Stark law donation exception extended to 2021 omw health law. The safe harbor regulations under the antikickback statute contain nearidentical provisions insulating office space and equipment rental agreements that satisfy certain conditions. The prohibition was later extended to medicaid, and a number of exceptions have been added for legitimate business arrangements. This final rule modifies an existing safe harbor to the antikickback statute. Federal register medicare and state health care programs. Safe harbors the aks makes it illegal for physicians and other providers to accept bribes or other renumeration in exchange for generating business through medicare.
Examine the requirements of the medicare antikickback, stark. Wade partner krieg devault llp 4101 edison lakes parkway, suite 100 mishawaka, in 46545 telephone. Oig releases proposed rule on new and amended antikickback. Both the stark law exception and the anti kickback statute safe harbor were scheduled to sunset on december 31, 20, but on friday, december 27, 20, two final rules were published in the federal register extending and modifying these programs. As described in more detail below, we propose to amend 42 cfr 1001. Comparison chart of stark exceptions and antikickback.
B will satisfy the conditions of the practitioner recruitment safe harbor in accordance with paragraph n of this section. Hhs proposes reforms to stark law and antikickback. Department of health and human hhs services office of inspector general oig has issued its proposed rule to reform the anti kickback statutes aks regulatory safe harbors to address valuebased arrangements. Website template antikickback statute and safe harbors. Anti kickback safe harbors, as set forth in regulations issued by the office of inspector general of the department of health and human services. The federal antikickback statute contains a statutory exception or safe harbor providing that the aks will not apply to any amount paid by an employer to an employee who has a bona fide employment relationship with such employer for employment in the provision of covered items or services. Anti kickback laws and safe harbor regulations selfreferral is enforced separately from the medicare and medicaid anti kickback laws. Timmons the office of inspector general of the department of health and human services oig and the centers for medicare and medicaid services cms recently took important steps in facilitating the growth of. History and development of the anti kickback statute 42 u. These modifications expand shelter to payment structures that incorporate valuebased care models. Oig releases proposed rule on new and amended anti kickback safe harbors and cmp exception.
Discount safe harbor to the anti kickback statute due to the broad language of the federal anti kickback statute, the office of inspector general oig has adopted safe harbor regulations to protect arrangements that may otherwise violate the statute. These charts have been updated to reflect the stark law amendments and additions that are effective january 1, 2016, and are current as of november 2017. While the selfreferral law must involve physicians, anti kickback regulations apply to anyone who knowingly and willfully offers, pays, solicits, or receives remuneration in order to induce business reimbursed. New stark exceptions and antikickback safe harbors for.
Subject to definitions and conditions set forth in the. Oct 29, 2019 in this article, we focus on the proposed care coordination arrangements safe harbor to the anti kickback statute and discuss how this new safe harbor may affect vendors of care management services such as remote patient monitoring, chronic care management services, transitional care management services, and behavioral health integration services. Cms, oig extend ehr stark law exception, antikickback. The department of health and human services hhs announced proposed changes to modernize and clarify the regulations that interpret the physician selfreferral law the stark law and the federal antikickback statute. Although there is a safe harbor for electronic health records ehr arrangements it must fit squarely in all safe harbor conditions to be protected. Below are 20 things to know about the antikickback statute. The department of health and human services office of inspector general oig on friday announced a new request for information on the federal antikickback statute aks safe harbors that would balance additional flexibility for industry stakeholders to provide efficient, wellcoordinated, patientcentered care with protections against the harms caused by fraud and abuse. Oig proposes to modify the current safe harbor rule in three meaningful ways. More on the changes to the federal antikickback statute.
Understanding stark anti kickback compliant ehr donation arrangements february 25, 2014 by elana zana 1 comment in 2006 and extended in december 20, cms issued stark and anti kickback exceptions safe harbors permitting ehr technology donation arrangements between hospitals and other organizations and physician groups. The oig notes that the safe harbor for eligible managed care organizations emcos, which protects payments between emcos and first tier contractors that satisfy certain criteria, potentially applies to the proposed arrangement. Stark law donation exception extended to 2021 december 23, 20 by elana zana 3 comments beating the deadline by mere days, cms and the oig released their final rules related to the stark law exception anti kickback safe harbor for ehr donation arrangements. Establishing fair market value under the antikickback and. As another part of the regulatory sprint to coordinated care, oig proposed revisions to the existing ehr antikickback safe harbor and added a cybersecurity component. 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 stated purpose of the proposed changes is to remove barriers to the. A relevant safe harbor is the personal services and management contracts safe harbor psmc safe. Summary of selfreferral and antikickback regulations. On friday, december 27, 20, the centers for medicare and medicaid services cms and the office of inspector general oig of the department of health and human services hhs will publish final rules that extend through december 31, 2021 the existing stark law exception 42 cfr 411. Discount safe harbor to the antikickback statute due to the broad language of the federal antikickback statute, the office of inspector general oig has adopted safe harbor regulations to protect arrangements that may otherwise violate the statute. The initial ehr safe harbor was developed in response to president george w. Proposed stark law, antikickback reforms aim to facilitate.
This safe harbor permits certain entities to provide technologyrelated items and services to certain parties to be used to create, maintain, transmit, or receive electronic health records. Supplier discounts offered to healthcare providers is. Modernizing and clarifying the physician selfreferral regulations. This safe harbor permits certain entities to provide certain items and services in the form of software and information technology and training services necessary and used predominantly to create, maintain, transmit. Anti kickback safe harbor for payments made for electronic health records the remuneration is nonmonetary and consists of items and services in the form of software or information technology and training services necessary and used predominantly to create, maintain, transmit, or. Authorized by the anti kickback provisions of the medicare and medicaid anti fraud and abuse amendments of 1977 and the medicare and medicaid patient and program protection act of 1987. Medicare modernization act congress medicare modernization act congress covered. Safe harbors the aks makes it illegal for physicians and other providers to accept bribes or other renumeration in exchange for. Comments are due 75 days after the expected federal register publication date of october 17, 2019 cms, proposed rule, medicare program. In todays federal register, the department of health and human services hhs or the department released a proposed rule that would modify several existing safe harbors under the anti kickback. Federal anti kickback law federal anti kickback law makes it illegal to. Exploring limits of antikickback law employee safe harbor.
The office of inspector general oig proposes modifications to the personal services and management contracts safe harbor of the federal anti kickback statute aks. Stark no comparable exception anti kickback safe harbor for payments and other transfers made to a federally qualified health center. Hhs oig, proposed rule, revisions to safe harbors under the anti kickback statute and civil monetary penalty rules regarding beneficiary inducements. Oct 15, 2019 hhs oig, proposed rule, revisions to safe harbors under the anti kickback statute and civil monetary penalty rules regarding beneficiary inducements. Antikickback safe harbors, as set forth in regulations issued by the office of inspector general of the department of health and human services. The safe harbor similarly requires proper documentation of discounts by suppliers and healthcare providers and, upon request, disclosure of discounts to the federal government. In 2006, as part of rules for the 2003 medicare modernization act, cms first created the exemption for hospitals to help physician practices acquire ehr systems. Historically, governmental regulatory agencies have not been overly aggressive in bringing enforcement actions against pharmacies under the medicare anti kickback statute, state anti kickback statutes, and other anti fraud laws.
Because the anti kickback statute is so broad, the office of inspector general oig has published a number of safe harbors. The safe harbor regulations describe various payment and business practices that, although they potentially implicate the federal antikickback statute, are not treated as offenses under the statute. Major changes proposed to stark rules, antikickback. Hhs proposes stark law and antikickback statute reforms. The department of health and human services hhs office of inspector general oig recently published a proposed rule to modify and add new protections under the federal anti kickback statute aks and codify a new civil monetary penalty law cmp exception for beneficiary inducements related to healthcare system improvements. In 2006, cms and the oig promulgated a stark exception and an anti kickback safe harbor to encourage the development and adoption of interoperable electronic health record systems in communities. Oct 11, 2019 similarly, the hhs office of inspector generals proposed rule revising safe harbors under the antikickback statute would add a new safe harbor for donations of cybersecurity technology and amend the existing safe harbors for electronic health records arrangements, warranties, local transportation, and personal services and management. Anti kickback no comparable safe harbor the referring physician a is a bona fide employee of a component of the academic medical center on a fulltime or substantial parttime basis. New antikickback safe harbors and cmp law exceptions. Hhs proposes reforms to stark law and antikickback statute. Sweeping changes proposed for medicare and medicaid anti. Oct 09, 2019 in addition, the facility could equip the physicians with data analytics software to help them monitor patients health outcomes. Dec 27, 20 the stark and anti kickback laws date back to 1989, when congress banned selfreferrals in medicare. Safe harbor regulations office of inspector general u.
Sunset of the stark and antikickback ehr donation exceptions. Major changes proposed to stark rules, antikickback statute. The antikickback statute and ems ambulance billing. Nov, 2019 as another part of the regulatory sprint to coordinated care, oig proposed revisions to the existing ehr antikickback safe harbor and added a cybersecurity component. Cms created an exception to the stark law, allowing an entity to provide a physician with nonmonetary remuneration in the form of software used predominantly to create, maintain, transmit, or receive ehrs and associated services. Cms and oig released highly anticipated proposed changes to the rules implementing the stark law, the safe harbors issued under the anti kickback statute aks and the beneficiary inducements provision in the civil monetary penalties law the beneficiary inducement cmp on october 9, 2019 the proposed rules. The federal antikickback statute is a healthcare fraud and abuse statute that prohibits the exchange of remunerationwhich the statute defines broadly as anything of valuefor referrals for services that are payable by a federal program, which, in the context of healthcare providers, is medicare. The anti kickback statute is frequently used to prosecute healthcare providers, including providers of hospice and home health services. The american dental association supports a new safe harbor for cybersecurity technology and services and modifying the existing safe harbor for electronic health records to add protections for cybersecurity.
This final rule modifies an existing safe harbor to the anti kickback statute. Supplier discounts offered to healthcare providers is risky. Advisory opinion, anti kickback statute, medicaid managed care, oig. The safe harbor applies only to discounts, defined as a reduction in the amount a buyer is charged for an item or service based on an armslength transaction. This safe harbor permits certain entities to provide certain items and services in the form of software and information technology and training services necessary and used predominantly to create, maintain, transmit, or receive electronic health records to certain parties. Hhs issues proposed rule to update antikickback statute safe. Hhs oig solicits input on changes in antikickback safe.
While the anti kickback statute generally restricts such donations, federallyfunded health centers have safe harbor protection for certain arrangements where a provider donates items of value, in cash or inkind, to a health center to support or expand the accessibility, availability, andor quality of services provided to health center patients. Antikickback exemption extended healthcare it news. The oig will change the language regarding the applicability of the safe harbor to ehr software from software that is deemed to be interoperable if certified to include software that is certified. Comparison chart of stark exceptions and anti kickback safe harbors. Oig releases proposed rule on new and amended anti. Links to federal register notices containing preambles to the safe harbor regulations appear below. The safe harbor regulations describe various payment and business practices that, although they potentially implicate the federal anti kickback statute, are not treated as offenses under the statute. If the arrangement falls within the fact situation, then the compensation paid does not violate the anti kickback statute. The antikickback statute remuneration paid with the intent to induce referrals violates the statute presumption that payment in excess of fmv or below fmv is payment for referrals fmv is component of certain aks safe harbors personal servicesmanagement agreements space and equipment leases. The ada told the two agencies that it appreciates efforts to address the growing threat of cyberattacks and supports amending the antikickback statute safe harbors and stark law exceptions to permit health care organizations to assist doctors in the acquisition of cybersecurity technology and services such as antivirus software and. Antikickback ehr and cybersecurity safe harbor tucker.
Hhs issues proposed rule to update antikickback statute. The new ruling prohibited business transactions that were once fairly innocuous, leading to the creation of safe harbors. The transfer is made pursuant to a contract, lease, grant, loan, or other agreement that a is set out in writing. Although some types of arrangements previously were offered safe harbor from prosecution, others had to be approved on a casebycase basis. Comments are due 75 days after the expected federal register publication date of october 17, 2019. Oct 15, 2015 the alert addresses a growing trend in the industry, arrangements involving the provision of software or information technology to a referral source. Hhs proposes stark law and antikickback statute reforms to. Similarly, the hhs office of inspector generals proposed rule revising safe harbors under the anti kickback statute would add a new safe harbor for donations of cybersecurity technology and amend the existing safe harbors for electronic health records arrangements, warranties, local transportation, and personal services and management. In this article, we focus on the proposed care coordination arrangements safe harbor to the anti kickback statute and discuss how this new safe harbor may affect vendors of care management services such as remote patient monitoring, chronic care management services, transitional care management services, and behavioral health integration services.
The federal antikickback statute created criminal penalties for knowingly and willfully paying for business referrals for services covered by any federal healthcare program. Hhs office of inspector general proposes modifications to. Supplier discounts offered to healthcare providers is risky business. Examine the requirements of the medicare antikickback. These anti kickback statute aks safe harbors and ethics in patient referrals act the stark law exceptions, when squarely met, afford protection for certain financial relationships between healthcare providers and other entities under the aks and stark law. Ada supports proposed rules to update federal antikickback.
Office of inspector general rin 0991ab33 medicare and. Oct 17, 2019 hhs issues proposed rule to update antikickback statute safe harbors what does it mean for life sciences companies. Jan 29, 2014 the oig established a similar safe harbor under the anti kickback statute. The department of health and human services office of inspector general oig on friday announced a new request for information on the federal anti kickback statute aks safe harbors that would balance additional flexibility for industry stakeholders to provide efficient, wellcoordinated, patientcentered care with protections against the harms caused by fraud and abuse. Employees of physicians, as in the selfreferral law, are exempt from anti kickback laws see regulation section 1001. A lease or rental agreement will not trigger aks liability if.
In this recent rulemaking, the oig proposes several new safe harbors for valuebased arrangements as well as modifications to the existing safe harbors for personal services arrangements, electronic health records, warranties and local transportation. New stark exceptions and antikickback safe harbors for electronic prescribing and electronic health records by sean a. On december 7, 2016, the department of health and human services office of the inspector general oig issued a final rule to establish new safe harbors under the anti kickback statute and civil monetary penalty cmp rules, as well as update existing safe harbors. A component of an academic medical center means an affiliated medical school, faculty practice plan, hospital, teaching facility, institution of higher. The oigs proposal includes new safe harbors and modifications to existing safe harbors to protect valuebased arrangements from liability. Oig finalizes new and amended antikickback and cmp safe. This final rule implements, with some modifications suggested by commenters, safe harbors that were initially proposed by the oig. The acceptance of improper discounts could potentially violate the federal anti kickback statute the aks, and result in criminal penalties, civil monetary sanctions andor exclusion from federal healthcare programs.
A may reasonably be expected to result in the recruitment of a new practitioner to take over the acquired practice within a one year period and. The antikickback safe harbor specifies that it applies only to hospitals that participate in federal health care plans such as medicare. After originally planning for the exemption to be phased out in 20. Bushs 2004 initiative to extend ehr nationwide within 10 years, i. Federal register medicare and state healthcare programs. The exception and safe harbor allowed hospitals to donate up to 85 percent of the cost of ehr software and training services to physician offices provided. The safe harbor regulations, in their entirety, can be found here. A safe harbor is a provision which would specify various payment and business practices that would not be treated as criminal offenses under the anti kickback statute, even though they may potentially be capable of inducing referrals of business under the federal health care programs. Hhs oigs proposed rule revising the aks safe harbors and. Ada supports proposed rules to update federal anti. Anti kickback changes too narrow to promote valuebased care proposed safe harbors under the anti kickback statute are too focused on riskbased models to truly promote valuebased care, aha argued.
Comparison chart of antikickback safe harbors and stark. Stark law and antikickback statute proposed rules would. Understanding starkantikickback compliant ehr donation. The proposed rule would modify an alreadyexisting safe harbor to the anti kickback statute. According to preamble commentary to the proposed rules, oig and cms have attempted to ensure as much consistency as possible between the proposed eprescribing exception and the corresponding safe harbor, taking into consideration the underlying differences between the stark law and the anti kickback law.
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