Healthcare Laws Chapter 4

Privacy and Confidentiality

• Privacy: being free from unwanted attention

• Confidentiality: legally protected rights of patients

  • all states have laws regarding confidentiality

  • if state law is stricter than federal law, it takes precendence

Health Insurance Portability and Accountability Act (HIPAA)

• Goals

  • simplify electronic exchange of information

  • reduce clerical burden and increase electronic transaction adoption

• Four Standards

  • Standard 1: transactions and code sets (CPT & ICD-10)

  • Standard 2: Privacy Rule (protect written/electronic/oral records)

  • Standard 3: Security Rule (electronic storage & transmission of records)

  • Standard 4: unique identifiers

    • National Provider Identifier (NPI)/ Health Plan Identifier (HPI)/ Employer Identification Number (EIN)

HIPAA-Related Terminology

• covered entities- providers, dentists, chiropractors, etc.

• protected health information (PHI)- identifiable health information

• business associate- person/business that provides services

• permission- reason for releasing/disclosing

• de-identify- remove information that can be linked to any person

• limited data set- PHI that has all direct patient identifiers removed

Privacy Rule

• Patients have the right to:

  • examine their health information

  • obtain a copy of their health records

  • request corrections to be make if information is incorrect

• Covered entities must comply with Privacy Rule

• The following permissions do not require written authorization from the patient to release PHI:

  • To the individual

  • treatment, payments, and healthcare operations (TPO)

  • use and disclosures with opportunity to agree or object- patient comes to clinic with partner/friend

  • incidental use and disclosure- overheard discussing PHI despite taking precautions

  • Public interest and benefit activities- public heath, workers’ compensation, coroners, research

  • Limited data set- research, healthcare operations

Disclosure Authorization Form

• if a person calls requesting information on a current patient, the medical assistant should first ask the caller’s name

  • if the caller’s name is not on the form, then the medical assistant cannot release the patient’s information and cannot acknowledge that the person is a patient of the facility

  • in some facilities, the patient comes up with a code word or number

Record Release Process

• patients must complete, date, and sign a records release form for their records to be transferred to another facility

• parts of the patient record are held at a higher level of confidentiality

  • psychotherapy notes

  • drug and alcohol substance abuse

  • HIV content

Security Rule

• safeguards ensure the security of ePHI

  • Administrative safeguards- policies and procedures

  • Physical safeguards- proper use of workstations

  • Technical safeguards- only authorized employees

Health Information Technology for Economic and Clinical Health Act (HITECH) ACT

• passed in 2009

• contains provisions that increased enforcement of privacy and security of electronic transmission and health information

• made business associates directly liable for compliance with HIPAA

• prohibited sale of PHI without patient’s consent

Food, Drug, and Cosmetic Act

• became law in 1937

• replaced food and drug act of 1906

• FDA is responsible for safety, effectiveness, security, and quality of drugs, cosmetics, and food

• FDA website provides useful information for healthcare facility

Controlled Substances Act

• part of comprehensive drug abuse prevention and control act of 1970

• DEA enforces the law

• DEA overseas manufacturing, importation, possession, use, and distribution of certain drugs and chemicals

• five schedules of medication

  • arranged from greatest to least abuse potential

Patient Protection and Affordable Care Act

• Commonly known as the affordable care act

• signed into law in 2010

• goal was to provide Americans with affordable health insurance

• attempted to reform healthcare system; reduce healthcare spending

Clinical Laboratory Improvement Amendments (CLIA)

• passed in 1988

• establishes quality standards

  • focus on accuracy, reliability, and timeliness

• regulates laboratory testing

• federal agencies involved:

  • The food and drug administration (FDA)

  • Centers for Medicare and Medicaid Services (CMS)

  • Centers for Disease Control and Prevention (CDC)

Occupational Safety and Health Act (OSH Act)

• passed in 1970

• enforced by Occupational Safety and Health Administration (OSHA)

• sets workplace standards

• conducts inspections to ensure employee safety

• employees must comply with all of OSHA’s regulations

Needlestick Safety and Prevention Act

• signed into law in 2000

• goal was to reduce risk of healthcare workers’ exposure to bloodborne diseases

• required OSHA to update Bloodborne Pathogens Standards

• Revised standards apply to all employees with anticipated occupational exposure to blood or other potentially infectious materials (OPIM)

Good Samaritan Laws

• state laws that provide legal protection for those assisting an injured person during an emergency

• person responding must:

  • not be paid for care given

  • act reasonably

  • not act negligibly or recklessly

Laws for End-of-Life Issues

• patient self-determination act

  • requires most healthcare institutions to inform patients of their right to make decisions; facility’s policies respecting advance directives

• Uniform Determination of Death Act (UDDA)

  • guide for state lawmakers to create their own laws that define death

• Uniform Anatomical Gift Act (UAGA)

  • purpose was to make organ donations easier

• National Organ Transplant Act (NOTA)

  • established national registry for organ matching

Compliance Reporting

• administration must have policies and procedures in place for employees to report issues

• reports need to be followed up on

• documentation may need to be done

• healthcare providers also need to report on specific diseases, injuries, or vaccine issues

Compliance with Public Health Statutes

• healthcare providers have a responsibility to report specific information to various authorities

  • births and deaths

  • specific diseases

  • sexually transmitted infections (STIs)

  • specific injuries related to violence

  • abuse, neglect, and exploitation

Reportable Diseases

• Communicable diseases that have significant public health impact

  • Examples of reporting levels and reporting procedures

    • Urgent reporting: hepatitis A, food or water disease outbreaks, pertussis, measles, plague

    • Less urgent reporting: sexually transmitted infections, Lyme disease, hepatitis B, C, D, and E

    • Highly confidential: acquired immune deficiency syndrome (AIDS) and HIV infections

Wounds of Violence

• statutes vary state to state

• typically, reportable cases include wounds caused by:

  • gunshots

  • stabbings

  • specific types of burns

  • knife

  • axe

  • sharp pointed instrument

Child Abuse, Neglect, and Exploitation

• federal child abuse prevention and treatment act (CAPTA) aided states as state statutes were drafted

  • also defined child abuse and neglect

• All states and territories require child maltreatment to be reported

• Mandatory reporters need to provide facts

Adult Abuse, Neglect, and Exploitation

• older Americans act (1965)

  • purpose was to maintain rights and dignity of older person

  • created administration on aging

• many ambulatory healthcare facilities are screening older adults to identify those who do not feel safe in their living conditions

• important to remember that both men and women can be victims of domestic abuse

Reporting Vaccination Issues

• Vaccine Information Statement (VIS)

• If a patient has an unusual side effect from vaccine, the provider might need to file a report with Vaccine Adverse Event Reporting System (VAERS)

• National Childhood Vaccine Injury Act (1986)

  • Created National Vaccine Injury Compensation Program (VICP)

  • Lifts burden of lawsuits from vaccine manufacturers and healthcare providers

Compliance Programs

• a program within a business that detects and prevents violations of state and federal laws

• an effective compliance program helps protect the organization from fines and lawsuits

• different reporting pathways in ambulatory care settings

Employment Concerns

• relate to discrimination, harassment, retaliation and retribution, and unfair employment practices

• employers cannot fire an employee for an illegal reason (wrongful terminations)

• Medical Assistant should be aware of employment laws

  • Follow up on reporting procedures outlined in facility’s compliance program

Interview Concerns

• stay away from specific topics during interviews

  • birthplace, ancestry, or national origin

  • marital status, children, or pregnancy

  • health or medical history, or physical disability

  • religion or religious days observed

  • age, race, ethnicity, gender, or color

  • criminal record

Incident Reports and Risk Management

• gather information about the situation in case of a future lawsuit

• communicate issues for risk managements procedures

• medical assistant should remember:

  • complete an incident report for patient complaints, medication errors, medical device malfunctions, or any injuries

  • complete an incident report clearly and accurately in pen or electronically

  • List the facts

  • Make sure to Completely it by the end of the day

  • Do not mention incident report in patient record

Patient Safety Concerns

• if medical assistant is involved in situation in which a person is harmed:

  • immediately notify provider

  • arrange to have the person seen by the provider immediately

  • complete the incident report

  • notify the department supervisor

  • notify state or federal governmental agencies

Closing Comments and Patient Education

• take the time to explain forms as needed

• if appropriate, use simple phrases when answering questions

• if possibly, help complete whatever information you can

• should a MA feel that a task conflicts with a law, talk to a supervisor

• focus on the patient

• be upfront and honest about errors with supervisor, provider, and patient (per agency policy)