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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)
Notice of Privacy Practices
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
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
Abuse and neglect of children
Abuse and neglect of the elderly and disabled
Vital records
Communicable diseases
Induced termination of pregnancy (abortion)
Birth defects
Abuse and neglect of children
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

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 prescribe timeframe

No conflict with HIPAA regarding authorization for disclosure due to public interest and benefit exceptions
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

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
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
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
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
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
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
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.
Information commonly reportable to ME or coroner:
-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
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 and other instances that might assist with public health prevention and control programs.
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 and Other State Reporting Requirements
Some states require reporting of unusual events
--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 and NRC information on use of radioactive materials and any misadministration of the material
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.
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
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.
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
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 percent reduction of reimbursement.
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
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
Healthcare Integrity and Protection Data Bank (HIPDB)
Established under Section 1128E of the Social Security Act; operational in 2000

Purpose - 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
NPDB and HIPDB
Information reported to the data banks is considered confidential and 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 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.
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.
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/or the FDA
--Where report was submitted (FDA, manufacturer, or distributor)
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
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 and confidential commercial or financial information related to the manufacturer
--Identifying information of the reporter of the event
Reporting of Occurrences with Electronic Health Record Systems
FDA has also been studying the issue of regulating EHRs

ONC working with FDA and 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 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
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
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
Types of Registries
Type of registry determines what patient information is reported
--Cancer registry
--Trauma registry
--Immunization
--Birth defects
--Diabetes
--Implant
--Transplant
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))
Compliance
Refers to adherence to federal statutes and regulations designed to
--Prevent unjust financial enrichment
--Patient privacy breaches by healthcare providers or organizations.
Fraud
--A false representation of fact
--A failure to disclose a fact that is material (relevant) to a healthcare transaction
--Damage to another party that reasonably relies on the misrepresentation or failure to disclose
Abuse
Inconsistent handling of sound fiscal, business, or medical practices resulting in:
--Unnecessary costs to the program
--Improper payment
--Services that fail to meet professionally recognized standards of care or are medically unnecessary
--Services that directly or indirectly result in adverse patient outcomes or delays in appropriate diagnosis or treatment
Most Common Types of Fraud
--Billing for services that were never rendered
--Billing for more expensive services or procedures than were actually provided - upcoding
--Performing medically unnecessary services
--Misrepresenting non-covered treatments as medically necessary
--Falsifying a patient's diagnosis to justify tests or procedures
--Unbundling
--Billing patients more than the co-pay amount for services
--Accepting kickbacks for patient referrals
--Waiving patient co-pays or deductibles and overbilling the health plan (NHCAA)
To Combat Fraud and Abuse
Revenue cycle management
--Supervision of all administrative and clinical functions that contribute to the capture, management, and collection of patient service revenues

Role of documentation
--Documentation must support the billing
--Claims, requests for reimbursement, and supporting documentation must be complete and accurate
--Reflect reasonable and necessary services ordered by an appropriately licensed medical professional
False Claims Act (FCA) (31 USC 3729)
Primary litigation tool for combating fraud, contains both criminal and civil provisions
Qui tam (whistleblower)
Private persons known as relators may enforce the FCA by filing a complaint, under seal, alleging fraud committed against government.

Provides protection to qui tam relators who are discharged, demoted, suspended, threatened, harassed, or in any other way discriminated against
What constitutes a false claim?
--Must establish that the claim was false or fraudulent
--Furnishing inaccurate or misleading information
--FCA has been extended to cover quality of care cases.
Knowing Standard
Provider must have knowingly submitted the false claim

FCA defines "knowing" and "knowingly" to mean that a person:
--Has actual knowledge of falsity of information
--Acts in deliberate ignorance of truth or falsity of information
--Acts in reckless disregard of truth or falsity of information
Fraud Enforcement and Recovery Act of 2009: Revisions to FCA
Expanded potential for liability under FCA and also expanded government's investigative powers

FCA penalties apply to "any person who knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval," regardless of to whom the claim was made.

Definition of a "claim" expanded to broaden the types of payments that fall within the scope of FCA.

Established that FCA penalties apply to "any person who knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim"

Expanded anti-retaliation protections for whistleblowers

Expanded US attorney general's authority to issue civil investigative demands

Broadened the federal government's authority to share documents obtained through subpoena with qui tam relators and other parties
Patient Protection and Affordable Care Act: Revisions to the FCA
Known as the health reform bill

Further amend the FCA by allowing private individuals more successful in filing false claims lawsuits

Broadened the definition of "original source" to allow public disclosure defense to be overcome if individual bringing suit possesses knowledge that adds to publicly disclosed information.

Clarified retention of overpayments
Federal Anti-Kickback Statute (42 USC 1320a-7b)
Establishes criminal penalties for individuals and entities that knowingly and willfully offer, pay, solicit, or receive remuneration in order to induce business for which payment may be made under any federal healthcare program

Remuneration - defined broadly to include the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind

Violation constitutes a felony punishable by a fine of up to $25,000, imprisonment for up to five years, or both

Clearly prohibits payments for patient referrals
Federal Anti-Kickback Statute (42 USC 1320a-7b)
Statutory exceptions created to protect legitimate business arrangements
--Discounts that are properly disclosed and reflected in the costs claimed
--Payments by an employer to an employee for provision of covered items and services
--Certain risk-sharing arrangements
--Waivers of coinsurance amounts in connection with certain federally qualified healthcare centers
Safe Harbors
activities that are not subject to prosecution and protect the organization from civil or criminal penalties
--Investments in certain large or small entities
--Investments in entities in underserved areas
--Space and equipment rental

Common theme - to protect certain arrangements in which commercially reasonable items or services are exchanged for fair market value compensation.

OIG issues Special Fraud Alerts and Advisory Opinions to provide insight into views on application of kickback statute
Civil Monetary Penalties
administrative remedies, CMP law authorized Secretary and Inspector General of HHS to impose CMPs, assessment, and program exclusions on individuals and entities whose wrongdoing caused injury to HHS programs or their beneficiaries
HIPAA
expanded OIG's sanction authorities and application of CMP provisions beyond those funded by HHS to include all federal healthcare programs (such as Tricare, Veterans Affairs, and Public Health Service)
Federal Physician Self-Referral Statute (the Stark Law)
Prohibits physicians from ordering designated health services for Medicare (and to some extent Medicaid) patients from entities with which the physician, or an immediate family member has a financial relationship

Exclusions
--Services that are reimbursed by Medicare as part of a composite rate
--Certain referral relationships are permitted, such as a request by a pathologist for clinical diagnostic laboratory tests.
--Physician services exception
--In-office ancillary services
--Financial arrangements between academic institutions and their affiliated hospitals and physicians
Sherman Antitrust Act
Illegal to restrain trade through contracts or conspiracies, and they prohibit price fixing and mergers that lessen competition

Federal Trade Commission (FTC) and the Department of Justice enforce these laws

Healthcare mergers and joint ventures and credentialing and peer review processes must be carefully handled to avoid anti-trust issues
Deficit Reduction Act of 2005
Significant to compliance because it has transformed compliance programs from voluntary to mandatory

Contains Employee Education about FCR provision, which requires any entity that annually receives or makes at least $5 million in Medicaid payments to establish written policies for all employees of the entity (including management) and for any contractor or agent of the entity

Written policy must provide:
--Detailed information about the FCA
--Administrative remedies for false claims and statements
--Any state laws pertaining to civil or criminal penalties for false claims and statements
--Whistleblower protections

Detailed provisions regarding the entity's policies and procedures for detecting and preventing fraud, waste, and abuse
High-Risk Areas for Potential Fraud and Abuse
--Billing for non-covered services
--Altered claim forms
--Duplicate billing
--Misrepresentation of facts on claim form
--Failing to return overpayments
--Unbundling
--Billing for medically unnecessary services
--Overcoding or upcoding
--Billing for items or services not rendered
--False cost reports
OIG office
responsibility to report program and management problems to both the HHS Secretary and Congress, along with recommendations to correct them.
--2011 Workplan includes: hospital admissions with conditions coded "present on admission," hospital readmissions, payments for diagnostic x-rays in hospital emergency departments, accurately coding claims for Medicare home health resource groups, quality of care in skilled nursing facilities, physician coding of place of service, laboratory test unbundling by clinical laboratories, and Medicare billings with the modifier GY
--OIG identifies payments for noncovered services, improper coding, and other types of improper payments for various inpatient and outpatient services.
Office of Audit Services
Provides auditing services for HHS, conducts audits with its own audit resources or by overseeing audit work done by others
Office of Evaluation and Inspections
Conducts national evaluations to provide HHS, Congress, and public with timely, useful, and reliable information on preventing fraud, waste, and abuse and promoting economy, efficiency, and effectiveness in departmental programs
Office of Investigations
Conducts criminal, civil, and administrative investigations of fraud and misconduct related to HHS programs, operations, and beneficiaries

Implementing state-of-the-art, cutting-edge technology to identify and analyze potential fraud with unprecedented speed and efficiency
Top Management Challenges facing HHS
Helping healthcare providers and suppliers adopt practices that promote compliance with program coverage, payment, and quality requirements must be an integral part of the HHS's program integrity strategy
Five principles to guide HHS's integrity strategy
1. Enrollment - scrutinize individuals and entities that seek to participate as providers

2. Payment - establish payment methodologies

3. Compliance - assist healthcare providers and suppliers in adopting practices that promote compliance

4. Oversight - monitor programs for evidence of fraud, waste, and abuse

5. Response - respond swiftly to detected fraud and impose appropriate punishment
Role of Department of Justice (DOJ)
Root out fraud and safeguard taxpayers from illegal conduct

Works in collaboration with a number of other federal agencies to investigate and prosecute fraudulent activities
Coordinated Fraud and Abuse Control Program
--Part of 1996 HIPAA legislation established nationwide
--Joint effort between the attorney general and HHS through the inspector general
--Coordinates federal, state, and local enforcement efforts to identify, prosecute and prevent healthcare fraud and abuse
Joint DOJ-HHS Medicare Fraud Strike Force
Multi-agency team designed to combat Medicare fraud through use of Medicare data analysis and focus on community policing

Supplements criminal enforcement activities of US Attorneys Office by targeting chronic fraud and other criminal schemes
Health Care Fraud Prevention and Enforcement Team (HEAT)
Interagency task force put into place in 2009; focuses on strengthening existing fraud tools and new ways to detect and prevent fraud

Medicare Fraud Strike Force part of HEAT
Recovery Audit Contractor (RAC) Program
Tax Relief and Health Care Act of 2006 requires Secretary of HHS to utilize Recovery Audit Contractors (RACs) under the Medicare Integrity Program.

Mission - reduce improper Medicare payments through detection and collection of overpayments, identification of underpayments, and implementation of actions to prevent future improper payments.

Review claims on a postpayment basis, utilizing data analysis techniques to identify claims most likely to contain overpayments (a process known as "targeted review")

Conduct two types of review: automated and complex
--Complex requires review of medical/health records

Paid on contingency fees based on amount of over and underpayments identified
--Report potential fraud to CMS and quality issues to QIOs
Program Safeguard Contractors (PSCs) and Zone Program Integrity Contractors (ZPICs)
Conduct medical reviews of claims either prepayment or postpayment. They identify claims suspected of fraud and take corrective action.
Medicare Administrative Contractors (MACs)
Medicare claims payment processors, also have responsibility for detecting fraud and abuse
Medicaid Integrity Contractors (MICs)
Responsible for detecting fraud and abuse, but limited in ability to suspend, deny, or recoup payments until specific state Medicare program has reviewed their findings
Corporate Compliance Programs
Evolved from 1991 US Sentencing Commission's Federal Sentencing Guidelines
--Fines and penalties reduced to organizations found guilty of fraud if organization has a fraud prevention and detection program in place
--Helps organizations identify problems and improve performance and avoid a corporate integrity agreement (program imposed by government with oversight and outside expert involvement)
--Program requires a compliance officer - responsible for overseeing processes that promote an organization's ethical business practices and its conformity to federal, state, and private payer program requirements.
Who should have compliance programs place?
--Hospitals
--Clinical laboratories
--Home health agencies
--Third-party medical milling companies
--Durable medical equipment providers
--Hospices
--Medicare+Choice organizations
--Nursing facilities
--Ambulance suppliers
--Individual and small group physician practices
--Pharmaceutical manufacturers
--Recipients of US Public Health Service (PHS) research awards
--Part D plan sponsors (included in the Medicare Prescription Drug, Improvement and Modernization Act of 2003)
Guidelines offer Seven Steps for an Effective Compliance Program
1. Establish compliance standards and procedures that are reasonably capable of reducing criminal conduct

2. Assign responsibility to oversee compliance with the standards and procedures to specific individual(s)

3. Use due care to avoid delegation of substantial discretionary authority to an individual

4. Communicate the standards and procedures to all

5. Achieve compliance with the standards through monitoring and auditing

6. Enforce standards through appropriate disciplinary mechanisms

7. Respond appropriately to any offense detected to prevent similar offenses in the future
Elements of a Corporate Compliance Program
Compliance programs should be tailored specifically to individual organization but should at least include elements that address:
--Corporate code of conduct
--Policies and procedures (practice standards)
--Education and training
--Auditing and monitoring
--Offense detection and corrective action initiatives
--Enforcing disciplinary standards through well-publicized guidelines
Governing Board (Board of Directors)
--Ultimate responsibility for the quality of care and financial well-being of the healthcare organization
--Controlling authority for healthcare organization
--Responsible for providing adequate staff
Responsibilities of the Governing Board
--Define the mission and purpose of the organization
--Select (hire) the chief executive officer (CEO)
--Review and support the CEO
--Ensure adequate organization planning
--Ensure the financial health of the organization (fiduciary duty)
--Ensure the quality of patient care
--Enhance the public image of the organization
--Serve as a court of appeals (for due process of the medical staff)
--Assess the performance of the board of directors (BOD)
Chief Executive Officer (CEO)
--Reports directly to governing board
--Works with medical staff to provide patient care
--Responsible for overall management of healthcare facility
Medical Staff
--Responsible for oversight of quality of patient care
--Directly accountable to governing board
--Governed by medical staff bylaws
Medical Staff Bylaws
Must be voted on by medical staff and approved by governing board

Bylaws outline medical staff obligations

Considered a contract; legally binding in most states

Requirement for a medical staff is found in:
--Hospital licensure regulations
--accreditation standards such as The Joint Commission
The Joint Commission and Medical Staff Standards
Requires medical staff bylaws address self-governance and accountability to governing body

Medical staff must operate under direction of medical staff officers and committee structure.

Officers:
--President, president-elect, chief of staff, vice chief of staff
--Others may be appointed depending on organization size.
Medical Staff Committees
Executive committee
--Elected members of the medical staff, act on its behalf, have voting rights

If hospitals uses Joint Commission accreditation for "deemed status" in lieu of Medicare or Medicaid certification process, executive committee is required.
Typical Medical Staff Committees
May be many more committees depending on type of hospital
--Credentials
--Bylaws
--Continuing medical education
--Nominating
--Professional affairs
--Clinical oversight
--HIM
--Quality improvement
--Infection control
--Pharmacy and therapeutics
Categories of Medical Staff
Active
Associate
Courtesy
Consulting
Honorary
Affiliate
Medical Staff Credentialing
Process of reviewing and validating qualifications of physicians and other licensed practitioners for granting medical staff membership

Credentialing protects:
--Public from professional incompetence
--Medical staff from working with incompetent professionals
--Facility form liability due to providing inadequate care
--Right of medical staff from unfair restrictions on their practice
Joining the Medical Staff
Must have rigorous application process in place

Primary verification process - must verify from primary source information on the application
--for example, request certified transcript rather than copy

Credentials verification organization - company that provides verification service to organization
Kadlec Medical Center v. Lakeview Anesthesia Associates
Louisiana Federal Court found hospitals have a duty to disclose information about current and former medical staff members to other healthcare providers to protect future patients when physician moves on.
Joining the Medical Staff
Must query National Practitioner Data Bank (NPBD) for any adverse actions taken against practitioner at time of initial application and every two years thereafter

Should check Office of Inspector General's list of individuals and organizations excluded from participating in Medicare, Medicaid or other federal program
--Civil penalties may be assessed if an excluded practitioner is hired.
Determination of Clinical Privileges
Similar to process for medical staff application, usually applies for privileges at same time

Expected competencies include:
--Patient care, medical/clinical knowledge, practice-based learning and improvement, interpersonal communication skills, professionalism, and systems-based practice

Determining of privileges also requires continuing evaluation.
--Focused professional practice evaluation
--Time-limited period in which organization evaluates and determines practitioner's professional performance
--Ongoing professional practice evaluation
--Documenting data on credentialed staff on an ongoing basis rather than on two-year cycle
Medical Staff Duties and Rights
Duty to provide patient care, treatment, and service as needed to patients

Must respond to calls from emergency dept. and provide consultation services when appropriate
--Potential area for sanction if physician does not

Maybe required to be "on call"

Must serve and attend medical staff committees

If teaching facility, then required to supervise fellows, residents, and interns
Health Record Integrity and Documentation Requirements
Rules for timely completion of records, legibility requirements, communication and coordination of care with others, completion of reports (for example, history and physical, progress notes, operative report)

Failure to comply may lead to disciplinary action
Disciplinary Actions and Suspensions
Procedures must be in place to deal with disciplinary actions and suspensions
--Revoke admitting privileges or time in operating room

Action must be reported to NPDB
Due Process
Required in hiring, disciplinary process or other actions affecting medical staff privileges or employment

Two elements of due process:
--Substantive - guarantees laws are fair, reasonable, and not arbitrary; allows for challenges to a law's content and substance
--Procedural- government shall not take a person's life, liberty, or property without due process of law

Places restrictions on government and public facilities and may also apply to private organizations that perform public functions or involved in state action

Hallmark of legal system but is increasingly being exercised outside of court system

Healthcare organizations are using policies and procedures to spell out adherence to due process
Other consideration - Antitrust Laws
Watch for anti-competitive conduct that violates antitrust laws including excessively restrictive noncompete clauses

Beware of "economic credentialing," that is, granting or denying privileges based on financial indicators rather than factors related to clinical performance.
Goal of Workplace Law
To strike a balance between employee and employer that protects the employee from personal injury, prejudice, duress, and unwanted sexual advances while allowing the employer to pursue desired business outcomes
Workplace Laws
Federal employment laws
--Deal with employee-employer issues

Federal labor laws
--Refer to employer-union issues or other labor practices
Equal Employment Opportunity Commission (EEOC)
Enforces federal laws that discriminate against employee or job applicant on basis of:
--Age
--Disability
--Compensation
--Genetic information
--National origin
--Pregnancy
--Race/color
--Religion
--Retaliation
--Sex
--Sexual harassment
Equal Employment Opportunity Act of 1972
Gives authority to the EEOC to sue in federal court if there is reasonable cause to believe discrimination

Uniform Guidelines on employee selection procedures
--EEOC publication that supports "employee selection must be made on qualifications related to job performance"
Title VII of the Civil Rights Act of 1964
Prohibits discrimination based on age, race, color, national origin, sex, religion, age, disability, political beliefs, and marital or familial status

EEOC was created as part of this act.

Prohibits intentional discrimination and practices that discriminate against someone

1991 act expanded to authorize compensatory and punitive damages in cases of intentional discrimination
Age Discrimination in Employment Act of 1967
Protects individuals 40 years or older; however, some states have laws that protect younger workers.

Applies to any aspect or terms of employment (hiring, promotion, discharge, pay, fringe benefits, job training, and classification referral)

Includes harassing someone because of their age verbally or in writing or condoning a hostile or offensive work environment
American with Disabilities Act of 1990
Protects individuals with disabilities, broadly defined to include physical conditions, psychological conditions, contagious diseases, substance abuse, and other conditions

Employers must provide "reasonable accommodations"
Equal Pay Act of 1963
Regulates the concept of equal pay for men and women who perform similar work requiring similar skills, effort, and responsibility under similar working conditions
Genetic Information Nondiscrimination Act (GINA) of 2008
Prohibits health insurers and employers from discriminating against an individual or employee based on genetic information

Restricts information about an individual's genetic tests; family members' genetic tests; manifestation of diseases or disorders in family members (family medical history); requests for or receipt of genetic services; or participation in research that includes genetic services by an applicant, employee, or family member
National Origin
Illegal to discriminate against an individual because of birthplace, ancestry, culture, or linguistic characteristics common to a specific ethnic group

Immigration Reform and Control Act of 1986 requires employers to assure that employees hired are legally authorized to work in the U.S.; however, can't single out individuals of a particular origin who appear foreign. Must treat everyone similarly.
Title VI of the Civil Rights Act
Focus of Title VI is on patients with limited English proficiency (LEP) and employees as well. Title VI applies to any healthcare organization or entity that receives federal funding
--obligation to translate vital materials such as informed consents LEP persons and provide interpreters
Civil Rights Act was expanded by the Pregnancy Discrimination Act of 1973
which prohibits discrimination against pregnancy, childbirth, or related medical conditions
Sexual harassment
unwelcome sexual advances, requests for sexual favors, and other verbal or physical harassment of a sexual nature
Labor Laws
Fair Labor Standards Act of 1938 (and amendments)
--Addresses minimum wage and overtime pay
--Age limitations on hiring children
--Sets minimum wage standard
--Exempt employees (professionals, administrators, salespeople)
--Non-exempt employees - paid minimum wage and time-and-a-half for overtime
Compensation and Benefits
Compensation includes direct and indirect pay

Benefits
--Medical, dental, life, accident insurance
--Child and elder care
--Retirement plans
--Longevity pay
Employment Retirement Income Security Act of 1974 (ERISA)
Sets minimum standards for most voluntarily established pension and health plans in private industry to provide protection for individuals in these plans
Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1986
Provides continued health insurance for a certain period of time for those who have lost coverage because of termination
Benefits and HIPAA
Includes protections for coverage under group health plans that limit exclusions for preexisting conditions; prohibits discrimination against employees and dependents based on their health status; and allows a special opportunity to enroll in a new plan to individuals in certain circumstances

Right to purchase individual coverage if you have no group health plan coverage available, and have exhausted COBRA or other continuation coverage
Unions
Total number of unionized workers in 2010 = 14.7 million, 9.2% of these union members are in healthcare support occupations

Issues that support union activity
--Minimum staffing, overtime pay issues, and recruitment; workers want protection of their jobs and formal method of communicating with management
National Labor Relations Act (NLRA) of 1935 (a.k.a. Wagner Act)
--Regulates union and employer relations in the private sector
--Gives employees the right to self-organize, to form, join, or assist labor organizations
--Allows employees to bargain collectively through whomever they chose as their representative and to engage in other activities for mutual and protection
Labor-Management Relations Act of 1947
Amended Wagner Act to prohibit unfair labor practices on part of unions and allows president of the United States to stop strikes in cases that might impact national health and safety

Identified behavior considered to be unfair labor practices on part of employers
National Labor Relations Board (NLRB)
Independent federal agency that safeguards employees' rights to engage in union activity

Oversees union elections and handles unfair labor practice committed by private sector employers and unions

Assumed jurisdiction over hospitals in 1974

Person most responsible for operation of union contract on a day-to-day basis is supervisor
--Training of supervisors and departmental management is important to ensure good relationships
NLRB
When union organizing begins, an election following NLRB regulations is conducted to determine if a union will be authorized to bargain and negotiate a labor contract with management, as well as which employees will be part of the bargaining unit that will be covered.

Contracts deal with union recognition, management rights, union security, wages, pensions, benefits, conditions, and hours of work, vacations, holidays, leaves of absence, seniority, promotions, and similar terms and conditions of employment.
Collective Bargaining
Process whereby contract is negotiated that sets forth the relationship between the employees and the healthcare organization

Must abide by the contract in matters of discipline when employees do not follow organization's rules and in handling employee grievances or complaints
Union process
Grievance procedure: Handles situations such as violation of a work rule or other condition of employment, begins with the employee and the supervisor

Union steward: Represents the employee

Employee has right to due process

Arbitration: Issues that are not settled go to hearings by a third party—to settle an agreement
State Laws on Unions
State labor laws may be fashioned after federal labor laws or a state law may establish its own version of the law.

Many states have enacted "right to work" laws, which means that a worker does not have to join a labor union to keep or land a job.

Federal labor law is considered minimum law.

A state may enact stricter labor laws or labor laws that go beyond the federal laws. If the state law is considered stricter than the federal law, then the state law will preempt the federal law.
Occupational Safety and Health Act of 1970
To help employers reduce injuries, illnesses and deaths on the job

Established Occupational Safety and Health Administration (OSHA)
--Responsible for setting and enforcing workplace safety standards, and providing information, training, and assistance to employers and workers
OSHA
Works closely with Center for Disease Control (CDC) in identifying best practices for management of diseases and/or injuries that may affect employees in workplace

Provides guidelines for handling hazardous chemicals, equipment, and waste products such as chemicals or equipment used in laboratories and radiology, and blood fluids, tissues, vaccines, etc. related to patient treatment
Occupational Exposure to Bloodborne Pathogens of 1991
Established to set safety standards for exposure to viruses and other microorganisms such as human immunodeficiency virus (HIV) and hepatitis viruses B and C and other bloodborne pathogens
Needlestick Safety and Prevention Act of 2001
Directed OSHA to revise bloodborne pathogen standard to require employers to establish an exposure control plan including controls to eliminate or minimize employee risk as a result of needlestick and other sharp devices
Employer Responsibility
Duty under OSHA standards to provide employees with a safe working environment especially in a healthcare setting

Must keep detailed records on all safety issues. Recordkeeping requirements are defined in the 2001 rule on Occupational Injury and Illness Recording and Reporting Requirements ("the recordkeeping rule").
Employer Responsibility
--Follow all relevant OSHA safety and health standards
--Find and correct safety and health hazards
--Inform employees about hazards
--Notify OSHA within 8 hours of a workplace fatality or when three or more workers are hospitalized
--Provide required personal protective equipment
--Post OSHA citations, injury and illness summary data
--Not discriminate or retaliate against any worker for using their rights under the law
Employee Responsibility
Employees also have a duty to comply with OSHA standards and report problems, follow safety rules and wear protective equipment if required to do so.

Employees have the right to:
--Working conditions that do not pose a risk of serious harm
--Receive information and training
--Review records of work-related injuries and illnesses
--Get copies of test results
--File a complaint asking OSHA to inspect their workplace
--Use their rights under the law without retaliation or discrimination
OSHA Inspections
Usually unannounced. However, under special circumstances an employer may be given 24 hour notice of a pending inspection for the following:
--Imminent danger situations that require correction as soon as possible
--Accident investigations
--Inspections that must take place after regular business hours or that require special preparation
--Cases where notice is required to ensure that the employer and employee representative or other personnel will be present
--Cases where an inspection must be delayed for more than 5 working days
--Situations in which the OSHA area director determines that advance notice would produce a more thorough or effective inspection