Healthcare & Life Sciences, USA, Sidley Austin LLP updates

Ninth Circuit invited to weigh in on public disclosure bar falsity
Sidley Austin LLP
  • USA
  • 20 November 2019

A US District Court for the Central District of California judge recently granted a stay and certified two questions for interlocutory appeal in a relator's False Claims Act suit. The case involved allegations that one of the defendants had perpetrated an upcoding scheme whereby it trained its doctors to describe medical conditions with language that would support increasing the severity levels of diagnosis-related groups that the defendant reported to Medicare, leading to inflated Medicare reimbursements.

DOJ defends Medicare Advantage upcoding claims against Sutter
Sidley Austin LLP
  • USA
  • 09 October 2019

The US government recently filed a brief in opposition to Sutter Health's motion to dismiss the Department of Justice's (DOJ's) complaint in intervention in a False Claims Act suit alleging that Sutter had knowingly submitted and caused the submission of unsupported diagnosis codes for Medicare Advantage organisation patients in order to inflate Medicare reimbursement. The brief reinforces the DOJ's increasingly aggressive enforcement of the Medicare Advantage space under the False Claims Act.

Government will allow broader use of co-pay accumulator programmes for 2020
Sidley Austin LLP
  • USA
  • 18 September 2019

The Department of Health and Human Services (HHS), the Department of Labour and the Treasury have jointly announced that they will not enforce the HHS's recently finalised policy that limits private health plans' use of accumulator programmes to prescription brand drugs for which a medically appropriate generic equivalent is available. Stakeholders should remain alert to any changes in state enforcement policies and consider opportunities to engage with the administration on future revisions.

Medicare Advantage providers pay $5 million to settle False Claims Act allegations
Sidley Austin LLP
  • USA
  • 11 September 2019

Beaver Medical Group LP and an affiliated physician recently agreed to pay a combined total of $5 million to resolve allegations that providers had knowingly submitted diagnosis codes that were not supported by medical records in order to inflate reimbursements from Medicare. The settlement reflects the Department of Justice's continuing efforts to use its enforcement power to pursue fraud in the Medicare Advantage space despite recent setbacks.

Sutter Health files motion to dismiss, criticising DOJ's outdated False Claims Act theories in Medicare Advantage case
Sidley Austin LLP
  • USA
  • 24 July 2019

Sutter Health recently filed a motion to dismiss the Department of Justice's (DOJ's) complaint in intervention in a False Claims Act suit which alleged that Sutter had knowingly submitted and caused the submission of unsupported diagnoses codes for Medicare Advantage patients in order to inflate Medicare reimbursements. Sutter's motion reflects the industry's continued resistance to the DOJ's enforcement under the False Claims Act on the basis of potentially unsupported diagnoses codes for Medicare Advantage beneficiaries, without more evidence.

Lethal injection opinion from DOJ OLC threatens FDA's claims-based interpretation of 'intended use'
Sidley Austin LLP
  • USA
  • 10 July 2019

In a recent opinion, the Office of Legal Counsel (OLC) in the US Department of Justice concluded that an article intended to effectuate capital punishment by a state or the federal government is not subject to regulation by the Food and Drug Administration (FDA) under the Federal Food, Drug and Cosmetic Act. The OLC's opinion appears to have been issued as a result of litigation involving the FDA's obligation to block the entry of misbranded and unapproved drugs used under state lethal injection protocols.

Rule 9(b)'s particularity requirement and constitutionality of False Claims Act qui tam provisions
Sidley Austin LLP
  • USA
  • 22 May 2019

In a recent decision, the Tenth Circuit reversed a district court's dismissal of qui tam claims, reasoning that the relator's allegations had satisfied Rule 9(b) of the Federal Rules of Civil Procedure. Among other things, the defendant contended that the court's intervention is necessary to resolve a deep circuit split on whether Rule 9(b)'s particularity requirement can be relaxed where a defendant exclusively holds the information necessary to state a claim.

Supreme Court appears poised to extend False Claims Act statute of limitations
Sidley Austin LLP
  • USA
  • 01 May 2019

The Supreme Court recently heard an oral argument in a case that appears likely to resolve a circuit split on a question of critical importance: in non-intervened False Claims Act cases, are relators entitled to invoke the act's alternative 10-year statute of limitations? Clarification of the circuit split on the availability of the 10-year statute of limitations will have a significant impact on False Claims Act cases throughout the United States.

Third Circuit finds individual ownership interest in corporation not required for False Claims Act liability
Sidley Austin LLP
  • USA
  • 24 April 2019

The Third Circuit recently affirmed and vacated in part a district court ruling granting the United States' motion for summary judgment. The case raised, among other things, the issue of whether an individual without any ownership interests in a company can face False Claims Act liability for the company's failure to perform a required act to qualify for reimbursement and whether an unsworn statement is sufficient to create a material issue of fact when weighed against facts admitted during a plea colloquy.

DOJ files complaint in intervention in Medicare Advantage case against Sutter Health
Sidley Austin LLP
  • USA
  • 17 April 2019

The Department of Justice recently filed a complaint in intervention against Sutter Health and its affiliate Palo Alto Medical Foundation (PAMF) in a False Claims Act suit, alleging that the defendants had knowingly submitted and caused the submission of unsupported diagnosis codes for Medicare Advantage patients in order to increase reimbursements from Medicare. Among other things, Sutter and PAMF allegedly failed to provide any meaningful training to affiliated physicians.

Court dismisses DOJ's complaint against pharmacy and private equity fund but permits re-pleading
Sidley Austin LLP
  • USA
  • 10 April 2019

The Department of Justice (DOJ) is pursuing a compounding pharmacy and its private equity fund owner, alleging that the pharmacy filed claims with Tricare that were rendered false by alleged kickbacks. However, a magistrate judge has filed an opinion recommending that the False Claims Act claims be dismissed due to the DOJ's failure to adequately plead its claims on either an implied or express certification theory of liability.

Eighth Circuit tightens False Claims Act pleading requirements
Sidley Austin LLP
  • USA
  • 20 March 2019

A recent US Court of Appeals for the Eighth Circuit decision follows a growing trend among courts in tightening False Claims Act pleading requirements. The court affirmed the dismissal of a qui tam action brought against a non-profit hospital because the relators had failed to meet the particularity standard set out under Rule 9(b) of the Federal Rules of Civil Procedure.

DOJ announces more than $2.5 billion in FY 2018 False Claims Act recoveries from healthcare industry
Sidley Austin LLP
  • USA
  • 20 February 2019

The Department of Justice (DOJ) recently announced that it had recovered more than $2.8 billion from False Claims Act (FCA) cases in the 2018 fiscal year. Although this number continues a multi-year downtrend in overall FCA recoveries, healthcare fraud remains a major DOJ focus. Of the $2.8 billion, $2.5 billion was extracted from various segments of the healthcare industry, including through major settlements with pharmaceutical and medical device manufacturers.

Preliminary considerations for healthcare industry for 116th Congress
Sidley Austin LLP
  • USA
  • 13 February 2019

Health policy issues are high on the agenda of the new Congress. The stated priorities for the new House majority include reducing drug prices, defending the Affordable Care Act, addressing the opioid abuse crisis and investigating the pharmaceutical industry. Given the potential for at least some bipartisan cooperation on each of these priorities, stakeholders in the healthcare industry should be prepared for legislative and regulatory opportunities and challenges.

Flexing its Granston muscle: DOJ seeks dismissal of patient support services in False Claims Act litigation
Sidley Austin LLP
  • USA
  • 06 February 2019

The Department of Justice (DOJ) recently stepped in to seek the dismissal of high-profile False Claims Act litigation being pursued by relators after the government initially declined to intervene. The DOJ's recent action, which pertains to approximately a dozen lawsuits involving pharmaceutical manufacturers and third-party service providers, is further evidence that the Granston Memo, in which the DOJ articulated clearer standards for seeking dismissal of non-intervened cases, has real teeth.

DOJ intervenes in Medicare Advantage False Claims Act suit against provider
Sidley Austin LLP
  • USA
  • 30 January 2019

The Department of Justice (DOJ) recently announced that it had intervened in a False Claims Act suit against Sutter Health and its affiliate Palo Alto Medical Foundation. This intervention is the latest example of the DOJ's aggressive enforcement under the False Claims Act in the Medicare Advantage space.

Court provides insight into when funds may be held responsible for portfolio company conduct
Sidley Austin LLP
  • USA
  • 19 December 2018

The government has intervened in a qui tam suit against a compounding pharmacy and its private equity fund owner in which it is alleged that the pharmacy filed claims with Tricare that were rendered false by kickbacks. The opinion provides further guidance as to the circumstances under which a private equity fund investor may incur False Claims Act liability as a result of its active involvement in a portfolio healthcare company that submits allegedly false claims.

District court invalidates relators' pre-filing releases on public policy grounds
Sidley Austin LLP
  • USA
  • 21 November 2018

Former Bayada Home Health Care employees recently alleged that the company had falsely billed Medicare for patients that it had known were not "homebound". Bayada moved to dismiss the suit on the ground that each employee had signed a separation agreement releasing Bayada from "any and all claims" prior to filing the False Claims Act lawsuit. With no binding Third Circuit precedent, the district court looked for guidance among other circuits that pre-filing releases can bar False Claims Act claims.

Private equity funds face increasing risk of False Claims Act liability
Sidley Austin LLP
  • USA
  • 14 November 2018

Evidence is mounting that the Department of Justice (DOJ) is willing to pursue private equity funds in False Claims Act cases, particularly ones based on alleged violations of healthcare fraud and abuse laws. Earlier in 2018, the DOJ intervened for the first time in one such False Claims Act case against a private equity sponsor, the fund's portfolio pharmacy and two pharmacy employees.

Court vacates Medicare Advantage overpayment rule and curtails DOJ's pursuit of False Claims Act damages
Sidley Austin LLP
  • USA
  • 03 October 2018

The US District Court for the District of Columbia recently vacated CMS's 2014 final overpayment rule, applicable to the Medicare Advantage programme, granting summary judgment to UnitedHealthcare that the final rule violated the Medicare statute, was inconsistent with the Affordable Care Act and the False Claims Act and violated the Administrative Procedures Act. Because the decision vacates the overpayment rule entirely, further rulemaking may be necessary.

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