HighPoint Blog

In this continuing blog series, we explore the adoption challenges of risk-based monitoring (RBM) of clinical trials. So far, we’ve addressed the risk assessment process and centralized monitoring of analytics. In our latest post, we explore the broader challenges of organizational change that research teams face when moving to RBM.

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In our first blog on data governance, we described what data governance is and the important role it plays in health care.

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Large pharma company facing a critical forecasting challenge

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In the life sciences industry, gross to net (GTN) is the management process at the heart of the pricing and contracting lifecycle. Within this process, manufacturers forecast demand and accrue for rebates, chargebacks, and any other adjustments to the price charged for a product’s sale.

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The shift to risk-based monitoring (RBM) is not without challenges for clinical research teams. In a previous blog, I outlined three key adoption challenges teams face. That blog also provides an in-depth review of the first challenge, risk assessment. In this blog, we focus on the challenge of establishing and performing the sophisticated statistical analyses which are critical to detecting...

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To begin, there should be two processes for integrating tendering and global price management that lead to a harmonized governance routine, as at the end of the tendering procurement process. It’s about governing the tender bid price.

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Co-authored by Olasile Abolade, Associate Consultant

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By now, there is strong consensus that Risk Based Monitoring (RBM) is an essential practice in clinical research. There are ample resources and supporting data on the benefits of a Risk-Based approach to monitoring, and we will not add to the chorus of voices promoting its adoption.

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One of the most stressful situations a patient can encounter is navigating through a hospital stay.  Throughout the process, the patient and family are trying to wrap their heads around the entire experience but forget the financial impact.

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Who doesn’t love Faith?

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Think of test management tools as the Swiss Army knife in the back of your pocket. Test management tools can be the one-stop resource for a multiple purpose benefit. There are thousands of test management tools available, however they all have a few benefits in common if used proficiently.

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Outcome-based contracting is definitely a buzzword in the life sciences industry. Over the past few years, many companies have tried to implement such contracting strategies. Nevertheless, after years of efforts, and even if the benefits are widely recognized, the reality is that only a few contracts have materialized. When looking at the last years’ numbers, these are not so promising.

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Co-authored by Suzanne Kunze, RN, CCM, MBA and Norita Wilson, RN BSN

Population health is advancing as the health care industry shifts from fee-for-service to value-based care. As population health evolves, we are seeing the merging of care management (CM), disease management (DM) and utilization management (UM).

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Co-authored by Ann Mendlowitz, Director, Provider Solutions

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SETTING THE SCENE

This is it. Your Global Price Management and Tender Management tool has finally been deployed based on your global and local requirements. Your data is integrated from various sources ranging from enterprise resource planning (ERP) to finance to publicly available sources. Your users are trained; roles and responsibilities are clearly defined; processes outlined and...

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Co-authored by Mattias Berger, Associate, Shared Services

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Medecision’s acquisition of AxisPoint Health brings 58 VITALS and CCMS solution clients under the Medecision umbrella. These organizations have been aware of plans to sunset CCMS and VITALS since before Medecision’s acquisition, but they now have the opportunity to make a streamlined transition to Medecision Aerial platform, in addition to the option of selecting a new vendor.

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Brief overview of 340B reimbursement

In 1992, the 340B drug discount program was passed as Section 340B of the Public Health Service Act. This program allows “covered entities”, hospitals and clinics which have enrolled in the program and demonstrated a minimum disproportionate share adjustment percentage, to receive discounted pricing when purchasing drugs from the manufacturer. 

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Co-authors: Norita Wilson and Becky Jones

In our previous blog A Closer Look at Population Health/Care Management Solution Vendors , we looked at Gartner’s March 2018 “Market Guide for Healthcare Payer Care Management Workflow Applications,” and its recommendations for health plans who are evaluating care management workflow application vendors.

We will now explore how health plans should...

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Co-authors: Norita Wilson and Becky Jones

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On July 18, 2018, the FDA published its guidance for biosimilars, “Labeling for Biosimilar Products.” This guidance provides an overview of the FDA’s recommendations for biosimilar labeling, so that prescribers can make informed decisions. The FDA states the intent of the guidance is to help manufacturers “develop draft labeling for proposed biosimilar products for submission in an application...

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At the simplest, Relative Value Units (RVUs) measure the value used in Medicare reimbursements for physician services.

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Co-authored by: Suzanne Kunze, Norita Wilson, and Lori Harris

In our previous blog, you learned about the strengths of both NCQA and URAC accreditation. Now we’ll look at how you can prepare for accreditation.

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In a world of frequent biopharma mergers and divestitures, the optimal size and structure for a pharma company’s contract operations department is a moving target. Whether you’re setting up a new department or adjusting an existing one, meeting these shifting expectations is a challenge. There is typically no single way to determine your company’s unique best fit – one that balances management...

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Co-authored by: Suzanne Kunze, Norita Wilson, and Lori Harris

Health plans will look to two prominent and nationally recognized organizations, NCQA or URAC, when they are seeking accreditation. Accreditation provides an impartial opinion on a health plan’s quality. URAC or NCQA accredit a health plan when it has been determined its practices meet national standards.

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The pharmacovigilance (PV) team at a large, global biopharma company faced a challenging operational environment. Plagued with a host of disconnected systems, their day-to-day operation weighed them down with a stream of recurring inefficiencies, inaccuracies, and added oversight costs.

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Co-author: Yann Chappuis, Senior Associate Consultant

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In the patented drug manufacturing world, fixed manufacturing costs are not usually a key driver of profitability. Achieving the right price is typically a much greater driver of profit.

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In the life sciences industry, gross to net (GTN) is the management process at the heart of the pricing and contracting lifecycle. Within this process, manufacturers forecast demand and accrue for rebates, chargebacks, and any other adjustments to the price charged for a product’s sale.

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"RIM provides an integrated view of regulatory information."

"Affiliates and regions should play a key role in the system."

"RIM is the foundation of the future IDMP implementation."

The quotes listed above paraphrase some of the typical feedback we hear from clients about the role of regulatory information management (RIM). RIM is a key supporting structure for successful operation in today’s...

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At first glance, tendering and contracting may appear as two completely different procurement methodologies within the life sciences industry. The general understanding is that contracting predominates in the United States and Japan, whereas tendering (with some contracting opportunities) predominates in the rest of the world. While this presents a fairly accurate overview, on closer...

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In an ideal world, global market access functions would be totally aware of all prices – from list to net – in all countries. The ability to access net prices for any transaction in real time would ensure zero revenue leakage along the pricing waterfall. Sadly, for life sciences companies, this ideal doesn’t materialize in the real world. Very few life sciences companies enable their global...

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HighPoint is currently conducting a Gross to Net Benchmarking Survey. Early, initial results from the survey have yielded some useful insights into industry trends around the following GTN organizational size and structure questions:

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Quick facts:

  • Health Records section added to Apple’s Health App for iOS mobile devices
  • Several major health systems on board at launch (Penn Medicine, Cerner, and more)
  • Uses FHIR-based integration (Fast Healthcare Interoperability Resources)

Apple’s recent announcement to enter the electronic health record (EHR) marketplace is intriguing. Health IT pundits largely agree – it was a long shot...

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Co-authored by Chris McShanag, VP Healthcare Provider Solutions

Last week in Las Vegas, Nevada, senior representatives from the Trump Administration and the Centers for Medicare and Medicaid Services (CMS) spoke at the Healthcare Information and Management Systems Society (HIMSS) conference, restating the administration’s commitment to overhaul “meaningful use”, place patients in the driver...

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Co authored by Luca Morreale, Manager, Life Sciences EU 

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Let’s face it – traditional on-site monitoring is becoming obsolete. Given the complexity of today’s global, multi-site clinical trials landscape, traditional site monitoring can be an inefficient method to ensure patient safety.

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The latest version of the European Public Procurement Directive (EU PPD 2014/24) supports the EU’s “2020” growth strategy, which aims to ensure that the European economy is built on sustainable growth that fosters innovation and social inclusion over merely short-term cost-containment measures.

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The industry is currently in a period of unprecedented transformation, driven by ongoing shifts in the regulatory sphere from document-driven to data-driven information management. This transition is certain to continue well into the next decade and poses a significant challenge to the industry, with profound impact on how we manage regulatory information going forward.

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What is an Early Access Program (EAP)?

Early access programs (EAPs) provide an alternative regulatory pathway for existing therapies and new medicines to more efficiently meet patient needs. Prior to market approval, promising new drugs can be made available outside of the clinical trial space to individuals with life threatening or chronic, debilitating diseases. Likewise, an existing...

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