SUBJECT: MediSource Corporation,

Petitioner,

Centers for Medicare & Medicaid Services

FINAL DECISION ON REVIEW OF
ADMINISTRATIVE LAW JUDGE DECISION

MediSource Corporation (MediSource) appealed the June 13, 2005 decision of Administrative Law Judge (ALJ) Marion T. Silva (ALJ Decision). In that decision, the ALJ reversed the December 15, 2004 decision of the Carrier Hearing Officer (Hearing Officer) upholding the revocation and denying reinstatement of MediSource's Medicare Durable Medical Equipment, Prosthetics, Orthodics and Supplies (DMEPOS) supplier number. She concluded that, while the Hearing Officer's decision was proper when issued, MediSource had subsequently come into compliance with Medicare DMEPOS supplier standards and that the National Supplier Clearinghouse (NSC) ⁽¹⁾ should reinstate its supplier number effective April 6, 2005.

On appeal, MediSource argues that it should have been reinstated earlier than April 6, 2005.

[Page 2] For the reasons explained below, we uphold the ALJ Decision.

Legal Background

In order to be eligible to receive payment for a Medicare-covered DMEPOS item, a supplier must have furnished the item "on or after the date CMS issued to the supplier a DMEPOS supplier number conveying billing privileges." 42 C.F.R. ��424.57(b)(2). Additionally, CMS, through the NSC, cannot have "revoked . . . the DMEPOS supplier's privileges during the period in which the item was furnished . . . ." 42 C.F.R. ��424.57(b)(3).

In order to meet the definition of a DMEPOS supplier and obtain a supplier number, an entity must meet the 21 standards set forth in 42 C.F.R. ��424.57(c) (supplier standards). 42 C.F.R. ��424.57(a). If a supplier is subsequently found to not meet the standards, NSC must revoke the supplier's number, effective 15 days after NSC mails the notice of revocation. 42 C.F.R. ��405.874(b).

The supplier standard at issue before the Board is set forth at section 424.57(a)(7) and requires that a supplier maintain a physical facility on an appropriate site.

Section 1866(j)(2) of the Social Security Act (the Act) gives suppliers appeal rights, for certain determinations involving enrollment, using the procedures that apply under section 1866(h)(1)(A) of the Act. ⁽²⁾ Those procedures are at 42 C.F.R. Part 498 and provide for ALJ hearings and Board review.

Burden of Proof and Standard of Review

The Medicare Provider Integrity Manual provides: "The burden of persuasion is on the . . . DMEPOS supplier . . . to show that its enrollment application was incorrectly disallowed or that the revocation of its billing number was incorrect." Manual, Ch. 10, � 19.B. This provision is consistent with the Board's conclusion in provider appeals under 42 C.F.R. Part 498 that a provider must prove substantial compliance by the preponderance of the [Page 3] evidence, once CMS has established a prima facie case that the provider was not in substantial compliance with relevant statutory or regulatory provisions. See Batavia Nursing and Convalescent Center, DAB No. 1904 (2004); aff'd,Batavia Nursing and Convalescent Center v. Thompson, No. 04-3325 (6^th Cir. April 15, 2005); cf. Hillman Rehabilitation Center, DAB No. 1611 (1997), aff'd, Hillman Rehabilitation Ctr. v. U.S. Dep't of Health and Human Services, No. 98-3789(GEB) (D.N.J. May 13, 1999).

We apply in this case the standards of review we adopted for provider appeals under part 498. See Guidelines�- Appellate Review of Decisions of ALJs Affecting a Provider's Participation in Medicare and Medicaid Programs at http://www.hhs.gov/dab/guidelines/prov.html . Our standard of review on a disputed conclusion of law is whether the ALJ decision is erroneous. Our standard of review on a disputed finding of fact is whether the ALJ decision is supported by substantial evidence on the record as a whole. The Board may modify, affirm, or reverse an ALJ Decision. 42 C.F.R. ��498.88(f)(1)(3).

Factual and Procedural Background ⁽³⁾

In October 2004, MediSource was a DMEPOS supplier as defined by 42 C.F.R. ��424.57(a). On October 12, 2004, NSC notified MediSource that its supplier number would be revoked effective 15 days from the postmarked date of the letter because MediSource failed to meet DMEPOS supplier standards 1, 8, and 10, found at section�424.57(c)(1), (8), and (10). R. Ex. 1, Att. 10. Standard [Page 4] 8 sets forth requirements for a supplier's location, one of which provides that the location "must be accessible during reasonable business hours to beneficiaries and to CMS." Id., Att. 3. NSC concluded that MediSource's home-based location did not meet standard 8 because the applicable zoning requirements provided that no transactions could be conducted at the home and the home business owner must "go to the customer." Id., Att. 16.

On October 21, 2004, MediSource requested a hearing before a Hearing Officer. R. Ex. 1, Att. 8. With its hearing request, MediSource submitted a CMS 855S, which is a CMS form titled "Application for DMEPOS Suppliers" and referred to hereafter as the October CMS 855S. The October CMS 855S notified NSC that MediSource had moved to a new location (second location). ⁽⁴⁾ Id., Att. 9. MediSource argued that it should be reinstated based on its second location. ⁽⁵⁾

In his December 15, 2004 decision, the Hearing Officer concluded that a supplier "must ensure that its address is different from [an]other supplier's address" and found that there was an existing supplier at MediSource's second location address. Id., Att. 4, at 2. (We refer to this holding as the "one supplier per site requirement.") Therefore, the Hearing Officer concluded that MediSource was not in compliance with a DMEPOS standard and not eligible for a supplier number. The Hearing Officer cited standard 8 as the basis for his conclusion; however, NSC subsequently indicated that the one supplier per site requirement is based on standard 7 found at section 424.57(c)(7) (quoted later in this decision). NSC letter dated 2/17/2005.

On December 16, 2004, NSC completed a site inspection of the second location. The inspector found that MediSource's "office is inside Express Care Pharmacy" and that MediSource had the same address as and "shared space" with Express Care Pharmacy, which was a Durable Medical Equipment (DME) supplier. R. Ex. 1, Att. 6.

[Page 5] MediSource appealed the Hearing Officer Decision to the ALJ "to correct the one remaining deficiency that the Hearing Officer .�.�. reported to us . . . ." MediSource letter dated 2/4/2005. With its hearing request it submitted the original of a "Change of Information" CMS 855S dated February 4, 2005 (February CMS 855S). P. Ex. 1. The changed information in the February CMS 855S was MediSource's move to a third location following the site inspection of the second location.

Before the ALJ, NSC argued that the Hearing Officer correctly determined that MediSource was not entitled to a supplier number because MediSource "was sharing space with a pharmacy that had an active supplier number," which violated standard 7. NSC letter dated 2/17/05. The scope of this dispute thus evolved as the case progressed. NSC first revoked MediSource's number because, under county zoning standards, MediSource's first location was not accessible to beneficiaries and therefore violated standard 8. At the initial hearing, MediSource did not argue that its first location complied with standard 8; rather, it argued that its second location complied with standard 8 and all other DMEPOS supplier standards. The Hearing Officer, with NSC's apparent consent, reviewed whether MediSource's second location complied with supplier standards. By the time the case reached the ALJ, MediSource had moved again and filed, with its ALJ hearing request, the February CMS 855S identifying the third location.

On April 21, 2005, NSC notified the ALJ that it had conducted a site inspection of MediSource's third location on April 6, 2005 and that MediSource had passed the inspection. NSC email dated April 21, 2005. NSC stated that it required the original of the February CMS 855S for the third location before it could find MediSource in compliance with section 424.57(c)(2). The ALJ transmitted the original of the February CMS 855S to NSC. The NSC representative then wrote the ALJ:

I have received the change of address with the original signature from the supplier. In reviewing the information submitted and the site inspection that was completed on April 6, 2005, the supplier is now in compliance with all 21 standards. If a favorable decision is made by the ALJ, the NSC requests that a reinstatement date be included in the decision letter.

NSC email dated 5/17/2005.

The ALJ reversed the determination of the Hearing Officer denying reinstatement of MediSource's supplier number. The ALJ held that the Hearing Officer's Decision, holding that MediSource's second [Page 6] location violated the one supplier per site requirement under standard 7, was proper at the time it was issued. ⁽⁶⁾ The ALJ concluded that MediSource had subsequently corrected all deficiencies and was entitled to a supplier number effective April 6, 2005, the date of the site inspection of the third location. ALJ Decision at 1. She made one numbered finding of fact and conclusion of law:

Petitioner has corrected all outstanding deficiencies and is in compliance with all 21 Medicare supplier standards, and is entitled to a Medicare supplier enrollment number.

MediSource appealed the ALJ Decision. The Board determined that MediSource had not received a copy of the Hearing Officer record or additional submissions by NSC to the ALJ or the record of communications between the ALJ's staff and NSC. On December 9, 2005, the Board mailed MediSource a complete copy of the record before the ALJ and offered it an opportunity to "supplement its appeal record in light of the enclosed documents." Board letter dated December 9, 2005. On December 30, 2005, the owner of MediSource stated that MediSource would not supplement its appeal record.

MediSource asserts that its supplier number should be reinstated prior to April 6, 2005. Specifically, MediSource requests that it be reinstated as of the date of its revocation (October 27, 2004) ⁽⁷⁾, because it had moved to a compliant second location by that date; or reinstated as of February 4, 2005, because it had moved to its compliant third location by that date; or reinstated four months prior to April 6, 2005, because of unreasonable delays by NSC and in the appeals process. MediSource letter dated 8/15/2005.

[Page 7] Below we explain why we deny the relief requested by MediSource.

1. The allegation that MediSource cured its noncompliance within the 15 days between the notice of revocation and the effective date of the revocation by moving to a second location, even if it were true, would not entitle MediSource to reimbursement from the date of the revocation to April 6, 2005.

On October 12, 2004, NSC notified MediSource that its supplier number would be revoked 15 days after the postmark on the revocation notice. ⁽⁸⁾

On appeal, MediSource argues that, pursuant to this notice, it "had 15 days from the date of postmark . . . to satisfy the three listed Supplier Standards," that it acted within that time period to correct its noncompliance, and that it "should be allowed to bill from the date our Medicare number was revoked (October 26, 2004) since we did meet all the required Supplier Standards." MediSource Notice of Appeal dated 8/15/05.

We disagree. When the NSC determines that a supplier does not meet the supplier standards, it revokes the supplier's number and notifies the supplier of the revocation, which is effective 15 days after the NSC mails the notice. 42 C.F.R. ��405.874(b). MediSource identified no regulation or NSC policy or practice that suspends or reverses a revocation where a supplier comes into compliance within the 15-day period between the mailing of the revocation notice and the revocation's effective date. ⁽⁹⁾ [Page 8] Therefore, we conclude that, since MediSource's enrollment number was revoked effective October 27, 2004, MediSource was not eligible to receive reimbursement until it was reinstated, even if its second location complied with supplier standards as MediSource contends.

2. MediSource failed to prove that its second location complied with the requirements set forth at section�424.57(c)(7) (Standard 7).

Section 424.57(c)(7) of 42 C.F.R. requires that a supplier --

maintains a physical facility on an appropriate site. The physical facility must contain space for storing business records including the supplier's delivery, maintenance, and beneficiary communication records. For purposes of this standard, a post office box or commercial mailbox is not considered a physical facility. In the case of a multi-site supplier, records may be maintained at a centralized location.

The physical facility regulation implements section 1834(j)(1)(B)(ii)(II) of the Act, which provides, "A supplier may not obtain a supplier number unless . . . the supplier . . . maintain[s] a physical facility on [an] appropriate site." It is one of a number of requirements enacted by Congress in 1994 to curb supplier abuses and to protect beneficiaries. ⁽¹⁰⁾ In implementing the 1994 amendments, CMS wrote:

These legislative changes indicate that the Congress has serious concerns about the business practices employed by certain suppliers, and that beneficiaries require additional protection from these practices. We believe it is the Congress' intent to strengthen existing standards in order to protect the public interest. We also view this proposed rule as another tool to further our efforts to prevent fraud and abuse in the Medicare program.

63 Fed. Reg. 2,926, 2,927 (Jan. 20, 1998).

[Page 9] The physical facility required of suppliers is the place where patients can contact the supplier directly. See Section 4.A. of the CMS 866S. Staff must be available at the facility during posted hours of operation. ⁽¹¹⁾

Multiple facts in the record controvert MediSource's assertion that at its second location it was maintaining a physical facility on an appropriate site as required by section 424.57(c)(7). The Hearing Officer concentrated on the undisputed fact that there was a DME supplier, a pharmacy, at the same address. We agree that this fact raises questions as to whether MediSource was actually operating at the second location. This alone might not constitute substantial evidence since section 424.57(c)(7) says nothing about whether a supplier may share a physical facility with another supplier. However, other evidence in the record supports the ALJ's conclusion that MediSource failed to show that the second location was a physical facility maintained at an appropriate site.

• The site investigation report states that MediSource's business records were maintained at its prior physical facility, i.e., the owner's home. R. Ex. 1, Att. 6. Additionally, MediSource's October 855S states that patient records were stored at the owner's home. Id., Att. 9. This fact supports the inferences that MediSource was not actually operating from the second location, that the physical facility did not contain appropriate space for storing business records, and that, as a single site supplier, MediSource was not maintaining its business records at an appropriate site.

• The site visit inspector found that MediSource had only six or seven boxes of supplies in a drawer of a desk at the second location; he described the inventory as "minimal." Id., Att. 6. The photograph of the few boxes of supplies in a drawer of a desk at the second location contrast sharply with the photograph of MediSource's inventory at its first location during a July 2004 site visit. The July photograph shows a closet with shelves of inventory. Id., Att. 17. These facts support the inference that MediSource was not maintaining its inventory at or actually operating from the second location.
  

• [Page 10] The photographs from the site visit show three signs on the door of the room MediSource rented from the pharmacy. The top sign said "MEDISOURCE," the middle sign (which was the largest) said "Consultation Room," and the bottom sign said "MediSource Corp." and listed its hours of operation and phone number. R. Ex. 1, Att. 6. The presence of a "Consultation Room" sign suggests one of two possibilities: that MediSource occupied other rooms as well or that this room also served as the pharmacy's consultation room. However, MediSource asserted that it occupied this room as its entire business site. These facts support the inferences that MediSource did not have exclusive use of the consultation room and could not protect the confidentiality of records maintained there.
  

• The phone number on the photograph of MediSource's sign in the pharmacy front window is not the same as the phone numbers listed in the CMS 855S for the second location. Compare R. Ex. 1, Att. 6 with R. Ex. 1, Att 9. This fact supports the inference that MediSource did not completely disclose to NSC the nature of its operation at the second location.
  

• The record is silent as to whether MediSource personnel were actually available every day during its posted business hours at the second location. ⁽¹²⁾
  

• The record is also silent as to whether MediSource continued to maintain the second location between December 16, 2004, when NSC made the site visit to the second location, and MediSource's move to the third location in February 2005. Thus, even if the second location had been compliant and the basis for the issuance of a supplier number after the December 16 site visit, this would not support reinstatement if MediSource abandoned the site prior to moving to the third location.
  

Substantial evidence in the record, which MediSource did not rebut, supports a conclusion that MediSource failed to prove that [Page 11] its second location complied with the requirements set forth at section�424.57(c)(7) (Standard 7), and, therefore, supports the ALJ Decision.

3. MediSource failed to show that the ALJ erred by not reinstating MediSource's number on February 4, 2005, the date MediSource mailed the third CMS 866S notifying NSC of its move to the third location.

The ALJ reinstated MediSource's supplier number as of April 6, 2005, the date of the site visit pursuant to which NSC concluded that MediSource's third physical facility complied with supplier standards. The site visit is NSC's mechanism for determining compliance with physical facility requirements. NSC informs suppliers that it will conduct a site visit for all initial applications, reenrollments and reactivations. ⁽¹³⁾

MediSource argues that its supplier number should have been reinstated on February 4, 2005, the date by which it had moved to the third location and mailed its CMS 855S for that location. MediSource letter dated 8/15/2005.

MediSource cites no authority that would require an effective date earlier than April 6, 2005, and we find no such requirement in the statute or regulations. Rather, we conclude that the ALJ Decision is supported by the Act and regulations governing issuance of supplier numbers. Section 1834(j)(1)(A) of the Act provides:

Payment. - Except as provided in subparagraph (C), no payment may be made under this part after the date of the enactment of the Social Security Amendments of 1994 for items furnished by a supplier of medical equipment and supplies unless such supplier obtains . . . a supplier number.

Section 1834(j)(1)(B)(ii)(II) provides that, in order to obtain a number, the supplier must be in compliance with the standards prescribed by the Secretary, including the requirement that the supplier maintain a physical facility on an appropriate site. Additionally, 42 C.F.R. ��424.57(b) provides that, in order to be eligible for payment, (1) a supplier must submit a completed application, (2) the item must have been furnished "on or after [Page 12] the date CMS issued to the supplier a DMEPOS supplier number conveying billing privileges," and (3) the number must not have been revoked during the period the item was furnished.

These provisions presume that the issuance of a supplier number will be based on and occur after a determination by NSC that a supplier meets the supplier standards. They do not indicate that NSC, or in this case the ALJ, must or should authorize a supplier number with an effective date prior to the date on which NSC makes that determination. ⁽¹⁴⁾ Here NSC was not able to determine that MediSource was in compliance prior to the April 6 site visit, therefore, the ALJ did not err by not reinstating MediSource prior to April 6. Since NSC did not object to the ALJ's reinstating MediSource as of April 6, we do not reach the question of whether NSC made its compliance determination after April 6 and, if so, whether the ALJ could or should have reinstated MediSource as of that later date rather than on the date of the site visit on which NSC based that determination.

4. MediSource is not entitled to a supplier number four months prior to April 6, 2005 on the ground the NSC allegedly failed to act within a reasonable time frame.

MediSource argues that it should be given an effective date "at least four months prior to the decided 4/6/05 reinstatement date." MediSource letter of 8/15/05, at 2. MediSource's ground for this assertion is that it "reached every deadline imposed on us by CMS, but there was no reasonable time frame that was adhered to by CMS." Id. MediSource also points out that it was subject to a new appeal procedure before the ALJ and that this also delayed the resolution of its case. MediSource relies on the portion of section 405.874 which provides that the NSC "must [Page 13] act promptly to determine if any entity submitting a request for a billing number . . . meets the standard set forth in part 424." MediSource letter dated 10/21/2005.

We reject these arguments. The regulation relied upon by MediSource does not provide a specific time frame. But even if it did, MediSource identifies no authority for the proposition that NSC's failure to meet such a time frame entitles a supplier to an earlier reinstatement date.

We also find that NSC did adhere to reasonable time frames in reviewing MediSource's two CMS 855S forms. On its website, NSC informs suppliers that the approximateprocessing time for a change of information is 45 days and the time for processing an initial enrollment, an enrollment of a new location for a currently enrolled supplier, or a reactivation of an inactivated supplier number is 60 days. ⁽¹⁵⁾ Seehttp://www.palmettogba.com (emphasis added.) ⁽¹⁶⁾ NSC's actions here are more analogous to processing an initial enrollment, reactivation or new location since MediSource's change of information involved a reinstatement and the relocation of its physical facility. NSC also informs suppliers that it will conduct a site visit for all initial applications, reenrollments and reactivations. (See note 13.) Here, NSC reasonably required a site visit for a supplier whose number had been revoked for violating the physical facility requirement. NSC conducted a site visit of each new location within 60 days of MediSource's filing the related 855S. For the second location, a determination was made within 60 days that the location did not comply with standard 7. For the third location, MediSource was given an reinstatement date that was within 60 days of NSC's receipt on February 7, 2005 of MediSource's CMS 855S for that location.

MediSource argues that the ALJ Decision was delayed because its case was the first appeal to the Civil Remedies Division under section 1866(j)(2) of the Act. However, any delay before the ALJ [Page 14] did not adversely impact the ultimate result in the case. The ALJ issued a favorable decision on June 13, 2005 on the basis of the site visit of April 6, 2005 for the third location. Had she issued a decision before April 6, presumably she would have denied reinstatement because there had been no site visit to the third location, and she concluded that the Hearing Officer's decision as to the second location was correct.

Finally, most of the time lapse between the revocation and the effective date of reinstatement is attributable to MediSource itself since MediSource occupied a noncompliant location for three of those five and a half months.

Conclusion

Based on the analysis explained above, we affirm the ALJ Decision.

Judith A. Ballard

Sheila Ann Hegy

Donald F. Garrett
Presiding Board Member

1. NSC is the entity authorized by the Centers for Medicare & Medicaid Services (CMS) to issue, revoke, and reinstate DMEPOS supplier numbers. 42 C.F.R. �� 405.874(a),�421.210(e)(3); see 57 Fed. Reg. 27,290 (June 18, 1992); 58 Fed. Reg 60,789 (Nov. 18, 1993).

2. Section 1866(j)(2) was enacted as part of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L. No. 108-173. Previously, supplier appeals were governed by 42 C.F.R. 405.874, which provided for review by a fair hearing officer and then a CMS official, designated by the Administrator of CMS. CMS did not challenge use of the Part 498 procedures for this appeal.

3. The record before the ALJ consisted of Medisource's February 4, 2005 letter of appeal to which it had attached the Hearing Officer's decision, a Certificate of Liability Insurance, and a CMS 855S form (which the ALJ designated Petitioner Exhibit 1); NSC's February 17, 2005 letter concurring with the Hearing Officer decision; an OIG Advisory (which NSC designated Attachment 1); a CMS decision letter (which NSC designated Attachment 2); a CMS list of supplier requirements (which NSC designated Attachment 3); the Hearing Officer's Administrative Record (which the ALJ designated Respondent Exhibit 1); and records of communication between the Civil Remedies Division (CRD) staff attorney and NSC. Because Respondent Exhibit 1 was over 100 pages and contained multiple documents, the Board provided the parties with a List of Materials identifying those documents by attachment numbers. In this decision, we refer to those attachment numbers.

4. The CMS 855S is used for multiple purposes. On the first page, the supplier chooses whether the form is being submitted as "Initial Enrollment," "Re-enrollment," "Reactivation," "Enrollment for a New Location for a Currently Enrolled DMEPOS Supplier," "Change of Information," or "Voluntary Termination of Billing Number." MediSource checked "Change of Information."

5. MediSource also asserted that it complied with standards 1 and 10. Those standards are not at issue in this case because the Hearing Officer ruled for MediSource as to those standards.

6. NSC did not appeal the ALJ's decision to reverse the Hearing Officer notwithstanding the ALJ's conclusion that the Hearing Officer's decision was proper when issued. Accordingly, that issue is not before the Board.

7. MediSource says the revocation's effective date was October 26, 2004. MediSource letter dated 8/15/2005, at 2. However, by law a revocation takes effect 15 days from the date the NSC mails notice of the revocation. Here there is no dispute that NSC mailed the notice on October 12, 2004; therefore, the revocation actually took effect October 27, 2004.

8. In the revocation letter, NSC informed MediSource that it could request a hearing to contest the revocation or seek reinstatement by completing a Corrective Action Plan. R. Ex. 1, Att. 10. (Section 405.874(f) provides that a supplier may be reinstated after "complet[ing] a corrective action plan, to which CMS has agreed.") MediSource does not allege, and there is nothing in the record that indicates, that MediSource sought or obtained an approved corrective action plan. Nor did MediSource ever allege that NSC erred in revoking its supplier number because MediSource failed to meet standards at its first site.

9. Current regulations also do not stay a revocation because of a pending appeal. In proposed regulations, CMS would allow suppliers "an opportunity to correct the deficient compliance requirement prior to a final determination to revoke billing privileges." See proposed 42 C.F.R. ��424.535(a)(1) at 68 Fed. Reg. 22,064, 22,081 (April 5, 2003). This provision is not applicable to this case because it has not been finally adopted by the Secretary.

10. Public Law No. 103-432.

11. http://www.palmettogba.com/palmetto/
Other.nsf/f45451e08e6ffeda852569ee00005c6d/
85256d430058d01d85256fe20049923e?OpenDocument.

12. The clear purpose of the posting requirement is to inform the public of the actual hours of operation, and the supplier cannot operate during those hours if no staff is available. We note that the NSC website informs suppliers that staff must be available at the facility during posted business hours. http://www.palmettogba.com/palmetto/Other.nsf/
f45451e08e6ffeda852569ee00005c6d/
85256d430058d01d85256fe20049923e?OpenDocument.

13. http://www.palmettogba.com/palmetto/
Other.nsf/f45451e08e6ffeda852569ee00005c6d/
85256d430058d01d85256fe20049923e?OpenDocument.

14. Concluding that these authorities do not require reinstatement prior to the site visit is also consistent with CMS's proposed regulations that "supplement, but do not replace or nullify, existing regulations concerning the . . . issuance .�. . of supplier billing numbers . . ." 68 Fed. Reg. 22,064, at 22,066 (April 25, 2003). The proposed regulations recognize the effectiveness of site visits as a means of verifying compliance. Id. at 22,068. Additionally, they provide that CMS will not issue Medicare billing numbers or grant Medicare billing privileges prior to the date that the supplier receives final approval of an enrollment application. They define "approval" as when "the . . . supplier has been determined to be eligible under Medicare rules and regulations to receive a Medicare billing number and Medicare billing privileges." Id. at 22,078.

15. We note that 60 days is consistent with the CMS guidelines for supplier application processing. Those guidelines provide that 90 percent of applications should be processed within 60 days, and 99 percent within 120 days. Medicare Program Integrity Manual, Ch.�10, � 15 at http://www.cms.hhs.gov/manuals/downloads/pim83c10.pdf.

16. The full website citation is http://www.palmettogba.com/palmetto/
Other.nsf/f45451e08e6ffeda852569ee00005c6d/
85256d430058d01d85256c4400647fcd?OpenDocument.