; Civ. Remedies Div. P. §§ 16(b), 19(b); *Pacific Regency Arvin,* DAB No. 1823 at 8 (2002).  Neither party has made such a request.  Consequently, I will not hold an in‐person hearing in this matter and issue this decision based on the written record.2
  Civ. Remedies Div. P. 19(b).

III.  Issue

Whether CMS had a legitimate basis to revoke Petitioner's Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(2).

IV.  Jurisdiction

I have jurisdiction to hear and decide this case.  42 C.F.R. §§ 498.3(b)(17), 498.5(*l*)(2); *see also* Social Security Act (Act) § 1866(j)(8) (42 U.S.C. § 1395cc(j)(8)).

V.  Discussion

**A. Applicable Law.**

The Act authorizes the Secretary of Health and Human Services (Secretary) to create 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)).  A "supplier" is "a physician or other practitioner, a facility, or other entity (other than a provider of services) that furnishes items or services" under the

Page 4

Medicare provisions of the Act.  42 U.S.C. § 1395x(d); *see also* 42 U.S.C. § 1395x(u).  Petitioner, an IDTF, is a supplier.  42 C.F.R. § 498.2 (definition of *Supplier*).

Pursuant to 42 C.F.R. § 424.505, a supplier like Petitioner must be enrolled in the Medicare program and issued a billing number to have billing privileges and be eligible to receive payment for services rendered to a Medicare-eligible beneficiary.  A supplier seeking billing privileges under the Medicare program must "submit enrollment information on the [Form CMS-855B] enrollment application.  Once the. . .supplier successfully completes the enrollment process. . .CMS enrolls the. . .supplier into the Medicare program."  42 C.F.R. § 424.501(a).  CMS then establishes an effective date for billing privileges.  The effective date of enrollment for IDTFs is determined under 42 C.F.R. § 410.33(i)(2).

Further, IDTFs must report "[c]hanges [in] general supervision. . .to the Medicare fee‐for-service contractor on the [Form CMS-855B] Medicare enrollment application within 30 calendar days of the change."  42 C.F.R. §§ 410.33(g)(2), 424.516(b).  "If an IDTF fails to meet one or more of the standards in [42 C.F.R. § 410.33(g)(2)]. . .CMS will revoke a supplier's billing privileges."  42 C.F.R. § 410.33(h).

An IDTF must certify on its Form CMS-855B enrollment application that it provided complete and accurate information.  42 C.F.R. 410.33(g).  An IDTF must report a change in general supervision to Novitas within 30 calendar days of the change.  MPIM, Ch. 10, § 10.2.2.4.  This 30-day requirement supersedes the obligation embodied in the certification language of Section 15 of the Form CMS-855B to notify CMS of more general changes to enrollment data within 90 days of the change.  By signing the certification statement, an IDTF agrees to abide by all Medicare rules for its supplier type, including the 30-day rule in 42 C.F.R. § 410.33(g)(2).  MPIM, Ch. 10, § 10.2.2.4.

The Secretary has delegated the authority to revoke enrollment and billing privileges to CMS.  42 C.F.R. § 424.535.  CMS or one of its contractors may revoke an enrolled provider's Medicare enrollment and billing privileges and provider agreement for any of the reasons listed in 42 C.F.R. § 424.535.

Relevant here, CMS may revoke a currently enrolled supplier's Medicare billing privileges if the "supplier, or any owner, managing employee, authorized or delegated official, medical director, *supervising physician*, or other health care personnel of the [supplier is excluded] from Medicare, Medicaid, and any other Federal health care program . . . ."  42 C.F.R. § 424.535(a)(2) (emphasis added).  Upon revoking a supplier's Medicare enrollment and billing privileges, CMS establishes a re-enrollment bar that may last a "minimum of one years, but not greater than ten years [], depending on the severity of the basis for revocation."  42 C.F.R. § 424.535(c).

Page 5

**B. Findings of Fact, Conclusions of Law, and Analysis3**

***CMS had a valid basis to revoke Petitioner's Medicare billing privileges for three years pursuant to 42 C.F.R. § 424.535(a)(2) because one of Petitioner's supervising physicians was excluded from practicing medicine under section 1128(b)(4) of the Act.***The record before me establishes that CMS had a valid basis to revoke Petitioner's status as a supplier to the Medicare program because one of its supervising physicians, RR, had been excluded from participation in federal health care programs by the OIG.  Petitioner identified RR as a supervising physician to Novitas on February 7, 2016 with an effective date of supervision of February 1, 2016.  CMS Ex. 5 at 53, 59.  Petitioner submitted documentation to Novitas on April 1, 2016 seeking to add another supervising physician, PP, effective that same day.  CMS Ex. 6 at 7.  Petitioner's owner, NC, concedes he did not submit documentation to remove RR as a supervising physician.  RFH at 9.

The OIG excluded RR from participation in federal health care programs on September 20, 2018, pursuant to section 1128(b)(4) of the Act, because the Maryland State Board of Physicians suspended his medical license.  CMS Ex. 3 at 2; CMS Ex. 4.  There is no dispute that RR was in fact excluded by the OIG on September 20, 2018.  *Id.* There is also no dispute that at the time of his exclusion, he had been identified by Petitioner as a supervising physician.  CMS Ex. 5 at 53, 59.  42 C.F.R. § 535(a)(2) permits CMS to revoke a supplier's Medicare billing privileges if its supervising physician is excluded by the OIG.  CMS therefore had a valid basis to revoke Petitioner's status as a supplier to the Medicare program.

Petitioner claims revocation of its Medicare billing privileges would be improper because it was "not informed about submitting a separate letter to remove previous physician [sic] from file [sic] who is no longer supervising physician [sic]."  RFH Supporting Doc. at 9.  Petitioner's claim of ignorance is unpersuasive.  First, Petitioner had no reasonable basis to assume identifying an additional supervising physician would result in the deletion of a previously identified supervising physician.  The regulation governing enrollment requirements for IDTFs contemplates the possibility of multiple supervising physicians as it specifies that "one or more" supervising physicians must provide general supervision.  42 C.F.R § 410.33(b)(1).

Moreover, none of the three enrollment applications submitted by Petitioner contains language suggesting addition of a new supervising physician would automatically delete a previously identified supervising physician; these enrollment applications instead offered the separate option of deleting a supervising physician.  RFH Supporting Doc. at

Page 6

6; CMS Ex. 5 at 59; CMS Ex. 6 at 7.  Such an option would be superfluous if deletion was automatic upon addition of another supervising physician.

Second, Petitioner affirmed the veracity of each of its three enrollment applications and agreed to notify Medicare of "any information in [its] application that is not true, correct, or complete . . . in accordance with the time frames established in 42 C.F.R. § 424.516."  CMS Ex. 5 at 45; CMS Ex. 6 at 5.  Petitioner was obligated to report a change in general supervision (like the deletion of a previously identified supervising physician) to Novitas within 30 calendar days of the change.  42 C.F.R. § 410.33(g)(2); MPIM, Ch. 10, § 10.2.2.4.  It did not do so.

Petitioner also contends that Novitas should have advised it to file a corrective action plan (CAP) to resolve the instant issue.  RFH at 8.  But a supplier may only submit a CAP in response to a revocation action for noncompliance under 42 C.F.R. 424.535(a)(1); the instant case arises under 42 C.F.R. 424.535(a)(*2*), making submission of a CAP inapplicable in these proceedings.  *See* 42 C.F.R. 405.809(a)(1).

Finally, Petitioner requests that I reinstate its Medicare privileges, explaining that RR was a supervising physician for only two months before NC opted to designate a new supervising physician.  P. Br. at 5.  I am sympathetic to Petitioner's situation.  Petitioner's revocation is based solely on a failure to timely submit paperwork.  Taking NC's affidavit to be true, RR had no employment relationship at all with Petitioner for over two years at the time of his exclusion, let alone a supervisory role.  P. Ex. 1.  It is unlikely Petitioner posed any threat to the integrity of the Medicare program by virtue of RR's brief tenure as a supervising physician long before the OIG excluded him from participation in federal health care programs.

Unfortunately, I do not have the authority to grant a request for equitable relief, whatever its merits.  *See, e.g*., *US Ultrasound*, DAB No. 2302 at 8 (2010) ("Neither the ALJ nor the Board is authorized to provide equitable relief by reimbursing or enrolling a supplier who does not meet statutory or regulatory requirements."); *Pepper Hill Nursing & Rehab. Ctr., LLC*, DAB No. 2395 at 11 (2011) (holding the ALJ and Board were not authorized to provide equitable relief by reimbursing or enrolling a supplier who does not meet statutory or regulatory requirements).

In sum, Petitioner identified RR to Novitas as a supervising physician.  It took no action to inform CMS or Novitas that RR was no longer a supervising physician, despite having an affirmative obligation to do so within 30 days.  42 C.F.R. § 410.33(g)(2); MPIM, Ch. 10, § 10.2.2.4.  RR was subsequently excluded by the OIG while still identified by Petitioner as one of its supervising physicians.  By failing to timely notify Novitas of RR's removal as supervising physician, no matter how short his tenure, Petitioner did not abide by the regulations it agreed to follow.

Page 7

Based on the record before me, I find CMS had a valid basis to revoke Petitioner's enrollment as a supplier to the Medicare program pursuant to 42 C.F.R. § 424.535(a)(2) because RR was still identified as a supervising physician under Petitioner's enrollment record on September 20, 2018, the date RR was excluded by the OIG.

VI.  Conclusion

For the foregoing reasons, I affirm CMS's revocation of Petitioner's Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(2).


          /s/
        Bill Thomas

                      Administrative Law Judge
      1. To minimize the disclosure of private information in a publicly available decision, I will abbreviate the full names of individuals who are not named parties to this proceeding. back to note 1
                      2. CMS's motion for summary judgment is denied as moot. back to note 2
                      3. My findings of fact and conclusions of law are set forth in italics and bold font. back to note 3 Back to top
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