Anti Fraud Abuse

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Introduction

Federal legislation addressing healthcare fraud and abuse includes the False Claims Act, the Anti-Kickback Statute, and Stark Laws, or “Ethics in Patient Referrals Act.” The Federal Government and society place enormous trust in physicians, and physicians must strive to work ethically, render high-quality medical care to their patients, and submit proper claims for payment. Patients are most vulnerable and rely on the provider, placing trust at the core of the physician-patient relationship. Additionally, Medicare, Medicaid, and other federal healthcare programs rely on physicians’ medical judgment to treat beneficiaries with appropriate services and to submit accurate and truthful claim information.

Dishonest healthcare providers who exploit the healthcare system for illegal personal gain have created the need for laws that combat fraud and abuse and ensure appropriate quality medical care. These federal laws guide physician relationships to help avoid potential conflicts of interest and liability.

Learning Objectives

  • Explain what constitutes Medicare fraud, a False Claim, a Stark violation, and a violation of the Anti-kickback statute
  • Discuss the value of an advisory opinion and the role of a legal safe harbor
  • Develop a policy to reduce the likelihood of facing liability under the False Claims, Anti-Kickback, and Stark laws.

Anti-Fraud Legislation

Established anti-fraud laws function in three ways: protecting taxpayers’ funds, protecting consumers, and encouraging fair competition in the market.

Protecting Public Funds and Taxpayers:

  • Prevent financial losses: Healthcare fraud is estimated to cost billions of dollars annually in the US alone. Antifraud laws aim to deter and punish such activities, safeguarding public funds and taxpayer dollars used to finance healthcare programs like Medicare and Medicaid.
  • Ensure program sustainability: By curbing fraud, these laws help ensure the long-term financial viability of healthcare programs, allowing them to continue providing crucial services to eligible individuals.

Protecting Patients and Consumers:

  • Preventing unnecessary or harmful procedures: Some fraudulent schemes involve billing for unnecessary services or even harmful procedures. Antifraud laws help protect patients from being unknowingly subjected to such practices.
  • Safeguarding access to quality care: Fraudulent activities can distort healthcare delivery and prioritize financial gain over patient well-being. Antifraud laws help ensure patients have access to ethical and high-quality healthcare.
  • Maintaining trust in healthcare systems: Widespread healthcare fraud can erode public trust in healthcare providers and institutions. Antifraud laws aim to uphold ethical standards and build confidence in the healthcare system.

Promoting Fair Competition and Market Integrity:

  • Leveling the playing field: Fraudulent practices can give some providers an unfair advantage over others. Antifraud laws help create a level playing field for legitimate healthcare providers, fostering fair competition and market integrity.
  • Discouraging unethical business practices: These laws act as a deterrent against illegal practices like kickbacks, bribery, and self-referrals, which can distort market dynamics and lead to inefficient allocation of resources.

Table 1: Comparison of Anti-Fraud Legislation

Anit-Kick Back Statues (AKS) Stark Law False Claims Act (FCA)
Prohibitions

-Prohibits offers of, solicitation of, or payment or receipt of remuneration intended to induce referrals for health care services covered by a government program.​

-Covers provision of anything of value to a person who refers, orders/purchases, or recommends

-Prohibits referrals of designated health service by a physician if the physician (or an immediate family member) has a financial relationship with the entity performing the designated health service​

-Regulates financial relationships with physicians only ( and physician’s immediate family members)

-Prohibits the submission of false or fraudulent claims, false statements material to a false claim, and conspiracy to commit violation​

-Prohibits concealing or avoiding the obligation to repay money to the government (failure to return overpayments)​

-Claims that violate AKS or Stark can also be considered false claims​

-Common false claims: lack of medical necessity quality of care; billing/coding issues; off-label marketing; retention of overpayments

Exceptions -Arrangements are not required to fit within a safe harbor; however, voluntary safe harbors exist -the arrangement must satisfy an exception, or it violates the Start Law N/A
Penalties

-Applies to either party involved in an arrangement that violates AKS​

-Criminal penalties ($25K/offense, up to 5 years imprisonment)​

-No criminal enforcement​

-CMP enforcement for knowing violations: CMP $15K/violation + 3x claims and/or $100K/circumvention scheme​

-Nonpayment of claims arising from prohibited arrangement​

-Recoupment of amounts received​

-Exclusion from federal health programs​

-FCA liability

-Treble damages​

-Per claim penalties between $10,781 & $21,562

Agency Office of Inspector General (OIG) Centers for Medicare & Medicaid Services (CMS) Department of Justice (DOJ)

Context

According to the American Medical Association (2023), U.S. healthcare spending reached $4.3 trillion in 2021. The majority of these payments came from the federal government (Medicare/Medicaid) or private insurance plans. Since payers are not present for the exchange of business transactions, the opportunities for fraud and abuse are enormous. Consequently, a variety of federal laws have been created to deter and penalize fraud and abuse cases.

False Claims Act (31 U.S.C. §§ 3729-3733)

During the Civil War, the False Claims Act (FCA) was enacted in 1863 to combat fraud by contractors supplying the Union Army and to stop war profiteers from defrauding the government. In 1986, the law was expanded to include whistleblower projections in its scope (Perry & Thompson, 2017).  The act itself states:

 (a)Any person who (1)knowingly presents, or causes to be presented, to an officer or employee of the United States Government or a member of the Armed Forces of the United States a false or fraudulent claim for payment or approval; (2) knowingly makes, uses, or causes to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the Government; (3) conspires to defraud the Government by getting a false or fraudulent claim paid or approved by the Government; . . . or (7) knowingly makes, uses, or causes to be made or used, a false record or statement to conceal, avoid, or decrease an obligation to pay or transmit money or property to the Government, . . . 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 term “knowingly” means that an individual has knowledge of the information and acts in reckless disregard of the truth or deliberate ignorance of the truth. Under FCA, no proof of specific intent to defraud is required. The whistleblower provisions allow individuals to file suit on behalf of the federal government. A whistleblower might be current or ex-business partners, hospital staff, patients, or competitors. A private citizen filing suit acts as a qui tam plaintiff on behalf of the government and is protected against retaliation by the employer.

Each civil claim can lead to an award of both five to ten thousand dollars plus treble damages as well as lead to criminal penalties with an individual fine of at least $250,000 and an institutional fine of at least $500,000 per false claim. This could include billing for services not provided or falsifying medical records or documentation to gain money.

Anti-Kickback (42 U.S.C. §§ 1320a-7b(b))

 

The Anti-Kickback Statute (AKS) was created in the Social Security Act Amendments of 1972. This statute makes paying for referrals a crime in federal healthcare programs. It applies to those who offer pay remuneration and recipients of any kickbacks, bribes, or rebates either directly or indirectly, overtly or covertly, in cash or in-kind in return for referrals.  Violations are federal offenses, and penalties can include fines of up to $25,000 and/or up to 5 years of imprisonment (Perry & Thompson, 2017).

Physicians are a great source of referrals for services from other physicians and pharmaceutical/medical supply vendors and are therefore attractive targets for kickback schemes. Physicians are in a unique position because they select what medications their patients use and who they refer the patients to for further care. There is justification for these practices, warranting a criminal statute with significant jail time and financial penalties. Courts recognize the presence of “knowingly” committing this action indicates a scienter requirement. The statute further guides that kickbacks in healthcare can lead to 1) overutilization 2) increased program costs 3) corruption of medical decision-making 4) patient steering 5) unfair competition. Therefore, the statute prohibits all sources of referrals where Medicare and Medicaid programs require copays for services. Waiving copays or advertisements for copay forgiveness could implicate the Anti-Kickback Statute. However, copays may be waived if the patient is unable to financial afford to pay or all collection efforts have failed. Free or discounted services can be offered to the uninsured population (Morgan, 2019).

In cases of AKS violations, the government does not need to prove patient harm or financial loss. If services were rendered medically necessary, a physician can still be found guilty of violating AKS. Any financial incentives, gifts, etc. from a vendor are unjustifiable (Morgan, 2019).

Safe Harbors

There are several safe harbors concerning AKS. Safe harbors listed below are examples of payments or arrangements that are generally considered to be fair and reasonable, and that are not likely to influence a healthcare provider’s clinical judgment.

  • Discounts that are disclosed and tied to the actual costs or charges incurred
  • Employee compensation, but not compensation for independent contractors
  • Group purchasing rebates, under certain conditions
  • Certain risk-sharing mechanisms

The Department of Health & Human Services established 25 other safe harbors that include:

  • fair market value leases (leases are in writing, signed by both parties and for at least one year),
  • fair market value personal services contracts,
  • fair market value  for the sale of practices, and
  • payments for referral services for patients with the proviso that the amount of the remuneration cannot depend on the number of referrals (Perry & Thompson, 2017).

Stark Law (42 U.S.C. §§ 1395nn)

Enacted in 1989, the Stark Law, also known as the Physician Self-Referral Law, is a federal law that prohibits physicians from referring Medicare or Medicaid patients to receive certain designated health services (DHS) payable by Medicare or Medicaid from entities in which the physician or an immediate family member has a financial relationship unless an exception applies.

The Stark Law is intended to prevent conflicts of interest and to protect patients from being referred to providers who may not be in their best interests. According to Perry and Thompson (2017), the law applies to a wide range of DHS, including:

  • clinical laboratory services;
  • physical therapy, occupational therapy, and outpatient speech-language pathology services;
  • radiology and certain other imaging services;
  • radiation therapy services and supplies;
  • DME 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

Proof of specific intent to violate the law is not required since Stark law is a strict liability statute. Violation penalties include fines and exclusion from participating in federal healthcare programs. While both the False Claims Act and Anti-Kickback Law require a showing that the wrongdoing was done “knowingly,” the Stark Law has no such requirement for intent. The Centers for Medicare & Medicaid Services (CMS) will deny payment when a Stark Law violation is determined and the entity can be fined up to $15,000 for each referral;  and potentially $100,000 for an arrangement designed to circumvent the law followed by exclusion from participating in Medicare and Medicaid. Moreover, Stark violations may lead to False Claims Act violations because courts can find that an entity submitting an illegal claim under Stark is equivalent to making a false claim.

The Stark Law is complex, and there are many nuances and exceptions. Physicians and healthcare organizations need to have a good understanding of the law to avoid compliance violations. Here is a summary of the key points of the Stark Law:

    • Prohibits physicians from referring Medicare or Medicaid patients to receive DHS from entities in which the physician or an immediate family member has a financial relationship unless an exception applies.
    • Applies to a wide range of DHS, including laboratory services, imaging services, physical therapy, and occupational therapy.
    • There are several exceptions to the law, including exceptions for in-office ancillary services, hospital-based physician services, bona fide employment arrangements, personal services arrangements, and shared savings arrangements.
    • Physicians and healthcare organizations should have a good understanding of the law to avoid compliance violations.

Exceptions

Due to the strict liability nature, once a referral is made that would violate Stark Law, an exception must apply to allow for a claim to be submitted. There are several exceptions to the Stark Law, including exceptions for:

  • In-office ancillary services
  • Hospital-based physician services
  • Bona fide employment arrangements
  • Personal services arrangements
  • Shared savings arrangements

Bona Fide Employment Relationships

A Bona fide employment relationship under the Stark Law Statute includes:

      (A) the employment is for identifiable services,

      (B) the amount of the remuneration under the employment—

                (i) is consistent with the fair market value of the services, and

                (ii) is not determined in a manner that takes into account (directly or indirectly) the volume or value of any referrals by the referring physician,

     (C) the remuneration is provided pursuant to an agreement that would be commercially reasonable even if no referrals were made to the employer, and

     (D) the employment meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.

Subparagraph (B)(ii) shall not prohibit the payment of remuneration in the form of a productivity bonus based on services performed personally by the physician (or an immediate family member of such physician).

Limiting Risks

  • Accurate coding and billing – If you do not know how to code a service, ask someone trusted.
  • Maintain accurate medical records – Good documentation ensures quality patient care.
  • Do not charge more than 15% above the Medicare rate.
  • Exercise caution when charging extra fees.
  • Admit patients to health entities that best serve their medical needs.
  • Be cautious with recruitment offers. Many hospitals will incentivize local providers to gain referrals.
  • Medical directors should exercise substantive responsibility.
  • Be cautious with interactions with pharmaceutical and medical device companies and representatives.
  • Do not sell free medication samples.
  • Scrutinize promotional speaking or consulting opportunities. Ensure arrangements are legitimate.
  • Review and abide by gift reporting requirements. In most cases, just say no.
  • Ensure you have a compliance program in place to monitor and track activities.
  • When in doubt, contact the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) with questions or concerns. 1-800-HHS-TIPS

Accurate Billing and Coding

Physicians are trusted by payers to provide necessary, cost-effective, and quality care. Physicians exert significant influence over what services their patients receive and control the documentation that describes those services. This documentation is used to bill insurers. The government pays claims based solely on the information provided in these documents.

Because the government invests so much trust in physicians, it has powerful criminal, civil, and administrative enforcement tools to prosecute fraud. The government has broad capabilities to audit claims and investigate providers when it suspects unscrupulous abuse. This suspicion may be raised by irregular billing patterns or reports from others, such as staff, competitors, and patients. In other words, the government expects physicians to be honest and ethical in their billing practices. If there is any evidence of fraud, the government will investigate and take action.

When a claim for services is submitted for a Medicare or Medicaid beneficiary, the bill is filed with the federal government and must certify that the payment requested is earned and complies with billing requirements.

The attempt to collect unearned money after submitting a false claim constitutes a violation. A common type of false claim is “upcoding,” which refers to using billing codes that reflect a more severe illness than existed or a more expensive treatment than was provided. Additional examples of improper claims include:

  • billing for services that you did not actually render;
  • billing for services that were not medically necessary;
  • billing for services that were performed by an improperly supervised or unqualified employee;
  • billing for services that were performed by an employee who has been excluded from participation in the Federal health care programs;
  • billing for services of such low quality that they are virtually worthless; and
  • billing separately for services already included in a global fee, like billing for an evaluation and management service the day after surgery.

Upcoding

Medicare uses Evaluation and Management (E&M) codes to pay for many physician services. New patient visits generally take longer than follow-up visits for established patients, so E&M codes for new patients pay more. Upcoding is when you bill for a higher level E&M code than the services actually provided. For example, if you provide a follow-up office visit but bill for a comprehensive new patient office visit, that is upcoding which is a serious offense that can result in fines, imprisonment, and exclusion from Medicare and Medicaid programs.

Another example of upcoding includes the misuse of Modifier 25 to claim payment for an E&M service when the patient care rendered was not significant, was not separately identifiable, and was not above and beyond the care usually associated with the procedure.

Physician Documentation

Physicians must keep accurate and complete medical records and documentation of the services they provide. They must also ensure that their claims are supported by this documentation. Medicare and Medicaid may review beneficiary medical records. Good documentation helps to ensure that patients receive the right care from all providers and that physicians can defend their bills against challenges. Physicians must document everything done for their patients, both for the patient’s benefit and to protect themselves from accusations of fraud.

Physician Investments in Healthcare Business Ventures

When physicians invest in outside businesses that provide ancillary services to their patients, they may refer disproportionately more patients to those businesses, leading to excessive and medically unnecessary referrals, which waste government and beneficiary money and can expose patients to harm. This can be a conflict of interest and may lead to patients receiving medically unnecessary and expensive services. These investment relationships have serious legal risks under the AKS and Stark Law.

Physician Recruitment

In some communities that possess multiple hospitals where the competition for patients is high, financial incentives to recruit physicians may be illegal. Meaning, that competition for loyalty to a specific hospital can cross the line into illegal arrangements for which the physician and the hospital can be liable (Perry & Thompson, 2017). Hospitals may offer financial incentives to attract physicians to underserved areas. However, competition between hospitals for patient referrals can lead to illegal inducements. As such, physicians must be aware of the Stark Law and Anti-Kickback Statute (AKS) regulations governing recruitment arrangements. Hospitals can provide legitimate relocation assistance and practice support, but cannot offer payments, free rent, or other benefits designed to influence referrals. Patient admissions should be based on medical needs or patient preferences, not promises to be admitted to a specific hospital. Physicians offered recruitment packages should not negotiate benefits in exchange for referrals unless they are hospital employees. If pressured to admit patients to specific locations, seeking legal counsel is crucial. Legal counsel should be sought if someone enters into a relationship that requires patient admission to a specific hospital or practice group.

Considerations for Directors

Keeping in mind that a medical director of a nursing home or other facility may be held professionally responsible for their patients as well as other attending physicians’ patients by State and Federal authorities, the following tips are recommended.

  • Directly manage and monitor the quality of clinical care provided in the facility.
  • Guide and inspire the medical staff to consistently meet and exceed the established standards of care.
  • Champion ongoing learning and development opportunities for all healthcare professionals, including physicians, nurses, and other staff members.
  • Proactively identify and address any issues or concerns impacting patient care quality.

Samples

Pharmaceutical samples from industry representatives can be legally provided free of charge to a physician; however, it can be problematic.  In theory, it is a good way to get low-income patients started on a medication. However, is it fair to provide samples to friends of the physician? How many samples should one patient receive? What happens if the medication gets recalled? How will those sample distributions be tracked? How will the clinic prevent theft, tampering, or reselling of samples? Billing Medicare patients for free samples has led to physician prosecution. If a clinic decides to make samples available to offer, several precautions safeguarding the above-mentioned concerns should be considered.

  • A Standard Operating Procedure (SOP) and policy should be developed which clearly documents the proper process for accepting samples.
  • A trusted individual should be responsible for accepting samples and logging them into an inventory log.
  • Have a reliable system in place to safely store the samples and ensure that samples are not commingled with commercial stock.
  • Log books for signing samples in and out should be available in the cabinet.
  • Monitoring for expiration, par levels, and compliance should be performed routinely.

Vendor and Sales Rep Relationships

Sales representative and physician collaboration is critical in supporting medical advances and using new innovations in the medical field. However, these relationships must be kept at a professional level to avoid conflicts of interest. Most companies are aware of laws forbidding free lunches, subsidized trips, and gifts (bribes) to providers in exchange for loyalty to their product; however, there are some circumstances where the company may offer financial incentives for research, speaking engagements, etc. The relationship can be kept legal if the physician asks the following questions:

  • Does the vendor’s company really need the provider’s particular expertise or input?
  • Does the amount of money the company is offering seem fair, appropriate, and commercially reasonable for what the provider is being asked to do?
  • Is it possible the company is paying the provider for their loyalty so that they will prescribe its drugs or use its devices?

Contributing time and effort can be legally compensated within the fair market value, and a provider can serve as a bona fide consultant. However, if providers are urged to prescribe a particular drug or medical device, it could likely violate fraud and abuse laws.

Transparency

The Department of Justice and OIG require “transparency” in physician-industry relationships, including the public disclosure of payments any physician receives from a vendor. The Patient Protection and Affordable Care Act of 2010 requires drug, device, and biologic companies to publicly report nearly all gifts or payments made to physicians beginning in 2013. Academic medical institutions have strict limitations on vendor interactions and policies concerning industry-sponsored research. Additionally, the pharmaceutical and medical device industry has adopted codes of ethics for provider-industry relationships.

Conflicts-of-Interest Disclosures

Healthcare providers are required to disclose their financial relationships with the pharmaceutical industry to their patients and institutions, even if legal, due to conflict-of-interest policies set by institutions, grant funders, or the FDA. Managing these conflicts involves understanding relevant policies, openly disclosing industry funding, and following any restrictions. A conflict of interest (COI) arises when an individual’s personal interests potentially influence their professional judgment or actions in a way that could harm patient care or public trust. This can happen in healthcare and pharmaceutical relationships which is a serious concern because it can lead to:

  • Overuse or inappropriate use of medications
  • Increased healthcare costs
  • Reduced quality of care
  • Loss of public trust in healthcare providers and the pharmaceutical industry

Serval measures should be in place to prevent COIs including disclosure of financial relationships; obeying laws that regulate COI, abiding by the professional code of either, and providing transparency. When unsure, consult someone.

Continuing Medical Education (CME)

Drug and device manufacturers sponsor many educational opportunities for physicians. Not all educational sessions are created equal. Watch out for industry-sponsored events, especially those promoting specific brands over broader treatment options. Even if presented by a respected doctor, their talk might be less about education and more about marketing. Beware of off-label recommendations in medical talks, especially for drugs or devices not approved for those uses. Double-check any such claims against independent data. While doctors can prescribe off-label, manufacturers can’t promote it. Remember, all drug ads must be truthful and approved-use focused. Help the FDA catch misleading ads through their Bad Ad Program. If an advertising violation occurs, it should be reported to the FDA.

Compliance and Monitoring

Maintaining a compliance program acts like a shield against fraud and guarantees accurate medical claims. Written policies and procedures outlining best practices for billing, coding, and other key areas should be clear. There should be a designated compliance officer responsible for overseeing and enforcing the program and should proactively audit and review billing and coding practices to identify errors. Lastly, swift response to violations should involve identifying compliance issues with corrective measures and disciplinary actions. The Patient Protection and Affordable Care Act of 2010 requires that physicians who treat Medicare and Medicaid beneficiaries establish a compliance program. The Office of Inspector General of the Department of Health & Human Services and the Centers for Medicare & Medicaid Services provide organizations with advice on these issues. However, the entity must disclose relevant facts and state specifically what the opinion is for (the specific grounds and law that it addresses).

Table 2. Anti-Kickback and Stark Law Comparison

THE ANTI-KICKBACK STATUTE (42 USC § 1320a-7b(b))

THE STARK LAW (42 USC § 1395nn)

Prohibition

Prohibits offering, paying, soliciting, or receiving anything of value to induce or reward referrals or generate Federal health care program business

  • Prohibits a physician from referring Medicare patients for designated health services to an entity with which the physician (or immediate family member) has a financial relationship unless an exception applies
  • Prohibits the designated health services entity from submitting claims to Medicare for those services resulting from a prohibited referral

Referrals

Referrals from anyone

Referrals from a physician

Items/ Services

Any items or services

Designated health services

Intent

Intent must be proven (knowing and willful)

  • No intent standard for overpayment (strict liability)
  • Intent required for civil monetary penalties for knowing violations

Penalties

CRIMINAL:

  • Fines up to $25,000 per violation
  • Up to a 5-year prison term per violation

CIVIL/ADMINISTRATIVE:

  • False Claims Act liability
  • Civil monetary penalties and program exclusion
  • Potential $50,000 CMP per violation
  • Civil assessment of up to three times the amount of kickback

CIVIL:

  • Overpayment/refund obligation
  • False Claims Act liability
  • Civil monetary penalties and program exclusion for knowing violations
  • Potential $15,000 CMP for each service
  • Civil assessment of up to three times the amount claimed

Exceptions

Voluntary safe harbors

Mandatory exceptions

Federal Health Care Programs

All

Medicare/Medicaid

Source: Healthcare Fraud Prevention and Enforcement Action Team (HEAT) Office of Inspector General (OIG)

Key Takeaways

  • Federal legislation addressing healthcare fraud and abuse includes the False Claims Act, the Anti-Kickback Statute, and Stark Laws.
  • The False Claims Act (FCA) was enacted in 1863 to combat fraud by contractors supplying the Union Army and to stop war profiteers from defrauding the government.
  • The Anti-Kickback Statute (AKS) was created in the Social Security Act Amendments of 1972. This statute makes paying for referrals a crime in federal healthcare programs.
  • Enacted in 1989, the Stark Law, also known as the Physician Self-Referral Law, is a federal law that prohibits physicians from referring Medicare or Medicaid patients to receive certain designated health services (DHS) payable by Medicare or Medicaid from entities in which the physician or an immediate family member has a financial relationship unless an exception applies.
  • There are several exceptions to the Stark Law, including exceptions for (1) In-office ancillary services, (2) Hospital-based physician services, (3) Bona fide employment arrangements, (4) Personal services arrangements, and (5) Shared savings arrangements.
  • Four key elements of a bona fide employment relationship under the Stark Law Statute:

(A) Identifiable Services: The physician must be employed to provide specific, identifiable services, not just generally to generate referrals.

(B) Fair Market Value & No Referral-Based Compensation: The physician’s compensation must be based on the fair market value of the services they provide, and it cannot be directly or indirectly tied to the volume or value of referrals they make to the employer.

(C) Commercially Reasonable Agreement: The employment agreement itself must be commercially reasonable, meaning it would be considered fair and appropriate even if no referrals were expected.

(D) Additional Requirements: The Secretary of Health and Human Services may impose additional requirements through regulations to further protect against program or patient abuse.

References

  • American Medical Association (AMA) (2023). Trends in Health Care Spending. https://www.ama-assn.org/about/research/trends-health-care-spending
  • Anti-Kickback 1972, (42 U.S.C. §§ 1320a-7b(b))
  • Healthcare Fraud Prevention and Enforcement Action Team (HEAT) Office of Inspector General (OIG)
  • Morgan, J. F. (2019), Business Law 6th ed., BVT Publishing
  • Perry, J. E. & Thompson, D. B. (2017) Law and ethics in the business of healthcare. West Academic Publishing.
  • Stark Law 1989, (42 U.S. Code § 1395nn)
  • The False Claims Act (FCA) 1863, (31 U.S.C. §§ 3729-3733)
  • § 1128B(b) of the Social Security Act (42 U.S.C. 1320a-7b(b)), previously codified at §§ 1877 and 1909 of the Act.
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Legal Fundamentals of Healthcare Law Copyright © 2024 by Tiffany Jackman is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License, except where otherwise noted.

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