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Reporting Requirements for Health Data
1.
© 2017 American
Health Information Management Association© 2017 American Health Information Management Association Chapter 16: Required Reporting and Mandatory Disclosure Laws Fundamentals of Law for Health Informatics and Information Management, Third Edition
2.
© 2017 American
Health Information Management Association Required Reporting • Federal and state laws require reporting certain protected health information to protect the health and safety of a community. • Information collected in this manner is not considered public information and patient privacy and confidentiality are protected.
3.
© 2017 American
Health Information Management Association HIPAA and Required Reporting Considerations • Disclosure without patient authorization or agreement – HIPAA Privacy Rule: 12 public interest and benefits activities exceptions (see figure 16.1) – Individual not given opportunity to agree or object to disclosure, no authorization required – Amount disclosed defined by state law, public health, serious threat to health or safety
4.
© 2017 American
Health Information Management Association HIPAA and Required Reporting Considerations (continued) • Preemption – Provides that federal law must be followed when federal and state laws conflict, unless the state law is more stringent on matter than federal law – State law will prevail if there are provisions of state law, including state procedures for reporting of disease or injury, child abuse, birth, or death, or for the conduct of public health surveillance, investigation, or intervention (45 CFR 160.203)
5.
© 2017 American
Health Information Management Association HIPAA and Required Reporting Considerations • Notice of privacy practice – Under HIPAA, generally “. . . an individual has a right to adequate notice of the uses and disclosures of protected health information that may be made by the covered entity. . .” (45 CFR 164.520). – Notice of Privacy Practices should include information regarding reporting without patient authorization under state and federal law
6.
© 2017 American
Health Information Management Association HIPAA and Required Reporting Considerations • Accounting of disclosures – Privacy Rule requires the tracking of disclosures of PHI made in writing, electronically, by telephone, or orally – Organization must track disclosures in a central tracking system that enables departments to record disclosures
7.
© 2017 American
Health Information Management Association Common State Reporting Requirements • Abuse and neglect of children – Reporting required by state law – Reportable to law enforcement – Types of neglect include • Neglect • Physical abuse • Sexual abuse • Emotional abuse – Child: Any person under of 18 or physically or mentally handicapped up to age of 21
8.
© 2017 American
Health Information Management Association Common State Reporting Requirements (continued) • Abuse and neglect of children – State laws define who must report • Protection from liability for reporting in good faith • Privilege exemptions – Must be orally reported immediately with written reports in a prescribed timeframe – No conflict with HIPAA regarding authorization for disclosure due to public interest and benefit exceptions
9.
© 2017 American
Health Information Management Association Common State Reporting Requirements (continued) • Abuse and neglect of the elderly and disabled – Includes individuals 60 years of age and older – Disability attributable to mental or physical impairment that results in functional limits – Types of abuse • Physical • Emotional • Financial • Sexual • Neglect • Abandonment
10.
© 2017 American
Health Information Management Association Common State Reporting Requirements (continued) • Abuse and neglect of the elderly and disabled – Laws covering abuse in home setting (domestic abuse) versus abuse in institutional setting such as a nursing home – State laws also vary regarding required reporting of abuse of the elderly and disabled – No conflict with HIPAA regarding authorization for disclosure due to public interest and benefit exceptions
11.
© 2017 American
Health Information Management Association Common State Reporting Requirements (continued) • Vital records – Required by state and federal law – National Center for Health Statistics (NCHS) responsible for working with state vital statistic laws – Birth certificates: Completed on every live birth • Two parts to certificate: Identifying information and information on mother’s pregnancy and any birth defects • Laws define how a father is acknowledged and what surname in entered for child
12.
© 2017 American
Health Information Management Association Common State Reporting Requirements • Vital statistics – Death certificates: Usually completed by funeral director • Includes identifying information about the deceased as well as information about the cause of death • Physician must provide the cause of death and sign the death certificate
13.
© 2017 American
Health Information Management Association Common State Reporting Requirements • Communicable diseases – Transmitted from infected person, animal, or inanimate reservoir to a susceptible person or host by either direct or indirect contact – State laws define what diseases are reportable, by whom, and how they should be reported, also have provisions to keep information confidential – Notifiable diseases classified according to their potential for endemic or epidemic spread and danger to public health, reportable within 24 hours usually
14.
© 2017 American
Health Information Management Association Common State Reporting Requirements • Induced termination of pregnancy (abortion) – State law requires healthcare organization where induced termination or pregnancy to report termination – Information typically reported: Date of birth, race, marital status, and county and state of residence; the type of procedure performed; and resulting complications • Birth defects – Information may be obtained from birth certificates filed with the state used to determine trends in birth defects and to look for ways to prevent them
15.
© 2017 American
Health Information Management Association Reportable Deaths • State law determines requirements for reporting certain deaths and what information can be disclosed in various cases (varies by circumstances and law enforcement involvement) – Accidental death – Homicide – Suicide – Sudden death – Suspicious death – Death from abortion – Induced termination of pregnancy
16.
© 2017 American
Health Information Management Association Reportable Deaths • Deaths reportable to medical examiner vs. coroner – ME is typically a physician with pathology training – Coroner appointed or elected official, who may or may not be a physician – Both responsibility for investigating suspicious deaths – MEs and coroners have right to receive medical information needed to investigate the case without authorization and may have subpoena powers to collect such information
17.
© 2017 American
Health Information Management Association Reportable Deaths • Name and address of the deceased • Age of the deceased, if known • Marital status of the deceased • Ethnicity of the deceased • Time of accident or onset of cause of death • Place, mode, and manner of injury • Place of death • Time of death • Location of body • Other pertinent data • Name of person reporting the case, including date and time • Name of physician who pronounced person dead Information commonly reportable to ME or coroner
18.
© 2017 American
Health Information Management Association Reporting of Wounds: Knife, Gunshot, Burns • Wounds, such as knife wounds, gunshot wounds, and burns indicative of crimes, must also be reported to legal authorities. • States also require reporting of unusual events and other instances that might assist with public health prevention and control programs.
19.
© 2017 American
Health Information Management Association Reporting Fetal Deaths • Refers to death of fetus of particular weight, frequently 500 grams or more, or 22 or more completed weeks of gestation • Depending on state law, responsibility for completing the fetal death certificate may lie with – Designated person in the institution where the fetal death occurred – Funeral director – Other person responsible for internment or cremation of remains – Physician in attendance if fetal death occurred outside an institution – If no one in attendance, must notify ME who completes death certificate
20.
© 2017 American
Health Information Management Association Unusual Events and Other State Reporting Requirements • Some states require reporting of unusual or adverse events – Medication errors – Transfusion reactions – Falls resulting in fractures – Wrong patient/wrong site surgical procedures – Operative complications
21.
© 2017 American
Health Information Management Association Unusual Events and Other State Reporting Requirements (continued) • Some states have implemented prescription drug monitoring programs (PDMPs) – Require pharmacies to report to state data bank on state identified controlled drugs • Nuclear Regulatory Commission (NRC) – Oversight for medical use of ionizing radiation – Medical centers must report to state agency and NRC information on use of radioactive materials and any misadministration of the material
22.
© 2017 American
Health Information Management Association Worker’s Compensation for Occupational Illnesses, Injury, Death • Purpose of legislation – Ensures employees injured on job or become ill as result of job are provided with some means of support while recovering from illness or injury • Process – Employee or employee representative files a worker’s compensation claim – Must sign an authorization to release medical information to the workers’ compensation entity – Information may be disclosed to other state or federal agency without patient authorization
23.
© 2017 American
Health Information Management Association National Reporting Requirements • Serious occurrences or deaths related to restraint or seclusion – Conditions of Participation patients rights rule, accredited hospitals deemed to meet Medicare requirements must report deaths from restraints or seclusion to CMS by phone within one business day – Must document in patient’s health record date and time that the death was reported – Must record in internal log/system with 7 days of death, key patient information
24.
© 2017 American
Health Information Management Association Serious Occurrences or Deaths Related to Restraint or Seclusion • Children’s Health Act of 2000 – Restrict the use of restraints and seclusion in all psychiatric facilities that receive federal funds and in non-medical community-based facilities for children and youth • Use of restraints and seclusion restricted to emergency safety situations only • Parent or legal guardian must be notified no later than 24 hours after the occurrence
25.
© 2017 American
Health Information Management Association National Reporting Requirements of Quality Measures • CMS, Joint Commission and other entities require – Quality measures for hospitals, physician’s offices, nursing homes, and other provider entities for purpose of improving the quality and safety of patient care – PHI collected is used for retrospective analysis and real-time reporting to comprehensively evaluate and manage quality improvement efforts – Data submitted to federally supported Quality Improvement Organizations (QIOs), Clinical Data Abstraction Centers (CDACs), CDC, and others
26.
© 2017 American
Health Information Management Association Quality Measures • 2010 Affordable Care Act established mandatory quality reporting requirements for long-term care hospitals, inpatient rehabilitation facilities, and hospice programs, went into effect in 2014; may change as new administration works on new healthcare legislation • Mandatory reporting by hospitals already required • Medicare providers that fail to comply with data reporting requirements are subject to 2 percent reduction of reimbursement
27.
© 2017 American
Health Information Management Association National Reporting Requirements • Programs designed to prevent fraud and abuse • Healthcare organizations must provide copies of health records – Recovery Audit Contractors (RACs) – Medicare Administrative Contractors (MACs) – Medicaid Integrity Contractors (MICs) • Purpose of these programs: To measure, prevent, identify, and correct incorrect payments under the Tax Relief and Health Care Act of 2006 and other federal healthcare reform legislations
28.
© 2017 American
Health Information Management Association National Reporting Requirements (continued) • National Practitioner Data Banks (NPDB) – Created by Health Care Quality Improvement Act of 1986, information expanded by Medicare and Medicaid Patient and Program Protection Act of 1987 – Purpose: Identify and discipline those who engage in unprofessional behavior and restrict ability of incompetent healthcare practitioners to move from State to State without disclosure or discovery of previous medical malpractice payment and adverse action
29.
© 2017 American
Health Information Management Association National Reporting Requirements • National Practitioner Data Banks (NPDB) (cont.) – NPDB merged with Healthcare Integrity and Protection Data Bank (HIPDB) established under Section 1128E of the Social Security Act; operational in 2000 to establish national healthcare fraud and abuse data collection program for reporting of final adverse actions (not including settlements in which no findings of liability have been made) against healthcare providers, suppliers, or practitioners
30.
© 2017 American
Health Information Management Association NPDB Formal Clearing House • Information reported to the data bank is considered confidential and is not disclosed except as specified by regulation • Requirements include: – Who reports – What information is available – Who can query database
31.
© 2017 American
Health Information Management Association Medical Device Reporting • Safe Medical Devices Act of 1990 – Requires reporting to the FDA and the product manufacturer of medical device occurrences that have or may have contributed to serious illness, serious injury, or death, including occurrences attributed to user error • Medical Device Amendments of 1992 clarified terms and established a single reporting standard for device users, manufacturers, importers, and distributors
32.
© 2017 American
Health Information Management Association Medical Device Reporting (continued) • Medical device: Anything that is used in treatment or diagnosis that is not a drug – X-ray machines, sutures, defibrillators, grafts, syringes, lasers, heating pads, bone screws, pumps, etc. • FDA requires specific information to be reported within 10 days – User facility report number – Name and address of the device manufacturer – Device brand name and common name – Product model, catalog, serial, and lot numbers – Brief description of event reported to manufacturer and the FDA – Where report was submitted (FDA, manufacturer, or distributor)
33.
© 2017 American
Health Information Management Association Medical Device Reporting (continued) • Reporting done through Safety Information and Adverse Event Reporting Program— MedWatch • FDA also encourages voluntary reporting of adverse events related to products or technologies to MedWatch • FDA does not regulate EHRs working with ONC and FCC representatives to improve the safe use of EHR technology, encourages voluntary reporting of problems with EHRs
34.
© 2017 American
Health Information Management Association Medical Device Reporting and HIPAA • HIPAA allows medical device reporting without patient authorization – To collect or report adverse events (or similar activities with respect to food or dietary supplements), product defects or problems (including problems with the use or labeling of a product), or biological product deviations – To track FDA-regulated products – To enable product recalls, repairs, replacements, or look back – To conduct post-marketing surveillance
35.
© 2017 American
Health Information Management Association Medical Device Reporting • Under Freedom of Information and Privacy Act, FDA information may be accessed but FDA is required to delete – Any personal, medical, and similar information that would constitute a clear, unwarranted invasion of personal privacy – Trade secrets and confidential commercial or financial information related to the manufacturer – Identifying information of the reporter of the event
36.
© 2017 American
Health Information Management Association Organ Procurement Organization • Federal law requires that hospitals notify designated organ procurement organization (OPO) in a timely manner regarding specified organ donors who die in the hospital or for whom death is imminent • Hospital and OPO must do annual death record reviews • Hospital is not violating confidentiality by calling the OPO and providing information about an individual who has died • No requirement in statute or regulations that family be informed about hospital’s notification to OPO before OPO can be contacted
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Health Information Management Association Occupational Fatalities, Injuries, and Illnesses • Federal occupational safety and health regulation requires employers to report work-related fatalities, injuries, and illnesses • Healthcare facilities may be required to release medical information relevant to fatality, injury, or illness to appropriate authorities per state law as well
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Health Information Management Association Clinical, Disease, and Outcome-Based Registries • Database containing information about a disease or condition – Used for a broad range of purposes in public health and medicine, from evaluating patient care to monitoring defective devices • May be required by federal or state laws – Common requirement is that data submitted to the registry be maintained in a confidential manner and identity of the patient be protected from disclosure
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Health Information Management Association Federal Registry on Implantable Cardiac Defibrillators (ICDs) • 2005: Medicare expanded its coverage ICDs to eligible Medicare beneficiaries • Every hospital that seeks reimbursement for ICDs must participate in ICD registry
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Health Information Management Association Variety of Registries • Type of registry determines what patient information is reported – Cancer registry – Trauma registry – Immunization – Birth defects – Diabetes – Implant – Transplant – Qualified Clinical Data Registries
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Health Information Management Association Disclosures to Public Health Authorities Not Required by Law • Covered entities may disclose PHI to public health entities even if law does not specifically require the disclosure, if the disclosure is for the purpose of – Preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions; or, at the direction of a public health authority, to an official of a foreign government agency that is acting in collaboration with a public health authority (45 CFR 164.512(b))
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