Health Administrative Agency

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OIG Approves Lease of Employees to Psych Hospital

On July 28 the Office of Inspector General (OIG) of Health & Human Services gave its blessing to a health system’s lease of employees to a related psychiatric system. Under the arrangement the system would also provide...more

Affirming the Need to Fix the Medicare Appeals Backlog: The AFIRM Act of 2015

If you are one of the many health care providers wanting to appeal a Medicare contractor’s reimbursement decision, you may need to be prepared for a long wait. Over the last few years, the backlog of appeals to the...more

FDA Investigates Children’s Cough and Cold Medication With Codeine Amid Safety Concerns

In the wake of the European Medicines Agency’s (EMA) recently announced warning against giving codeine to children under 12 years old, the FDA announced its own safety investigation of the drug for use in children. The FDA’s...more

Federal Circuit Confirms Both New Biosimilar Bring-to-Market Procedural Option and Additional Six-Month Exclusivity Period for...

On July 21, 2015, brand-name biologics companies and companies developing biosimilars received a split in a significant decision with industry-wide ramifications in the high-stakes battle about how and when biosimilar...more

Stark Litigation: The Tuomey Saga Draws to a Close

In what may be the penultimate chapter of the long–running saga of the Tuomey case, the Fourth Circuit affirmed the final judgment and award in favor of the government in its case against Tuomey Healthcare System, Inc....more

Federal Circuit Delays Sandoz Biosimilar Launch

In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz's...more

FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial

The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company...more

FDA Issues Final Guidance on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements

On July 1, 2015 the FDA issued its final guidance regarding the intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved...more

Connecticut General Assembly Enacts Reforms To Medicaid Audit Statute

For many years, Medicaid providers have vigorously protested the Connecticut Department of Social Services' (DSS's) audit process and methodology, which many believe to be unfair and unnecessarily punitive. As a result, in...more

OSHA Targets Workplace Violence

For decades, acts of workplace violence were viewed as being limited to altercations between employees and "active shooter" situations involving a disgruntled employee or former employee. Generally speaking, those incidents...more

House Passes 21st Century Cures Act

On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research. The central aim of H.R. 6, the “21st...more

EPA Gets Closer To Issuing Final Rule On Revisions To Minimum Risk Exemption For Pesticides

On June 24, 2015, the U.S. Environmental Protection Agency (EPA) issued a notification that the EPA Administrator has forwarded to the Secretary of the United States Department of Agriculture (USDA) and the Secretary of the...more

Think Twice about DEA Voluntary Surrender

It can be an intimidating experience to be sure… A DEA agent or Diversion Investigator, on an unscheduled visit to your office, confronts you with a KASPER, a KBML complaint or some other state regulatory action and alleges...more

Blog: JAMA: Study Shows “Significant Positive Progress” in Managing Conflicts of Interest Among IRB Members, But More Work Needed

JAMA Internal Medicine published a report this week titled, Industry Relationships Among Academic Institutional Review Board Members: Changes From 2005 Through 2014, which is an update to a similar study conducted in 2005....more

Privacy and Security Guidance: Cloud Computing in the MUSH Sector

I. Purpose of this Guidance Document and How to Apply - This document is intended to be used by decision makers in the MUSH Sector when considering using cloud services....more

Final Drug Shortage Reporting Rules Will Go Into Effect September 2015

Earlier this week, FDA issued its final rule implementing statutory requirements for drug manufacturers to report the permanent discontinuation or temporary interruption in the manufacturing of certain drugs and biological...more

Judge Affirms OSHA Citation in Death of Healthcare Worker Killed by Mentally Ill Client

An Occupational Safety and Health Review Commission Administrative Law Judge has determined that a healthcare provider company did not protect a social service coordinator, who was fatally stabbed outside her client’s home in...more

The Compounding Regulations Surrounding Drug Compounding

Drug compounding as a practice has, until recently, been met with far looser regulation than the manufacture of drugs. This practice serves to meet the needs of individuals who require certain formulations not available in...more

Health Law Wire: OMIG Standards for PRI Audits Held Arbitrary and Capricious (7/15)

The Office of the Medicaid Inspector General (OMIG) was recently given a set-back in its on-going audits of nursing home case mix submissions. These audits focus on “Patient Review Instruments” (PRIs) which form the basis of...more

Blog: OIG Announces New Special Litigation Team

The Office of Inspector General (OIG) announced this week that it will launch a special litigation team devoted solely to Civil Money Penalty (CMP) and Exclusion cases. The announcement was made by representatives of the...more

OIG Announces New Penalty and Exclusion Litigation Team to ‘Level the Playing Field’

The federal government’s health care fraud enforcement efforts expanded this week with an announcement by the Office of the Inspector General (OIG), of the U.S. Department of Health and Human Services, that it has created a...more

FDA Provides 11th Hour Delay of Product Tracing Requirements for Pharmacies

On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until...more

Executive Labor Summary - June / July 2015

What are the labor implications of Supreme Court’s decision in King v. Burwell? - On June 25, the U.S. Supreme Court upheld the Affordable Care Act (also known as “Obamacare”) in a 6-3 decision written by Chief...more

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

CMS Pays $1.3 Billion to Hospitals for Settlements of Medicare Inpatient Appeals

On June 11, 2015, CMS announced that it had entered into settlements with over 1,900 hospitals for over 300,000 disputed inpatient billing claims. CMS updated its website dedicated to inpatient hospital reviews, noting that...more

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