Policy & Medicine

Johnson & Johnson Still Dealing with Risperdal Lawsuits

Thomas Sullivan Nov 22, 2019 0

In early October, a Philadelphia jury awarded Nicholas Murray $8 billion in punitive damages over claims that Johnson & Johnson and its subsidiary Janssen failed to warn young men using Risperdal that they could grow breasts. This case follows a 2013 agreement by the company to pay $2.2 billion to resolve civil and criminal probes into…

When Money and Doritos Don’t Suffice – The…

Thomas Sullivan Oct 12, 2019 0

The Chaos Over Drug Compounding Continues As Judge Throws…

Thomas Sullivan Sep 17, 2019 0

Johnson & Johnson Still Dealing with Risperdal Lawsuits

In early October, a Philadelphia jury awarded Nicholas Murray $8 billion in punitive damages over claims that Johnson & Johnson and its subsidiary Janssen failed to warn young men using Risperdal…

DEA Amends Regulations Applicable to Registrants Ordering…

Last month, the Drug Enforcement Administration (DEA) published a notice in the Federal Register that it is amending its regulations and issuing a final rule to implement a new single-sheet format for…

POD Kickbacks Land Entire Medical System in Hot Water

In late October 2019, the Department of Justice (“DOJ”) announced a settlement with Sanford Health, Sanford Medical Center, and Sanford Clinic (collectively, “Sanford”) in which the government alleged…

Health Coverage Transparency Proposed Rule Would Require…

On November 15, 2019, the Centers for Medicare and Medicaid Services (“CMS”) published a proposed rule entitled the Transparency in Coverage Proposed Rule, which would require health plans to disclose…

Trump Administration Releases Hospital Price Transparency Final…

After a brief delay, the Trump administration published the Hospital Outpatient Prospective Payment System (“OPPS”) Price Transparency final rule, which will take effect on January 1, 2021. The final…

FDA Issues Draft Guidance on Patient Engagement in Medical…

The US Food and Drug Administration (“FDA”) recently published a draft guidance, entitled Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations: Draft Guidance,…

Analysis of Hospital Chargemasters Shows Hospitals Have Room for…

As part of its cost transparency initiative, the Centers for Medicare and Medicaid Services (”CMS”) issued a final rule in 2018 requiring hospitals to publish price lists, referred to as…

Numerous State Laws and Pending Bills Intended to Address Rising…

While the federal government continues to debate various policies for lowering prescription drug prices, many states have already enacted laws to do just that. According to a report by the National…

FDA Issues Four Final Guidances on 510(k) Medical Device…

The US Food and Drug Administration (“FDA”) recently issued four final guidance documents related to 510(k) medical device programs. The guidance documents relate to the Special 510(k) and Abbreviated…

Step Therapy: Is it Really More Cost Effective?

Step therapy, the requirement that more cost effective/inexpensive drugs and therapies must be prescribed for a patient before a more expensive/less cost-effective drug or therapy will be reimbursed,…

HHS Secretary Alex Azar Addresses Changes to Kidney Care…

On Thursday, November 7, 2019, Health and Human Services (HHS) Secretary Alex Azar spoke at the American Society of Nephrology Kidney Week. Secretary Azar spoke about American kidney health and the…

Physicians Disagree with Judge Who Struck Down Site-Neutral…

In September 2019, District of Columbia Federal Judge Rosemary Collyer issued a court ruling that struck down the Trump Administration’s rule instituting site-neutral payments. Judge Collyer opined…