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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

Regulatory Capture Vitiates State Action Immunity

The Supreme Court has ruled that when an oversight mechanism created by a State —here a State Board — is under the control of those it was supposed to be regulating (sometimes referred to by economists as “regulatory...more

How Does the King v. Burwell Decision Affect the Affordable Care Act?

The Supreme Court handed the Obama administration a key victory this morning, upholding the tax credits that allow many low-income Americans to purchase health care insurance in states where the federal government is running...more

FDA Approves St. Jude Medical’s Upgradeable, MRI-Compatable Spinal Cord Stimulation System

St. Jude Medical, Inc., a global medical device manufacturer, announced that it has received FDA approval of the company’s Protégé MRI™ spinal cord stimulation (SCS) system, along with approval for related percutaneous leads,...more

Beyond Ebola: Environmental Regulatory Issues Creating Business Risks for Health Care Providers

Business and legal risks to health care companies reach far beyond scientific uncertainties in the prevention protocols for infectious diseases due to lack of clarity among regulators with public health...more

Health Law Wire: Court Invalidates DOH Retroactive Clinic Rate Changes (6/15)

The Appellate Division Fourth Department recently invalidated DOH’s attempts to retroactively revise Diagnostic & Treatment Center (D&TC) rates and upheld statutory requirements for 30 day advance notice of capital rate...more

Healthcare.gov Too Big to Fail: Supreme Court Once Again Upholds the Administration on ACA Challenge

Today's surprising decision from the Supreme Court accepted the government's argument: that a technical glitch cannot be allowed to undermine the fundamental purposes of the law, so the statute must be interpreted to provide...more

HHS Removes Extra Hurdle for Marijuana Research

The process for studying the potential medical benefits of marijuana became more streamlined on Tuesday, when the U.S. Department of Health and Human Services eliminated a controversial requirement for Public Health Service...more

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

NLRB Affirms Its Previous Decision Requiring Employer to Continue Providing Annual Wage Increases Beyond Contract Expiration

We previously blogged about the NLRB’s relatively shocking September 2012 decision in Finley Hospital (359 NLRB No. 9), in which the Board held that an employer was required to continue providing wage increases after the...more

Medical Device Update: FDA Issues Draft Guidance on Benefit-Risk Determinations for IDEs

The US Food and Drug Administration (FDA or the Agency) issued draft guidance on June 18 about assessing the benefits and risks for Investigational Device Exemption (IDE) applications. The draft guidance provides a...more

Pharmacy Benefit Manager Group Opposes 21st Century Cures Act’s Cost Offset

The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care...more

Government Announces Health Care Fraud “Takedown”

Earlier today, Attorney General Loretta Lynch announced the largest coordinated crackdown in the Medicare Fraud Strike Force’s eight-year history. The government brought charges against 243 individuals for approximately $712...more

An Unforgiving NLRB Holds That Protecting Patient Data Under HIPAA Can Still Violate Section 7 Rights

It would make sense that the systems housing patient records at a physician’s office should be protected by a robust duty on the part of the physician’s employees to keep such records confidential. The purpose, of course, is...more

The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling

On June 2, 2015, AbbVie submitted a citizen petition to the FDA arguing against its interim labeling requirements for biosimilar products under the Biologics Price Competition and Innovation Act (“BPCIA”). As of now, the FDA...more

Written Reasons in Administrative Decisions

Fashoranti v. College of Physicians and Surgeons of Nova Scotia, 2015 NSCA 25, dismissing an appeal from the disciplinary committee’s finding that a physician committed unprofessional conduct. A physician was charged...more

Senate Committee Passes Bill Addressing Medicare Appeals Inefficiencies

On June 3, 2015, the Senate Finance Committee passed an original bill that aims to streamline and improve the Medicare Audit and Appeals Process. The Medicare appeals process has recently faced scrutiny from industry leaders...more

Senate Finance Committee Approves Medicare Appeals Reform Proposal

On June 3, 2015, the Senate Finance Committee approved by voice vote a bipartisan proposal to reform the Medicare audit and appeals process in an attempt to help ease the backlog of Medicare appeals and promote efficiency and...more

Employing Excluded Individuals a Continuing Risk to Providers

Since June 1st, two different skilled nursing facilities in Texas have settled cases with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) involving the employment of individuals...more

New York Governor Andrew Cuomo names Anthony Albanese Acting Superintendent of Financial Services

Bloomberg reported last week that Anthony Albanese, Chief of Staff to Departing Superintendent Ben Lawsky, has been named to head the New York Department of Financial Services on an acting basis. He will lead the Department...more

Blog: General Wellness Products: Will the FDA Regulate Your Medical App or Device?

In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than...more

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