Leland Henry Dao, D.O., DAB CR6559 (2024)

DECISION

Noridian Healthcare Solutions, LLC (Noridian), an administrative contractor acting on behalf of the Centers for Medicare & Medicaid Services (CMS), revoked the Medicare enrollment and billing privileges of Petitioner, Leland Henry Dao, D.O., because he failed to provide Qlarant Integrity Solutions, LLC (Qlarant), a Unified Program Integrity Contractor (UPIC), with requested documentation for 20 Medicare beneficiaries for whom he had ordered durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). Thereafter, CMS upheld Petitioner’s revocation. For the reasons stated herein, I affirm the revocation of Petitioner’s Medicare enrollment and billing privileges.

I. Background

Petitioner is a doctor of osteopathic medicine. See, e.g., CMS Ex. 12 at 1-2. As an enrolled supplier in the Medicare program, Petitioner listed a correspondence address in both Haleiwa, Hawaii and Aliso Viejo, California. CMS Ex. 11 at 2; CMS Ex. 12 at 3.

On January 17, 2020, Qlarant informed Petitioner that it was conducting a review of DMEPOS claims and requested that he submit records within 45 days for 20 beneficiaries for whom he was the ordering physician for DMEPOS items. CMS Ex. 7. Qlarant mailed the letter to Petitioner’s correspondence address in Haleiwa, Hawaii, and the letter

Page 2

was received on January 20, 2020. CMS Ex. 7 at 1, 7-8. On July 14, 2020, Qlarant issued a second notice in which it cautioned that it may revoke Petitioner’s Medicare enrollment if it did not receive the requested records within 15 days. CMS Ex. 8 at 1-2; CMS Ex. 9 at 1-2. The letter was sent to Petitioner’s correspondence address in Haleiwa, Hawaii and Aliso Viejo, California. CMS Exs. 8 and. 9.

Petitioner provided a signed attestation to Qlarant on July 27, 2020, indicating that he did not have documentation related to the treatment of the 20 beneficiaries. CMS Ex. 10 at 2. After Petitioner did not submit the requested records, Noridian issued an initial determination, dated August 19, 2020, informing him that it had revoked his Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10), effective September 18, 2020, due to his failure to comply with 42 C.F.R. § 424.516(f). CMS Ex. 2; CMS Ex. 3. Noridian also informed Petitioner that it had imposed a 10-year bar to re-enrollment. CMS Ex. 2 at 3; CMS Ex. 3 at 2-3.

Petitioner submitted a request for reconsideration dated December 9, 2020. CMS Ex. 4 at 1. Petitioner reported he had just received the revocation request. CMS Ex. 4 at 1. A follow-up email and letter supplementing his request for reconsideration were filed on December 17, 2020 and December 29, 2020, respectively. CMS Ex. 5; CMS Ex. 6. Petitioner explained that he believed any record request should be directed to Redidoc, a telemedicine company. CMS Ex. 5 at 1; CMS Ex. 6 at 1. He further stated that he tried to contact Redidoc himself to request records but was unable to reach the company and believed it may be defunct. CMS Ex. 5 at 1; CMS Ex. 6 at 2. He expressed concern that he may not be able to obtain the records. CMS Ex. 5 at 1; CMS Ex. 6. Petitioner stated that he hoped his submission would help explain why he did not provide the records that were requested. CMS Ex. 5 at 1; CMS Ex. 6 at 2-3.

In a letter dated January 26, 2021, CMS’s Provider Enrollment & Oversight Group informed Petitioner that although he had not timely requested reconsideration of the initial determination revoking his enrollment, it had granted a “good cause waiver” and was issuing a reconsidered determination. CMS Ex. 1 at 1. In upholding the revocation of Petitioner’s enrollment pursuant to 42 C.F.R. § 424.535(a)(10), CMS explained, in pertinent part:

The documentation the physician is required to maintain for seven years includes written and electronic documents (including the NPI of the physician who ordered, certified, referred, or prescribed the Part A or B service, item, or drug) relating to written orders, certifications, referrals, prescriptions, and requests for payments for Part A or B services, items or drugs. Since Dr. Dao is a physician who provides Medicare Part B services, including ordering and certifying DMEPOS, this regulation applies to him.

Page 3

Dr. Dao argues that CMS should not revoke his Medicare enrollments because the requested records actually belong to Redidoc. However, the responsibility to maintain documentation ultimately lies with the physician who orders, certifies, refers, or prescribes Part A or B services, items, or drugs. The fact that the records allegedly belong to his former employer does not absolve Dr. Dao of his obligation to maintain proper documentation as required by § 424.156(f)(2)(i)(A). On July 10, 20201 , Dr. Dao signed an attestation that he did not have the documentation requested by Qlarant. This attestation is sufficient to establish that Dr. Dao failed to comply with the maintenance requirement at § 424.516(f)(2)(i)(A). In addition, Dr. Dao failed to provide access to the documentation at the request of CMS contractor Qlarant. As a result, Dr. Dao also failed to comply with the documentation and access requirements at § 424.516(f)(2)(i)(B). Therefore, the revocation of Dr. Dao’s Medicare enrollments pursuant to § 424.535(a)(10) is upheld.

CMS Ex. 1 at 4 . CMS also upheld the 10-year bar to re-enrollment, explaining that “[e]ach failure [to maintain and provide access to medical record documentation] constitutes an individual act of noncompliance for each beneficiary” and “there are no Medicare claims data evidencing . . . interaction with any Medicare beneficiary to establish medical necessity.” CMS Ex. 1 at 4.

Petitioner submitted a timely request for an administrative law judge (ALJ) hearing that was received on February 19, 2021. Petitioner explained that the records requested by CMS exist, but they had been lost or stolen. Request for Hearing at 1. Petitioner explained that he had requested time to recreate the records from his recollection but that his request was not addressed by the CMS hearing officer. Request for Hearing at 1.

On February 22, 2021, Judge Bill Thomas issued a standing pre-hearing order (Pre-Hearing Order).2 Pursuant to the Pre-Hearing Order, CMS filed a pre‑hearing brief and motion for summary judgment, along with 12 proposed exhibits (CMS Exs. 1-12). Petitioner filed a pre-hearing brief and an opposition to the motion for summary judgment, along with five proposed exhibits (P. Exs. 1-5), including Petitioner’s written direct testimony. CMS filed objections to Petitioner’s Exhibits 1-4. Petitioner did not file a response to the objections.

Page 4

CMS did not propose any witnesses and has not requested the cross-examination of Petitioner’s witness. See Pre‑Hearing Order §§ 12-13. Because an in-person hearing for the purpose of cross-examination is unnecessary, I may decide this case on the written record without ruling on the motion for summary judgment.

II. 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)(10).

III. Jurisdiction

I have jurisdiction to hear and decide this case. 42 C.F.R. §§ 498.3(b)(17), 498.5(1)(2); see also 42 U.S.C. § 1395cc(j)(8).

IV. Evidentiary Matters

CMS objects to the admission of Petitioner’s Exhibits 1, 2, 3, and 4. CMS Obj. CMS argues that these exhibits represent new evidence that can only be admitted with a showing of good cause. Id. Petitioner did not file a response to CMS’s objections. Petitioner’s Exhibit 1 consists of ads for various positions with Redidoc. Petitioner’s Exhibit 2 is a copy of the reconstructed medical records dated January 1, 2021. Petitioner’s Exhibit 3 is a copy of Petitioner’s email correspondence with a CMS attorney. And, Petitioner’s Exhibit 4 is an article addressing medical record retention from a CMS publication, MLN (Medicare Learning Network) Matters. CMS also objects to the police report submitted by Petitioner on March 3, 2021, and labeled Pet. Ex. A. CMS Br. at 6.

Any new documentary evidence offered by Petitioner at the ALJ level must be examined to determine whether any good cause exists for failure to previously present the evidence. 42 C.F.R. § 498.56(e). Any new evidence must be excluded if there is a failure to show good cause. Id. While “good cause” is not defined in the regulations, the term has been interpreted to mean an event beyond a party’s control that prevents the party from offering the evidence timely. City Crown Home Health Agency, Inc., CR3130 at 4 (2014). Here, Petitioner did not offer any of its proposed Exhibits 1-4 during either the initial or reconsideration determination phases of the case.

Petitioner has made no argument as to why Petitioner’s Exhibits 1 and 4, which were available in some format at the time of the reconsideration request, were not previously produced. Therefore, I find that Petitioner has not alleged any factor amounting to good cause for why he did not submit Exhibits 1 and 4 earlier.

Page 5

Even if I were to find good cause and admit Petitioner’s Exhibits 1 and 4 into the record, the proposed exhibits do not relate to the issue of whether Petitioner produced the requested documents to CMS. The proposed Exhibit 4 is an article explaining the possible formats for retaining medical records and further explains that whatever system the provider or supplier uses must allow the records to be accessed and retrieved. P. Ex. 4; P. Br. at 9. Similarly, the Redidoc job opening ads mention an “internet-based technology platform” available to physicians. P. Ex. 1; P. Br. at 3-4. The availability of such a system, as further discussed below, did not relieve Petitioner of his responsibility to maintain medical records and make them available for CMS’s inspection.

Petitioner’s Exhibit 3 is an email exchange between Petitioner and an attorney for CMS. There are no attachments to the emails but they purport to show that Petitioner sent reconstructed medical records to CMS on March 5, 2021. I find that this email exchange is not relevant to whether or not Petitioner made the requested medical records available for inspection by CMS in January 2020 and July 2020. Further, I do not find that good cause exists to admit the emails into evidence.

As for Petitioner’s Exhibit 2 and the police report, I find the exhibits were likely not available until after the initial and reconsidered determinations. However, this is because the recreated medical records and the police report were not created until January 2021 and February 2021, respectively. Noridian’s initial determination revoking Petitioner’s Medicare enrollment stated plainly that Petitioner must submit with his reconsideration request all information that he wished to have considered by the hearing officer or by an ALJ. CMS Ex. 3 at 2. Similarly, Petitioner has not alleged any events beyond his control that prevented him from offering the evidence timely. As a result, I do not find that good cause exists to admit Petitioner’s Exhibit 2 or the police report into evidence.

However, even if I were to find good cause exists and admit these exhibits into the record, neither the reconstructed medical records dated almost six months after the second request by Qlarant and almost a year after the first request, nor the police report filed in February 2021, shows that Petitioner maintained medical records and made them available for inspection pursuant to 42 C.F.R. § 424.535(a)(10).

As a result, I sustain CMS’s objections and do not admit Petitioner’s Exhibits 1-4 and the police report into evidence. Petitioner’s Exhibit 5 is admitted. Petitioner did not raise any objections to CMS’s proposed exhibits. Therefore, CMS Exhibits 1-12 are admitted into evidence.

Page 6

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

1. CMS made a prima facie case that Petitioner ordered DMEPOS items for 20 Medicare beneficiaries but did not maintain documentation relating to those orders and could not provide access to that documentation upon request by Qlarant which violates 42 C.F.R. 424.516(f)(2).

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 supplier under specified circumstances. See 42 C.F.R. § 424.535(a). Relevant to this case, CMS may revoke a supplier’s billing privileges based on a “[f]ailure to document or provide CMS access to documentation.” 42 C.F.R. § 424.535(a)(10); see 42 U.S.C. § 1395u(h)(9). The relevant revocation authority, 42 C.F.R. § 424.535(a)(10), states the following:

(i) The provider or supplier did not comply with the documentation or CMS access requirements specified in § 424.516(f) of this subpart.
(ii) A provider or supplier that meets the revocation criteria specified in paragraph (a)(10)(i) of this section, is subject to revocation for a period of not more than 1 year for each act of noncompliance.

Section 424.516 provides additional requirements for enrolling and maintaining active enrollment status in the Medicare program, stating:

(f) Maintaining and providing access to documentation.

* * * *

(2)(i) A physician or, when permitted, an eligible professional who orders, certifies, refers, or prescribes Part A or B services, items or drugs is required to —

(A) Maintain documentation (as described in paragraph (f)(2)(ii) of this section) for 7 years from the date of the service; and
(B) Upon request of CMS or a Medicare contractor, to provide access to that documentation (as described in paragraph (f)(2)(ii) of this section).

The regulation further directs that documentation that must be maintained includes “written and electronic documents . . . relating to written orders, certifications, referrals, prescriptions or requests for payments for Part A or B services, items, or drugs.” 42 C.F.R. § 424.516(f)(2)(ii).

Page 7

At the time of the initial determination, if CMS revoked a provider or supplier’s enrollment, it could impose a bar on re‑enrollment for a minimum of one year, but no more than 10 years. 42 C.F.R. § 424.535(c)(1)(i).

Qlarant, in its capacity as the UPIC, requested that Petitioner provide copies of medical records for 20 Medicare beneficiaries for whom he had ordered DMEPOS items. CMS Exs. 7-9. Petitioner concedes that he did not maintain and retain the requested documentation. CMS Ex. 10 at 2. Petitioner had an agreement with Redidoc to treat patients through their telemedicine platform and the resulting records were maintained as electronic health records in that same platform. P. Br. at 7. Regardless of whether another entity purports to maintain copies of beneficiary records, Petitioner, as the ordering practitioner and a supplier in the Medicare program, was required, pursuant to 42 C.F.R. § 424.516(f), to maintain and retain for at least seven years documentation supporting his DMEPOS orders for Medicare beneficiaries. Because Petitioner was unable to produce the requested documentation for 20 Medicare beneficiaries upon the request of the UPIC, as required by 42 C.F.R. § 424.516(f), CMS had a legitimate basis to revoke his Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10).

2. Petitioner failed to prove by a preponderance of the evidence that he complied with the documentation and access requirements of 42 C.F.R. 424.516(f)(2).

Petitioner claims that he did not learn of the request to produce medical records until July 2020, when he became aware of Qlarant’s July 2020 letter. P. Br. at 5. Petitioner explained that he tried to access the documents online through Redidoc’s portal and via phone but was unsuccessful. P. Br. at 5-6. He further claims that at that time he was unable to produce the medical records in the 15 days provided by Qlarant and that is why he signed the form attesting he did not have documentation related to the treatment of the 20 beneficiaries. P. Br. at 5-6. Petitioner argues that he was unaware that his Medicare provider enrollment had been revoked until December 9, 2020, when he contacted Noridian after a healthcare organization he worked with informed him that he no longer had billing privileges. P. Br. at 6.

Petitioner states in his brief that he hired a private investigator in January 2021 to assist him with contacting the patients whose records had been requested. P. Br. at 7. This investigator was only able to locate the caretaker of one of the patients. P. Br. at 7. It was at this point that Petitioner reconstructed the medical records for the requested beneficiaries. P. Br. at 7-8. Petitioner admits the medical records were not created until January 2021.3 P. Ex. 5 at 9.

Page 8

Petitioner, as a Medicare participant, was independently required to maintain and retain, for a period of seven years, documentation supporting, among other things, his written orders and prescriptions for Part A or B items and services. 42 C.F.R. § 424.516(f)(2). Specifically, as relevant here, Petitioner was required to maintain documentation relating to his orders for DMEPOS items. Id. Petitioner’s recreation of the medical records and the filing of a police report almost six months after the second letter from Qlarant do not relieve him of his obligations under the regulations. Petitioner’s failure to maintain, retain, and provide access to records supporting the DMEPOS orders that were requested by the UPIC subjects him to revocation of his enrollment pursuant to 42 C.F.R. §§ 424.535(a)(10) and 424.516(f). See 42 U.S.C. § 1395u(h)(9) (“The Secretary may revoke enrollment, for a period of not more than one-year for each act . . . if such physician or supplier fails to maintain and . . . provide access to . . . written orders or requests for payment for durable medical equipment . . . .”). As a participant in the Medicare program, Petitioner was required to independently maintain documentation of his orders for, inter alia, DMEPOS items for Medicare beneficiaries, even when another entity separately maintains those records. 42 C.F.R. § 424.516(f)(2) (“[A]n eligible professional who orders . . . items . . . is required to . . . [m]aintain documentation . . . for 7 years from the date of the service; and . . . provide access to that documentation . . . .”).

To the extent Petitioner had an agreement that Redidoc would maintain and retain documentation supporting his DMEPOS orders to Medicare beneficiaries, such an agreement cannot exempt him from Medicare participation requirements. In fact, the rulemaking adding the instant basis for revocation and revising 42 C.F.R. § 424.516 specifically explained that both a practitioner and another entity may simultaneously be required to maintain, inter alia, records supporting DMEPOS orders, stating that “[t]his final rule places the responsibility for the maintenance of records on both the ordering and certifying physician and the provider and supplier.” 77 Fed. Reg. 25,284, 25,310 (Apr. 27, 2012) (emphasis added).4 The rulemaking unambiguously clarified that “[t]he physician or other eligible professional who signed the order or certification is responsible for maintaining and disclosing the documentation.” Id.

Petitioner ultimately admits that he neither independently maintained documentation of his DMEPOS orders nor furnished the requested documentation to either the UPIC or

Page 9

CMS. P. Br. at 4-7. As noted above, Petitioner signed a form indicating that he did not have documentation pertaining to the treatment or evaluation of the beneficiaries. CMS Ex. 10 at 2.

Ultimately, Petitioner would like me to make a determination that the medical records recreated in January 2021 which were not submitted to CMS during either the initial or reconsidered determination phases of this case, should result in a reversal of the revocation, thereby making the re-enrollment bar moot. However, these arguments amount to a challenge to how CMS exercised its discretion. See 42 C.F.R. § 424.535(a) (stating that CMS “may” revoke a provider or supplier’s enrollment for one of the enumerated reasons). The scope of my review is not whether CMS should have revoked Petitioner’s Medicare enrollment pursuant to 42 C.F.R. § 424.535(a)(10), but rather, whether CMS could have revoked his enrollment, in that I am only authorized to review whether CMS had a legitimate basis to revoke Petitioner’s enrollment. The DAB has explained that “it is not for the ALJ and the [DAB] to look behind that exercise of discretion to ask whether he or she, or the Board, standing in CMS’s shoes, would reach the same decision to revoke.” George M. Young, M.D., DAB No. 2750 at 11 (2016); see also Letantia Bussell, M.D., DAB No. 2196 at 13 (2008) (holding that an ALJ could not substitute her discretion for that of CMS in a Medicare enrollment determination); Decatur Health Imaging, LLC, DAB No. 2805 at 8-9 (2017) (DAB does not review CMS’s exercise of discretion to take other actions that the regulations authorize relating to the enrollment of suppliers and providers). I find that CMS had a legitimate basis at the time of the reconsidered determination to revoke Petitioner’s Medicare enrollment and billing privileges.

Petitioner also argues that the 15 days provided by Qlarant in its July 2020 letter was insufficient to allow him time to produce the requested medical records. However, Petitioner was given 45 days in the January 17, 2020 Qlarant letter and failed to produce records at that time, too. The January 17, 2020 notice was sent to Petitioner’s registered address in Hawaii. If that address was no longer valid, Petitioner had an obligation to inform CMS. As a result, the timing argument is without merit as Petitioner was given multiple opportunities and more than just 15 days to produce the records. Further, at no point did Petitioner ask for an extension of time to produce any records.

3. I have no authority to review the length of the reenrollment bar.

Finally, Petitioner states the 10-year length of the re-enrollment bar is excessive. P. Br. at 18. However, he acknowledges that such a matter is beyond the scope of an ALJ’s review. Id. CMS’s decision setting the length of a reenrollment bar is not an initial determination subject to administrative review. Vijendra Dave, M.D., DAB No. 2672 at 9-12 (2016).

Page 10

4. CMS had a legal basis to revoke Petitioner’s Medicare enrollment pursuant to 42 C.F.R. 424.535(a)(10).

CMS was authorized to revoke Petitioner’s Medicare enrollment under section 424.535(a)(10). CMS produced records showing the Petitioner ordered DMEPOS items for 20 Medicare beneficiaries. Petitioner admits that he treated the 20 beneficiaries. And, ultimately, Petitioner failed to produce the records or give CMS access to them when requested by Qlarant. I must therefore affirm the revocation under section 424.535(a)(10).

5. Petitioner’s other arguments are not bases to reverse the revocation of his Medicare enrollment.

To the extent Petitioner argues that revocation of his Medicare enrollment and billing privileges is inequitable under the circumstances presented, CMS’s discretionary act to revoke a provider or suppler is not subject to review based on equity or mitigating circumstances. Bussell, DAB No. 2196 at 13. An ALJ may not substitute his or her “discretion for that of CMS in determining whether revocation is appropriate under all the circumstances.” Abdul Razzaque Ahmed, M.D., DAB No. 2261 at 19 (2009). Because I have found that CMS had a legal basis to revoke Petitioner’s Medicare enrollment and billing privileges, the regulations do not permit me to overturn CMS’s decision to revoke.

VI. Conclusion

For the reasons explained above, I affirm the revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10).