(a)Qualified entity means either a single public or private entity, or a lead entity and its contractors, that meets the following requirements:
(1) Is qualified, as determined by the Secretary, to use claims data to evaluate the performance of providers and suppliers on measures of quality, efficiency, effectiveness, and resource use.
(2) Agrees to meet the requirements described in this subpart at §§ 401.705 through 401.721.
(b)Provider of services (referred to as a provider) has the same meaning as the term “provider” in § 400.202 of this chapter.
(c)Supplier has the same meaning as the term “supplier” at § 400.202 of this chapter.
(d)Claim means an itemized billing statement from a provider or supplier that, except in the context of Part D prescription drug event data, requests payment for a list of services and supplies that were furnished to a Medicare beneficiary in the Medicare fee-for-service context, or to a participant in other insurance or entitlement program contexts. In the Medicare program, claims files are available for each institutional (inpatient, outpatient, skilled nursing facility, hospice, or home health agency) and non-institutional (physician and durable medical equipment providers and suppliers) claim type as well as Medicare Part D Prescription Drug Event (PDE) data.
(e)Standardized data extract is a subset of Medicare claims data that the Secretary would make available to qualified entities under this subpart.
(f)Beneficiary identifiable data is any data that contains the beneficiary's name, Medicare Health Insurance Claim Number (HICN), or any other direct identifying factors, including, but not limited to postal address or telephone number.
(g)Encrypted data is any data that does not contain the beneficiary's name or any other direct identifying factors, but does include a unique CMS-assigned beneficiary identifier that allows for the linking of claims without divulging any direct identifier of the beneficiary.
(h)Claims data from other sources means provider- or supplier-identifiable claims data that an applicant or qualified entity has full data usage right to due to its own operations or disclosures from providers, suppliers, private payers, multi-payer databases, or other sources.
(i)Clinical data is registry data, chart-abstracted data, laboratory results, electronic health record information, or other information relating to the care or services furnished to patients that is not included in administrative claims data, but is available in electronic form.
Title 42 published on 2014-10-01
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