Compliance 2

What is the ADA?

Americans with Disabilities Act of 1990

What is the American with Disabilities Act of 1990?

A civil rights law that prohibits discrimination against individuals with disabilities in all areas of public life, including:

Jobs

Schools

Transportation

All public & private places that are open to the public

Under the Americans with Disabilities Act, individuals with disabilities are members of what class?

A protected class

What is a protected class?

A group of of individuals to whom Congress or a state legislature has given legal protection against discrimination or retaliation

Health care workers need to understand what issues around application of the ADA?

That things go beyond physical access.

Their roles align with providing accommodations to ensure equal access to health care for people with disabilities.

When it comes to getting into the door, what are some barriers?

Transportation to access healthcare services

Parking

Accessibility to buildings

Inadequate access to health care information - health literacy interventions

When it comes to inadequate access to health care information, what can be done to alleviate?

Health literacy interventions

What are the two ways health care providers must make services accessible?

Effective Communication &

Accommodating Service Animals

What is effective communication in regards to providers making services accessible through the ADA?

They must provide services to deaf patients, through a qualified interpreter.

What's important to keep in mind regarding service animals and the health care system?

In a hospital, there may be certain areas of the hospital where having a service animal could jeopardize safety, such as in the sterile environment of an operating room.

What is the intent of the Fraud Enforcement Recovery Act of 2009 (FERA)?

The reduce fraud involving federal funds and property

What did FERA expand on?

The False Claims Act

How did FERA expand on the False Claims Act?

By "clarifying" that the FCA covers false claims for government money or property:

#1: Whether or not the claim was presented to a government employee or official

#2: Whether or not the government has custody of the money or property

#3: Whether or not the person or entity specifically intended to defraud the government

What did FERA amended regarding the grounds for liability under the FCA?

It amended the grounds for liability, via:

Clarifying the definition of "claim" and expanding the concept of reverse false claims

How did FERA clarify the definition of a "claim" from the FCA?

It expanded it o include false records or claims to the government OR to a contractor or other recipients of federal funds.

AND

Any request or demand, whether under a contract or otherwise, for money or property and whether or not the U.S has title to the money or property. This includes any request or demand presented to the U.S or made to a contractor, grantee, or other recipient if "the money or property is to be spent or use on the government's behalf".

How did FERA expand on the concept of reverse false claims under the FCA?

It makes explicit that it is a violation of the FCA to improperly avoid or decrease an obligation to pay or transmit money or property to the Government.

Expands the definition of "Obligation" to include an established duty arising from the retention of any overpayment.

These changes are aimed at prohibiting the improper retention of discovered overpayment.

What are the Anti-Trust laws?

Laws that protect the process of competition for the benefit of consumers, making sure there are strong incentives for businesses to operate efficiently, keep prices down, and keep quality up.

What are the three major Anti-Trust Laws?

The Sherman Act,

The Federal Trade Commission Act

The Clayton Act

What did the The Sherman Act do?

Outlawed monopolistic business practices, including entering into contracts or conspiring to restrain trade

What is "trade"?

The act of buying and selling goods and services (commercial transaction)

What are violations of the Sherman Act?

When competing individuals or competing companies:

Fix prices

Market division/allocaton

Rig bids

What is price fixing?

An agreement (written, verbal or inferred from conduct) among competitors that raises, lowers, or stabilizes prices or competitive terms.

Generally, antitrust laws require that each company establish prices and other terms on its own WTHOUT agreeing with a competitor.

What is market division/allocation?

Agreements in which competitors divide the market among themselves.

In such schemes, competing firms allocate specific customers or types of customers, products, or territories among themselves.

What is bid rigging?

Competitors conspire to raise prices when bids are solicited.

Bid rigging can take many forms, but one frequent form is when competitors agree in advance which firm will win the bid.

What are some examples of bid rigging?

For instance, competitors may agree to take turns being the low bidder, or sit out of a bidding round, or provide unacceptable bids to cover up a bid-rigging scheme.

Other such agreements involve subcontracting part of the main contract to the losing bidders or forming a joint venture to submit a single bid

What are the Sherman Act Penalties for violating the Sherman Act?

In case of intention and clear violations (price fixing/bid riggin), It can be up to:

$100 million in fines for corporations. Up to $1 million fine for individuals OR 10 years in prison (or both)

Under federal law, how much can the maximum fine for violating the Sherman Act be increased to?

The maximum fine may be increased to twice the amount the conspirators gained from the illegal acts, OR twice the money lost by the victims of the crime --> if either of those amounts exceed $100 million

What is the Federal Trade Commission Act (FTC Act)?

An act that bans the unfair method of competition and unfair or deceptive acts or practices.

What did the Supreme Court dictate regarding the FTC act?

All violations of the Sherman Act ALSO violate the FTC act.

There are still a few additional activities/conducts that do not meet the standards of the Sherman Act, but are still violations of the FTC Act

Who is the only group that can bring cases under the FTC act?

The Federal Trade Commission (FTC)

What is the Clayton Act?

It addressed specific practices that the Sherman Act does not clearly prohibit, specifically:

Mergers and acquisitions where the effect may substantially to lessen competition, or to tend to create a monopoly.

What must large corporations do after the passing of the Clayton Act when it comes to mergers and acquisitions?

They must notify the government of their plans in advance of mergers.

What are private companies and individuals are entitled to do when they have been harmed by conduct either the Sherman or Clayton Act?

Sue for triple damages

Who are the enforcers the antitrust laws?

Both the FTC and the U.S. Department of Justice (DOJ) Antirust Division

What areas does the FTC have antitrust violation prosecution jurisdiction?

Antitrust violations in healthcare, pharma, professional services, food, energy, computer technology, and internet services

What industries does the DOJ have sole antitrust jurisdiction over?

Certain industries, such as telecommunications, banks, railroads, and airlines

What is also known as the "Physician Self-Referral Law"?

The Stark Law

What is Stark Law?

It prohibits physicians from referring patients to receive designated health services (payable by Medicare or Medicaid) from facilities with which the physician or an immediate family member has a financial relationship (exceptions may apply)

The Stark Law prohibits physicians from submitting or causing the submission of referrals or claims to an entity where they have a financial interest

What do financial relationships include?

Ownership/investment interest and competition arrangements

Violations of the Stark Law results in what?

A false claim under the False Claims Act

Is proof of intent required to violate the Stark Law?

No. Proof of intent is not required for prosecution

What is the penalty for violating the stark law?

Fines, and more importantly, exclusion from participation in the federal health care programs

Is Medicaid a federal health care program?

It is a joint federal and state program. The federal government provides a significant portion of funding for Medicaid; however, the states each run their own Medicaid program and determine eligibility, rates, etc.

What is the Anti-Kickback Statute (AKS)?

A law that prohibits the knowing and willful payment to induce OR reward patient referrals OR the generation of business involving any item/service payable by the federal health care programs.

What does remuneration (payment) include regarding the AKS?

Anything of value. It can be cash, free rent, hotel stays, meals, and excessive compensation for work or other services.

The AKS makes paying for referrals a crime, and payers of kickbacks AND the recipient of payment/solicitors of payments may be prosecuted.

What is key to liability under the AKS?

Intent. If intent is shown and proven, then a criminal prosecution will be held.

It is hard, because giving literally anything of value is likely to influence a Medicare/Medicaid beneficiary

A violation of the AKS is a false claim under what?

The False Claims Act

What is exclusion provision?

The U.S Department of Health and Human Services (DHHS) Office of Inspector General (OIG) has the authority to:

Exclude individuals and entities who engaged in fraud, abuse, or other types of misconduct from participation in Medicare. Medicaid, AND other federal health care programs.

Health care organizations that employ or contract with individuals or entities who are excluded from federal programs may face what?

Civil or monetary penalties, and more importantly, exclusion from the federal healthcare programs.

Therefore, organizations are required to have a process to screening for excluded individuals or services.

What are federal healthcare programs restricted from doing regarding excluded providers?

They may not pay for items or services, provided.

All payment methods are impacted by this ban, including payments resulting from itemized claims, cost reports, fee schedules. prospective payment system.

The internal control Stony Brook Medicine entities have implemented toc omply with the Exclusion Process is how often?

Monthly; The monthly screenings of workforce members.

What is The Sarbanes Oxley Act (SOA) of 2002?

A law that intended to increase the accountability of corporate executives and board members for their actions by implementing a checks and balances system.

It requires corporate managers and executives to personally attest to the accuracy of their company's financial statements

When financial statements are found to be fradulent, who can be prosecuted under the SOA?

Managers and executives who sign the statements can be prosecuted

What did the National Research Act of 1974 create?

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

What did the US Public Health Service (now know as the DHHS) conduct research on from 1932 to 1972?

On black man to determine the effects of syphilis when left untreated. This study was known as the Tuskegee Syphilis Study as it was performed in collaboration with Tuskegee University

How did the National Research Act come to be?

After a whistleblower, Peter Buxtun, reported the Tuskegee Syphilllis Study to the press after federal agencies ruled against his initial reports

What are the three ethical principles/guidelines for research involving Human Subjects established by the Belmont Report?

Respect for Persons

Beneficence

Justice

What are the applications of the Belmont Report in practice?

Informed Consent

Assessment of Risk and Benefits

Selection of Subjects

What is experimental therapy?

Medical behavior or therapy that is notably different than the standard practice of care

What is practice?

Medical interventions, including diagnosis and preventive treatment or therapy, that are designed to enhance the wellbeing of a patient with a reasonable expectation for success

What is research?

Activity designed to test a hypothesis, permit conclusions to be drawn, and contribute to generalized knowledge expressed in theories, principles, and statements

Is Research, Practice, and Experimental Therapy the same thing?

No. Absolutely not. There are specific boundaries between practice and research, each with compliance terms.

What is Respect for Persons?

individuals should be treated as autonomous agents (have the right to govern themselves)

Individuals with diminished autonomy are entitled to protection

What is an autonomous person?

A person who is capable of making decisions about personal goals after careful consideration. Such person may voice opinions and make choices without obstruction

What is beneficence?

An obligation to secure the well-being and protect from harm research subjects.

What are beneficient actions?

#1: Do no harm

#2: Maximize possible benefits, and minimize possible harm

What is justice?

Benefits being distributed fairly:

An equal share, according to individual need, individual effort, societal contribution, and merit.

In order to comply with the principle of beneficence, what must be done, and how?

An Assessment of Risks and Benefits must be done, and it must include the gathering of systematic and comprehensive information about propsed research

What must a research committee determine in regards to Assessment of Risks and Benefits?

Whether the risks presented to subjects are justified

For prospective subjects, the assessment will assist in their determination whether or not to participate in the study

What must an Assessment of Risks and Benefits entail?

The probability and magnitude of risk or harm must be determined in an analysis of:

Psychological harm

Physical harm

Legal harm

Social harm

What is benefit as used in research?

The positive value related to health or welfare of the subjects.

The risks to subjects must outweigh the sum of both the anticipated benefit to the subject (if any), and the anticipated benefit to society in the form of knowledge to be gained from the research

Does benefit assess probability?

No. It does NOT assess probability.

What is an advanced directive?

Written statement of a patient's intent regarding medical treatment if they should become incapacitated

What is POLST?

Physicians Orders for Life Sustaining Treatment (for chronically ill patients)

It is an advance care planning tool (not an advanced directive) that reflects the patient's here-and-now goals for medical decisions, BUILDING on advance directives.

It can also function in the absence of an advance directive through a surrogate if the patient lacks the capacity to make decisions.

The POLST allows patients to make decisions in light of their current condition and discuss the available care options as explained by the treating health care provider.

What is MOLST?

Medical Orders for Life-Sustaining Treatment, which is New York State's answer/version of the POLST

What state is MOLST specific to?

New York State

Who is approved to complete the MOLST form according to NYS?

Physicians and Nurse Practitioners

In NYS, the MOLST is used for what kind of patients?

Patients with serious health conditions who:

• Want to avoid or receive any or all life sustaining treatment

• Reside in a long-term care facility or require long-term care services

• Might die with the next year

What is a healthcare proxy?

One can appoint a competent adult to make decisions about one's medical treatment if one loses the ability to decide for oneself (Including decisions to remove or provide life-sustaining treatment)

One can give a health care proxy as little or as much authority as they want to decide about all or only specific healthcare treatments.

What is a living will?

A written statement of an individual's wishes or instructions about health care treatment.

What must a healthcare proxy do in regards to a living will?

They must carry out the wishes and instructions written in a living will

Can a healthcare proxy be sued for decisions made in good faith?

No

Is the healthcare proxy financially responsible for the patient's healthcare costs?

No

What are the documentation rules regarding healthcare proxies?

Individuals must maintain a copy of the Health Care Proxy, give a copy to the proxy, physician, and other close friend

What is the FHCDA?

Family Health Care Decisions Act

Under the Family Health Care Decisions Act (FHCDA), what is allowed?

A close friend or family member may act as a surrogate, a representative of the patient who has not signed a health care proxy.

What may a surrogate appointed by the Family Health Care Decisions Act (FHCDA) do?

They may make health care decisions, including withholding or withdrawing of life-sustaining treatment, after a patient loses the ability to make decisions.

Who does the Family Health Care Decisions Act protect?

The patient

Organizational culture is implemented by whom?

Leaders

How is organizational culture implemented?

At local levels

Because organizational culture is implemented at local levels, what must be prioritized?

Discussing safety data results by:

-Department

-Units

-Roles

Why is it important to focus on group-level data?

It depersonalizes the discussion and fosters actionable ideas for improving care at the unit or department level.

What is the first step for many departments to improve culture and safety?

Feedback to members of the workforce at the unit or department level

What is The Joint Commission?

An independent not-for-profit organization that sets standards for health care and accredits health care institutions and programs that meet the established criteria including:

-Hospitals

-Ambulatory care facilities

-Behavioral health agencies

-Home health care agencies

-Laboratory service agencies

-Nursing care center

Their standards focus on patient safety and quality of care

What did The Joint Commission establish in 2002?

National Patient Safety Goals (NPSGs)

What do the National Patient Safety Goals assist with?

They assist accredited organizations with addressing specific areas of concern regarding patient safety

What standards do The Joint Commission include?

-Patient's rights and education

-Infection control

-Medication management

-Preventing medical errors

-Verification of qualifications and competence for doctors, nurses and other staff

-Emergency preparedness

-Collection and analysis of performance data for quality improvement

When were the first set of National Safety Patient Goals in effect?

January 2003

What are never events?

Errors in medical care that are clearly identifiable, preventable, and serious in their consequences for patients, and that indicate a real problem in the safety and credibility of a health care facility.

These incidents should NEVER happen.

What do never events result in?

Patient injury, illness and death, and additional health care costs