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191 Cards in this Set

  • Front
  • Back
Access
right of an individual to inspect and obtain a copy of his or her own health information that is contained in a designated record set
Use
sharing, employment, application, utilization, examination, or analysis of individually identifiable health information within an entity that maintains such information
Disclosure
(release of information) release of confidential information that identifies a patient to another entity or person
Primary Data Source
A record developed by healthcare professionals in the process of providing patient care
Records can be used for
* public health reporting *research *quality & safety measures *payment *provider certification & accreditation *marketing
Data
may be patient specific or de-identified aggregate for statistical purposes
Secondary Data
When data from a record are used for purposes other than what was intended
ARRA - the American Recovery and Reinvestment Act provides
Provides financial incentives to promote the use and electronic sharing of PHI through the implementation of *EHR'S *HIE'S *HIO'S
What are 3 things that ARRA initiated
*HIE - Health Information Exchange *HIO - Health Information Org *RHIO - Regional Health Info Org
HIE - Health Information Exchanges
Electronic movement of health related information among organizations within a region or community that facilitates access to & retrieval of clinical data in support of safe, timely, efficient patient-centered care
HIE - Health Information Exchanges
an organization or entity that forms to create an electronic framework to connect physicians to pharmacies, hospitals & other healthcare entities
HIO - Health Information Organization
An Organization that oversee's & governs the exchange of health related information among organizations according to nationally recognized standards
RHIO - Regional Health Information Organization
A health information organization that brings together health care stakeholders within a defined geographic area & governs health information exchange among them for the purpose of improving health in that community
HITECH remains
silent on the issue of who owns the information generated through the HIE, HIO, & RHIO's
DHHS - ONC - Office of the National Coordinator for Health Information Technology
is addressing issues of access, use & disclosure of PHI among the HIE's etc, including what rights patients have to allow or deny disclosure of their PHI to these entities for secondary data uses
The Office of the National Coordinator published
"National Privacy & Security Framework for Electronic Exchange of Individual Identified Health Information" for the purpose of establishing a single, consistent approach to address the privacy & security challenges related to electronic health information exchange through a network for all persons regardless of the legal framework that may apply to a particular organization
AMIA - American Medical Informatics Association suggests that
organizations develop a full disclosure policy on ownership - informs patients that while they do not have exclusive ownership of their information, they have the right to know what is collected about them & what secondary uses may be made of the information
Access to Patient Health Information Federal Regulations - HIPAA
Individual has certain rights to access, use, & disclose his or her protected health information (PHI). Authorization & accounting of disclosure requirements
HITECH - Health Information Technology for Economic & Clinical Health
passed as a portion of the ARRA - American Recovery and Reinvestment Act - contains changes to the HIPAA Privacy Rule - who is covered, what information is protected, & what safeguards must be in place to ensure appropriate protection of electronic protected health information
Oregon law - Internal Release of Information
Recommendation regarding continuing care: Request release information to outside facility in non-emergency situations but the transfer of information should not be delayed waiting for release/*Healthcare Facility employees & appointed representatives: Need to Know is the guiding principle for employees & appointed representatives. Access must be limited to specific information required for the individual to fulfill their job responsibilities.
Who Can Access Health Information?
*Competent Adult *Age of majority - MOST STATES AGE 18 *Individual's authorized personal representative *Individual who holds persons durable power of attorney or durable power of attorney for healthcare decisions
UHCDA - Uniform Health-Care Decision Act
A model created in 1993 that provides that an individual may give an oral or written instruction to a healthcare provider that remains in force even after the individual loses capacity, and suggests decision-making priority for that individuals surrogates.
Decision making priority
-Spouse -Adult child -Parent -Adult sibling -Adult non-relative familiar with patient -Court appointed individual
Competent Adult
an individual who is mentally & physically competent to tend to his own affairs & has reached the age of majority - 18 - * Can appoint a person to be their PERSONAL REPRESENTATIVE
Personal Representative
Someone who is legally authorized to make healthcare decisions on an individuals behalf or to act on behalf of a deceased individual and/or their estate
Age of Majority
18 in most states
How does an Incompetent adult access their health information?
Age of majority, but is incapacitated, Court must legally deem person incompetent & appoint legal guardian who may be spouse, parent, sibling, agent, attorney, or surrogate
Rights of competent adult or legal guardian of incompetent adult
To request, receive, examine, copy & authorize disclosure/release of PHI
Minors - who can access health information
Individuals under the age of 18 who are not legally emancipated (declared an adult) by the court require parental authorization
Minors are considered legally incompetent & unable to make decisions regarding treatment or handling of health information unless per state law
minors can consent to treatment for abortions, mental health, substance abuse treatment, and/or STD treatment, then minors can authorize access, use, & disclosure of their own healthcare information
Who can access a Minors Health Information
Parental authorization typically required as recognized by law -Married biological parents -Separated or divorced biological parent(s) -Adoptive parents -Foster parents -Grandparents -Legal guardians -Relative with guardianship while parent is overseas or in service -State law defines parent who can sign
Parental Authorization Not Required
-Emancipated minor under the age of majority & self-supporting with parents who have surrendered their rights of custody, care, and support -Minor who is married or previously married -Minor in the military -Minor who is a parent of a child -Minor who reaches age of majority while under treatment -Minor treated for drug or alcohol dependency, mental health, STDs or HIV/AIDs, contraception & abortion per state laws
Rights of a noncustodial parent or others
-Parent who does not have legal custody of the child -Legally endowed with parental rights which allow access unless stated otherwise by state law *Scenario: Father seeks medical records of his child. It is learned that the father has visitation rights with the child, but is the non custodial parent. Should the requested records be given to him?
Minors - Best practice regardless of person's age or competence
- in case of noncustodial parent, seek authorization whenever possible.
Emancipated minor - Best practice regardless of person's age or competence
- request copy of court order and/or other proof that minor is emancipated
Incompetent adult - Best practice regardless of person's age or competence
require legal documentation of the incompetent adult's legal position & the reason the adult is unable to sign the authorization, along with documentation of the personal representative's authority to access or authorize disclosure of the incompetent adult's PHI
Types of Sensitive Health Information
-Behavioral (mental) health information -Substance (alcohol and drug) abuse records -HIV/AIDS records -Genetic information -Adoption information -Specific authorization required
Behavioral Health Records
General rule: mental health information is to be kept confidential *What state law says: *provides protections *provides exceptions
Behavioral Health Records - Requests by patients
-Historically, denied (believed injurious to their mental health) -Today, facility policies may still require asking the physician first -Some states specifically grant right of access to patient, which is consistent with HIPAA Privacy Rule
Requests by others - Behavioral Health Records
Right of access is generally per state statute *Factors to consider: *Authorization form shall specify that release of behavioral health information is authorized *Identity of mental health patients are often protected by state statute. Why? How has HIPAA changed this? State statute must comply with HIPAA
Duty to warn
Required under certain circumstances *State laws may permit or even compel psychologists & psychiatrists to use their discretion to warn intended victims of potential harm without the patient's authorization *Tarasoff v/s The Regents of the University of California
Substance Abuse Records Federal laws apply to:
-Any "federally assisted" drug & alcohol programs (broadly defined) -"Programs" providing diagnosis, treatment or referral for drug & alcohol abuse (also broadly defined) **Entity dedicated to these services **Unit of a general medical facility dedicated to these services **Medical personnel with primary function to provide these services
Federal Law on Substance Abuse Records
-Protects the identity of substance abuse patients (not just their clinical information) -Form shall specify release of substance abuse information is authorized; must contain certain items to be valid -If minor can consent to treatment per state law, minor authorizes release of the records -Limited exceptions to authorization requirement: medical emergency; scientific research, audits, program evaluation, court order; suspected child abuse -If federal and state law conflict, the most restrictive (most protective of patient confidentiality) wins
Re-disclosure Statement Drug & Alcohol Records
This information has been disclosed to you from records protected by federal confidentiality rules (42 CFR Part 2). The federal rules prohibit you from making any further disclosure of this information unless further disclosure is expressly permitted by the written consent of the person to whom it pertains or as otherwise permitted by 42 CFR Part 2. A general authorization for the disclosure of medical or other information is NOT sufficient for this purpose. The federal rules restrict any use of the information to criminally investigate or prosecute any alcohol or drug abuse patient. Rev. 04/12
ROI General rule: HIV/AIDS information is to be kept confidential
Example of an HIV/AIDS state law that: -Provides protections -Then provides exceptions **Wrongful disclosure leads to civil penalties *For example, Ohio law protects: -ID of individual receiving HIV test -Results of HIV test in form that IDs individual -ID of individual diagnosed with AIDS or AIDS-related condition (ARC)
Genetic Information Nondiscrimination Act (GINA) of 2008
-Prohibits discrimination by health insurers & employers based on genetic information -Title I effective December 7, 2009, focuses on genetic nondiscrimination in health insurance; states that health plans may not use genetic information to make eligibility, coverage, underwriting, or premium-setting decisions
Title I of GINA modifies the HIPAA Privacy Rule to state that genetic information is health information & prohibits the use & disclosure of genetic information by covered health plans for underwriting purposes. Two exceptions:
1. Health insurers may request genetic information in the case that coverage of a particular claim would only be appropriate if there is a known genetic risk 2. When working in collaboration with external research entities, health insurers may request (but not require) in writing that an individual undergo a genetic test. The individual may do so voluntarily, but refusal to participate will have no negative effect on his or her premium or enrollment status. The collected genetic information may be used for research purposes only, not for underwriting decisions
Disclosure of Active Records of Currently Hospitalized or Ambulatory Care Patients
Currently hospitalized patient (inpatient) or a patient currently being seen in a clinic setting (outpatient) or their personal representative may access, inspect, obtain a copy of, or disclose PHI from the patient's record
Active record
is the term used to denote the health records of individuals who are currently hospitalized inpatients or outpatients
If active inpatient or outpatient wishes to access, copy, or disclose his or her PHI,
then the healthcare provider should follow the same policies & procedures that are in place for allowing the access, copying, and disclosure of PHI for patients not currently hospitalized or being treated as an outpatient
Deceased Patients
Access or disclosure of patient information on deceased patient usually determined by state law *HIPAA - individual has the same privacy rights in death as they did in life but leaves it up to states in terms of who qualifies as deceased person's legal representative for access, use, and disclosure purposes
Legal executor or administrator of the estate
has first rights to access deceased's PHI or records
In absence of executor
rely on UHCDA in identifying next-of-kin priority
Other states require that these individuals become
the deceased's official personal representative through appointment by a probate court or court order
Proposed HITECH rule changes to HIPAA Privacy Rule related to deceased patients provide for additional flexibility in the disclosure of PHI by:
(1) removing the PHI status from health records 50 years after the patient's death (2) permitting CE's to disclose decedent records to family members & others involved in the patient's care or payment of care unless doing so would be inconsistent with any known preference of the patient
Re-disclosure of Deceased Patient Records
-Generally, protected health information of a decedent is treated the same as when the decedent was alive -After death, the personal representative or other person authorized by law to act on behalf of the decedent takes on the role of the decedent under HIPAA -Covered entities must keep patient protected health information for at least 6 years
Regulations allow covered entities to release protected information
to a coroner or funeral director without consent or authorization -Use of deceased patient information for research is permitted without consent -Oregon law contains special protections for use of genetic information for research & preempts HIPAA in specific instances
Autopsies performed to determine cause of death
Objectionable to some religions & cultures
Consent to autopsy required
except where autopsy is needed to determine cause of death for public policy purposes
Privacy Rule allows release of PHI without authorization
to a medical examiner or coroner for purpose of identifying deceased person, determining cause of death, and other authorized purposes
If the death of the individual is not a medical examiner or coroner's case
the surviving spouse or descendants of the deceased may authorize the autopsy
Healthcare organization should require that an authorization form be
completed & retained in the health record for evidentiary purposes
When is a valid authorization required for Third Party Payers
Unless contractual agreement in place - written authorization -Written policies & procedures
When is a valid authorization required for a CEO
not required
When is a valid authorization required for the Governing Board
owner of record -need to know basis *Patient authorization required in all other instances
When is a valid authorization required for Facility Attorney
* No - when hospital is party to a lawsuit * Yes - when hospital is not a party
When is a valid authorization required for Facility insurance carrier
- not required when investigating claims
When is a valid authorization required for Medical record personnel
- not required
When is a valid authorization required for Admitting office personnel
- not required on "need to know" basis
When is a valid authorization required for Business office personnel
- final Dx and procedures only - not required
When is a valid authorization required for Nursing staff
- access while patient is being treated - after discharge "need to know" authorization not required
Anti-terrorism Initiatives
Homeland Security Act of 2002
Homeland Security Act of 2002
-is designed to prevent terrorist attacks in the U.S. while reducing vulnerability to terrorism, minimizing its damages, and assisting in recovery from attacks in US
What does the Homeland Security Act of 2002 give to the Secretary of Homeland Security, the Authority to do
Access information that includes PHI without the authorization of the patient or personal representative
ROI for Public figures/celebrities
Special procedures must be implemented to protect patient confidentiality HIPAA: directory; general information released only with authorization -Omission of name from record, code name, or alias -Computer access & paper record access restricted on need-to-know basis -Designated spokesperson to address media questions -Staff training & nondisclosure statements
Guidelines for Release of Information
Follow all regulations & procedures for safeguarding the confidentiality of electronically created stored & transmitted records, including passwords & level of access
Do not leave medical charts or insurance reports
out where patients or medical facility visitors can see them
See that When talking on the telephone
you do not use the caller's name if others in the room might overhear
Use caution in giving the results of medical tests
to patients over the phone or when leaving messages
Confidentiality protocol is
duly noted in the policy & procedure manual
Other Access, Requests, Disclosure Situations
-Laboratory Test Results -Clinical Laboratory Improvements Amendments (CLIA) -Insurance companies and government agencies payment requests -Medical Emergencies
Laboratories only to disclose test results or reports
to an "authorized person," who ordered test, unless state law states otherwise
Individual who is the subject of information is
not authorized to immediately & directly receive his or her laboratory test results unless defined by state law
Access to the individual's clinical laboratory information
will occur through the provider who ordered the test(s)
Medical Emergencies
-Obligation is to treat the patient & provide whatever information is necessary -This usually entails disclosing patient information without authorization
Insurance companies & government agencies payment requests
-Authorization if the information is for the payment of a specific episode of care (45 CFR 164.506) -Other information requests require patient authorization HIPAA Privacy Rule & requests for payment purposes, including utilization review & medical necessity review, do not require
Types of Request
-Verification of requester -Validity of authorization -Mail request -Telephone request -Electronic requests -fax, Internet -Walk-in request -On-site request -Request to send information electronically
ROI Reimbursement & Fee Structure
is a function of doing business
Federal regulations address cost for ROI
-HIPAA permits reasonable charges for labor, postage, etc -Other federal program set fees: CMS, QIO, OSHA, etc
State regulations on costs for ROI
See state medical record copying charges at: http://www.lamblawoffice.com/medical-records-copying-charges.html
Managing the Release of Information Process
-Accounting of disclosure & tracking releases -Steps to account for disclosure -Right to request restrictions -Reasons for refusing to disclose information
Release of Information - Rule of Thumb
Do not disclose any information about a patient to a third party without a signed consent. This extends to insurance companies, attorney & friends or family. It includes acknowledging whether or not the person is a patient
Patient Information Disclosure
DO NOT release information from a patient's medical record, except when specified by law or facility policy, without the written authorization of the patient, the guardian in the case of a minor, the Power of Attorney for health care in the case of an incompetent person, or the next of kin or executor of the estate in case of death
10 point consent
1. who is to release information 2. who is to receive information 3. name of the patient 4. description of the information to be released 5. purpose of the request 6. revocation statement ---"Consent is subject to revocation except to the extent that action has been taken in reliance upon consent" 7. signature of patient 8. date consent is given 9. time period it is valid 10. Re-disclosure statement - "Information disclosed may be protected by federal law & state law & I specifically consent to disclosure of such information."
HIPAA Privacy Rule - 12 public interest & benefits activities exceptions
1. Required by law, 45 CFR 164.512(a) 2. Public Health activities , 45 CFR 164.12(b) 3. Victims of Abuse, neglect, domestic violence 45 CFR 164.12(c) 4. Health oversight activities 45 CFR 164.12(d) 5. Judicial and administrative proceedings 45 CFR 164.12(e) 6. Law enforcement purposes 45 CFR 164.12(f) 7. Decedents 45 CFR 164.12(g) 8. Cadaver organ, eye or tissue donation 45 CFR 164.12(h) 9. Research 45 CFR 164.12(i 10. Prevent or lessen serious threat to health or safety 45 CFR 164.12(j) 11. Specialized government functions 45 CFR 164.12(k) 12. Workers Compensation 45 CFR 164.12(l)
For the 12 HIPAA exceptions, an individual is not
given the opportunity to agree or object to the disclosure of their information, nor is authorization required. The amount of information disclosed is usually defined by law or statute.
Doctrine of PREEMPTION
-Provides that federal law must be followed when federal & 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)
Notice of Privacy Practices
Under HIPAA, generally "..an individual has a right to adequate notice of the uses & 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 & federal law
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
Common State Reporting Requirements
Births, Deaths, Abuse of a child or elderly, notifiable diseases, statewide cancer registry, trauma, medical examiner cases
Definition of a Child
any person under of 18 or physically or mentally handicapped up to age of 21
Abuse & neglect of children
Required by state law, reportable to law enforcement or county childrens' services boards in the county where the incident occurred
4 Types of neglect (maltreatment) defined by state law include
o Neglect o Physical abuse o Sexual abuse o Emotional abuse
State laws identify
-who must report child and neglect -the time frame for reporting -the kind of information reported
Most common reporting individuals are
healthcare practitioners, police officers, educators & human service workers
Reporting individuals
are given protection from civil or criminal liability through state statutes for reporting abuse & neglect made in good faith **No conflict with HIPAA regarding authorization for disclosure due to public interest & benefit exceptions
Abuse & Neglect of the Elderly & Disabled
-Includes individuals 60 years of age & older -Disability attributable to mental or physical impairment that results in functional limits
Types of Abuse & Neglect of the Elderly & Disabled
• Physical • Emotional • Financial • Sexual • Neglect • Abandonment
There may be separate 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 & disabled **No conflict with HIPAA regarding authorization for disclosure due to public interest & benefit exception
T or F State required reporting laws are an exception to the doctrine of Preemption
True
T or F When information is released to meet state required reporting laws, the release does not have to be included in the facilities accounting of disclosures
False
T or F Central Registries are covered by & must adhere to the requirements of HIPAA
False
T or F Abuse of the elderly is limited to financial exploitation of an elder persons assets
False
T or F Physical abuse is usually the only type of maltreatment that must be reported under child abuse laws
False
Vital records
Required by state & federal law - are births, deaths, marriages, divorces, abortions & fetal deaths
National Center for Health Statistics (NCHS) responsible
for working with state vital statistic laws
State laws requiring the reporting of vital statistics do not conflict with HIPAA
because under the privacy rule, the public interest & benefit exception of "public health activities" are permissible without authorization
Birth certificates
completed on every live birth •Two parts to certificate - identifying information & information on mother's pregnancy & any birth defects •Laws define how a father is acknowledged & what surname in entered for child
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 & sign the death certificate
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 & danger to public health, reportable within 24 hours usually (ie - anthrax, Ebola, hepatitis, malaria, measles , the more dangerous the shorter the reportable time frame)
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 & 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 & to look for ways to prevent them ** Reportable under HIPAA exception public health activities
Reportable Deaths
•State law determines requirements for reporting certain deaths & what information can be disclosed in various cases (varies by circumstances & law enforcement involvement)
Types of reportable deaths
- Accidental death - Homicide - Suicide - Sudden death - Suspicious death - Death from abortion - Induced termination of pregnancy
Medical Examiner (ME)
is typically a physician with pathology training
Coroner
appointed or elected official, who may or may not be a physician
Deaths reportable to medical examiner vs. coroner
-Both responsible for investigating suspicious deaths -ME's & coroners have right to receive medical information needed to investigate the case without authorization & may have subpoena powers to collect such information
Information in Reportable Deaths form
*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 & time *Name of physician who pronounced person dead
Reportable deaths have no issue with HIPAA due to
under the exceptions of public health activities & disclosure for law enforcement purposes, and about decedents
Reporting of Wounds
•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 & other instances that might assist with public health prevention & control programs
Reporting of Wounds have no issue with HIPAA due to
exceptions of public health activities & disclosure for law enforcement purposes, and about decedents
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
Unusual Events & Other State Reporting Requirements
-Medication errors -Transfusion reactions -Falls resulting in fractures -Wrong patient/wrong site surgical procedures -Operative complications
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 & NRC information on use of radioactive materials & any mis-administration of the material
Reporting Unusual Events & Other State Reporting Requirements have no issue with HIPAA due to
HIPAA Public interest & benefit exception of "required by law" or to "prevent or lessen a serious threat to public health or safety"
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
Worker's Compensation 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
Reporting Worker's Compensation, have no issue with HIPAA due to
under the public interest & benefit section of workers compensation
Children's Health Act of 2000
-Restrict the use of restraints & seclusion in all psychiatric facilities that receive federal funds & in non-medical community-based facilities for children & youth •Use of restraints & seclusion restricted to emergency safety situations only •Parent or legal guardian must be notified no later than 24 hours after the occurrence
Quality Measures for CMS, Joint Commission & other entities require:
-Quality measures for hospitals, physician's offices, nursing homes, and other provider entities for purpose of improving the quality & safety of patient care -PHI collected is used for retrospective analysis & real-time reporting to comprehensively evaluate & manage quality improvement efforts -Data submitted to federally supported Quality Improvement Organizations (QIOs), Clinical Data Abstraction Centers (CDACs), CDC, & others
2010 Affordable Care Act
established mandatory quality reporting requirements for long-term care hospitals, inpatient rehabilitation facilities, and hospice programs, goes into effect in 2014 **•Mandatory reporting by hospitals already required •Medicare providers that fail to comply with data reporting requirements are subject to 2% reduction of reimbursement
Programs designed to prevent fraud & abuse
-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 & Health Care Act of 2006 & other federal healthcare reform legislation's
Purpose RACs, MACs, and MICs
to measure, prevent, identify, and correct incorrect payments under the Tax Relief & Health Care Act of 2006 & other federal healthcare reform legislation's
National Practitioner Data Banks (NPDB)
-Created by Health Care Quality Improvement Act of 1986, information expanded by Medicare & Medicaid Patient & Program Protection Act of 1987
Purpose of NPDB
identify & discipline those who engage in unprofessional behavior & restrict ability of incompetent healthcare practitioners to move from State to State without disclosure or discovery of previous medical malpractice payment & adverse action
Healthcare Integrity & Protection Data Bank (HIPDB)
- Established under Section 1128E of the Social Security Act; operational in 2000 *Purpose - to establish national healthcare fraud & 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
NPDB & HIPDB
• Information reported to the data banks is considered confidential & is not disclosed except as specified by regulation • Requirements include: - Who reports - What information is available - Who can query databases
Safe Medical Devices Act of 1990
-Requires reporting to the FDA & 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 & established a single reporting standard for device users, manufacturers, importers, and distributors
Definition of Medical device
defined as 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
Medical Device Reporting
FDA requires specific information to be reported within 10 days: -User facility report number -Name & address of the device manufacturer -Device brand name & common name -Product model, catalog, serial, and lot numbers -Brief description of event reported to manufacturer and/or the FDA -Where report was submitted (FDA, manufacturer, or distributor)
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
Medical Device Reporting Under Freedom of Information and Privacy Act, FDA information maybe 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 & confidential commercial or financial information related to the manufacturer -Identifying information of the reporter of the event
T or F The attending physician usually has responsibility for filing the death certificate
False
T or F Reporting of Notifiable diseases without the patients authorization is allowed under the public interest & benefit exception under HIPAA
True
T or F National Hospital quality data may only be released to the QIO or the CDAC with a signed authorization from the patient
False
T or F Every hospital receiving reimbursement from Medicare for implantable cardiac defibrillators must submit data to the American College of Cardiologists National Cardiovascular Data Registry
True
T or F Federal Law requires that a hospital study the designated organ procurement organization (OPO) in a timely manner regarding specified organ donors who die in the hospital or for whom death is iminent
True
Reporting of Occurrences with Electronic Health Record Systems
•FDA has also been studying the issue of regulating EHR's •ONC working with FDA & representatives of patient, clinician, vendor, and healthcare organizations to determine role FDA should play to improve the safe use of certified EHR technology
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
Organ Procurement Organization
•Federal law requires hospital 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 & OPO must do annual death record reviews •Hospital is not violating confidentiality by calling the OPO & 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
•Occupational Fatalities, Injuries, and Illnesses
•Federal occupational safety & 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
Registries
•Database containing information about a disease or condition -Used for a broad range of purposes in public health & 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 & identity of the patient be protected from disclosure
Types of Registries
- Cancer registry - Trauma registry - Immunization - Birth defects - Diabetes - Implant - Transplant
Type of registry determines
what patient information is reported
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))
T or F Information included in state registries is considered public information
False
T or F Immunization registries are different from other state registries because they allow access by the individuals included in the registry or their representatives such as parents
True
T or F Transplant registries may include data about organ donors as well as organ recipients
True
T or F Implant registries are frequently developed in response to highly publicized cases of harm resulting from implants to provide for easier notification of individuals
True
T or F Statewide cancer registries are frequently required to report data to the National Center for Health Statistics
False
T or F Ownership of a health record has traditionally bean granted to the patient
False
T or F A competent adult may wish to appoint another person to be their personal representative
True
T or F A minor who is emancipated must still have their parents authorize for disclosure of health information
False
T or F A noncustodial parent has the right to access the healthcare information of their minor child subject to other mitigating circumstances related to the minors rights to access
True
T or F Attorneys have automatic access to patient information because they are officers of the court
False
T or F HIPAA does not distinguish highly sensitive health information from other types of health information
False
T or F Privilege statutes legally protect confidential communications between provider & patient related to diagnosis & treatment from disclosure during civil & some criminal misdemeanor litigation
True
T or F The duty to warn obligation enables a physician to disclose information to a third party who may be the victim of harm perpetrated by a patient
True
T or F In order for a substance abuse program to be in compliance with the Privacy Rule, the authorization of disclosure of information should include specific elements required by the Privacy Rule
True
T or F The health records of HIV/AIDS patients should be clearly marked as such
False
AHIMA's Recommended Retention Standards for 5 years
Diagnostic images- xrays
AHIMA's Recommended Retention Standards for 10 years
-Disease index -Fetal heart records infant reaches age of majority -Operative Index - Patient records-adults-after most recent encounter -Physician Index
AHIMA's Recommended Retention Standards for permanent retention
-Register of births -Register of deaths -Register of surgical procedures -Master Patient Index
AHIMA's Recommended Retention Standards for Minors
Age of Majority plus statute of limitations