Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Accudose Pharmacy
(NPI/PTAN: 1164883294/7738700001),
Petitioner,
v.
Centers for Medicare & Medicaid Services.
Docket No. C-26-10
Decision No. CR6924
DECISION
The Medicare enrollment and billing privileges of Petitioner are revoked pursuant to 42 C.F.R. §§ 424.57(e)(1) and 424.535(a)(23)(ii),1 effective June 19, 2025, based on violation of 42 C.F.R. § 424.57(c)(22) (Supplier Standard 22).
Page 2
I. Background and Undisputed Facts
On March 14, 2025, Novitas Solutions, a Medicare administrative contractor (MAC) for the Centers for Medicare & Medicaid Services (CMS) requested by letter that Petitioner provide accreditation information. CMS Exhibit 1 at 11. Petitioner denies that it was notified of the need to submit proof of accreditation before it received the MAC’s initial determination dated May 20, 2025. CMS Ex. 2. I accept as true for purposes of summary judgment that Petitioner was not aware before receiving the initial determination dated May 20, 2025, that it was required to send the MAC accreditation information.
On May 20, 2025,2 the MAC notified Petitioner that its Medicare enrollment and billing privileges were revoked effective 30 days from the postmark date of the letter. The MAC cited violations of 42 C.F.R. §§ 424.57(c)(21) (Supplier Standard 21) and (c)(22) (Supplier Standard 22) as the basis for revocation. The MAC cited 42 C.F.R. §§ 424.57(e) and 424.535(a)(1) as the authority for the revocation. CMS Ex. 1 at 14-15. The MAC advised Petitioner that, pursuant to 42 C.F.R. § 424.535(c) it was subject to a one-year bar to reenrollment beginning 30 days from the postmark of the letter. CMS Ex. 1 at 15. The MAC advised Petitioner it had 35 calendar days to provide a corrective action plan (CAP) to show it complied with the supplier standards and 65 days to request reconsideration. CMS Ex. 1 at 15-17.
There is no allegation or evidence before me that Petitioner submitted a CAP. But on July 18, 2025, Petitioner requested a reconsidered determination. CMS Ex. 1 at 19-23.
On August 12, 2025, Chags Health Information Technology, LLC (C-HIT) on behalf of CMS, upheld the revocation of Petitioner’s Medicare enrollment and billing privileges based on the violation of 42 C.F.R. § 424.57(c) (21) and (22) (Supplier Standards 21 and 22). C-HIT stated in the reconsidered determination that Petitioner failed to submit its accreditation information on reconsideration and remained noncompliant with Supplier Standards 21 and 22. CMS Ex. 1 at 4. But C-HIT stated more specifically that Petitioner violated:
Page 3
42 C.F.R. § 424.57(c)(21) because Petitioner failed to respond to the MAC’s March 14, 2025 request for Petitioner’s accreditation information (CMS Ex. 1 at 11-12); and
42 C.F.R. § 424.57(c)(22) because Petitioner was not properly accredited.
CMS Ex. 1 at 3. C-HIT upheld the one-year reenrollment bar pursuant to 42 C.F.R. § 424.535(c). CMS Ex. 1 at 4.
On October 6, 2025, Petitioner filed a request for hearing before an administrative law judge (ALJ). CMS Ex. 2. On October 7, 2025, this case was assigned to me for hearing and decision, and my Standing Order was issued.
On December 18, 2025, CMS filed a combined prehearing brief and motion for summary judgment with CMS Exs. 1 through 4. Petitioner did not object to CMS’s exhibits, and they are admitted as evidence.
On January 20, 2026, Petitioner informed me that it had no additional information or documents to present for my consideration. Petitioner filed with its request for hearing an August 28, 2025 letter from The Compliance Team that I treat as Petitioner’s Exhibit (P. Ex.) 1. The letter advised Petitioner that it was accredited effective August 25, 2025 through August 25, 2028, as a supplier of Durable Medical Equipment, Prosthetic Devices, Prosthetics, Orthotics, & Supplies (DMEPOS) for blood glucose monitors and supplies, both mail order and non-mail order. P. Ex. 1. CMS did not object to my consideration of P. Ex. 1 and it is admitted. In provider and supplier appeals, 42 C.F.R. § 498.56(e) requires that I determine whether good cause exists to admit new documentary evidence not submitted at the time of reconsideration. If I conclude good cause exists, I “must include” the evidence. 42 C.F.R. § 498.56(e)(2)(i). P. Ex. 1 did not exist at the time the reconsidered determination and could not have been submitted by Petitioner at that time. I conclude that the nonexistence of P. Ex. 1 was good cause for it not being submitted on reconsideration. Therefore, I conclude that P. Ex. 1 is not subject to exclusion under 42 C.F.R. § 498.56(e)(2)(ii).
There is no dispute that Petitioner was accredited by The Compliance Team effective August 25, 2025 (P. Ex. 1), more than three months after the May 20, 2025 initial determination of the MAC to revoke and 13 days after the reconsidered determination was issued. The Compliance Team accredited Petitioner for blood glucose monitors and
Page 4
supplies, both mail order and non-mail order. There is no dispute that The Compliance Team is a CMS-approved accreditation organization.3
II. Discussion
A. Applicable Law
Section 1831 of the Social Security Act (the 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.4 Act §§ 1835(a) (42 U.S.C. § 1395n(a)), 1842(h)(1) (42 U.S.C. § 1395u(h)(1)). Petitioner was enrolled in Medicare as a DMEPOS supplier.
The Act requires the Secretary of Health and Human Services (Secretary) to 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 such as Petitioner 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.
Page 5
Pursuant to 42 C.F.R. §§ 424.57(b) and 424.505, a DMEPOS supplier such as Petitioner must be enrolled in the Medicare program to be reimbursed for durable medical equipment, prosthetics, orthotics, or supplies sold or rented to Medicare beneficiaries. The regulations establish detailed requirements that suppliers must meet and maintain to enroll in Medicare and to receive and maintain Medicare billing privileges. 42 C.F.R. pt. 424, subpt. P. DMEPOS suppliers have additional requirements imposed by 42 C.F.R. § 424.57(b) and (c). To receive direct-billing privileges, a DMEPOS supplier must meet and maintain the Medicare application certification standards set forth in 42 C.F.R. § 424.57(c), which are the Supplier Standards. A DMEPOS supplier must operate and furnish Medicare-covered items in compliance with all applicable federal and state licensure and regulatory requirements. 42 C.F.R. § 424.57(c)(1). The two supplier standards CMS alleges were violated are Supplier Standards 21 and 22. A DMEPOS supplier must provide “to CMS, upon request, any information required by the Medicare statutes and implementing regulations. 42 C.F.R. § 424.57(c)(21) (Supplier Standard 21). A DMEPOS supplier must be accredited by a CMS-approved accreditation organization, and the accreditation must indicate the products and services for which the supplier is accredited. 42 C.F.R. § 424.57(c)(22) (Supplier Standard 22).
The Secretary has delegated the authority to revoke enrollment and billing privileges to CMS. 42 C.F.R. §§ 424.57(e)(1), 424.535. CMS or a MAC 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. Noncompliance with DMEPOS specific enrollment requirements established by 42 C.F.R. § 424.57(b) and (c) for DMEPOS suppliers is also a basis for revocation of Medicare enrollment and billing privileges pursuant to 42 C.F.R. § 424.57(e)(1). When Medicare enrollment and billing privileges are revoked pursuant to 42 C.F.R. § 424.57(e)(1), revocation is effective 30 days after the DMEPOS supplier is sent notice of the revocation. If a supplier’s Medicare enrollment and billing privileges are revoked, the supplier is barred from reenrolling in the Medicare program for one to 10 years. 42 C.F.R. § 424.535(c).
A supplier whose enrollment and billing privileges are revoked may request reconsideration and review as provided by 42 C.F.R. pt. 498. 42 C.F.R. § 424.545(a). A supplier submits a written request for reconsideration to CMS or the MAC. 42 C.F.R. § 498.22(a). CMS or the MAC must give notice of its reconsidered determination to the supplier, giving the reasons for its determination, specifying the conditions or requirements the supplier failed to meet, and advising the supplier of its 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 (the Board). Act § 1866(j)(8) (42 U.S.C. § 1395cc(j)(8)); 42 C.F.R. §§ 424.545, 498.3(b)(17), 498.5. A hearing on the record, also known as an oral hearing, is required under the Act. Crestview Parke Care Ctr. v. Thompson, 373 F.3d 743, 748-51 (6th Cir. 2004). The supplier bears the burden to
Page 6
demonstrate that it meets enrollment requirements with documents and records. 42 C.F.R. § 424.545(c).
B. Issues
Whether there was a basis for the revocation of Petitioner’s billing privileges and enrollment in Medicare.
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.
CMS filed a motion for summary judgment.
A supplier whose enrollment has been revoked has a right to a hearing and judicial review, and a hearing on the record is required under the Act. Act §§ 205(b) (42 U.S.C. § 405(b)), 1866(h)(1), (j) (42 U.S.C. §§ 1395cc(h)(1), (j)); 42 C.F.R. §§ 498.3(b)(17), 498.5; Crestview Parke Care Ctr, 373 F.3d 743, 748-51 (6th Cir. 2004). A party may waive appearance at an oral hearing but must do so affirmatively in writing. 42 C.F.R. § 498.66(a). Petitioner has not waived the right to an oral hearing.
Summary judgment is not automatic upon request but is limited to certain specific conditions. The Secretary’s regulations that establish the procedure to be followed in adjudicating Petitioner’s case are at 42 C.F.R. pt. 498. 42 C.F.R. §§ 405.800; 405.803(a); 424.545(a); 498.3(b)(17), (20). The regulations 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 Procedure (Fed. R. Civ. Pro.) do not apply in administrative adjudications such as this. However, the Board has accepted that Fed. R. Civ. Pro. 56 and related cases provide useful guidance for determining whether summary judgment is appropriate. Furthermore, a summary judgment procedure was adopted as a matter of judicial economy within my authority to regulate the course of proceedings and made available to the parties in the litigation of this case by my Standing Order. The parties were given notice by the Standing Order that summary judgment is an available procedural device and that the law as it has developed related to Fed. R. Civ. Pro. 56 will be applied. Standing Order ¶¶ D, G.
Page 7
Summary judgment is appropriate when there is no genuine dispute as to any issue of material fact for adjudication and/or the moving party is entitled to judgment as a matter of law. The party requesting summary judgment bears the burden of showing that there are no genuine issues of material fact for trial and/or that it is entitled to judgment as a matter of law. In determining whether there are genuine issues of material fact for trial, the reviewer must view the evidence in the light most favorable to the non-moving party, drawing all reasonable inferences in that party’s favor. Generally, the non-movant may not defeat an adequately supported summary judgment motion by relying upon the denials in its pleadings or briefs but must furnish evidence of a dispute concerning a material fact, i.e., a fact that, if proven, would affect the outcome of the case. Mission Hosp. Reg’l Med. Ctr., DAB No. 2459 at 4 (2012) (and cases cited therein); Experts Are Us, Inc., DAB No. 2452 at 4 (2012) (and cases cited therein); Senior Rehab. & Skilled Nursing Ctr., DAB No. 2300 at 3 (2010) (and cases cited therein); see also Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).
The standard for deciding a case on summary judgment and an ALJ’s decision-making in deciding a summary judgment motion differs from that used in resolving a case on the merits after a hearing or when hearing is waived. On summary judgment, the ALJ does not make credibility determinations, weigh the evidence, or decide which inferences to draw from the evidence, as would be done when finding facts after a hearing on the record. Rather, on summary judgment, the ALJ construes the evidence in a light most favorable to the non-movant and avoids deciding which version of the facts is more likely true. Holy Cross Vill. at Notre Dame, Inc., DAB No. 2291 at 5 (2009). The Board also has recognized that on summary judgment it is appropriate for the ALJ to consider whether a rational trier of fact could find that the party’s evidence would be sufficient to meet that party’s evidentiary burden. Dumas Nursing & Rehab., L.P., DAB No. 2347 at 5 (2010). 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. 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 & Conv. Ctr., DAB No. 1904 (2004), aff’d, 129 Fed. App’x 181 (6th Cir. 2005).
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 material fact relevant to revocation under 42 C.F.R. §§ 424.57(e)(1) and 424.535(a)(23) based on violation of Supplier Standard 22 (42 C.F.R. § 424.57(c)(21)).
There is a genuine dispute of material fact related to Supplier Standard 21, specifically whether Petitioner received any request for information from CMS. Petitioner states in its request for hearing that it received no notification from the MAC prior to the May 20, 2025 notice of initial determination that CMS wanted accreditation information. Supplier
Page 8
Standard 21 (42 C.F.R. § 424.57(c)(21)) is violated when a DMEPOS supplier fails to deliver information required to be maintained by the supplier in response to a request from CMS. The plain language of the regulation shows it applies only if there is a request for information by CMS. The March 14, 2025 CMS request for information (CMS Ex. 1 at 11-12) is in evidence. But Petitioner denies receiving or knowing about the request. It is only reasonable to conclude that if a CMS request was made but not received, then the request can be of no effect. I advised the parties in my Standing Order that on summary judgement a fact alleged and not specifically denied may be accepted as true for purposes of ruling on the motion. Standing Order ¶ G. CMS states in it brief that the March 14, 2025 demand for information was sent. CMS Br. at 2, 7. CMS was on notice by the request for hearing that Petitioner alleged it never received the March 14, 2025 CMS request. But CMS does not specifically deny in its brief that Petitioner did not receive the request or submit evidence that shows receipt by Petitioner. In considering summary judgment on the CMS motion, I am required to draw all favorable inferences for Petitioner. Based on the allegation in the request for hearing, Petitioner is benefited by the uncontested favorable inference it did not receive the March 14, 2025 CMS request for accreditation information. Receipt of the CMS request for information is a critical element of 42 C.F.R. § 424.57(c)(21) and whether the notice was received is, therefore, a material fact. Dispute of the material fact could only be resolved after a hearing or waiver of hearing and decision on the merits when credibility and the weight of the evidence can be addressed. Therefore, summary judgment based on a violation of Supplier Standard 21 is not appropriate.
But the violation of a single Medicare requirement provides CMS a sufficient basis for revocation of a provider’s or supplier’s Medicare enrollment. 1866ICPayday.com, L.L.C., DAB No. 2289 at 13 (2009). Supplier Standard 22 (42 C.F.R. § 424.57(c)(22)) requires that a DMEPOS supplier be accredited by a CMS approved accrediting organization and the accreditation must list the specific products and services for which the supplier is accredited in order for the supplier to receive payment for those specific products and services. 42 C.F.R. § 424.57(c)(22)(i). There is no dispute that Petitioner did not receive its required accreditation until August 25, 2025 (P. Ex. 1), more than three months after the May 20, 2025 initial determination of the MAC to revoke and 13 days after the reconsidered determination was issued. I have no authority to provide Petitioner equitable relief. I conclude that CMS is entitled to judgment as a matter of law because the undisputed facts establish the violation of 42 C.F.R. § 424.56(c)(22) and that violation is a basis for revocation under 42 C.F.R. §§ 424.57(e)(1) and 424.535(a)(23)(ii). Accordingly, summary judgment is appropriate.
2. Petitioner was not in compliance with 42 C.F.R. § 424.57(c)(22) (Supplier Standard 22) because Petitioner did not have the required accreditation by a CMS-approved accreditation organization at the time of the reconsidered determination.
Page 9
3. There is a basis for revocation of Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. §§ 424.57(e)(1) and 424.535(a)(23)(ii) based on Petitioner’s violation of 42 C.F.R. § 424.57(c)(22) (Supplier Standard 22).
4. The effective date of revocation of Petitioner’s Medicare enrollment and billing privileges is June 19, 2025, 30 days after May 20, 2025, the date the MAC mailed the notice of the initial determination to revoke. 42 C.F.R. §§ 424.57(e)(1), 424.535(g)(1).
It is well established that even a single violation of a single supplier standard is a sufficient basis for revocation of Medicare enrollment and billing privileges under 42 C.F.R. § 424.57(e)(1). 1866ICPayday.com, L.L.C., DAB No. 2289 at 13.
Pursuant to 42 C.F.R. § 424.57(e)(1), CMS revokes a DMEPOS supplier’s enrollment and billing privileges if it is determined that the supplier does not meet a supplier standard established by 42 C.F.R. § 424.57(b) and (c). The language of 42 C.F.R. § 424.57(e)(1) which states that “CMS revokes” arguably grants CMS no discretion not to revoke when a DMEPOS supplier is not compliant with a requirement of 42 C.F.R. § 424.57(b) or (c). Revocation is effective 30 days after the supplier is sent notice of the revocation. 42 C.F.R. § 424.57(e)(1).
C-HIT did not list 42 C.F.R. § 424.57(e) in its reconsidered determination as the authority for revocation but listed 42 C.F.R. § 424.535(a)(1) as the authority. Under 42 C.F.R. § 424.535(a)(1), CMS is granted discretionary authority to revoke for noncompliance with any enrollment requirement if the provider or supplier has not submitted an acceptable CAP. 42 C.F.R. § 424.535(a)(1).
C-HIT also failed to cite as authority for the revocation 42 C.F.R. § 424.535(a)(23)(ii).5 Under 42 C.F.R. § 424.535(a)(23)(ii), CMS has authority to revoke a DMEPOS supplier’s Medicare enrollment and billing privilege based on the supplier’s noncompliance with any requirement of 42 C.F.R. § 424.57(c). The language of 42 C.F.R. § 424.535 indicates that CMS has discretion to revoke or not. Because CMS
Page 10
revoked, it is not necessary to resolve whether CMS has discretionary authority to revoke in this case under 42 C.F.R. § 424.535(a)(23)(ii) or whether revocation is mandatory under 42 C.F.R. § 424.57(e)(1). But it is clear that the general authority of 42 C.F.R. § 424.535(a)(1) is not the appropriate revocation authority on the facts of this DMEPOS supplier revocation, because both 42 C.F.R. §§ 424.57(e)(1) and 424.535(a)(23)(ii) specifically apply to revocation in this case. The citation to 42 C.F.R. § 424.535(a)(1) by C-HIT is a nonprejudicial legal error that did not prevent Petitioner from requesting a hearing or obtaining my review.
I conclude that CMS and the MAC had authority to revoke Petitioner’s Medicare enrollment and billing privileges pursuant to both 42 C.F.R. §§ 424.57(e)(1) and 424.535(a)(23)(ii). I conclude that there is a basis for revocation based on Petitioner’s noncompliance with the accreditation requirement of 42 C.F.R. § 424.57(c)(22).
The requirement of 42 C.F.R. § 424.57(c)(22) at the time of the initial and reconsidered determination was:
(22) All suppliers of DMEPOS and other items and services must be accredited by a CMS-approved accreditation organization in order to receive and retain a supplier billing number. The accreditation must indicate the specific products and services, for which the supplier is accredited in order for the supplier to receive payment for those specific products and services.
The burden is upon a provider or supplier to show that it meets enrollment requirements and to produce the documents necessary to show it complies with enrollment requirements. 42 C.F.R. § 424.545(c).
Petitioner states in its request for hearing that it was not aware it needed to provide the MAC proof of accreditation until it received the May 20, 2025 initial determination revoking its Medicare enrollment and billing privileges. CMS Ex. 2. Petitioner’s failure to provide a copy of its accreditation at CMS/MAC request was the allegation of noncompliance with the requirement of 42 C.F.R. § 424.57(c)(21) for which I have concluded summary judgment is not appropriate.
But the alleged noncompliance under 42 C.F.R. § 424.57(c)(22) is that Petitioner was not accredited and not that it failed to produce evidence of accreditation when requested by CMS or the MAC. Therefore, whether Petitioner received the March 14, 2025 MAC request for evidence of accreditation is not material to the alleged noncompliance with 42 C.F.R. § 424.57(c)(22). Petitioner does not dispute that it was not accredited when the initial determination and the reconsidered determination were issued. Petitioner does not
Page 11
deny that the regulation required that it be accredited. The Board has consistently found that people and entities that enroll in Medicare are presumed to know Medicare requirements. John Hartman, D.O., DAB 2564 at 3 (2014) (citing Heckler v. Cmty. Health Servs. of Crawford Cnty., Inc., 467 U.S. 51, 63 (1984) (“the general rule [is] those who deal with the Government are expected to know the law”)). Moreover, providers and suppliers must, pursuant to 42 C.F.R. §§ 424.510(d)(3) and 424.516(a)(2), attest or certify that they meet all Medicare requirements, which is further evidence supporting the presumption of their knowledge of the requirements. Petitioner does not deny that it was not accredited for blood glucose monitors and supplies (by mail or by non-mail orders) before being accredited by The Compliance Team effective August 25, 2025, after the reconsidered determination was issued. P. Ex. 1; CMS Ex. 2. Accordingly, I conclude that Petitioner was in violation of 42 C.F.R. § 424.57(c)(22) (Supplier Standard 22) and that single violation is a basis for revocation under 42 C.F.R. §§ 424.57(e)(1) and 424.535(a)(23)(ii).
I have no authority to review the exercise of discretion by CMS to revoke a DMEPOS supplier’s Medicare enrollment and billing privileges once I have found that a basis for revocation exists, in this case, the violation of Supplier Standard 22. The scope of my authority is limited to determining whether there is a legal basis for revocation of Petitioner’s Medicare enrollment and billing privileges. Abdul Razzaque Ahmed, M.D., DAB No. 2261 at 19, aff’d, Ahmed v. Sebelius, 710 F. Supp. 2d 167 (D. Mass. 2010). Once I determine there is a basis for revocation, I do not consider whether CMS should have revoked.
Petitioner states in its request for hearing that:
[Petitioner is] a closed door long term care pharmacy that provides pharmacy services to thousands of patients including those in assisted living facilities/senior living facilities as well as many seniors receiving care at home. Not being able to provide the necessary diabetic supplies or medications covered under Medicare Part B will increase the risk of these patients not having access to these prescriptions. We provide delivery of these prescriptions for these patients and many of them live in areas that have “pharmacy deserts” and will not have access if we are unable to provide them these medications.
CMS Ex. 2. Petitioner’s argument may be construed to be a request for equitable relief that I have no authority to grant. US Ultrasound, DAB No. 2302 at 8 (2010) (neither the ALJ nor the Board is authorized to provide equitable relief). I am bound to follow the
Page 12
Act and regulations, and I have no authority to declare statutes or regulations invalid or ultra vires or ignore their application. 1866ICPayday.com, L.L.C., DAB No. 2289 at 14.
Pursuant to 42 C.F.R. § 424.57(e)(1), revocation for noncompliance with the supplier standards established by 42 C.F.R. § 424.57(c) is effective 30 days after the supplier is sent notice of the revocation. Pursuant to 42 C.F.R. § 424.535(g)(2)(viii)(D), the effective date of revocation is determined pursuant to 42 C.F.R. § 424.535(g)(1), if none of the listed exceptions apply, and they do not in this case. Revocation under 42 C.F.R. § 424.535(g)(1) is effective 30 days after CMS or the MAC mailed the notice of the initial determination to revoke. Under either regulation the correct effective date for revocation of Petitioner’s Medicare enrollment and billing privileges is 30 days after the notice of the revocation was issued or mailed. Accordingly, I conclude that the effective date of revocation of Petitioner’s Medicare enrollment and billing privileges was June 19, 2025, which is 30 days after the May 20, 2025 notice of revocation was issued.
III. Conclusion
For the foregoing reasons, I conclude that Petitioner’s Medicare enrollment and billing privileges are revoked pursuant to 42 C.F.R. §§ 424.57(e)(1) and 424.535(a)(23)(ii), effective June 19, 2025, for violation of 42 C.F.R. § 424.57(c)(22) (Supplier Standard 22).
Keith W. Sickendick Administrative Law Judge
- 1
Citations are to the 2024 revision of the Code of Federal Regulations (C.F.R.), which was in effect at the time of the initial determination, unless otherwise indicated.
An appellate panel of the Departmental Appeals Board (Board) concluded in Mark A. Kabat, D.O., DAB No. 2875 at 9-11 (2018), that the applicable regulations are those in effect at the time of the initial determination. The Board previously concluded that the only determination subject to my review in a provider and supplier enrollment case such as this is the reconsidered determination. Neb Group of Ariz. LLC, DAB No. 2573 at 7 (2014).
- 2
Petitioner does not dispute that May 20, 2025, was the date of mailing of the MAC’s initial determination.
- 3
The complete listing of CMS-approved accreditation organizations updated January 9, 2026 is available at: https://www.cms.gov/files/document/dmepos-accreditation-organizations.pdf (last visited June 17, 2026). The Compliance Team is listed as an approved DMEPOS accreditation organization.
- 4
A “supplier” furnishes services under Medicare and includes physicians and other practitioners and facilities that are not included within the definition of the phrase “provider of services.” Act § 1861(d) (42 U.S.C. § 1395x(d)). A “provider of services,” commonly shortened to “provider,” includes hospitals, critical access hospitals, skilled nursing facilities, comprehensive outpatient rehabilitation facilities, home health agencies, hospice programs, and a fund as described in sections 1814(g) (42 U.S.C. § 1395f(g)) and 1835(e) (42 U.S.C. § 1395n(e)) of the Act. Act § 1861(u) (42 U.S.C. § 1395(x)(u)). The distinction between providers and suppliers is important because they are treated differently under the Act for some purposes.
- 5
Effective January 1, 2024, CMS amended 42 C.F.R. § 424.535 to add subsection (a)(23)(ii), which authorizes CMS or the MAC to revoke a DMEPOS supplier’s Medicare enrollment and billing privileges for noncompliance with any of the requirements of 42 C.F.R. § 424.57(c). 88 Fed. Reg. 79,541 (Nov. 16, 2023).