Histocompatibility Laboratories
A histocompatibility laboratory does “matching” tests in preparation for procedures such as kidney transplants, bone marrow transplants, and blood platelet transfusions. It is the only type of laboratory that must submit a Form CMS-855A application. Each histocompatibility lab must meet all applicable requirements in 42 CFR Part 493 (see 42 CFR §493.1278 in particular) and undergo a State survey.
For information on the appropriate contractor jurisdiction for incoming histocompatibility lab applications, see CMS Pub. 100-04, chapter 1, section 20.
Receipt/Review of Internet-Based PECOS Applications
A. Submission of Paper Certification Statement
1. Background and Timeframe
If the provider chooses to submit its certification statement via paper rather than through e-signature, it may do so by mail, fax, or scanned e-mail. Unless stated otherwise in this chapter or in another CMS directive:
• The provider must submit the certification statement within 45 calendar days of the date on which it submitted its Internet-based PECOS application. (This applies to all Form CMS-855 Internet-based PECOS submissions, regardless of the type of transaction involved.)
• If the contractor does not receive the certification statement in its mailroom (or via fax/email) within the 45-day period, the contractor may either return the application (unless another CMS directive states otherwise) or contact the provider via any means to request the certification statement. If the contractor chooses the latter option, it shall inform the provider (1) of the deadline by which the statement must be received and (2) that the provider may still sign the application via e-signature. (The specific deadline in (1) lies within the contractor’s discretion.)
• If the provider submits an invalid certification statement (e.g., undated; incorrect individual signed it; not all authorized officials signed it), the contractor shall treat this as missing information and shall develop for a correct certification statement using – unless another CMS directive states otherwise - the procedures outlined in this chapter.
• If the provider wishes to submit a paper CMS-855 certification statement (downloaded from www.cms.gov), it should write the tracking ID on the top of the certification statement.
2. Switch to “In Review” and Application Returns
After – and only after – the contractor receives the provider’s certification statement and application fee (if applicable), the contractor shall: (1) enter the date of signature in the “Certification Date” box in the logging & tracking (L & T) record, and (2) change the L & T status to “In Review.” The contractor shall not begin processing the application prior to its receipt of the certification statement and its completion of tasks (1) and (2) in the previous sentence.
If the provider submitted an invalid certification statement, the contractor shall still complete tasks (1) and (2) above. (If the certification statement was undated, the contractor shall use the date that the 45-day clock expired as the date of signature.) An appropriate certification statement can be solicited as part of the development process.
If the contractor can determine (without having yet begun processing the application) that an application can be returned under section 15.8.1 of this chapter (e.g., Form CMS-855I was submitted more than 60 days prior to the effective date), the contractor may return the application without waiting for the arrival of the certification statement.
B. Processing of Application
After tasks (1) and (2) above have been completed, the contractor shall begin processing the application. Subject to the processing alternatives in sections 15.7.1.3.1 through 15.7.1.3.4, processing includes (but is not limited to):
• Ensuring that all required data elements on the application have been completed and that all required supporting documentation has been submitted (either via paper or the Digital Data Repository (DDR))
• Validating all data on and submitted with the application
A histocompatibility laboratory does “matching” tests in preparation for procedures such as kidney transplants, bone marrow transplants, and blood platelet transfusions. It is the only type of laboratory that must submit a Form CMS-855A application. Each histocompatibility lab must meet all applicable requirements in 42 CFR Part 493 (see 42 CFR §493.1278 in particular) and undergo a State survey.
For information on the appropriate contractor jurisdiction for incoming histocompatibility lab applications, see CMS Pub. 100-04, chapter 1, section 20.
Receipt/Review of Internet-Based PECOS Applications
A. Submission of Paper Certification Statement
1. Background and Timeframe
If the provider chooses to submit its certification statement via paper rather than through e-signature, it may do so by mail, fax, or scanned e-mail. Unless stated otherwise in this chapter or in another CMS directive:
• The provider must submit the certification statement within 45 calendar days of the date on which it submitted its Internet-based PECOS application. (This applies to all Form CMS-855 Internet-based PECOS submissions, regardless of the type of transaction involved.)
• If the contractor does not receive the certification statement in its mailroom (or via fax/email) within the 45-day period, the contractor may either return the application (unless another CMS directive states otherwise) or contact the provider via any means to request the certification statement. If the contractor chooses the latter option, it shall inform the provider (1) of the deadline by which the statement must be received and (2) that the provider may still sign the application via e-signature. (The specific deadline in (1) lies within the contractor’s discretion.)
• If the provider submits an invalid certification statement (e.g., undated; incorrect individual signed it; not all authorized officials signed it), the contractor shall treat this as missing information and shall develop for a correct certification statement using – unless another CMS directive states otherwise - the procedures outlined in this chapter.
• If the provider wishes to submit a paper CMS-855 certification statement (downloaded from www.cms.gov), it should write the tracking ID on the top of the certification statement.
2. Switch to “In Review” and Application Returns
After – and only after – the contractor receives the provider’s certification statement and application fee (if applicable), the contractor shall: (1) enter the date of signature in the “Certification Date” box in the logging & tracking (L & T) record, and (2) change the L & T status to “In Review.” The contractor shall not begin processing the application prior to its receipt of the certification statement and its completion of tasks (1) and (2) in the previous sentence.
If the provider submitted an invalid certification statement, the contractor shall still complete tasks (1) and (2) above. (If the certification statement was undated, the contractor shall use the date that the 45-day clock expired as the date of signature.) An appropriate certification statement can be solicited as part of the development process.
If the contractor can determine (without having yet begun processing the application) that an application can be returned under section 15.8.1 of this chapter (e.g., Form CMS-855I was submitted more than 60 days prior to the effective date), the contractor may return the application without waiting for the arrival of the certification statement.
B. Processing of Application
After tasks (1) and (2) above have been completed, the contractor shall begin processing the application. Subject to the processing alternatives in sections 15.7.1.3.1 through 15.7.1.3.4, processing includes (but is not limited to):
• Ensuring that all required data elements on the application have been completed and that all required supporting documentation has been submitted (either via paper or the Digital Data Repository (DDR))
• Validating all data on and submitted with the application
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