According to the HHS OIG, some of the most common transactions or business arrangements involving the AKS's safe harbor provisions include: posed rule dovetails with OIG's efforts in other areas of the health care industry.4 This article discusses many of the proposed rule's safe harbor and CMPL changes. On December 2, 2020, the Department of Health and Human Services ("HHS") Office of Inspector General ("OIG") issued final rules including a host of reforms to the AKS, including three changes to the personal services and management contracts safe harbor ("Safe Harbor"). In August 2006, CMS and OIG finalized a Stark exception and an AKS safe harbor for certain arrangements involving the donation of interoperable electronic health record (EHR) software or information technology and training services. On November 20, 2020, following months of coordination, OIG and CMS issued their Final Rules revising the AKS safe harbor and the Stark Law exception, respectively, for donations of EHR items and . The safe harbor requires that at least 75 percent of the recruited practitioner's revenue be from patients who reside in HSPAs or medically underserved areas or are members of medically underserved populations, such as the homeless or migrant workers. The interplay between this safe harbor and reimbursement for remote patient monitoring services, including the provision of devices to monitor physiologic parameters remotely, if OIG excludes from protection federally reimbursable items and services. Reg. This article will dis- cuss the history and purposes of the anti-kickback statute, OIG's The United States Department of Health and Human Services ("HHS"), Office of Inspector General ("OIG") recently issued an important final rule (the "Final Rule") that makes significant changes to existing "Safe Harbors" under the Federal Anti-kickback Statue ("AKS") and that adds new Safe Harbors that provide protection from AKS sanctions for certain types of arrangements. Federal physician self-referral law: The Federal physician self-referral law, commonly known as the "Stark Law," generally prohibits a physician from referring Medicare and Medicaid patients for certain "designated health services" ("DHS") to an entity with which the physician (or a member of the physician's immediate family) has . [25] Testimony of Vicki L. Robinson, Senior Counselor for Policy, Office of Inspector General, Before the United States Senate Special Committee on Aging. These Final Rules encourage the broader adoption and increased interoperability of EHR technology. Original Alert: On November 20, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued a Final Rule to finalize a February 6, 2019 proposal stripping rebates received from drug manufacturers by pharmacy benefit managers (PBMs) from safe harbor protection under the Anti-Kickback Statute (AKS), creating . For additional information on safe harbors, see "OIG's Safe Harbor Regulations." As a physician, you are an attractive target for kickback schemes because you can be a source of referrals for fellow physicians or other health care providers and suppliers. [24] Id. Cost-Sharing Waivers As Medicare expends considerably more on its Part D benefit, scrutiny of such payments has increased. New OIG Regsand Guidance (cont.) If you experience technical difficulties, please email the webmaster at webmaster@oig.hhs.gov. Although the terms are somewhat restrictive, the final regulation provides more flexibility than reflected by the criteria set out in . Subject to definitions and conditions set forth in the regulations in the Final Rule, the final safe harbor regulations protect: OIG noted that while adding facilities under common ownership would cause the Requestor to fall outside of the definition of "GPO" in the safe harbor, OIG did not believe that adding the Affiliated Facilities would . Stark EHR Donation Exception (42 C.F.R. Taken as a whole, the OIG Proposed Rule proposed significant new flexibilities for value-based arrangements and modernization of the safe harbor regulations to account for the Since 1991, the Office of Inspector General (OIG) of HHS has periodically issued safe harbor act regulations. . Reg. On January 31, 2019, the Department of Health and Human Services ("HHS") Office of Inspector General ("OIG") issued a proposed rule ("Proposed Rule") that would restrict safe harbor protection under the federal Anti-Kickback Statute ("AKS") for pharmaceutical rebates, while permitting certain pharmaceutical manufacturer price reductions at the pharmacy point of sale ("POS . regulations establishing ''safe harbors'' in various areas.1 These OIG safe harbor provisions have been developed ''to limit the reach of the statute somewhat by permitting certain non-abusive arrangements, while encouraging beneficial or innocuous arrangements.'' (56 FR 35952, 35958; July 21, 1991). Safe harbors are regulated in 42 C.F.R. Common Transactions that May Violate the AKS. According to the HHS OIG, some of the most common transactions or business arrangements involving the AKS's safe harbor provisions include: Under the safe harbor, government-owned/operated ambulance providers and suppliers can receive protection under the AKS if they choose to waive the collection of beneficiary cost-sharing amounts, if . Comparison of the Anti-Kickback Statute and Stark Law handout. On December 7, 2016, the Office of the Inspector General (OIG) published a new "safe harbor" regulation under the anti-kickback statute (AKS). The regulations will become effective in 30 days. In November 2020, four months after the Trump Administration issued a series of Executive Orders reiterating its policy goals on reducing the costs to consumers for prescription drugs and directing the Department of Health and Human Services, Office of Inspector General ("HHS-OIG") to implement those policy objectives, HHS-OIG issued a Final Rule to amend certain provisions in the safe . Activities That are Legal. designed to ensure that the safe harbor or exception protected beneficial arrangements and reduced risks of fraud and abuse. the proposed changes to the AKS safe harbor regulations may live . OIG Recognizes New Local Transportation Safe Harbor and Exceptions to CMP in Updated Fraud and Abuse Regulations On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule (Final Rule) that expands the safe harbor regulations under the Not only is the judge's interpretation of the OIG's safe harbor regulations contrary to the plain language of those rules, but it undoes the very change the agency made in 1999 in an effort to . Because of the broad reach of the AKS, the OIG has promulgated regulations, known as "Safe Harbors," regarding certain payment and business practices that would not be subject to sanctions under the AKS, even though they otherwise may be capable of inducing referrals of business for which payment may be made under a Federal health care program. ACTION: Proposed rule. Acting Inspector General Office of Inspector General Department of Health and Human Services 330 Independence Avenue, SW, Room 5250 Washington, DC 20201 RE: OIG-0936-AA10-P, Medicare and State Healthcare Programs: Fraud and Abuse; Revisions To Safe Harbors Under the Anti-Kickback Statute, and Civil 77684 (Dec. 2, 2020); See also CMS and Thus, OIG's new safe harbor regulations for value-based care arrangements are more restrictive than CMS's, and both agencies state that the AKS acts as a "backstop" to protect against arrangements that meet a Stark Law exception but are nonetheless considered abusive. Issued simultaneously with CMS' proposed changes to the Stark Regulations, the OIG's proposed changes are primarily designed at adding new (and modifying existing) "safe harbors" for coordinated care and value-based arrangements that might otherwise result in criminal and civil penalties. If you experience technical difficulties, please email the webmaster at webmaster@oig.hhs.gov. As with the AKS, the CMPL does not apply to private pay patients, although state kickback, rebate or fee . Personal services safe harbor for outcomes-based payments. Introduction. These amendments include updating the provision under which EHR software is considered interoperable, eliminating the electronic prescribing requirement from safe harbor and The final rule . Perhaps most significantly, the Court recognized that the statutory discount exception has "independent status" from the discount safe harbor regulation. An OIG advisory opinion is legally binding on HHS and the requesting party or parties. The Action: OIG and CMS coordinated to finalize similar revisions to the EHR items and services safe harbor under the AKS (42 C.F.R. Consistent with other changes brought about by the Trump administration's Regulatory Sprint to Coordinated Care, the intent of the revision is to facilitate . 223/Friday, November 19, 1999/Rules and Regulations63519 2 The OIG's interim final rule addressing the safe harbors for shared-risk arrangements is published in today's edition of the Federal Register. The new safe harbor protects payments by a manufacturer to a PBM for services the PBM provides to the manufacturer "related to the pharmacy benefit management services that the PBM furnishes to one or more health plans." posed rule dovetails with OIG's efforts in other areas of the health care industry.4 This article discusses many of the proposed rule's safe harbor and CMPL changes. Ben- Violation of the statute is a felony with high monetary fines and imprisonment, and it allows the OIG to initiate proceedings to exclude the party from the Federal health care programs. The Health and Human Services (HHS) Office of Inspector General (OIG) issued a final rule that expands the extremely narrow warranties safe harbor to include bundled items and services. at 2343, n. 36. The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. The Physician Self-Referral Law (Stark Law) The Stark Law prohibits a physician from making a referral for certain designated health services The title in the OMB submission does not refer to which safe harbor(s) would be modified to "remove" safe harbor protection—e.g., OIG may propose to modify the shared risk exception at 42 CFR 1001.952(t) and/or the discount safe harbor at 42 CFR 1001.952(h). While the OIG and CMS attempted to align the requirements of the value-based safe harbors and exceptions, including through the use of related terminology, the OIG's safe harbors for value-based arrangements are more restrictive than CMS's comparable exceptions because the AKS is a criminal intent-based statute, whereas the HHS/OIG also finalized a new safe harbor to protect certain service fees paid by manufacturers to PBMs. prosecution.2 Accordingly, Congress directed the Office of Inspector General ("OIG") in the U.S. Department of Health and Human Services ("DHHS") to develop "safe harbor" regulations "to limit the reach of the statute" and "encourag[e] beneficial and innocuous arrangements."3 Common Transactions that May Violate the AKS. The Proposed Rule also included a new safe harbor for payments from pharmaceutical manufacturers to PBMs for certain services. 77857. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. § 1001.952(y)) In August 2006, CMS and OIG finalized a Stark exception and an AKS safe harbor for certain arrangements involving the donation of interoperable electronic health record (EHR) software or information technology and training services. Safe Harbor Regulations. (June 19, 2019). [2] There is commentary in the regulations adopting the employee safe harbor indicating that OIG was willing to extend safe harbor protection to employee compensation because it was "confident that the employer-employee relationship is unlikely to be abusive, in part because the employer is generally fully liable for the actions of its . The Office of Inspector General has proposed three significant changes to safe harbor regulations pertaining to electronic health record services, according to a notice in Wednesday's Federal Register. These historic reforms became effective January 19, 2021 and are part of HHS's "Regulatory Sprint to . Exclusions Online Searchable Database LEIE Downloadable Databases Monthly Supplement Archive Quick Tips Waivers Even though the OIG established this safe harbor, failure to strictly satisfy every element doesn't mean an arrangement violates the law. § 1001.953(y)) and exception under the Stark Law (42 C.F.R. 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. What Is Safe Harbor Healthcare Compliance? The Requestor already operates as a GPO that complies with the GPO safe harbor according to the Requestor's certifications. 85 Fed. § 411.357(w)) and AKS Safe Harbor (42 C.F.R. late yesterday, the office of inspector general (oig) of the department of health and human services (hhs) released a proposed rule to amend the anti-kickback safe harbors [1] in response to perceived risks that rebates paid by pharmaceutical manufacturers to payors and pharmacy benefit managers (pbms) may contribute to pharmaceutical list price … Safe Harbor Regulations Self-Disclosure Information Special Fraud Alerts, Bulletins, and Other Guidance A Roadmap for New Physicians Request for Information: Modernization Initiative To Improve HHS-OIG Public Resources Exclusions. CMS and OIG released final rules amending the regulations to the Stark Law and the Anti-Kickback Statute and Beneficiary Inducement Civil Monetary Penalty Law. The safe harbor limits the duration of payments to three years. The Stark Rule Arrangements that do not comply with a safe harbor are analyzed by the HHS OIG / DOJ, on a case-by-case basis, for compliance with the statute. Arrangements that do not comply with a safe harbor are analyzed by the HHS OIG / DOJ, on a case-by-case basis, for compliance with the statute. The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) is publishing a final rule . (Health and Human Services Office of the Inspector General details criminal and civil sanctions for certain tax shelter payment practices in Medicare/Medicaid) (column) by "Physician Executive"; Business Health care industry Laws, regulations and rules Medical professions Taxation Physicians In line with the proposed rule, the OIG's final rule includes two new safe harbors addressing value-based arrangements with financial risk assumed by the VBE participants from a payor, which protect both in-kind and monetary remuneration. [23] Id. Office of Inspector General (OIG), HHS. The OIG's Special Advisory Bulletin does not mean that radiologists should stop analyzing potential contractual joint ventures with physicians in their . On December 7, 2016, the Office of Inspector General (OIG) published new safe harbor regulations, one of which provided safe harbor protection in connection with the provision of local transportation services. Primarily, providers should adhere as closely as possible to the OIG's safe harbor regulations which require, among other things, that there be a written policy in place which restricts how transportation services are used and advertised. Notably, the OIG's safe harbor regulations do not control how a court interprets and applies the statutory discount exception, even if some deference would be given to the agency's . Visit our tips page to learn how to best use the Exclusions Database. HHS has promulgated safe harbor regulations that define practices not subject to AKS because the practices are unlikely to result in fraud or abuse. 64, No. Primarily, providers should adhere as closely as possible to the OIG's safe harbor regulations which require, among other things, that there be a written policy in place which restricts how transportation services are used and advertised. OIG's final safe harbor regulations seek to remove barriers to coordinated and value-based care and include safeguards to protect federal health care programs and patients. AKS Safe Harbor Proposed Changes 1. at 2343. More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback Statute (AKS) regulatory safe harbors and adds protections for certain payment practices and business arrangements under the beneficiary inducement provisions of the Civil . 3. The safe harbor regulations, in their entirety, can be found here. According to safe harbor compliance, the "safe harbor" regulations describe various payment and business practices that are not treated as offenses under the AKS. However, care should be taken to ensure patient rideshares are done in a legally compliant way. 77492 (Dec. 2, 2020) and OIG: Revisions to Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements - 85 Fed. It is not an official legal edition of the CFR. Issued simultaneously with CMS' proposed changes to the Stark Regulations, the OIG's proposed changes are primarily designed at adding new (and modifying existing) "safe harbors" for coordinated care and value-based arrangements that might otherwise result in criminal and civil penalties. Federal Register/Vol. Start Preamble Start Printed Page 2340 AGENCY: Office of Inspector General (OIG), Department of Health and Human Services (HHS). This rule updates the existing safe harbor regulations and enhances flexibility for providers and others to engage in health care business arrangements to improve efficiency and access to quality care while protecting programs and patients from fraud and abuse. Stark Law Refer to the . The initial EHR donation exception and safe harbor were scheduled to expire on December 31, 2013. Most significant changes: -New beneficiary inducement exceptions to the definition of "remuneration" Items or services that promote access to care and pose low risk of harm Financial hardship exception (reasonable connection to individual's medical care) -A new safe harbor to protect free or discounted Safe harbors are regulations issued in intervals since 1991 by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS). Ben- The Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) recently released a Notice in the Federal Register of it intent to develop regulations for new Safe Harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act, as well as developing new OIG Special Fraud Alerts. Before sharing sensitive information, make sure you federal government site.The site secure.The https ensures that you are connecting. Free Online Library: HHS inspector general publishes final safe harbor regulations. Visit our tips page to learn how to best use the Exclusions Database. Safe Harbors • Safe Harbors protect certain payment and business practices that could otherwise implicate the AKS or Physician Self-Referral Statute from criminal and civil protection. OIG has confirmed that the warranties safe harbor's protection could extend to arrangements conditioned on clinical outcomes guarantees, which could include warranties conditioned upon ''value-based'' outcomes that meet the safe harbor's other requirements. 1001.952 and include the following concepts: Investment interests in publicly traded companies and small private entities The HHS OIG has proposed the following revisions to the AKS's current safe harbor regulations: Electronic Health Records : added protections for business transactions that involve certain . Key takeaways: This Advisory Opinion demonstrates the OIG's willingness to permit one such solution where appropriate safeguards are in place and an applicable AKS exception or safe harbor is met. As part of these final rules, the agencies liberalized the requirements under the existing exception and safe harbor for donations of electronic health record items and services, and created a new exception and safe harbor to allow . AKS Safe Harbor Proposed Changes 1. Cost-Sharing Waivers As Medicare expends considerably more on its Part D benefit, scrutiny of such payments has increased. The safe harbor regulations promulgated by OIG are found at 42 CFR part 1001. DATES: These regulations are effective on January 6, 2017. 1. OIG has attempted to respond to the con- cerns of the health care community by providing guidance on the implications of the statute through promulgation of the "safe har- bor" regulations' as well as by other means. Additionally, since drivers will have access to individually identifiable and/or protected health . how you knowThe .gov means official.Federal government websites often end .gov .mil. For more information, visit the OIG's . Sect. Start Further Info The OIG declined to create an exception for groups of patients with special needs, but noted the availability of a new safe harbor for patient engagement tools and supports, 10 which could be used . This is a remarkable development by the OIG and has caused health care attorneys to question the usefulness of the safe harbor regulations if the OIG can look beyond compliance with them. A safe harbor is a voluntary regulation, not a mandatory . (OIG Bulletin, Offering Gifts and Inducements to Beneficiaries (8/02); 66 FR 24410-11). Reg. B. OIG Special Fraud Alerts OIG periodically issues Special Fraud Alerts to give continuing guidance to health care industry stakeholders regarding practices OIG considers to be suspect or of particular concern.3 Value-Based Arrangements with Substantial Downside Financial Risk Safe Harbor. 2 CMS: Modernizing and Clarifying the Physician Self Referral Regulations - 85 Fed. As the OIG . OIG Adds New Safe Harbor Protections in 2017 January 24, 2017 | Health Services In December 2016, the Office of Inspector General ("OIG") for the U.S. Department of Health and Human Services amended existing safe harbors and issued a number of new safe harbors to protect certain business practices and arrangements of doctors, hospitals, and pharmacies from sanctions under the anti-kickback . DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General 42 CFR Parts 1001 and 1003 RIN 0936-AA06 Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements and Gainsharing AGENCY:. protected by making the regulatory language more precise. New Safe Harbors In A Storm of Risk and Regulations: A Review of the OIG's Proposed Changes to the Federal Anti-Kickback Laws . § 411.357(w)) ("Final Rules"). An OIG advisory opinion is a legal opinion issued by OIG to one or more requesting parties about the application of the OIG's fraud and abuse authorities to the party's existing or proposed business arrangement. SUMMARY: In this proposed rule, the Department of Health and Human Services (Department or HHS) proposes to amend the safe harbor regulation concerning discounts, which are defined as certain conduct that is protected from liability under the . On November 20, 2020, the Department of Health and Human Services ("HHS") Office of Inspector General ("OIG") issued a sweeping set of final rules to amend the safe harbors under the Federal anti-kickback statute ("AKS")1 and to amend the civil monetary penalty law ("CMP") by codifying a revision to the definition of Anti-Kickback Statute vs .
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