Lillie C. Cox

UPDATE - January 29, 2025: The Trump Administration rescinded the OMB memorandum ordering the federal grant and loan pause on January 29, 2025.   UPDATE - January 28, 2025: The federal grant and loan pause described in this blog post has been temporarily enjoined by a U.S. District Court until February 3, 2025 for funds that were already set to be disbursed. We will continue to monitor the status of the pause on federal assistance. UPDATE - January 28, 2025: Following a widespread lock out to Medicaid portals in all 50 states, the White House Press Secretary issued a statement  on X that Medicaid would not be impacted by the OMB spending freeze memo and the Medicaid portal should be back online soon. A memorandum from the Office of Management and Budget (“OMB”) on January 27, 2025 notified heads of federal agencies of a temporary pause on all disbursements of federal grants and loans, effective at 5pm Eastern on January 28, 2025.  The OMB memorandum requires federal agencies to submit detailed information on programs, projects, or activities subject to the pause by February 10, 2025 so that OMB can evaluate their alignment with the Administration’s priorities for federal spending which have been revealed in part through recent Executive Orders. There is some uncertainty as to how broadly the pause in federal funding will apply, as the OMB memo permits OMB to grant exceptions on a case-by-case basis, and notes that the pause is subject to what is “permissible under applicable law.” The memo states that the pause does not impact direct federal assistance to individuals, and therefore should not disrupt the flow of Medicare reimbursement to health care providers, or impact Social Security payments. Many in the health care industry will be impacted, however, as the pause will impact federal funding disbursed by the Department of Health and Human Services, which is the largest grant-making agency in the U.S. Access to Medicaid payment portals was cut off in all 50 states as of January 28, 2025, creating uncertainty about the pause’s applicability to Medicaid and Medicaid beneficiaries’ ability to access care. The federal funding pause will likely impact every state-federal cooperative program which receives funding through the federal government  For example, health centers providing family planning, HIV treatment/prevention and other services which are paid for through federal funding, including impacting these clinics’ ability to make payroll and keep the centers open for patient care. The pause will also have an impact on federal research and loans to research institutions, as well as to universities and other private organizations. The pause raises questions regarding the President’s ability to override spending decisions made by Congress and compliance with a federal statute called the Impoundment Control Act. The first lawsuit challenging the pause, which includes health care industry plaintiffs, was filed on January 28, 2025. For additional guidance on steps for recipients of federal grant and loan funding to take now, please see this post by our Dorsey colleagues. An important first step is to seek clarification from your grants management official regarding permissible activities under the grants during this period of time covered by the pause. Then, continue to follow up and monitor any changes to that advice as the issues continue to play out over the coming days, weeks and months. Dorsey attorneys are actively monitoring Executive Orders and other activities of the new Administration and will continue to publish updates and analysis on the impacts of these actions in health care.

Iowa’s fetal heartbeat law, House File 732, which was signed into law by Governor Kim Reynolds in 2023, will go into effect on Monday, July 29, 2024. This blog post gives a brief background and summary to help hospitals and providers understand their obligations under the law. The fetal heartbeat law has been temporarily enjoined from enforcement since July 2023. However, a 4-3 decision from the Iowa Supreme Court in June 2024 in Planned Parenthood of the Heartland, Inc. v. Reynolds ex rel. State, 2024 Iowa Sup. LEXIS 74, 2024 WL 3209943, and a subsequent order from District Court Judge Jeffrey Farrell dissolving the temporary injunction, will allow the fetal heartbeat law to go into effect on July 29. The fetal heartbeat law bans abortions, with exceptions for rape, incest, non-viability of the fetus and medical emergencies, after a fetal heartbeat can be detected. A fetal heartbeat can be detected as early as six weeks into a pregnancy. In order to be effective as an exception to the law, the rape and incest exceptions require reporting to law enforcement, a public health agency, or doctor within 45 days for rape, and 140 days for incest. With regard to the medical emergency exception, some have read the Iowa Supreme Court in Planned Parenthood of the Heartland, Inc., to interpret this exception narrowly. Under this narrow reading, “medical emergency” (which permits an abortion after fetal heartbeat detection), would include neither “psychological conditions, emotional conditions, familial conditions, or the woman’s age” or, “when continuation of the pregnancy will create a serious risk of substantial and irreversible impairment of a major bodily function of the pregnant woman.” Id. at 6. This interpretation would mean that unless a woman has a life-threatening condition, an abortion is not permitted in order to preserve the health of the mother – even if the mother’s health would be at risk of substantial and irreversible impairment of a major bodily function. However, federal law, known as the Emergency Medical Treatment and Labor Act (EMTALA), currently preempts Iowa law to the extent that Iowa law conflicts with EMTALA. EMTALA defines “emergency medical condition” to encompass health-jeopardizing, and not merely life-threatening conditions. Therefore, if the treating physician determines that an abortion is necessary to stabilize a women’s emergency medical condition, then EMTALA would control the decision under those circumstances. While this potential conflict between state and federal law will come to the forefront in Iowa starting on July 29th, the issue of EMTALA pre-emption of a state abortion restriction was already addressed in June 2024 by the U.S. Supreme Court. In that case, the U.S. Supreme Court allowed an order by a federal judge in Idaho to remain in place that temporarily blocks the State of Idaho from enforcing an abortion ban (which is similar to Iowa’s fetal heartbeat law) to the extent that the Idaho law conflicts with EMTALA. This means that Idaho doctors currently have the discretion to perform emergency abortions if a provider determines that an abortion is necessary in order to stabilize a woman’s medical emergency. It is likely that other cases will come before federal courts across the country to test EMTALA pre-emption of abortion restrictions in the context of medical emergencies, so hospitals and providers should continue to monitor the status of these cases. In order to better understand their EMTALA obligations, hospitals and physicians should review the CMS guidance which addresses the EMTALA obligations of hospitals and physicians in light of new state laws prohibiting or restricting access to abortion. It is important to note that in addition to the fetal heartbeat law, there are other requirements in Iowa related to providing an abortion. For example, Iowa Code Chapter 146A includes a number of prerequisites that a physician performing an abortion must complete. These prerequisites include a written certification from the pregnant woman 24 hours prior to the abortion that she has undergone an ultrasound, an opportunity to view the ultrasound and hear a description of the ultrasound and heartbeat, and has been provided information regarding alternative options to abortion, risks associated with abortion and materials developed by the State. Notably, the Iowa Code Chapter 146A abortion prerequisites do not apply in the event of an abortion performed in a medical emergency. We will continue to monitor the progress of these laws and provide updates in this blog. If you have any questions about these laws’ impact on you or your organization, please contact the authors or your regular Dorsey attorney.

On May 26, 2023, the Governor of Minnesota signed into law Minnesota bill HF 402 to increase government oversight of health care transactions that occur in Minnesota or involve Minnesota-based health care entities. A general overview of the new law’s oversight provisions can be found in a previous Dorsey Health Law blog post. The new law also contains provisions specific to nonprofit health care organizations, including additional transaction requirements and extension of the moratorium on certain conversion transactions. Given the prevalence of nonprofit health care organizations in Minnesota, we expect this new legislation to materially impact both payors and providers in the State. This blog post summarizes those provisions, all of which have already gone into effect. Additional Transaction Requirements for Nonprofit Health Care Entities In addition to the general notice requirements now effective under this new law and summarized in our previous post, HF 402 imposes further requirements on (1) nonprofit health care entities that are either incorporated under the Minnesota Nonprofit Corporation Act or organized as a Minnesota nonprofit limited liability company, and (2) the subsidiaries of such nonprofit entities, regardless of their incorporation or organizational status. These entities are now required to ensure the following before proceeding with a transaction: The transaction complies with the Minnesota Nonprofit Corporation Act, the charitable trusts statutes, and other applicable laws; The transaction does not involve or constitute a breach of charitable trust; The transferring nonprofit entity will receive the full and fair value for its public benefit assets, unless the discount between the full and fair value of the assets and the value received for the assets will further the nonprofit purposes of the entity or is in the public interest; The value of the public benefit assets to be transferred has not been manipulated in a manner that causes or has caused the value of the assets to decrease; The proceeds of the transaction will be used in a manner consistent with the public benefit for which the assets are held by the nonprofit health care entity; The transaction will not result in a breach of fiduciary duty; and There are procedures and policies in place to prohibit any officer, director, trustee, or other executive of the nonprofit health care entity from directly or indirectly benefiting from the transaction. Currently, it is not entirely clear how or to what extent these additional transaction requirements for nonprofit health care entities will be reviewed in conjunction with the general notice requirements for health care entities. Moratorium on Conversion Transactions A moratorium on conversion transactions involving nonprofit health plan entities operating under the Minnesota Nonprofit Health Service Plan Corporations Act or Health Maintenance Act that was set to expire July 2023 has been extended through July 2026. The moratorium was initially enacted in response to concerns of some lawmakers that nonprofit assets could be transferred to for-profit carriers in a merger or acquisition. These nonprofit health plan entities “may only merge or consolidate with; convert; or transfer, as part of a single transaction or a series of transactions within a 24-month period, all or a material amount of its assets to” an entity that is incorporated under the Minnesota Nonprofit Corporation Act; “or to a Minnesota nonprofit hospital within the same integrated health system as the health maintenance organization.” A “material amount” is defined as the “lesser of ten percent of an entity’s total admitted net assets as of December 31 of the previous year, or $50,000,000.” The moratorium does not apply if the nonprofit health plan entity files an intent to dissolve due to insolvency of the corporation or if insolvency proceedings are commenced. Related Study and Recommendations HF 402 requires that the Minnesota commissioner of health study and develop recommendations on the regulation of conversions, mergers, transfers of assets, and other transactions primarily affecting Minnesota-domiciled nonprofit health maintenance organizations (HMOs). These recommendations must address the following: Monitoring and regulation of Minnesota-domiciled for-profit HMOs; Issues related to public benefit assets held by a nonprofit HMO, including identifying the portion of the organization’s assets that are considered public benefit assets to be protected, establishing a fair and independent process to value the assets, and determining how public benefit assets should be stewarded for the public good; Providing a state agency or executive branch office with authority to review and approve or disapprove a nonprofit HMO’s plan to convert to a for-profit organization; Establishing a process for the public to learn about and provide input on a nonprofit HMO’s proposed conversion to a for-profit organization; and Issues, including statutory language and regulatory implementation, related to a potential statutory requirement that nonprofit HMOs licensed under Minnesota Statutes chapter 62D, and health systems organized as a charitable organization, upon the sale or transfer of control to an out-of-state or for-profit entity, return to the state’s general fund an amount equal to the value of any charitable assets the HMO or health system received from the state. The commissioner is required to seek public comment on the regulation of conversion transactions involving nonprofit HMOs no later than October 1, 2023. A final recommendations report must be submitted to the appropriate legislative committees by June 30, 2024. If you have any questions regarding HF 402 and how your organization or transaction may be impacted, please contact the authors or your regular Dorsey attorney. Summer Associate Lindsey VerMurlen provided substantial assistance researching and drafting this blog post.

On May 26, 2023, the Governor of Minnesota signed into law Minnesota bill HF 402 to increase government oversight of health care transactions that occur in Minnesota or involve Minnesota-based health care entities. Minnesota joins a growing number of states considering or enacting similar measures, including New York, Connecticut, Delaware, Massachusetts, Nevada, New Jersey, Oregon, Rhode Island, Washington, and California. The following is a general overview of this new law, many portions of which have gone into effect already. General Prohibition and Key Definitions HF 402’s purpose is to prohibit transactions by any health care entity that would “substantially lessen competition or tend to create a monopoly or monopsony.” In order to enforce this prohibition, HF 402 institutes a number of transaction notification requirements and grants the Minnesota attorney general with the power to review, enjoin, or unwind any applicable transaction in violation of HF 402. Here are key definitions from HF 402 that outline the law’s scope: “Health care entity” is defined as hospitals, hospital systems, captive professional entities, medical foundations, health care provider group practices, entities organized or controlled by one of the above entity types, and entities that own or exercise control over one of the above entity types. “Transaction” is defined as a single action or a series of actions that occur within a five-year period in Minnesota or involving a health care entity formed or licensed in Minnesota, that constitutes: A merger or exchange of a health care entity with another entity; The sale, lease, or transfer of 40 percent or more of the assets of a health care entity to another entity; The granting of a security interest of 40 percent or more of the assets of a health care entity to another entity; the transfer of 40 percent or more of the shares or other ownership of a health care entity to another entity; An addition, removal, withdrawal, substitution, or other modification of one or more members of a health care entity’s governing body that transfers control, responsibility for, or governance of the health care entity to another entity; The creation of a new health care entity; An agreement or series of agreements that results in the sharing of 40 percent or more of a health care entity’s revenues with another entity, including affiliates of such other entity; An addition, removal, withdrawal, substitution, or other modification of the members of a health care entity formed under the Minnesota Nonprofit Corporation Act that results in a change of 40 percent or more of the membership of the health care entity; or Any other transfer of control of a health care entity to, or acquisition of control of a health care entity by, another entity. “Control,” along with “controlling,” “controlled by,” and “under common control with” is defined as the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a health care entity, whether through the ownership of voting securities, membership in an entity formed under the Minnesota Nonprofit Corporation Act, by contract other than a commercial contract for goods or nonmanagement services, or otherwise, unless the power is the result of an official position with, corporate office held by, or court appointment of, the person. Control is presumed to exist if any person, directly or indirectly, owns, controls, holds with the power to vote, or holds proxies representing 40 percent or more of the voting securities of any other person, or if any person, directly or indirectly, constitutes 40 percent or more of the membership of an entity formed under the Minnesota Nonprofit Corporation Act. Furthermore, the attorney general may determine that control exists in fact, notwithstanding the absence of a presumption to that effect. If a transaction meets the definition above (noting that certain transactions are excluded from the definition, including, for example, those involving only nursing homes and home care providers), such transaction may be subject to certain reporting requirements as outlined further below. Reporting Requirements Now effective, HF 402 requires notice to the attorney general and the Minnesota commissioner of health at least 60 days before the proposed closing date of any transaction where either “(i) the health care entity involved in the transaction has average revenue of at least $80,000,000 per year; or (ii) the transaction will result in an entity projected to have average revenue of at least $80,000,000 per year once the entity is operating at full capacity.” The notice to the attorney general and the commissioner of health must include a number of disclosures, including the following non-exhaustive list of items: The entities involved in the transaction; The leadership of the entities involved in the transaction, including all board members, managing partners, member managers, and officers; The services provided by each entity and the attributed revenue for each entity by location; The primary service area for each location; The proposed service area for each location; The current relationships between the entities and the affected health care providers and practices, the locations of affected health care providers and practices, the services provided by affected health care providers and practices, and the proposed relationships between the entities and the affected health care providers and practices; The terms of the transaction agreement or agreements; All consideration related to the transactions; Markets in which the entities expect post-merger synergies to produce a competitive advantage; Potential areas of expansion, whether in existing markets or new markets; Plans to close facilities, reduce workforce, or reduce or eliminate services; The brokers, experts, and consultants used to facilitate and evaluate the transaction; The number of full-time equivalent positions at each location before and after the transaction by job category, including administrative and contract positions; The current governing documents for all entities involved in the transaction and any amendments to these documents; The transaction agreement or agreements and all related agreements; Any collateral agreements related to the principal transaction, including leases, management contracts, and service contracts; All expert or consultant reports or valuations conducted in evaluating the transaction, including any valuation of the assets that are subject to the transaction prepared within three years preceding the anticipated transaction closing date and any reports of financial or economic analysis conducted in anticipation of the transaction; Copies of all filings submitted to federal regulators, including any filing the entities submitted to the Federal Trade Commission under the Hart-Scott-Rodino Act in connection with the transaction; A certification sworn under oath by each board member and chief executive officer for any nonprofit entity involved in the transaction; Audited and unaudited financial statements from all entities involved in the transaction and tax filings for all entities involved in the transaction covering the preceding five fiscal years; and Any other information or documents relevant to evaluating the transaction that are requested by the attorney general or the commissioner of health.   Effective January 1, 2024, HF 402 requires data reporting of certain smaller transactions to the commissioner of health at least 30 days before the proposed closing date of the transaction or within 10 business days of the date the parties first reasonably anticipate entering into the transaction if the expected completion is within less than 30 days, where either “(i) the health care entity involved in the transaction has average revenue between $10,000,000 and $80,000,000 per year; or (ii) the transaction will result in an entity projected to have average revenue between $10,000,000 and $80,000,000 per year once the entity is operating at full capacity.” This data reporting includes disclosure of much of the same type of information as outlined above. Please note that HF 402 imposes additional requirements on nonprofit health care entities not identified above. Attorney General Enforcement Powers HF 402 grants the attorney general broad enforcement powers. It permits the attorney general to extend the notice and waiting period for the $80,000,000+ transactions for an additional 90 days by notifying the health care entity in writing of the extension or to waive all or any part of the waiting period or disclosure requirements, including requirements for disclosures to the commissioner of health. Additionally, the attorney general is permitted to bring an action in district court to compel compliance with the notice, waiting period, disclosure and submission requirements, or to enjoin or unwind a transaction or seek other equitable relief necessary to protect the public interest if a health care entity or transaction violates HF 402 or is contrary to the public interest. Failure of the entities involved in a transaction to provide timely information to the attorney general or the commissioner of health is an independent and sufficient ground for a court to enjoin or unwind the transaction or provide other equitable relief, however the attorney general must notify the entities of the deficiency and provide a reasonable opportunity to remedy it. If you have any questions regarding HF 402 and how your organization or transaction may be impacted, please contact the authors or your regular Dorsey attorney.

With the enactment of the Eliminating Kickbacks in Recovery Act (“EKRA”) in 2018, the permissibility of commission-based compensation to laboratory sales representatives based on volume, revenue, or profit has come under question, and there is still little case law interpreting the Act. Despite EKRA being a relatively newer law, laboratories should remain mindful of how the more established Anti-Kickback Statute (the “AKS”) impacts the permissibility of such commission-based compensation as well. Under current law, commission-based payments (including commission based on volume, revenue, profit, etc.) should be permissible when paid to employee sales representatives. However, labs should be cautious when considering commission-based compensation to independent contractor sales representatives. I. The Anti-Kickback Statute The AKS subjects to criminal and civil penalties anyone who knowingly and willfully offers, pays, solicits, or receives remuneration to induce or reward the referral of business reimbursable under any federal health care programs. 42 U.S.C. § 1320a-7b(b). Importantly, the AKS extends beyond paying value in exchange for direct patient referrals; it also prohibits paying remuneration intended to induce or reward someone to arrange for or recommend that others purchase, lease, or order any good, facility, service, or item reimbursable by any federal health care program. See Id. The AKS contains numerous safe harbors, the compliance with which protects parties from violation of the AKS. One of these is the employment safe harbor, which permits any payments to an employee if there is a bona fide employment relationship. 42 U.S.C. § 1320a-7b(b)(3)(B). This safe harbor does not extend to independent contractors. Id. II. The Eliminating Kickbacks in Recovery Act EKRA subjects to criminal penalties anyone who, with respect to services covered by certain public health care benefit programs, knowingly and willfully: (1) solicits or receives any remuneration in return for referring a patient or patronage to a recovery home, clinical treatment facility, or laboratory; or (2) pays any remuneration to induce a referral of an individual to a recovery home, clinical treatment facility, or laboratory or in exchange for an individual using the services of that recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 220(a). Laboratory is defined to include all laboratories, not just those that perform testing related to substance abuse. 18 U.S.C. § 220(e)(4). Notably, EKRA’s language appears to be limited to paying for direct referrals. Unlike AKS, EKRA does not include language that extends its prohibitions to paying for arranging or recommending others to make referrals or order services. In addition, EKRA does not have an employee safe harbor analogous to the employee safe harbor under AKS, but rather has a narrower exception permitting payments made under a bona fide employment relationship (including with independent contractors, unlike under the AKS employment safe harbor) where the payment does not vary based on the procedures performed, or amounts billed or received from the health care benefit program from the individuals referred. 18 U.S.C. § 220(b)(2). In 2021, a federal district court in Hawaii issued the first and, to date, only judicial opinion interpreting EKRA in S&G Labs Haw., LLC v. Graves, 2021 U.S. Dist. LEXIS 200365. The district court held that while the employment agreement with Graves (a client account manager) provided for commission-based payments that varied based on the number of tests S&G performed, the arrangement did not violate EKRA since there was only an attenuated connection between the commission-based payments and patient referrals: “Undoubtedly, Graves’s commission-based compensation structure induced him to try to bring more business to S&G . . . However, the ‘client’ accounts they serviced were not individuals whose samples were tested at S&G. Their ‘clients’ were ‘the physicians, substance abuse counseling centers, or other organizations in need of having persons tested.’ However, S&G was not compensated by those ‘clients’; S&G was ‘compensated for the testing services on a ‘per test’ basis by third party insurers, government agencies under the Medicare and Medicaid programs, and direct self-pay by some individuals.’ There is no evidence that Graves’s client accounts included individuals who self-paid for S&G to perform urinalysis on their samples.” Id. at 33-34. The district court concluded that since “Graves was not working with individuals, the compensation that S&G paid him was not paid to induce him to refer individuals to S&G.” Id. at 34. In other words, the district court concluded that because Graves was not himself a source of lab referrals, EKRA’s prohibitions could not reach the volume-based compensation arrangement between Graves and his laboratory employer. III. Commissions to Employee Sales Representatives vs. Independent Contractor Sales Representatives Under current law discussed above, labs should generally be able to make commission-based payments (including commissions based on volume, revenue, profit, etc.) to employee sales representatives, but should carefully consider the AKS when proceeding with respect to independent contractor sales representatives. A. Employee Sales Representatives Commission-based payments, including commission based on volume, revenue, profit, etc., to employee sales representatives are permissible under the AKS. Such payments would fall within the AKS employment safe harbor so long as a bona fide employment relationship exists. Per the S&G Labs interpretation of EKRA, commission-based payments, including commission based on volume, revenue, profit, etc., to employee sales representatives are also permissible under EKRA, provided that a lab’s employee sales representatives have a similar relationship to their client accounts as that described in S&G Labs, wherein sales representatives are working with physician clinics, hospitals, and other organizations and facilities that would utilize the lab, and are not working with individual patients. B. Independent Contractor Sales Representatives Based on the only case law to address the issue at this point, so long as independent contractor sales representatives work with organizations and facilities, and are not in a position to refer individual patients, then EKRA should not bar commission-based payments to a lab’s independent contractor sales representatives. However, commission-based payments to independent contractor sales representatives remain an issue under the AKS if the laboratory business involves federal health care programs. Such payments fall outside of the employment safe harbor to the AKS, and the broad reach of the AKS prohibition on arranging or recommending that others order items and services could extend to payment arrangements with independent contractor sales representatives. Consequently, laboratories should proceed cautiously when considering compensating independent contractor sales personnel based in whole or in part on a volume- or value-based methodology. We will continue to closely monitor the state of EKRA and the AKS for guidance, revisions to the law, and enforcement. If you have further questions or need advice on how to restructure compensation arrangements to comply with EKRA and the AKS, please contact the authors or your regular Dorsey attorney.  

On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a revised Provider Self-Disclosure Protocol, renamed Health Care Fraud Self-Disclosure Protocol (“SDP”).  Prior to this update, the SDP had not been updated since 2013.  While many of the revisions were procedural only, some of the revisions were notable, including an increase in the minimum amount required to settle fraud claims under the SDP. Background.  The SDP was established in 1998 as a mechanism for health care providers, suppliers and other persons subject to the OIG’s civil monetary penalty (“CMP”) authorities to voluntarily disclose self-discovered evidence of possible fraud implicating federal health care program funds.  Benefits of the SDP include potentially minimizing costs and disruptions for the disclosing party by avoiding a government-initiated investigation and accompanying litigation, paying a lower multiplier on damages than would be required in a government-initiated investigation, and a release from the OIG’s permissive exclusion authorities without integrity agreement obligations.  The OIG has a website related to the SDP with additional information, including a list of recently settled SDP submissions.  The OIG reported in the revised SDP that, between 1998 and 2020, it resolved over 2,200 disclosures, resulting in recoveries of more than $870 million to the federal health care programs.  Certain conduct is not eligible for the SDP, such as disclosure of an arrangement that involves only liability under the federal physician self-referral law (or “Stark Law”) without also involving potential liability under the federal anti-kickback statute (“AKS”).  The CMS Self-Referral Disclosure Protocol (“SRDP”) is available for conduct that involves only liability under the Stark Law. Updates. The most important update in the revised SDP is that the OIG increased the minimum amount required to settle fraud claims under the SDP in conformity with 2018 changes to statutory minimum penalty amounts for CMPs.  The new minimum settlement amounts are $100,000 for kickback-related SDP submissions (up from $50,000) and $20,000 for all other SDP submissions (up from $10,000). In addition, all SDP submissions must now be made through OIG’s website (rather than either by mail or through the website), an SDP submission must disclose whether the disclosing party is subject to a Corporate Integrity Agreement, Corporate Integrity Agreement reportable events can be disclosed through the SDP, and an SDP submission must separately list damages to each impacted federal healthcare program as well as total damages. Next, the OIG clarified that the Department of Justice may participate in the settlement of a matter disclosed through the SDP and resolve it under the False Claims Act.  The OIG also clarified that grant- or government contract-related disclosures should be done through the OIG’s Grant Self-Disclosure Program or Contractor Self-Disclosure Program, respectively, not the Health Care Fraud SDP.  Finally, the OIG made several miscellaneous changes to statistics, terminology, and background information. Many of the core requirements for SDP submissions have not changed, however, such as timing and content requirements and damages calculation methodologies.  In addition, the potential benefits of SDP submissions have not changed, including a potential exclusion release and lower multiplier for damages calculations. If you have any questions about the SDP or a potential disclosure through the SDP, please contact the authors or your regular Dorsey attorney.