Last week, our own Brian Bewley chaired the HCCA Midwest Regional Conference in Overland Park, Kansas.  The conference addressed current compliance issues such as the compliance officer’s evolving role, RAC audits and appeals, and HIPAA.  The conference had a great turnout – in fact, the most attendees in the conference’s history.

Husch Blackwell’s Julianne Story

Pfizer, Inc. recently petitioned the Supreme Court, seeking review of three companion decisions from the First Circuit Court of Appeals.  These decisions found against Pfizer and in favor of multiple third-party payors (TPPs)—the Kaiser Foundation Health Plan, Inc. (an HMO), Aetna, Inc. (a health insurer), and a putative class of employer health plans—on civil Racketeer Influenced and Corrupt Organizations Act (RICO) claims for damages suffered due to Pfizer’s fraudulent marketing of off-label uses for the prescription drug Neurontin, an anti-convulsive approved for the treatment of epilepsy.  At the heart of the dispute is causation—the causal chain that runs from a drug manufacturer, such as Pfizer, to third-party payors of prescription drug benefits, such as HMOs, insurers and other health plans.

The First Circuit’s lead opinion—laying the common predicate necessary to understand each of the companion cases—came in the action brought against Pfizer by Kaiser, in which the court affirmed a $142 million jury award to the HMO.

The Development and Marketing of Neurontin

Neurontin was developed during the 1980s and early 1990s as an anti-epileptic drug.  In 1993, the Food and Drug Administration approved Neurontin for treatment of partial seizures in adults with epilepsy.  A campaign to market Neurontin for off-label conditions—conditions not included on the official label approved by the FDA—began in 1995.  These off-label conditions included neuropathic pain (pain from nerve damage), migraine headaches, and bipolar disorder.  Neurontin was marketed for treatment of these off-label conditions by way of, among other things:  (1) direct marketing to doctors, which misrepresented Neurontin’s effectiveness for off-label indications; (2) misleading information supplements and continuing medical education programs; and (3) articles published in medical journals that touted Neurontin’s off-label effectiveness but suppressed negative information about the drug. 

In response to healthcare reform, terms such as “physician alignment strategies” and “physician integration” have resurfaced in our vocabulary as healthcare providers.  In our new healthcare environment, many experts advocate that only hospitals that are aligned, or integrated, with their physician providers will be able to organize delivery systems that are capable of meeting current and future demands for efficiency, quality, price and services expected from patients and payers.  As the demands on health care providers continue to escalate, will experts also someday advocate that only hospitals that are aligned with other hospitals, or other health systems, be positioned to meet the then-current and future expectations related to providing high-quality and cost-efficient health care?

As the future of hospital and physician alignment strategies continue to evolve, more physicians, hospitals and health systems are affiliating.  Even large organizations such hospitals and health systems are teaming together to form loose associations in order to better manage the demands for efficiency, quality, price and service being thrust upon all providers by health reform, payers and patients.

There are a number of recent examples of health systems and hospitals forming strategic alignments to better manage healthcare costs and patient care. 

You have picked a strong trademark, had it searched and filed your intent to use application.  All went well and you have a trademark registration.  You have created your trademark usage manual. The marketing department has been advised to follow those guidelines and to use the ® symbol next to the mark in advertising.  You are doing everything right.

Is it time to just kick back and build brand equity?  No.

There are still a few additional issues you need to pay attention to.  One of these issues is maintenance of your trademark registration.  A trademark registration does not continue indefinitely.  It requires tending.

Declaration of Continued Use

A declaration of continued use (under § 8 of the Lanham Act) must be filed during the year preceding the 6th anniversary of the registration date. The declaration can also be filed within a 6 month grace period, upon payment of an additional fee.  It is also necessary to file a current specimen showing use of the mark.

Some employers may have rejoiced when IRS Notice 2013-45 delayed until 2015 the implementation of the employer shared-responsibility penalties mandated by the Patient Protection and Affordable Care Act (ACA). Certainly, this delay is a win for employers; however, other healthcare reforms will demand the attention of health plan sponsors before January 1, 2014.  Husch Blackwell

Pursuant to the Affordable Care Act, the Centers for Medicare and Medicaid Services recently adopted a final rule implementing $1.1 billion in cuts to the Medicaid disproportionate share hospital (DSH) program in 2014 and 2015.  The new rule reduces Medicaid DSH payments by $500 million in 2014 and $600 million in 2015. 

There are several

We have talked about why it is important to use your trademark consistently.  The easiest way to be sure that everyone in your organization knows the proper way to use the company’s trademarks is to create and distribute a trademark usage manual.  The trademark usage manual should also include easy to follow guidelines setting out that the mark is to be used as an adjective and not a noun. The usage manual does not need to be a complex or confusing document.  It should be a straightforward listing of the acceptable ways that the company’s trademark should be used.  For example:

1) Where color is an option the, Ô   logo is to be printed in “PANTONE® Classic Blue 19-4052 TPX.”  The wordmark FLOWER POWER is to be printed in “Pantone® Virtual Pink 18-1856 TPX.”

New rules by the Office of Federal Contract Compliance Programs (OFCCP) will require federal contractors and subcontractors to ask applicants and current employees whether they are individuals with disabilities.  These new rules are described in a recent alert by Husch Blackwell attorney Molly Kurt

While such an inquiry is otherwise prohibited by the Americans

In our companion post today, we are talking about the importance of using your trademarks in a consistent manner.  This consistency helps consumers know that when they see KalmKap,that it identifies a product coming from a single company and that they can trust that the quality is the same as the last time they bought the product. Consistent use helps to identify your mark as being owned by you. Another way to identify your marks as yours is to use the recognized trademark symbols and to make appropriate attribution statements somewhere within your ads.

Failure to use trademark symbols won’t result in a loss of trademark rights, but using these symbols will help place competitors on notice regarding what you believe you own and that you are serious about protecting and enforcing your valuable trademark rights.

The three symbols that can be used directly with the mark are ®, TM and SM.  If a trademark is registered with the United States Trademark Office, then you can use the ® symbol.  If the mark is not registered, then you should use the TM or SM symbols. The TM symbol can be used for any mark whether in use on goods and/or services.  SM may used for marks that are specifically used for services, rather than a product.

We have discussed the need to use your trademarks as adjectives (and not nouns or verbs) to avoid having them become descriptive or even generic terms. Today, we will talk about how you should be using your trademarks in a prominent and consistent manner.

Trademarks help consumers identify and distinguish your goods or services from those of your competitor. You should be using your marks in a way that builds “brand awareness” so that consumers will see your mark and immediately think of your company.  If the appearance of your trademark is different every time a consumer sees it, it will take longer to build up a good, strong association between the mark and your goods and services. And, with less distinctive marks, inconsistent use can undermine your rights completely.

Consistent use of a mark will help strengthen your rights in that mark as well as in any registrations that you may have. Consistency in use is particularly important with descriptive or highly suggestive marks and will assist in developing secondary meaning.