December 2011  -  NAI PUBLISHED IN MEDTECH EXECUTIVE ON CHANGES TO THE 510(K) PROCESS

The Institute of Medicine’s recent recommendation that the FDA should scrap the 510(k) process earlier this year sent shockwaves through the medical device industry. While the FDA has announced that it does not intend to end this approval process, device companies must expect additional, significant changes to the 510(k) process and post-market safety requirements.

In 510(k) Clearance -- Change Is in the Wind, published by MX: Medtech Executive, NAI Consultant Stephen Rothenberg, J.D. and Senior Consultant Jill Sackman, Ph.D., D.V.M. explain what these changes are likely to entail, and how medical device companies should prepare.

November 2011  -  NAI PUBLISHED IN PM360 ON MARKET ACCESS

Recent legislation and growing anxiety about debt have put healthcare in the spotlight, where it’s likely to stay for an indefinite period. Payers and providers are under enormous pressure to reduce costs and improve quality.

As reimbursement rates for hospitals decrease, the way decisions about care are made is changing as well. Administrators' influence on purchase and even clinical decisions is growing at the expense of that wielded by physicians. And physicians themselves are exerting price pressure on manufacturers as they become more aligned with new reimbursement incentives.

In Impact of the Changing Reimbursement Landscape on Healthcare Marketers, which appeared in PM360 this month, NAI Managing Partner Michael Abrams, M.A. and Consultant Kim White, M.B.A. describe what the tumultuous reimbursement environment will mean for medical product marketers, and how they can increase their odds of success.

November 2011  -  NAI PUBLISHED IN H&HN DAILY ON PHYSICIAN ENGAGEMENT

Reform is driving an industry redefinition of "value" that challenges traditional healthcare business models. Several solutions to move healthcare delivery organizations toward evidence-based value orientations have been proposed, including accountable care organizations and new payment models like bundled pricing.

Any new business model that acknowledges the critical role of clinical decision making in determining cost and quality requires the creation and use of predictive care paths to define the sequence of actions and options in treatment. Given the complexity of clinical practice, physician input is central to any of these efforts, both to ensure buy-in and to leverage their expertise. In their article Engaging Physicians to Improve Quality and Lower Costs, published by H&HN Daily, NAI Managing Partner Michael Abrams, M.A., Business Analyst Dana Hage, M.P.H., and Consultant Eric Abrams, M.B.A. describe the steps that healthcare leaders should take to secure physician buy-in to care paths, and to the broader goal of improved quality and lower costs.

November 2011  -  NAI PUBLISHED IN PHARMACEUTICAL COMMERCE ON ACOS

CMS’s release of the final regulations for accountable care organizations in October created a buzz across the healthcare sector. Industry organizations, policy specialists, and other stakeholders were quick to note that the regulations were much less onerous than expected, and projections for participation in the Shared Savings Program grew.

The final regulations did little to improve the likelihood that the Shared Savings Program will actually improve healthcare cost or quality, however. In an editorial for Pharmaceutical Commerce, ACOs and Their Impact on Pharma, NAI President Rita E. Numerof, Ph.D. explains how the final rules failed to address the fundamental flaws of the ACO model, and outlines implications of ACOs for pharmaceutical companies’ commercial and product development strategies going forward.

November 2011  -  NAI PUBLISHED IN BECKER’S HOSPITAL REVIEW ON BUNDLED PRICING

Most hospitals have learned to manage financially with the discounted fee-for-service model that’s been in place, but that’s history. In light of reform and demands for better health outcomes at lower cost, alternative payment models -- specifically bundled payment -- are gaining momentum.

In, Bundled Pricing: Strategies for Success, published by Becker’s Hospital Review, Eric R. Abrams, M.B.A., consultant for NAI, explores the main drivers of bundled pricing and describes five steps providers need to take to move to this new payment model.