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Compliance Dictionary

Financial reporting related enforcement actions concerning civil lawsuits brought by the Commission in federal court and notices and orders concerning the institution and/or settlement of administrative proceedings

—Voluntary groups of physicians, hospitals, and other health care providers that are willing to assume responsibility for the care of a clearly defined population of Medicare beneficiaries attributed to them on the basis of patients’ use of primary care services.

CMS/HCFA’s best estimate for the amount of money it costs to care for Medicare recipients under fee-for-services Medicare in a given area. The AAPCC is made up of 142 different rate cells; 140 of them are factored for age, sex, Medicaid eligibility, Institutional status, working ages, and whether a person has both Part A and Part B of Medicare. The 2 remaining cells are for individuals with end stage renal disease.

Under the ACA, insurers can't raise premiums based on health status, medical claims, gender, or most of the other factors that they had previously used to determine rates prior to ACA implementation. 

Under HIPAA, legally separate covered entities under common ownership or control have an option to be treated as a single legal entity by choosing to designate as ACE. This enables the entities to share information in a way that would otherwise be impermissible (use vs. disclosure).

Agency within the Department of Health and Human Services, whose mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within HHS and other partners to make sure that the evidence is understood and used. 

Commonly referred to as the Stimulus Package, ARRA aims to create and maintain jobs, spur economic activity and long-term growth, and foster accountability and transparency in government spending through tax incentives, entitlement programs, and funding federal contracts, grants, and loans.

CMS's Health Care Finance Administration’s formal evaluation report of Medicare contractor’s performance for the fiscal year. It is based upon results of the Contractor Performance Evaluation Program (CPEP) reviews, along with results of other special evaluations which are considered when evaluating contractor performance. 

Federal criminal statute that prohibits the exchange (or offer to exchange) of anything of value, in an effort to induce (or reward) the referral of federal health care program business.

Legal status of person or entity that cannot repay the debts it owes to creditors. 

The measurement of performance against “best practice” standards.

Law enacted in 2003 that sets the rules for commercial email, establishes requirements for commercial messages, gives recipients the right to have you stop emailing them, and lists penalties for violations.

Previously known as the Health Care Financing Administration (HCFA), the agency that administers the Medicare and Medicaid Programs within the Department of Health and Human Services. 

A federal program providing healthcare coverage to families of military personnel and others. 

Federal regulations that include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease.

A joint initiative of five private sector organizations that are dedicated to providing thought leadership through the development of frameworks and guidance on enterprise risk management, internal control and fraud deterrence.

A conflict of interest occurs when an individual’s private interest interferes in any way―or even appears to interfere―with the interests of the corporation as a whole. A conflict situation can arise when an employee, officer, or director takes action or has interests that may make it difficult to perform his or her company work objectively and effectively.

Continuation health coverage legislation that gives employees and families who lose health benefits the right to choose to continue group health benefits provided by their group health plan for limited periods of time under certain cirumstances

An initiative by the federal government for Medicare & Medicaid, the aim of which is to develop a set of satisfaction surveys built off a core of standardized items and supplemented by additional targeted elements to make the surveys both adaptable to different sub-population and suitable for making some cross group comparisons.

HHS is the U.S. government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. Also referred to as HHS.

The Department of Justice works to enforce federal law, to seek just punishment for the guilty, and to ensure the fair and impartial administration of justice. It accomplishes this with various agencies under its umbrella.

Under Stark, the services covered are: (i) Clinical laboratory services.
(ii) Physical therapy, occupational therapy, and outpatient speech-language pathology services.
(iii) Radiology and certain other imaging services.
(iv) Radiation therapy services and supplies.
(v) Durable medical equipment and supplies.
(vi) Parenteral and enteral nutrients, equipment, and supplies.
(vii) Prosthetics, orthotics, and prosthetic devices and supplies.
(viii) Home health services.
(ix) Outpatient prescription drugs.
(x) Inpatient and outpatient hospital services.
(2) Except as otherwise noted in this subpart, the term “designated health services” or DHS means only DHS payable, in whole or in part, by Medicare. DHS do not include services that are reimbursed by Medicare as part of a composite rate (for example, SNF Part A payments or ASC services identified at § 416.164(a)), except to the extent that services listed in paragraphs (1)(i) through (1)(x) of this definition are themselves payable through a composite rate (for example, all services provided as home health services or inpatient and outpatient hospital services are DHS).

Outlines critical steps to build an electronic, inter-operable system to identify and trace certain prescription drugs as they are distributed in the United States, identify illegitimate drugs, and facilitate recalls.

Medical equipment owned or rented which is placed in the home of an insured to facilitate treatment and/or rehabilitation. DME generally consists of items which can withstand repeated use. DME is primarily and customarily used to service a medical purpose and is usually not useful to a person in absence of illness or injury. 

An industry that sells or rents certain medical equipment that is closely controlled by CMS

See PHI: Protected Health Information. HIPAA covered entities are required to protect electronic protected health information from data breach or loss and improper use or disclosure.

Federal law ensuring public access to emergency services regardless of ability to pay. Medicare-participating hospitals that offer emergency services must provide a medical screening examination (MSE) when a request is made for examination or treatment for an emergency medical condition (EMC), including active labor, regardless of an individual's ability to pay. Hospitals must provide stabilizing treatment for patients with EMCs.

Established in 1974, ERISA set up plan design, funding and administration requirements for employee pension plans to protect the rights of plan participants and beneficiaries including preempting certain state laws relating to employee benefit plans, including medical plans self-insured by employers.

A risk-based approach to managing an enterprise, a framework to identify, assess, mitigate and communicate risk in an integrated approach to help influence decision making and strategic development.

Institutes civil and criminal penalties for submitting false or fraudulent claims to the federal government. 

The Federal Act that provides for the protection of student educational records for both K-12 students and secondary education students.

Enacted November 1, 1991 by the US Sentencing Commission. Organizations with Compliance and Ethics Programs meeting defined standards earn credit toward reduced penalties if employees engage in wrongdoing. 

A requirement for 501(c)(3) hospitals to maintain tax-exempt status by establishing a written financial assistance policy governing billing and collection of certain eligible individuals.

A federal law enacted in 2009 that expands the reach of the False Claims Act that prohibits defrauding the government, including Medicare and Medicaid payments.

FDA regulations governing the conduct of clinical trials describe good clinical practices (GCPs) for studies with both human and non-human animal subjects

Rules for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the FDA. May also apply to conducting studies related to health effects, environmental effects, and chemical fate testing to ensure the quality of data for the Toxic Substances Control Act (TSCA).

A set of codes used by Medicare that describes services and procedures; HCPCS Level 1 codes are CPT codes, Level II codes are for suppliers and non –CPT code, and level III are locally set codes.

Created in 1977 to combine under one administration the oversight of the Medicare program, the Federal portion of the Medicaid program, and related quality assurance activities. HCFA was renamed the Centers for Medicare and Medicaid Services in July 2001.

Auditing team focused on preventing fraud and abuse in the Medicare and Medicaid programs by identifying fraud perpetrators and those abusing the system. 

Health information management (HIM) professionals work in a various settings and job titles in the healthcare industry.  They often serve in roles connecting clinical, operational, and administrative functions.

Organization that established a Common Security Framework that can be used by all organizations that create, access, store or exchange sensitive and /or regulated date. 

A federal law stating that a covered entity may not use or disclose protected health information, except as permitted or required.

A managed care organization that aims to lower health care costs by contracting with a network of providers to provide services for reduced cost. Though contracts with providers, the HMO can predict costs by shifting risk to the provider for services used by members. The HMO manages costs by limiting members to seeing approved providers and controlling access to specialty services.

Agency within the Department of Health and Human Services. Is the primary Federal agency for improving access to health care by strengthening the health care workforce, building health communities and achieving health equity. HRSA's programs provide health care to people who are geographically isolated, economically or medically vulnerable. 

Part of the American Recovery and Reinvestment Act of 2009. Contains incentives related to health care information technology in general and contains specific incentives designed to accelerate the adoption of electronic health record systems among providers. 

An organization primarily engaged in providing skilled nursing services and other therapeutic services; Has policies established by a group of professionals (associated with the agency or organization), including one or more physicians and one or more registered professional nurses, to govern the services which it provides;

For purposes of Part A home health services under Title XVIII of the Social Security Act, the term “home health agency” does not include any agency or organization which is primarily for the care and treatment of mental diseases.

A CMS requirement that involves monitoring and detecting unacceptable reimbursement claims and ensuring accuracy of claims.

CMS's web-enabled information system that serves a critical role in the operations of the Medicare Advantage, Part D, and Accountable Care Organization programs. 

A covered entity that does both covered and non-covered functions under the HIPAA Privacy Rule has the option to restrict the application of the Privacy Rule to certain parts of its organization by designating health care components. 

A CMS Audit Finding. The result of non-compliance with specific requirements that has the potential to cause significant beneficiary harm. 

Part of Corporate Integrity Agreements. Provide objective, unbiased determinations on what the root cause of a particular treatment was, or whether there was a medical necessity for a treatment. 

International Classification of Diseases, 10th Revision (ICD-10)

A coding of diseases, signs and symptoms, abnormal findings, complaints, social circumstances and external causes of injury or diseases, as classified by the World Health Organization

International Classification of Disease, Ninth Edition, Clinical Modifications (ICD-9-CM)

Based on the ICD-9, ICD-9-CM is the official system of assigning codes to diagnoses and procedures associated with hospital utilization in the United States. 

International Classification of Diseases, 9th Revision (ICD-9)

An international system to report health care diagnosis and procedures. Now replaced by the expanded ICD-10. 

An international classification system that describes and measures health and disability and includes environmental factors.

An independent, non-governmental,  non-profit organization that certifies and accredits health care organization for quality.

"Low Probability” is based on 4 factors:
What was the nature and extent of the protected health information (PHI) involved, including the types of identifiers in the information and the likelihood of re-identification?
To whom was the unauthorized information disclosed?
Was the PHI actually acquired or viewed?
What was the extent to which the risk to PHI has been mitigated?

Provides for the delivery of Medicaid health benefits and additional services through contracted arrangements between state Medicaid agencies and MGOs that accept a set per member per month payment for these services. 

An organization that combines the functions of health insurance, delivery of care, and administration. An umbrella term for health plans that provide health care in return for a predetermined monthly fee and coordinate care through a defined network of physicians and hospitals. Examples: HMO, POS, PPOs.

A program under the Department of Health and Human Services that provides low or no-cost basic health coverage for low income adults and children.

Single entity of state government annually certified by the secretary of HHS, responsible for conducting a state initiative aimed at investigating and prosecuting providers that defraud the Medicaid program

Created by the Deficit Reduction Act of 2005 as the first comprehensive federal strategy to prevent and reduce provider fraud, waste, and abuse in the Medicaid program. Two responsibilities: hire contractors to review provider activities and to support states in their efforts to combat fraud and abuse.

A health insurance program administered by the Centers for Medicare & Medicaid Services under the Department of Health and Human Services. Medicare is comprised of several parts including hospital insurance, medical insurance, and prescription drug insurance for people over 65, people under 65 with disabilities, and people of all ages with End Stage Renal Disease.

Monitoring is a quality control tool for determining whether study activities are being carried out as planned, so that deficiencies can be identified and corrected.

Brought together by the American Hospital Association (AHA) in 1975, NUBC includes the participation of all the major national provider and payer organizations. The NUBC was formed to create a uniform billing form and standard data set for institutional providers and payers to use for handling health care claims.

An agency within in the Department of Health and Human Services that enforces civil rights claims and the HIPAA Privacy and Security Rules.

Provides leadership in the protection of the rights, welfare, and well-being of subjects involved in research conducted or supported by the US Dept of Health and Human Services.

The Office of Inspector General of the U.S. Department of Health & Human Services (HHS) fights waste, fraud, and abuse in Medicare, Medicaid and more than 300 other HHS programs.

Independent agencies within individual state departments of health tasked with improving the integrity of state Medicaid programs by coordinating the fraud and abuse activities for multiple state agencies that provide Medicaid-funded services.

(1) A clinically integrated setting in which individuals typically receive health care from more than one health care provider; (2) an organized system of health care in which which more than one covered entity participates and in which the participating covered entities hold themselves out to the public as participating in a joint arrangement and participate in joint activities; (3) a group health plan and a health insurance issuer or HMO with respect to such group health plan, but only with respect to protected health information created or received by such health insurance issuer or HMO that relates to individuals who are or who have been participants or beneficiaries in such group health plan; (4) a group health plan and one or more other group health plans each of which are maintained by the same plan sponsor; or (5) the group plans described in (4) and health insurance issuers or HMOs with respect to such group health plans, but only with respect to PHI created or received by such health insurance issuers or HMOs that relates to individuals who are or have been participants or beneficiaries in any such group health plans.

Law enacted in 2005, that creates Patient Safety Organizations to collect, aggregate, and analyze confidential information reported by health care providers in order to identify patterns of failures and propose measures to eliminate patient safety risks and hazards. 

Commonly referred to as the Affordable Care Act or ObamaCare. Enacted to increase the affordability and quality of health insurance, lower the uninsured rate by expanding public and private insurance coverage, and reduce the cost of healthcare for individuals and the government. The law requires insurance companies to cover all applicants within minimum standards and offer the same rates regardless of pre-existing conditions or sex. 

Part of the Affordable Care Act that requires manufacturers of drugs, medical devices and biologicals that participate in the Federal health care programs, to report certain payments and items of value given to physicians and teaching hospitals. CMS implements the program and calls it the "Open Payments Program."

A CMS reporting tool that provides incentives and penalties to eligible professionals for reporting quality information. 

A comparative data report that summarizes one provider's Medicare claims data statistics for services vulnerable to improper Medicare payments

CMS System-generated reports of statistical and reimbursement data applicable to the processed and finalized Medicare Part A claims. 

Legal term for the mechanism in the federal False Claims Act that allows persons and entities with evidence of fraud against federal programs or contracts to sue the wrongdoer on behalf of the Government. A qui tam action is one brought under the False Claims Act by a private plaintiff (relator) on behalf of the Federal Government (rather than by the Government itself). 

The process of verifying that diagnosis codes submitted for payment by an Medicare Advantage organization are supported by medical record documentation for an enrollee.

A mix of centralized monitoring and on-site monitoring.  Monitoring activities should focus on preventing or mitigating important and likely sources of error in conduct, collection, and reporting of critical data and processes necessary for human subject protection and study data integrity.

A law that reformed the accounting and audit of public companies to prevent fraud. The Act enhanced corporate responsibility and financial disclosure and created the Public Company Accounting Oversight Board to oversee auditors. 

A federal agency that  regulates and monitors securities exchange, accounting, and auditing and enforces securities law.