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Moving from boilerplate language to decision-useful disclosure Quality of disclosure varies by issue, source document and company No disclosureBoilerplate StatementsIndustry-specific Metrics 11/15/20131 The illegal distribution and sale by 3 rd parties of counterfeit versions of our products or stolen products could have a negative impact on our reputation and business [BMY - Form 10-K FY 2012] We continue to address the problem of counterfeit medicines. In China, we added serial numbers to 31 products, resulting in a significant reduction in the number of reports of counterfeit medicines [GSK - Form 20-F FY 2012] Counterfeit Drugs Climate change impacts on human health [Most companies] Climate change is a serious issue for our planet, and it has the potential to affect businesses in many ways (…) climate change could lead to significant changes in the global disease burden. [ABT - CSR report 2012] The Company has been recognized for pricing many of its products through a differential pricing framework, taking into consideration such factors as a countrys level of economic development and public health need. [MRK - Form 10-K FY 2012] Access to low income individuals ViiV Healthcare [an independent company founded by GSK and PFE focused on improving access and affordability of HIV medicines] grew reported turnover by 1% in 2011 to 1.6 billion pounds. (…) offering royalty-free voluntary licenses and not-for-profit pricing. [GSK – Annual Report 2011] © 2013 SASB CONFIDENTIAL & PROPRIETARY
Disclosure examples on Manufacturing and Supply Chain Quality Mgmt. In particular, reporting on current Good Manufacturing Practices 11/15/2013© 2013 SASB CONFIDENTIAL & PROPRIETARY2 No disclosureBoilerplateIndustry-specific Metrics Manufacturing and Supply Chain Quality Management Product quality may be influenced by many factors including product and process understanding, consistency of manufacturing components, compliance with current Good Manufacturing Practice (cGMP), accuracy of labelling, reliability and security of the supply chain, and the embodiment of an overarching quality culture (…) non- compliance with cGMP requirements for US supply could ultimately result, in the most severe circumstances, in fines and disgorgement of profits [GSK – Form 20F 012] (…) We have faced, and continue to face, significant manufacturing issues. For example, in November 2011, we received a Warning Letter from the FDA with respect to three of our Sandoz Division's facilitiesin Broomfield, Colorado, Wilson, North Carolina, and Boucherville, Canada. The Warning Letter raised concerns regarding these facilities' compliance with FDA cGMP regulations (…) In the fourth quarter of 2012, Sandoz announced that the FDA upgraded the compliance status of its Broomfield, Colorado site. The division is on track to meet its remediation commitments for the other two sites as well [NVS – Form 10K 012] Our manufacturing operations are subject to routine inspections by regulatory agencies (…) the FDA conducted a routine inspection of our San Dimas manufacturing facility, where we exclusively manufacture Cayston and AmBisome. At the conclusion of that inspection, the FDA issued Form 483 Inspectional Observations stating concerns over: the maintenance of aseptic processing conditions in the manufacturing suite for our AmBisome product; environmental maintenance issues in the San Dimas warehousing facility; batch sampling; and the timeliness of completion of annual product quality reports. [GILD – Form 10K 2012] [Some companies]
Disclosure examples on Product Design and Lifecycle Management Only a handful of companies have started reporting on the issue 11/15/2013© 2013 SASB CONFIDENTIAL & PROPRIETARY3 No disclosureBoilerplateIndustry-specific Metrics Product Design and Lifecycle Management We have gathered data to understand the magnitude of the global greenhouse gas or CO2 footprint generated not only by our fuel and electricity use, but also the products we sell and our use of supply chains. We are now working to establish goals and will start to make reductions in these emissions. This includes new ways of managing our vehicle fleets, incorporating new design features into our products [MTD – Form 10K 2012] In response to the hospital markets growing needs to implement environmentally friendly, or green, products and to decrease costs to remain competitive, Masimo developed the SpO2 ReSposable sensor system (…) ReSposable sensors produce 90% less waste and 41% fewer carbon emissions than disposable sensors, while recycled sensors only decrease waste by 34% and actually increase carbon emissions by 43% compared to disposable sensors. We expect to go to full market release in 2012 [MASI – Form 10K 2011] We have re-directed all sales efforts to our new Class 1 medical products that are green, and anti-microbial in nature to address specifically the hospital and clinic markets [NANM – Form 10K 2012] [Most companies]
Disclosure examples on Pricing and Billing Transparency Reporting on this issue underlines need for useful and comparable standards 11/15/2013© 2013 SASB CONFIDENTIAL & PROPRIETARY4 No disclosureBoilerplateIndustry-specific Metrics Pricing and Billing Transparency The healthcare industry is required to comply with extensive and complex laws and regulations at the federal, state and local government levels relating to, among other things: hospital billing practices and prices for services; relationships with physicians and other referral sources; adequacy of medical care and quality of medical equipment and services [UHS – Form 10K 2012] (…) In March 2009, one of our hospitals received an information request from the DOJ regarding these procedures and, in July 2010, we were notified that seven additional hospitals were also under review. (…) We entered into an agreement with the DOJ in January 2013 for approximately $900,000 (which was previously reserved) to settle claims relating to the first hospital to receive an information request. (…) Because we have not reached agreement with the DOJ on the appropriate methodology to review the billing practices of the remaining five hospitals under review, we are unable to calculate an estimate of loss or range of loss with respect to those hospitals [THC – Form 10K 2012] Federal and state government agencies have increased their focus on and coordination of civil and criminal enforcement efforts in the health care area. The Office of Inspector General (OIG) and the Department of Justice (DOJ) have, from time to time, established national enforcement initiatives, targeting all hospital providers that focus on specific billing practices or other suspected areas of abuse. [HCA – Form 10K 2012] [Most companies]
Disclosure examples on Counterfeit Drugs Only a handful of companies report on this important issue 11/15/2013© 2013 SASB CONFIDENTIAL & PROPRIETARY5 No disclosureBoilerplateIndustry-specific Metrics Counterfeit Drugs Certain provisions of the federal Food, Drug and Cosmetic Act govern the handling and distribution of pharmaceutical products. This law exempts many pharmaceuticals and medical devices from federal labeling and packaging requirements as long as they are not adulterated or misbranded and are dispensed in accordance with and pursuant to a valid prescription [MIT – Form 10K 2012] We continue to address the problem of counterfeit medicines. In China, we added serial numbers to 31 products, resulting in a significant reduction in the number of reports of counterfeit medicines. This track and trace technology will help us implement similar initiatives elsewhere in the world [GSK* – Form 20F 2012] The FDA Amendments Act of 2007 requires the FDA to establish standards and identify and validate effective technologies to secure the pharmaceutical supply chain against counterfeit drugs. These standards may include track-and- trace and/or authentication technologies that leverage data carriers applied by the manufacturer to the sellable units and cases [ABC – Form 10K 2012] * GSK is classified under the Biotechnology and Pharmaceutical industry; it is shown here for illustration purposes [Most companies]
Disclosure examples on Plan Performance In particular on the PPACAs 5 Star Quality Rating System 11/15/2013© 2013 SASB CONFIDENTIAL & PROPRIETARY6 No disclosureBoilerplateIndustry-specific Metrics Plan Performance PPACA ties a portion of each Medicare Advantage plan's reimbursement to the plan's star rating under a five-star quality rating system administered by CMS. Star ratings are based on a plan's performance on a variety of measures, including quality of preventative services, chronic illness management and overall member satisfaction. (…) if we are unable to significantly increase the level of membership in plans with a rating of 4 stars or higher for the 2015 payment year, our results of operations and cash flows could be adversely affected [CVH – Form 10K 2012] Our average star rating increased from 3.48 in 2012 to 3.53 in 2013, and for % of our Medicare Advantage members are in plans rated at least 3.5 stars. CMS will release updated stars ratings in October 2013 that will determine the portion of our Medicare Advantage membership that will reside in plans with ratings of four stars or higher and qualify for bonus payments in 2015 [AET – Form 10K 2012] For the 2014 payment year, our California and Oregon HMO and California PPO contracts with CMS were measured at 3.5 Stars and our Arizona HMO and Oregon PPO contracts were measured at 4.0 Stars under the Star Ratings system. We are continuing to make efforts to improve our Star Ratings and other quality measures, but a failure to achieve a 4 Star Rating, and consequently to receive a quality-based payment in any year, would have an adverse effect on our revenue, income and reputation, and could hinder our ability to compete effectively in the Medicare marketplace [HNT – Form 10K 2012] [Most companies]
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