Another Stark Law Action

Seth Goldberg
Seth Goldberg

I recently wrote about what appears to be a surge in Stark Law enforcement by the DOJ, and just days later the DOJ announced another Stark Law enforcement action.   The Stark Law, or Physician Self-Referral Law, 42 U.S.C. § 1395nn, which is a strict liability statute that prohibits physicians from referring patients to an entity for “designated health services,” such as inpatient hospital, laboratory, or radiology services, in which the physician has a financial relationship, such as an ownership interest or compensation arrangements where the remuneration exceeds fair market value.

On July 26, 2024, the DOJ filed a Complaint against Murphy Medical Center, Inc. doing business as Erlanger Western Carolina Hospital and Chattanooga-Hamilton County Hospital Authority doing business as Erlanger Health System and Erlanger Medical Center (collectively, Erlanger) in the U.S. District Court for the Western District of North Carolina, alleging that Erlanger violated the Stark Law and thereby violated the False Claims Act, which permits the government to recover treble damages, among other relied.

The Complaint alleges, based on information provided by two qui tam relators, or whistleblowers, who worked for Erlanger as Chief Compliance Officer and Chief Financial Officer, that Erlanger developed a strategy to drive business to it by knowingly paying physicians large salaries and bonuses without regard to whether work was actually performed.  Consequently, the Complaint alleges, Erlanger was paying more than fair market value in violation of the Stark Law.   The Complaint notes instances where Erlanger should have been on notice of the disproportionate payment, but lacked or ignored internal controls and warning signs that could have resulted in a correction.  The Complaint also notes that Erlanger had previously settled DOJ claims of Stark Law violations, agreeing to pay $40 million in 2005.

The Complaint provides specific examples of services provided by ten physicians who were compensated by Erlanger in amounts exceeding fair market value.  Because those services, among others, billed to Medicare allegedly violated the Stark Law, the government asserted claims against Erlanger under the False Claims Act and for common law unjust enrichment and payment by mistake.  The DOJ seeks damages against Erlanger of approximately $27.8 million.

The Erlanger action and the others I previously wrote about should remind hospitals and health systems to be vigilant about physician compensation structures, as the fair market value assessment may result in subtle disparities that nonetheless raise the specter of Stark Law violations.   This is an area of compliance to be particularly mindful about.

 

DOJ Enforcing Stark Law Violations Through False Claims Act

Seth Goldberg
Seth Goldberg

The Stark Law, or Physician Self-Referral Law, 42 U.S.C. § 1395nn, prohibits physicians from referring patients to an entity for “designated health services,” such as inpatient hospital, laboratory, or radiology services, in which the physician has a financial relationship, such as an ownership interest or compensation arrangements where the remuneration exceeds fair market value.  Although there is no private right of action under the Stark Law, an alleged Stark Law violation can provide the basis for a civil qui tam or whistleblower action under the False Claims Act.

For example, in March 2024, in United States ex rel. Lisa Parker v. Mohammad Athari M.D., et al. (4:20-cv-02056), the DOJ intervened and settled a claim for Stark Law violations where the qui tam relator asserted that a Houston-based physician had allegedly referred neurology patients to a diagnostic imaging center the physician owned.  The settlement also resolved allegations that the physician falsely billed for medically unnecessary services under Medicare Part B.  The whistleblower received 18% of the $1.8 millon settlement.  Similarly, in October 2023, the DOJ intervened and settled the qui tam action styled U.S. ex rel. Pinto v. Cardiac Imaging, Inc., et al., No. 18-cv-2674 (S.D. Tex.), where the defendant, Cardiac Imaging Inc. and its owner, paid referring cardiologists fees exceeding fair market value for their referrals.  The settlement value totaled $85,480,000.

While the anti-kickback laws are often the vehicle for claims under the False Claims Act, healthcare providers and entities doing business with them should be aware of the potential for Stark Law claims arising out of compensation arrangements for services and be focused on compliance accordingly.

 

 

Healthcare False Claims Act Judgments/Settlements Lead Way in 2023

Seth Goldberg
Seth Goldberg

The DOJ recently reported that two-thirds of the $2.68 billion in False Claims Act judgments and settlements in 2023, or $1.8 billion, came from the healthcare industry.  2023 also marked the highest number of FCA settlements and judgments in a year, totaling 543.

The treble damages that result from FCA violations provide a powerful tool to the federal government to root out fraudsters who knowingly defraud the U.S. or fail to pay money owed to the U.S.  As Principal Deputy Assistant Attorney General Boynton, head of the Justice Department’s Civil Division, stated, “the record-breaking number of recoveries reflects, those who seek to defraud the government will pay a high price.”

Healthcare FCA settlements and judgments spanned the industry, including managed care providers, hospitals, pharmacies, laboratories, long-term acute care facilities, and physicians.  FCA claims settled or decided included charges against providers for overbilling and medically unnecessary billing, and charges against insurers for submitting inaccurate information, such as diagnosis codes, in order to increase reimbursement.  Kickbacks and lab testing fraud were also the subject of FCA settlements and judgments.

 

Another Healthcare Fraudster Convicted

In addition to the sentencing Tuesday of Patricia Akamnonu, owner of Ultimate Care Home Health Services, for 10 years for conspiring with her husband and others to commit healthcare fraud, late yesterday the owner and manager of three Miami-area home health agencies, Khaled Elbeblawy, was convicted on counts of conspiracy to commit healthcare fraud and wire fraud and one count of conspiracy to defraud the United States and pay healthcare kickbacks.

The $57 million healthcare fraud scheme involved Elbeblawy and his co-conspirators submitting false claims to Medicare for services that were not actually provided, not medically necessary, or for patients who were procured through kickbacks to doctors and patient recruiters.

The case was brought as part of the Medicare Fraud Strike Force, which operates in nine cities across the country, and has charged nearly 2,000 defendants who have collectively billed more than $6 billion.

 

 

False Claims Act Claims Dismissed by Federal Court in Florida

In an important decision for providers facing a lawsuit alleging violations of the False Claims Act, the U.S. District Court for the Middle District of Florida, in U.S. ex rel. Pelletier v. Liberty Ambulance Service, Inc., Case No. 3:11-cv-587-J-32MCR (Middle District of Florida, Jacksonville Division), dismissed the government’s complaint intervening in a qui tam action that alleged that Liberty Ambulance Service, among other providers that settled with the government prior to the dismissal, submitted false claims to Medicare and Medicaid for ambulance services that were never provided, on the basis that the government’s complaint failed to satisfy the heightened pleading requirements under Federal Rules of Civil Procedure 8 and 9.

The Court’s decision is significant because the government attached to its complaint affidavits of current and former employees of Liberty and a dispatcher, along with other materials, suggesting that falsified reports were submitted to Liberty that would be payable by Medicare and Medicaid, but, as the Court found, “the allegations stop short of describing what happened once the run reports were submitted to the Liberty office for processing.”  The Court’s decision hinged on the lack of any evidence pertaining to the actual billing process employed by Liberty.  In fact, the affidavit of the person who claimed the most familiarity with that process, did not claim to have witnessed the submission to the government of any actual false claims.

Although the dismissal was without prejudice to the government amending the complaint to provide greater particularity, the decision is an important example for providers facing False Claims Act claims of how the heightened pleading requirements under FRCP 8 and 9 may strengthen their defense.

 

Final AKS and Stark Waivers in Connection With the Shared Savings Program

The Centers for Medicare and Medicaid Services (CMS) and Office of Inspector General (OIG) issued the final rule regarding waivers of the application of the physician self-referral law, the Federal anti-kickback statute, and the civil monetary penalties (CMP) law provision relating to beneficiary inducements to specified arrangements involving accountable care organizations (ACOs) under section 1899 of the Social Security Act (the Act) (the “Shared Savings Program”). For purposes of the Shared Savings Program, providers must integrate in ways that potentially implicate fraud and abuse laws addressing financial arrangements between sources of Federal health care program referrals and those seeking such referrals. The Shared Savings Program focuses on coordinating care between and among providers, including those who are potential referral sources for one another—potentially in violation of the fraud and abuse laws.

In order to provide flexibility for ACOs and their constituent parts, the following five waivers have been created:

  • ACO pre-participation waiver – waives the physician self-referral law and the Federal anti-kickback statute that applies to ACO-related start-up arrangements in anticipation of participating in the Shared Savings Program, subject to certain limitations, including limits on the duration of the waiver and the types of parties covered.
  • ACO participation waiver – waives the physician self-referral law and the Federal anti-kickback statute that applies broadly to ACO-related arrangements during the term of the ACO’s participation agreement under the Shared Savings Program and for a specified time thereafter.
  • Shared savings distributions waiver – waives the physician self-referral law and the Federal anti-kickback statute that applies to distributions and uses of shared savings payments earned under the Shared Savings Program.
  • Compliance with the physician self-referral law waiver – waives the Federal anti-kickback statute for ACO arrangements that implicate the physician self-referral law and satisfy the requirements of an existing exception.
  • Patient incentive waiver – waives the Beneficiary Inducements CMP and the Federal anti-kickback statute for medically related incentives offered by ACOs, ACO participants, or ACO providers/suppliers under the Shared Savings Program to beneficiaries to encourage preventive care and compliance with treatment regimes.

The waivers apply uniformly to each ACO, ACO participant, and ACO provider/supplier participating in the Shared Savings Program. The waivers are self-implementing; parties need not apply for a waiver. Rather, parties that meet the applicable waiver conditions are covered by the waiver.

Recent Trends In FCA Litigation Against Hospice Care Providers

The Office of Inspector General identified “reducing waste in . . . hospice care” as one of the “top management challenges” for the 2015 fiscal year.   The federal government’s efforts to respond to that challenge are illustrated by several recent developments in False Claims Act (“FCA“) cases brought against hospice care providers.  For example, the Robinson-Hill, Betts, and Gooch cases discussed herein underscore the attention given to hospice care providers and their alleged billing and personnel-related practices, and the high monetary settlements that can result from such attention.

Continue reading “Recent Trends In FCA Litigation Against Hospice Care Providers”

False Claims and Anti-Kickback Defendants Should Insist on Discovery from the Whistleblower/Relator

One arrow in the quiver for healthcare providers sued for violations of false claims and anti-kickback statutes is pressing for discovery from the whistleblower/relator, including a deposition of the relator.  The failure of the whistleblower to comply with the discovery obligations could result in meaningful sanctions, including dismissal.

In Guthrie v. A Plus Home Health Care, Inc. et al, 0:12-cv-60629-WPD (S.D. FL), the relator, William Guthrie, sued a home health care provider, its seven doctors, and their spouses, alleging that the doctors and their spouses implemented a fraudulent scheme of compensation and referral payments resulting in violations of the False Claims Act, the Stark Act, and the federal Anti-Kickback Statute. Continue reading “False Claims and Anti-Kickback Defendants Should Insist on Discovery from the Whistleblower/Relator”

7th Circuit Clarifies FCA Fraud Standard

In an opinion openly skeptical of a relator’s knowledge, the 7th Circuit Court of Appeals recently affirmed the dismissal of False Claims Act claims against a Chicago pharmacy brought by a former employee of the pharmacy.  The principal claims in the case, Grenadyor v. Ukrainian Village Pharmacy, Inc., were that the pharmacy’s practice of soliciting and keeping its base of mostly Ukrainian customers by providing gifts of caviar and Russian language TV Guides, as well as waiving co-pays, amounted to kickbacks in violation of the federal (and several state) anti-kickback statutes.

Judge Richard A. Posner, the author of the court’s opinion, revealed his distaste for the relator early in the opinion by describing him as a “bounty hunter”.  The court rejected most of the relator’s claims because he had failed to identify a single patient who received gift bags worth more than the de minimis $50, even though the relator had amended his complaint ostensibly to correct this deficiency, and had not alleged that the pharmacy intended to offer kickbacks when it certified to the government that it would abide by Medicare and other federal laws. Continue reading “7th Circuit Clarifies FCA Fraud Standard”

A Summary of Medicare Shared Savings Program and ACO Proposed Regulations

On March 30, 2011, the Centers for Medicare and Medicaid issued the long-awaited, proposed regulations for the Medicare Shared Savings Program, including details of the requirements for qualifying as an accountable care organization (ACO), such as:

  • Eligible legal entities
  • Criteria for shared governance
  • Assignment of beneficiaries to ACOs
  • Different types of risk contracts
  • Benchmarks and calculations of savings
  • Shared savings, antitrust issues and policies, Medicare anti-kickback, and other regulatory requirements as applied to ACOs

The full text of the summary is available as a Duane Morris Alert.

© 2009- Duane Morris LLP. Duane Morris is a registered service mark of Duane Morris LLP.

The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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