corporate compliance and regulation test one

Willfully

deliberate disregard; reckless disregard. Knowingly and willfully executing, or attempting to execute a scheme to defraud any government program or to obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any health care benefits program

Persons

any/all individuals and corporate entities, for profit or non-for-profit organizations and partnerships as well as independent contractors and vendors, suppliers and subcontractors

POA present on admission

certain diagnosis that are coded as being present when patients are admitted into a hospital certain diagnoses cause hospitals to receive a lower payment amount, so hospitals should list these diagnoses present on admission to distinguish them from Hospital Acquired Condition (HAC)

Referral

defined more broadly than merely recommending a vendor to a DHS to a patient

Legal Culpability

o A person acts purposefully o A person acts knowingly, Usually a yes and taken right away off the table because it's part of their job to know what they are doing is wrong o A person acts recklessly o A person acts negligently

Auditing

o Done before development to look at the workflow of the department o More extreme o Who should get the reports of the audit Management/Upper management

DOJ (department of justice)

o Highest Priority: to prosecute, FCA is the weapon of choice to do this o Under the guidance of the Attorney General o Federal law enforcement o Ensure public safety o Prevent and control crime

Classification of Patients

o Inpatient: Hospitalized individual requiring around the clock skilled nursing o Outpatient : "ambulatory" individual seeking services that can be delivered in less than a 24 hour period o Observation: 8-48 hours of care newly defined category to prevent the expense of an inpatient hospitalization for care that requires a higher level of acuity than standard outpatient services Meant to prevent inpatient hospitalization o Resident: Individuals who reside in long-term care facilities. Almost always for the rest of their lives o Hospice: Comfort care for patients with a terminal illness Needs to have a life expectancy of 8 months or less Skilled nursing/rehab Following hospitalization for specialized care

APC (Ambulatory Payment Classification)

o Prospective payment system o Outpatient services o (what was created based on the PPS)

HCPCS (Healthcare Common Procedural Coding System)

o Standard Coding System o Identifies products, supplies and services

HIPAA (Health Insurance Portability and Accountability Act)

o Standard Transaction Sets; Privacy; Security; OCR o Title I - Insurance Reform. Continuous insurance coverage ,Limits preexisting condition exclusions,Prohibits discrimination,Purchase new health insurance o Title II - Administrative Simplification focus on the health care practice setting, reduces administrative costs, standardizes the exchange of health information o HITECH (Super HIPAA)

two midnight rule: start clock

o When hospital care begins The minute the patient comes into the Emergency Department, the surgery takes place, etc. Observation care o The start of care after registration and initial triggering activities (such as vital signs) o Exclude excessive wait times o Both date and time are necessary for the "clock"

OIG (Office of the Inspector General)

o federal level, promotes integrity - Voluntary program. 8 elements of the program o audits misconduct, goal is to recoup as much money (lost or stolen) o investigates fraud and abuse recoveries: excluded list of individuals and organizations, a list that organizations have to check to see if the places/organizations/individuals they work with are not on this list o if people default on any of their charges they are on this list o was created on October 15, 1976 when President Ford signed into law legislation under the Department of Health, Education, and Welfare (HEW) which later became the Department of health and Human Services

OMIG (NY Office of Medicaid Inspector General)

o promotes integrity - mandatory program o audits and investigates o refers information to regulating and licensing boards o refers criminal cases o recoveries - exceeded $468 M

Unbundling

taking a "bundle" of tests and bill them as separate tests to make more money

Compliance Officer

Roles: Implementation, Operations, Training, Auditing, Investigations o What is the purpose of appointing a compliance officer? If you don't have an effective compliance program its solely on the back of the compliance officer

Subpart B

Administration... Compliance with Federal, State and Local Laws, governing body, patients rights

Code of Conduct

Ex: misrepresentation, accurate billing, avoid theft, proper use of organizations assets •Not a HIPAA violation to loop up your own info but a Compliance violation to do so on the hospitals computer

6 Divisions of the OIG:

OAS (Office of Audit Services) OEI (Office of Evaluation and Inspections) OI (Office of Investigations) OCIG (Office of Counsel to the Inspector General) OMP (Office of Management and Policy) OI (Immediate Office of the Inspector General)

Model Program Elements (7)

Written standards Designation of a compliance officer Effective education and training Audits, monitoring and other evaluations Internal reporting mechanism Disciplinary mechanism Investigation and remediation

Anti-Kickback

"giving me something so I refer my patients to you" Criminal; knowing and willing Prohibits remuneration to induce referrals Unless there is an exception referred to as "safeharbors" • Academic hospitals are created to be these and not create a kickback

Relators

(aka Whistleblowers) are what the FCA refers to these individuals bringing the lawsuit

two midnight rule: unforeseen circumstances

(that the beneficiary would require a stay greater than 2 midnights) oex: death, transfer, departure against medical advice, unforeseen recovery. such claims may be considered appropriate for hospital inpatient payment •in certain cases, the physician may have an expectation of a hospital stay less than 2 midnights, yet inpatient admission may be appropriate

CAH critical access hospital

A hospital that is certified to receive cost-based reimbursement from Medicare Reviewed with a little less scrutiny because of their high demand need An alternative for small, rural hospitals

Internal Reporting Mechanism

A way to report abuse and fraud from within the own organization.. Need to be: anonymous in order to protect the person reporting An investigation protocol needs to take place to see how true the report is

ABN - Advance Beneficiary Notice

Aka: Limitation of Liability Statute.. Puts the services up front to show which services will not be paid for, Requires written notice • 3 OPTIONS: o Agree to pay out of pocket o Not have the services o (2009) bill Medicare first then pay if denied

Subpart C

Basic Hospital Functions... Quality Assessment and Performance Improvement Program, Medical Staff, Nursing Services, Medical Record, Pharmaceutical, Radiologic, Lab,Food and Dietetic, Utilization review, physical environment, infection control, discharge planning, Organ, Tissue and Eye Procurement

Anti Trust Laws

Changing trends in healthcare: Competitors consolidate their assets Formation of Account Care Organizations Clinical Integration Leveraging the small independent practice against the large health plans and managed care organizations

Scope

Determines whether a hospital qualifies for a provider agreement under Medicare and Medicaid

U.S. Sentencing Commission

Developed as an Act of Congress in 1984 to Establish fair and equitable sentencing policies and practices for the federal courts Develop guidelines related to the form and severity of punishment for offenders convicted of federal crimes, Advise and assist Congress and the executive branch in the development of effective and efficient crime policy

Robinson-Patman Act

Discriminatory pricing to the extent that it affects competition

Termination Procedures

Documented non-compliance with one or more CoPs and Cited Deficiencies limiting the capacity of the provider to furnish adequate level or quality of care • Immediate jeopardy: Risk to patient health & safety, Substantial non-compliance with program requirements

the Subsequent Legislative Improvements to OIG

False Claims Amendments Act of 1986 (Lincoln Law) Health and Insurance Portability and Accountability Act of 1996 (HIPPA

Subpart A

General Provisions. Basis and scope & Provisions of emergency services by nonparticipating hospitals

The New York Mandatory Medicaid Compliance Program

Mandates that each covered provider's compliance program include the following eight elements: • Policies and procedures • Compliance officer • Training and education • Communication • Discipline • Auditing & monitoring/identify risk area • Reporting and response • Non-retaliation

LCD (Local Coverage Decision)

Medicare contractors , Medical Policies o Circumstances include: 1. A significant number of inquiries from the public, providers, or patients 2. New evidence or a reexamination of previously available evidence 3. Inconsistent or conflicting national or local coverage policies 4. Program integrity concerns If the patient saw a visit of service that was never performed, the concern is reviewed 5. Substantial clinical advances 6. Technologies for which rapid diffusion could have a significant programmatic impact. Technologies created in certain locations are used and tested in those locations first before being sent to other locations 7. Significant uncertainty about the health benefit, patient selection, or appropriate facility and staffing requirements for a new technology

Subpart E

Optional Hospital Services, Special Provisions Applying to Psychiatric Hospitals, Special Medical Record Requirements for Psychiatric Hospitals, Special Staff Requirements for Psychiatric Hospitals, Special Requirements for Hospital Providers of Long-term Care Services ("swing-beds"),

Subpart D

Optional Hospital Services, Surgical, anesthesia, nuclear medicine, outpatient, emergency, rehab, respiratory care.

Stark

Prohibits referrals when a physician has a financial interest in a Designated Health Services (DHS) "safeharbor" exceptions Difference between the Anti-Kickback Statute and the Stark Laws is when the physician owns the lab vs. another person

Statutory basis

Required of hospitals participating in Medicare and Medicaid

The Deficit Reduction Act of 2005

Requires entities with $5 million or more in annual Medicaid payments to establish written policies and procedures informing and educating their employees, contractors, and agents about Federal and State false claims acts and whistle blower protection

Clayton Act

Section 7 mergers, joint ventures, acquisitions and other arrangements among two or more entities prohibits an acquisition that lessen competition

PPS (Protective Payment System)

What it's going to take to treat that patient ex: drugs, supplies, surgeries, procedures.. inpatient

Penalties

Withholding Medicare payments or Exclusion from federal programs.. Probably the worst thing that can be done because that's the highest and largest source of income for a hospital

CIA (Corporate Integrity Agreement)

a written agreement imposed by the federal government telling you need to do to fix what wrong imposed compliance program settlement - fines & repayment

FI (Fiscal Intermediary)

adjudicates claims for hospitals, Medical Coverage Reviews

Organizational Sentencing Guidelines

allow organizations to mitigate (find a way to diminish the extent of harm that was done) sentences if they can demonstrate adherence to 7 elements that demonstrate an effective compliance program. These 7 elements are identified in the voluntary OIG Compliance Guideline

Financial Relationship

an ownership or investment in an entity or compensation relationship between the physician and the entity

Compliance

demonstrates an institutions commitment to abiding by government regulations, instills a culture that promotes integrity and ethical behavior >any individual who operates according to the policies of the organization even if they might not be paid by the them (ex: student, vendors) >adherence to the requirements of the Medicare and Medicaid laws and regulations and as stated in the Social Security Act and the regulations administered by CMS and other federal and state agencies

False

depends on the application of the statute, regulation and contract terms. Minor technical violations do not result in a false claim actions unless the violation is highly relevant (material) to the payment decision

Types of fraud

• Billing for services not rendered • Misrepresenting services as medically necessary • Falsifying medical records for the purpose of obtaining payment • Upcoding to describe more extensive services • DRGs (Diagnosis-related group) • Physician Group • Faculty Practice Plan • Billing for services in excess of those needed by the patient • Billing Company

Enforcement

• Criminal: uses federal statutes to indict penalties>fines & imprisonment • Civil: repayment & substantial fines

States Operations Manual

• Federal and State work together State is the one who actually conduct the survey • Done prior to opening and about every 3 years • Size and Composition of the Survey Team is based on the size of the hospital

(survey protocol) Task 6 Post-survey Activities

• General Objective: Complete the survey and certifications requirements o Address the things that need to be fixed • General Procedure: Timelines, Notification to the facility, Compilation of documents for the provider file, Signed letter of authorization forwarded to RO, Enter information collected into Medicare database •Plan of Correction, Each item that is identified as a deficiency has to have a thorough plan Ex: "how are we going to fix it? What it's going to take to fix it?"

(survey protocol) Task 2 Entrance Activities

• General Objective: Explain the survey process to the hospital and obtain information to conduct the survey • Procedures: Arrival Very little notice about arrival o Entrance Conference, Initial on-site team meeting, Determine sample size (how many charts will be reviewed) and selection

(survey protocol) Task 5 Exit Conference

• General Objective: Inform the facility staff of preliminary findings. Recording General principles • Sequences: o Introductory remarks, Ground rules, Presentation of findings, Closure, (After this the surveyors leave)

(survey protocol)Task 4 Preliminary Decision Making and Analysis of Findings

• General Objective: Integrate findings, review and analyze information obtained & determine if hospital met the CoP • General Procedures: Preparation, Discussion meeting, Determine the severity of deficiencies, Gathering additional information. (usually meeting with the high level CEOs (C-suite))

(survey protocol) Task 1 Off-Site Survey Preparation

• General Objective: to analyze information about the hospital to identify potential areas of concern • The State Agency will: Determine survey team size, Develop preliminary survey plan, Conducts preliminary meeting, Gather copies of additional resources, Only there for a short time o Want to leave that day with all the info

(survey protocol) Task 3 Information Gathering/Investigation

• General Objective: to determine the hospitals compliance with Medicare CoP • Guiding principles • General Procedures:, Survey location, Patient review, Observations, Interviews, Patients, staff, etc., Document review, Photocopies Sign a confidentiality agreement for all the confidential info they are looking at (ex: chart)

Sherman Act

• Prevents restraint of trade (Section 1) • Prevents monopolization (Section 2) • Requires two or more entities acting together o Entities - two or more individuals or organizations sharing a common interest can be considered a single entity by integrating their operations clinically, financially or legally thereby removing any economic incentive for them to compete with each other

FI/MAC (Fiscal Intermediary/Medicare Administrative Contractors)

• Private insurance companies or contractors that serve as the federal governments agents in the administration of the Medicare program o Adjudication & payment of claims.. Adjudication = review the claim • Makes sure services match diagnosis (kind of like an audit) Medical coverage reviews

Sanctions

• Provider education and warning • Withhold Medicare payments • Exclusion from federal programs • Corporate integrity program o It is expected that health care spending will double in the next ten years

TWO-MIDNIGHT RULE

• Surgical procedures, diagnostic tests and other treatments are generally appropriate for an inpatient hospitalization payment under Medicare part A when: oThe physician expects the patient to require a stay that crosses at least 2 midnights, and Admits the patient to the hospital based on that expectation

Damages, Penalties, and Criminal Enforcement:

• Temporary Suspension, Permanent Disbarment, Payment of Damages • Penalties ($5,500-$11,000 per false claim) • Criminal penalties: up to 5 years in prison and $25,000 o Unusual to get 10 years under False Claims but 10 years minimum under HIPAA

Self-Disclosure

• Voluntary Disclosure • Method for health care providers to voluntarily report fraudulent conduct affecting deferral health care programs • Major antifraud initiative, Detailed guidance • Telling that you made a mistake with billing Most time if the company doesn't, and the person responsible gets fired, will become a whistle blower which is worse for the company

Risks for Pharmaceutical Manufacturers:

• off-label marketing claiming a drug can do something else it has not been approved of onot the same thing as a doctor prescribing a drug for something else only for the manufacture themselves marketing the drug as doing something else • illegal kickbacks • inflating drug prices • Medicaid "best price" fraud • Pharmaceutical benefits manager fraud

Qui Tam

•Primary responsibility for enforcement is the DOJ •Private citizens are permitted to bring a lawsuit on behalf of the US Government when the citizen has information that an individual or organization has knowingly submitted or caused to be submitted a false claim

Coercion

•Routine waiving of co-insurance and/or deductibles for Medicare patients when the patient has the ability to pay oPeople want to go to somewhere that will wave this for the patient >Illegal