System Name: "Post-Acute Care Payment Reform / Continuity of Assessment Record and Evaluation Demonstration and Evaluation (PAC-CARE)," HHS/CMS/ORDI.
Security Classification: Level Three Privacy Act Sensitive Data.
The Centers for Medicare & Medicaid Services (CMS) Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850 and at various contractor sites and at CMS Regional Offices.
Categories of Individuals Covered by the System: This system will collect and maintain individually identifiable and other data collected on Medicare and potentially, Medicaid beneficiaries who require treatment in a designated acute care or post-acute care provider. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries.
Categories of Records in the System: The collected information will include, but is not limited to: Medicare claims and eligibility data, name, health insurance claims number (HICN), social security number (SSN) (the submission of a beneficiary's SSN is optional), race/ethnicity, gender, date of birth, provider name, unique CMS Certification Number (CCN), medical record number, as well as clinical, demographic, medication, procedure, treatment information, health/well-being, and background information relating to Medicare issues. Data will be collected from Medicare administrative and claims records, PAC-CARE site administrative data systems, patient medical charts, physician records, and via information submitted by beneficiaries and providers.
Authority for Maintenance of the System: The statutory authority for this system is given under Sections 5008 of the Deficit Reduction Act of 2005.
Purpose(s): The primary purpose of this proposed system is to collect and maintain, and release when appropriate, demographic, health records, and health resource use related data on the target population of Medicare and potentially, Medicaid beneficiaries who require treatment by a designated acute care or post-acute care provider. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support the functions of Quality Improvement Organizations; (5) support the functions of national accreditation organizations; (6) permit the release of personal health information to complete a transfer-out (discharge) event and/or a transfer-in (admission) event; (7) support litigation involving the agency; and (8) combat fraud, waste, and abuse in certain Federally-funded health benefits programs.
Routine Uses of Records Maintained in the System, Including Categories of Users and the Purposes of such Uses:
The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a "routine use." The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system:
1. To agency contractors, consultants or grantees, who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity.
2. To another Federal or state agency to:
a. Contribute to the accuracy of CMS's proper payment of Medicare benefits;
b. Enable such agency to administer a Federal health benefits program, or, as necessary, to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and/or
c. Assist Federal/state Medicaid programs within the state.
3. To an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects.
4. To support Quality Improvement Organizations (QIO) in connection with review of claims, or in connection with studies or other review activities conducted pursuant to Part B of Title XI of the Act, and in performing affirmative outreach activities to individuals for the purpose of establishing and maintaining their entitlement to Medicare benefits or health insurance plans.
5. To assist national accreditation organization(s) whose accredited facilities are deemed to meet certain Medicare conditions of participation for inpatient hospital rehabilitation services (e.g., the Joint Commission and the American Osteopathic Association) with their survey process, information will be released by CMS for only those providers that they deem and that participate in the Medicare program and if they meet the following requirements:
a. Provide identifying information for post acute care facilities that have deemed status with the requesting accreditation organization;
b. Submission of a finder file identifying beneficiaries/patients receiving post acute care services;
c. Safeguard the confidentiality of the data and prevent unauthorized access; and
d. Upon completion of a signed data exchange agreement or a CMS data use agreement.
6. To assist with a transfer-out event from a discharging acute or post-acute care provider and/or a transfer-in event to an admitting acute or post-acute care provider to:
a. Contribute to the accuracy of CMS' proper payment of Medicare benefits; and
b. Enable such providers to ensure the proper transfer of health records, and/or as necessary to enable such a provider to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal fund.
Individuals from the admitting providers will only be granted access to personal health information, if they have the approved, authenticated, role-based authority, and the defined need for access to that information. Individuals will only be granted access to information if they meet the following requirements:
a. Provide an attestation or other qualifying information that they are providing assistance to a qualified acute or post-acute care beneficiary receiving care/services through their provider site;
b. Have physically admitted the beneficiary to their care site, and are initiating an assessment of the beneficiary, and can validate the beneficiary's name, HICN (or payer number or SSN), date of birth, and gender;
c. Safeguard the confidentiality of the data and prevent unauthorized access; and
d. Accept a written, on-line statement attesting to the information recipient's understanding of and willingness to abide by these provisions.
7. To the Department of Justice (DOJ), court or adjudicatory body when:
a. The agency or any component thereof, or
b. Any employee of the agency in his or her official capacity, or
c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or
d. The United States Government is a party to litigation or has an interest in such litigation, and, by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records.
8. To a CMS contractor (including, but not necessarily limited to, Medicare Administrative Contractors (MAC), fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, and abuse in such program.
9. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs.
B. Additional Provisions Affecting Routine Use Disclosures.
To the extent this system contains Protected Health Information (PHI) as defined by HHS regulation "Standards for Privacy of Individually Identifiable Health Information" (45 CFR Parts 160 and 164, Subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the "Standards for Privacy of Individually Identifiable Health Information." (See 45 CFR 164.512(a)(1)).
In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that individuals could, because of the small size, use this information to deduce the identity of the beneficiary).
Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System—
Storage: All records are stored on magnetic media.
Retrievability: The Medicare records are retrieved by the HICN and SSN.
Safeguards: CMS has safeguards in place for authorized users and monitors such users to ensure against unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access.
This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002; the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: All pertinent National Institute of Standards and Technology publications; the DHHS Information Systems Program Handbook and the CMS Information Security Handbook.
Retention and Disposal: Records will be retained until an approved disposition authority is obtained from the National Archives and Records Administration. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ.
System Manager(s) and Address(es):
Director, Research and Evaluation Group, Office of Research Development & Information, Mail Stop C3-19-26, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849.
Notification Procedure: For purpose of access, the subject individual should write to the system manager who will require the system name, HICN, address, date of birth, and gender, and for verification purposes, the subject individual's name (woman's maiden name, if applicable), and SSN. Furnishing the SSN is voluntary, but it may make searching for a record easier and prevent delay.
Record Access Procedures: For purpose of access, use the same procedures outlined in Notification Procedures above. Requestors should also specify the record contents being sought. (These procedures are in accordance with department regulation 45 CFR 5b.5(a)(2)).
Contesting Record Procedures: The subject individual should contact the system manager named above, and reasonably identify the records and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These Procedures are in accordance with Department regulation 45 CFR 5b.7).
Record Source Categories: Data will be collected from Medicare administrative and claims records (Outcome and Assessment Information Set, Inpatient Rehabilitation Facilities Patient Assessment Instrument, Long Term Care Minimum Data Set), post-acute care site administrative data systems, patient medical charts, physician records, and via information submitted by beneficiaries and providers.
System Exempted from Certain Provisions of the Act: None.