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Marginal Evidence of Customer Diversion Won’t Support a Price Discrimination Claim

In Cash & Henderson Drugs, Inc v. Johnson & Johnson, Case No. 12-4689 (2nd Cir. Aug. 27, 2015), the Second Circuit upheld a summary judgment in favor of defendant pharmaceutical manufacturers accused of price discrimination....more

Federal Trade Commission Guidance Addresses Stand-alone Claims of Unfair Competition Under Section 5 of the FTC Act

Section 5 of the FTC Act, in effect since 1914, authorizes the FTC to pursue claims of unfair competition beyond the reach of both the Sherman and Clayton Acts. 15 U.S.C. § 45(a)(1). Until now however, the FTC has been...more

Proposed Changes to Stark Rule Would Create New Hospital Exceptions and Lessen Burden of Self-Disclosures

In a development that is limited in scope but still welcomed by hospitals, the proposed 2016 Physician Fee Schedule proposes a number of new exceptions to the physician self-referral or Stark law and other refinements that...more

Corridors September 2015 - News for North Carolina Hospitals

This article will provide an outline of some of the most significant points for hospitals to use when confronted with a formal government investigation under the Criminal or Civil False Claims Act. As noted below, you should...more

The Health Law Guide to Hospital Operations

This operations guide provides a brief look at health law issues hospitals deal with on a daily basis. While a detailed coverage of the elements, drafting, implementation and continued governance of a hospital compliance...more

Mechanical Ventilation Innovation Challenge

According to press releases, the American Association for Respiratory Care (AARC) and Edison Nation Medical have partnered to search for innovations for improving the process, outcomes, and comfort for patients requiring...more

CMS Releases Data Regarding Hospital and Physician Utilization

CMS recently announced that it would be releasing Medicare hospital utilization and payment data, as well as physician and supplier utilization and payment data. This is the third year that the hospital data has been released...more

Massachusetts Proposes New Rules for Nursing Home Sales and Closures

Massachusetts regulators recently announced new rules that, if adopted, will change the requirements for nursing home sales and closures in the state. The proposed new rules require nursing home owners intending to sell a...more

Health Alert (Australia) - August 24, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: Victoria 17 August 2015 - Bourke v Coroners Court [2015] VSC...more

Continuity of Care and Provider Rights

When a health care service plan (“Plan”) or an Independent Practice Association (“IPA”) terminates its contract with a provider, enrollees have certain continuity of care rights which permit them to continue care and...more

Another FTC Conduct Case to Bolster Generic Drug Competition: Pharmaceuticals Charged with Illegal Non-Compete for Generic ADHD...

The Federal Trade Commission’s (“FTC” or “Commission”) ever-expanding list of enforcement actions to preserve competition for generic pharmaceuticals just grew in a new direction. This week, two generic pharmaceutical...more

IREG Update - August 2015 #2

Hot Topic: New York Emergency Medical Services and Surprise Bills Law - Earlier this year, New York’s Emergency Medical Services and Surprise Bills Law went into effect (the full text of the bill is available on the...more

Does the “No-Rehire” Provision in Your Settlement Agreement Restrain the Lawful Practice of a Profession?

When resolving an employment dispute, employers often wish to include a “no-rehire” provision in the settlement agreement. In a typical no-rehire clause, the parties agree that they wish to resolve their dispute and sever any...more

Waivers of Co-Pays and Deductibles: Insurance Benefit Exclusions Grow

Recent changes to policy and plan language and increased litigation by third-party payers suggests that out-of-network providers who waive co-pays and deductibles may be in for some rough sailing. Providers must be aware of...more

CMS Clarifies Written Agreement Requirement

CMS has acknowledged that arrangements among providers to satisfy the Stark exceptions need not be created in a single document. Although a single written document memorializing the key facts of an arrangement could provide...more

OIG Compliance Guidance for Health Care Governing Boards

On the front page of the Saturday New York Times (NYT) was an obituary for Edward Thomas, who joined the Houston Police Department (HPD) in 1948 and finally retired in 2011 at the age of 90. As reported in the article,...more

Orthofix Deferred Prosecution Agreement Extended for Two Months

In a recently-filed status report, the DOJ and medical device manufacturer Orthofix revealed that the company’s Deferred Prosecution Agreement (DPA) will be extended by two months. The DPA was due to expire on July 17, 2015,...more

CMS Proposes New Stark Exceptions: Timeshare Lease

In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions. Over the next few days, I will post comment on what I consider the most significant new...more

European Competition Law Newsletter – August 2015

Continuing an EU-wide trend, yet another trade association has been fined in the UK for cartel activities. This time it was a medical professionals’ association. The message is clear; trade associations of all types need to...more

DOJ Hires Compliance Counsel to Aid in Charging Decisions

In today’s robust enforcement climate, most companies have taken at least the first steps towards establishing a formal corporate compliance program. The mere existence of such a program, however, will not by itself protect a...more

The Top Six Things You Need to Know About the Internet of Things: A Legal Perspective

IoT is discussed in the media more and more frequently. It has important social, economic and legal implications, most of which are yet to be fully understood. The following sets out a brief list of things you should...more

The Clock’s Running Fast: SDNY Is First to Interpret “Identification” Under the FCA’s “60-Day Rule” for Government Overpayments

On August 3, 2015, in United States ex rel. Kane v. Healthfirst, Inc., et al., No. 1:11-cv-02325 (S.D.N.Y. Aug. 3, 2015), the United States District Court for the Southern District of New York issued the first reported...more

DOJ Appoints Compliance Counsel to Provide Advice in FCPA Investigations

The U.S. Department of Justice (DOJ) is creating a new compliance counsel position in the Criminal Division’s Fraud Section to scrutinize the compliance programs of companies under investigation for possible Foreign Corrupt...more

CON laws, COPAs and the FTC: 7 Antitrust Points For The Healthcare Sector

The Federal Trade Commission is on a roll in its attack on what it considers anti-competitive effects in the healthcare industry. And that roll has consistently involved challenging activity that once appeared to be protected...more

Mead Johnson: Baby Formula and Bribes

Last week, the SEC announced a settlement of an FCPA enforcement action for $12 million against Mead Johnson Nutrition for payment of bribes in China to health care professionals at state-owned hospitals. Mead Johnson’s...more

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