The FDA and industry: Recipe for collaborating in the New Health Economy
Balancing innovation and risk when developing new drugs and devices requires tradeoffs. To improve access to new treatments, the pharmaceutical and medical device industry is willing to consider regulatory reforms such as stricter post-market safety requirements.
SEC comment letter trends for healthcare providers
To help you gain insight into the SECÃ¢Â€Â™s current areas of interest, we analyzed comments released by the SEC staff to domestic large accelerated, accelerated and non-accelerated registrants within the healthcare provider industry during the two year period ended August 31, 2014. From this analysis, we identified the following Ã¢Â€Âœhot topicÃ¢Â€Â areas we believe you may find useful as you prepare for the upcoming year-end reporting cycle.
Healthcare delivery of the future
How digital technology can bridge time and distance between clinicians and consumers
Top Health Industry Issues of 2015
PwC's Top Health Industry Issues report includes feedback from 1,000 consumers regarding their point of view on several issues related to reform and their healthcare experience. Their input on many topics is presented in the report and in detail on this website.
US Health Services Deals Insights
The pace of deal activity has picked up in the third quarter of 2014 with a total of 169 deals announced as compared to 143 and 138 deals in the first and second quarters.
MoneyTree: Biotech trending high
Investments in both the biotech and medical devices industries have continued to increase year-over-year. However, investments for the two industries declined compared to the exceptionally strong last quarter, which saw record high investments in biotech.
2014 SEC comment letter trends Pharmaceutical and Life Sciences
Our 2014 SEC comment letter trend compiles and analyzes the SEC staffÃ¢Â€Â™s comment letters issued over the past few years to registrants across different sectors within the Pharmaceutical and Life Sciences industry and provides highlights surrounding current hot topics and sample comments.
Health wearables: Early days
In summer 2014, PwCÃ¢Â€Â™s Health Research Institute and Consumer Intelligence Series launched research to better understand consumersÃ¢Â€Â™ attitudes and behaviors toward wearable technology amid rapid growth in the health industry.
The rise of retail health insurance exchanges
Retail health insurance marketplaces, also known as exchanges, are changing both the employer benefits environment and the health insurance business.
PwC's Patient Digital Care Solution
PwC leveraged its experience in working with healthcare providers and in consumer experience to develop a digital solutionÃ¢Â€Â”combined with our consulting servicesÃ¢Â€Â”that helps address the complex needs of todayÃ¢Â€Â™s healthcare providers. PwCÃ¢Â€Â™s Patient Digital Care solution embraces the cloud and the Salesforce1 Platform to enable providers to enhance connections with their patients throughout the treatment cycle.
Medicaid 2.0: Health system have and have nots
Medicaid expansion under the Affordable Care Act has delivered higher volumes and increased revenue to providers across the 26 states and the District of Columbia that expanded the program, while dramatically reducing the amount of care that goes unpaid. Hospitals in states that did not expand have seen the opposite.
Health Industry Executive Advisory Board on Privacy and Security highlights
In June 2014, representatives of the payer, provider, and pharmaceutical industries as well as four representatives of federal regulatory agencies came together in Washington, DC. to discuss data access and use as well as the challenges of maintaining privacy and security as information moves across the healthcare ecosystem.
Health Services Deals Insights
We see a steady pace in the volume of deals for the health services sectors from the first to second quarters with 143 and 138 announced deals (281 total deals), respectively. This volume is also consistent on a year to date basis with 2013 and its 289 announced deals. However, we also note that on a quarterly basis, the second quarter of 2014Ã¢Â€Â™s deal volume (138 deals) has declined almost 13% from the same period in 2013 (158 deals).
Pharmaceutical and Life Sciences Deals Insights Quarterly Q2 2014
As anticipated in our Q1 report, M&A activity surged in the second quarter of 2014 with 62 deals announced representing almost $170 billion of total value. TurkeyÃ¢Â€Â™s healthcare industry is poised for significant growth as a result of government initiatives and increasing urbanization. Additionally, its geographic location is an ideal hub for companies seeking to expand in the region. Insights from PwCÃ¢Â€Â™s 2014 Integration Survey highlighting key focus areas for executives to achieve M&A integration success.
Hispanics: A growing force in the New Health Economy
Hispanics represent unparalleled growth opportunities for businesses aiming to succeed in the New Health Economy. But, if healthcare companies fail to Ã¢Â€Âœspeak their language,Ã¢Â€Â they will miss opportunities to capture the fastest growing demographic in the US and gain their customer loyalty.
Behind the numbers: Medical cost trend 2015
At first glance, the health sector appears to be reverting to historical trends of bouncing back as the nation recovers from the economic doldrums. Several factors triggered the first significant bump in growth in the first quarter of 2014 and we expect that to continue through next year. Moderating that growth, however, is the $2.8 trillion industry becoming more efficient.
QMS 3.0: The next generation of quality management systems
In this age of intense scientific discovery, life sciences companies are becoming increasingly complex. Biopharmaceutical and medical device businesses are developing more complicated products in the form of bio-similars, implantables, combination products, and others. These companies are operating across multiple industry segments (pharmaceuticals, diagnostics, medical devices, OTC, etc.), and they are entering varied emerging markets. In this environment, current quality management systems (QMS) have not kept pace with a growing variety of products and technological complexity. A new QMS framework is needed to inject heightened effectiveness and efficiency into the industry quality processes.
California Biomedical Industry Report 2015
California holds a unique position in the worldwide life sciences community, producing some of the worldÃ¢Â€Â™s most innovative therapies and diagnostics.
MoneyTree: Biotech soars to record high
Biotech soars to record high: Investment in biotechnology was the highest since the start of the MoneyTree data series in 1995. Biotech and medical devices industries both see year-over-year double-digit growth in investments.
Phase 2: The next generation of HIPAA audits
Earlier this year, the Office for Civil Rights (OCR) announced the implementation of a Ã¢Â€ÂœPhase 2Ã¢Â€Â audit program to begin in fall 2014 based on the findings of the 2012 pilot privacy and security audits of payers and providers. In Phase 2, the OCR will conduct audits of HIPAA-covered entities, with audits for business associates anticipated to begin in 2015. For more information about the impact and how best to prepare download and read our four page brief which includes highlights, additional background, analysis and FAQs for planning.
Data driven progress: As informatics evolves, clinicians find ways to stay ahead of illness and revamp care delivery
PwCÃ¢Â€Â™s Health Industries practice brought together a panel of three specialists from the clinical, technical and operational side of healthcare during the Healthcare Information and Management Systems Society (HIMSS) annual conference to discuss and share best practices in medical informatics. While the participants varied in their pace and depth of commitment to informatics, all agreed that the potential of technology to positively impact patient care and coordination is profound.
MoneyTree: Biotech deals rising
Investments increased year over year for biotech as well as medical devices. The average deal size for early stage medical device investments was the highest since 1995. However, life sciences investments underperformed total venture capital investments and are now at the lowest proportion of total investments since 2001.
Health Services Deals Insights
In 2013 the most notable transaction activity was in the hospital sector. While hospital deal volume was down 5% in 2013 hospital transaction value increased from $1.9 billion in 2012 to $18.6 billion in 2013. Moving into 2014 we expect this level of deal activity to be sustained - including the potential for additional $1+ billion deals - as distressed hospitals seek a buyer's access to capital and larger health systems seek sellers' access to new patient populations.
Pharmaceutical and Life Sciences Deals Insights Quarterly
Deal volume and value increase in the quarter while fundamentals and pending deals point to potential for heightened activity in the fourth quarter of 2013. Total deal volume increased approximately 10% during the third quarter of 2013 in comparison with the second quarter of 2013, while declining by approximately the same amount relative to the third quarter of 2012. Deal value increased by nearly 50% over the previous quarter while declining approximately 15% relative to the third quarter of 2012. The increase in the third quarter owes primarily to two large transactions in the medical device segment.
Why Customer Centricity matters
Unique Devices Identification System: Practical perspectives on implementation and compliance readiness
In our experience to date, manufacturers have been more focused on device labeling and GUDID reporting than on conforming amendments. This may represent a blind spot for some manufacturers.
Pharmaceutical and Life Sciences: 2013 SEC comment letter trends
Pharmaceutical and Life Sciences - 2013 SEC comment letter trend compiles and analyzes the SEC staffÃ¢Â€Â™s comment letters issued over the past few years to registrants across different sectors within the Pharmaceutical and Life Sciences industry and provides highlights surrounding current hot topics and sample comments.
Healthcare’s new entrant: Who will be the industry’s Amazon.com
The health sector's center of gravity is shifting toward consumers and new tech-savvy players are moving fast to capitalize on the change. These new entrants are poised to shake up the industry, drawing billions of dollars in revenue from traditional healthcare organizations while building lucrative new markets in the burgeoning New Health Economy.
Rx Marketplace Quarterly Newsletter
The PwC Rx Marketplace Quarterly features a wide range of financial reporting developments, accounting and tax developments, regulatory updates and general industry trends impacting the pharmaceutical and life sciences industry.
Top health industry issues for life sciences in 2014
Michael Swanick, global leader of PwC's pharmaceutical and life sciences practice has shared findings based on our Health Research Institute's annual Top health industry issues report to address which issues we believe will directly impact the pharma, biotech and device manufacturers in 2014 (in no particular order are): Corporate venture capital, clinical research methods, counterfeit drugs and the new regulations intended to eliminate them as well as social, mobile, analytics and cloud technologies that are changing existing business models.
Serialization and ePedigree PwC perspectives for manufacturers
Pharmaceutical and biotech manufacturers are working to comply with serialization and drug security legislation from around the globe. The intent of the US Drug Quality and Security Act, and the EU directive on serialization are US drug supply chain security and EU serialization.
EFPIA and Global Transparency Requirements
Implementing an aggregate spend program in a global marketplace. Treating industry codes, laws, and regulations without considering the broader global transparency landscape, is not an option if companies intend to develop smart transparency approaches and supporting models that more efficiently and effectively address what is required of them. Many of the regulations and requirements imposed on pharmaceutical and life sciences companies have commonalities that create opportunities for businesses to incorporate process efficiencies and economies of scale when developing their transparency strategies.
Health Industry Executive Advisory Board on Privacy and Security highlights
To ensure that the healthcare industry keeps patient information safe, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) regularly issue and update privacy and security regulations that healthcare entities must adopt to stay in compliance with the law. These regulationsÃ¢Â€Â”perceived by the industry as alternately burdensome and vitalÃ¢Â€Â”aim to help healthcare entities protect sensitive patient information from cyber threats, data breaches, and identity theft.
180 Health Forum Highlights: The changing faces of healthcare
More than 100 thought leaders and CxO's from across all sectors of the US health industries, along with recent entrants, gathered to explore the new health economy that is emerging in the United States at PwC's 180 Health Forum. Since its inception, the Forum has provided a venue for challenging the status quo by bringing in some of the most provocative thinkers in the healthcare arena to share their insights with our clients. Our Forum Highlights provide an overview of the conversations that occurred at the 2013 180 Health Forum.
Healthcare provider 2013 SEC comment letter trends
To help registrants gain insight into the SECÃ¢Â€Â™s current areas of interest, PwC analyzed comments released by the SEC staff to domestic large accelerated, accelerated and non-accelerated registrants within the healthcare provider industry during the three year period ended September 30, 2013. It also provides a discussion of the related guidance as well as sample comment letters on each area. Included for your information are some best practices on how to effectively respond to comments received and a summary of the SECÃ¢Â€Â™s filing review process.
Partnering for change: Report on the 2013 annual CBO consortium
The Central Business Office (CBO) Consortium is a gathering of the revenue cycle leaders from large healthcare systems across the country who come together each year to share information that can help them enhance their revenue cycle performance.
Top health industry issues of 2014
A new health economy takes shape
California Biomedical Industry, 2014 Report
This report demonstrates CaliforniaÃ¢Â€Â™s medical device and biopharmaceutical industry was resilient through the worst of the Great Recession, being one of only two states to add employment in this industry from 2008-2012.
MoneyTree Report from PricewaterhouseCoopers (PwC) LLP and the National Venture Capital Association (NVCA)
While a slowdown in funding occurred in life sciences, venture funding for all industries increased sharply, with 1,005 deals driving revenues of $7.8 billion in the third quarter, an increase of 17% in value and 7% in the number of deals year over year.
Q3 2013 US Health Services Deals Insights
The third quarter of 2013 realized a slight uptick over the prior two quarters in the volume of healthcare service deals with 138 total transactions. The value of the deals announced in the third quarter, $15.8 billion, was up 35% over the second quarter. However, in both volume and value the year-to-date period for 2013 continues to lag the same period in 2012 with volume down 4.6% and value down 25%.
US GAAP: Issues and solutions for pharmaceuticals and life sciences industry
Internet, Communications and Publishing sub-sectors saw increased deal activity, contributing to the 9% growth in announced deals for the 3 quarters ended 2013 versus prior year. In addition to deal trends for the year to date, a deeper look at one sub-sector -- telecom operations -- and the deal opportunities abounding as telecom companies look to improve network operations and spectrum efficiency.
A Conversation with Mike Swanick, PwC
The November / December issue of Pharmaceutical Commerce features PwC's Michael Swanick, Global and US practice leader for pharmaceuticals and life sciences on their cover. In the feature article Michael discusses national and international issues affecting the pharmaceutical and life sciences industry.
Customer experience in the pharmaceutical sector
As patients exert greater control over their healthcare, drug makers need to master the complexities of consumer behavior. Consumers are willing to offer feedback that informs who they are, how they behave and how existing biases impact their behavior. Drug makers that tap into this feedback will reach a new level of success.
Medical Technology Company Innovation Scorecard
Medtech companies prepare for an innovation makeover
US GAAP: Issues and solutions for the medical technology industry
This publication highlights factors the medical technology industry should consider and provides guidance on the most pertinent accounting solutions under US GAAP. The solutions presented are meant to provide a framework for determining the appropriate accounting answer for general solutions.
Spotlight Lease Accounting: Transformational Change
Included in this brief are next steps organizations should consider as well as an FAQs section and key contacts you may reach out to for additional follow up.
Five Strategies for Improving Performance of Academic Medical Centers
Academic medical centers should research and embrace new approaches to financing, operations, and governance to become more cost-efficient and profitable in an era of reform.
Medical Cost Trend: Behind The Numbers 2014
Aggressive and creative steps by employers, new venues and models for delivering care, and elements of the Affordable Care Act (ACA) are expected to exert continued downward pressure on the health sector
MoneyTreeTM Report from PricewaterhouseCoopers (PwC) LLP and the National Venture Capital Association (NVCA)
US venture capital (VC) funding for the life sciences sector, which includes biotechnology and medical devices, improved dramatically, during the second quarter of 2013. According to the MoneyTreeÃ¢Â„Â¢ Report, venture capitalists invested $1.8 billion in 174 life sciences deals.
The Massachusetts Experience employer sponsored health insurance post reform
As implementation of the Affordable Care Act presses forward, questions remain about its impact on employers. The 2006 Massachusetts universal healthcare legislation provides a guidepost for employers considering a path forward and offers lessons learned.
Scoring healthcare: Navigating customer experience ratings
PwC's insights on the impact of the ratings culture on healthcare
Solving the talent equation for health IT
Top healthcare executives are revisiting talent strategies to overcome technology and skill availability pressures.
Emerging markets growth: The critical role of operations in driving competitive advantage
Biopharmaceutical companies are expanding into emerging markets, sometimes without involving supply chain operations. The operational function (operations) should play a strategic role in emerging market expansion planning.
Risk-based monitoring: Reduce clinical trial costs while protecting safety and quality
The demand for higher value from pharmaceuticals and medical devices is increasing. Risk-based monitoring can reduce the development time of safe and effective products at lower cost.
How to respond to the Final Omnibus HIPAA Rule
The Final HIPAA Omnibus Rule calls for changes to privacy and security requirements that healthcare organizations should address, especially where current practices and processes could be less effective and expensive to build and maintain.
CMS shines light on Transparency Final Rule: Insights and impact