June 2010  -  NAI PUBLISHED IN PM360 ON GROWTH STRATEGIES FOR HEALTHCARE

In a reform environment mandating "better care outcomes at lower cost", a new basis of competition for healthcare product manufacturers has emerged -- economic and clinical value (ECV). This change has profound implications for even the most successful companies, requiring a re-thinking of fundamental business models and go-to-market strategies. In their June 2010 article published in PM360 titled Reinventing Marketing to Reinvigorate Growth, authors Rita E. Numerof, Ph.D., President, and Bill Ott, M.B.A., Senior Consultant, explain the steps necessary for manufacturers to succeed under these circumstances.

Competing in this market will require a reinvention of marketing … traditional market practices will be increasingly ineffective and cost prohibitive. In this article, the authors describe the factors that have contributed to this difficulty, and identify three critical steps manufacturers must take to reinvent marketing and thrive in this environment.

June 2010  -  NAI PUBLISHED IN PHARMACEUTICAL COMMERCE ON FAIR MARKET VALUE FEES

Pharmaceutical and medical device companies' financial relationships with physicians are a large and growing focus of OIG and DOJ enforcement activity, which makes it more important than ever to ensure that these arrangements can withstand critical examination. In his article Defending Fair Market Value (FMV) Assessments published June 28, 2010 in Pharmaceutical Commerce author Stephen Rothenberg, Business Analyst, discusses the need for companies to go beyond developing basic fee schedules for hiring consultants.

Determining fair market value (FMV) fees is difficult, and little practical guidance is available. Finding a defensible way to value the specialized services physicians provide as speakers, advisory board members, clinical researchers, etc. is central -- but not the whole answer to the FMV challenge. Companies must also focus on consistency of practice across business and functional groups, ensuring transparency, and the broader framework for handling consultative relationships with providers. The author provides guidance on how to structure defensible fee determinations, and how to ensure that your broader FMV framework can stand up to the heightened scrutiny that is part of today's compliance environment.

April 2010  -  NAI PUBLISHED IN CORPORATE COMPLIANCE INSIGHTS ON ENSURING COMPLIANCE PROGRAM SUCCESS

For companies trying to read the enforcement ‘tea leaves’ of the OIG, recent settlements and corporate integrity agreements often provide insight. In their article Compliance, Commercial Risk, and Pfizer: Lessons Learned published April 20, 2010 by Corporate Compliance Insights, authors Stephen Rothenberg, Business Analyst, and Michael Abrams, Managing Partner, review the lessons to be drawn by compliance groups from Pfizer’s and other recent high-profile settlements

Commercial groups face some of the greatest challenges in dealing with today’s compliance environment and enforcement trends. Every aspect of industry relationships with physicians is under scrutiny, if not under investigation. Off-label marketing and industry financial relationships with physicians will continue to be the focus of many investigations. These trends indicate that the risk for companies will likely increase. Both the OIG and DOJ have indicated their intention to redouble their efforts by prosecuting individual employees and physicians to build cases against companies.

With the stakes growing ever higher, those responsible for compliance need to use every bit of intelligence they can to understand how to mitigate risk. Based on Pfizer’s and other recent settlement, the authors discuss the five key lessons to be drawn, and the steps companies must take to ensure success in an increasingly challenging regulatory environment.

April 2010  -  NAI PUBLISHED IN APPLIED CLINICAL TRIALS ON STRATEGIC USES OF SAFETY MONITORING DATA

Growing public concern about adverse consequences of FDA-approved drugs and devices has led to new regulatory focus on safety monitoring. Going forward, the FDA has made clear its intent to require more rigorous efforts in this realm. In their just-published article Using Compliance Data for Strategic Advantage, (appearing in this month’s issue of Applied Clinical Trials), authors Rita E. Numerof, Ph.D., President, Jill E. Sackman, D.V.M., Ph.D., Senior Consultant, and Stephen Rothenberg, J.D., Business Analyst describe how to turn this hurdle into a strategic opportunity.

Issues raised about a product by physicians and consumers are obviously critical to public health and compliance. The authors suggest, however, that most companies overlook the potential to use such data to enhance performance and mitigate risks of related and new products across their entire lifecycles. They discuss how safety data can be used proactively to contribute more broadly to the economic and clinical value of whole product lines, with the potential for creating significant competitive advantage.

MARCH 2010  -  NAI PUBLISHED IN MANAGED HEALTHCARE EXECUTIVE ON DISEASE STATE MODELING

Our healthcare system puts payers in a key position to drive change because they structure the financial incentives that shape provider behavior. In their recently published article, Comprehensive Disease State Modeling Adds Value which appeared in the March, 2010 issue of Managed Healthcare Executive, authors Michael Abrams, M.A., Managing Partner, and Mark Morgan, M.S.(R), Senior Business Analyst, examine how payers can use disease state modeling to advocate for greater cost effectiveness and differentiate themselves in the market place at the same time.

Disease state modeling is a tool in its infancy, but it offers a data-based method for capturing the impacts of treatment interventions and their costs in a way that facilitates dialogue about more effective care delivery. This opens up considerable potential for payers to offer greater value to customers at lower cost and gain a competitive edge in the process. This article explains why payers can -- and should -- add disease state modeling to their strategic arsenal.

MARCH 2010  -  NAI PUBLISHED IN TRUSTEE MAGAZINE ON NEW WAYS TO REDUCE COSTS

Multiple factors are rapidly converging to push the US health care delivery to the brink of insolvency, and even Congress is growing concerned about being at the wheel. Better care at lower cost is quickly becoming the mantra that guides policy makers in their implementation of healthcare reform legislation, and will need to become a higher priority for healthcare leaders. In their article Reducing Costs, recently published in the March 2010 issue of Trustee Magazine, authors Rita E. Numerof, Ph.D., President, Michael N. Abrams, M.A., Managing Partner, and Bill Ott, M.B.A., Senior Consultant, offer some fresh perspectives on this perennial challenge for healthcare delivery.

The formulaic approaches to cost reduction that have been so popular over the past decade like Six Sigma or lean have one thing in common: the assumption that providing common tools to all managers will yield improved outcomes. The reality is both simpler and more difficult. This article explains what's really needed to achieve outcomes like cost reduction (and longer term strategic goals, too) -- and how to get the most for what you're already spending.

March 2010  -  NAI PUBLISHED IN EYE FOR PHARMA ON NEW COMMERCIAL MODELS

As healthcare manufacturers struggle to adapt to the evolving requirements imposed by healthcare reform, one of the more broadly recognized needs is change to the industry’s commercial model. In their article How to Build a Post-Reform Commercial Model, published March 2, 2010 in Eye for Pharma, authors Michael Abrams, M.A., Managing Partner, and Bill Ott, M.B.A., Senior Consultant, discuss three disruptive strategies to sustain success in today’s rapidly changing marketplace.

Many pharma companies have undertaken initiatives to reconfigure their commercial organizations, with a particular emphasis on field sales. While these initiatives acknowledge the need for change, just downsizing field sales won’t address the underlying market dynamics. The authors discuss the fundamental assumptions that have changed, and describe the kind of transformative approach that is required for success.

March 2010  -  NAI INTRODUCES PHARMA INDUSTRY COLUMN IN PHARMA PHILOS

NAI announces the first of a series of monthly columns on the pharmaceutical industry written by Rita E. Numerof, Ph.D., President, and published by Pharma Philos starting April 15, 2010.

In her ongoing column, titled In the Eye of the Storm: Insights for an Industry in Transition, Rita will examine the multitude of critical issues the pharma industry currently faces, and offer insights and solutions based on her firm’s extensive industry consulting experience.

In becoming a regular contributor to Pharma Philos, Rita joins other innovative practitioners and editor Lisa Roner in their commitment to facilitating collaborative innovation across the industry. Pharma Philos provides thought leadership, news and analysis that pharma and its partners can use to drive increased value for a growing range of stakeholders.

March 2010  -  NAI PUBLISHED IN MARKETING MANAGEMENT ON GLOBAL BRANDING

The allure of the blockbuster global brand is irresistible -- but too often, plans for global dominance don’t work out, even when the company in question already has an established name. In their article Why Global Brands Have Become a Long Shot (published as Grow it Globally), which appeared in the Spring 2010 issue of Marketing Management, authors Rita E. Numerof, Ph.D., President, Michael Abrams, M.A, Managing Partner, and Bill Ott, M.B.A., Senior Consultant share their perspective on rapidly changing global market forces, and how companies should design their market strategies.

Globalization -- especially the increasing importance of emerging markets -- has made a consistent brand identity much more difficult to maintain. But when the purchasing power in your target markets is as different as London and Delhi, how do you find the right price points and value proposition -- ones that won’t encourage grey market transactions or cheapen your brand, yet can be successful in both? And how do you manage a portfolio of similar products with different brand appeals, at very different price points, targeted at vastly different segments?

In this article, the authors address these questions, and make the case for a structured approach to understanding and segmenting the market based on real needs, and applying that understanding in a way that influences business strategy and drives portfolio decision-making.

March 2010  -  NAI PUBLISHED IN HOSPITALS & HEALTH NETWORKS WEEKLY ON BUSINESS MODEL REDESIGN

Growing local and global competition, major shifts in the power of payers and consumers, shrinking margins, increased regulation and costs make the point -- healthcare as it’s traditionally been defined is history. In their article Competing for Patients, published February 16, 2010 in H&HN, authors Rita E. Numerof, Ph.D., President and Bill Ott, M.B.A., Senior Consultant share their perspective on the new business model required to adapt to these rapidly changing market forces, and how hospitals should approach their go-to-market strategies.

The key to success in this market is also at the core of health care reform -- provide better care at lower cost. Reflecting on their experience working across the industry developing and implementing more competitive strategy, the authors call for business approaches that provide more economic and clinical value than traditional models. They build a strong case for innovation that creates a truly differentiated and compelling value proposition as the path to being the preferred choice of consumers and payers.

March 2010  -  NAI PUBLISHED IN MD&DI ON COMPLIANCE STRATEGY

Compliance demands continue to intensify for healthcare industry manufacturers. With top FDA administrators promising more executive accountability and more serious financial penalties, NAI’s March 2010 publication in MD&DI Magazine proposes that manufacturers recognize The Need for Compliance as Business Strategy.

According to authors Stephen E. Rothenberg, Business Analyst, Michael N. Abrams, Managing Partner, and Rita E. Numerof, Ph.D., President, manufacturers should seize the issue, using compliance as a differentiator, and even to enhance relationships with physicians. They outline the business case for doing so, and proven techniques for integrating accountability for compliance into roles across the organization.

March 2010  -  NAI PUBLISHED IN MD&DI ON MANAGING CLINICAL INVESTIGATOR RELATIONSHIPS

Healthcare manufacturers find themselves on the horns of a dilemma regarding their relationships with physicians. Those relationships -- particularly with clinical investigators -- are essential to continued innovation. On the other hand, they’ve been specifically targeted by FDA and the Department of Justice (DOJ) for heightened scrutiny to root out abuse in rewarding product purchase decisions or endorsements. Finally, past practice regarding the selection and compensation of physicians for such services no longer withstands the stringent requirements DOJ is looking for to ensure appropriateness and transparency.

In their article Putting Value at the Center of Healthcare Professional Partnerships published March 2010 in MD&DI Magazine, authors Stephen E. Rothenberg, Business Analyst and Michael N. Abrams, Managing Partner, provide guidelines for companies for building a structured framework to engage clinical investigators in a way that satisfies evolving requirements for transparency and value-based decision making.

March 2010  -  NAI PUBLISHED IN MD&DI ON NEW PRODUCT DEVELOPMENT STRATEGY

The growing pressure for "better care at lower cost" is changing the fundamental rules of the medical device and diagnostics business. New rules call for new strategies, and that’s the case made by authors Rita E. Numerof, Ph.D., President and Bill Ott, M.B.A., Senior Consultant, in their article, A Seat at the Strategy Table , published January 2010 in MD&DI Magazine.

At the core of the change is the growing emphasis on economic and clinical value (ECV). US payors are increasing following the rest of the world, insisting on demonstrated ECV to justify reimbursement premiums, or sometimes, reimbursement at all. This requires that ECV become a consideration as early as new product development decisions, and calls for a broader range of functional participation in strategic product portfolio decision-making.

March 2010  -  NUMEROF PRESENTS ON MANAGING LENGTH OF STAY AT ACHE CONGRESS

Rita Numerof, Ph.D., President of Numerof & Associates, Inc. (NAI), presented to members of the American College of Healthcare Executives (ACHE) at the 2010 Congress on Healthcare Leadership, March 21-23, 2010.

In her session, titled New Strategies For Reducing Length Of Stay, Dr. Numerof shared insights on managing patient throughput based on her extensive work with leading delivery systems.

Length of stay (LOS) has been a perennial sore spot for most delivery organizations, because it's been so challenging to manage through conventional approaches, and it's easy to rationalize away small variances. But there's big money there. Every quarter-day above the norm costs over $5 million per ten thousand discharges -- annually. In these tough times, hospitals can’t afford to ignore such opportunities.

Dr. Numerof illustrated how systemic approaches to the throughput challenge can yield breakthrough success, and how to build support for such initiatives.

For more information on NAI's approach to length of stay, download our article, Length of Stay: The Management Headache That Won't Go Away.

February 2010  -  NUMEROF PROVIDES EXPERT COMMENTARY ON OBAMA ADMINISTRATION’S HEALTHCARE SUMMIT

Rita E. Numerof, Ph.D., President of Numerof & Associates, Inc. (NAI), joined a distinguished panel of experts contributing to the Center for Healthcare Transformation’s American People's Online Health Summit, February 25, 2010.

CHT sponsored the live online session concurrently with the Administration’s Healthcare Summit, hosting key members of both parties to discuss healthcare reform.

While the Administration’s televised event was widely considered ineffective in resolving Congressional differences, CHT’s online session provided an opportunity for a broader audience to add their running commentary, and for invited experts to offer key questions and policy insights. To read Rita’s comments, click here.

February 2010  -  NAI PUBLISHED IN HFMA: STRATEGIC FINANCIAL PLANNING ON CHANGING HEALTHCARE DELIVERY

Healthcare providers hoping to meet the better-care-at-lower-cost mandate of healthcare reform are going to have to develop a new business model, rethinking assumptions about the care they provide and how it is managed. In their article Kick-Start Your Management Team to Achieve Transformational Change, published February 16, 2010 in HFMA's online newsletter, Strategic Financial Planning, authors Rita E. Numerof, Ph.D., President, and Bill Ott, M.B.A., Senior Consultant, share their perspective on what it will take to be successful in today's challenging healthcare marketplace.

The authors point out that the kind of fundamental changes in performance that will be required by healthcare reform depend on the ongoing efforts of capable managers to deploy and integrate people and financial resources into carefully redesigned work processes. For many organizations, these require competencies that don't exist at the needed levels to successfully adapt to these new market requirements. They outline just what competencies are needed, and a "kick-start" plan for ratcheting up organizational performance to get there.

February 2010  -  UPCOMING WEBINAR: WHERE HEALTHCARE REFORM IS GOING: A CONVERSATION WITH DR. RITA NUMEROF

• Date: Thursday, March 31, 2010
• Time: 11:00 a.m. - 12:00 p.m. CST
• Pre-Register online now! We will call you to arrange payment.

With Congressional action on healthcare reform in limbo, many in the industry are opting just to "wait and see". That’s a risky strategy, because even without Congressional consensus, CMS must act to avoid its own financial meltdown -- and that action has the potential to revolutionize the marketplace just as DRGs did 20 years ago.

Join this webinar and hear what Rita Numerof, healthcare strategy consultant, author, and Congressional advisor has to share about the changes you can expect in the healthcare landscape, and what you should do about it.

Learn More >>

February 2010  -  UPCOMING WEBINAR: FAIR MARKET VALUE: ESTABLISHING A DEFENSIBLE FRAMEWORK

• Date: Thursday, March 18, 2010
• Time: 11:00 a.m. - 12:00 p.m. CST
• Pre-Register online now! We will call you to arrange payment.

Pharmaceutical and medical device companies’ financial relationships with physicians are a large and growing focus of OIG and DOJ enforcement activity. That makes it more important than ever to ensure that these arrangements can withstand critical examination. Determining fair market value (FMV) fees is difficult, and little practical guidance is available. Old ways of valuing professional services -- surveys of historical data, opportunity cost, etc. -- won’t be good enough. Building a defensible valuation approach and a broader framework to document compliance is the only way to insure your organization against compliance risk.

Learn More >>

February 2010  -  NAI PUBLISHED IN HEALTHLEADERS MEDIA ON LENGTH OF STAY

Like antibiotic-resistant bacteria, the challenge to reduce length of stay (LOS) persists...despite the best efforts of most healthcare organizations. And this uncomfortable reality comes at a time when more stringent reimbursement promises to put even more pressure on hospital revenues.

In their article Length of Stay: The Management Headache That Won’t Go Away, published February 4, 2010 in HealthLeaders Media, authors Michael N. Abrams, Managing Partner and Bill Ott, Senior Consultant summarize why current LOS improvement efforts haven’t worked, and outline the requirements for patient throughput success.

The authors’ perspective and advice reflects their experience working with leading healthcare delivery organizations. Their summary of the untapped financial opportunities for breakthrough patient throughput improvement builds a strong case for a sense of urgency in focusing on this persistent management nemesis.

January 2010  -  NUMEROF "SECOND OPINION" PUBLISHED IN MEDICAL PROGRESS TODAY

Rita Numerof, President of NAI, was invited to contribute to Second Opinion, a regular feature of Medical Progress Today in which experts publish brief commentary on current policy issues. The focus in the January 28 forum was conflict of interest regulation, specifically by academic medical centers constraining participation of staff in work with pharmaceutical companies. To read her comments and those of the rest of the expert panel, click here.