SORN 09-70-0522

System Name: "Home Health Agency (HHA) Outcome and Assessment Information Set (OASIS)," HHS/CMS/CMSO.

Security Classification: Level Three Privacy Act Sensitive Data.

System Location(s):

The Centers for Medicare & Medicaid Services (CMS) Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850 and South Building, Baltimore, Maryland 21244-1850.

Categories of Individuals Covered by the System: The system of records (SOR) will contain clinical assessment information (OASIS) for all patients receiving the services of a Medicare and/or Medicaid approved HHA, except pre-partum and post-partum patients, patients under 18 years of age, and patients receiving other than personal care or health care services; i.e., housekeeping services and chore services. Identifiable information will be maintained in the SOR only for those individuals whose payments come from Medicare or Medicaid.

Categories of Records in the System: This SOR will contain individual-level demographic and identifying data, as well as clinical status data for patients with the payment sources of Medicare traditional fee for service, Medicaid traditional fee for service, Medicare HMO/managed care or Medicaid HMO/managed care.

Authority for Maintenance of the System: Authority for maintenance of this system is given under Sections 1102(a), 1154, 1861(m), 1861(o), 1861(z), 1863, 1864, 1865, 1866, 1871, 1891, and 1902 of the Social Security Act. These provisions of the Act authorize the Administrator of CMS to require HHAs participating in the Medicare and Medicaid programs to complete a standard, valid, patient assessment data set; i.e., the OASIS, as part of their comprehensive assessments and updates when evaluating adult, non-maternity patients as required by section 484.55 of the Conditions of Participation. Authority is also given under section 951 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173).

Purpose(s): The primary purposes of the SOR are to collect and maintain information to: (1) Study and help ensure the quality of care provided by home health agencies (HHA); (2) aid in administration of the survey and certification of Medicare/Medicaid HHAs; (3) enable regulators to provide HHAs with data for their internal quality improvement activities; (4) support agencies of the state government to determine, evaluate and assess overall effectiveness and quality of HHA services provided in the state; (5) provide for the validation, and refinements of the Medicare Prospective Payment System; (6) aid in the administration of Federal and state HHA programs within the state; and (7) monitor the continuity of care for patients who reside temporarily outside of the state. Information maintained in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor, consultant, or grantee; (2) assist another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent, for evaluating and monitoring the quality of home health care and contribute to the accuracy of health insurance operations; (3) support research, evaluation, or epidemiological projects related to the prevention of disease or disability, or the restoration or maintenance of health, and for payment related projects; (4) support the functions of Quality Improvement Organizations (QIO); (5) support the functions of national accrediting organizations; (6) support litigation involving the Agency; (7) combat fraud, waste, and abuse in certain health care programs.

Routine Uses of Records Maintained in the System, Including Categories of Users and the Purposes of such Uses:

A. 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 support 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 assist another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent 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. evaluate and monitor the quality of home health care and contribute to the accuracy of health insurance operations.

3. To assist an individual or organization for research, evaluation or epidemiological projects related to the prevention of disease or disability, or the restoration or maintenance of health, and for payment related projects.

4. To support Quality Improvement Organizations (QIO) in order to assist the QIO to perform Title XI and Title XVIII functions relating to assessing and improving HHA quality of care.

5. To support national accrediting organizations with approval for deeming authority for Medicare requirements for home health services (i.e., the Joint Commission on Accreditation of Healthcare Organizations, Accreditation Commission for Health Care, Inc., and the Community Health Accreditation Program). Information will be released to these organizations upon specific request, and only for those facilities that they accredit and that participate in the Medicare program and if they meet the following requirements:

a. Provide identifying information for HHAs that have an accreditation status with the requesting deemed organization,

b. Submit a finder file identifying beneficiaries/patients receiving HHA services,

c. Complete a signed data exchange agreement or a CMS data use agreement, and

d. Safeguard the confidentiality of the data and prevent unauthorized access.

6. To support 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.

7. To assist a CMS contractor (including, but not necessarily limited to 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, or abuse in such program.

8. To assist 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 Fed. Reg. 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 paper and magnetic disk.

Retrievability: The Medicare and Medicaid records are retrieved by health insurance claim number, Social Security number (SSN) or by state assigned Medicaid number.

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 HHS Information Systems Program Handbook and the CMS Information Security Handbook.

Retention and Disposal: CMS will retain identifiable OASIS assessment data for a total period not to exceed fifteen (15) years.

System Manager(s) and Address(es):

Director, Division of Continuing Care Providers, Survey and Certification Group, Center for Medicaid and State Operations, CMS, 7500 Security Boulevard, S2-12-25, Baltimore, Maryland 21244-1850.

Notification Procedure: For purpose of access, the subject individual should write to the system manager who will require the system name, health insurance claim number, and for verification purposes, the subject individual's name (woman's maiden name, if applicable), SSN (furnishing the SSN is voluntary, but it may make searching for a record easier and prevent delay), address, date of birth, and sex.

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: The data contained in this system of records are obtained from The Outcome and Assessment Information Set.

Exemptions Claimed for the System: None.

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