Standards, Policies, Procedures Flashcards
- *Discuss regulatory requirements: False Claims Act**
- *(“Lincoln Law”) (Overview).**
The False Claims Act (first enacted in 1863 and updated in 1986 with subsequent amendments) allows the government to recover money paid as the result of the submission of false or fraudulent claims to government programs (such as Medicare and Medicaid). Liability results from knowingly submitting a false claim, or making a false record/statement in order to receive payment for a false claim. False claims are those that the entity knows or should know are violations. These claims may include claims for care not rendered, care already billed for miscoding/upcoding, and services not supported by documentation.
Fraudulent claims may also result from referrals made in violation of the Anti-kickback (Stark) Law. The reverse false claims section applies to those who act improperly to avoid paying money to the government The law provides incentives to whistleblowers, who may collect up to 30% of the False Claims Act recovery. If an entity receives an overpayment, the entity must repay the money within 60 days or be subject to penalties corresponding to three times the loss and $11,000 per claim.
Discuss regulatory requirements: False Claims Act:
Qui tam action.
An individual (relator) may file suit for violations of the False Claims Act on behalf of the government. The qui tam action is filed with the court under seal and the complaint and all relevant information served on the US Attorney for the judicial district and on the Attorney General of the United States. The seal continues for 60 days, during which time the government must investigate. However, if the investigation is not completed within 60 days, an extension may be granted. If the government takes action (intervenes), then it prosecutes the action. The government may dismiss or settle the action as long as the relator is notified.
Relator awards:
- If the government intervenes, the relator receives 15% to 25% of the recovered amount.
- If the government declines to intervene, the relator receives 25% to 30%.
- If the qui tam action is successful, the relator is entitled to payment of legal fees and other expenses.
Circumstances under which a relator is prohibited from filing or pursuing a qui tam action include:
- The relator was convicted of criminal conduct from his/her role in the FCA violation.
- Another relator was the first to file for the same conduct.
- The government is already involved in a civil or administrative proceeding for the same conduct.
- The action is based on information that was publicly disclosed by other than the relator.
Discuss regulatory requirements: CAN-SPAM Act (FTC)
The Federal Trade Commission implements the CAN-SPAM Act, which regulates all types of commercial messaging, including bulk mailing, email messages, and other electronic communications. The regulations, for example, apply to a website that advertises services or products. The law applies to both for-profit and non-profit organizations.
Requirements include:
- Header information must be accurate: Names must be accurate so that the person receiving a message can clearly determine the sender.
- Subject lines must be accurate and avoid any deception.
- Postal address that is valid and provides the physical location (street address and USPS PO box must be included).
- Receivers must have a means of indicating that they want no further communications, such as through an “unsubscribe” option.
- Requests to unsubscribe or receive no further communications must be promptly acted upon.
- All third-party contractors engaged in commercial messaging must be monitored for compliance with the regulations.
If communication is primarily transactional (discussing a transaction that was already agreed upon or providing updated information about a transaction), the law does not apply.
Discuss regulatory requirements: Environmental Protection Agency (EPA) laws and regulations.
The Health Care and Social Assistance Sector of the laws and regulations of the Environmental Protection Agency (EPA) cover:
- National Emission Standards for Hazardous Air Pollutants (NESHAP) (40 CFR, 63): Hospital Ethylene Oxide Sterilizers: Full loads of items with a common aeration time should be sterilized except when medical necessity requires a less than full load. Entities must submit an Initial Notification of Compliance Status or certify the use of a control device to limit emissions. Sterilization records must be kept for 5 years with the last 2 years’ records on site.
- Hospital, Medical, and Infectious Waste Incinerators (40 CFR 60, 62): Standards are set for solid waste incineration units and limits on pollutants (cadmium, carbon monoxide, hydrogen chloride, lead, mercury, nitrogen oxide, particulate matter, polychlorinated dibenzo-p-dioxins, polychlorinated dibenzofurans, and sulfur dioxide).
- Medical waste, on the other hand, is not regulated by the EPA but by state environmental laws as well as regulations of the CDC, OSHA, and FDA.
Discuss regulatory requirements: Occupational Safety and Health Administration.
The Occupational Safety and Health Administration (OSHA) is part of the Department of Labor and is charged with ensuring safe, healthful working conditions, and setting and enforcing workplace standards. OSHA covers most employers in the private sector, but state and federal safety regulations also generally conform to OSHA standards. Employers must provide safety training, must inform workers of chemical hazards, and must provide required personal protective equipment. OSHA must be notified of a workplace-related death within 8 hours** and **workplace-related injury that results in hospitalization, loss of an eye, or amputation within 24 hours. Workers may file a complaint about the workplace, conditions with OSHA and request an inspection. OSHA whistleblower program prohibits retaliation. OSHA provides HAZWOPER training courses (8-hour, 24-hour, 40-hour, and refresher) for first responders. OSHA has established regulations and guidelines that are industry-specific. For example, OSHA has regulations regarding emergency medical services. OSHA requires hazardous material to be color-coded with red indicating danger; yellow, caution; orange, warning; and fluorescent orange/orange-red, biological hazard.
Discuss regulatory requirements: OSHA Safety and Health Administration.
The Occupational Safety and Health Administration (OSHA) requires that safeguards to prevent occupational exposure and incidents be a part of infection control policies. Additionally, the FDA has requirements related to the safety of medical devices. Some states have regulations that are more restrictive than those of OSHA. Important elements include:
- An exposure control plan that outlines methods to reduce staff injury/ exposure.
- Use of universal precautions at all times with all individuals.
- Planning work practices to minimize danger and using newer and safer technologies as they become available, such as needles engineered to prevent injury.
- Sharps disposal methods prohibit bending, recapping, shearing, breaking, or handling contaminated needles or other sharps.
- Scooping with one hand may be used if recapping is essential.
- Workers must be trained in the use of universal precautions and methods to decrease exposure.
- Procedures for post-exposure evaluation and treatment must be part of the exposure control plan.
- Immunization with Hepatitis B vaccine available to healthcare workers.
Discuss regulatory requirements: Omnibus Budget Reconciliation Act (OBRA).
The Omnibus Budget Reconciliation Act (OBRA) of 1987 contains the 1990 Nursing Home Reform Amendments (NHRA). These amendments establish guidelines for nursing facilities (such as long-term care facilities).
Provisions include:
- Complete physical and mental assessment of each patient on admission, annually, and with the change of condition.
- Requirement for 24 hours nursing with RNs on duty for at least one shift.
- Nurse aide training is mandated as well as regular in-service and state registry of trained/qualified aides.
- Rehabilitative services must be available.
- Physicians/physician’s assistants/nurse practitioners must visit every 30 days for the first 3 months and then every 90 days thereafter.
- Outlawing/Discouraging Medicaid discrimination.
- Requirement for independent monitoring of psychopharmacologic drugs.
- Recognition of patients’ rights.
- Survey protocols to assess patient care and patient outcomes.
- State sanctions to enforce nursing home regulations.
Discuss regulatory requirements: CLSI, CLIA, and CDC
CLSI: The Clinical and Laboratory Standards Institute provides standards for a wide range of performance and testing and covers all types of laboratory functions and microbiology. These standards are used as a basis for quality control procedures. Standards include labeling, security/information technology, toxicology/drug testing, statistical quality control, and performance standards for various types of antimicrobial susceptibility testing.
CLIA: In the United States, all laboratory testing, except for research, is regulated by the CMS (Centers for Medicare and Medicaid) through the Clinical Laboratory Improvement Amendments. CLIA is implemented through the Division of Laboratory Services and serves approximately 244,000 laboratories. Laboratories receiving reimbursement from CMS must meet CLIA standards, which ensure that laboratory testing will be accurate and procedures followed properly.
CDC: The Centers for Disease Control and Prevention is a federal agency that supports health promotion, prevention, and health preparedness. The CDC partners with CMS and the FDA in supporting CLIA programs.
Discuss regulatory requirements: Centers for Disease Control and Prevention (CDC).
The Centers for Disease Control and Prevention are agencies of the US Health and Human Services. The CDC, headquartered in Atlanta, Georgia maintains the Center for Global Health (CGH), whose goal is to protect the health and safety of Americans by tracking disease and ensuring efforts to reduce disease worldwide. The CGH monitors outbreaks throughout the world, taking measures to prevent the spread, and provides technical assistance, often in conjunction with the World Health Organization. The CDC also focuses health efforts on both communicable and non-communicable diseases, antibiotic resistance, and traveler’s health. The CDC provides lists of recommended immunizations for healthcare personnel and has established isolation guidelines and precautions to reduce the risk of infection. The CDC implements public health laws that have been enacted by Congress, including regulations regarding reporting, isolation, and/or quarantine for specific diseases, such as Ebola or virulent strains of tuberculosis. Some drugs, such as those for parasitic diseases, may be available only through the CDC.
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Discuss regulatory requirements: National Committee for Quality Assurance (NCQA) guidelines.
The National Committee for Quality Assurance (NCQA) has addressed safety issues as part of its accreditation standards in response to the Institute of Medicine (I0M) call for accrediting agencies to ensure organizations focus on patient safety. Guidelines directed at managed care organizations provide useful information for other organizations as well.
Organizations should:
- Educate staff regarding clinical safety by providing information.
- Provide collaborative training within the network related to safe clinical practice.
- Combine data within the network [organization] on adverse outcomes/polypharmacy.
- Make improving patient safety a priority for quality improvement activities.
- Provide and distribute information about safe practices that includes information about computerized pharmacy order systems, intensive care trained physicians, best practices, research on safe clinical practices.
Discuss regulatory requirements: World Health Organization (WHO).
The World Health Organization (WHO), established in 1948 and headquartered in Geneva, Switzerland, is charged with directing and coordinating international public health efforts as an agency of the United Nations. The WHO focuses on communicable diseases (such as Zika, HIV/AIDS, tuberculosis, and malaria) and non-communicable diseases (such as diabetes, mental health disorders, injuries associated with violence, and vision impairment), preparedness, surveillance, and response through the provision of leadership and technical support, research, setting of standards, corporate services, and monitoring trends in health. When outbreaks or serious health problems occur in countries, the WHO leads the health response. There are currently 194 member states. The WHO works in partnerships with other organizations, such as the CDC. The WHO maintains a multilingual website with health information for healthcare providers and consumers, such as vaccination requirements for travel, and issues a number of publications. The WHO issues the World Health Report, the World Health Survey, and World Health Day.
Discuss regulatory requirements: Sexual harassment regulations.
Sexual harassment regulations include:
- The 1964 Civil Rights Act (Title VII) prohibited gender discrimination and sexual harassment by employers.
- The 1972 Education Amendments (Title IX) extended protection to education institutions.
- The 1980 Equal Employment Opportunity Commission (EEOC) defined sexual harassment as quid pro quo (expecting something in return for a favor) or hostile work environment (unwelcome advances or conduct).
- The 1991 Civil Rights Act allowed victims to obtain punitive/compensatory awards if subjected to sexual harassment.
- Additionally, many state laws have requirements regarding sexual harassment, and protection has been extended to same-gender harassment.
Sexual harassment includes unwelcome verbal advances (comments, asking for dates), personal comments (appearance, lifestyle, body), offensive behavior (bullying, leering), offensive materials (jokes, posters, videos, emails), and unwelcome physical contact (touching, hugging, kissing, molesting). Sexual harassment in the healthcare industry is high, with studies showing that offenders are most often physicians, but co-workers, supervisors, and patients also commit sexual harassment. Healthcare providers may be legally and financially liable for harassment.
When must compliance policies and procedures and standards of conduct be distributed to employees?
Within 90 days of hire, when there are updates, and annually thereafter
What is the purpose of the Code of Conduct?
State the overarching principles and values by which the company operates and define the underlying framework for compliance policies and procedures.
Describes the company’s expectations that employees conduct themselves in an ethical manner; that issues of non-compliance are reported, and that reported issues will be addressed.
When should policies and procedures be updated?
When there are changes in applicable laws, regulations, and federal healthcare program requirements.
