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(ACO) regulations - American Society of Anesthesiologists

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CMS-1345-P 422<br />

(2) The minimum necessary Part D data elements may include the following data<br />

elements:<br />

(i) Beneficiary ID.<br />

(ii) Prescriber ID.<br />

(iii) Drug service date.<br />

(iv) Drug product service ID.<br />

(v) Quantity dispensed.<br />

(vi) Days supplied.<br />

(vii) Gross drug cost.<br />

(viii) Brand name.<br />

(ix) Generic name.<br />

(x) Drug strength<br />

(xi) Indication if the drug is on the formulary, as designated by CMS.<br />

(f) Data Use Agreement. Prior to receiving any beneficiary identifiable data, <strong>ACO</strong>s must<br />

enter into a DUA with CMS. The DUA must--<br />

(1) Specify that the <strong>ACO</strong> will comply with the limitations on the use and disclosure <strong>of</strong><br />

individually identifiable health information that the HIPAA Privacy Rule places on HIPAA<br />

covered entities, as well as all other applicable privacy and confidentiality requirements;<br />

(2) Prohibit the <strong>ACO</strong> from using the data received under the Shared Savings Program for<br />

any prohibited use <strong>of</strong> individually identifiable health information.<br />

(3) Specify that if an <strong>ACO</strong> misuses or discloses data in a manner that violates any<br />

applicable statutory or regulatory requirements or that is otherwise non-compliant with the<br />

provisions <strong>of</strong> the DUA, it will no longer be eligible to receive data, could potentially be

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