False Claims Act
A Hefty Speaking Fee: Biogen Inc. Agrees to Settle False Claims Act Suit In Violation of Anti-Kickback Statute for $900 Million
The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Samuel Aduley for the following post on the FCA Now blog: On July 20, 2022, Biogen Inc. (“Biogen”) disclosed in a quarterly earnings report that it had agreed to pay $900 million to resolve a qui tam claim by a former employee that the company had violated the False Claims Act (“FCA”) and the Federal Anti-Kickback Statute (“AKS”). See Biogen Reports Second Quarter 2022 Results; see also United States ex rel. Bawduniak v. Biogen Idec, Inc., No. 12-cv-10601-IT, ECF No. 132 (Third Amended Complaint), ECF 615 (Notice of Settlement) (D. Mass. Apr. 27, 2018). Read more here.
September 1, 2022
by Samuel F.B. Audley
False Claims Act
DOJ Secures FCA Settlement with Health Services Companies
The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Alex Hartzell for the following post on the FCA Now blog: The U.S. Attorney’s Office for the District of Massachusetts recently secured a settlement agreement resolving allegations that Molina Healthcare, Inc. and its prior subsidiary, Pathways of Massachusetts, which provide mental health services in Springfield and Worcester, Massachusetts, violated the False Claims Act (“FCA”), 31 U.S.C. § 3729 et seq. and the Massachusetts-equivalent to the FCA. The settlement agreement also resolves similar claims brought by employees of Molina Healthcare and Pathways under the qui tam provisions of these statutes. Under the terms of the settlement agreement, Molina Healthcare and Pathways have agreed to pay the federal government and Massachusetts $4,625,000 to resolve these claims. Read more here.
July 18, 2022
by Alex Hartzell
False Claims Act
DOJ Announces Settlement with Home-Health Services Company Over FCA Kickback and Overbilling Allegations
The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Tess Erickson for the following post on the FCA Now blog: The Department of Justice recently announced that it resolved two civil lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act to the tune of nearly $4 million. The suits alleged that a suburban Chicago diagnostics company, SNAP Diagnostics, LLC, that provides home testing for sleep disorders was defrauding Medicare and four other federal health care programs through kickbacks and unnecessary testing. Since Medicare began covering home sleep testing in 2009, SNAP has received nearly $9 million from Medicare – almost all of it the result of fraud and kickbacks, according to the government’s allegations. Read more here.
June 20, 2022
by Tess Erickson
False Claims Act
Healthcare Fraud Settlement Showcases Government’s Additional Focus on COVID-19-Related Fraud
The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Alex Hartzell for the following post on the FCA Now blog: The Department of Justice (“DOJ”) last month announced a new blockbuster settlement agreement under the False Claims Act, 31 U.S.C. § 3729 et seq (“FCA”), involving alleged violations of the Stark law and other efforts to defraud federal and state healthcare programs. The agreement also resolved the government’s allegations that the defendants—having allegedly engaged in healthcare fraud—further violated the FCA by obtaining a loan through the Paycheck Protection Program (“PPP” or “Program”) while certifying they were not engaged in illegal activities. Although this settlement appears principally to address allegations of healthcare fraud, the resolution of FCA claims involving alleged PPP fraud highlights the government’s efforts to root out those who attempt to defraud COVID-19 relief programs. Read more here.
June 1, 2022
by Alex Hartzell
False Claims Act
More DOJ Double-Dipping PPP Fraud News
The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Alex Hartzell for the following post on the FCA Now blog: The Department of Justice (“DOJ”) continues rolling out new settlement agreements related to COVID-19 fraud—highlighting the government’s and a common relator’s efforts to crack down on those alleged to have improperly received monies through the Paycheck Protection Program (“PPP” or “Program”). A new settlement agreement once again showcases these trends and illustrates the civil liability that businesses and individuals may face under the False Claims Act, 31 U.S.C. § 3729 et seq (“FCA”) for double-dipping into PPP loan funds made available in 2020 during the height of the pandemic. Read more here.
May 23, 2022
by Alex Hartzell
False Claims Act
Latest PPP Fraud Settlement Showcases Civil and Criminal Penalties for Knowingly Submitting False Claims
The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Alex Hartzell for the following post on the FCA Now blog: The Department of Justice (“DOJ”) continues racking up more settlement agreements under the False Claims Act, 31 U.S.C. § 3729 et seq (“FCA”) with companies and individuals alleged to have improperly used funds received through the Paycheck Protection Program (“PPP” or “Program”). The latest PPP fraud settlement illustrates that attempts to fraudulently obtain forgiveness of PPP loans used for ineligible expenses invites potential liability under the FCA in addition to liability under its criminal counterpart, 18 U.S.C. § 287. Read the rest of the post here.
April 28, 2022
by Alex Hartzell
False Claims Act
DOJ Shows No Sign of Slowing Down Prosecution of Individuals Connected to FCA Cases
The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Katherine Chaves for the following post on the FCA Now blog: Following a record year for False Claims Act (“FCA”) settlements and judgments in 2021, the Department of Justice (”DOJ”) continues to aggressively pursue the prosecution of not only corporations, but also the individuals connected to corporate criminal cases. Within the first quarter of 2022, the DOJ has already announced numerous False Claims Act violations involving corporate defendants, including a $260 million settlement with pharmaceutical company Mallinckrod, a $48.5 million settlement with TriMark USA, LLC, and a $20 million settlement with BayCare Health System Inc. A notable theme emerging from the DOJ’s stream of FCA prosecution press releases, however, is its focus on holding individual defendants accountable for crimes committed in connection with their corporate activity. Read the rest of the article here.
April 27, 2022
by Katherine Chaves
False Claims Act
Home-Health Services Company Settles After Allegations of Double-Billing Scheme
The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Ryan Cole for the following post on the FCA Now blog: The Department of Justice recently announced that a home-health services company has agreed to pay over $45,000 to resolve alleged False Claims Act (“FCA”) violations. Professional Family Care Services, Inc. (“PFCS”), a North Carolina corporation, faced allegations of fraudulent billing for work by an employee that was convicted of wire fraud and sentenced to prison for her role in the alleged scheme. Read more here.
March 8, 2022
by Ryan Cole
False Claims Act
DOJ Announces More FCA Settlement Agreements Over PPP Fraud
The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Alex Hartzell for the following post on the FCA Now blog: Fresh off the new year, the Department of Justice (“DOJ”) continues to announce new settlements under the False Claims Act, 31 U.S.C. § 3729 et seq (“FCA”)—further cementing the trend of private parties suing borrowers for violating requirements of the Paycheck Protection Program (“PPP” or the “Program”). Two new FCA settlements were announced earlier this month involving relators’ allegations that borrowers made false statements when applying for PPP loans in violation of Program rules. Read more here.
March 1, 2022
by Alex Hartzell
False Claims Act
Enforcement Standards Tighten on Private Insurers: Sutter Health Settles for $90 Million Following Dispute With DOJ
The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Samuel Audley for the following FCA Now blog post: On August 30, 2021, the Department of Justice (“DOJ”) announced that Sutter Health and several of its affiliated entities (“Sutter”) agreed to pay a total of $90 million to settle allegations that Sutter violated the False Claims Act (“FCA”), 31 U.S.C. §§ 3729-3733, by “knowingly submitting inaccurate information about the health status of beneficiaries enrolled in Medicare Advantage Plans.” Read more here.
November 5, 2021
by Samuel F.B. Audley
False Claims Act
Eight Years Later: “Speculative” and “Straightforward” FCA Allegations Against Walmart Dismissed
The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Donna Reuter from Dorsey’s FCA Now blog for today’s post: Walmart successfully ended eight years of protracted litigation under the False Claims Act (“FCA”) on June 4, 2021, when the Sixth Circuit affirmed dismissal of Medicare and Medicaid fraud allegations against the major retailer. The case was first filed in February 2013. See United States ex rel. Sheoran v. Wal-Mart Stores E., No. 13-10568, 2019 U.S. Dist. LEXIS 140710, at *2 (E.D. Mich. Aug. 20, 2019). The case was originally filed by Ashwani Sheoran, a former Walmart pharmacist. (Read more here.)
June 21, 2021
by Donna Reuter
False Claims Act
Borrowers and Banks Beware: The New Year Brings the Nation’s First False Claims Act Settlement for Paycheck Protection Program Fraud
The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s FCA Now blog for today's post.
January 15, 2021
by Kirk Schuler, Alex Hontos, RJ Zayed, John Marti, Caitlin L.D. Hull, and Eric Weisenburger
False Claims Act
DOJ Demonstrates Continued Focus on Opioid Crisis with $600 Million Criminal and Civil Settlement Against Indivior Solutions, Indivior Inc., and Indivior plc
The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. We would like to thank Vanessa J. Szalapski for the following post from Dorsey’s FCA Now blog: The Department of Justice’s (“DOJ”) most recent settlement with Indivior Solutions, Inc., Indivior Inc., and Indivior plc (together, “Indivior”) demonstrates not only that the DOJ is continuing its pursuit of claims and settlements related to the opioid crisis, but also that the DOJ is searching for creative penalties beyond large monetary payouts. [Continue Reading]
August 25, 2020
by Vanessa J. Szalapski
False Claims Act
False Claims Act Exposure for Beneficiaries of the Public Health and Social Services Emergency Relief Fund: Mitigating Risks of Ambiguous Terms & Conditions
The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Andrew Brantingham, Ross C. D'Emanuele, and Alex Hontos for the following post from Dorsey's FCA Now blog: The CARES Act allocated $100 billion in relief funds to hospitals and other healthcare providers, to be distributed by the Department of Health and Human Services (“HHS”) through the Public Health and Social Services Emergency Relief Fund (or “Provider Relief Fund”). Many healthcare providers across the country have received payments from the Fund...[Continue Reading]
May 7, 2020
by Andrew Brantingham, Ross C. D'Emanuele, and Alex Hontos
False Claims Act
CMS Issues Explanatory Guidance on Stark Law Blanket Waivers
As we explained in our prior blog post, on March 30, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued certain blanket waivers of sanctions under the federal physician self-referral law (or “Stark Law”) for “COVID-19 Purposes” (the “Stark Blanket Waivers”), which are available here. On April 21, 2020, CMS issued explanatory guidance, available here, on the scope and application of the Stark Blanket Waivers to certain financial relationships (the “Explanatory Guidance”). In addition to answering a variety of questions raised by the initial announcement of the Stark Blanket Waivers, the Explanatory Guidance provides an important reassurance to stakeholders. CMS states: “The Secretary will work with the Department of Justice to address False Claims Act relator suits where parties using the blanket waivers have a good faith belief that their remuneration or referrals are covered by a blanket waiver.” Despite this reassurance, however, it is crucial that parties seeking to rely on a Stark Blanket Waiver ensure that their arrangement, in fact, relates to “COVID-19 Purposes” (as defined in the Stark Blanket Waivers document), falls within the parameters of a specifically enumerated waiver within the Stark Blanket Waivers document, and that all non-waived requirements of an applicable Stark Law exception are met. We also note that, as CMS reminds parties in the Explanatory Guidance, relying on a Stark Blanket Waiver may not be necessary for certain arrangements related to COVID-19 Purposes, if these arrangements satisfy the requirements of an existing Stark Law exception. The following information summarizes the Explanatory Guidance. A. Compliance with Non-Waived Requirements of an Applicable Exception Many of the Stark Blanket Waivers eliminate or alter some, but not all, of the existing requirements of particular Stark Law exceptions. CMS warns that financial relationships or referrals must satisfy all non-waived requirements of an applicable exception in order to avoid implicating the Stark Law’s referral and billing prohibitions. We note that this includes, for example, meeting the “set in advance” requirement of applicable compensation exceptions, as this requirement is not waived by any of the Stark Blanket Waivers. B. Amendment of Compensation Arrangements The Explanatory Guidance clarifies when parties may modify the remuneration terms of an existing arrangement during the COVID-19 emergency period, and whether such terms can be amended during the emergency period and again at the conclusion of the emergency period to return to the original terms. This guidance applies when parties are relying on a compensation exception that has both a one-year term requirement and a “set in advance” requirement (such as the personal services arrangements exception). CMS points to the preamble guidance in the Fiscal Year 2009 Inpatient Prospective Payment System final rule (“FY 2009 IPPS Rule”), which CMS interprets as allowing for a second or subsequent amendment of the compensation terms of an arrangement, even within the first year of an initial amendment of those terms, as long as each time those terms are amended, “all requirements of an applicable exception are satisfied, the amended remuneration is determined before the amendment is implemented, the formula for the amended remuneration does not take into account the volume or value [of] referrals or other business generated by the referring physician, and the overall arrangement remains in place for at least 1 year following the amendment.” CMS reiterates that if parties amend a compensation arrangement during the emergency period, all non-waived requirements of an applicable exception must be met. The compensation terms of the arrangement may again be amended after the public health emergency is over. This further amendment may restore the original terms of the arrangement or make additional changes, as long as each of the criteria from the FY 2009 IPPS Rule (described above) are met. Finally, CMS points out that a modification of an existing arrangement could instead be analyzed as an additional compensation arrangement, for which the parties could use the Stark Blanket Waivers (if all applicable requirements are met). C. Applicability of Blanket Waivers to Indirect Compensation Arrangements The Explanatory Guidance states that the Stark Blanket Waivers do not apply to indirect compensation arrangements, and only apply to direct compensation arrangements. Parties can, however, seek an individual waiver of sanctions related to indirect compensation arrangements. The Explanatory Guidance goes on to note that many compensation arrangements that may appear to be indirect may be analyzed as direct compensation arrangements under the “stand in the shoes” provisions of the Stark Law. D. Repayment Options for Loans between a DHS Entity and a Physician (or the Immediate Family Member of a Physician) Two Stark Blanket Waivers (waivers #10 and #11) involve remuneration in the form of a loan with an interest rate below fair market value or on terms that are unavailable from a lender that is not in a position to make referrals to or generate business for the party making the loan. CMS states that these waivers do not require cash payments to the lender to satisfy a borrower’s debt. Loans may be repaid through in-kind payments, as long as the aggregate value of the in-kind payments is consistent with the amount of the loan and the arrangement is commercially reasonable. CMS provides that an example in-kind payment could be the maintenance of a medical practice and continuing to serve patients in the community where the entity is located. E. Repayment of Loans, Rent Abatement, or Other Amounts Due Following the End of the Emergency Period CMS clarified that, if parties use the Stark Blanket Waivers such as the loan arrangements described above, repayment obligations do not need to be completed prior to the termination of the Stark Blanket Waivers (which will be at the end of the public health emergency that was declared related to the COVID-19 outbreak). Many parties expressed concern that, after the termination of the Stark Blanket Waivers, the compensation arrangements entered into would no longer satisfy the requirements of an applicable exception because the interest charges or other charged amounts would not be consistent with the fair market value of the remuneration provided. The Explanatory Guidance provides that appropriate repayment terms agreed to before the termination of the Stark Blanket Waivers may continue beyond the termination of the waivers. However, disbursement of loan proceeds or additional remuneration after the termination of the Stark Blanket Waivers must satisfy all requirements of the applicable Stark exception. F. Restructuring of Existing Recruitment Arrangements with Income Guarantees CMS also responded to inquiries about the extension or restructuring of existing physician recruitment arrangements, such as whether a hospital could extend an income guarantee to address a recruited physician’s medical practice interruption due to the COVID-19 pandemic. The Explanatory Guidance states that CMS maintains its position that, under the Stark Law exception for physician recruitment, the terms of a recruitment arrangement cannot be altered once the physician has relocated their practice. Some Stark Blanket Waivers, however, may be available for remuneration from a hospital (or other entity) to assist a relocated physician whose medical practice is disrupted due to the pandemic in order to maintain the availability of medical care and related services for patients and the community. * * * For help determining whether an existing or proposed arrangement complies with a Stark Blanket Waiver and/or for inquiries regarding individual waiver requests, please contact the authors of this post or your regular Dorsey attorney. We continue to closely monitor the legal landscape related to the COVID-19 pandemic. You can access Dorsey’s health law blog providing health law updates, available here. You can also access Dorsey’s coronavirus resource center, containing a wide variety of legal resources related to the coronavirus outbreak, available here.
April 29, 2020
by Alissa Smith, Laura B. Morgan, and Charis Zimmick
False Claims Act
Triggering the Public Disclosure Bar: It’s in the Details
The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Lindsey Schmidt for the following post to Dorsey's FCA Now Blog:
February 18, 2020
by Lindsey Schmidt
False Claims Act
Escobar in Action: Physician-owners’ fraud claims against hospital defeated in Fifth Circuit appeal for lack of materiality
Following the passage of the Affordable Care Act (“ACA”), which placed new limits on physician-owned hospitals, St. Luke’s Health System (“System”) took action to change one of its hospital’s ownership structures through a buy-out of the physicians’ partnership interests pursuant to the Texas Securities Act (“TSA”). The TSA allows rescission for the original price paid for a security, plus interest, in exchange for a release of potential liability under TSA. Three of the physician-owners, who resisted the System’s attempt to rescind their ownership interests, sued the System and other defendants in connection with the buy-out alleging state-law violations and violations of the Anti-Kickback Statute, and by extension, the False Claims Act. To read the full article, view our FCA Now blog, linked here:
December 11, 2019
by Siena Caruso
False Claims Act
DOJ Issues Consolidated Guidance for False Claims Act Cooperation Credit
The United States Department of Justice this month released a revised and consolidated set of guidelines for determining cooperation credit for organizations facing exposure under the False Claims Act. The consolidated guidelines identify the main factors that the DOJ will consider when assessing the maximum “credit” parties will get for (1) voluntarily self-disclosing misconduct; (2) proactively cooperating with FCA investigations; and (3) taking effective remedial measures. The guidelines define “credit” as, typically, “reducing the penalties or damages multiple sought by the Department.” The guidance aims to consolidate and add uniformity to how these issues will be addressed—something that historically could vary considerably. And while much of the guidance is common knowledge among experienced FCA practitioners, it is nonetheless DOJ’s most concise statement of how cooperation credit plays out in the specific context of the False Claims Act. 1. Voluntary Self Disclosure DOJ continues to focus on the importance of voluntary disclosures. Companies and individuals that discover false claims and make a “proactive, timely, and voluntary self-disclosure” to the DOJ will receive credit. Such parties will also qualify for credit for disclosing “additional misconduct going beyond the scope of the known concerns” uncovered during an internal investigation. Partial credit is available to defendants who “meaningfully assist” the DOJ’s investigations after failing to self-disclose the underlying conduct. And the DOJ will not give credit to any entity or individual that “conceals involvement in the misconduct by members of senior management or the board of directors, or to an entity or individual that otherwise demonstrates a lack of good faith to the government during the course of its investigation.” Voluntary disclosure, the DOJ guidelines caution, does not include disclosure of information required by law or in responding to a subpoena, investigative demand, or other compulsory process. Nor does it include the disclosure of information under an imminent threat of discovery or investigation. 2. Proactive Cooperation Individuals and entities under investigation can also receive credit for taking steps to cooperate with the DOJ. Steps that would qualify for credit include: identifying individuals substantially involved in or responsible for the misconduct; disclosing relevant facts and identifying opportunities for the DOJ to obtain evidence not in the possession of the entity or individual or not otherwise known to the government; preserving, collecting, and disclosing relevant documents and information beyond existing business practices or legal requirements; identifying individuals who are aware of relevant information or conduct, including an entity’s operations, policies, and procedures; making company employees with relevant information available for meetings, interviews, examinations, or depositions; disclosing relevant facts gathered during the entity’s independent investigation (not to include information subject to attorney-client privilege or work product protection), including attribution of facts to specific sources rather than a general narrative of facts, and providing timely updates on the organization’s internal investigation into the government’s concerns, including rolling disclosures of relevant information; providing facts relevant to potential misconduct by third-parties; providing technological expertise and assistance to the government in their review of relevant information; admitting liability or accepting responsibility for the wrongdoing or relevant conduct; and assisting in the determination or recovery of the losses caused by the organization’s misconduct. DOJ will determine the value of any self-disclosure and cooperation by considering the following factors: the timeliness and voluntariness of the assistance; the trustfulness, completeness and reliability of information provided; the nature and extent of the assistance; and the significance and usefulness of the cooperation. 3. Effective Remedial Measures Remedial actions taken by an entity in response to an FCA violation that would receive credit include: analyzing the root cause of the underlying misconduct and how to address it; implementing or improving an effective compliance program designed to ensure the misconduct does not reoccur; disciplining or replacing those responsible for the misconduct (including supervisors) either through direct participation or failure in oversight; and any additional steps that demonstrate that the entity recognizes how serious the misconduct is, accepts responsibility for it, and will implement preventative measures to make sure it doesn’t reoccur. Although the guidelines do not significantly alter existing DOJ policy, they provide a clearer and concise set of guidelines to the AUSAs and Civil Frauds trial attorneys who will evaluate an organization’s cooperation and self-disclosure. For organizations seeking to understand their own obligations and potential options, understanding the Government’s playbook has never been more important.
May 21, 2019
by Alex Hontos, John Marti, and Kirk Schuler
False Claims Act
DOJ Levels False Claims Act at Pharmacies to Combat Opioid Crisis
This month the Department of Justice rough a "first of its kind" action against two pharmacies, their owner, and three pharmacists for allegedly dispensing and billing Medicare for prescriptions in violation of both the Controlled Substances Act and the False Claims Act. For more on information on this, visit our FCA Now blog, linked here: https://dorseyfca.com/doj-levels-false-claims-act-at-pharmacies-to-combat-opioid-crisis/
February 14, 2019
by John Marti, Alex Hontos, Kirk Schuler, Lauren Roso, and David Green
False Claims Act
Drug Rebates Threatened Under Proposed Anti-kickback Rule
The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical manufacturers pay to Medicare and Medicaid plan sponsors and their pharmacy benefit managers (“PBMs”). The OIG proposed replacing the current safe harbor protection for drug price discounts and rebates with a new safe harbor to protect only those drug price reductions that are set in advance and are applied fully to the price of the product charged to the Medicare or Medicaid beneficiary at the point of sale. In addition, the OIG proposed a new safe harbor to protect compensation from pharmaceutical manufacturers to PBMs for services provided to the manufacturer, but only if those payments are fixed, fair market value payments not tied to volume or value, and the PBM discloses such payments to its health plan customers. The OIG’s proposals could have a significant impact on the drug discount and rebate arrangements that are commonly in place between manufacturers and Medicare Part D plans/Medicaid managed care organizations (and PBMs acting on behalf of these plans). The OIG’s proposals would also impact Medicare and Medicaid beneficiaries who would be entitled to receive any such discounts directly at the point of sale. The proposed rule release can be found here and is expected to be published in the Federal Register on February 6. The proposed effective date of the new rules is January 1, 2020, with an earlier effective date of 60 days after the final rule is published, for the new point of sale safe harbor. I. Discount Safe Harbor – Changes to Focus on Point-of-Sale Reductions in Drug Prices The federal anti-kickback statute (Social Security Act § 1128B(b)) makes it a criminal offense for anyone knowingly and willfully to pay, solicit, or receive anything of value to induce referrals of items or services that are reimbursable under any federal health care program. Violation of the statute is a felony, and can carry civil fines, imprisonment, exclusion from federal health care programs, and be the basis for liability under the False Claims Act. An existing safe harbor protects from anti-kickback statute liability discounts and rebates on drug prices that pharmaceutical manufacturers pay to health plans or their PBMs. The OIG’s proposal would revise the discount safe harbor to exclude from protection any reduction in price or other compensation in any form paid from a pharmaceutical manufacturer to a Medicare Part D or Medicaid managed care organization or their PBM in connection with the sale or purchase of a prescription drug. The proposal reflects OIG’s concern that the current manner in which drug price discounts and rebates are structured does not result in lower drug costs to federal programs and federal program beneficiaries, and in fact may be a cause of rising drug costs, and may be contrary to the purposes of the anti-kickback statute. In its place, the OIG proposes to add a new safe harbor focused narrowly on point-of-sale reductions in prescription drug prices. That safe harbor would protect reductions in the price charged by a manufacturer for drug products that are payable by a Medicare Part D or Medicaid managed care organization or their PBM, but only if that price reduction meets three conditions (the “Point of Sale Safe Harbor”): First, the reduced price must be set in advance. OIG intends this to mean that the terms of the price reduction are fixed and disclosed in writing to the plan sponsor by the time of the initial purchase. Second, the sale may not involve a rebate unless the full value of the price reduction is provided to the dispensing pharmacy through chargebacks. This means that when a pharmacy dispenses a drug to a beneficiary, the total payment to the pharmacy (including the beneficiary co-payment, payment from the health plan, and any chargeback payment from the manufacturer) must be no less than the drug price agreed between the manufacturer and the health plan sponsor or their PBM. Lastly, the reduction in price must be completely applied to the price charged to the beneficiary at the time of sale. This means that the drug price to which the beneficiary’s cost-sharing obligations apply at the point of sale must be the same price (taking into account all discounts) that the manufacturer charges to the plan sponsor or their PBM. The OIG also noted that the discount safe harbor would continue to not apply if a manufacturer offered a price reduction to payors other than Medicare and Medicaid payors (i.e., situations in which parties “carve out” referrals of federal health care program beneficiaries or business from otherwise “questionable” financial arrangements). The OIG is especially concerned with these “carve out” arrangements if the offer of a discount on products would serve as an inducement for the purchase of products that are reimbursable by federal healthcare programs (e.g., offering a discount to a private health plan that is conditioned, even implicitly, on a product’s favorable formulary placement in the health payor’s Part D plans). II. New PBM Service Fee Safe Harbor In addition, the OIG proposed a new safe harbor to protect compensation from pharmaceutical manufacturers to PBMs for services rendered to the manufacturers that relate to PBMs’ arrangements to provide PBM services to health plans (the “PBM Service Fee Safe Harbor”). The OIG did propose three specific conditions that must be met in order for compensation to be protected under the PBM Services Fee Safe Harbor. The first proposed condition of the safe harbor would require the PBM and the pharmaceutical manufacturer to have a written agreement that covers all of the services the PBM provides to the manufacturer in connection with the PBM’s arrangements with health plans for the term of the agreement, and specifies each of the services to be provided by the PBM and the compensation for such services. Notably, the OIG declined to propose a specific definition for PBM services but did provide a list of examples of services that it generally considers to be PBM services, including: contracting with a network of pharmacies; establishing payment levels for network pharmacies; negotiating rebate arrangements; developing and managing formularies, preferred drug lists, and prior authorization programs; performing drug utilization review; and operating disease management programs. The second proposed condition requires that compensation paid to the PBM must: (i) be consistent with fair market value in an arm’s-length transaction; (ii) be a fixed payment, not based on a percentage of sales; and (iii) not be determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the parties, or between the manufacturer and the PBM’s health plans, for which payment may be made in whole or in part under Medicare, Medicaid, or other Federal health care programs. Finally, the Department proposes that the PBM disclose in writing to each health plan with which it contracts at least annually, and to the Secretary upon request, the services it rendered to each pharmaceutical manufacturer that are related to the PBM’s arrangements with that health plan and the associated costs for such services. Other than the proposed revisions to the discount safe harbor, and the new PBM Service Fee Safe Harbor, the OIG did not propose to modify any other existing safe harbors which PBMs may use to protect payments from manufacturers. The OIG specifically noted the possibility that certain types of remuneration that manufacturers might pay to PBMs could continue to be protected under another existing safe harbor. For example, PBMs could presumably continue to rely on the Group Purchasing Organization (GPO) safe harbor to protect certain administrative fees paid by drug manufacturers to PBMs for GPO services, even if those fees are based on the total prescription volumes of health plans on behalf of which the PBM contracts with the manufacturers. III. Conclusion The OIG proposal reflects a clear intent to substantially alter many of the current drug discount and services compensation practices among pharmaceutical manufacturers and Part D/Medicaid MCO payers and their PBMs. The proposal also reflects the OIG’s skepticism that current drug discount and compensation practices among manufacturers and PBMs are sufficiently transparent to health plans to ensure that all appropriate cost reductions and value is passed through to health plans and reflected in lower health plans costs and lower premiums for beneficiaries. The proposal to exclude drug price reductions to Part D and Medicaid MCO health plan sponsors and PBMs is proposed to be effective on January 1, 2020. The OIG is also proposing that the new Point-of-Sale Safe Harbor will take effect in a shorter time frame of sixty (60) days after the rule is finalized. Comments to the proposed rule may be submitted 60 days after publication in the Federal Register. There are a number of steps that parties to the type of arrangements covered by the proposed rule should take, including reviewing their current discount and rebate agreements to determine whether there will need to be amendments to these contracts in order to comply with the proposed rule, if it is finalized. Parties will also need to evaluate what compliance measures are needed in order to operationalize the changes in these arrangements to ensure compliance with the new safe harbor requirements. Finally, in light of the attention OIG is giving to these type of arrangements, now would be an opportune time to review arrangements for compliance with the current safe harbor restrictions, such as the carve out restriction described above. If you have further questions about this proposed rule, please contact the authors or any other health care transaction and regulatory attorneys at Dorsey & Whitney.
February 6, 2019
by Ross C. D'Emanuele, Alissa Smith, and Benjamin Fee
False Claims Act
For FY2018, Justice Department Touts Nearly $3 Billion in False Claims Act Recoveries, Mostly From Qui Tams and Alleged Healthcare Frauds
The Justice Department announced in a recent press release that it obtained more than $2.8 billion in settlements and judgments from cases involving fraud and false claims against the government. For more information, visit our FCA Now Blog: https://dorseyfca.com/for-fy2018-justice-department-touts-nearly-3-billion-in-false-claims-act-recoveries-mostly-from-qui-tams-and-alleged-healthcare-frauds/
January 18, 2019
by Alex Hontos, John Marti, and Kirk Schuler
False Claims Act
Third Circuit: False Claims Act Liability Premised on an Anti-Kickback Statute Violation Requires Proof that at Least One Federal Claim Resulted from an Improper Referral or Recommendation
https://dorseyfca.com/third-circuit-false-claims-act-liability-premised-on-an-anti-kickback-statute-violation-requires-proof-that-at-least-one-federal-claim-resulted-from-an-improper-referral-or-recommendation/
February 7, 2018
by Ben Kappelman
False Claims Act
Two Recent Justice Department Memoranda May Have Significant Consequences for Pending and Future False Claims Act Enforcement
In recent weeks, the United States Department of Justice (“DOJ”) issued two memoranda that might change the calculus of False Claims Act (“FCA”) cases. The memoranda at a minimum provide organizations with new—or at least invigorated—defenses to qui tam actions and civil enforcement matters. First, on January 10, Michael Granston, Director of DOJ’s Civil Frauds section, issued a memorandum encouraging DOJ trial attorneys to consider dismissing unmeritorious qui tam cases (even over the objection of the relator). The DOJ’s authority to dismiss FCA cases has long been built directly into the governing statute, 31 U.S.C. § 3730(c)(2)(A), which provides that: The Government may dismiss the action notwithstanding the objections of the person initiating the action if the person has been notified by the Government of the filing of the motion and the court has provided the person with an opportunity for a hearing on the motion. In practice, DOJ trial attorneys rarely uses this power, preferring to allow qui tam cases they declined to intervene in to continue being prosecuted by the relator. The Granston Memo encourages a shift in practice by suggesting that DOJ attorneys should dismiss qui tam cases that lack substantial merit. Meritless qui tam cases drain limited government resources and may “generate adverse decisions that may affect the government’s ability to enforce the FCA.” To aid in determining whether a DOJ attorney should seek dismissal of a declined qui tam action, the Granston Memo sets forth seven factors, including curbing parasitic qui tams and preserving government resources. Second, on January 25, the Associate Attorney General (“AAG”) issued a memorandum prohibiting reliance on government agency “guidance documents” as a basis for liability in DOJ affirmative civil enforcement matters—including FCA cases. Such “guidance documents” include all non-statutory or regulatory documents that purport to advise the public of legal rights or obligations, as are commonly issued by agencies like the US Environmental Protection Agency and the Department of Health and Human Services. The memo advises DOJ litigators that because “[g]uidance documents cannot create binding requirements that do not already exist by statute or regulation . . . [DOJ] litigators may not use noncompliance with guidance documents as a basis for proving violations of applicable law.” The AAG's memo acknowledges that sub-regulatory guidance serves a valuable function, and does not likely presage a government-wide change in agency’s use of such documents. But FCA matters—qui tam or otherwise—that are built on such sub-regulatory guidance are on shakier ground. These memoranda create interesting implications for FCA cases. First, the AAG’s memo narrows potential FCA liability by excluding a wide range of agency documents from being the basis of FCA violations. The AAG’s memo also raises interesting questions about what agency materials might be evidence of “materiality,” particularly after the Supreme Court’s recent Escobar decision. Second, although the authority of the DOJ to dismiss qui tam actions has not changed, the government may be newly receptive to arguments for the dismissal of plainly deficient qui tam cases. The memo thus presents an opportunity for legal counsel to affirmatively seek dismissal of a weak FCA case—a move that could potentially save the accused violator the time and expense of otherwise defending against the case. The two memoranda are available here and here.
January 31, 2018
by John Marti, RJ Zayed, Alex Hontos, and Caitlin L.D. Hull
False Claims Act
Applying Escobar’s Materiality Standard, Florida Federal Court Reverses $350 Million False Claims Act Verdict against a Nursing Home Operator
If the government does not take action and continues to pay for Medicare/Medicaid claims after it learns of non-compliance related to the claims, is the non-compliance material to the government’s decision to pay? This is a question being answered in the negative by courts across the country, who have concluded that the government (or a qui tam relator) is not able to proceed under a False Claims Act (FCA) “implied certification” theory if evidence shows that the government did not take action and continued to pay claims after learning of non-compliance with laws associated with those claims. A Florida Federal Court in United States ex. rel. Ruckh v. Salus Rehabilitation, LLC et. al (Case No. 8:11-cv-1303-T-23TBM), is one of the latest to address this issue and find no FCA violation. Background In 2016, the United States Supreme Court addressed the issue of whether a claim submission without disclosure of a statute or regulation infraction could potentially trigger a FCA violation in Universal Health Services, Inc. v. United States ex rel. Escobar, spawning a new line of cases that have interpreted the new standards the Court set forth for implied certification FCA cases. Prior to the Escobar decision, the circuit courts across the U.S. were split on the issue. In these so-called “implied certification” cases, the government alleged that the party submitting a claim to the government impliedly certified that the services were provided in compliance with laws. In Escobar, the Supreme Court analyzed the reach of the FCA in situations in which a party was alleged to have made a misrepresentation in a payment claim to the federal government because the services provided were, in fact, not in compliance with the law. The Court recognized the implied certification theory, but held, among other things, that under the theory, FCA liability depends on whether the defendant violated a requirement that it knew was material to the government’s decision to pay. In providing guidance on how to determine “materiality”, the Court noted that, “[t]he materiality standard is demanding. The False Claims Act is not ‘an all-purpose antifraud statute’ or a vehicle for punishing garden-variety breaches of contract or regulatory violations.” The Court went on to note: “[I]f the Government pays a particular claim in full despite its actual knowledge that certain requirements were violated, that is very strong evidence that those requirements are not material” and “if the Government regularly pays a particular type of claim in full despite actual knowledge that certain requirements were violated, and has signaled no change in position, that is strong evidence that the requirements are not material.” Analysis In light of the guidance in Escobar, many courts in analyzing “implied certification” allegations under the FCA, have given significant consideration to evidence about how the government acted following a defendant’s non-compliance disclosure. Courts will make a fact-intensive inquiry into the post-disclosure conduct of the government in order to determine whether a given violation is material to the governments’ payment decision on the related claims. If the government refused to make further payment or took other action against the provider after learning of the non-compliance, that refusal may help the government or a relator to establish that compliance with the particular law at issue was material to the government’s decision to pay. However, if the government continues to pay the claims, and takes no other action, it has proven difficult for the government or a relator to succeed. A recent example of the uphill battle Escobar is presenting for relators and the government in these “implied certification” FCA cases is the Salus case. On January 11, 2018, a federal court in Florida followed a line of post-Escobar cases, denying an implied certification theory case under the FCA based on evidence that the government continued to pay claims related to the subject matter of the relator’s complaint, even after the government learned about the non-compliance. In Salus, a nurse relator alleged FCA violations against the owners and operators of 53 specialized nursing facilities based on the nursing facility’s alleged failure to maintain a comprehensive care plan for residents required under Medicaid, as well as defects in paperwork required to support claims to the Medicare program, such as unsigned or undated documents. The judge in Salus vacated a $350 million verdict against Salus Rehabilitation, which had been entered less than a year earlier (on March 1, 2017), because the evidence in the case showed that the government knew about the non-compliance, and did nothing about it. In overturning the prior verdict against the nursing homes, the court stated, “[n]ot only did the relator fail to prove that the governments regarded the disputed practices as material and would have refused to pay, but the relator failed to prove that the defendants submitted claims for payment despite the defendants’ knowing that the governments would refuse to pay the claims if either or both governments had known about the disputed practices. In fact, both governments were—and are—aware of the defendants’ disputed practices, aware of this action, aware of the allegations, aware of the evidence, and aware of the judgements for the relator—but neither government has ceased to pay or even threatened to stop paying the defendants for the services provided to patients throughout Florida continuously since long before this action began in 2011.” The judge noted that the government had never made any complaint or imposed any administrative sanction on the practices alleged by the relator. The judge further wrote, “federal and state governments regard the disputed practices with leniency or tolerance or indifference, or perhaps with resignation to the colossal difficultly of precise, pervasive, ponderous and permanent record-keeping in the pertinent clinical environment.” The Salus decision is another win for health care providers who have long lived in fear of the enormous penalties under the FCA whenever non-compliance is discovered with the highly complex, technical and ever-changing health care regulations. While each case applying the materiality standard must be analyzed on its particular facts and circumstances at issue, the post-Escobar cases analyzing the materiality standard have provided a welcomed, more consistent approach that providers can look to when defending these cases.
January 23, 2018
by Alissa Smith
False Claims Act
HIPAA As a Basis for FCA Liability? One Court Says Yes
https://dorseyfca.com/hipaa-as-a-basis-for-fca-liability-one-court-says-yes/
January 22, 2018
by Nathan J. Ebnet
False Claims Act
Consultant found guilty of illegal kickbacks by “referring” doctors’ patients to another medical provider in exchange for remuneration
Under 42 U.S.C. § 1320a-7b(b)(1)(A) it is a felony for a physician to solicit or receive a kickback “in return for referring” a Medicaid or Medicare patient to another medical provider. But as a recent decision by the Eighth Circuit in United States v. Iqbal demonstrates, physicians are not the only ones capable of making illegal referrals under the statute—consultants can, too. Defendant Iqbal was a consultant that managed a group of physicians. He approached a medical provider (“PCP,” a home care agency) with a profit-splitting scheme: he would send physicians’ patients to PCP in exchange for fifty-percent of PCP’s profits for serving the patient. PCP contacted authorities about the scheme and thereafter accepted Iqbal’s proposal while working undercover with authorities. The sting operation resulted, at first, in a March 2011 meeting between Iqbal and PCP. At that meeting Iqbal touted his strong relationship with the group of physicians and his ability to refer their patients to PCP, and reiterated his fifty-fifty profit sharing scheme to which PCP agreed. Iqbal’s physicians later referred two patients to PCP, which PCP served and received Medicaid and Medicare reimbursement. PCP sent Iqbal separate payments in June and August for his fifty-percent share of the profits that PCP made from serving the two patients. Iqbal was charged with three counts of illegal kickbacks: One, for soliciting illegal kickbacks during his March 2011 meeting with PCP; Two, for receiving an illegal kickback in June; and Three, for receiving an illegal kickback in August. All three counts were “in return for referring” patients to PCP under § 1320a-7b(b)(1)(A). Iqbal challenged the sufficiency of the evidence, and conceded that the statutory phrase “in return for referring” meant that one must cause or induce the referral. The two-judge majority willingly assumed as much, declined to interpret the statute any narrower, and found the evidence sufficient to affirm his convictions. Although the majority’s reasoning was not surprising, Judge Kelly in a partial dissent and concurrence took up the task of interpreting the statutory phrase, “in return for referring.” The Eighth Circuit had not previously defined the term. Judge Kelly relied on cases from other circuits in similar contexts to adopt the interpretation “that a person refers an individual for a service only when, as a practical matter, the person exercises decision-making control over the selection of the service provider.” As a result, Judge Kelly utilized a narrower definition than Iqbal and the majority. Under that definition, Judge Kelly found insufficient evidence to affirm Iqbal’s convictions for receiving a kickback for referring the two patients, because the government failed to show that Iqbal exercised decision-making control over the physicians’ referrals. Judge Kelly, however, affirmed Iqbal’s conviction for soliciting a kickback during his March meeting with PCP because Iqbal held himself out to PCP as having the ability to make the referrals, regardless of his actual ability to do so. So physicians, consultants, and everyone in between dealing with Medicaid and Medicare patients should keep in mind that while decision-making control over a referral is likely necessary evidence to prove a “referral” in return for an illegal kickback, solicitations do not require such decision-making control. All that is required is representing that one has the ability to do so.
August 29, 2017
by RJ Zayed, Alex Hontos, and Kirk Schuler
False Claims Act
Creation of Health Care Fraud Unit in Chicago and Recent “Takedown” Shows Continued Emphasis on Health Care Fraud Enforcement
On July 18, 2017, the United States Attorney’s Office for the Northern District of Illinois announced that it was creating a new unit located in Chicago within the office’s Criminal Division dedicated to prosecuting criminal health care fraud (the Health Care Fraud Unit). The office explained that it expected the unit, which will include five prosecutors, to build on its successful prosecution of numerous health care fraud cases in recent years and “bring even greater focus, efficiency and impact to [its] efforts in this important area.” The Health Care Fraud Unit will also build on the office’s previous prosecution of significant diversion of controlled substances cases, in line with the office’s emphasis on battling the opioid crisis. Other United States Attorney’s Offices may follow suit in creating such units. Chicago is also one of nine areas where a Medicare Fraud Strike Force team is located, which are inter-agency teams that focus on the worst offenders in health care fraud “hot spots.” The week prior to the announcement of the new Health Care Fraud Unit in Chicago, there was a national health care fraud “takedown” involving more than 400 defendants allegedly responsible for $1.3 billion in false billings to Medicare and Medicaid, which was the largest health care fraud enforcement action in the history of the Department of Justice and involved coordination among multiple federal and state agencies. While such “takedowns” occur on approximately a bi-annual basis, this one is notable for its size. These events and others like them show the continued emphasis on combating health care fraud under the new administration. In Chicago and across the country, prosecution of criminal healthcare fraud cases will likely continue to increase, and civil health care fraud investigations and qui tam actions will also likely increase.
August 29, 2017
by Laura B. Morgan and Edwin N. McIntosh