The False Claims Act was involved because some of the cardiac procedures were billed to Medicare. OIG will continue to examine and investigate those relationships that violate federal statutes in an effort to protect vital taxpayer dollars.”. Posted in 3rd Circuit, Anti-Kickback Statute, Causation, D.N.J., S.D.N.Y. “Rialto, through RL BB, acquired KMC as part of KMC’s bankruptcy reorganization in 2013. In fact, it is not much of a stretch to say that the Government views pretty much all marketing as quasi-violative of the Anti-Kickback statute. Until we both sign In these cases, it is not uncommon to agree to stipulate to the amount of restitution based on the total amount of … Anti-Kickback Statute Washington, D.C. Whistleblower Lawyers. In the last two cases, they may not have been named defendants because the whistleblowers were physicians in the practices or related somehow to the practices. It also discusses the interplay between the AKS and other laws, including the False Claims Act and Stark Law. Contact Cohen Healthcare Law Group, PC to learn what financial relationships between doctors or medical practices and any health provider, hospital, family, investment firm, or other entity might fit within a Stark exception or safe harbor and which ones might result in enforcement. The federal anti-kickback statute created criminal penalties for knowingly and willfully paying for business referrals for services covered by any federal healthcare program. The Federal Anti-Kickback Statute and the Stark Law are often confused because both laws deal with remuneration related to improper referrals.The Anti-Kickback Statute is a criminal law that applies broadly and prohibits the knowing and willful payment of remuneration to induce or … “Kickbacks give doctors an incentive to pursue unnecessary treatments that are costly and sometimes even dangerous to patients,” said U.S. Attorney Robert K. Hur. “The practice of providing any kind of remuneration in exchange for the referral of Medicare patients is a violation of the Anti-Kickback Statute. TULSA, Okla. – Three physicians and five marketers have been charged in U.S. District Court with violations of the federal anti-kickback statute and other criminal offenses, announced U.S. Attorney Trent Shores. The anti-kickback statute gives protection to Medicare/Medicaid patients, who are typically elderly. The claims were settled without a determination of liability. But in every kickback case, healthcare providers will provide some material benefit in return for other providers prescribing or using their products or services. Federal Anti-Kickback Statute Congress passed the federal anti kickback law in 1972. Specific intent is required for AKS violations but not for Stark Law violations. The case resulted in an agreement to pay the government an estimated $20.7 million to settle the claims. § 1320a-7b(b), covers a broader range of activity than the Stark Law, and extends to all medical providers in a position to arrange or recommend medical services.“Referrals” under the Anti-Kickback Statute include “any item or service for which payment may be made in whole or in part under a Federal health care program.” On November 24, 2020, the Eleventh Circuit issued an opinion in U.S. v Shah (Case No. Federal laws prohibit kickbacks and improper compensation to doctors and other healthcare providers as specified by the Stark Law because those financial incentives often result in medically unnecessary treatment and the use of more expensive products. When the statute is violated and intent is discovered, everybody involved can be prosecuted. The basis for the False Claim Act claim was that the orthopedic practice billed for services for physical therapy that were performed by unauthorized athletic trainers and an exercise psychologist. In the case of an entity that has not yet been in business for 12 months, compliance with this standard will be determined by examining the composition of the entity's business over the entire period of its existence. Stark Law involves referrals between a doctor and another entity. 1395nn). The anti-kickback statute includes harsh penalties, even for anyone who is a first-time offender. I. “Referrals” under the Anti-Kickback Statute include “any item or service for which payment may be made in whole or in part under a Federal health care program.” Medical Groups, Medical Centers The illegal kickbacks can be cash payments, but often include other items of monetary value, such as gifts, free or discounted supplies or services, and travel. Doctors and practices need to understand that many referrals may be legal – if the referral is covered by the Stark Law exceptions of AKS safe harbor. OIG’s Fraud and Abuse Laws: A Roadmap for Physicians. The Anti-Kickback Statute is a criminal statute, but it provides both civil and criminal penalties for violations that do not fall within one of its safe harbors. The lawsuit was brought pursuant to the qui tam provisions of the False Claims Act which reward individual whistleblowers for disclosing fraud by paying the whistleblower a percentage of any recoveries. 2. If an arrangement does not meet a Stark exception then the arrangement is non-compliant; on the other hand, the safe harbor elements need not necessarily be strictly met. Medical and pharmaceutical kickbacks come in many forms. The Anti-Kickback Statute, 42 U.S.C. § 1320a-7b) was established to protect patients by ensuring that all medical professionals make healthcare decisions based on their patients’ specific needs, not based on any influence from corporations who might profit from a diagnosis or prescription. (a) exclude from safe harbor protections under the anti-kickback statute, section 1128B(b) of the Social Security Act, 42 U.S.C. It is a criminal law although few people are sentenced to prison for violating its provisions. Medical Spas § 1320a-7b a healthcare kickback, you could be facing 10 years in federal prison and a fine up to $100,000 fine. On Aug. 24, 2016, the U.S. District Court for the District of Massachusetts issued an order allowing an ongoing False Claims Act/Anti-Kickback Statute (AKS) case, U.S. ex rel. As part of that reorganization, KMC and Rialto initially offered to award partial ownership in the hospital’s real estate to certain physicians who had been important referral sources for KMC, but those offers were challenged in the bankruptcy proceedings. One area of growth has been FCA cases based on violations of Medicare and Medicaid anti-kickback and self-referral laws. The Anti-Kickback Statute prohibits anyone from offering or receiving kickbacks in any form to induce or reward those who generate business involving the treatment of patients and services that are reimbursed by Medicare, Medicaid and other government healthcare programs. The AKS applies to Medicare – and Medicaid and TRICARE. It is also important to ensure that documents and records within a particular health provider’s office are thoroughly reviewed to ensure the Government’s investiga… “We will not tolerate medical care providers who put their patients at risk and waste taxpayers’ dollars in order to line their own pockets.”, “Patients rightly expect their doctors will make recommendations based on sound medical practice – not payoffs that too often result in needless and sometimes even harmful procedures,” said Maureen R. Dixon, Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services. DO YOU KNOW THE KEY DIFFERENCES BETWEEN THE 4 AMBULATORY SAFE-HARBORS TO THE FEDERAL ANTI-KICKBACK STATUTE (AKS)? The Federal Anti-Kickback Statute: At the outset, it is important to keep in mind that the Anti-Kickback Statute is a criminal statute. The announcements confirm settlements for violations of the Stark Law, a federal anti-self-referral law and the Anti-Kickback Statute (AKS). For example, they might pay doctors inflated rates for speaking engagements or pay above fair market value to lease office space. The Federal Anti-Kickback Statute and Safe Harbors (2020) This book covers all safe harbors currently in place, including investments, office and equipment leases, personal and management services, warranties, discounts, and many others. Health Coaching Lawyer Reveals Secrets to Health Coaching Laws, Terms of Use, Disclaimer, and Privacy Policy. Phillips & Cohen works with whistleblowers on a contingency basis, which means there is no payment unless the government recovers funds from the case and pays the whistleblower a reward. The Anti-Kickback Statute is rigid in interpreting the safe harbors for cases to be exempted. The Department of Justice announced in 2019, that Rialto Capital Management LLC (Rialto) and a former affiliate agreed to the $3.6 million payment based on claims they and a hospital in Indiana entered into illegal financial arrangements with two doctors who referred patients to the Indiana hospital. In this case, the whistleblower was a former employee of the medical practice. It will also show how violation of the AKS can raise FCA concerns, and it will provide an assessment of enforcement activities, … Prior results do not guarantee a similar outcome. The Anti-Kickback Law or Anti-Kickback Statute (AKS) is the federal criminal law that forbids kickbacks involved in federal health care programs. Several Medical Facilities Agree to Pay $35 million to settle False Claims Act Charges based on Stark Law – involving Kickbacks to a Maryland cardiology practice. The OIG office of the US Department of Health and Human Services and the Defense Criminal Investigative Service brought the legal actions on behalf Medicare and TRICARE. Here are some examples of our qui tam cases involving the Stark Law and Anti-Kickback Statute: Phillips & Cohen also has brought successful whistleblower cases involving kickback allegations against blood testing labs, pharmacies, hospitals, nursing home chains and others in the healthcare industry. However, Congress did not define the phrase “resulting from.” The AKS, as mentioned, includes criminal sanctions. In most instances, kickbacks are illegal. Investment Interests in Ambulatory Surgical Centers The Anti-Kickback Statute (“AKS”) is a federal law that prohibits paying or receiving remuneration in order to induce the referral of government paid healthcare business. DaVita Healthcare Partners(2014) – In October 2014, DaVita, one of the leading providers of dialysis services in the United States, agreed to pay $350 million to resolve allegations that it offered improper investment deals to physicians in exchange for the physicians’ referral of Medicare and Medicaid patients to DaVita. Courts Grapple with Causation Requirement in FCA Cases Based on Violations of Anti-Kickback Statute By Molly Ruberg on March 17, 2020 Posted in 3rd Circuit , Anti-Kickback Statute , Causation , D.N.J. Dietary Supplement Companies I. Improper billing and Stark Law referrals harm anyone who uses Medicare or other federal healthcare services – in addition to hurting the patent by not providing the best medical care possible. The law attempts to make the anti-kickback statute a more useful prosecutorial tool by expanding the definition of prohibited conduct and by making the statute applicable to a broader range of persons involved in … Indeed, in fiscal year 2020, DOJ recovered more than $2.2 billion in False Claims Act (FCA) cases, with $1.8 billion of that amount coming from the health care industry. The illegal transactions, in this case were violations of the Physician Self-Referral Law, also called Stark Law. The Anti-Kickback Statute and the Stark Law have key differences in what they prohibit and by whom, while sharing similar goals of protecting patients and preventing waste, fraud and abuse in government healthcare programs. In late August 2017, a federal judge in Pennsylvania held that violations of the federal Stark Law and Anti-Kickback Statute that defendants characterized as merely “technical” were, in fact, material to the federal government’s decision to reimburse healthcare entities for goods and services. A second whistleblower lawsuit was brought by patients of one medical doctor and several other medical facilities that some of the procedures weren’t medically necessary. In some cases, a drug manufacturer or laboratory may owe a fee to a doctor for specimen processing, event speaker fees, or participation in research projects. The False Claims Act Anti-Kickback Statute is a federal law making it illegal to offer, pay, solicit, or receive “remuneration” in exchange for referring a patient or furnishing or arranging for a healthcare good or service billed under Medicaid. Violations of the Anti-Kickback Statute can result in fines of up to … There are four types of ambulatory safe harbors in the federal Anti-Kickback Statute. Although some types of arrangements previously were offered “safe harbor” from prosecution, others had to be approved on a case-by-case basis. [i] Moreover, a deeper dive into those numbers reflects that a significant portion of that amount resulted from cases predicated on violations of the Anti-Kickback Statute (AKS). Stark Law and Anti-Kickback Statute Cases That Can Kill Your Healthcare Venture. Section 1320a-7b(b), makes it a crime to . First, on March 8, 2018, the U.S. Attorney’s Office for the District of Massachusetts announced a $3.1 million dollar settlement with Abiomed, Inc., to resolve allegations that Abiomed violated the Anti-Kickback Statute (AKS) and False Claims Act (FCA) by inducing physicians to use its products. Is your medical practice, home health agency or hospice facing kickback allegations? Very interesting topic Hetal. Federal health care programs. We explain the key differences between the ambulatory safe harbors to the federal anti-kickback statute (AKS), Orthopedic surgery and physical therapy practice agree to pay $1.25 million to settle Stark Law claims. Hospitals and other companies often try to disguise their medical kickbacks as legitimate payments. The session will provide an overview of the Anti-Kickback Statute (AKS) and review what it prohibits, as well as review the Statute's available safe harbors. § 1320a-7b(b), is a criminal law that prohibits medical providers from offering, soliciting, paying, or receiving anything of value in exchange for referrals of patients whose resulting treatment will be paid for by a federal health care program (e.g., Medicare, Medicaid, TRICARE, and others). Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture. Here are some items to continue to look out for in 2020 in Anti-Kickback prosecutions. Here are some items to continue to look out for in 2020 in Anti-Kickback prosecutions. 6 These laws prohibit payment of money, or anything of value, in exchange for the referral of patients to a specific physician. the OIG Anti-Kickback Statute . Two recent cases in the pharmacy space exemplify the risks of paying commissions to 1099 independent contractor marketing reps. The Anti-Kickback Statute (42 U.S.C. One. The purpose of Stark Law is to ensure that patients will receive medical advice and will treat with physicians based on their medical needs and not on what profits the doctors or medical practices involved. The Anti-Kickback Statute (AKS), 42 U.S.C. Kickbacks to doctors or other healthcare providers are prohibited by two federal laws: the Anti-Kickback Statute [42 U.S. Code § 1320a–7b(b)] and the Stark Law (42 U.S.C. Stark does not require proof of intent. Restitution in anti-kickback cases is a highly under-litigated issue. Recent Anti-Kickback Cases Emphasize Government Scrutiny of Speaker’s Bureaus and Lavish Meals Funded by Pharmaceutical and Device Manufacturers. Even if there is a lawful basis for a payment, the financial arrangement may still be fraudulent if one purpose of the payment is to influence a doctor or other healthcare provider to use the company’s products or services. ... Anti-Kickback Statute In other words, only those arrangements that precisely meet all of the conditions set forth can only afford the safe harbor protection. The US Attorney for the Southern District of Alabama announced in 2019 that Baldwin Bone & Joint,  had agreed to settle claims it violated the False Claims Act, a law designed to help the government recover funds for illegal transactions involving the government. If convicted for violating 42 U.S.C. The federal Anti-Kickback Statute (AKS) is one of the best-known federal fraud and abuse statutes, due largely to its wide-ranging effects on business relationships in the health care, pharmaceutical, and medical device sectors. The federal anti-kickback statute prohibits the knowing and willful offer or receipt of remuneration to induce the referral of business or services covered by a federal health care program, including Medicare. [i] Moreover, a deeper dive into those numbers reflects that a significant portion of that amount resulted from cases predicated on violations of the Anti-Kickback Statute (AKS). Digital & Mobile Health Companies Anti Kickback Law. Under the Anti-Kickback Statute, a company commits fraud when it offers doctors and other healthcare providers financial incentives to use the company’s products or services, for which payment may be made under Medicare, Medicaid or other federally funded healthcare programs. The whistleblower in this case was a doctor who was awarded $612,000 for disclosing the alleged fraud. The statute makes it a crime to exchange (or offer to exchange), anything of value, in an effort to induce (or reward) the referral of federal health care program business. Courts Grapple with Causation Requirement in FCA Cases Based on Violations of Anti-Kickback Statute By Molly Ruberg on March 17, 2020 Posted in 3rd Circuit , Anti-Kickback Statute , Causation , D.N.J. Stark also prohibits health-industry entities from submitting claims to Medicare and Medicaid for services based on a physician referral prohibited by Stark. In addition, the doctors and providers may be subject to triple damages on the overpayment. , S.D.N.Y. Additional State Telehealth Waivers During the COVID-19 Pandemic. TULSA, Okla. – Three physicians and five marketers have been charged in U.S. District Court with violations of the federal anti-kickback statute and other criminal offenses, announced U.S. Attorney Trent Shores. The AKS is a criminal law that prohibits the knowing and willful payment of \"remuneration\" to induce or reward patient referrals or the generation of business involving any item or service payable by the Federal health care programs (e.g., drugs, supplies, or health care services for Medicare or Medicaid patients). Often medical practices can be named as defendant. The new and amended regulations related to the federal Anti-Kickback statute and the civil monetary penalties law issued by OIG address stakeholder concerns that these laws unnecessarily limit the ways in which healthcare providers can coordinate care … Medical Management (MSOs) KICKBACKS, FEE-SPLITTING, CORPORATE PRACTICE OF MEDICINE, STARK, MSOS: GUIDING HEALTHCARE VENTURES THROUGH THE MAZE, Fundamentally, you’re worried about legal rules prohibiting kickbacks, fee-splitting, corporate practice of medicine, as well as Stark law; you don’t know whether the MSO or management structure […], A Capital Management Company and Its Affiliate Agree to Pay $3.6 Million to Settle Stark Law, AKS, and False Claim Act Allegations Doctors Referred Patients to Them Illegally. The US Department of Justice announced in 2019 the terms and basis of the settlement. Emanuele v. Medicor Assocs., 2017 WL 3675921, No. Anti-Kickback Statute Washington, D.C. Whistleblower Lawyers. While we will treat any information The Anti-Kickback Statute, codified at 42 U.S. Code § 1320a–7b(b), is an American federal law which imposes criminal and, particularly in association with the federal False Claims Act, civil liability on those that knowingly and willfully offer, solicit, receive, or pay any form of remuneration in exchange for the referral of services or products covered by any federal healthcare program … One. Recent Stark Law and Anti-Kickback Statute Cases, https://cohenhealthcarelaw.com/michaelhcohen/wp-content/uploads/2018/09/cohen-healthcare-horizontal-web.png, Cohen Healthcare Law Group | Healthcare Lawyers | FDA & FTC Law, https://cohenhealthcarelaw.com/michaelhcohen/wp-content/uploads/2018/10/bigstock-206463712.jpg, Compliance Issues for Medical Fitness Centers, Gyms, and Wellness Centers – Part 2, Non-Compliance with California’s Version of the Federal EKRA Law can result in Criminal Convictions and Civil Penalties, M&A (Acquisitions & Sales of Healthcare Businesses), Fraud & Abuse (Anti-Kickback, Fee-Splitting, Stark), Management Services Organizations (MSO) Issues, Medical Device & Mobile Medical App Issues, ANTI-AGING & FUNCTIONAL MEDICINE PRACTICES, BEHAVIORAL & MENTAL HEALTHCARE PROVIDERS AND LIFE COACHES, COMPLEMENTARY & INTEGRATIVE MEDICINE PROVIDERS, CONCIERGE & DIRECT PRIMARY CARE MEDICAL PRACTICES, DIETARY SUPPLEMENT & NUTRACEUTICAL COMPANIES, HEALTHCARE FACILITIES (HOSPITALS, LABS, PHARMACIES, DME, IMAGING), Several recent announcements by the US Department of Justice, US Attorney for the Southern District of Alabama announced. § 1320a-7b. Speaking with investigators can result in the disclosure of information that may be interpreted in ways that could be used against the individual at a later time. WHAT MEDICAL PRACTICES SHOULD KNOW ABOUT THE STARK LAW, The Stark Law is named after California U.S. 3523 , enacted November 7, 1986, originally codified at 41 U.S.C. The intent of the law is to protect patients and eliminate abuse and health care fraud from federal programs such as Medicare , Medicaid, and the Children's Health Insurance Program (CHIP), among others. AMARILLO, TX - The Medicare anti-kickback statute makes it a felony to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce a person or entity to refer an individual for the furnishing or arranging for the furnishing of any item or service reimbursable by a federal health care program, or to induce such person to purchase or lease or recommend the purchase or lease of any item or service … Stark Law and Anti Kickback Statute are some of the most challenging issues in physician compensation today. West Virginia hospital agrees to pay $50M to settle whistleblower case alleging Stark and Anti-kickback violations, Qui tam lawsuits – whistleblower guide & FAQs, Five Phillips & Cohen whistleblower attorneys named to 2020 “Leading Lawyers” list, Medical equipment maker ResMed settles whistleblower lawsuits for $39.5 million, Wisconsin hospital and affiliated physician group pay $10M to settle whistleblower lawsuit alleging kickbacks, Whistleblower cases brought by Phillips & Cohen featured on CBS “Whistleblower” TV Series, Anti-money laundering whistleblower program. about a potential case to Phillips & Cohen LLP, we do not become your attorneys. “We will continue to protect patients and taxpayer-funded government health programs from these unnecessary services, as the government contended in this case.”. In these cases, it is not uncommon to agree to stipulate to the amount of restitution based on the total amount of the client’s gain. The Anti-Kickback Statute is rigid in interpreting the safe harbors for cases to be exempted. knowingly and willfully. The session will provide an overview of the Anti-Kickback Statute (AKS) and review what it prohibits, as well as review the Statute’s available safe harbors. The Anti-Kickback statue is similar to Stark Law but there are key differences. Congressman, Peter Stark. Stark Law is a civil law, unlike the AKS which allows for criminal prosecution. Restitution in anti-kickback cases is a highly under-litigated issue. For physicians, nurses, and other professionals, including office staff, facing either of these types of investigations, it is important to treat them as seriously as any other federal offense. The Stark Law, which is codified at 42 U.S. Code Section 1395 nn is another anti-kickback law which specifically applies to physician referrals. The men allegedly caused federal health care insurance programs to pay reimbursement costs for fraudulent and expensive compounding drug … Common Anti-Kickback Violations in Medicaid Scenarios. These pages should not be construed to contain legal advice. If a reduction in price is conditioned on more than a simple purchase, it is not a mere ‘discount,’ but rather a form of remuneration whose legitimacy must be evaluated under the anti-kickback statute separate and apart from the statutory discount exception or regulatory … That in turn results in higher costs to patients, Medicare, Medicaid and other healthcare insurance programs. § 1320a-7b. Our Stark and Anti-kickback attorneys have a strong track record of helping physicians and medical practices structure arrangements, and craft documents, with an eye toward mitigating potential regulatory risk. Under the Anti-Kickback Statute, a company commits fraud when it offers doctors and other healthcare providers financial incentives to use the company’s products or services, for which payment may be made under Medicare, Medicaid or other federally funded healthcare programs. There are often correct ways to establish referral arrangements that an experienced healthcare lawyer can explain. Legal Penalties for Anti-Kickback Statute. Those who violate the Anti-Kickback Statute may be subject to criminal as well as civil penalties, while those who violate the Stark Law are subject to only civil penalties. The settlement is not an admission of liability. Experienced Stark Law attorneys explain to physicians and practices when Stark Law and a similar law, the Anti-Kickback Statute (AKS), apply to their medical relationships. See U.S. ex rel. Concierge Medical Practices They include the: False Claims Act: states that it’s illegal to file false Medicare or Medicaid claims. “Illegal financial arrangements between health care providers undermine the integrity of our health care system, and we will continue to pursue those who engage in such conduct.”. The False Claims Act offers whistleblowers an effective way to expose and stop pharmaceutical and medical kickbacks in the healthcare system. § 51 et seq., recodified at 41 U.S.C. The settlement was based on claims the hospital, under the direction of the capital management company, made personal loans to the two doctors who referred patients and then “repeatedly forbore from requiring repayment of those loans.” The government claimed that the failure to make the effort to collect on the loans was “remuneration” in return for referrals – which is prohibited by both Stark Law and the AKS. , S.D.N.Y. 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