2. Commonly referred to as the Stark law, the Physician Self-Referral Law prohibits physicians from referring patients to receive "designated health services" payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. Types of Healthcare Fraud and The Support You Need, Investment in ambulatory surgical centers, Receiving a performance bonus tied to the number of lab tests ordered at the hospital, Use of free or discounted office space, access to administrative support staff, or equipment, Payment for a physicians travel and expenses for conferences, Kickbacks paid through consultant fees for services that require few substantive duties by the physician, Civil monetary penalties and program exclusion, Civil assessment of up to three times the amount of kickback, Prosthetics, orthotics, and prosthetic devices and supplies, Inpatient or outpatient hospital services, Referral to certain physicians in the same group, Non-monetary compensation (off-campus meals, gift baskets, flowers, holiday gifts, etc. Physicians found guilty of submitting false health care claims have received prison time. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. Combining these practices can protect health care organizations from future violations of the Stark Law, AKS, and other laws that the OIG has mandated. This site uses cookies and other tracking technologies to assist with navigation and your ability to provide feedback, analyze your use of our products and services, assist with our promotional and marketing efforts, and provide content from third parties. The Anti-Kickback Statute final rule also includes the following additional value-based related safe harbors: 1. All three safe harbors protect in-kind (i.e. The information contained in this blog is general in nature and is not offered and cannot be considered as legal advice for any particular situation. On the other hand, the AKS requires that intent of violating the law must be proven as knowing and. The federal government instituted the Anti-Kickback Statute and Stark Law in an effort to eliminate healthcare fraud and abuse. If we return to the value-based arrangement example above, in which a hospital provides a care coordinator to a SNF, and we assume the VBE has not accepted any risk, the hospital is limited to providing the care coordinator the hospital would not be permitted to provide money to the SNF to employ or provide a care coordinator. In the preamble to the proposed rule, the OIG listed a number of examples of outcomes-based payment arrangements, including shared savings payments, shared losses payments, gainsharing payments, pay-for-performance payments, or episodic or bundled payments. Then compare each providers time sheet to their contract to confirm they are providing the services and time specified in the contract. To comply with the Anti-Kickback Statute, you must record the dollar amount of each gift received by each provider, and address gifts that exceed the thresholds established by CMS and your organization. The author has provided the links referenced above for information purposes only and by doing so, does not adopt or incorporate the contents. Financial relationships include both ownership/investment interests and compensation arrangements. Penalties for Anti-Kickback can include criminal penalties like jail time, while the highest penalty for Stark violations are civil penalties like fines and False Claims Act liability. Opinions and conclusions in this post are solely those of the author unless otherwise indicated. If the physician and the health care entity comply with one of these three exceptions, then the value-based arrangement, and subsequent claims to Medicare for DHS, will not violate the Stark law. For example, one pharmaceutical corporation paid over $591 million to resolve claims that its sales representatives paid kickbacks (via speaker fees) to doctors to persuade them to prescribe several drugs. The Stark Law and the Anti-Kickback Law are very similar with a few key differences. Patient care and clinical outcomes suffer when treatment protocol decisions and patient referrals are based on financial incentives, not patients best interests. HELLO@SYMPLR.COM 866-373-9725 Legal and Privacy, How to Avoid Stark Law and Anti-Kickback Statute Penalties, List of Excluded Individuals and Entities, Space Lease - the Stark Exception | symplr, Revised Elements of Performance and Standards | symplr, Health Connect Partners Conference 2104 | symplr. Civil penalties of the AKS include False Claims Act liability, civil monetary penalties (CMP) and program exclusion, up to $50,000 CMP per violation, and civil assessment of up to three times the amount of kickback. If a medical claim results from a kickback or violates the Stark law, that claim may be false or fraudulent, creating liability under the civil False Claims Act as well as the Anti-Kickback Statute or Stark law. Possible civil sanctions and criminal penalties per violation include: If youre facing audits, investigations, or subpoenas due to accused AKS violations or prescription fraud in Texas, dont wait to seek legal counsel from Westfall Sellers. This field is for validation purposes and should be left unchanged. The patient engagement and support safe harbor protects patient engagement tools or supports furnished directly by a VBE participant to patients in the VBEs target population, if such tools or supports are directly connected to specified goals, including: (1) adherence to treatment/drug regimens; (2) adherence to a follow-up care plan; (3) disease/health condition management; (4) improving health outcomes; and (5) ensuring patient safety. Stark law violation penalties: The Stark law is a strict liability statute, which means proof of specific intent to violate the law is not required. Build a Morning News Brief: Easy, No Clutter, Free! Dont battle it alone. Make it count. ), Referring patients to an imaging center you have invested in, Improper billing codes resulting in a greater reimbursement (whether intentional or accidental), Allowing a specialized medical group to use your office for free or for a reduced rent, Paying specific physicians higher than market value salaries, Referring a patient for medically unnecessary procedures or testing, Exclusion from Medicare or Medicaid reimbursement, Civil monetary penalties and program exclusion for knowing violations, Civil assessment of up to three times the amount claimed, Guide you on gathering evidence that refutes any claims, Decrease or avoid civil or criminal punishments, Identify or establish safe harbors and ensure all arrangements are legal, Determine whether your practice is in compliance with the AKS and Stark Law, Navigate private insurance company investigations. Responding promptly to detected offenses and undertaking corrective action. The PRC houses hundreds of customizable policy and procedure templates that cover Stark Law and AKS, along with a variety of other compliance topics. the hospitals payment to the physician group for each post-discharge meeting a physician attends) would not violate the Stark Law. The definitions for value-based arrangement, value-based enterprise, value-based activity, and value-based purpose in the Anti-Kickback Statute final rule are substantially similar to the definitions in the Stark law final rule. You also have the option to opt-out of these cookies. In this article, the skilled healthcare fraud attorneys from Westfall Sellers will help you understand each law, the differences, and advise you on when to find a Stark Law attorney. The OIG may impose administrative civil monetary penalties for false or fraudulent claims. Here are a few examples: A violation of the Anti-Kickback Law is considered a federal felony and can severely affect your reputation, profession, and personal life. It does not apply to cash or cash equivalents. Suite 300 To comply with the Anti-Kickback Statute and Stark law, provider compensation for clinical and administrative activities must be consistent with Fair Market Value and not take into consideration the value or volume of referrals the provider brings to the health care organization. Although these laws are similar in the ways they address remuneration related to improper referrals, there are several distinctions between them: One of the major differences between the Stark Law and the AKS is the type and degree of each laws associated penalties. Whistleblowers are entitled to a percentage of any monetary recoveries. Of the $1.8 billion in settlements and judgments that the Department of Justice (DOJ) recovered in 2020 in civil cases involving health care fraud and false claims, numerous health care organization types were hit, including: On top of that, fines for noncompliance are no longer always insurable, so in some cases health care executives are being held personally liable when significant gaps in oversight are discovered. Included under documents and templates for these laws, the PRC has policies for gifts, joint ventures, patients, physician arrangements, physician recruitment, safe harbors, and vendor relationship. These can be as subtle as accepting or offering free items, cash, gift cards, and event tickets in exchange for purchasing or selling their products. The safe harbor applies only to in-kind items, goods, or services. 2022 Strategic Management Services, LLC. Conducting internal monitoring and auditing. Health care organizations can explore these topics in depth in the PRC to bolster their compliance programs effectiveness and remain compliant with federal fraud, waste, and abuse laws. One such component is the different consequences that the organization, physician, or other entity will face should either law be violated. Law Firms: Be Strategic In Your COVID-19 Guidance [GUIDANCE] On COVID-19 and Business Continuity Plans. Conversely, the Stark Law is for referrals from physicians only and covers a set list of Designated Health Services (DHS). Compliance Resource Centers Policy Resource Center (PRC) is a beneficial resource for health care organizations that want to make sure they have the right policies and procedures in place to stay compliant with the Stark Law and the AKS. Simply stated, both regulatory laws prohibit medical providers and/or entities from making health service referrals in exchange for compensation of any kind. It is mandatory to procure user consent prior to running these cookies on your website. Environmental Due Diligence Requires Reporting of Oil Contamination to the Maryland Department of the Environment, 2022 Hot Topics in Employment Law Seminar Highlights, USCIS Temporarily Increases Automatic Extension Period for Work Authorization - From 180 Days to Up to 540 Days, Government Contractors Must Complete AAP Certification by June 30, 2022, Public and Regulatory Attention to Forever Chemicals is at an All-Time High, Centers for Medicare & Medicaid Services (CMS), No inducement to reduce medically necessary items/services, Remuneration is not conditioned on referrals of patients who are not part of the target patient population/business not covered under the value-based arrangement, Standard limitations on required referrals, Remuneration is for value-based activities undertaken for the target patient population, Any outcome measures must be written, objective/measurable, with only prospective changes, No express requirement, but the physicians downside financial risk must be tied to the value-based purpose, Only if the remuneration paid is conditioned on referrals to a particular provider, practitioner, or supplier, Volume/value of referral or other business generated prohibition, Must establish one or more legitimate outcome or process measures, Applies to participant-participant arrangements. While the news focused on the hefty monetary fines, the truth is that Stark law and Anti-Kickback Statute violations can also lead to exclusion from federal health care programs, prison time, and reputational damage. If successful, the remuneration paid by the hospital to the physician group for any value-based activity (e.g. The Stark Law has mandatory exceptions, such as the Fair Market Compensation Exception or the In-Office Ancillary Services Exception, and the AKS only has voluntary safe harbors that can protect certain payment and business practices that would otherwise violate the law. Based on its fraud and abuse investigations, the OIG concluded that payments to speakers and attendees (in the form of free meals) are often used to induce (or are received in return for) ordering or prescribing items paid for by federal health care programs, thus violating the Anti-Kickback Statute. The stories behind headlines like these can have a chilling effect on health care administrators and compliance professionals: Texas Heart Hospital to pay $48M in alleged kickback settlement, Oklahoma hospital to pay $72.3M settlement over alleged kickback scheme. We respect your privacy and will never share any of your personal information with third parties. The value-based activity is the provision of care coordinators. One could imagine a hospital-physician compensation arrangement under which the hospital incentivized a physician group to improve the quality of care for patients who undergo lower extremity joint replacement procedures, with a goal of reducing readmissions, by paying the physician group for each post-discharge meeting one of its physicians attends. Like CMS, the OIG created three value-based safe harbors, with each safe harbor providing a sliding scale of flexibility based on the amount of financial risk undertaken by the participants (with greater financial risk providing greater flexibility). Criminal penalties can include fines of up to $25,000 per violation and up to a five-year prison term per violation.
Remuneration includes anything of value, such as cash, free rent, expensive hotel stays and meals, and excessive compensation for medical directorships or consultancies. Examples of remuneration referred to in this law could include anything from cash payments and paying for expensive hotels and meals to excessive compensation for medical directorships.
The civil FCA contains a whistleblower provision that allows a private individual (e.g., current or ex-business partners, hospital/office staff, patients, or competitors) to file a lawsuit on behalf of the United States.
In an effort to simplify compliance with the Anti-Kickback Statute for CMS-sponsored model participants, the OIG introduced this safe harbor, which effectively permits CMS to grant Anti-Kickback Statute safe harbor protection when defining the particular CMS-sponsored model. Visit our sister company Compliance Resource Center for custom tools and services, designed to meet your compliance program needs. Under the civil False Claims Act, each instance of an item or a service billed to Medicare or Medicaid counts as a claim, so fines can add up quickly. Medicare or Medicaid fraud, as well as any other offenses related to the delivery of items or services under Medicare or Medicaid (e.g., Anti-Kickback Statute or Stark law violations), Felonies resulting from other health-care-related fraud, theft, or other financial misconduct, Felonies related to unlawful manufacture, distribution, prescription, or dispensing of controlled substances, Presenting a claim that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent, Presenting a claim that the person knows or should know is for an item or service for which payment may not be made (e.g., a claim violating the Stark law). Compliance Program Design & Implementation, Compliance Program Effectiveness Evaluation, HIPAA Privacy Program Design & Implementation, HIPAA Privacy & Security Program Evaluation, How to Comply with Stark Law and Anti-Kickback Policies and Procedures. Any offer to a physician or entity that aims to increase referral rates in exchange for something of value is considered a violation of the Anti-Kickback Law. Government agenciesincluding the DOJ, the Department of Health & Human Services Office of Inspector General (OIG), and the Centers for Medicare and Medicaid Services (CMS)enforce these federal laws. A number of other corporate settlements required individuals, particularly senior executives or owners, to pay a portion of the settlement amount. Excluded physicians may not bill directly for treating Medicare and Medicaid patients, nor may their services be billed indirectly through an employer or a group practice. Implementing written policies, procedures and standards of conduct. In the OIGs Compliance Program Guidance documents, there are seven key elements of an effective compliance program including: The most notable of these elements as it relates to compliance with the Stark Law and the AKS is implementing written policies, procedures and standards of conduct.
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