Penalties for physicians who violate the stark law include fines as well as exclusion from. Remuneration does not include any payment made to a practitioner by a hospital or other entity where the practitioner is selling his or her practice to. Disclosure of clientoriented information pa mental health procedures act. Herschman, a member of the firm, with victoria vaskov sheridan, and paulina grabczak, associates, in the health care and life sciences practice, in the firms newark office, authored an article in compliance today, titled stark law. Double click on the pdf and a separate page will open. Review and update all policies related to physician arrangements to follow the new rules. The law applies to any physician who receives payment from medicare, medicaid or another federal program. Investigating noncompliance under new stark law regs law360, new york october 14, 2016, 12. Establishing and following a compliance program will help physicians avoid fraudulent activities and ensure that they submit true and accurate claims. For foot and ankle surgeons, stark issues are mostly likely to be triggered by investments in ascs and group practice arrangements. These healthcare law compliance policies address the laws and regulations of the food and drug administration fda, centers for medicare and medicaid services cms, and other healthcare regulatory agencies, and are enforceable by criminal, civil, and administrative penalties.
General stark compliance concepts arrangement in writing services well. Antikickback statute and stark law compliance pci healthdev. Although the consequences of violating these laws are no small matter, there are many policies, procedures, and practices available to help health care organizations remain compliant with both the stark law and the aks. The physician selfreferral statute stark law the health insurance portability and accountability act hipaa 42 cfr part 2. Physician selfreferral law stark law 8 criminal health care fraud statute 9 exclusion statute 9 civil monetary penalties law cmpl 10. How to build and maintain an effective compliance and ethics. Attorneys with knowledge of the stark law and other fraud and abuse laws should be. However, on november 15, 2007, cms delayed the effective date of the socalled stand in the shoes provisions of stark iii for academic. Master guide to clinical lab compliance 20192020 edition. The stark law is an important healthcare fraud and abuse statute that prohibits doctors from referring patients to entities with which they have a financial relationship for certain designated health services.
Office of inspector general oig compliance program. Holdovers beyond what is permitted by the stark law. Mar 21, 2017 establishes a number of specific exceptions and grants the secretary the authority to create regulatory exceptions for financial relationships that do not pose a risk of program or patient abuse. Mln booklet page 7 of 27 icn mln4649244 february 2019. How to comply with stark law and antikickback policies and.
Wood a publication of the health care compliance association. The genesis of the stark law, also known as the physician selfreferral law 42 u. How to build and maintain an effective compliance and. Compliance with the stark law is mandatory, and violations that do not fall within an exception or safe harbor can result in significant civil monetary penalties. Compliance considerations for clinical laboratories. Have systems to ensure properly structured payments.
Applicable stark exceptions require written contract covering services. The 20192020 g2 master guide to clinical lab compliance is designed to give you the practical, plainlanguage help you need to understand the laws affecting labs, and take practical, proven steps to protect your lab from costly falseclaims, antikickback, stark law, and other legal and compliance violations. The centers for medicare and medicaid services cms and the office of the inspector general oig are enforcing stark and federal antikickback laws with renewed vigor, and hospitals need to be wary of any and all. As a result, cms will not finalize the proposed stark law changes until 2020. But remember that prospective compliance may not be enough.
Stark law archives strategic management services, llc. Department of health and human services hhss office of inspector general oig would change enforcement of the antikickback statute. Suspected violations of the antikickback statute, stark law and this policy should be reported in accordance with millenniums business code of conduct and compliance program policies. Samford university s cumberland school of law and mcwhorter school of pharmacy offer a coordinated degree plan for students who wish to earn both a pharm. The stark law prohibits the submission, or causing the submission, of claims in violation of the laws restrictions on referrals. Penalties can include fines, jail time, and exclusion from federal healthcare programs. Stark law is a set of united states federal laws that prohibit physician selfreferral, 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 the term referral means the request by a physician for the item or. Act, the anti kickback statute and the stark statute by engaging in. New stark law changes ease compliance burden on health care. Comparison of the antikickback statute and stark law the antikickback statute 42 usc 20a7bb the stark law 42 usc 95nn prohibition prohibits offering, paying, soliciting or receiving anything of value to induce or reward referrals or generate financial relationship, unless an exception appliesfederal health care program business. Making sense of the stark law massachusetts medical society. Compliance and the transition to valuebased care law360. Stark law contract management compliance healthcare.
Nevertheless, the final rule suggests that cms will continue to assess the elements of the stark law and its various exceptions on an ongoing basis, and hopefully continue to eliminate unnecessary compliance burdens as it balances between the need to prevent medicare program abuse and allow health care providers to arrange for better and. This is not cmss first effort to ease the stark laws regulations. Compliance with the antikickback statute and stark law is a required condition of employment or continued engagement with millennium. The stark law class gives students an opportunity to explore, indepth, the federal physician selfreferral prohibition, including implications of violations of the stark law, mitigating risk of legal exposure, and compliant physician relationships. All parts of the new regulations were to be effective december 4, 2007. False claims act fca antikickback statute aks physician selfreferral law stark law social security act, which includes the. Many of the laws discussed apply to all federal health care programs. The stark law is a strict liability statute, which means proof of specific intent to violate the law is not required. C 95nn, or the public contracts antikickback law with respect to the performance of its obligations under this. This coordinated program is designed for students currently enrolled in the mcwhorter school of pharmacy.
Repayment of all amounts received by medicare based on hospital inpatient or outpatient services ordered by anesthesiologists during the period of noncompliance. Making sense of the stark law compliance for the medical practice the information contained in this manual is intended to serve as a general resource and guide. After more than 80 years, our attorneys continue to deliver practical, efficient solutions to clients in new jersey, pennsylvania, new york and throughout the united states. Although the consequences of violating these laws are no small matter, there are many policies, procedures, and practices available to help health care organizations remain compliant with.
Anti kickback statute and stark law in managed care contracts. The stark law is related to, but not the same as, the federal antikickback law. This document sets forth the scope and application of the secretarys blanket waivers of section. Sylla 51 cms implements important changes to stark and incidentto regulations scott r.
Civil monetary penalties law like aks, applies if marketing govt program beneficiaries or business. To oig, if there was knowing violation of false claims act, antikickback statute or civil monetary penalties law. Medicare or a state health program without violating the stark law. Antikickback statute and stark law compliance in managed. The stark law prohibits a physician from referring a patient for certain services to be reimbursed by federal health care programs to an entity with which the. In november 2015, cms published a final rule relaxing aspects of the stark law, including the easing of some of the strict liability features and cmss burden in dealing with the interpretation of key terms, requirements and other issues. Law stark law, the exclusion authorities, and the civil monetary penalties law. Here is a list of stark guidelines and their ramifications. Boards commitment to the compliance program is essential for its. The federal antikickback statute, and federal physician selfreferral law.
Third, as noted above, the stark law is a strict liability statute. Blanket waivers of section 1877g of the social security act. A compliance program provides a more accurate view of employee and contractor behavior relating to fraud and abuse. What works for a large nonprofit hospital cannot be repackaged to meet the needs of a longterm care facility and vice versa. Stark law is a conflict of interest statute, says mary i. The law is named for united states congressman pete stark, who sponsored the initial bill. Supervise implementation of the compliance program and coordinate all compliance efforts. Document financial relationships with referring physicians.
Clinical trials research is subject to a number of federal and state laws and regulations. The information contained in this manual is intended to serve as a general resource and. Each party agrees that it shall not violate the federal antikickback statute, set forth at 42 u. Apr 06, 2020 on april 3, 2020, oig released a policy statement indicating oig will exercise its enforcement discretion not to impose administrative sanctions under the federal antikickback statute aks for certain financial arrangements related to a covid19 purpose that are covered under the blanket stark waivers issued by the secretary of the u. Physicians involved in any venture that may implicate stark should consult legal counsel. This article briefly discusses five interesting stark law and antikickback cases and issues emerging in healthcare. Falbo, mba, cpc, ceo of millennium healthcare consulting, inc. Offering inducements to program beneficiaries if know.
Preparing for and defending stark law and antikickback. An effective compliance program provides ongoing training of employees and contractors, monitors their understanding and compliance with program rules, and provides the mechanisms to discipline those individuals. This compliance program covers all subsidiaries and affiliates of privia health, llc. A focus on the aksssae abos,sta safe harbors, stark. Compliance with stark law and antikickback statute american. Offering, soliciting, giving or receiving remuneration to induce referrals i. Whereas the antikickback statute applies to medicare and any federal healthcare program, the stark law is limited only to designated health services dhs paid for by medicare. Kusserow has worked with health care organizations to conduct compliance program effectiveness evaluations, deliver advisory services, develop policies and procedures and deliver compliance and internal investigations training.
Federal laws governing medicare fraud and abuse include the. What you should know katie scott, ms, atc national athletic trainers association athletic trainer in residence general overview on stark law stark law, made up of three separate provisions, governs physician selfreferrals for medicare and medicaid patients. C 20a7bb antikickback statute, the federal stark law, set forth at 42 u. Starks exceptions for certain compensation arrangements. Sanctions for violation of the referral and claims submission prohibitions are set forth in section 1877g of the act. On october 4, 2016, cms issued a final rule that significantly revised the rops, including the rop related to compliance and ethics programs, that. A system to identify compliance risk areas annual selfevaluation based on audit results internal and external, hotline calls, and investigation results a. This paper examines the operational aspects of a research compliance program and the steps that can be taken when there is evidence of regulatory or. An overview of the stark law in relation to medical staff. The stark law is a federal statute that prohibits physicians from referring medicare patients and clients to medical service facilities where they hold a financial interest, or have immediate relatives financially associated with the facility. In what will be welcome news to the provider community, the office of inspector general oig issued a policy statement on april 3, 2020, announcing that it will not impose administrative sanctions relating to the commission of acts described in the federal antikickback statute, with respect to remuneration that is covered in the first 11 stark law blanket waivers. How to comply with stark law and antikickback policies. A system to identify compliance risk areas annual selfevaluation based on audit results internal and external, hotline calls, and investigation results a process to respond to identified risk areas.
Oct 23, 2019 program materials if you have not printed the conference materials for this program, please complete the following steps. We know from decades of experience in the health care space that an effective compliance program is unique to each organization. The statute requires snfs and nfs to have a compliance and ethics program that is effective in preventing and detecting criminal, civil and administrative violations and promoting quality of care. Herschman, victoria vaskov sheridan, paulina grabczak. Hcca 21st annual compliance institute march 28, 2017 anti. Compliance overview there exist a number of constituents within a sales compliance program. As it relates to this case, falsely certifying compliance with the stark law in connection with a claim submitted to a federally funded insurance program is actionable under the fca. Maintaining effective auditing and monitoring systems and protocols to evaluate compliance with applicable laws, regulations, other federal healthcare program requirements and the compliance program standards.
Incentive compensation that includes credits for ancillaries. A compliance plan is a formal statement of a healthcare practices intention to conduct itself ethically in regard to business operations, government regulations, and patient services and care. Investigating noncompliance under new stark law regs. Stark law, actually three separate provisions, governs physician selfreferral for medicare and medicaid patients. Compliance program aveanna healthcare has a robust compliance program consisting of several elements, including. Sentencing commission guidelines manual are the seven fundamental elements of an effective. The following seven components provide a solid basis upon which a physician practice can create a voluntary compliance program. Stark and physician referrals to facilities in which there is a financial interest. Compliance for the medical practice march 9, 2018 in recognition of the complexity and onerous penalties of the stark law, the massachusetts medical society is working to develop a series of briefs and accompanying webinars that will help providers better understand the law and how it applies to them. Compliance committee is essential for the ongoing improvements that are planned for uw medicine compliance.