Author: Julie Kaloides

CSafe, the world’s largest provider of active and passive cold chain solutions, hosted a highly-successful workshop for over 120 delegates from the leading Korean biopharmaceutical manufacturing and logistics service sector.
Under the title ‘Pharma Focus: Introducing Biosimilars Successfully’ the event was held in Incheon and attracted an audience comprised of many key stakeholders involved in the supply chain for this fast growing South Korean industry segment which by 2019, is expected to almost double in value to 150 billion Won ($130m).
Brian Kohr, President and CEO of CSafe Global, welcomed delegates and spoke of how CSafe Global is continuing to grow to support the Korean biopharmaceutical cold chain including an enhanced local service facility and the extension of its product availability in the region.
Speakers from top forwarding companies outlined through case studies how their partnership with CSafe continues to allow South Korean manufacturers effective incident-free door-to-door delivery of biopharmaceutical products from Korea. Exelsius also gave delegates an update on the important aspect of GDP regulations and their global application, particularly in relation to qualification of supply chain partners.
A well-respected and highly experienced member from a successful biopharmaceutical company and a leading manufacturer in this sector, delivered an insightful address on best practices in supply chain qualification that drew considerable interest from the audience during the subsequent sixty-minute Q & A which covered a wide variety of topics from packaging techniques through to data collection and air cargo labeling regulations.
Kevin Lee, CSafe Director of Sales Korea said, “We are naturally delighted to have been able to host this event to such an extensive and interested audience and provide them with information that will enhance their knowledge and understanding of the international supply chain for biopharmaceuticals.”
About CSafe Global
CSafe Global manufactures AcuTemp® brand passive packaging and hand-held mobile carriers, the CSafe® brand of active containers, and is the exclusive manufacturer and provider of ThermoCor® vacuum insulation. The active solution product assortment includes the industry leading CSafe RKN, which utilizes heating and compressor-driven cooling technology to eliminate the risks associated with extreme ambient conditions as well as the conditioning, cost, aggravation and environmental challenges associated with dry ice and PCM’s. CSafe Global’s AcuTemp brand has provided temperature management solutions since its founding more than 25 years ago. The courier is a simple-to-use, reusable temperature management system with multiple sizes, temperature ranges and durations designed to protect vital shipments during last mile delivery. The passive packaging assortment includes solutions for 2-8°C, CRT and frozen shipments with temperature hold times up to 240 hours.

During the 2017 Drug Delivery Partnerships Conference (DDP), Dirk Smith, Co-founder of Minnetronix, spoke about key factors to consider when integrating a drug delivery system into a combination therapy. Understanding the medical device mindset and framework—including timing, risk management, design controls, and systems complexity—can help leverage concurrent development processes to a successful market introduction.
When integrating a drug and delivery system into a combination therapy, developers need to consider a number of factors beyond their traditional processes. Understanding the medical device mindset and framework—including timing, risk management, design controls, and systems complexity—can help leverage concurrent development processes to a successful market introduction. Dirk will discuss key factors from a medical device perspective. Topic points include:
Key capabilities/qualities in a medical device delivery partner

• Medical device process know-how
• Medical device quality and regulatory expertise
• Systems thinking, integrating and addressing challenges with multiple technologies
• Usability – improving delivery accuracy, simplicity and compliance while reducing risk
• Scalability from prototype to trial to delivery system manufacturing

State-of-the-art med device technologies beneficial to the pharmaceutical industry

• Sensors, connectivity, wireless power, miniaturization, complex software/hardware integration, batteries, data analysis, human factors, etc.

Unique aspects an experienced device partner brings to pharmaceutical delivery device development

• Proven design controls from requirements through verification
• System architecture and integration of complex systems
• Embedded software, electronics and electromechanical design
• User interface and human factors design
• DFx – design for manufacturing, test, safety, usability, etc.
• Project management

Plano, TX Feb 2, 2017: GAFFEY Health continues to deliver against the financial demands of its customers by expanding the company’s ability to provide a suite of Revenue Integrity tools based on our revenue cycle automation platform in a cost effective manner. Data acquisition from disparate core operating systems is the single largest challenge for healthcare providers in being able to access and utilize RCM software tools today to ensure that services are paid for correctly and in a timely manner. The complexity of this challenge is accelerating rapidly with the vast number of value based care models that demand integration of a larger number of disparate data sources.
Healthcare entities of all types and sizes fight denials and underpayments on a daily basis. Much of the information necessary to identify, manage and reduce these denials and underpayments is located in the remittances (835’s) that are provided with payment by the payor. The challenge has always been in having the ability to translate the data into usable information for the facility to act on.
GAFFEY’s ClaimCPR – Click.Process.Recover™ is a healthcare Revenue Integrity platform built on GAFFEY’s Data Integration Engine. ClaimCPR™ was built to provide a number of automated cost effective Revenue Integrity tools. Remittance360 is the first module of the new platform. Remittance360 is a data management and analysis tool for 835 (EDI remittance) data feeds. The tool enables the user to automatically import 835’s into a standardized data platform and then provides the ability to query, analyze, export and print EOB’s. There are a number of embedded tools with Remittance360 that automatically identify denials and potential underpayments enabling the end user to identify and manage revenue leakage almost immediately.
“Revenue integrity and leakage continues to be a major issue for all providers. Cost effective data acquisition for revenue integrity tools has prevented smaller entities from being able to afford these tools,” stated Derek Morkel, GAFFEY CEO. “We recognized that being able to provide a series of tools that focuses on revenue integrity using our Data Integration Engine was the key to making them effective and affordable. ClaimCPR™ Remittance360 is the first module that targets easy to identify denials and underpayments at a price that any entity can afford.”
GAFFEY Healthcare provides revenue cycle technology and services that enable health care organizations to accelerate cash flow, improve productivity and increase profitability with short-term and demonstrable ROI. From patient eligibility and payment verification to billing and claims management to third-party collections, their software relies upon cloud-based, state-of-the art workflow supported by a business intelligence platform. GAFFEY’s systems are in use at more than 200 healthcare systems and physician practices across the U.S.
Contact:
Jennifer LeMieux GAFFEY Health
Jennifer.lemieux@gaffeyhealth.com

Timonium, MD Jan 31, 2017: With a new private equity partner on board, Senior Helpers is looking forward to a growth year in 2017.
New programs and entry into new markets should give Timonium, Maryland-based Senior Helpers, one of the nation’s largest home care franchise companies, an even larger footprint and more sway across the health care continuum, co-founder and CEO Peter Ross told Home Health Care News.
While ongoing workforce challenges and uncertainty over policies coming out of Washington, D.C., have home care providers on notice, Ross recently spoke to HHCN about why he remains “bullish” in the new year.
HHCN: Give us a quick year in review for Senior Helpers. What were some 2016 highlights?
Ross: It was another record year in 2016 for revenue and profitability. We brought on another 24 franchisees, and were up to around 284 around the end of 2016.
We also launched our Parkinson’s program. We started several years back trying to differentiate ourselves from what’s out there, and early on I latched on to disease management. I think this is going to be key going forward, with the Baby Boomers aging. We have a special training program for our caregivers and staff, so they can better understand [care needs] of clients with Parkinson’s. Like with our Gems [Alzheimer’s program], it gives us a dedicated focus and care plan that we can do for these families. We are very confident in it, having worked a lot with Johns Hopkins in developing the program. We can be a go-to home care company for Parkinson’s, just as for Alzheimer’s and dementia.
We also expanded into Canada, and now are in three countries.
Senior Helpers back in 2012 had taken on a capital partner in [Los Angeles-based] Levine Leichtman. They made a decision to exit their investment with Senior Helpers—very profitably, I would add—and almost four years to the day, we had another private equity partner take over for Levine, [New York City-based] Altaris Capital. We have a lot of opportunity to continue on focused growth as we move to the future, and I think the capital partner will help us with additional focus on where we need to go.
HHCN: What kind of growth specifically are you looking at for 2017?
Ross: We’re looking at rolling out another disease management program, probably COPD [chronic obstructive pulmonary disease]. We’re going to continue to expand in our franchise development, and look at some corporate acquisitions of independent home care companies in areas where we don’t have franchise locations sold. We now have access to the capital to do that. It’s an exciting time for us in that regard.
HHCN: What are some of the markets you’re looking at for expansion?
Ross: Some of the markets we’re looking at are Connecticut, Virginia, parts of Ohio. The sweet spot [for a company to acquire] would be between $3 million and $5 million in revenue, with a payor mix of [about] 90% private pay, 10% reimbursement. The [acquisition] would be rebranded as Senior Helpers, and we would divvy it out if there are clients that would overlap with a Senior Helpers franchisee. But we’re focused on states we’re not involved in at all, because some health care organizations—Medicare Advantage providers like Humana or UnitedHealth—want providers across the country.
HHCN: Do you see a big opportunity there, to partner with Medicare Advantage or with health systems, accountable care organizations (ACOs), and the like?
Ross: I believe home home plays an important role in the health care continuum. It brings so much benefit to the government, payors, the community, families, for people to age in place. Home care [provides] the lowest-cost option to do so, and 96% of seniors want to live out their life in their own home.
I think it’ll be interesting to see how CMS [the Centers for Medicare & Medicaid Services] and the new health department looks going forward, but we’re looking for opportunities to partner with hospitals, home health, health systems, to be the home care arm of managed care organizations (MCOs). We want to solidify home care being a part of that, and for Senior Helpers to have a seat at the table and not be on the menu. It’s a strategic focus for the industry as well.
I think you’ll see, in the future, CMS and others asking, how do we make some financial contribution through these ACOs and MCOs to reimburse good decisions? And a good decision would be to let people live at home.
That’s why we look at Senior Helpers as being a health care company. When we first started, I didn’t want to be part of the care continuum, now I see it as a great strategy. We may not be providing home health services, but the services we provide help someone live at home safely, take their medications, don’t fall, see their doctors. [But] how do we look at partnering? Everyone talked about [home care] being non-medical, non-skilled. It would drive me nuts that you would lead with two negatives.
HHCN: Are you finding that other parts of the care continuum see the value in home care these days and are receptive to partnering?
Ross: We’re finding that health care systems and hospitals and home health organizations understand what home care can do for them. What they’re trying to do is navigate the reimbursement waters. Where I don’t live in that environment, they’re immersed in it.
We’re looking at Medicare Advantage companies. We’ve had pretty receptive conversations with some of these organizations that see value in home care and want to build an aide into their plan benefit coverage. I think they’re waiting for some kind of grand poobah to begin laying out some groundwork on how does this all flow through. No question we’re getting a lot of interest from these MCOs and ACOs to play a part in that system.
We’re also seeing a lot of interest from hospitals. We have hospitals in some parts of the country reimburse us for home care. Some franchisees have been contracted to help by the hospital, for a short-term respite kind of arrangement, because [hospitals] are concerned about those readmissions. The light are now on in our industry, saying there’s a way home care can play a role here. I think that’s a good thing. But we’re in uncharted waters, especially with what’s going on in D.C. right now. We still think the insurance providers are looking for ways to figure this out, and Medicare has to figure out how to sustain itself.
HHCN: What about workforce issues? We routinely hear that this is the biggest challenge for providers these days.
Ross: I’m also president of the Home Care Association of America. I get a chance to see a lot of independents and competitors, or “frenemies,” on the board. I think if you asked anybody, the No. 1 issue is recruiting and staffing.
When I first started, finding family caregivers was pretty common. It was pretty easy to hire someone with some experience and train the in the Senior Helpers way. About four years ago, we knew that dynamic was going to change. In years past, we said, “Where are we going to get our clients?” Now we ask, “Where are we going to get our caregivers?”
We developed Centers of Excellence, with a built-in training lab with a bathroom, hoyer lift, a weighted [mannequin] to use in transfers, so you can actually come in and learn ADLs. We began teaching these skills from scratch. It helped us get ahead of that curve maybe more than others in the marketplace, and now we have a pipeline of caregivers.
HHCN: And on the wage front?
Ross: Senior Helpers has always paid more, because you have to get good caregivers. As we see the minimum wage go up, I see it as a good opportunity to create a better environment from a compensation perspective for caregivers. You have to balance that and make sure that what you’re charging is a fair, reasonable rate. Home care in almost all cases will be the least expensive option for families by quite a margin.
In states that have increased the minimum wage—and we’re in 41 states—when you look at where the rate is going, we do see that as a good thing for the industry, to create a career opportunity for people told o something they really spiritually want to do.
HHCN: What about competitive pressures? There have been some new entrants into the sector in recent years, that have come in with a tech-forward approach and a lot of venture capital behind them.
Ross: In the last couple years you’ve seen Honor, Hometeam, HomeHero … I’ve talked to all of them. I think everyone was worried that was going to be a tech disruption, and change how it’s done. But I’ve seen how they’ve had to change their model since then. They’re becoming employers, [directly] employing their caregivers. They’re still using tech to communicate with clients, but a lot of us were doing that already.
Now that Honor is converting itself to an employer model, they’re like us. Maybe they’re using tech a little better than we are. They might have some bells and whistles more than we do, but we feel confident that client acquisition is not an issue for us. We have great referral sources. In this industry, you’re dealing with people on the community level, where 81% of your clients come from referral and the rest from advertising or the Internet. That’s a lot of people coming from hospitals or from others who have had a family member in need and say, I know someone who can help you. That’s why you don’t see a Microsoft or Apple in this business.
I think Honor’s a good company, I like the people managing it, but I look at them like I look at Home Instead, or Maxim, or Bayada. Another competitor. I think Honor will do well over time, but they’re going to be just like us.
HHCN: If you can swap your Senior Helpers hat for your HCAOA hat for a minute, what do you see for 2017 as the association president?
Ross: I think under the new administration, there’s still a lot to be understood, but from what I’ve seen so far, there’s a lot of opportunity for our industry to be front and center. I think we’ll get really good support for home care tax credits as well as over misclassification of workers. That is, home care companies trying to contract workers, which we feel is illegal, as it doesn’t meet IRS standards for what an independent contractor is … [Overall, I’m] very bullish on what’s going on in the industry.

In December, I was invited to participate in a panel discussion at the Opal Medical Device Summit in Scottsdale, Arizona. Minnetronix’ reputation for quality earned us a spot at the Summit that provides a platform for bench-to-bedside discussions and attracts professionals from Medical Device, Pharma, Biotech, and Drug Delivery industries. The 2017 summit included a series of discussions on topics such as 13485:2016 compliance, design control process, medical device innovation and funding, device connectivity, cyber security, lifecycle management, human factors, and combination products.
Specifically, I joined a moderator and another subject expert to discuss “Full Product Lifecycle Traceability: The Golden Key to Proof of Compliance.” An estimated one hundred people participated in the town hall forum. The panel discussed traceability best practices for compliance to ensure business and engineering alignment, information management, and contextualized communication from start to finish. Specific topics included:

• Importance of identifying critical to quality (CTQ) requirements: By identifying critical parts and processes in the design, extra rigor can be strategically applied to the critical areas of the design.
• Significance of traceability matrices for continuation engineering: Traceability matrices (Hazards -> System Requirements ->Software Requirements -> Tests) provide engineers with the tools to ensure that they are not missing the “big picture” when making changes to devices after initial release. Because these matrices provide the context to mitigate risk, they are invaluable continuation engineering tools.
• Need for manufacturing documents to trace from requirements: When manufacturing inspection and test procedures are requirements based, they lead to a consistent manufacturing output and a more robust product.
• Effective tools for tracking changes in requirements and design documentation: Rapid product to market design models introduce significant churn in design requirements. Because of this, it is important to have an effective tool to track changes in requirement and risk items. Additionally, it is critical to track their associated traceability to verification methods to support regression and impact analysis.
• Effective Quality Management System (QMS) Traceability: Having a QMS that provides outputs from one activity into the next and allows for feedback to previous activities as new discoveries are made are key because it gives you the ability to make accurate risk-based impact assessments.

In a single year, Minnetronix does numerous design iterations across multiple customers spanning all classes of medical devices, providing me with a unique and broad perspective to add to the discussion. At Minnetronix we believe that full product lifecycle traceability is critical to project success. Our protocol (or process) results in a comprehensive Design History File (DHF) and ensures alignment across internal and external customers. I view traceability as the “long term memory” of the design process, ensuring alignment and accountability.
Participating in conferences, such as the Opal Medical Device Summit, encourages the exchange of best practices and ideas that benefit the medical device industry. It also underscores Minnetronix’ commitment to quality as we create new technologies and therapies that solve unmet clinical and business needs for patients and medical device companies.

Santa Ana, CA Jan 17, 2017: It was after her mother suffered a stroke that Laura Harpster realized she had the skills and innate desire to care for others. Patience, empathy and helping patients adjust to their new lifestyle came easily to her. After her father‘s health declined, Harpster became his primary caregiver, finding it most rewarding when she saw how her efforts helped him be more independent, self-sufficient and happier overall.
In 2010, when the manufacturing recession hit, and Harpster lost her job, she knew it was time to put her newfound passion to good use and became a full-time caregiver at Senior Helpers, an organization providing dependable care to improve the quality of life of elderly clients and their families. Her kindness and endless devotion to the Orange County seniors under her care made her the perfect recipient for Fairhaven Memorial Park & Mortuary’s January/February Oliver Halsell Care Award.
“Laura possesses the qualities inherent in an Oliver Halsell Care Award recipient,” said Marla Noel, president of Fairhaven. “Throughout her life she has shown endless empathy and kindness toward the people she has cared for, family and patients alike.”
The Orange resident has been caring for the same client for over six years, helping her through her decline due to Alzheimer’s disease. Her day-to-day tasks range from housekeeping, hygiene care and meal preparation to social activities, including playing cards and going on outings. One of their favorite activities is to read from a memory book filled with anecdotes and stories of Harpster’s client, which they collected together when they were first matched.
When not working, Harpster volunteers her time at the Art Alliance of Yorba Linda. Harpster also creates whimsical greeting cards featuring photos of her own cats that she sells online. Her work as been featured in various arts and crafts festivals throughout Orange County.
“I’m very proud to be recognized with this award. Caregiving gives me the opportunity to make a huge difference in someone’s life,” said Harpster. “Being a good caregiver requires a delicately balanced set of skills to develop that very intimate relationship with your patient built on trust, patience, knowledge and gentle care. I am my clients’ eyes, ears and voice and they can always depend on me to be there for them.”
Fairhaven Memorial Park & Mortuary, which has facilities in Santa Ana and Mission Viejo, introduced the Oliver Halsell Care Awards honoree program in 2012 as a way to spotlight local residents who are making a positive impact in Orange County by showing care and compassion through work or volunteering.
In November 2017, Harpster will be presented with her award at Fairhaven’s Oliver Halsell Care Awards ceremony at its Mission Viejo facility. The Care Award banquet will recognize six honorees’ accomplishments awarded during the coming year. Additionally, Fairhaven will make a donation on her behalf to her chosen charity, the Alzheimer’s Association.
Fairhaven is accepting nominations for the 2017 Oliver Halsell Care Awards. For more information and to nominate an outstanding citizen, call 714-633-1442 or email CareAwards@FairhavenMemorial.com.
Visit dignitymemorial.com for more information.

Austin, TX Jan 5, 2017: Senior Helpers®, the nation’s premier provider of in-home senior care, today announced that America’s oldest veteran, Mr. Richard Overton, has selected the company to provide in-home care. Overton, a 110-year-old World War II veteran, resides in Austin, Texas, and is currently in need of full-time care. In an effort to help pay for the expense, his cousin, Volma Overton, has set up a GoFundMe page, where supporters can donate to the cause.
“Though my cousin is still sharp as a tack at 110-years-old, it’s been getting harder and harder for him to care for himself,” said Volma Overton. “I was recommended Senior Helpers by a friend of mine and I’m relieved to have a company that cares about his well-being as much as I do. It eases my mind to know he will have 24/7 care while living in the home he built for himself over 70 years ago.”
Senior Helpers is a nationwide franchise, and Senior Helpers of Central Texas serves the state’s Austin, Georgetown, Round Rock, Cedar Park, and Lakeway communities. Frank Hayes, owner and president of Senior Helpers Central Texas, opened the local franchise in 2009 and has been committed to helping both veterans and civilians alike. Hayes is also passionate about educating the veteran community about the Aid & Attendance program, and works to ensure veterans are aware of in-home care benefits they are able to receive.
“As a veteran myself, I have made it my personal mission to help as many United States veterans as possible, so it is an honor for our company to provide care for Mr. Overton,” Hayes said. “Most senior citizens would prefer to stay in their own homes as they age and Mr. Overton is no different. We’re pleased to offer a service that allows him to remain happy at home, where he is most comfortable.”
Founded in 2001 with a vision to help seniors who wish to remain in their homes – despite age-related illnesses and mobility challenges – Senior Helpers serves elderly individuals and their families around the world. Senior Helpers differentiates itself with its proprietary, specialized programs that have been developed in collaboration with leading medical experts. The company was the first provider in the industry to offer specialized care services for individuals with Alzheimer’s, dementia and Parkinson’s disease.
To learn more about Mr. Overton and his efforts to raise funds which will enable him to stay in his home as he continues to age, please visit his GoFundMe page. For more information about Senior Helpers, visit www.seniorhelpers.com.
About Senior Helpers
Senior Helpers is a premier in-home senior care provider in the U.S. with over 285 franchised businesses operating across the globe. Founded in 2001 with a vision to help seniors who wish to remain in their homes despite age-related illnesses and mobility challenges, Senior Helpers has now cared for tens of thousands of seniors with a pledge to provide “care and comfort at a moment’s notice.” Senior Helpers offers a wide range of personal care and companion services, including trained Alzheimer’s, dementia and Parkinson’s care, to assist seniors who wish to live independently. Learn more by visiting www.seniorhelpers.com.
Contact:
Melissa Masters
Havas Formula
(619) 234-0345
seniorhelpers@havasformula.com

Plano, TX Dec 8, 2016: GAFFEY Health continues to deliver against the financial demands of its customers by expanding the company’s ability to provide a suite of Revenue Cycle automation tools in a cost effective manner. Data Acquisition from disparate core operating systems is the single largest challenge for Healthcare Providers in being able to access and utilize RCM software tools today to ensure that services are paid for correctly and in a timely manner. The complexity of this challenge is accelerating rapidly with the vast number of value based care models that demand integration of a larger number of disparate data sources.
GAFFEY’s Integration Engine is a healthcare data management and integration platform that is capable of taking virtually any form of health-related data such as 837, 835, and other x12 EDI data (270/271 Eligibility, 276/277 Claim Status, etc.) to create a standardized common data structure so that data can be leveraged in a multitude of ways. This data structure is the foundation of GAFFEY’s current applications such as AlphaCollector, Claims Management and AutoStatus. Providing a standardized method of data import and mapping ensures that future application development is greatly accelerated because the GIE allows for immediate and cost effective access to EDI and other data transactions. The data acquisition and mapping tools the GIE provides will dramatically reduce the cost of data acquisition and thus open up traditional Revenue Cycle tools to any healthcare provider regardless of size and complexity.
“Data acquisition and management has always been a struggle for healthcare providers,” stated Derek Morkel, GAFFEY CEO. “We recognized that being able to provide a seamless and easy to use standardized data mapping and integration platform will transform our ability to deliver all of our tools in a much more cost effective manner to all healthcare providers regardless of size.”
GAFFEY Healthcare provides revenue cycle technology and services that enable health care organizations to accelerate cash flow, improve productivity and increase profitability with short-term and demonstrable ROI. From patient eligibility and payment verification to billing and claims management to third-party collections, their software relies upon cloud-based, state-of-the art workflow supported by a business intelligence platform. GAFFEY’s systems are in use at more than 200 healthcare systems and physician practices across the U.S.
For more information contact:
Jennifer LeMieux
GAFFEY Health
jennifer.lemieux@gaffeyhealth.com

Austin, TX Nov 23, 2016: HealthTronics and the Texas Stars are partnering for the third year in a row to help raise awareness and funds for Movember.
Russell Newman talked to Fox 7 Austin about the collaboration. Click on the link below to watch the entire interview.
http://www.fox7austin.com/good-day/218721068-story

Austin, TX Nov 18, 2016: Connected technology is increasingly becoming an integral part of our everyday lives. It is particularly important for healthcare companies to prepare to maintain the security of these devices.
Click on the link below to read the full article.
http://machine-to-machine.cioreview.com/cioviewpoint/iot-and-its-acceptance–nid-23353-cid-113.html