Screening Categories
Background
Consistent with 42 CFR § 424.518, newly-enrolling and existing providers and suppliers will, beginning on March 25, 2011, be placed into one of three levels of categorical screening: limited, moderate, or high. The risk levels denote the level of the contractor’s screening of the provider when it initially enrolls in Medicare, adds a new practice location, or revalidates its enrollment information.
A. Limited
The “limited” level of categorical screening consists of the following provider and supplier types:
• Physicians
• Non-physician practitioners other than physical therapists
• Physician group practices
• Non-physician group practices other than physical therapist group practices
• Ambulatory surgical centers
• Competitive Acquisition Program/Part B Vendors
• End-stage renal disease facilities
• Federally qualified health centers
• Histocompatibility laboratories
• Hospitals (including critical access hospitals, Department of Veterans Affairs hospitals, and other federally-owned hospital facilities.
• Health programs operated by an Indian Health Program (as defined in section 4(12) of the Indian Health Care Improvement Act) or an urban Indian organization (as defined in section 4(29) of the Indian Health Care Improvement Act) that receives funding from the Indian Health Service pursuant to Title V of the Indian Health Care Improvement Act
• Mammography screening centers
• Mass immunization roster billers
• Organ procurement organizations
• Outpatient physical therapy/outpatient speech pathology providers enrolling via the Form CMS-855A
• Pharmacies that are newly enrolling or revalidating via the Form CMS-855B application
• Radiation therapy centers
• Religious non-medical health care institutions
• Rural health clinics
• Skilled nursing facilities For providers and suppliers in the “limited” category, the contractor shall (unless section 15.19.2.5 of this chapter applies) process initial, revalidation, and new location applications in accordance with existing instructions.
B. Moderate
The “moderate” level of categorical screening consists of the following provider and supplier types:
• Ambulance service suppliers
• Community mental health centers (CMHCs)
• Comprehensive outpatient rehabilitation facilities (CORFs)
• Hospice organizations
• Independent clinical laboratories
• Independent diagnostic testing facilities
• Physical therapists enrolling as individuals or as group practices
• Portable x-ray suppliers (PXRSs)
• Revalidating home health agencies (HHAs)
• Revalidating DMEPOS suppliers
For providers and suppliers in the “moderate” level of categorical screening, the contractor shall (unless section 15.19.2.2 of this chapter or another CMS directive applies):
1. Process initial, revalidation, and new location applications in accordance with existing instructions; and
2. Except for revalidating DMEPOS suppliers, order a site visit through the Provider Enrollment, Chain and Ownership System (PECOS) in accordance with sections 2(a) through (e) below. The site visit, which the National Site Visit Contractor (NVSC) will perform, is to ensure that the supplier is in compliance with CMS’s enrollment requirements.
Unless stated otherwise in this chapter, the scope of the site visit will be consistent with section 15.19.2.2.
a. Ambulance suppliers, independent clinical laboratories, physical therapists, and physical therapist groups
• Initial application – If the supplier submits an initial application, the contractor shall order a site visit. The contractor shall not convey Medicare billing privileges to the supplier prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
• Revalidation – If the supplier submits a revalidation application, the contractor shall order a site visit. The contractor shall not make a final decision regarding the application prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
• New location - The contractor shall order a site visit of the location. The contractor shall not make a final decision regarding the application prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
b. CMHCs
• Initial application - In addition to the site visit discussed in section 15.4.1.1(B)(1) of this chapter, the contractor shall order a site visit after the contractor receives the tie-in notice (or approval letter) from the RO but before the contractor conveys Medicare billing privileges to the CMHC.
The contractor shall not convey Medicare billing privileges to the provider prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
• Revalidation - If the CMHC submits a revalidation application, the contractor shall order a site visit. The contractor shall not make a final decision regarding the application prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
• New location - The contractor shall order a site visit of the location after the contractor receives notice of approval from the RO but before the contractor switches the provider’s enrollment record to “Approved.” The contractor shall not switch the provider’s enrollment record to “Approved” prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
c. CORFs, hospices and PXRSs
• Initial application – If the provider/supplier submits an initial application, the contractor shall order a site visit after the contractor receives the tie-in notice (or approval letter) from the RO but before the contractor conveys Medicare billing privileges to the provider/supplier. The contractor shall not convey Medicare billing privileges to the provider/supplier prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
• Revalidation – If the provider/supplier submits a revalidation application, the contractor shall order a site visit. The contractor shall not make a final decision regarding the application prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
• New location - The contractor shall order a site visit of the location after the contractor receives notice of approval from the RO but before the contractor switches the provider/supplier’s enrollment record to “Approved.” The contractor shall not switch the provider/supplier’s enrollment record to “Approved” prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
d. IDTFs
• Initial applications – The NSVC will conduct site visits of initially enrolling IDTFs consistent with section 15.4.19.6 of this chapter.
• Revalidations - The NVSC will conduct site visits of revalidating IDTFs (prior to the contractor’s final decision regarding the revalidation application) consistent with section 15.4.19.6 of this chapter.
• Code Changes – The NSVC will conduct site visits for IDTF code changes as specified in section 15.4.19.6(B) of this chapter.
e. Revalidating HHAs –
If an HHA submits a revalidation application, the contractor shall order a site visit. The contractor shall not make a final decision regarding the revalidation application prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
f. Revalidating DMEPOS suppliers –
The National Supplier Clearinghouse (NSC) shall conduct a site visit of the DMEPOS supplier prior to making a final decision regarding the revalidation application.
C. High
The “high” level of categorical screening consists of the following provider and supplier types:
• Newly enrolling DMEPOS suppliers
• Newly enrolling HHAs (including HHAs that must submit an initial enrollment application pursuant to § 424.550(b)(1)) For providers and suppliers in the “high” level of categorical screening:
1. The contractor shall process the application in accordance with existing instructions; and
2. The NSVC will perform a site visit for newly enrolling HHAs. (The NSC will perform a site visit for newly enrolling DMEPOS suppliers.)
For initially enrolling HHAs, the contractor shall order a site visit via PECOS after the contractor receives the tie-in notice or approval letter from the RO but before the contractor switches the provider’s enrollment record to “Approved.” The contractor shall not switch the provider’s enrollment record to “Approved” prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
NOTE:
• Enrolled DMEPOS suppliers that are adding another location will be classified as “high” for screening purposes. (See section 15.19.2.3 below for information regarding DMEPOS changes of ownership and tax identification number (TIN) changes.)
• Newly-enrolling HHA sub-units fall within the “high” level of categorical screening.
• The addition of a new HHA branch falls within the “moderate” level of categorical screening. The contractor shall order a site visit of the location through PECOS after the contractor receives notice of approval from the RO but before the contractor switches the provider’s enrollment record to “Approved.” This is to ensure that the provider is in compliance with CMS’s enrollment requirements.
The scope of the site visit will be consistent with section 15.19.2.2(B) of this chapter. The National Site Visit Contractor (NSVC) will perform the site visit. The contractor shall not switch the provider’s enrollment record to “Approved” prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
This is the only site visit of the new HHA branch that must be performed prior to the record being switched to “Approved.”
Scope of Site Visit
A. DMEPOS Suppliers and IDTFs
The scope of site visits of DMEPOS suppliers and IDTFs shall continue to be conducted in accordance with existing CMS instructions and guidance.
B. Other Provider and Supplier Types
For all provider and supplier types – other than DMEPOS suppliers and IDTFs – that are subject to a site visit in accordance with this section, the SVC will perform such visits consistent with the procedures outlined in sections 20 and 20.1 of this chapter. This includes the following:
• Documenting the date and time of the visit, and including the name of the individual attempting the visit;
• Photographing the provider or supplier’s business for inclusion in the provider/supplier’s file. All photographs will be date/time stamped;
• Fully documenting observations made at the facility, which could include facts such as: (a) the facility was vacant and free of all furniture; (b) a notice of eviction or similar documentation is posted at the facility, and (c) the space is now occupied by another company;
• Writing a report of the findings regarding each site verification; and
• Including a signed declaration stating the facts and verifying the completion of the site verification. (The sample declaration identified in section 20.1 of this chapter is recommended.)
In terms of the extent of the visit, the SVC will determine whether the following criteria are met:
• The facility is open
• Personnel are at the facility
• Customers are at the facility (if applicable to that provider or supplier type)
• The facility appears to be operational This will require the site visitor(s) to enter the provider or supplier’s practice location/site, rather than simply conducting an external review.
If any of the 4 elements listed above are not met, the enrollment contractor will, as applicable - and using the procedures outlined in this chapter and in existing CMS instructions - deny the provider’s enrollment application pursuant to §424.530(a)(5)(i) or (ii), or revoke the provider’s Medicare billing privileges under§424.535(a)(5)(i) or (ii).
Changes of Information and Ownership
A. Limited
Changes of information (including additions of practice locations) submitted by providers and suppliers in the “limited” level of categorical screening shall be processed in accordance with existing instructions.
B. Moderate and High
Unless otherwise specified in this chapter or in another CMS directive, this section 15.19.2.3(B) applies to providers and suppliers in the “moderate” or “high” level of categorical screening.
1. Addition of Practice Location
With the exception of suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS), if a provider or supplier submits a Form CMS-855 request to add a practice location (including a home health agency (HHA) branch):
• The contractor shall process the application in accordance with existing instructions, and
• A site visit shall be performed consistent with section 15.19.2.1 above. (As explained earlier, a DMEPOS supplier that is adding a new practice location falls within the “high” screening category.)
2. Change of Location
a. DMEPOS Suppliers
If a DMEPOS supplier reports a change in the physical location of an existing practice location, the National Supplier Clearinghouse shall perform a site visit in accordance with existing instructions.
b. Non-DMEPOS Suppliers
If a provider or non-DMEPOS supplier reports a change in the physical location of an existing practice location, the contractor shall order a site visit through the Provider Enrollment, Chain and Ownership System (PECOS) in accordance with the following:
i. Ambulance service suppliers, independent clinical laboratories, independent diagnostic testing facilities, physical therapists enrolling as individuals or group practices – The contractor shall order a site visit of the changed location prior to the contractor’s final decision regarding the application. This is to ensure that the location is in compliance with CMS’s enrollment requirements.
The scope of the site visit will be consistent with section 15.19.2.2 of this chapter. The National Site Visit Contractor (NSVC) will perform the site visit. The contractor shall not make its final decision regarding the application prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
ii. Community mental health centers, comprehensive outpatient rehabilitation facilities, hospices, portable x-ray suppliers, HHAs - The contractor shall order a site visit of the changed location after the contractor receives notice of approval from the RO but before the contractor switches the provider/supplier’s enrollment record to “Approved.”
This is to ensure that the location is in compliance with CMS’s enrollment requirements. The scope of the site visit will be consistent with section 15.19.2.2 of this chapter. The NSVC will perform the site visit. The contractor shall not switch the provider’s enrollment record to “Approved” prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
For purposes of this requirement:
• A change of location includes situations in which the provider/supplier is switching suite numbers or floors within a building. A site visit is required.
• If the provider/supplier’s physical location is not changing (e.g., the provider’s street name is changing but its actual office space is not), no site visit is required.
3. Change of Ownership
With the exception of DMEPOS suppliers and HHAs, if a provider or supplier undergoes a change of ownership resulting in a new tax identification number (TIN), the contractor shall:
(1) Process the application in accordance with existing instructions, and
(2) Order a site visit through PECOS in accordance with the following:
• For ownership changes that must be approved by the RO under current CMS instructions, the site visit shall be ordered and performed after the contractor receives notice of approval from the RO but before the contractor switches the provider/supplier’s enrollment record to an “Approved” status.
The contractor shall not switch the provider/supplier’s enrollment record to “Approved” prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
• For ownership changes that do not require RO approval under current CMS instructions, the site visit shall be ordered and performed prior to the contractor’s final decision regarding the application.
A DMEPOS supplier that is:
• Undergoing a change of ownership with a change in TIN falls within the “high” screening category.
• Undergoing a change of ownership with no change in TIN falls within the “moderate” screening category.
• Undergoing a change in TIN with no change in ownership falls within the “moderate screening category. With respect to HHAs: • For HHAs undergoing a change in majority ownership, the contractor shall – consistent with section 15.26.1 of this chapter – determine whether the provisions of 42 CFR §424.550(b)(1) and (2) apply.
If the contractor determines that a change in majority ownership has occurred and that none of the exceptions in §424.550(b)(2) apply, the HHA must enroll as a new entity, in which case the newly-enrolling HHA will be placed into the “high” level of categorical screening.
If the contractor determines that an exception does apply, the transaction will be subject to the “moderate” level of categorical screening; a site visit will be necessary. In addition, if: (1) the contractor determines that one of the exceptions to the 36month rule applies, and (2) the ownership change is one that requires a recommendation for approval to the RO, the contractor shall ensure that its recommendation letter specifies:
• That the transaction qualifies as a change in majority ownership
• The particular exception that applies.
• For HHAs reporting an ownership change that is not a change in
majority ownership as that term is defined in §424.502, the contractor shall process the change in accordance with existing instructions. A site visit is not necessary.
• For HHAs seeking to reactivate their Medicare billing privileges, the transaction shall be processed under the “moderate” level of categorical screening. A site visit will be necessary prior to the reactivation of the provider’s billing privileges.
4. All Other Changes of Information
All other changes of information for providers and suppliers in the moderate or high level of categorical screening shall be processed in accordance with existing instructions.
Background
Consistent with 42 CFR § 424.518, newly-enrolling and existing providers and suppliers will, beginning on March 25, 2011, be placed into one of three levels of categorical screening: limited, moderate, or high. The risk levels denote the level of the contractor’s screening of the provider when it initially enrolls in Medicare, adds a new practice location, or revalidates its enrollment information.
A. Limited
The “limited” level of categorical screening consists of the following provider and supplier types:
• Physicians
• Non-physician practitioners other than physical therapists
• Physician group practices
• Non-physician group practices other than physical therapist group practices
• Ambulatory surgical centers
• Competitive Acquisition Program/Part B Vendors
• End-stage renal disease facilities
• Federally qualified health centers
• Histocompatibility laboratories
• Hospitals (including critical access hospitals, Department of Veterans Affairs hospitals, and other federally-owned hospital facilities.
• Health programs operated by an Indian Health Program (as defined in section 4(12) of the Indian Health Care Improvement Act) or an urban Indian organization (as defined in section 4(29) of the Indian Health Care Improvement Act) that receives funding from the Indian Health Service pursuant to Title V of the Indian Health Care Improvement Act
• Mammography screening centers
• Mass immunization roster billers
• Organ procurement organizations
• Outpatient physical therapy/outpatient speech pathology providers enrolling via the Form CMS-855A
• Pharmacies that are newly enrolling or revalidating via the Form CMS-855B application
• Radiation therapy centers
• Religious non-medical health care institutions
• Rural health clinics
• Skilled nursing facilities For providers and suppliers in the “limited” category, the contractor shall (unless section 15.19.2.5 of this chapter applies) process initial, revalidation, and new location applications in accordance with existing instructions.
B. Moderate
The “moderate” level of categorical screening consists of the following provider and supplier types:
• Ambulance service suppliers
• Community mental health centers (CMHCs)
• Comprehensive outpatient rehabilitation facilities (CORFs)
• Hospice organizations
• Independent clinical laboratories
• Independent diagnostic testing facilities
• Physical therapists enrolling as individuals or as group practices
• Portable x-ray suppliers (PXRSs)
• Revalidating home health agencies (HHAs)
• Revalidating DMEPOS suppliers
For providers and suppliers in the “moderate” level of categorical screening, the contractor shall (unless section 15.19.2.2 of this chapter or another CMS directive applies):
1. Process initial, revalidation, and new location applications in accordance with existing instructions; and
2. Except for revalidating DMEPOS suppliers, order a site visit through the Provider Enrollment, Chain and Ownership System (PECOS) in accordance with sections 2(a) through (e) below. The site visit, which the National Site Visit Contractor (NVSC) will perform, is to ensure that the supplier is in compliance with CMS’s enrollment requirements.
Unless stated otherwise in this chapter, the scope of the site visit will be consistent with section 15.19.2.2.
a. Ambulance suppliers, independent clinical laboratories, physical therapists, and physical therapist groups
• Initial application – If the supplier submits an initial application, the contractor shall order a site visit. The contractor shall not convey Medicare billing privileges to the supplier prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
• Revalidation – If the supplier submits a revalidation application, the contractor shall order a site visit. The contractor shall not make a final decision regarding the application prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
• New location - The contractor shall order a site visit of the location. The contractor shall not make a final decision regarding the application prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
b. CMHCs
• Initial application - In addition to the site visit discussed in section 15.4.1.1(B)(1) of this chapter, the contractor shall order a site visit after the contractor receives the tie-in notice (or approval letter) from the RO but before the contractor conveys Medicare billing privileges to the CMHC.
The contractor shall not convey Medicare billing privileges to the provider prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
• Revalidation - If the CMHC submits a revalidation application, the contractor shall order a site visit. The contractor shall not make a final decision regarding the application prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
• New location - The contractor shall order a site visit of the location after the contractor receives notice of approval from the RO but before the contractor switches the provider’s enrollment record to “Approved.” The contractor shall not switch the provider’s enrollment record to “Approved” prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
c. CORFs, hospices and PXRSs
• Initial application – If the provider/supplier submits an initial application, the contractor shall order a site visit after the contractor receives the tie-in notice (or approval letter) from the RO but before the contractor conveys Medicare billing privileges to the provider/supplier. The contractor shall not convey Medicare billing privileges to the provider/supplier prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
• Revalidation – If the provider/supplier submits a revalidation application, the contractor shall order a site visit. The contractor shall not make a final decision regarding the application prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
• New location - The contractor shall order a site visit of the location after the contractor receives notice of approval from the RO but before the contractor switches the provider/supplier’s enrollment record to “Approved.” The contractor shall not switch the provider/supplier’s enrollment record to “Approved” prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
d. IDTFs
• Initial applications – The NSVC will conduct site visits of initially enrolling IDTFs consistent with section 15.4.19.6 of this chapter.
• Revalidations - The NVSC will conduct site visits of revalidating IDTFs (prior to the contractor’s final decision regarding the revalidation application) consistent with section 15.4.19.6 of this chapter.
• Code Changes – The NSVC will conduct site visits for IDTF code changes as specified in section 15.4.19.6(B) of this chapter.
e. Revalidating HHAs –
If an HHA submits a revalidation application, the contractor shall order a site visit. The contractor shall not make a final decision regarding the revalidation application prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
f. Revalidating DMEPOS suppliers –
The National Supplier Clearinghouse (NSC) shall conduct a site visit of the DMEPOS supplier prior to making a final decision regarding the revalidation application.
C. High
The “high” level of categorical screening consists of the following provider and supplier types:
• Newly enrolling DMEPOS suppliers
• Newly enrolling HHAs (including HHAs that must submit an initial enrollment application pursuant to § 424.550(b)(1)) For providers and suppliers in the “high” level of categorical screening:
1. The contractor shall process the application in accordance with existing instructions; and
2. The NSVC will perform a site visit for newly enrolling HHAs. (The NSC will perform a site visit for newly enrolling DMEPOS suppliers.)
For initially enrolling HHAs, the contractor shall order a site visit via PECOS after the contractor receives the tie-in notice or approval letter from the RO but before the contractor switches the provider’s enrollment record to “Approved.” The contractor shall not switch the provider’s enrollment record to “Approved” prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
NOTE:
• Enrolled DMEPOS suppliers that are adding another location will be classified as “high” for screening purposes. (See section 15.19.2.3 below for information regarding DMEPOS changes of ownership and tax identification number (TIN) changes.)
• Newly-enrolling HHA sub-units fall within the “high” level of categorical screening.
• The addition of a new HHA branch falls within the “moderate” level of categorical screening. The contractor shall order a site visit of the location through PECOS after the contractor receives notice of approval from the RO but before the contractor switches the provider’s enrollment record to “Approved.” This is to ensure that the provider is in compliance with CMS’s enrollment requirements.
The scope of the site visit will be consistent with section 15.19.2.2(B) of this chapter. The National Site Visit Contractor (NSVC) will perform the site visit. The contractor shall not switch the provider’s enrollment record to “Approved” prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
This is the only site visit of the new HHA branch that must be performed prior to the record being switched to “Approved.”
Scope of Site Visit
A. DMEPOS Suppliers and IDTFs
The scope of site visits of DMEPOS suppliers and IDTFs shall continue to be conducted in accordance with existing CMS instructions and guidance.
B. Other Provider and Supplier Types
For all provider and supplier types – other than DMEPOS suppliers and IDTFs – that are subject to a site visit in accordance with this section, the SVC will perform such visits consistent with the procedures outlined in sections 20 and 20.1 of this chapter. This includes the following:
• Documenting the date and time of the visit, and including the name of the individual attempting the visit;
• Photographing the provider or supplier’s business for inclusion in the provider/supplier’s file. All photographs will be date/time stamped;
• Fully documenting observations made at the facility, which could include facts such as: (a) the facility was vacant and free of all furniture; (b) a notice of eviction or similar documentation is posted at the facility, and (c) the space is now occupied by another company;
• Writing a report of the findings regarding each site verification; and
• Including a signed declaration stating the facts and verifying the completion of the site verification. (The sample declaration identified in section 20.1 of this chapter is recommended.)
In terms of the extent of the visit, the SVC will determine whether the following criteria are met:
• The facility is open
• Personnel are at the facility
• Customers are at the facility (if applicable to that provider or supplier type)
• The facility appears to be operational This will require the site visitor(s) to enter the provider or supplier’s practice location/site, rather than simply conducting an external review.
If any of the 4 elements listed above are not met, the enrollment contractor will, as applicable - and using the procedures outlined in this chapter and in existing CMS instructions - deny the provider’s enrollment application pursuant to §424.530(a)(5)(i) or (ii), or revoke the provider’s Medicare billing privileges under§424.535(a)(5)(i) or (ii).
Changes of Information and Ownership
A. Limited
Changes of information (including additions of practice locations) submitted by providers and suppliers in the “limited” level of categorical screening shall be processed in accordance with existing instructions.
B. Moderate and High
Unless otherwise specified in this chapter or in another CMS directive, this section 15.19.2.3(B) applies to providers and suppliers in the “moderate” or “high” level of categorical screening.
1. Addition of Practice Location
With the exception of suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS), if a provider or supplier submits a Form CMS-855 request to add a practice location (including a home health agency (HHA) branch):
• The contractor shall process the application in accordance with existing instructions, and
• A site visit shall be performed consistent with section 15.19.2.1 above. (As explained earlier, a DMEPOS supplier that is adding a new practice location falls within the “high” screening category.)
2. Change of Location
a. DMEPOS Suppliers
If a DMEPOS supplier reports a change in the physical location of an existing practice location, the National Supplier Clearinghouse shall perform a site visit in accordance with existing instructions.
b. Non-DMEPOS Suppliers
If a provider or non-DMEPOS supplier reports a change in the physical location of an existing practice location, the contractor shall order a site visit through the Provider Enrollment, Chain and Ownership System (PECOS) in accordance with the following:
i. Ambulance service suppliers, independent clinical laboratories, independent diagnostic testing facilities, physical therapists enrolling as individuals or group practices – The contractor shall order a site visit of the changed location prior to the contractor’s final decision regarding the application. This is to ensure that the location is in compliance with CMS’s enrollment requirements.
The scope of the site visit will be consistent with section 15.19.2.2 of this chapter. The National Site Visit Contractor (NSVC) will perform the site visit. The contractor shall not make its final decision regarding the application prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
ii. Community mental health centers, comprehensive outpatient rehabilitation facilities, hospices, portable x-ray suppliers, HHAs - The contractor shall order a site visit of the changed location after the contractor receives notice of approval from the RO but before the contractor switches the provider/supplier’s enrollment record to “Approved.”
This is to ensure that the location is in compliance with CMS’s enrollment requirements. The scope of the site visit will be consistent with section 15.19.2.2 of this chapter. The NSVC will perform the site visit. The contractor shall not switch the provider’s enrollment record to “Approved” prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
For purposes of this requirement:
• A change of location includes situations in which the provider/supplier is switching suite numbers or floors within a building. A site visit is required.
• If the provider/supplier’s physical location is not changing (e.g., the provider’s street name is changing but its actual office space is not), no site visit is required.
3. Change of Ownership
With the exception of DMEPOS suppliers and HHAs, if a provider or supplier undergoes a change of ownership resulting in a new tax identification number (TIN), the contractor shall:
(1) Process the application in accordance with existing instructions, and
(2) Order a site visit through PECOS in accordance with the following:
• For ownership changes that must be approved by the RO under current CMS instructions, the site visit shall be ordered and performed after the contractor receives notice of approval from the RO but before the contractor switches the provider/supplier’s enrollment record to an “Approved” status.
The contractor shall not switch the provider/supplier’s enrollment record to “Approved” prior to the completion of the NSVC’s site visit and the contractor’s review of the results.
• For ownership changes that do not require RO approval under current CMS instructions, the site visit shall be ordered and performed prior to the contractor’s final decision regarding the application.
A DMEPOS supplier that is:
• Undergoing a change of ownership with a change in TIN falls within the “high” screening category.
• Undergoing a change of ownership with no change in TIN falls within the “moderate” screening category.
• Undergoing a change in TIN with no change in ownership falls within the “moderate screening category. With respect to HHAs: • For HHAs undergoing a change in majority ownership, the contractor shall – consistent with section 15.26.1 of this chapter – determine whether the provisions of 42 CFR §424.550(b)(1) and (2) apply.
If the contractor determines that a change in majority ownership has occurred and that none of the exceptions in §424.550(b)(2) apply, the HHA must enroll as a new entity, in which case the newly-enrolling HHA will be placed into the “high” level of categorical screening.
If the contractor determines that an exception does apply, the transaction will be subject to the “moderate” level of categorical screening; a site visit will be necessary. In addition, if: (1) the contractor determines that one of the exceptions to the 36month rule applies, and (2) the ownership change is one that requires a recommendation for approval to the RO, the contractor shall ensure that its recommendation letter specifies:
• That the transaction qualifies as a change in majority ownership
• The particular exception that applies.
• For HHAs reporting an ownership change that is not a change in
majority ownership as that term is defined in §424.502, the contractor shall process the change in accordance with existing instructions. A site visit is not necessary.
• For HHAs seeking to reactivate their Medicare billing privileges, the transaction shall be processed under the “moderate” level of categorical screening. A site visit will be necessary prior to the reactivation of the provider’s billing privileges.
4. All Other Changes of Information
All other changes of information for providers and suppliers in the moderate or high level of categorical screening shall be processed in accordance with existing instructions.
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