Latest updates

FDA's new guidance on emergency use authorisations for COVID-19 vaccines
Baker McKenzie
  • USA
  • 18 November 2020

The Food and Drug Administration (FDA) recently approved the antiviral drug Veklury (remdesivir) for hospitalised COVID-19 patients, making it the first drug to receive approval for the treatment of COVID-19. Before approving this drug, the FDA issued an emergency use authorisation for the use of Veklury in COVID-19 treatment.

Telehealth privacy issues due to COVID-19
Baker McKenzie
  • USA
  • 23 September 2020

The COVID-19 pandemic has led to a significant expansion in the need for telehealth, with as many patient visits as possible being conducted using telehealth platforms. As a result, healthcare providers must meet patient needs while at the same time meeting data protection regulatory requirements under the Health Insurance Portability and Accountability Act. This video discusses the recent changes to the telehealth sector and what healthcare providers need to do to ensure that they comply with data regulations.

FDA issues draft guidance on clinical research of cannabis and cannabis-related products
Baker McKenzie
  • USA
  • 05 August 2020

The US Food and Drug Administration recently issued its draft guidance on clinical research for the development of drugs that contain cannabis or cannabis-derived compounds of botanical origin (as opposed to synthetic). The guidance provides some clarity on the use of cannabis in clinical research in light of the changes made by the Agriculture Improvement Act 2018, which federally legalised hemp and derivatives that contain no more than 0.3% by dry weight of THC.

Compliance with medical product shortage reporting requirements during COVID-19 pandemic
Baker McKenzie
  • USA
  • 17 June 2020

The consequences of supply chain interruptions from a compliance perspective vary slightly, depending on the type of product and its indication. Human drug products and medical device products have different requirements for reporting supply chain disruptions and the impact of COVID-19 has cast a bright light on this inequity. Compliance with reporting requirements is therefore paramount during the ongoing pandemic.

Ninth Circuit invited to weigh in on public disclosure bar falsity
  • 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
  • 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
  • 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
  • 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
  • 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'
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.