Category: Health Law Highlights

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Health Law Highlights

Labs Take Note New OIG Opinion Highlights That Fair Market Value Per Test Payments Can Still Violate the Anti-Kickback Statute Publications

From Bass, Berry & Sims, by Jennifer E. Michael & Danielle M. Sloane:

  • The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-06, wherein the OIG reiterated its longstanding position that carving out federal health care program (FHCP) business from an arrangement does not insulate the arrangement from Anti-Kickback Statute liability.
  • The arrangement would involve laboratories that conduct both the Technical Component (TC), preparing the slides, and the Professional Component (PC), interpreting the slides.
  • The Requestor would pay fair market value (FMV) for the TC services from other labs, provide the PC, and then bill commercial insurance for both the TC and PC services. The commercial insurance policies allowed this practice.
  • The arrangement would not involve any service reimbursable by FHCP, but the Requestor did expect the labs to refer FHCP services outside of this arrangement.
  • The Requestor admitted the arrangement was not commercially reasonable because it could provide TC services itself for less than FMV.
  • Despite the FMV payment and FHCP business carve-out, OIG determined that the arrangement could increase the likelihood that the labs or their referring physicians would order federally reimbursable services from Requestor.
  • Citing its Special Fraud Alert on Laboratory Payments to Referring Physicians, OIG reiterated that the Anti-Kickback Statute is violated if even one purpose of the payment is to induce referrals of FHCP business, regardless of whether that payment is FMV.
  • Finally, the proposed arrangement in Advisory Opinion 23-06 failed to meet a safe harbor only because Requestor effectively certified that the arrangement was not commercially reasonable.
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Health Law Highlights

HHS OIG Introduces Managed Care Strategic Plan

From Squire Patton Boggs, by Bevan Blake:

  • In response to the continued growth of managed care in government-sponsored health plans over the last several years, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) introduced a new “Strategic Plan for Oversight of Managed Care for Medicare and Medicaid.”
    • A majority of Medicare beneficiaries are enrolled in a Medicare Advantage Plan.
    • It is estimated that the share of beneficiaries enrolled in Medicare Advantage Plans will increase to 60% in ten years.
    • For Medicaid, almost seventy-five percent (75%) of beneficiaries are now enrolled with comprehensive Managed Care Organizations.
  • The Strategic Plan identifies three areas of focus for OIG: (1) promoting access to care for enrollees, (2) providing comprehensive financial oversight, and (3) promoting data accuracy.
  • Promoting Access to Care: OIG will review plans and assess whether they meet network adequacy standards.
  • Financial Oversight: OIG will work with managed care plans to identify and prevent fraud within the plans and to ensure the accuracy of the risk-adjusted capitated payments provided to managed care plans.
  • Data Accuracy: OIG wants provider identifiers on Medicare Advantage encounter data so it can provide oversight of the program, and avoid losses caused by enrollees who are enrolled in two different states or managed care organizations.
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Health Law Highlights

Patient Privacy: Preventing Data Leakage in Healthcare

From Security Boulevard, by Chantel Rodrigues:

  • Tracking pixels are tiny, invisible images or code snippets embedded in web pages, emails, or mobile apps. They can be used for legitimate purposes, such as monitoring website traffic, measuring user engagement, and improving user experience.
  • They can also lead to data leakage and privacy breaches, which can constitute HIPAA violations if they compromise patient privacy or security.
  • Identify all pixels and trackers on your web pages and remove the ones that are unnecessary or could be reading sensitive data.
  • Implement JavaScript security controls throughout both the development and Application Security (AppSec) lifecycles.
  • If you do use tracking technologies, ensure they only use and share protected health information (PHI) following HIPAA Privacy Rule guidelines.
  • If you use technology vendors, establish a robust business associate agreement (BAA) to protect PHI.
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Health Law Highlights

Federal Judge Rules Government Must Demonstrate “But-For” Causation for Anti-Kickback Statute Claims

From ArentFox Schiff LLP, by D. Jacques Smith , Randall A. Brater , Michael F. Dearington , Nadia Patel , Heather M. Zimmer:

  • Chief Judge Dennis Saylor of the US District Court for the District of Massachusetts ruled that the federal government must demonstrate but-for causation in order to prove that Regeneron Pharmaceuticals, Inc., the manufacturer of the drug Eylea, submitted false claims resulting from violations of the Anti-Kickback Statute (AKS).
  • The 2010 amendments provide that any Medicare claim that includes items or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA.
  • The government urged that the court to adopt the “exposure” theory of causation set forth in United States ex rel. Greenfield v. Medco Health Sols., Inc., 880 F.3d 89, 96-98 (3d Cir. 2018) — that once the government has proven an AKS violation occurred, to demonstrate causation, it need only prove a causal link that (1) a patient has been “exposed to an illegal recommendation or referral” and (2) that the provider has submitted a reimbursement claim for that patient.
  • In contrast, Regeneron argued for the stricter “but-for causation standard — that the government must demonstrate that an AKS violation occurred and that the remuneration actually caused the provider to provide different medical treatment and thus caused the false claims.
  • The court held that the adoption by Congress of the ‘resulting from’ language in the AKS statute required a finding that the appropriate standard is but-for causation.
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Health Law Highlights

U.S. Supreme Court Declines to Clarify Key Provisions of the False Claims and Anti-kickback Statutes

From Stevens & Lee, by Charles Honart:

  • The Supreme Court declined to resolve a circuit court split on the issue of causation, to wit, when a provider’s claim for reimbursement results from a violation of the Anti-kickback Statute (“AKS”) for purposes of liability under the False Claims Act (“FCA”).
  • Remuneration: A hospital’s decision not to hire an ophthalmologist in return for a general commitment of continued surgery referrals from another ophthalmologist was not “remuneration” covered by the AKS.
  • Causation: The term “resulting from” means that there must be “but-for” causation, *i.e.*, the claim for reimbursement would not have been submitted but-for the violation of the AKS.
  • This ruling is consistent with the Eighth Circuit in United States ex rel. Cairns v. D.S. Med. LLC, 42 F.4th 828 (8th Cir. 2022), but contrasts with the Third Circuit’s opinion in United States ex rel. Greenfield v. Medco Health Sols., Inc., 880 F.3d 89 (3d Cir. 2018), where the court held there must only be a “link” between the AKS violation and the filing of the claim.
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Health Law Highlights

Healthcare AI and HIPAA Compliance

From AI in Healthcare by Dave Pearson:

  • AI can accumulate a large amount of data from many sources. Using large datasets, AI can realistically re-identify previously de-identified healthcare data.
  • Under the HIPAA de-identification safe harbor, even if you remove the 18 specific identifiers, you cannot have actual knowledge that the information could be used alone or in combination with other information to identify patients. Is it possible to meet that standard in the age of AI?
  • This is an evolving area. These issues and others will continue to develop for years to come.
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Health Law Highlights

HHS-OIG Says Anatomic Pathology Lab’s Purchased Service Arrangement Could Violate Anti-Kickback Statute

From Barnes & Thornburg, LLP, by Jason D. Schultz, Anne B. Compton-Brown, Mary Elizabeth “Lizzie” Ford:

  • U.S. Department of Health and Human Services issued an unfavorable opinion addressing an anatomic pathology laboratory that purchases services at fair market value from other labs, and bills commercial payors for such services
  • Even though the proposed arrangement carved out services reimbursed by Federal healthcare programs, the agency determined the arrangement posed a risk of fraud and abuse under the Anti-Kickback Statute
  • The opinion reiterates the HHS-OIG’s long-standing position against arrangements that “carve out” Federal healthcare program business, but still result in increased referrals of Federal healthcare program business outside of the arrangement