Oakland Orthopedic Appliances, Inc., DAB CR6955 (2026)

DECISION

Petitioner did not violate 42 C.F.R. § 424.57(c)(21) or (30).1  There was no basis for revocation of Petitioner’s Medicare enrollment and billing privileges. 

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I.  Background and Findings of Fact

On December 6, 2024, Novitas Solutions, a Medicare durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) administrative contractor (DME MAC),2 received a Medicare enrollment application from Petitioner.  Petitioner, who was already enrolled in Medicare, submitted the application to revalidate its Medicare enrollment information (revalidation application).  Centers for Medicare & Medicaid Services (CMS) Exhibit (Ex.) 1 at 8, 54.  The DME MAC received Petitioner’s corrections to the revalidation application on December 17, 2024.  CMS Ex. 1 at 54. 

The revalidation application listed Petitioner’s physical address as 1117 S. Van Dyke Road, Suite 100, Bad Axe, Michigan.  According to the application, Petitioner had been operating from that location since November 1, 2018.  CMS Ex. 1 at 9, 55. 

Petitioner’s revalidation application listed Petitioner’s hours of operation as Monday, Tuesday, and Thursday from 9:00 a.m. to 4:00 p.m., a total of 21 hours per week.  The application indicates that Petitioner changed the hours previously listed in its Medicare enrollment record by adding hours on Tuesday from 9:00 a.m. to 4:00 p.m. and deleting an equal number of hours on Wednesday.  CMS Ex. 1 at 9-10, 56. 

The revalidation application indicates in section 2 that Petitioner was first accredited for orthotic personnel effective October 23, 2012, prosthetic personnel effective October 9, 2009, and pedorthic personnel effective October 9, 2009.  When Petitioner filed its revalidation application on December 6, 2024, Petitioner’s accreditation for each specialty continued through October 31, 2025.  CMS Ex. 1 at 10, 43, 56.  Products and services furnished by Petitioner are listed in the application as neuromuscular electrical stimulators; custom fabricated, prefabricated custom fitted, and off-the-shelf orthoses; limb prostheses; diabetic shoes and inserts; custom diabetic shoes and inserts; and lymphedema compression treatment items.  There is also a note that Petitioner fills orders, fabricates or fits items from Petitioner’s inventory, and contracts with another company to fill orders.  CMS Ex. 1 at 10-11, 56-57. 

On December 13, 2024, the DME MAC requested corrections to the revalidation application it received from Petitioner on December 6, 2024.  CMS Ex. 1 at 8-19. 

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Among other things,3 the DME MAC requested that Petitioner list all hours of operation for Petitioner’s business location and stated that the “total number of operations hours per week must be at a minimum of 30 hours.”  CMS Ex. 1 at 20.  But the corrected application received by the DME MAC on December 17, 2024, continued to list a total of only 21 hours per week.  CMS Ex. 1 at 54, 56. 

A site investigation was conducted on December 17, 2024, at Petitioner’s address 1117 S. Van Dyke Road, Suite 100, Bad Axe, Michigan.  CMS Ex. 1 at 23-53.  Posted hours open to the public were 9:00 a.m. to 4:00 p.m. on Monday, Tuesday, and Thursday, which I note to be 21 hours per week.4  CMS Ex. 1 at 24, 32.  The report states that Petitioner provides custom-fitted or fabricated orthotic and prosthetic items.  But Petitioner does not fabricate items onsite.  CMS Ex. 1 at 25.  The report shows that Petitioner had four locations in Michigan and one in Texas in addition to Petitioner’s location in Bad Axe, Michigan, which is the location at issue in this case.  CMS Ex. 1 at 34. 

On July 31, 2025, the DME MAC notified Petitioner by letter that its Medicare supplier number, Medicare enrollment, and Medicare billing privileges for DMEPOS would be revoked effective 30 days from the date the letter was postmarked.  Petitioner has not challenged that the July 31, 2025 letter was postmarked on that date.  Therefore, Petitioner’s Medicare enrollment and billing privileges were revoked effective August 30, 2025.  The DME MAC cited 42 C.F.R. § 424.535(a)(1) as the authority for the revocation based on violation of 42 C.F.R. § 424.57(c)(21) and (30) (Supplier Standards 21 and 30).  According to the DME MAC Petitioner violated 42 C.F.R. § 424.57(c)(30) (Supplier Standard 30) because the site visit and Petitioner’s revalidation application showed that Petitioner was not open to the public at least 30 hours per week.  The DME MAC also alleged Petitioner violated 42 C.F.R. § 424.57(c)(21) (Supplier Standard 21).  The DME MAC alleges the violation of Supplier Standard 21 because on December 13, 2024, a DME MAC representative requested that Petitioner change its revalidation application to show the total number of hours Petitioner was open to the public weekly was a minimum of 30 hours.  The DME MAC alleges that Petitioner failed to respond.  CMS Ex. 1 at 67-68.  The DME MAC imposed a one-year reenrollment bar pursuant to 

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42 C.F.R. § 424.535(c), beginning the day the notice letter was postmarked.  The DME MAC advised Petitioner of its rights to submit a corrective action plan (CAP) and to request reconsideration.  CMS Ex. 1 at 68-70. 

On August 4, 2025, Petitioner sent the DME MAC a corrective action plan and a request for a reconsidered determination.  Petitioner advised the DME MAC that because it supplied custom-fabricated orthotics and prosthetics it was exempt from the requirement of 42 C.F.R. § 424.57(c)(30) to be open to the public at least 30 hours per week.  Petitioner explained that its primary fabrication laboratory was at its Bay City, Michigan location but all locations have on-site laboratories to perform adjustments and modifications to meet patient needs.  Petitioner also explained that it had prefabricated, off-the-shelf, and custom-fitted orthotic devices and provided photographs.  Petitioner requested that its Medicare enrollment and billing privileges be reinstated.  CMS Ex. 1 at 72-88, 94-110. 

On October 3, 2025, Chags Health Information LLC (C-HIT) issued a reconsidered determination on behalf of CMS.  C-HIT upheld revocation citing as authority 42 C.F.R. § 424.535(a)(1) based on violations of 42 C.F.R. § 424.57(c)(21) and (30) (Supplier Standards 21 and 30).  C-HIT also upheld the one-year reenrollment bar.  CMS Ex. 1 at 1-7.  C-HIT reviewed that Petitioner submitted a revalidation application on December 6, 2024; the DME MAC requested correction on December 13, 2024, advising Petitioner that 30 hours open to the public was not enough; and Petitioner submitted corrections to its revalidation application on December 17, 2024, without increasing its hours of operation to 30 or more.  CMS Ex. 1 at 2-3.  C-HIT found the CAP insufficient, but that decision is not subject to my review.  42 C.F.R. § 498.5(l)(2); Conchita Jackson, MD, DAB No. 2495 at 7 (2013); DMS Imaging, Inc., DAB No. 2313 at 5-11 (2010).  C-HIT conducted reconsideration but denied any relief referring to its analysis of the corrective action plan.  C-HIT noted that on December 13, 2025, the DME MAC requested that Petitioner update its revalidation application to reflect 30 hours for customers each week.  Petitioner did not make that change and C-HIT concluded that was a basis for revocation for violation of 42 C.F.R. § 424.57(c)(21).  C-HIT concluded that Petitioner did not meet the exemption for the 30-hour per week requirement of 42 C.F.R. § 424.57(c)(30) because Petitioner does not work with only custom-made orthotics and prosthetics.    CMS Ex. 1 at 3-4. 

On November 26, 2025, Petitioner filed a request for hearing (RFH) before an administrative law judge (ALJ).  On January 16, 2026, CMS filed a motion for summary judgment, prehearing brief and memorandum in support of summary judgment, and CMS Ex. 1.  Petitioner filed its prehearing exchange (P. Br.) on January 29, 2026.  On March 9, 2026, CMS waived filing a reply.  Petitioner did not object to my consideration of CMS Ex. 1, which is admitted as evidence.  Petitioner advised me it had no additional evidence 

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to offer.  Neither party identified any witnesses to testify at an oral hearing.   Petitioner waived an oral hearing.  P. Br. at 2. 

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.5  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. 

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. 

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424, subpt. P.  DMEPOS suppliers have additional requirements imposed by 42 C.F.R. § 424.57(b) and (c).  Pursuant to 42 C.F.R. § 424.56(b)(1), a DMEPOS supplier must enroll in Medicare separate physical locations it uses to furnish Medicare-covered items, except for a location used only as a warehouse or repair facility.  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 30.  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 open to the public a minimum of 30 hours per week except for the three cases listed in 42 C.F.R. § 424.57(c)(30)(ii).  42 C.F.R. § 424.57(c)(30) (Supplier Standard 30). 

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 (2009). 

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 Medicare administrative contractor (MAC) may revoke an enrolled supplier’s Medicare enrollment and billing privileges and any related supplier agreement for any of the reasons listed in 42 C.F.R. § 424.535.  C-HIT upheld revocation in this case pursuant to the general revocation authority of 42 C.F.R. § 424.535(a)(1).  CMS Ex. 1 at 1.  But noncompliance with DMEPOS specific enrollment requirements established by 42 C.F.R. § 424.57(b) and (c) is a basis for revocation of Medicare enrollment and billing privileges of a DMEPOS supplier pursuant to 42 C.F.R. § 424.57(e)(1).  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) as authority for revocation.  C-HIT also failed to cite as authority for the revocation 42 C.F.R. § 424.535(a)(23)(ii).6  Under 42 C.F.R. § 424.535(a)(23)(ii), 

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CMS has discretionary 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).  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 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 Medicare enrollment and billing privileges. 

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

My conclusions of law are set forth in bold followed by my analysis. 

1. Decision on the documentary evidence and written argument is appropriate. 

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. 

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§ 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 waived oral hearing in its brief.  P. Br. at 2.  I conclude that decision upon the documentary evidence and pleadings is appropriate.  42 C.F.R. § 498.66. 

2. Petitioner was in compliance with 42 C.F.R. § 424.57(c)(21) (Supplier Standard 21) because: 

a. Petitioner was not required to falsely change its pending revalidation application as requested by the DME MAC to list hours open to the public of 30 hours or more; and

b. There is no requirement in the Medicare statutes or regulations that a DMEPOS supplier request the exception provided by 42 C.F.R. § 424.57(c)(30)(ii)(C) to the rule that a DME POS supplier be open to the public 30-hours per week. 

3. Petitioner was in compliance with 42 C.F.R. § 424.57(c)(30), because it was exempt from the requirement to be open to the public for 30 or more hours per week because it provided custom-made or fitted orthotics and prosthetics. 

4. There is no basis for revocation of Petitioner’s Medicare enrollment and billing privileges based on alleged violations of 42 C.F.R. § 424.57(c)(21) or (30) (Supplier Standards 21 or 30). 

C-HIT’s October 3, 2025 reconsidered determination is the decision subject to review in this supplier revocation case.  Neb Group of Ariz. LLC, DAB No. 2573 at 7. 

Petitioner argued to C-HIT on reconsideration that it is not required to be open to the public a minimum of 30-hours per week by 42 C.F.R. § 424.57(c)(30) (30-hour rule) because it works with custom made orthotics and prosthetics and is entitled to the exception provided by 42 C.F.R. § 424.57(c)(30)(ii)(C).   The pertinent part of the regulation provides: 

(30) (i) Except as specified in paragraph (c)(30)(ii) of this section, is open to the public a minimum of 30 hours per week.

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(ii) The provision of paragraph (c)(30)(i) of this section is not applicable at a practice location where a—

* * * *

(C) DMEPOS supplier is working with custom made orthotics and prosthetics. 

The December 6, 2024 revalidation application and the updated or corrected December 17, 2024 revalidation application show that: 

Petitioner was only opened to the public at its 1117 S. Van Dyke Road Suite 100, Bad Axe, Michigan (Bad Axe) location 21 hours per week (CMS Ex. 1 at 9-10, 56);

Petitioner was certified for prosthetics, orthotics, and pedorthics at its Bad Axe location (CMS Ex. 1 at 10, 43, 56); and

Petitioner’s products included custom fabricated, custom-fitted prefabricated, and off-the-shelf orthoses, limb prostheses, and custom diabetic shoes and inserts (CMS Ex. 1 at 10-11, 56-57). 

The December 17, 2024 site investigation report also shows that Petitioner provided custom-fitted or fabricated orthotic and prosthetic items that were not fabricated on site.  CMS Ex. 1 at 25. 

C-HIT did not reject Petitioner’s argument and evidence showing that Petitioner worked with custom made orthotics and prosthetics at its Bad Axe location.  Rather, C-HIT determined that Petitioner did not meet the exception to the 30-hour rule because Petitioner “provides certain items that are outside the scope of the exemption” including lymphedema compression treatment items, neuromuscular electrical stimulators and supplies, and off-the-shelf orthoses.  CMS Ex. 1 at 4.  C-HIT upheld the violation of 42 C.F.R. § 424.57(c)(21) because it found Petitioner never informed the DME MAC that it considered itself exempt from the 30-hour rule.  CMS Ex. 1 at 3.  I conclude that C-HIT’s interpretation and application of 42 C.F.R. § 424.57(c)(30)(ii)(C) is in error.  I also conclude that C-HIT erred in concluding that Petitioner failed to communicate to the DME MAC that it was not subject to the 30-hour rule. 

First, I consider C-HIT’s error regarding 42 C.F.R. § 424.57(c)(30)(ii)(C).  C-HIT’s reading of the exception is that it only applies if a DMEPOS supplier works exclusively with custom made orthotics and prosthetics.  C-HIT’s interpretation is reflected by its conclusion that Petitioner did not qualify for the exception because it sold other items.  

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The plain language of 42 C.F.R. § 424.57(c)(3)(ii)(C) is inconsistent with C-HIT’s interpretation and application of the provision because there are no such limiting words.  The plain meaning of 42 C.F.R. § 424.57(c)(30)(ii)(C) is that any work with custom-made orthotics or prosthetics is sufficient to trigger the exception to the 30-hour rule.  There is no language in the regulation that suggests that the exemption does not apply if the DMEPOS supplier provides some additional items that are not custom-made orthotics or prosthetics.  My interpretation is supported by the regulatory history of the provision. 

Because the language of 42 C.F.R. § 424.57(c)(30) is clear and the meaning plain, there should be no reason to resort to the regulatory history for the subsection.  But C-HIT did not simply comply with the plain language of the regulation.  C-HIT applied a different interpretation that required more than simply working with custom-made orthotics or prosthetics.  C-HIT did not point to any authority or CMS policy supporting its interpretation and application of 42 C.F.R. § 424.57(c)(30).  Therefore, it is necessary to review the regulatory history to determine whether C-HIT’s interpretation and application is consistent with or in violation of CMS policy.7 

Section 424.57(c)(30) of 42 C.F.R. was promulgated by CMS in August 27, 2010, with the effective date September 27, 2010.  75 Fed. Reg. 52,629 (Aug. 27, 2010).  CMS explained when issuing the new regulation: 

In § 424.57(c)(30), we proposed a new supplier standard that would require a DMEPOS supplier to be open to the public a minimum of 30 hours per week, except for those DMEPOS suppliers who are working with custom-made or fitted orthotics and prosthetics.  We believe that most legitimate DMEPOS suppliers are open to the public for more than 40 hours per week and that all legitimate DMEPOS would need to be open a minimum of at least 30 hours per week in order to attract, retain, and serve Medicare beneficiaries.  Given 

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that Medicare beneficiaries may not be able to find transportation during limited operating hours, the DMEPOS supplier must be open and available for periods long enough for beneficiaries to readily access their facility.  We believe that most legitimate DMEPOS suppliers are open to the public for more than 40 hours per week and that all legitimate DMEPOS would need to be open a minimum of at least 30 hours per week in order to attract, retain, and serve Medicare beneficiaries. 

75 Fed. Reg. at 52,632 (emphasis added).8   It is important to note that in this passage CMS reveals it intended that the exception in 42 C.F.R. § 424.57(c)(30)(ii)(C) applies not only to DMEPOS suppliers working with custom-made orthotics and prosthetics, but also those who “fitted orthotics and prosthetics.”  75 Fed. Reg. at 52,632.  CMS does not inform the public in the preamble that a DMEPOS supplier is entitled to the exception to the 30-hour rule only if it primarily or exclusively works with custom-made or fitted orthotics and prosthetics or that the DMEPOS supplier cannot provide other items that are not custom-made or fitted orthotics or prosthetics and benefit from the exception.  The foregoing text also indicates CMS’ position is that the 30-hour rule is not necessary to ensure that DMEPOS suppliers working with custom-made or fitted orthotics or prosthetics are legitimate DMEPOS suppliers.  Another comment and CMS response is enlightening: 

Comment: One commenter stated that this requirement does not allow a sole proprietor, being the only certified fitter as well as the owner, to be sick, go on vacation, or have a personal emergency without violating Medicare standards. 

Response: We agree and have adopted an exception to this provision for suppliers working with custom-made orthotics and prosthetics. 

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75 Fed. Reg. at 52,643.  CMS also clarified that orthotics and prosthetics are defined in the Healthcare Common Procedure Coding System (HCPCS) codes related to each product and as described in the DMEPOS quality standards.  75 Fed. Reg. at 52,644.  The HCPCS codes and the DMEPOS quality standards do not further clarify the application of the 30-hour requirement to suppliers who work with custom-made or fitted prosthetics or orthotics. 

Based on my review of the plain language of 42 C.F.R. § 424.57(c)(30) and its rule-making preamble, I conclude that CMS has not adopted or expressed any policy requirement that a DMEPOS supplier working with custom-made or fitted orthotics and prosthetics is not subject to the exception to the 30-hour rule under 42 C.F.R. § 424.57(c)(30)(ii)(C) if the supplier also provides other DMEPOS supplies.  I further conclude that C-HIT had no authority to refuse to apply the exception to the 30-hour rule to Petitioner where Petitioner worked with custom-made or fitted orthotics or prosthetics and provided other DMEPOS supplies. 

The second C-HIT error was the conclusion that Petitioner violated 42 C.F.R. § 424.57(c)(21).  Under 42 C.F.R. § 424.57(c)(21), a DMEPOS supplier must provide to CMS on request “any information required by the Medicare statue and implementing regulations.”  42 C.F.R. § 424.57(c)(21).  C-HIT explains in the reconsidered determination that Petitioner filed its December 6, 2024 revalidation application and reported in the application that it was open to the public 21 hours per week.  The DME MAC notified Petitioner on December 13, 2024, that Petitioner needed to correct its revalidation application by reporting Petitioner was open to the public at least 30 hours per week.  On December 17, 2024, Petitioner submitted a corrected revalidation application but did not change the information that it was only open to the public 21 hours per week.  C-HIT concluded Petitioner violated 42 C.F.R. § 424.57(c)(21) because Petitioner failed to change its revalidation application to show it was open to the public more than 21 hours and Petitioner failed to otherwise comment or reply to the DME MAC’s demand for a correction.  CMS Ex. 1 at 2-3. 

There is no question that Petitioner was required to report in its revalidation application the days and hours it was open to the public and the total number of hours it was open to the public per week.  Both the December 6, 2024 revalidation application and the December 17, 2024 corrected revalidation application, were completed by Petitioner to show the days and hours Petitioner was open to the public and the total number of hours open to the public each week.  CMS Ex. 1 at 9-10, 56.  Therefore, Petitioner did provide the information required by the Medicare statutes and implementing regulations.  Petitioner could not accede to the DME MAC’s demand that Petitioner report more than 21 hours per week because that would have been false subjecting Petitioner to adverse action.  C-HIT also asserts that Petitioner failed to provide evidence that it contacted the DME MAC about the exception to the 30-hour per week requirement available under 

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42 C.F.R. § 424.57(c)(30)(ii)(C).  CMS Ex. 1 at 3.  But C-HIT points to no requirement under the Medicare statutes or implementing regulations that a DMEPOS supplier must contact a DME MAC and claim the exception under 42 C.F.R. § 424.57(c)(30)(ii).  C-HIT overlooks that Petitioner clearly gave the DME MAC notice of the asserted exception by stating its hours which were under the minimum of 30; by providing information that it was certified for orthotics, prosthetics, and pedorthics; and by reporting that it provided custom-made and fitted orthotics and prosthetics.  CMS Ex. 1 at 9-11, 56-57.  The application required no further information and C-HIT points to no other form, regulation, or policy that requires that a DMEPOS supplier working with custom-made or fitted prosthetics or orthotics request the exception or that the exception requires DME MAC approval.  The information required by the application and information provided by Petitioner clearly gave the DME MAC notice that Petitioner claimed it was entitled to the exception to the 30-hour rule.  The application also shows Petitioner had been operating at the Bad Axe location since November 1, 2018 (CMS Ex. 1 at 9, 55) and at least part of the time between November 1, 2018 and December 6, 2024, Petitioner was only open 21 hours per week based on the adjustments to its schedule listed in the application (CMS Ex. 1 at 9-10, 56).  Petitioner asserts in its request for hearing that it has been operating since 2018 with the same hours of operation and products and services.  RFH at 2.  Petitioner’s assertions are unrebutted and credible. 

I conclude that Petitioner did not violate either 42 C.F.R. § 424.57(c)(21) or (30).  I further conclude that there was no basis for revoking Petitioner’s Medicare enrollment and billing privileges pursuant to 42 C.F.R. §§ 424. 57(e)(1), 424.535(a)(1), or 424.535(a)(23)(ii). 

III.  Conclusion

For the foregoing reasons, I conclude that there was no basis to revoke Petitioner’s Medicare enrollment and billing privileges based on the alleged violations of 42 C.F.R. §§ 424.57(c)(21) or (30) (Supplier Standards 21 or 30).