Md. Code Regs. 10.25.05.06

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.25.05.06 - Requests for Data from Nongovernmental Entities

A. Submission of Applications.

(1) An applicant shall complete and submit a written application in the form and manner specified by the Commission.

(2) An applicant shall disclose on an application all potential or approved funding sources at the time of submission of an application.

(3) If applicable, an applicant shall disclose any data sharing or other requirements imposed by a funding source as a condition of receipt of funding.

(4) An applicant shall disclose on an application whether an applicant or any person or entity that is an officer, owner, operator, or part of management of an applicant's organization who will have access and use of the requested data is currently, or has been within 10 years prior to the date of the application, a subject of or a party to a state or federal regulatory agency action or civil or criminal action involving a data breach, HIPAA violation, or other matter involving unauthorized access, use, and disclosure of data regardless of whether there has been a finding or admission of guilt, including being:

(a) Convicted of a felony or pleading guilty, nolo contendere, entering a best interest plea of guilty, or receiving a diversionary disposition regarding a felony;

(b) A subject of an investigation conducted by, or a pending complaint, charge, or indictment issued by, a local, state, or federal governmental regulatory agency or other state or federal law enforcement agency; or

(c) A party to a final dispositive action in a state or federal governmental agency regulatory action or a civil action that resulted in entry into a settlement agreement, consent agreement, decree or order, corporate integrity agreement, corrective action agreement, or other similar agreement or other disposition in a civil action regardless of whether there has been an admission or finding of guilt or liability.

(5) A person who signs an application shall:

(a) Be an officer of an applicant's organization who has been given signatory authority to bind the organization, unless an applicant is not part of an organization and is requesting data in an applicant's individual capacity, in which case the applicant shall sign an application; and

(b) Sign the following affirmation statement: "I solemnly affirm under the penalties of perjury that the contents of the application and any supplementary information are true to the best of my knowledge, information, and belief."

(6) An applicant shall pay a nonrefundable application fee in the amount specified in the list of fees published on the Commission's website at the time of submission of an application.

B. Completeness Review.

(1) An application is not complete until an applicant has submitted a completed application, as determined by Commission staff, and provided any additional information, documentation, answers to questions, and clarifications requested by Commission staff within the time limit specified by Commission staff.

(2) After Commission staff has determined that an application is complete, Commission staff shall refer an application requesting Medicaid data to Medicaid for review in accordance with Regulation .04 of this chapter.

(3) If Commission staff has received a written response from Medicaid specifying its decision on whether to proceed on the request for Medicaid data under either Regulation .04B(1), (2) or (3) of this chapter, Commission staff shall refer a completed application, Medicaid's written response, all supporting documentation, and any public comment received under Regulation .07 of this chapter, to the DRAC for further review in accordance with Regulation .09 of this chapter.

(4) In accordance with Regulation .04C of this chapter, if Commission staff has not received a written response from Medicaid within 15 business days of Commission staff's referral of the application to Medicaid, then Commission staff shall proceed with processing the application, including the request for Medicaid data, in accordance with Regulations .07-11 of this chapter.

(5) If Medicaid disapproves the part of an application requesting Medicaid data pursuant to Regulation .04B(3) of this chapter, an applicant shall notify Commission staff in writing within 15 business days of an applicant's wishes regarding further consideration of a non-Medicaid part of an application, specifically, whether an applicant requests that:

(a) Commission staff refer the part of a completed application requesting non-Medicaid data to the DRAC for further review in accordance with Regulation .09 of this chapter; or

(b) An applicant's entire application be withdrawn and receive no further consideration, in which case Commission staff shall administratively close the application pursuant to §B(7) of this regulation.

(6) If an applicant fails to notify Commission staff in writing within 15 business days of receiving notice that Medicaid has disapproved the Medicaid part of an application as required under §B(5) of this regulation, Commission staff may administratively close an application pursuant to §B(7) of this regulation.

(7) An application may be administratively closed and receive no further consideration if:

(a) An applicant fails to provide a complete application, in the judgment of Commission staff, including providing all additional information, documentation, answers to questions, and clarifications requested by Commission staff, or by the DRAC during its review of an application under Regulation .09 of this chapter, within the time limit specified by Commission staff or the DRAC; or

(b) An applicant fails to provide the written notification within 15 business days as required under §B(5) of this regulation.

(8) For an applicant to receive further consideration of a request for data in an application that was administratively closed under §B(7) of this regulation, an applicant shall file a new application and pay the required fees that are in effect at the time of submission of a new application.

Md. Code Regs. 10.25.05.06

Regulation .06 adopted effective 48:25 Md. R.1071-1098, eff. 12/13/2021