Health Law Litigation

Practice Points

What you need to know in a quick-to-read format. Find all of the Health Law Litigation Committee’s practice points in this archive.

2017

Voices of Recovery Podcast Series
By ABA CoLAP – November 10, 2017
The ABA Commission on Lawyer Assistance Programs debuted the first of a series of podcasts that will address substance use disorders, mental health issues, addiction, and recovery issues. Episode 1 features attorney Laurie Besden, the Executive Director of Lawyers Concerned for Lawyers of Pennsylvania, who shares her battles with alcohol and drug addiction.

Federal Judge Finds Attorney Conduct Not “Egregious” in Bayer Suit
By Eric W. Shannon – January 13, 2017
The attorney had accused plaintiffs’ counsel of “attempting to malign” him and trying to unnecessarily burden the deponent with an additional deposition.

2016

House Passes 21st Century Cures Act
By J. Nicole Martin and Chris Raphaely – December 6, 2016
Notably, the bill seeks to improve upon the federal regulatory structure regarding FDA approval and expediting the development of new drugs.

FDA Rolls Out Site for Medical Device Violation Reporting
By Eric W. Shannon – October 27, 2016
The Center for Devices and Radiological Health will review any allegations and decide if investigation and further enforcement action is warranted.

CMS Issues Final Rule Impacting Long-Term-Care Facilities
By J. Nicole Martin and Dana Petrillo – October 18, 2016
Nursing homes may no longer require prospective nursing-home residents to agree to binding arbitration, much to the satisfaction of elder-care advocates.

CMS Provides Physician Feedback Regarding MACRA
By J. Nicole Martin – September 13, 2016
CMS will allow physicians to select their level of participation for the first performance year of MACRA Quality Payment Program.

HHS OIG Issues New Criteria for Exclusion from Federal Programs
By Eric W. Shannon – April 22, 2016
Per the updated criteria, the OIG "evaluates healthcare fraud cases on a continuum," based on how likely a provider is to commit fraud again and the impact on patients.

FDA Approves Second-Ever Biosimilar
By Eric W. Shannon – April 8, 2016
Celltrion's Inflectra is a copy of Janssen Biotech's Remicade.

Medicare Proposes Mandatory Participation in Part B Drug Payment Model
By Kara Cardinale – March 25, 2016
A proposed rule published by CMMI would require all physicians, outpatient hospitals, and suppliers nationwide to participate in a payment-model demonstration covering all Part B drugs.

Office of Civil Rights Announces Two Significant HIPAA Breach Settlements
By Gregory M. Fliszar and J. Nicole Martin – March 21, 2016
Both cases resulted from the all-too-familiar scenario of breaches resulting from stolen, unencrypted laptops.

Hepatitis C Risk Adjuster Maintained for 2017 in Medicare Part D
By Kara Cardinale – February 23, 2016
Maintaining the current hepatitis C reimbursement policy in 2017 represents a short-term “win” for the brand biopharmaceutical industry

Hospital Argues That Texas Court Lacked Jurisdiction in Ebola Nurse's Case
By Eric W. Shannon – January 7, 2016
Texas Health Resources claims that the suit should be moved from the state court to the state workers’ comp division.

Aetna Kickback Suit Against Laboratory Marketing Company Allowed to Proceed
By Andrew A. Kasper – January 6, 2016
The Eastern District of Pennsylvania held that the action may proceed, even though Bluewave did not submit false or fraudulent claims to Aetna.

2015

Allergan, NY State End Antitrust Fight over Alzheimer's Drug Switching
By Eric W. Shannon – December 3, 2015
The suit triggered debate over the controversial practice known as “forced switching” or “product hopping.”

Medicare Part B Reimbursement for Biosimilars Could Change
By Kara Cardinale – November 18, 2015
The market will evolves based on the 2016 Physician Fee Schedule final rule.

Hospitals Will Pay Government $250 Million for Cardiac Device Coverage Violations
By Eric W. Shannon – November 3, 2015
Hundreds of hospitals and others were defendants in a federal whistleblower suit brought under the federal False Claims Act.

$256 Million FCA Settlement May Force Lab Company into Bankruptcy
By Andrew A. Kasper – October 23, 2015
According to the DOJ Millennium Health induced physicians to order medically unnecessary urine and genetic tests without making any assessment of individualized needs for such tests.

OIG Issues Alert on Data Arrangements and AKS Safe Harbor Exception
By Eric W. Shannon – October 16, 2015
“Blunt message from the OIG: follow the EHR safe harbor closely, and beware if you are using EHR donated technology to block information from competitors.”

HRSA Proposes Relatively Broad Eligibility Criteria in Drug-Pricing Program
By Kara Kasper Cardinale – September 25, 2015
The Health Resources and Services Administration’s authority to issue interpretive guidance regarding the 340B program is the subject of ongoing litigation.

DOJ Reaches $115 Million Settlement with Adventist
By Andrew A. Kasper – September 24, 2015
Adventist Health System agreed to pay the federal government to resolve potential FCA liability primarily related to allegedly improper compensation arrangements with its employed physicians.

FDA Dramatically Reduces Counterfeit Drug Alert Forecast
By Eric W. Shannon – September 16, 2015
The FDA initially predicted that regulated entities under the law would issue 5,000 such alerts per year; it now estimates that they will issue 1,000.

Mergers Should Be Presumed Likely To Enhance Market Power, AMA Says
By Andrew A. Kasper – September 11, 2015
The AMA concluded that the proposed mergers between Anthem and Cigna as well as Aetna and Humana would impermissibly enhance the combined entities’ market power for purposes of federal antitrust review.

UCLA Not Responsible in Medical Data Breach Suit
By Eric W. Shannon – September 4, 2015
The jury felt the blame lay with a physician affiliated with the school and a former employee who borrowed his credentials.

SCOTUS Upholds Tax Subsidies for Healthcare.gov Consumers
By Sarah Anna Santos – June 25, 2015
The Court ruled in King v. Burwell that tax credits are available to consumers shopping on the Affordable Care Act’s federal marketplace, not just those shopping on state exchanges.

Should Home-Care Providers Be Exempt from FLSA Wage Requirements?
By Samantha France – May 15, 2015
The D.C. Circuit will soon decide.

FTC and DOJ under Fire for "Anti-Hospital" Bias at Conference
By Sarah Anna Santos – March 25, 2015
The American Hospital Association and other trade groups condemned a recent workshop’s “lack of objectivity and balance” and “overwhelming anti-hospital points of view.”

Doctors and Terminal Patients Sue over NY Assisted-Suicide Law
By Sarah Anna Santos – February 4, 2015
The complaint alleges that evolving medical standards and public views support aid-in-dying.

CMS Administrator to Resign
By Sarah Anna Santos – January 16, 2015
The resignation comes only days before the Supreme Court hears the critical Affordable Care Act (ACA) tax-subsidy case, King v. Burwell.

OIG Reveals Heightened Risk of Fraud in Assisted Living Hospice Care
By Sarah Anna Santos – January 15, 2015
The report comes as a resource to help the CMS reform the hospice payment system as required by the Affordable Care Act.

DOJ Intervenes in Whistleblower Suits Accusing Omnicare of Kickbacks
By Sarah Anna Santos – January 5, 2015
The company is the nation’s largest provider of pharmacy services to nursing homes.