Hospital costs were (60 percent) higher in the United States than in 12 other nations

Nothing will change until their fellow citizens step into the ballot box and insist on something better.

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In the face of a grave injury, a series of calculations follow: The clear and urgent need for medical attention is weighed against the uncertain and potentially monumental expense of even basic services, like a bandage or a ride to the hospital, and that cost, in turn, weighed against all the known expenses of living that run through any given head on any given day.

This discord, between agony and arithmetic, has become America’s story, too.

The United States spends vastly more on health care than other industrialized countries, nearly 17 percent of the nation’s gross domestic product in 2014, according to a report by the Commonwealth Fund, compared with just 10 percent of G.D.P. in Canada and Britain. But that disparity is not because Americans use more medical services — it’s because health care is far more expensive here than in other countries. One 2010 study by the Organization for Economic Cooperation and Development found that hospital costs were 60 percent higher in the United States than in 12 other nations.

modern woman nurse or doctor is using innovative technologies, touching a holographic panel for monitoring patient general health data and recording a live myocardial biopsy scan

And that cost is often passed on to patients, either in the form of deductibles and other out-of-pocket expenses or through ever-soaring insurance premiums.

The Affordable Care Act has improved access to health care, especially for lower-income families that now qualify for Medicaid or subsidies to buy private health insurance. Wider access, however, has not come cheaply for most people. As a result, many Americans, including those who are insured, have determined that they must avoid going to the hospital, visiting doctors or filling prescriptions that they need. A 2017 Kaiser Family Foundation survey found that 43 percent of people with insurance said that they struggled affording their deductibles, and 27 percent said that they put off getting care because of cost. Turning to GoFundMe and other crowdsourcing websites has become the norm in medical crises.

Whether the woman on the train platform received the medical attention she needed is unknown. Ms. Cramer said on Monday that she had not been able to get an update on the woman’s condition yet. Ms. Cramer went on to tweet that after several minutes had passed, an ambulance still had not arrived. Instead, fellow passengers tried to help. “One man stood behind her so she could lean against him,” she wrote. “Another pressed cold water bottles to her leg.”

Health care is a complicated problem, one exacerbated by the gridlock in Washington. But the trade-offs that everyday people are being asked to make, the calculations they are being forced to undertake in the scariest of situations, suggest that far too many of America’s politicians have placed too little value on the well-being of its citizens. Nothing will change until their fellow citizens step into the ballot box and insist on something better.

https://nyti.ms/2lP6piU

National health targets lead to perverse outcomes

Those health targets were such a miserable failure that we have to find something that works and that’s better.

National has warned that there will be more preventable deaths in the health system now that the Government has dropped national health targets.

The performance targets for district health boards, which the former government introduced in 2009, have been stopped by the Coalition Government, and no data has been published since August 2017.

“Over time dropping the targets, losing the accountability, will mean more illnesses and more fatalities in our health system that could have been avoided,” National leader Simon Bridges told reporters today.

But Ian Powell, executive director of the Association of Salaried Medical Specialists, said that was not true.

“That’s crap. The obsessional nature of certain targets has contributed to some patients going blind,” he said.

Powell said the targets had not worked and they needed to be outcomes–based.

“They have led to superficial assessments of how the system has performed, they grossly mislead the public and they have had, especially in the context of underfunding, very perverse outcomes.

“The [Health] Minister, and we would agree with him, is looking more towards things that focus more on improved health outcomes,” he said.

Acting Prime Minister Winston Peters said the targets had been a “miserable failure”.

“It’s not correct to say we’ve dropped health targets. I just think those health targets were such a miserable failure that we have to find something that works and that’s better,” Peters told reporters this morning.

Health Minister David Clark said the Ministry of Health had stopped publishing data based on the previous government’s targets while other measures were developed.

“The previous government’s targets produced perverse incentives leading to what were traditionally cheaper surgeries being performed in more expensive environments. That meant the health dollar was not being spent as wisely as it could be,” Clark said.

“I want a health system that has honest and transparent measures, unlike the previous Government, which was pumping up its numbers by counting Avastin injections [used to treat eye disease] and skin lesion removals as surgeries when many could have been done in primary care.”

http://bit.ly/2Kbi2iP

Echolight’s CEO Sergio Casciaro explained the benefits of his technology

Most of the victims have fractures without even knowing they suffer from this disease.

What role does tailored financing have in driving innovation? Business Planet looked into the world of medical devices, an industry booming with new solutions to help healthcare professionals and patients.

The medical devices industry employs around 650,000 people across Europe. It’s an important sector for Europeans, aiding them in finding the right treatments and diagnosis.

One example of an SME (small and medium-sized enterprises) driving the sector is Echolight. Echolight has created a non-invasive technology to scan people at risk of developing osteoporosis. It can determine if people are in the early stages of developing the disease through a scan of around a minute which builds up a clear picture of the spine and femur. With Europe’s ageing population increasing (by 2016 almost 20% of the EU’s residents will be aged 65 or over) new technologies like Echolight are changing lives.

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Echolight’s CEO and cofounder Sergio Casciaro explained the benefits of his technology: “In Europe, for example, we have between 3 million to 300 thousand people suffering from bone fractures due to osteoporosis each year. Only 3% of them had done tests to assess their bone health. Most of the victims have fractures without even knowing they suffer from this disease.”

He went on to say: “This technology is one of a kind and allows us to give a diagnosis when people are still young. We can intervene not only through pharmacology but also by changing lifestyles, diet, sun exposure and physical activities.”

The success of the technology is such that it’s now being used in several European medical centres. For Echolight this means their turnover has increased fivefold between 2017 and 2016 and they’ve tripled their staff numbers from 10 to 30 people.

Echolight might not be the success story it is today were it not for the equity financing it received from a venture capital investor which helped fund its main clinical studies. The funder, Panakès Partners, was backed by the EU COSME programme.

http://bit.ly/2MKnt5Q

How to Comply with Both in the same Organization

A leading provider of professional trainings in all the areas of regulatory compliance.

Medical devices being a global market; it is not surprising to see many medical device companies marketing their products in both the US and the European Union (EU), two huge markets for these products. Given that these are two different markets; each has its own regulatory requirements. These requirements focus mainly on its Quality Management Systems (QMS). The QMS for the two markets are described in two documents: one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR 820).

On the surface, these two systems appear similar as they have many features in common. But as one delves a little into them, it turns out that they are not identical. A regulatory professional who markets medical devices into these two markets is likely to face crucial questions:

·        Is it possible, and is it permitted to have a QMS on the same site that complies with both requirements?

·        Should one QMS comply with both, and should that be put in place, or is it necessary to have two QMS coexist on the same site?

Thorough learning of the ISO and FDA QMS requirements

Answering questions such as these requires a thorough understanding of the background of both these documents, their legal status, what is expected by the regulatory authorities, and some basic concepts in quality and medical devices quality in specific. This is the learning that a webinar from Compliance4All, a leading provider of professional trainings in all the areas of regulatory compliance, will impart.

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At this webinar, Compliance4All brings the owner of ELC Consulting Services, Eyal Lerner, as expert. Eyal’s organization offers the pharmaceutical and medical devices industries support in all quality related issues, such as Preparation for inspections, CAPA and RCA, quality manual QSM, self-inspection (internal audits), compliance gap analysis, 3rd party audits (FDF and API’s), Management Review, GMP, GLP, MD: ISO 13485:2016 adjustments, DHF, DMR, V&V, 510k submission preparation and ISO 17025 (lab accreditation) and Validation. Eyal has preformed more than 100 audits in various facilities around the world as a lead auditor and auditor.

Please visit http://bit.ly/2JDpIWO to enroll for this webinar and have important doubts about the implementation of the QSRs of the ISO 13485 and 21 CFR 820 regulations clarified.

Offering insights into the two regulations

At this webinar, Eyal will give clarity to participants on how to understand what is required by both. It is necessary for regulatory professionals to understand semantic and substantial differences between the two documents. To give an example, while the ISO requires what it calls a Quality Manual (QM), the FDA QSR does not find mention of such a term. An in-depth look at the policies and Standard Operating Procedures facilitates the ease of handling of such terms. Eyal will focus on other issues that require more attention. He will explain the main features of these areas and describe what should be done from the perspective of a site or a manufacturer which wants to comply with both QMS.

The objective of this learning session is to offer a clear understanding to organizations in the medical devices industry that either develop or plan to market medical devices to USA and Europe of how to plan and implement a QMS that complies with both regulatory authorities. Eyal will help them ask themselves how to get the QMS right and make it work efficiently.

This session is aimed at professionals who are involved in implementing their organizations’ QMS, and includes Medical Devices Quality Personal (QA and QC), Laboratory Managers, R&D Researchers of Medical Devices and Combined Products, Quality Control Staff, and Regulatory Affairs (RA) Staff.

The speaker at this webinar will cover the following areas:

·        Introduction

·        Brief review of regulations and standard: status and history

·        ISO 13485:2016 short review

  • Principals
  • Quality management system
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis and improvement

·        FDA QSR (21CFR820) short review

  • Quality System Requirements
  • Design Controls
  • Document Controls
  • Purchasing Controls
  • Identification and Traceability
  • Production and Process Controls
  • Acceptance activities
  • Nonconforming Product
  • Corrective and Preventive Action
  • Labeling and Packaging Control
  • Handling, Storage, Distribution, and Installation
  • Records
  • Servicing
  • Statistical Techniques

·        Comparison between both QMS

  • Common features
  • Variances between both

·        Terms/ vocabulary

  • Comparison between terms

·        Summary.

 

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Executive Council hears pitch to overhaul N.H.’s state retiree health care plan

Presenting the plan, DAS Commissioner Charlie Arlinghaus called it an opportunity to save money and keep the program viable.

The New Hampshire Department of Administrative Services (DAS) is proposing a sweeping overhaul of the state’s retiree health care plan, seeking to switch users into a Medicare program that officials say could help the state save $11.8 million through 2020.

The proposal, presented to the Executive Council on Wednesday, would move the state’s 9,600 Medicare-eligible public retirees off their present plan – a state-funded program called “Medicomp” – and onto a federal initiative known as Medicare Advantage.

That move would allow the state to take advantage of a higher federal match rate under Medicare Part C, the Medicare Advantage program. The proposal would reduce projected costs from January 2019 to December 2020 from $41 million to $29.2 million, according to the department.

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Anthem health insurance would continue administering care for retirees, but under a new funding structure overseen by the federal government.

The proposal comes as the state has struggled to keep up with rising health care costs in its retiree health plans, forcing legislators to address multiple budget shortfalls in recent years, according to the department.

Presenting the plan, DAS Commissioner Charlie Arlinghaus called it an opportunity to save money and keep the program viable. And he said no patient would lose his or her doctor or experience a change in benefits.

“The doctors you will be able to go to are anyone who takes Medicare,” he said. “Which, theoretically, if you’re already in the Medicare program, that’s who you’re using now.”

Under the proposal, Medicare-eligible retirees would receive insurance through Anthem, which would in turn be reimbursed by the federal Centers for Medicare and Medicaid Services on a per-person basis.

The rate would be determined by the health of the people being served and the quality of the care offered, incentivizing Anthem to improve its service, according to the department. By working under Part C of the Medicare program, retirees would benefit from a coordination between Medicare parts A and B, which cover hospital expenses and provider costs, respectively, and Part D, which covers pharmaceuticals.

“Other than the increased attention to the care retirees are receiving, members should experience minimal disruption while continuing with the same level of medical coverage with the flexibility to see the same Medicare participating providers they see today,” Arlinghaus wrote in a letter accompanying the proposal.

The plan comes months after Anthem announced that it had expanded its presence in the state enough to leverage more federal dollars through the Part C program and lower premiums, the department said, a major factor in the cost savings to the state.

And it comes in response to years of struggles with the state’s retiree health care service.

In 2015, the Joint Legislative Fiscal Committee struggled to plug a $10.6 million gap after the biennial budget failed to account for cost increases. Meanwhile, the latest fiscal year 2018-19 budget, passed last year, required a $25.4 million boost just to keep the program on course, according to the department.

Last year, the department commissioned a study with an outside party, the Segal Co., to study options to resolve the problems; the Medicare Advantage program was one of the options recommended, the department said.

http://bit.ly/2LpIJME

How can a Culture of Quality and Compliance Impact your Company’s Success?

At this very important learning session on Quality, Suzanne will cover all the perspectives of Quality.

If there is one attribute that sits at the very core of an organization, it has to be Quality. If Quality is this critical to organizations; then, what is Quality in the context of an organization?  If Philip Crosby defined Quality as conformance to requirements and Sam Walton considered it as being able to give the customers what they want; William A. Foster explained Quality in an organization in the following words: “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution. It represents the wise choice of many alternatives”.

Those in charge of Quality in organizations have to consider many questions relating to it. These are some of them: do we consider it an attribute or characteristic in relation to a certain standard or customer requirement? Is it all about achieving a state where our product is free from defects? Is it a system that we create for holding inspection standards or making the Quality System accountable to? Or is there something beyond all these?

Quality should become part of the organization’s culture

If there is one truly critical work that an organization has to carry out to become successful and to stay ahead; it is to imbibe Quality into its very core. Going beyond the semantics; Quality should become a way of life for the organization. it should become a philosophy, an inalienable part of its culture, and a habit. For organizations to meet and exceed customer expectations all the time and every time, Quality has to be implanted into the very essence of an organization.

Compliance4All, a well-known provider of professional trainings for the areas of regulatory compliance, explain all the elements of Quality at a webinar that it is organizing. Susanne Manz, a highly regarded leader in the medical device industry, who emphasizes Quality, compliance, and Six Sigma, and who brings extensive background in Quality and compliance for medical devices from new product development, to operations, to post-market activities, will be the speaker at this webinar.

Please register for this webinar by visiting http://bit.ly/2Hs2QMI

Quality from all perspectives

At this very important learning session on Quality, Suzanne will cover all the perspectives of Quality. Among the important learning objectives of this session is to teach participants to identify the warning signals that indicate that there could be Quality issues within the organization and the risks the organization faces from Quality and compliance issues. Participants will understand the ways of changing their organizations from being reactive to becoming proactive. Participants will understand how a culture of Quality and compliance can impact their organization’s success, and will learn the ways of creating a culture of Quality and compliance at all levels in their organization.

Suzanne will cover the following areas at this webinar:

  • FDA and NB expectations for Quality Systems
  • Lessons Learned from 483s and warning letters
  • How culture can impact Quality and compliance risk
  • Management commitment and responsibility
  • Maturity Modeling
  • Key capabilities
  • Roles and responsibilities
  • Quality planning and strategy
  • Tools and techniques
  • Best Practices.

How to survive an FDA Audit

FDA audit is to understand the factors that prompt an inspection of research.

Surviving an FDA audit is like trial by fire for many organizations. Even the most meticulous organizations have the potential for being nitpicked by the FDA for the smallest noncompliance.

The FDA has devised the Bioresearch Monitoring Program, or BIMO, an on-site inspections and data audit programs, designed to monitor all aspects of the conduct and reporting of FDA-regulated research.

howToSurviveAnFdaAudit

How to survive an FDA audit largely depends on how well the organization implements the requirements of the BIMO. BIMO is quite comprehensive, as it monitors Sponsors or Contract Research Organizations (CROs)/Monitors, the Institutional Review Boards (IRBs), Clinical Investigators (CIs) and nonclinical laboratories.

BIMO Program Objectives

Basically, surviving an FDA audit is dependent on how well it understands and implements the provisions of BIMO. The core objectives of the BIMO Program are:

  • Protect the safety, rights, and welfare of human research subjects; and
  • Assuring the integrity, reliability and quality of data collected.

The BIMO’s functions

If organizations have to survive an FDA audit; they need to understand the BIMO Program’s functions:

  • Auditing clinical data
  • Inspecting ongoing clinical research
  • Inspecting nonclinical laboratories and IRBs
  • Educating, training, and implementing FDA’s Application Integrity Policy.

close up of scientists making test in lab

Understanding factors that trigger an inspection

Another key to surviving an FDA audit is to understand the factors that prompt an inspection of research. These could be any of all of these:

  • New product or indication
  • Any new technology
  • Complaints
  • History of non-compliance, and
  • Even routine surveillance.

So, any organization that has to survive an FDA audit has to be aware of the intricacies of this program. Following and implementing its requirements step-by-step acts as a checklist for ensuring that it stays compliant.