Mammography Screening Centers
As defined in 42 CFR § 410.34(a)(2), a screening mammography is a radiologic procedure “furnished to a woman without signs or symptoms of breast disease, for the purpose of early detection of breast cancer, and includes a physician's interpretation of the results of the procedure.” Section 410.34(a)(4) defines a “supplier of screening mammography” as “ a facility that is certified and responsible for ensuring that all screening mammography services furnished to Medicare beneficiaries meet the conditions and limitations for coverage of screening mammography services as specified in (§ 410.34)(c) and (d).”
To enroll in Medicare, a mammography screening center must have a valid provisional certificate, or a valid certificate, that has been issued by the Food and Drug Administration (FDA) indicating that the supplier meets the certification requirements of section 354 of the PHSAct, as implemented by 21 CFR Part 900, subpart B. (The FDA is responsible for collecting certificate fees and surveying mammography facilities (screening and diagnostic).) Unless stated otherwise in this chapter or in another CMS directive, the supplier shall submit a copy of its FDA certificate with its application.
It is important that the contractor review and adhere to the following regulations and instructions regarding the required qualifications of mammography screening centers:
• 42 CFR § 410.34 (in full)
• Pub. 100-04, Claims Processing Manual, chapter 18, sections 20 through 20.1.2
• Pub. 100-02, Benefit Policy Manual, chapter 15, section 280.3
Application Review and Verification Activities
Unless stated otherwise in this chapter or in another CMS directive:
(A) The instructions in sections 15.7 through 15.7.1.6.2 apply to:
• The Form CMS-855A, Form CMS-855B, Form CMS-855I, Form CMS-855R, and Form CMS-855O.
• All Form CMS-855 transaction types identified in this chapter (e.g., changes of information, reassignments).
(B) Except for situations where a “processing alternative” applies (see sections 15.7.1.3.1 through 15.7.1.3.4 of this chapter), the contractor shall:
• Ensure that the provider has completed all required data elements on the Form CMS-855 (including all effective dates) and that all supporting documentation has been furnished. The contractor shall also ensure that the provider has completed the application in accordance with the instructions (1) in this chapter and in all other CMS directives and (2) on the Form CMS-855. (The instructions on the Form CMS-855 shall be read and applied in addition to, and not in lieu of, the instructions in this chapter and all other applicable CMS directives.)
• Verify and validate all information furnished by the provider on the Form CMS-855.
(C) The instructions in sections 15.7 through 15.7.1.6.2 are in addition to, and not in lieu of, all other instructions in this chapter.
In general, the application review and verification process is as follows:
1. Contractor receives application
2. Contractor reviews application and verifies data thereon
3. If (a) required data/documentation is missing, (b) data cannot be verified, and/or (3) there are data discrepancies, contractor requests missing/clarifying information from the provider.
4. If applicable, contractor (a) verifies any newly furnished data, or (2) seeks additional data/clarification from provider.
5. Final determination
Sections 15.7.1 through 15.7.1.6.2 are structured so as to generally follow Steps 2 through 5 above.
Receipt/Review of Paper Applications
A. Background
The contractor shall begin processing the application once the application fee has been paid (if applicable). This includes, but is not limited to (and subject to the processing alternatives in sections 15.7.1.3.1 through 15.7.1.3.4):
• Ensuring that all required data elements on the application have been completed and that all required supporting documentation has been submitted
• Submitted a valid and dated certification statement signed by an appropriate individual (e.g., the enrolling physician for Form CMS-855I applications)
• Validating all data on and submitted with the application
• Entering all information contained on the application into the Provider Enrollment, Chain and Ownership System (PECOS).
The contractor may begin the verification process at any time. Also, the contractor is not required to create a PECOS logging and tracking (L & T) record within a certain specified timeframe (e.g., within 20 days after receipt of the application).
B. Other Guidelines
1. Acknowledgment of Receipt of Application – The contractor may, but is not required to, send out acknowledgment letters or e-mails.
2. “Not Applicable” – Unless a “processing alternative” applies, the provider cannot write “N/A” in response to a question that requires a “yes” or “no” answer. This is considered an incomplete reply, thus warranting the issuance of a request for missing information.
3. Unsolicited Submission of Information - If the provider submits missing/clarifying data or documentation on its own volition (i.e., without being contacted by the contractor), the contractor shall include this additional data/documentation in its overall application review.
4. Reenrollment Bar – If the contractor suspects that a provider or supplier is attempting to circumvent an existing reenrollment bar by enrolling under a different business identity or as a different business type, the contractor shall contact CMS’ Provider Enrollment Business Function Lead (PEBFL) for guidance.
5. State and Country of Birth – The state of birth and country of birth are optional data elements on the Form CMS-855. As such, the contractor shall not develop for this information if it was not disclosed on the application and shall not request other contractors to update the PECOS Associate Control (PAC) ID to include this data.
6. Photocopying Pages - The contractor may accept photocopied pages in any Form CMS-855 it receives so long as the application contains an original signature. For example, suppose a corporation wants to enroll five medical clinics it owns. The section 5 data on the Form CMS-855B is exactly the same for all five clinics. The contractor may accept photocopied section 5 pages for these providers. However, original signatures must be furnished in section 15 of each application.
7. White-Out & Highlighting - The contractor shall not write on or highlight any part of the original Form CMS-855 application or any supplementary pages the applicant submits (e.g., copy of license). Provider usage of white-out is acceptable, although the contractor should contact the applicant to resolve any ambiguities. In addition, the contractor must determine whether the amount of white-out used on a particular application is within reason. For instance, if an entire application page is whited-out, the contractor should request that the page be resubmitted.
As defined in 42 CFR § 410.34(a)(2), a screening mammography is a radiologic procedure “furnished to a woman without signs or symptoms of breast disease, for the purpose of early detection of breast cancer, and includes a physician's interpretation of the results of the procedure.” Section 410.34(a)(4) defines a “supplier of screening mammography” as “ a facility that is certified and responsible for ensuring that all screening mammography services furnished to Medicare beneficiaries meet the conditions and limitations for coverage of screening mammography services as specified in (§ 410.34)(c) and (d).”
To enroll in Medicare, a mammography screening center must have a valid provisional certificate, or a valid certificate, that has been issued by the Food and Drug Administration (FDA) indicating that the supplier meets the certification requirements of section 354 of the PHSAct, as implemented by 21 CFR Part 900, subpart B. (The FDA is responsible for collecting certificate fees and surveying mammography facilities (screening and diagnostic).) Unless stated otherwise in this chapter or in another CMS directive, the supplier shall submit a copy of its FDA certificate with its application.
It is important that the contractor review and adhere to the following regulations and instructions regarding the required qualifications of mammography screening centers:
• 42 CFR § 410.34 (in full)
• Pub. 100-04, Claims Processing Manual, chapter 18, sections 20 through 20.1.2
• Pub. 100-02, Benefit Policy Manual, chapter 15, section 280.3
Application Review and Verification Activities
Unless stated otherwise in this chapter or in another CMS directive:
(A) The instructions in sections 15.7 through 15.7.1.6.2 apply to:
• The Form CMS-855A, Form CMS-855B, Form CMS-855I, Form CMS-855R, and Form CMS-855O.
• All Form CMS-855 transaction types identified in this chapter (e.g., changes of information, reassignments).
(B) Except for situations where a “processing alternative” applies (see sections 15.7.1.3.1 through 15.7.1.3.4 of this chapter), the contractor shall:
• Ensure that the provider has completed all required data elements on the Form CMS-855 (including all effective dates) and that all supporting documentation has been furnished. The contractor shall also ensure that the provider has completed the application in accordance with the instructions (1) in this chapter and in all other CMS directives and (2) on the Form CMS-855. (The instructions on the Form CMS-855 shall be read and applied in addition to, and not in lieu of, the instructions in this chapter and all other applicable CMS directives.)
• Verify and validate all information furnished by the provider on the Form CMS-855.
(C) The instructions in sections 15.7 through 15.7.1.6.2 are in addition to, and not in lieu of, all other instructions in this chapter.
In general, the application review and verification process is as follows:
1. Contractor receives application
2. Contractor reviews application and verifies data thereon
3. If (a) required data/documentation is missing, (b) data cannot be verified, and/or (3) there are data discrepancies, contractor requests missing/clarifying information from the provider.
4. If applicable, contractor (a) verifies any newly furnished data, or (2) seeks additional data/clarification from provider.
5. Final determination
Sections 15.7.1 through 15.7.1.6.2 are structured so as to generally follow Steps 2 through 5 above.
Receipt/Review of Paper Applications
A. Background
The contractor shall begin processing the application once the application fee has been paid (if applicable). This includes, but is not limited to (and subject to the processing alternatives in sections 15.7.1.3.1 through 15.7.1.3.4):
• Ensuring that all required data elements on the application have been completed and that all required supporting documentation has been submitted
• Submitted a valid and dated certification statement signed by an appropriate individual (e.g., the enrolling physician for Form CMS-855I applications)
• Validating all data on and submitted with the application
• Entering all information contained on the application into the Provider Enrollment, Chain and Ownership System (PECOS).
The contractor may begin the verification process at any time. Also, the contractor is not required to create a PECOS logging and tracking (L & T) record within a certain specified timeframe (e.g., within 20 days after receipt of the application).
B. Other Guidelines
1. Acknowledgment of Receipt of Application – The contractor may, but is not required to, send out acknowledgment letters or e-mails.
2. “Not Applicable” – Unless a “processing alternative” applies, the provider cannot write “N/A” in response to a question that requires a “yes” or “no” answer. This is considered an incomplete reply, thus warranting the issuance of a request for missing information.
3. Unsolicited Submission of Information - If the provider submits missing/clarifying data or documentation on its own volition (i.e., without being contacted by the contractor), the contractor shall include this additional data/documentation in its overall application review.
4. Reenrollment Bar – If the contractor suspects that a provider or supplier is attempting to circumvent an existing reenrollment bar by enrolling under a different business identity or as a different business type, the contractor shall contact CMS’ Provider Enrollment Business Function Lead (PEBFL) for guidance.
5. State and Country of Birth – The state of birth and country of birth are optional data elements on the Form CMS-855. As such, the contractor shall not develop for this information if it was not disclosed on the application and shall not request other contractors to update the PECOS Associate Control (PAC) ID to include this data.
6. Photocopying Pages - The contractor may accept photocopied pages in any Form CMS-855 it receives so long as the application contains an original signature. For example, suppose a corporation wants to enroll five medical clinics it owns. The section 5 data on the Form CMS-855B is exactly the same for all five clinics. The contractor may accept photocopied section 5 pages for these providers. However, original signatures must be furnished in section 15 of each application.
7. White-Out & Highlighting - The contractor shall not write on or highlight any part of the original Form CMS-855 application or any supplementary pages the applicant submits (e.g., copy of license). Provider usage of white-out is acceptable, although the contractor should contact the applicant to resolve any ambiguities. In addition, the contractor must determine whether the amount of white-out used on a particular application is within reason. For instance, if an entire application page is whited-out, the contractor should request that the page be resubmitted.
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