CPHRM Legal and Regulatory 2014
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| Statutory law | enacted by congress and approved by the president (PSQA, EMTALA, COP)
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| Administrative law | Regulations and rules developed and implemented by a federal or state agency to provide direction for carrying out the purposes of the Acts it oversees (how to implement EMTALA, COP)
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| Patient Self-Determination Act | provide written info to all adult patients on admission; comply with state law regarding pt rights; document in MR; do not condition the provision of care on execution of advance directive; educate staff and community
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| Types of Advance Directives | Living Wills and Power of Attorney
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| Advance Directives vs. DNR | Advance Directives come from patient vs. DNR is physician’s order
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| Rescinding of DNR orders | may be rescinded for surgical interventions
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| Capacity | normally determined by physician; patient must be able to understand the nature of the situation and the consequences of the decision and are able to communicate the wishes to the caregiver
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| Outcome of Quinlan Case | established ethics committee and led to creation of advanced directives
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| Outcome of Cruzan Case | Developed Patient Self Determination Act
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| Outcome of Stamford Case | Theory of “battery” resulted
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| Outcome of Schlinder Case | Withdrawal of life support; Support of patient’s wishes
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| Ethics Committee decisions | nonbinding; consultative only
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| Informed consent basic elements | disclosure of nature and purpose; probable risks and benefits; risks and benefits of alternatives; risks and benefits of foregoing; opportunity for questions and understandable answers; opportunity to make decision free of coercion and undue influence
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| Battery vs Negligent Consent | battery is intentional and does not require proof of harm; negligent consent is unintentional that requires injury
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| CoP | provides minimum health and safety standards providers must meet for Medicare and Medicaid certification
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| CoP Nursing Mandated reporting | reporting blood transfusion reactions, adverse drug reactions, and medication errors
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| HACs | CMS Hospital Acquired Conditions: retained objects; air embolism; blood incompatibility; stage III and IV Pressure Ulcers; Falls and Trauma: Iatrogenic Pndumothorax; poor glycemic control; CAUTI; Vascular Catheter-Associated Infection; SSI; DVTl/PE
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| HCQIA | Health Care Quality Improvement Act: National Practitioner Data Bank provides conditional immunity from anti-trust suits against healthcare facilities and their medical staff that participate in peer review
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| NPDB reporting requirements | report payments of judgments or settlements within 30 days; actions taken which adversely affect privileges of physicians report within 15 days; disciplinary actions report within 30 days
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| HIPDB | Healthcare Integrity and Protection Data Bank: clearinghouse for the reporting and disclosure of certain final “adverse actions” taken against health care practitioners, suppliers, and other providers in an effort to combat fraud and abuse
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| Hospital Value-Based Purchasing Program domains | Clinical Process of Care; Patient Experience of Care; Outcome
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| Hospital Value-Based Purchasing Program | Quality incentive program built on the Hospital Inpatient Quality Reporting (IQR) measure reporting infrastructure
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| SMDA | Safe Medical Device Act: Gathers information regarding safety of medical devices, including reports about adverse incidents associated with their use (including user error)
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| SMDA required to report vs. exempt | Reports: Hospitals, ambulatory surgical centers, outpatient diagositc, nursing homes, home care agencies, ambulance providers, rehab/psych facilities; Exempt: Physicians’ offices, etc
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| SMDA what and when to report | Death to manufacturer and FDA within 10 days; serious injury to manufacturer (or FDA if manufacturer is unknown) within 10 working days; eMDR summary no later than January 1st
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| EMC | Emergency Medical Condition (under EMTALA) which includes psychiatric illness, including alcohol and drug intoxication
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| Criteria for discharging unstable patient | patient refuses treatment or requests transfer; hospital does not have capability; physician certifies that benefits of transfer outweigh the risks
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| EMTALA Mandatory Reporting | required to report suspected improper transfers within 72 hours
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| EMTALA Sanctions | termination of the hospital’s Medicare provider agreement or civil monetary penalties of up to 50K per violation
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| LTC Laws | Long Term Care Laws: requirements that an institution must meet in order to qualify to participate as a SNF (skilled nursing facility) in the Medicare program, and as a nursing facility in the Medicaid program
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| Child Abuse and Elder/Dependent Abuse Reporting Laws | need process in place to define who is allowed to do reporting
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| ADA Title III | Nondiscrimination on the Basis of Disability in Public Accommodations and Commercial Facilities
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| ADA definition of disability | a physical or mental impairment that substantially limits one or more of the major life activities of such individual
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| HITECH | Health Information Technology for Economic and Clinical Health Act: promotes and advances the adoption of health information technology (HIT)
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| HITECH Breach Notification timeframe | within 60 days notify individual, post on home page, imminent misuse notice by telephone, written notice, if over 500 residents must provide to prominent media
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| Omnibus Budget Reconciliation Act | Stark I, II, III – Anti self-referral law; deters fraud by prohibiting a physician from referring patients to an entity if the physician or a member of his immediate family has a financial relationship with the entity
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| RAC | Recovery Audit Program: to identify and correct Medicare improper payments through the detection and collection of overpayments and underpayments made on claims of health care services provided to Medicare beneficiaries
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| MMSEA | requires that liability insurers (including self-insurers), no-fault insurers, and workers’ compensation plans report specific information about Medicare beneficiaries
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