Tasha D. Grissett, DAB CR6549 (2024)

DECISION

Acting through an administrative contractor, Respondent, the Centers for Medicare & Medicaid Services (CMS), revoked the Medicare enrollment and billing privileges of Petitioner, Tasha D. Grissett, because she failed to maintain and timely provide access to medical records for Medicare beneficiaries for whom she ordered Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS). As explained herein, I affirm CMS’s revocation determination.

I. Background and Procedural History

Petitioner is a Physician Assistant who was enrolled as a supplier in the Medicare program. CMS Ex. 10 at 1; CMS Ex. 11 at 1. On February 18, 2020,1 Qlarant Integrity Solutions, LLC (Qlarant), a Unified Program Integrity Contractor,2 mailed notice to

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Petitioner requiring her to submit “any and all documentation to support the medical necessity of the durable medical equipment” Petitioner ordered for 20 Medicare beneficiaries between February 15, 2018 and June 18, 2018. CMS Ex. 5 at 1-4; CMS Ex. 6 at 1-4. Qlarant required a response within 45 days. CMS Ex. 5 at 2; CMS Ex. 6 at 2. Qlarant issued this notice via FedEx overnight delivery to Petitioner at two addresses: 3711 South MoPac Expressway, Suite 400, Austin, TX 78746 (the Austin address) and 960 Joe Frank Harris Parkway SE, Cartersville, GA 30120 (the Cartersville address). CMS Exs. 5, 6.3 FedEx was unable to deliver Qlarant’s notice to the Austin address and returned it to Qlarant on February 19, 2020. CMS Ex. 5 at 6. FedEx successfully delivered Qlarant’s notice to the Cartersville address on February 19, 2020. CMS Ex. 6 at 5.

On July 14, 2020,4 having received no response, Qlarant reissued its demand for production to Petitioner at the Austin address, this time giving Petitioner 15 days to respond. CMS Ex. 7. It reissued its production demand to the Cartersville address on July 23, 2020.5 CMS Ex. 8. FedEx again successfully delivered Qlarant’s renewed notice to the Cartersville address on July 24, 2020 but could not deliver it to the Austin address. CMS Ex. 7 at 5; CMS Ex. 8 at 5.

On August 31, 2020, CMS administrative contractor Palmetto GBA revoked Petitioner’s privileges to bill the Medicare program in Georgia, effective September 30, 2020, for failing to provide Qlarant the documentation it requested. CMS Ex. 2 at 1. On September 1, 2020, CMS administrative contractor Novitas Solutions revoked Petitioner’s Medicare billing privileges in Texas, effective October 1, 2020, for the same reason. CMS Ex. 3 at 1. Both contractors advised Petitioner that pursuant to 42 C.F.R. § 424.535(c), CMS would bar her from re-enrolling as a supplier for a period of 10 years. CMS Ex. 2 at 2; CMS Ex. 3 at 3.

Palmetto and Novitas issued these revocation notices to Petitioner at the Cartersville and Austin addresses respectively. CMS Ex. 2 at 1; CMS Ex. 3 at 1. Unsurprisingly, Petitioner remained unaware of her revocation until November 19, 2020, when she

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received notice of her revoked status from her employer at the time. CMS Ex. 4 at 1. Petitioner sought reconsideration of these revocation actions via e-mail the next day. Id. She explained she never received Qlarant’s correspondence and offered to provide the requested records. Id. On December 15, 2020, CMS responded to Petitioner at the same e-mail address she used to seek reconsideration and asked her to upload the requested records using a supplied link within one week. CMS Ex. 4 at 1; CMS Ex. 9 at 1. According to CMS, Petitioner did not respond to this e-mailed request by the deadline. CMS Ex. 12 at 2.

On January 21, 2021, CMS issued an unfavorable reconsidered determination upholding the revocation actions taken by Palmetto and Novitas concerning Petitioner’s enrollment and billing privileges. CMS Ex. 1. Hearing Officer Minisha Hicks explained that 42 C.F.R. § 424.516(f)(2)(i) required Petitioner to maintain documentation of any service, item, or drug she ordered, certified, referred, or prescribed for seven years, and to provide access to that documentation upon request of CMS or one of its contractors. Id. at 3. She noted Qlarant requested access to such medical records on two occasions by mailed requests sent to two addresses Petitioner identified for correspondence in her enrollment records. Id. at 4. The hearing officer observed that while Petitioner claimed these addresses to be incorrect, it was her responsibility to update her enrollment information and that in any event, CMS had provided her a third opportunity to submit the requested records after she became aware of the request, to which she had not responded. Id.

Hearing Officer Hicks also upheld the 10-year re-enrollment bar imposed by CMS’s contractors, claiming that she considered “the specific circumstances underlying this revocation…” Id. She specified that Petitioner failed to maintain and provide access to records for 20 Medicare beneficiaries, that this failure amounted to individual acts of noncompliance for each beneficiary, and that there was “no Medicare claims data evidencing [Petitioner’s] interaction with any Medicare beneficiary to establish medical necessity,” leading her to conclude Petitioner “ordered medically unnecessary item(s) or orthotics for affected Medicare beneficiaries.” Id.

Petitioner timely sought review by an Administrative Law Judge in the Civil Remedies Division, and I was designated to hear and decide this case. On February 19, 2021, I issued an Acknowledgment and Pre‑hearing Order (Pre‑hearing Order) setting forth directives concerning the submission of arguments and evidence by the parties. CMS submitted a motion for summary judgment or, in the alternative, pre-hearing brief (CMS Br.), and 12 proposed exhibits (CMS Exs. 1-12). Petitioner filed her response (P. Br.) and three proposed exhibits, all unmarked and unpaginated.6

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Petitioner thereafter moved for an expedited decision in this matter. I denied that motion citing a lack of regulatory authority to prioritize cases and the obligation to decide older cases first.

II. Admission of Exhibits

Petitioner made no objection to CMS’s proposed exhibits. CMS objected to Petitioner’s proposed exhibits, contending she has not demonstrated good cause to submit “new” evidence she did not provide at the initial or reconsidered determination stages, as required by 42 C.F.R. § 498.56(e).

I find good cause to admit Petitioner’s submissions and overrule CMS’s objection. CMS urges me to preclude Petitioner’s exhibits because she did not submit them at lower administrative levels, but as CMS acknowledges, there is no regulatory definition for good cause. CMS Objections at 2. I decline to define that term narrowly, particularly when CMS seeks its application against an unrepresented non-governmental party that lacks the resources CMS brings to bear at every level of the appeals process. Moreover, Petitioner’s submissions in no way prejudice CMS and merely serve to provide corroborative details to her narrative response, which as I explain below, does not change the outcome here.

Accordingly, I admit CMS Exhibits 1 through 12 and Petitioner’s Exhibits 1 through 3 into the record.

III. A Decision on the Record is Appropriate

I required the parties to submit written direct testimony for each proposed witness and advised I would hold an in‑person hearing only if a party requested to cross-examine an opposing party’s witness. Pre-Hearing Order at 7-8; see also Civ. Remedies Div. P. §§ 16(b), 19(b); Pac. Regency Arvin, DAB No. 1823 at 8 (2002). Neither party sought to cross-examine an opposing party’s witness. Consequently, an in-person hearing is not necessary and I decide this case based on the written record. Civ. Remedies Div. P. § 19(b). CMS’s motion for summary judgment is denied as moot.

IV. Issue

Whether CMS had a legal basis to revoke Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10).

V. Jurisdiction

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

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VI. Discussion

A. Statutory and Regulatory Authority

The Act provides for CMS to regulate the enrollment of providers and suppliers in the Medicare program. Act § 1866(j)(1)(A); 42 U.S.C. § 1395cc(j)(1)(A). Congress established the following basis for revoking a supplier’s Medicare enrollment:

The Secretary may revoke enrollment, for a period of not more than one year for each act, for a physician or supplier under section 1395cc(j) of this title if such physician or supplier fails to maintain and, upon request of the Secretary, provide access to documentation relating to written orders or requests for payment for durable medical equipment, certifications for home health services, or referrals for other items or services written or ordered by such physician or supplier under this subchapter, as specified by the Secretary.

42 U.S.C. § 1395u(h)(9). The regulations implementing this statute provide CMS may revoke if:

(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.

42 C.F.R. § 424.535(a)(10).

42 C.F.R. § 424.516(f)(2) provides:

(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

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(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).

(ii) The documentation includes written and electronic documents (including the NPI of the physician . . . who ordered . . . the Part A or B service, item, or drug) relating to written orders, certifications, referrals, prescriptions or requests for payments for Part A or B services, items, or drugs.

The act of revocation terminates any existing provider or supplier agreement and bars the provider or supplier “from participating in the Medicare program from the effective date of the revocation until the end of the reenrollment bar.” 42 C.F.R. § 424.535(b), (c). CMS may impose a re-enrollment bar lasting up to ten years. 42 C.F.R. § 424.535(c)(1).7

B. Analysis8

1. Petitioner failed to maintain required documentation related to beneficiaries for whom she ordered DME and failed to provide access to those records upon request.

2. CMS had a basis to revoke Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10), for violating the requirements of 42 C.F.R. § 424.516(f).

CMS may revoke the enrollment and billing privileges of a provider or supplier who does not maintain or provide CMS access to certain documents. 42 C.F.R. § 424.535(a)(10); 42 C.F.R. § 424.516(f). These include “written and electronic documents . . . relating to written orders, certifications, referrals, prescriptions, or requests for payments” made by a provider or supplier who orders, certifies, refers, or prescribes services, items, or drugs covered by Part A or B of the Medicare program. 42 C.F.R. § 424.516(f)(2)(ii).

42 C.F.R. § 424.516(f) therefore requires a provider or supplier to do two things: (1) maintain for seven years any documents related to written orders, certifications, referrals, prescriptions, or requests for payments for covered services, items, and drugs; and (2) provide CMS or its contractor access to those documents upon request. George M. Young, M.D., DAB No. 2750 at 8 (2016).

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The record before me demonstrates Petitioner did not comply with these regulatory requirements. In February and July of 2020, CMS contractor Qlarant demanded Petitioner produce records related to durable medical equipment she ordered for 20 Medicare beneficiaries. CMS Exs. 5-8. Qlarant issued these demands to two addresses associated with Petitioner’s enrollment records in Georgia and Texas. CMS Ex. 10 at 2; CMS Ex. 11 at 2. Petitioner did not respond to these requests. And as she acknowledged in her response brief, Petitioner never maintained these records. P. Br. at 1.

Petitioner does not contest her failure to maintain or produce the records identified by CMS. Nor does she contest examining the 20 beneficiaries Qlarant identified in its production requests or generating medical records for them. CMS Ex. 4 at 1 (“I learned that in [February] 2020 correspondence had been sent out by CMS requesting medical records for patients I had seen.”). Petitioner instead explains that Qlarant issued its production demands to incorrect addresses, noting that the Austin address belonged to an urgent care at which she worked only two shifts in the summer of 2018 while the Cartersville address belonged to a hospital where she accepted a job but never worked owing to a family emergency. P. Br. at 1-2.

The record confirms Qlarant should have recognized the Austin address to be invalid, as FedEx returned both production requests issued to Petitioner at that address as undeliverable. CMS Ex. 5 at 6; CMS Ex. 7 at 6. But as CMS observes, Qlarant obtained the Austin and Cartersville addresses directly from Petitioner’s enrollment records for Texas and Georgia, respectively; Petitioner bore an ongoing obligation as a supplier to the Medicare program to update the correspondence addresses in her enrollment records and is therefore ultimately at fault for failing to do so. CMS Br. at 9-10 (citing 42 C.F.R. § 424.516(d), which requires non-physician practitioners like Petitioner to report any changes to her enrollment record within 90 days); CMS Ex. 10 at 2; CMS Ex. 11 at 2.

Petitioner explains that her employers have always managed her enrollment records and that she never supplied an address for correspondence other than her home address, leading her to conclude her employer updated her enrollment record with an inaccurate address.9 CMS Ex. 4 at 1. Putting aside Petitioner’s independent obligation to ensure the accuracy of her own enrollment records, CMS cured any prejudice to Petitioner resulting

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from Qlarant’s reliance on those enrollment records when it provided her a third opportunity in December 2020 to produce the requested documents after she sought reconsideration and explained she had never received Qlarant’s requests. CMS Ex. 4 at 1; CMS Ex. 9 at 1. There is no dispute, however, that Petitioner received this third request but did not respond to it. CMS Ex. 12 at 2.

3. I have no authority to consider Petitioner’s equitable arguments or afford her equitable relief, including modification of the 10-year re-enrollment bar CMS imposed without adequate explanation.

The remainder of Petitioner’s arguments are equitable in nature. She points out that she could not have seen 20 beneficiaries at either location and that she could have timely sought out and produced the records requested by Qlarant had the contractor addressed its production demands to her personal address. P. Br. at 1. She also argues that her revocation has caused her to suffer because she cannot procure employment without being approved as a biller to the Medicare and Medicaid programs and seeks to have her privileges restored to permit her to return to caring for her patients. Id.

I am sympathetic to Petitioner’s arguments but cannot afford her relief. I am required to follow the Act and its implementing regulations and have no authority to disregard them. 1866ICPayday.com, L.L.C., DAB No. 2289 at 14 (2009) (“An ALJ is bound by applicable laws and regulations and may not invalidate either a law or regulation on any ground, even a constitutional one.”). My jurisdiction is limited to determining whether CMS had a valid basis under the regulations to revoke Petitioner’s enrollment as a supplier to the Medicare program. 42 C.F.R. § 498.3(b)(17)(i); 42 C.F.R. § 424.535. Where CMS has done so, as here, I cannot fashion an equitable remedy to achieve a more just outcome. US Ultrasound, DAB No. 2302 at 8 (2010) (“Neither the ALJ nor the [DAB] is authorized to provide equitable relief by reimbursing or enrolling a supplier who does not meet statutory or regulatory requirements.”).

Similarly, I have no jurisdiction over CMS’s decision to bar Petitioner from re-enrolling as a supplier to the Medicare program for 10 years, the maximum default period. See 42 C.F.R. § 498.3(b)(17)(i). Unfortunately, CMS does not appear to have adequately explained to Petitioner why it applied the maximum default period here. When CMS amended its regulations in 2019 to increase the maximum default re-enrollment bar from three years to 10 years, numerous commenters opposed the rule change, expressing their concern that expanding the re-enrollment bar period to 10 years was “excessive and overly punitive.” 84 Fed. Reg. 47,794, 47,826-27 and 47,854-56 (Sep. 10, 2019). In response, CMS asserted it required the capacity to impose a longer bar period in “certain cases” to prevent “[c]ertain behavior” that could prove harmful to the Medicare program and its beneficiaries. Id. at 47,826-27. CMS assured commenters the longer 10-year ban period would “typically be reserved for more serious conduct and not be imposed unless

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the agency determined it to be warranted after careful consideration of all the required factors.” Id. CMS emphasized that “10-year timeframes will generally be restricted to serious behavior” and that the maximum bar period was intended to apply to “particularly improper or fraudulent behavior.” Id. at 47,827.

Despite these assurances, the record before me does not document CMS engaged in “careful consideration” to determine Petitioner engaged in “particularly improper or fraudulent behavior” before it applied the maximum default re-enrollment bar against her. Id. Neither CMS nor its contractors explain how Petitioner’s failure to produce records on request for a limited number of beneficiaries amounts to “serious” or “particularly improper” conduct. The notices of revocation Petitioner received from CMS’s administrative contractors state only that she would be subject to a 10-year re-enrollment without explanation. CMS Ex. 2 at 2; CMS Ex. 3 at 2 (“Pursuant to 42 CFR §424.535(c), CMS is establishing a re-enrollment bar for a period of 10 years that shall begin 30 days after the postmark date of this letter.”).

CMS’s reconsidered determination also fails to provide Petitioner an adequate rationale for imposing a 10-year re-enrollment bar at reconsideration. Hearing Officer Hicks offered only this statement:

Considering the specific circumstances underlying this revocation, we uphold this bar. Here, [Petitioner] failed to maintain and provide access to medical record documentation pertaining to 20 beneficiaries. Each failure constitutes an individual act of noncompliance for each beneficiary. In addition, there are no Medicare claims data evidencing [Petitioner’s] interaction with any Medicare beneficiary to establish medical necessity. [Petitioner] ordered medically unnecessary item(s) of orthotics for affected Medicare beneficiaries.

CMS Ex. 1 at 4.

The grounds cited by Hearing Officer Hicks for imposing the maximum bar do not amount to an explanation for why she did so.10 The regulatory provision she cites merely

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sets the maximum period CMS can bar a suppler revoked on this basis from re-enrolling for each “act of noncompliance.” It does not oblige CMS to select the maximum bar period for each instance. Hearing Officer Hicks did not explain why CMS believed it necessary to impose the maximum one-year bar for each beneficiary.

Instead, the hearing officer appears to have used Petitioner’s failure to produce records as proof she never treated the beneficiaries in question. Applying this rationale, any supplier who cannot produce records would be deemed to have fraudulently billed the Medicare program, making the imposition of the maximum re-enrollment bar appropriate in every instance (thus obviating the need for “careful consideration” at all). 11

Petitioner’s explanation – that she was unable to produce records she never controlled for beneficiaries she saw virtually on behalf of a supplier of durable medical goods that is now out of business – is at least as reasonable as inferring she ran the risk of criminal prosecution and losing the ability to bill federal health care programs (essentially career suicide for most health care practitioners) all for the chance to fraudulently bill the Medicare program for seeing 20 beneficiaries she did not actually see.

Of course, it is entirely possible that CMS has good reason to believe Petitioner’s failure to produce records bears a more nefarious reading and that a 10-year re-enrollment bar is amply justified. But it has not provided that explanation to Petitioner. Indeed, a review of other cases docketed before me concerning the revocation of a supplier’s enrollment for failure to produce records on demand reveals Hearing Officer Hicks uses this precise same boilerplate language to justify imposition of a 10-year enrollment bar in every case.

By using the same boilerplate explanation in multiple cases, CMS does not appear to have engaged in the “careful consideration” it promised the public when it increased the default enrollment bar period. CMS risks appearing disingenuous by failing to act in accordance with the assurances it made to the public during the rulemaking process, particularly where the agency’s regulations deprive suppliers like Petitioner the

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opportunity to challenge its re-enrollment bar determinations before impartial fact-finders.

To be clear, I have no jurisdiction over CMS’s selection of the length of a re-enrollment bar once it has established a valid basis for revocation, as it has done here, unless that bar period exceeds 10 years. Nevertheless, by highlighting this issue, my hope is that CMS counsel will consider negotiating a shorter re-enrollment bar with Petitioner in exchange for a waiver of appeal, if appropriate, or at least provide Petitioner a meaningful explanation as to why CMS believes it necessary to prevent her from re-enrolling for 10 years. Alternatively, Petitioner may wish to appeal this decision to the Board and then to federal district court, which can consider the equitable arguments she made that I cannot.

Conclusion

For the foregoing reasons, I affirm CMS had a basis to revoke Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.535(a)(10) for failing to comply with the requirements of 42 C.F.R. § 424.516(f).