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Stark Law

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Stark Law is a set of United States federal laws that prohibit physician self-referral , specifically a referral by a physician of a Medicare or Medicaid patient to an entity for the provision of designated health services ("DHS") if the physician (or an immediate family member) has a financial relationship with that entity.

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125-1198: The term "referral" means "the request by a physician for the item or service" for Medicare Part B services and "the request or establishment of a plan of care by a physician which includes the provision of the designated health service" for all other services. DHS includes "clinical laboratory services"; "physical therapy services"; "occupational therapy services"; "radiology services, including magnetic resonance imaging, computerized axial tomography scans, and ultrasound services"; "radiation therapy services and supplies"; "durable medical equipment and supplies"; "parenteral and enteral nutrients, equipment, and supplies"; "prosthetics, orthotics, and prosthetic devices and supplies"; "home health services"; "outpatient prescription drugs"; "inpatient and outpatient hospital services"; and "outpatient speech-language pathology services." A "financial relationship" includes ownership, investment interest, and compensation arrangements. The Stark Law contains several exceptions, including physician services, in-office ancillary services, ownership in publicly traded securities and mutual funds, rental of office space and equipment, and bona fide employment relationship. It

250-478: A federal structure with two overlapping power centers so that each citizen as an individual is subject to the powers of state government and national government. To protect against abuse of power, each branch of government – executive, legislative, and judicial – had a separate sphere of authority and could check other branches according to the principle of the separation of powers . Furthermore, there were checks and balances within

375-490: A "remarkably resilient institution". Congress is the "heart and soul of our democracy", according to this view, even though legislators rarely achieve the prestige or name recognition of presidents or Supreme Court justices ; one wrote that "legislators remain ghosts in America's historical imagination." One analyst argues that it is not a solely reactive institution but has played an active role in shaping government policy and

500-706: A 2000 case, Vermont Agency of Natural Resources v. United States ex rel. Stevens , 529 U.S. 765 (2000), the United States Supreme Court held that a private individual may not bring suit in federal court on behalf of the United States against a State (or state agency) under the FCA. In Stevens , the Supreme Court also endorsed the "partial assignment" approach to qui tam relator standing to sue, which had previously been articulated by

625-506: A 2023 combined case, United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway , a unanimous U.S. Supreme Court opinion rejected an attempt to dilute the FCA's "knowledge standard." Under the knowledge standard, a defendant is liable under the FCA if a false claim is "knowingly" submitted to the government for payment. The statute defines "knowingly" as acting with actual knowledge, deliberate ignorance, or reckless disregard. The unanimous opinion found that

750-423: A FCA suit filed by two whistleblowers. The suit alleged that Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) acted improperly concerning the marketing, promotion and sale of the anti-convulsant drug Topamax . Specifically, the suit alleged that OMJPI "illegally marketed Topamax by, among other things, promoting the sale and use of Topamax for a variety of psychiatric conditions other than those for which its use

875-427: A captive referral system, which limits competition by other providers. Those who defend the practice contend that these problems are not widespread. They argue that physicians who own, invest in, or operate medical facilities are responding to a need for medical services which would otherwise not be met, particularly in medically under-served areas. In addition, it is often the case that physician owned entities present

1000-525: A claim. The Fraud Enforcement and Recovery Act of 2009 reversed the Court's decision and made the types of fraud to which the False Claims Act applies more explicit. In a 2009 case, United States ex rel. Eisenstein v. City of New York , the United States Supreme Court considered whether, when the government declines to intervene or otherwise actively participate in a qui tam action under

1125-620: A clinical laboratory if the physician or his/her family member has a financial interest in that laboratory. It was codified in the United States Code , Title 42, Section 1395nn (42 U.S.C. 1395nn, "Limitation on certain physician referrals"). The Omnibus Budget Reconciliation Act of 1993 contained what is known as "Stark II" amendments to the original law. "Stark II" extended the "Stark I" provisions to Medicaid patients and to DHS other than clinical laboratory services. The Centers for Medicare and Medicaid Services has issued rules in

1250-543: A complaint from whistleblower Jerry H. Brown II, the US Government filed suit against Maersk for overcharging for shipments to US forces fighting in Iraq and Afghanistan. In a settlement announced on 3 January 2012, the company agreed to pay $ 31.9 million in fines and interest, but made no admission of wrongdoing. Brown was entitled to $ 3.6 million of the settlement. The largest healthcare fraud settlement in history

1375-424: A copy of a complaint in a secret whistleblower suit that was under seal. In 2017, bio-pharmaceutical giant Celgene Corporation paid $ 240 million to settle allegations it sold and marketed its drugs Thalomid and Revlimid off-label in U.S. ex rel. Brown v. Celgene , CV 10-03165 (RK) (C.D. Cal.). In 2021, A South Carolina pain management company was ordered to pay $ 140 million under the False Claims Act after

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1500-475: A defendant is liable if it submits a false claim to the government based on its own knowledge and subjective beliefs — not what an objectively reasonable person may have thought. In a 2024 case, Murray v. UBS Securities, LLC , et al. 601 U. S. ____ (2024), a unanimous U.S. Supreme Court endorsed a lower burden of proof for whistleblowers, holding that whistleblowers do not need to prove that an employer acted with "retaliatory intent" in order to be protected under

1625-499: A different law, the Federal Food, Drug, and Cosmetic Act ; the intersection occurs when off-label marketing leads to prescriptions being filled and bills for those prescriptions being submitted to Medicare/Medicaid. As of 2019, over 72% of all federal FCA actions were initiated by whistleblowers. The government recovered $ 62.1 billion under the False Claims Act between 1987 and 2019 and of this amount, over $ 44.7 billion or 72%

1750-472: A false claim had to be presented directly to the Federal government, or if it merely needed to be paid with government money, such as a false claim by a subcontractor to a prime contractor. The Court found that the claim need not be presented directly to the government, but that the false statement must be made with the intention that it will be relied upon by the government in paying, or approving payment of,

1875-477: A lower-cost alternative to the facilities that are located at hospitals. This is due mostly to higher overhead costs that hospitals must pass down to their services. Multiple federal entities oversee enforcement of Stark Law. These include the Department of Justice , CMS , and the Department of Health and Human Services . In recent years, enforcement of Stark Law has become increasingly aggressive, largely as

2000-455: A patient to a medical facility in which the physician has a financial interest, be it ownership, investment, or a structured compensation arrangement. Critics argue that this practice is an inherent conflict of interest , because the physician benefits from the physician's own referral. They suggest that such arrangements may encourage overutilization of services, in turn driving up health care costs. In addition, they believe that it would create

2125-526: A political party does not mean that such members are unable to caucus with members of the political parties. Members can also switch parties at any time, although this is quite uncommon. Article One of the United States Constitution states, "All legislative Powers herein granted shall be vested in a Congress of the United States, which shall consist of a Senate and House of Representatives." The House and Senate are equal partners in

2250-444: A powerful effect of waking up a somewhat dormant Congress which investigated presidential wrongdoing and coverups; the scandal "substantially reshaped" relations between the branches of government, suggested political scientist Bruce J. Schulman . Partisanship returned, particularly after 1994; one analyst attributes partisan infighting to slim congressional majorities which discouraged friendly social gatherings in meeting rooms such as

2375-419: A relator to recover, in addition to his award for reporting fraud, double damages plus attorney fees for any acts of retaliation for reporting fraud against the government. This provision specifically provides relators with a personal claim of double damages for harm suffered and reinstatement. Under the False Claims Act, the Department of Justice is authorized to pay rewards to those who report fraud against

2500-659: A result of the Patient Protection and Affordable Care Act and its amendments to the False Claims Act . 2014 saw some of the largest Stark Law violation settlements to date. On June 9, 2015, the Office of Inspector General issued a fraud alert targeting physician compensation arrangements with hospitals and health systems. Contracts between physicians and hospitals must fit within the seven safe harbors for Stark Law in order to fully alleviate violation risk:

2625-524: A revised constitution with a two-chamber or bicameral Congress. Smaller states argued for equal representation for each state. The two-chamber structure had functioned well in state governments. A compromise plan, the Connecticut Compromise , was adopted with representatives chosen by population (benefiting larger states) and exactly two senators chosen by state governments (benefiting smaller states). The ratified constitution created

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2750-553: A separate penalty for each violation of the statute. Under the Civil Penalties Inflation Adjustment Act, False Claims Act penalties are periodically adjusted for inflation. In 2020, the penalties range from $ 11,665 to $ 23,331 per violation. Certain claims are not actionable, including: There are unique procedural requirements in False Claims Act cases. For example: In addition, the FCA contains an anti-retaliation provision, which allows

2875-634: A state's at-large representation to the federal government by senators. Most incumbents seek re-election, and their historical likelihood of winning subsequent elections exceeds 90 percent. The historical records of the House of Representatives and the Senate are maintained by the Center for Legislative Archives, which is a part of the National Archives and Records Administration . Congress

3000-506: Is an abbreviated form of the Latin legal phrase qui tam pro domino rege quam pro se ipso in hac parte sequitur ("he who brings a case on behalf of our lord the King, as well as for himself") In a qui tam action, the citizen filing suit is called a "relator". As an exception to the general legal rule of standing , courts have held that qui tam relators are "partially assigned" a portion of

3125-766: Is an accepted version of this page Minority (49) Minority (212) Vacant (3) [REDACTED] [REDACTED] The United States Congress is the legislature of the federal government of the United States . It is bicameral , composed of a lower body, the United States House of Representatives , and an upper body, the United States Senate . It meets in the United States Capitol in Washington, D.C. Members are chosen through direct election , though vacancies in

3250-693: Is directly responsible for the governing of the District of Columbia , the current seat of the federal government. The First Continental Congress was a gathering of representatives from twelve of the Thirteen Colonies . On July 4, 1776, the Second Continental Congress adopted the Declaration of Independence , referring to the new nation as the "United States of America". The Articles of Confederation in 1781 created

3375-440: Is elected and gives each House the power to create its own structure. Section Seven lays out the process for creating laws, and Section Eight enumerates numerous powers. Section Nine is a list of powers Congress does not have, and Section Ten enumerates powers of the state, some of which may only be granted by Congress. Constitutional amendments have granted Congress additional powers. Congress also has implied powers derived from

3500-493: Is essentially charged with reconciling our many points of view on the great public policy issues of the day. Congress is constantly changing and is constantly in flux. In recent times, the American South and West have gained House seats according to demographic changes recorded by the census and includes more women and minorities . While power balances among the different parts of government continue to change,

3625-433: Is extraordinarily sensitive to public pressure. Several academics described Congress: Congress reflects us in all our strengths and all our weaknesses. It reflects our regional idiosyncrasies, our ethnic, religious, and racial diversity, our multitude of professions, and our shadings of opinion on everything from the value of war to the war over values. Congress is the government's most representative body   ... Congress

3750-561: Is named for United States Congressman Pete Stark (D-CA) who sponsored the initial bill. In 1988, Stark introduced an "Ethics in Patient Referrals Act" bill concerning physician self-referrals. Some of the ideas in the bill became law as part of the Omnibus Budget Reconciliation Act of 1990. In specific, what is referred to as "Stark I" prohibited a physician referring a Medicare patient to

3875-428: Is not a "party" for FRAP 4 purposes, and therefore, petitioner's appeal filed after 30 days was untimely. In a 2016 case, Universal Health Services, Inc. v. United States ex rel. Escobar , the United States Supreme Court sought to clarify the standard for materiality under the FCA. The court unanimously upheld the implied certification theory of FCA liability and strengthened the FCA's materiality requirement. In

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4000-532: Is required before an impeached person can be removed from office. The term Congress can also refer to a particular meeting of the legislature. A Congress covers two years; the current one, the 118th Congress , began on January 3, 2023, and will end on January 3, 2025. Since the adoption of the Twentieth Amendment to the United States Constitution , the Congress has started and ended at noon on

4125-437: Is the federal government's primary litigation tool in combating fraud against the government. The law includes a qui tam provision that allows people who are not affiliated with the government, called "relators" under the law, to file actions on behalf of the government. This is informally called " whistleblowing ", especially when the relator is employed by the organization accused in the suit. Persons filing actions under

4250-488: Is the safest and most expeditious way I have ever discovered of bringing rogues to justice." In the massive military spending leading up to and during World War II , the US Attorney General relied on criminal provisions of the law to deal with fraud, rather than using the FCA. As a result, attorneys would wait for the Department of Justice to file criminal cases and then immediately file civil suits under

4375-529: The tabloidization of media coverage. Others saw pressure to squeeze a political position into a thirty-second soundbite. A report characterized Congress in 2013 as unproductive, gridlocked, and "setting records for futility". In October 2013, with Congress unable to compromise, the government was shut down for several weeks and risked a serious default on debt payments, causing 60% of the public to say they would "fire every member of Congress" including their own representative. One report suggested Congress posed

4500-544: The Board of Education . Congress began reasserting its authority. Lobbying became a big factor despite the 1971 Federal Election Campaign Act . Political action committees or PACs could make substantive donations to congressional candidates via such means as soft money contributions. While soft money funds were not given to specific campaigns for candidates, the money often benefited candidates substantially in an indirect way and helped reelect candidates. Reforms such as

4625-541: The Commerce Clause , the enumerated power to regulate commerce, in rulings such as McCulloch v. Maryland , have effectively widened the scope of Congress's legislative authority far beyond that prescribed in Section Eight. Constitutional responsibility for the oversight of Washington, D.C. , the federal district and national capital, and the U.S. territories of Guam , American Samoa , Puerto Rico ,

4750-650: The Congress of the Confederation in its legislative function. Although not legally mandated, in practice since the 19th century, members of Congress are typically affiliated with one of the two major parties , the Democratic Party or the Republican Party , and only rarely with a third party or independents affiliated with no party. In the case of the latter, the lack of affiliation with

4875-469: The Congress of the Confederation , a unicameral body with equal representation among the states in which each state had a veto over most decisions. Congress had executive but not legislative authority, and the federal judiciary was confined to admiralty and lacked authority to collect taxes, regulate commerce, or enforce laws. Government powerlessness led to the Convention of 1787 which proposed

5000-609: The Conservative Coalition . Democrats maintained control of Congress during World War II . Congress struggled with efficiency in the postwar era partly by reducing the number of standing congressional committees. Southern Democrats became a powerful force in many influential committees although political power alternated between Republicans and Democrats during these years. More complex issues required greater specialization and expertise, such as space flight and atomic energy policy. Senator Joseph McCarthy exploited

5125-599: The FDA . ChloraPrep is the commercial name under which CareFusion produced the drug chlorhexidine , used to clean the skin before surgery. In 2017, this case was called into question and was under review by the DOJ because the lead attorney for the DOJ serving as Assistant Attorney General in the case, Jeffery Wertkin, was arrested by the FBI on January 31, 2017, for allegedly attempting to sell

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5250-538: The Federal Register to implement Stark Law, including a 2001 "Phase I" final rule, a 2004 "Phase II" interim final rule, and a 2007 "Phase III" final rule. Penalties for violations of Stark Law include: denial of payment for the DHS provided; refund of monies received by physicians and facilities for amounts collected; payment of civil penalties of up to $ 15,000 for each service that a person "knows or should know"

5375-636: The Medicaid program. The California False Claims Act was enacted in 1987, but lay relatively dormant until the early 1990s, when public entities, frustrated by what they viewed as a barrage of unjustified and unmeritorious claims, began to employ the False Claims Act as a defensive measure. In 1995, the State of Texas passed the Texas Medicaid Fraud Prevention Act (TMFPA), which specifically aims at combating fraud against

5500-523: The Northern Mariana Islands . These six members of Congress enjoy floor privileges to introduce bills and resolutions, and in recent Congresses they vote in permanent and select committees, in party caucuses and in joint conferences with the Senate. They have Capitol Hill offices, staff and two annual appointments to each of the four military academies. While their votes are constitutional when Congress authorizes their House Committee of

5625-576: The U.S. Virgin Islands , and the Northern Mariana Islands rests with Congress. The republican form of government in territories is devolved by congressional statute to the respective territories including direct election of governors, the D.C. mayor and locally elective territorial legislatures. False Claims Act The False Claims Act of 1863 ( FCA ) is an American federal law that imposes liability on persons and companies (typically federal contractors ) who defraud governmental programs. It

5750-408: The U.S. census results, provided that each state has at least one congressional representative. Each senator is elected at-large in their state for a six-year term, with terms staggered , so every two years approximately one-third of the Senate is up for election. Each state, regardless of population or size, has two senators, so currently, there are 100 senators for the 50 states. Article One of

5875-449: The second-wave feminism movement , when activists moved into electoral politics. Beginning in the 1970s, donors and political action committees like EMILY's List began recruiting, training and funding women candidates. Watershed political moments like the confirmation of Clarence Thomas and the 2016 presidential election created momentum for women candidates, resulting in the Year of

6000-484: The "biggest risk to the U.S. economy" because of its brinksmanship , "down-to-the-wire budget and debt crises" and "indiscriminate spending cuts", resulting in slowed economic activity and keeping up to two million people unemployed. There has been increasing public dissatisfaction with Congress, with extremely low approval ratings which dropped to 5% in October 2013. In 2009, Congress authorized another delegate for

6125-439: The 1960s opened the possibility for Black, Asian American, Latina and other non-white women candidates to run for Congress. Racially polarized voting, racial stereotypes and lack of institutional support still prevent women of color from reaching Congress as easily as white people . Senate elections, which require victories in statewide electorates, have been particularly difficult for women of color. Carol Moseley Braun became

6250-790: The 2002 Bipartisan Campaign Reform Act limited campaign donations but did not limit soft money contributions. One source suggests post-Watergate laws amended in 1974 meant to reduce the "influence of wealthy contributors and end payoffs" instead "legitimized PACs" since they "enabled individuals to band together in support of candidates". From 1974 to 1984, PACs grew from 608 to 3,803 and donations leaped from $ 12.5   million to $ 120   million along with concern over PAC influence in Congress. In 2009, there were 4,600 business, labor and special-interest PACs including ones for lawyers , electricians , and real estate brokers . From 2007 to 2008, 175 members of Congress received "half or more of their campaign cash" from PACs. From 1970 to 2009,

6375-482: The Act stand to receive a portion (15–30%, depending on certain factors) of any recovered damages . As of 2019, over 71% of all FCA actions were initiated by whistleblowers. Claims under the law have typically involved government health care programs (Medicare, Medicaid and TriCare), military, or other government spending programs. FCA actions dominate the list of largest pharmaceutical settlements . Between 1987 and 2019,

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6500-574: The American response as a "police action". According to Time magazine in 1970, "U.S. presidents [had] ordered troops into position or action without a formal congressional declaration a total of 149 times." In 1993, Michael Kinsley wrote that "Congress's war power has become the most flagrantly disregarded provision in the Constitution," and that the "real erosion [of Congress's war power] began after World War   II." Disagreement about

6625-462: The Constitution's Necessary and Proper Clause . Congress has authority over financial and budgetary policy through the enumerated power to "lay and collect Taxes, Duties, Imposts and Excises, to pay the Debts and provide for the common Defence and general Welfare of the United States". There is vast authority over budgets, although analyst Eric Patashnik suggested that much of Congress's power to manage

6750-557: The Court. In this time, the department decides whether it will pursue the case. If the case is pursued by DOJ, the amount of the reward is less than if the Department of Justice had decided not to pursue the case and the plaintiff/relator continues the lawsuit himself. However, the success rate is higher in cases that the Department of Justice decides to pursue. Technically, the government has several options in handing cases. These include: In practice, there are two other options for

6875-453: The Department of Justice: There is case law where claims may be prejudiced if disclosure of the alleged unlawful act has been reported in the press, if complaints were filed to an agency instead of filing a lawsuit, or if the person filing a claim under the act is not the first person to do so. Individual states in the U.S. have different laws regarding whistleblowing involving state governments. The U.S. Internal Revenue Service (IRS) takes

7000-570: The Eleventh Circuit ruling in U.S. ex rel. Hopper v. Solvay Pharms., Inc. (2009) were both appealed to the U.S. Supreme Court . The Court denied certiorari for both cases, however, declining to resolve the divergent appeals court decisions. In 2009, the American Civil Liberties Union (ACLU), Government Accountability Project (GAP) and OMB Watch filed suit against the Department of Justice challenging

7125-431: The FCA, a practice decried as "parasitic" at the time. Congress moved to abolish the FCA but at the last minute decided instead to reduce the relator's share of the recovered proceeds. The law was again amended in 1986, again due to issues with military spending. Under President Ronald Reagan 's military buildup, reports of massive fraud among military contractors had become major news, and Congress acted to strengthen

7250-532: The FCA. The first qui tam case under the amended False Claims Act was filed in 1987 by an eye surgeon against an eye clinic and one of its doctors, alleging unnecessary surgeries and other procedures were being performed. The case settled in 1988 for a total of $ 605,000. However, the law was primarily used in the beginning against defense contractors . By the late 1990s, health care fraud began to receive more focus, accounting for approximately 40% of recoveries by 2008 Franklin v. Parke-Davis , filed in 1996,

7375-405: The False Claims Act on March 2, 1863, 12  Stat.   696 . Because it was passed under the administration of President Abraham Lincoln , the False Claims Act is sometimes referred to as the "Lincoln Law". Importantly, a reward was offered in what is called the qui tam provision, which permits citizens to sue on behalf of the government and be paid a percentage of the recovery. Qui tam

7500-510: The False Claims Act, $ 2.2 billion of which were generated by whistleblowers. Since 2010, the federal government has recovered over $ 37.6 billion in False Claims Act settlements and judgments. In 2020, the DOJ recovered $ 2.2 billion from FCA cases: $ 1.6 billion of that total was from cases filed under the FCA. Qui tam whistleblowers received a total of $ 309 million in whistleblower rewards in 2020. The Act establishes liability when any person or entity improperly receives from or avoids payment to

7625-426: The False Claims Act, including: The False Claims Act has a detailed process for making a claim. Mere complaints to the government agency are insufficient to bring claims under the Act. A complaint (lawsuit) must be filed in a U.S. District Court (Federal court) in camera (under seal). The Department of Justice (DOJ) must thence investigate within 60 days, but it often enjoys several months' worth of extensions by

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7750-405: The False Claims Act, the United States is a "party" to the suit for purposes of Federal Rule of Appellate Procedure 4(a)(1)(A) (which requires that a notice of appeal in a federal civil action generally be filed within 30 days after entry of a judgment or order from which the appeal is taken). The Court held that when the United States has declined to intervene in a privately initiated FCA action, it

7875-667: The Federal government. The Act prohibits: The statute provides that anyone who violates the law "is liable to the United States Government for a civil penalty of not less than $ 5,000 and not more than $ 10,000, as adjusted by the Federal Civil Penalties Inflation Adjustment Act of 1990, plus 3 times the amount of damages which the Government sustains because of the act of that person." The False Claims Act requires

8000-564: The Fraud Enforcement and Recovery Act of 2009 (FERA) was signed into law. It includes the most significant amendments to the FCA since the 1986 amendments. FERA enacted the following changes: With this revision, the FCA now prohibits knowingly (changes are in bold): On March 23, 2010, the Patient Protection and Affordable Care Act (also referred to as the health reform bill or PPACA) was signed into law by President Barack Obama . The Affordable Care Act made further amendments to

8125-545: The Government of the United States, or in any Department or Officer thereof". Article Four gives Congress the power to admit new states into the Union. One of Congress's foremost non-legislative functions is the power to investigate and oversee the executive branch. Congressional oversight is usually delegated to committees and is facilitated by Congress's subpoena power. Some critics have charged that Congress has in some instances failed to do an adequate job of overseeing

8250-491: The House expanded delegates, along with their powers and privileges representing U.S. citizens in non-state areas, beginning with representation on committees for Puerto Rico's resident commissioner in 1970. In 1971, a delegate for the District of Columbia was authorized, and in 1972 new delegate positions were established for U.S. Virgin Islands and Guam . In 1978, an additional delegate for American Samoa were added. In

8375-510: The House of Representatives are elected for the two-year term of a Congress. The Reapportionment Act of 1929 established that there be 435 representatives, and the Uniform Congressional Redistricting Act requires that they be elected from single-member constituencies or districts . It is also required that the congressional districts be apportioned among states by population every ten years using

8500-477: The House of Representatives have equal legislative authority, although only the House may originate revenue and appropriation bills . Congress has an important role in national defense , including the exclusive power to declare war, to raise and maintain the armed forces , and to make rules for the military. Some critics charge that the executive branch has usurped Congress's constitutionally defined task of declaring war. While historically presidents initiated

8625-625: The Jeffersonian Republican Party and began the era of the First Party System . In 1800, Thomas Jefferson 's election to the presidency marked a peaceful transition of power between the parties. John Marshall , 4th chief justice of the Supreme Court , empowered the courts by establishing the principle of judicial review in law in the landmark case Marbury v. Madison in 1803, effectively giving

8750-485: The Ninth Circuit Federal Court of Appeals and is an exception to the general legal rule for standing. In a 2007 case, Rockwell International Corp. v. United States , the United States Supreme Court considered several issues relating to the "original source" exception to the FCA's public-disclosure bar. The Court held that (1) the original source requirement of the FCA provision setting for

8875-490: The Sarbanes-Oxley Act. The Supreme Court found that a whistleblower needs only to prove that their actions in making a whistleblower complaint were a "contributing factor" in the employer's unfavorable action. The unanimous opinion found that liability hinges on a defendant's “knowledge and subjective beliefs” — not what an objective, reasonable person would have thought — at the time they submitted their claims to

9000-464: The Senate may be filled by a governor 's appointment. Congress has 535 voting members: 100 senators and 435 representatives. The vice president of the United States , as President of the Senate, has a vote in the Senate only when there is a tie. The House of Representatives has six non-voting members . Congress convenes for a two-year term , commencing every other January. Elections are held every even-numbered year on Election Day . The members of

9125-572: The Supreme Court a power to nullify congressional legislation. The Civil War , which lasted from 1861 to 1865, which resolved the slavery issue and unified the nation under federal authority but weakened the power of states' rights . The Gilded Age (1877–1901) was marked by Republican dominance of Congress. During this time, lobbying activity became more intense, particularly during the administration of President Ulysses S. Grant in which influential lobbies advocated for railroad subsidies and tariffs on wool. Immigration and high birth rates swelled

9250-546: The Texas Medicaid Program, which provides healthcare and prescription drug coverage to low-income individuals. The Texas law enacts state qui tam provisions that allow individuals to report fraud and initiate action against violations of the TMFPA, imposes consequences for noncompliance and includes whistleblower protections. In Australia, The Treasury Laws Amendment (Enhancing Whistleblower Protections) Act ,

9375-449: The U.S. Constitution requires that members of Congress be at least 25 years old for the House and at least 30 years old for the U.S. Senate, be a U.S. citizen for seven years for the House and nine years for the Senate, and be an inhabitant of the state which they represent. Members in both chambers may stand for re-election an unlimited number of times. The Congress was created by the U.S. Constitution and first met in 1789, replacing

9500-578: The UK more than £24 billion a year. In the context of anti-corruption, the paper acknowledged that there was a need to not only target serious and organised criminals but also support those who seek to help identify and disrupt serious and organised criminality. Three UK agencies, the Department for Business, Innovation and Skills , the Ministry of Justice and the Home Office , were tasked with considering

9625-554: The White House a little more in favor of the executive branch", according to one account. Past presidents, including Ronald Reagan , George H. W. Bush , Bill Clinton , and George W. Bush , have made public statements when signing congressional legislation about how they understand a bill or plan to execute it, and commentators, including the American Bar Association , have described this practice as against

9750-504: The Whole votes, recent Congresses have not allowed for that, and they cannot vote when the House is meeting as the House of Representatives. On January 6, 2021, the Congress gathered to confirm the election of Joe Biden, when supporters of the outgoing president Donald Trump attacked the building . The session of Congress ended prematurely, and Congress representatives evacuated. Trump supporters occupied Congress until D.C police evacuated

9875-552: The Woman and the election of members of The Squad , respectively. Women of color faced additional challenges that made their ascension to Congress even more difficult. Jim Crow laws , voter suppression and other forms of structural racism made it virtually impossible for women of color to reach Congress prior to 1965. The passage of the Voting Rights Act that year , and the elimination of race-based immigration laws in

10000-662: The area. The event was the first time since the Burning of Washington by the British during the War of 1812 that the United States Congress was forcefully occupied. Various social and structural barriers have prevented women from gaining seats in Congress. In the early 20th century, women's domestic roles and the inability to vote forestalled opportunities to run for and hold public office. The two party system and

10125-417: The budget has been lost when the welfare state expanded since "entitlements were institutionally detached from Congress's ordinary legislative routine and rhythm." Another factor leading to less control over the budget was a Keynesian belief that balanced budgets were unnecessary. The Sixteenth Amendment in 1913 extended congressional power of taxation to include income taxes without apportionment among

10250-721: The case for a US-style False Claims Act in the UK. In July 2014, the Financial Conduct Authority and the Bank of England Prudential Regulation Authority recommended Parliament enact strong measures to encourage and protect whistleblowers, but without offering whistleblower rewards, rejecting the US model. Under Rule 9(b) of the Federal Rules of Civil Procedure , allegations of fraud or mistake must be pleaded with particularity. All appeals courts to have addressed

10375-515: The constitutionality of the "seal provisions" of the FCA that require the whistleblower and the court to keep lawsuits confidential for at least 60 days. The plaintiffs argued that the requirements infringe the First Amendment rights of the public and the whistleblower, and that they violate the separation of powers , since courts are not free to release the documents until the executive branch acts. The government moved for dismissal, and

10500-443: The contract's duration must be at least a year; in writing and signed by both parties; specify aggregate payment which is set in advance; payment is reasonable and fair market value; payment must not relate to volume or value of business; the exact services to be performed must be outlined; and be commercially reasonable. Because current processes for monitoring contract compliance and logging physician work hours are often done on paper,

10625-594: The course of justice in legal proceedings that were concerned with the title to land. This act is still in force today in the Republic of Ireland , although in 1967 it was extinguished in England. The idea of a common informer bringing suit for damages to the Commonwealth was later brought to Massachusetts , where "penalties for fraud in the sale of bread [are] to be distributed one third to inspector who discovered

10750-623: The district court granted that motion in 2009. The plaintiffs appealed, and in 2011 their appeal was denied. In 2004, the billing groups associated with the University of Washington agreed to pay $ 35 million to resolve civil claims brought by whistleblower Mark Erickson, a former compliance officer, under the False Claims Act. The settlement, approved by the UW Board of Regents, resolved claims that they systematically overbilled Medicaid and Medicare and that employees destroyed documents to hide

10875-612: The early years as political parties became pronounced. With the passage of the Constitution and the Bill of Rights , the anti-federalist movement was exhausted. Some activists joined the Anti-Administration Party that James Madison and Thomas Jefferson were forming about 1790–1791 to oppose policies of Treasury Secretary Alexander Hamilton ; it soon became the Democratic-Republican Party or

11000-487: The electorate. Lame duck reforms according to the Twentieth Amendment reduced the power of defeated and retiring members of Congress to wield influence despite their lack of accountability. The Great Depression ushered in President Franklin Roosevelt and strong control by Democrats and historic New Deal policies. Roosevelt 's election in 1932 marked a shift in government power towards

11125-425: The exclusive power of removal , allowing impeachment and removal of the president, federal judges and other federal officers. There have been charges that presidents acting under the doctrine of the unitary executive have assumed important legislative and budgetary powers that should belong to Congress. So-called signing statements are one way in which a president can "tip the balance of power between Congress and

11250-595: The executive branch. Numerous New Deal initiatives came from the White House rather initiated by Congress. President Roosevelt pushed his agenda in Congress by detailing Executive Branch staff to friendly Senate committees (a practice that ended with the Legislative Reorganization Act of 1946). The Democratic Party controlled both houses of Congress for many years. During this time, Republicans and conservative southern Democrats formed

11375-463: The extent of congressional versus presidential power regarding war has been present periodically throughout the nation's history. Congress can establish post offices and post roads, issue patents and copyrights , fix standards of weights and measures, establish Courts inferior to the Supreme Court , and "make all Laws which shall be necessary and proper for carrying into Execution the foregoing Powers, and all other Powers vested by this Constitution in

11500-564: The fear of communism during the Second Red Scare and conducted televised hearings. In 1960, Democratic candidate John F. Kennedy narrowly won the presidency and power shifted again to the Democrats who dominated both chambers of Congress from 1961 to 1980, and retained a consistent majority in the House from 1955 to 1994. Congress enacted Johnson's Great Society program to fight poverty and hunger. The Watergate Scandal had

11625-494: The federal government and are not convicted of a crime related to the fraud, in an amount of between 15 and 25 (but up to 30% in some cases) of what it recovers based upon the whistleblower's report. The relator's share is determined based on the FCA itself, legislative history, Department of Justice guidelines released in 1997, and court decisions. False Claims Act Amendments ( Pub. L.   99–562 , 100  Stat.   3153 , enacted October 27, 1986 ) On May 20, 2009,

11750-412: The first woman of color to reach the Senate in 1993. The second, Mazie Hirono , won in 2013. In 2021, Kamala Harris became the first female President of the Senate , which came with her role as the first female Vice President of the United States . Article One of the Constitution creates and sets forth the structure and most of the powers of Congress. Sections One through Six describe how Congress

11875-734: The fraud and the remainder for the benefit of the town where the offense occurred." Other statutes can be found on the colonial law books of Connecticut , New York , Virginia and South Carolina . The American Civil War (1861–1865) was marked by fraud on all levels, both in the Union north and the Confederate south. During the war, unscrupulous contractors sold the Union Army decrepit horses and mules in ill health, faulty rifles and ammunition, and rancid rations and provisions, among other unscrupulous actions. In response, Congress passed

12000-574: The government recovered more than $ 62 billion under the False Claims Act. Qui tam laws have history dating back to the Middle Ages in England . In 1318, King Edward II offered one third of the penalty to the relator when the relator successfully sued government officials who moonlighted as wine merchants. The Maintenance and Embracery Act 1540 of Henry VIII provided that common informers could sue for certain forms of interference with

12125-411: The government's legal injury, thereby allowing relators to proceed with their suits. U.S. Senator Jacob M. Howard , who sponsored the legislation, justified giving rewards to whistle blowers, many of whom had engaged in unethical activities themselves. He said, "I have based the [ qui tam provision] upon the old-fashioned idea of holding out a temptation, and ‘setting a rogue to catch a rogue,’ which

12250-426: The government. As of 2020, 29 states and the District of Columbia have false-claims laws modeled on the federal statute to protect their publicly funded programs from fraud by including qui tam provisions, which enables them to recover money at state level. Some of these state False Claims Act statutes provide similar protections to those of the federal law, while others limit recovery to claims of fraud related to

12375-402: The internal structure of Congress is important to understand along with its interactions with so-called intermediary institutions such as political parties , civic associations , interest groups , and the mass media . The Congress of the United States serves two distinct purposes that overlap: local representation to the federal government of a congressional district by representatives and

12500-818: The issue of whether Rule 9(b) pleading standards apply to qui tam actions have held that the heightened standard applies. The Fifth Circuit , the Sixth Circuit , the Seventh Circuit , the Eighth Circuit , the Tenth Circuit , and the Eleventh Circuit have all found that plaintiffs must allege specific false claims. In 2010, the First Circuit decision in U.S. ex rel. Duxbury v. Ortho Biotech Prods., L.P. (2009) and

12625-486: The lack of term limits favored incumbent white men, making the widow's succession – in which a woman temporarily took over a seat vacated by the death of her husband – the most common path to Congress for white women. Women candidates began making substantial inroads in the later 20th century, due in part to new political support mechanisms and public awareness of their underrepresentation in Congress. Recruitment and financial support for women candidates were rare until

12750-430: The late 20th century, the media became more important in Congress's work. Analyst Michael Schudson suggested that greater publicity undermined the power of political parties and caused "more roads to open up in Congress for individual representatives to influence decisions". Norman Ornstein suggested that media prominence led to a greater emphasis on the negative and sensational side of Congress, and referred to this as

12875-488: The law. Generally militia forces are controlled by state governments, not Congress. Congress also has implied powers deriving from the Constitution's Necessary and Proper Clause which permit Congress to "make all laws which shall be necessary and proper for carrying into Execution the foregoing Powers, and all other Powers vested by this Constitution in the Government of the United States, or in any Department or Officer thereof". Broad interpretations of this clause and of

13000-408: The legislative process – legislation cannot be enacted without the consent of both chambers. The Constitution grants each chamber some unique powers. The Senate ratifies treaties and approves presidential appointments while the House initiates revenue -raising bills. The House initiates impeachment cases, while the Senate decides impeachment cases. A two-thirds vote of the Senate

13125-441: The legislature since there were two separate chambers. The new government became active in 1789. Political scientist Julian E. Zelizer suggested there were four main congressional eras, with considerable overlap, and included the formative era (1780s–1820s), the partisan era (1830s–1900s), the committee era (1910s–1960s), and the contemporary era (1970–present). Federalists and anti-federalists jostled for power in

13250-836: The majority of Stark Law violation settlements are the result of technical violations. Healthcare experts agree that information technology is necessary to streamline hospital processes, including those relating to compliance and Stark Law. Certain electronic health record companies help healthcare systems collect, organize, and store data. Multiple technology solutions exist that specifically automate physician time logging and eliminates Stark Law violation risk. The Stark law may impede certain pay for performance value-based arrangements, which led to discussions around reform as of 2019. [REDACTED]  This article incorporates public domain material from Medicare: Physician Self-Referral ("Stark I and II") (PDF) . Congressional Research Service . United States Congress This

13375-468: The original-source exception to the public-disclosure bar on federal-court jurisdiction is jurisdictional; (2) the statutory phrase "information on which the allegations are based" refers to the relator's allegations and not the publicly disclosed allegations; the terms "allegations" is not limited to the allegations in the original complaint, but includes, at a minimum, the allegations in the original complaint as amended; (3) relator's knowledge with respect to

13500-584: The other branches of government. In the Plame affair , critics including Representative Henry A. Waxman charged that Congress was not doing an adequate job of oversight in this case. There have been concerns about congressional oversight of executive actions such as warrantless wiretapping , although others respond that Congress did investigate the legality of presidential decisions. Political scientists Ornstein and Mann suggested that oversight functions do not help members of Congress win reelection. Congress also has

13625-417: The pondcrete fell short of the direct and independent knowledge of the information on which the allegations are based required for him to qualify as an original source; and (4) the government's intervention did not provide an independent basis of jurisdiction with respect to the relator. In a 2008 case, Allison Engine Co. v. United States ex rel. Sanders , the United States Supreme Court considered whether

13750-528: The position that, for Federal income tax purposes, qui tam payments to a relator under FCA are ordinary income and not capital gains . The IRS position was challenged by a relator in the case of Alderson v. United States; and, in 2012, the U.S. Court of Appeals for the Ninth Circuit upheld the IRS' stance. As of 2013, this remained the only circuit court decision on tax treatment of these payments. In

13875-416: The practice. The fraud settlement, the largest against a teaching hospital since the University of Pennsylvania agreed to pay $ 30 million in 1995, ended a five-year investigation that resulted in guilty pleas from two prominent doctors. The whistleblower was awarded $ 7.25M. In 2010, a subsidiary of Johnson & Johnson agreed to pay over $ 81 million in civil and criminal penalties to resolve allegations in

14000-597: The process for going to war, they asked for and received formal war declarations from Congress for the War of 1812 , the Mexican–American War , the Spanish–American War , World War I , and World War II , although President Theodore Roosevelt 's military move into Panama in 1903 did not get congressional approval. In the early days after the North Korean invasion of 1950 , President Truman described

14125-703: The ranks of citizens and the nation grew at a rapid pace. The Progressive Era was characterized by strong party leadership in both houses of Congress and calls for reform; sometimes reformers said lobbyists corrupted politics. The position of Speaker of the House became extremely powerful under leaders such as Thomas Reed in 1890 and Joseph Gurney Cannon . By the beginning of the 20th century, party structures and leadership emerged as key organizers of Senate proceedings. A system of seniority, in which long-time members of Congress gained more and more power, encouraged politicians of both parties to seek long terms. Committee chairmen remained influential in both houses until

14250-504: The reforms of the 1970s. Important structural changes included the direct popular election of senators according to the Seventeenth Amendment , ratified on April 8, 1913. Supreme Court decisions based on the Constitution's commerce clause expanded congressional power to regulate the economy. One effect of popular election of senators was to reduce the difference between the House and Senate in terms of their link to

14375-413: The several States, and without regard to any census or enumeration. The Constitution also grants Congress the exclusive power to appropriate funds, and this power of the purse is one of Congress's primary checks on the executive branch. Congress can borrow money on the credit of the United States, regulate commerce with foreign nations and among the states, and coin money. Generally, the Senate and

14500-736: The spirit of the Constitution. There have been concerns that presidential authority to cope with financial crises is eclipsing the power of Congress. In 2008, George F. Will called the Capitol building a "tomb for the antiquated idea that the legislative branch matters". The Constitution enumerates the powers of Congress in detail. In addition, other congressional powers have been granted, or confirmed, by constitutional amendments. The Thirteenth (1865), Fourteenth (1868), and Fifteenth Amendments (1870) gave Congress authority to enact legislation to enforce rights of African Americans, including voting rights , due process , and equal protection under

14625-401: The third day of January of every odd-numbered year. Members of the Senate are referred to as senators; members of the House of Representatives are referred to as representatives, congressmen, or congresswomen. Scholar and representative Lee H. Hamilton asserted that the "historic mission of Congress has been to maintain freedom" and insisted it was a "driving force in American government" and

14750-813: The tobacco industry and carbon pricing schemes. In October 2013, the UK Government announced that it was considering the case for financially incentivising individuals reporting fraud in economic crime cases by private sector organisations, in an approach much like the US False Claims Act. The 'Serious and Organised Crime Strategy' paper released by the UK's Secretary of State for the Home Department sets out how that government plans to take action to prevent serious and organised crime and strengthen protections against and responses to it. The paper asserted that serious and organised crime costs

14875-438: The unlawful marketing of its drug Rapamune for uses that were not FDA-approved and potentially harmful. In 2014, CareFusion paid $ 40.1 million to settle allegations of violating the False Claims Act by promoting off label use of its products in the case United States ex rel. Kirk v. CareFusion et al., No. 10-2492. The government alleged that CareFusion promoted the sale of its drug ChloraPrep for uses that were not approved by

15000-457: Was approved by the Food and Drug Administration, (i.e., " off-label " uses)." It also states that "certain of these uses were not medically accepted indications for which State Medicaid programs provided coverage" and that as a result "OMJPI knowingly caused false or fraudulent claims for Topamax to be submitted to, or caused purchase by, certain federally funded healthcare programs. In response to

15125-425: Was from qui tam cases brought by relators. In 2014, whistleblowers filed over 700 False Claims Act lawsuits. In 2014, the Department of Justice had its highest annual recovery in False Claims Act history, obtaining more than $ 6.1 billion in settlements and judgments from civil cases involving fraud and false claims against the government. In fiscal year 2019, the Department of Justice recovered over $ 3 billion under

15250-515: Was made by GlaxoSmithKline in 2012 when it paid a total of $ 3 billion to resolve four qui tam lawsuits brought under the False Claims Act and related criminal charges. The claims include allegations Glaxo engaged in off-label marketing and paid kickbacks to doctors to prescribe certain drugs, including Paxil, Wellbutrin and Advair. In 2013, Wyeth Pharmaceuticals Inc ., a pharmaceutical company acquired by Pfizer, Inc . in 2009, paid $ 490.9 million to resolve its criminal and civil liability arising from

15375-478: Was passed in December 2018 and went into effect in 2019. The law expanded protections for whistleblowers, allowing them to report misconduct anonymously, as well as applying anti-retaliation protections to additional kinds of whistleblowers. Importantly, the law does not provide for rewards for whistleblowers. There have been calls since 2011 for legislation modeled on the False Claims Act and for their application to

15500-462: Was provided in violation of the law, and three times the amount of improper payment the entity received from the Medicare program; exclusion from the Medicare program and/or state healthcare programs including Medicaid; and payment of civil penalties for attempting to circumvent the law of up to $ 100,000 for each circumvention scheme. Physician self-referral is the practice of a physician referring

15625-415: Was the first case to apply the FCA to fraud committed by a pharma company against the government, due to bills submitted for payment by Medicaid / Medicare for treatments that those programs do not pay for as they are not FDA-approved or otherwise listed on a government formulary. FCA cases against pharma companies are often related to off-label marketing of drugs by drug companies, which is illegal under

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