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Cigar Review

5 Vegas Limitada 2019  | Toro Honduras                   6.0” x 50                    Medium                93-Rated I always look forward to this annual release. The 2019 variety is blended with aged ligeros from the Dominican and […]

5 Vegas Limitada 2019  | Toro
Honduras                   6.0” x 50                    Medium                93-Rated

I always look forward to this annual release. The 2019 variety is blended with aged ligeros from the Dominican and Nicaragua bound by a genuine Cameroon leaf. A chestnut-brown Nicaraguan wrapper completes the cigar. I find this handmade to be medium in body, but rich and smooth throughout. I get notes of espresso bean and oak up front and sweet cedar on the finish. Now and then a peanut-like flavor from the Cameroon binder shines through. The finale has a dash of pepper, completing a complex yet soothing cigar fit for anytime enjoyment.

CAO Flathead V19  | Robusto
Nicaragua                       5.5” x 50                      Full             94-Rated

Dark and oily. Solid from head to toe. Heavy in the hand. CAO Flathead V19 is a dense handmade with a luxurious, barnyard pre-light aroma. Well-aged long-fillers from Nicaragua and the Dominican reside within a Connecticut Habano binder, which is then hugged by a dark chocolate brown Connecticut Broadleaf wrapper. I find this to be CAO’s fullest and most flavorful blend to date. Rich, dense smoke offers notes of leather and earth, while a semi-sweet molasses lingers on the aftertaste. I enjoy this cigar after a big feast from the grill.

Diesel Whiskey Row Sherry Cask  Gigante
Nicaragua                   6.0” x 58                     Medium                       92-Rated

A dark, toothy Connecticut Broadleaf wrapper conceals a vintage blend of Nicaraguan long-fillers secured by a feisty Arapiraca binder from Brazil. The binder, which has been patiently aged in oak sherry casks, lends layers of flavor to an already complex bouquet. Sweet cedar and bittersweet chocolate mingles with pepper and a unique, stone fruit nuance on the finish. A satisfying and eventful profile, that’s smooth, medium in body and would pair extremely well with a bold red wine, port or aged bourbon.

TatuajeMexican2

Tatuaje Mexican Experiment II  | Belicoso
Nicaragua                    5.0” x 52                       Full                         94-Rated

Big, heavy in the hand, dark and oily, solid from head to toe and softly box-pressed. That’s the look and feel of this 60-ring Man O’ War. From the get-go, the flavor is bold and pronounced. An earthy spice blasts the front of the palate, while each puff pumps out thick, pillowy clouds of gray, aromatic smoke above. The spice mellows after an inch, giving way to notes of leather and oak that linger long on the aftertaste. Midway through, the cigar grows more powerful down to the nub, with satisfying spices returning just before the end. A complex and eventful cigar.

ZinoScepter

Zino Platinum Scepter Series  | Grand Master
Nicaragua                     5.5” x 52                           Mellow                      93-Rated

To me, a good cigar is something I can light up, enjoy and not think about. If I’m thinking, something is off. With the Scepter Series, everything is on. Every Grand Master I’ve ever had has been perfectly soothing and smooth. I find it elegant, displaying subtle hints of coffee and cream with a touch of nougat and nuts. The smoke is velvety, forming thick clouds of white smoke and a sweet, cedar aroma. Few cigars pair as well with coffee than this Connecticut-wrapped, Dominican and Peruvian-filled premium.

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Four Season Resort at Sayan, Bali

Nestled on a hillside on the banks of the Ayung River in Ubud, Bali sits the five-star Four Seasons at Sayan Resort.  Named by Travel and Leisure as the #1 resort in the world in 2018, the Four Seasons at Sayan is a stunning resort that WOWs guests immediately upon arrival. The entrance to the […]

Nestled on a hillside on the banks of the Ayung River in Ubud, Bali sits the five-star Four Seasons at Sayan Resort.  Named by Travel and Leisure as the #1 resort in the world in 2018, the Four Seasons at Sayan is a stunning resort that WOWs guests immediately upon arrival. The entrance to the lobby is dramatically positioned at the end of a suspension bridge set high above the treetops where guests descend from the roof above.  The bridge ends at an infinity-edge lotus pond with 360 views of the terraced rice paddies, river, and jungles below.  This open-air pavilion leads down through a spiral staircase to the main restaurant, spa, gym, and the resort’s 18-acre property.

Architect John Heah incorporated the natural beauty of the surrounding area, which is part of the Unesco World Heritage listed irrigation network to transport guests into a tropical paradise, removed from the hustle of Ubud.  With only 60 accommodations, which include 18 suites and 42 villas, this Four Seasons is uncommonly smaller, which makes their guest to staff ratio incredibly high.  The staff prides itself in calling their guests by their names within hours of check-in.

The 42 villa accommodations feature huge private plunge pools, outdoor living space with Bali beds, and four-poster king-size beds; complete with elaborate canopy netting. The décor is a blend of contemporary and traditional Balinese features that include complimentary incense, snacks, tea/coffee, and nightly turndown is highlighted with a small vial of essential oils that promote a well-nights-rest.   Complimentary services for all guests include cooking classes, garden tours, several yoga classes, and free transfers into the town of Ubud every 2 hours.  The yoga pavilion is an open-air bamboo yoga hut which is positioned among the rice fields.  The pavilion specializes in anti-gravity yoga, and several classes are offered (additional fees apply).

With three dining options, as well as in-room dining, the various restaurants incorporate produce grown on their property as well as infusing their menu with Indonesian specialty dishes.  Known for creating intimate in-destination experiences, the Four Seasons at Sayan has designed several unique Balinese excursions for guests to get up close and personal with their surroundings at an additional cost.  These options include: private rafting down the Ayung River (with access to the river from the resort), biking through the Kintamani Village, a secret bathing ritual at a very secluded ancient water temple or experiencing a day in the life of a Balinese rice farmer.

The Four Seasons Resort at Sayan celebrated its 20th year in 2018 and continues to deliver an authentic Balinese experience combined with five-star luxuries that exceed expectations.

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Calling All Homebuilders: The Lehigh Valley Housing Market Needs More Supply

The Greater Lehigh Valley REALTORS® (GLVR) reported August data showed another impressive summer month, but also showed how new construction could greatly improve the real estate market – both locally and nationally. “As the summer draws to a close, multiple opposing factors and trends are competing to define the direction of the real estate market,” […]

The Greater Lehigh Valley REALTORS® (GLVR) reported August data showed another impressive summer month, but also showed how new construction could greatly improve the real estate market – both locally and nationally.

“As the summer draws to a close, multiple opposing factors and trends are competing to define the direction of the real estate market,” said GLVR CEO Justin Porembo. “Despite the Federal Reserve lowering its benchmark interest rate, resulting in 30-year mortgage rates declining to 2016 levels, the lack of affordable inventory and the persistence of historically high housing prices have led to lower-than-expected existing home sales.”

Low inventory numbers impact the nation’s overall economy, according to Lawrence Yun, chief economist for the National Association of REALTORS®. “A boost to home building would greatly improve economic growth,” he said. “More free-market prices on construction materials without government interference about where homebuilders have to get their supply will also help produce more and grow the economy. The housing industry cannot grow without more supply.”

That said, as many homeowners refinanced their homes to take advantage of declining interest rates, consumer confidence in housing was reported to be at historically high levels.

“Our real estate professionals continue to monitor the market for signs of imbalances,” said GLVR President Carl Billera. “Although the inventory of affordable homes at this point remains largely stable, it is stable at historically low levels, which may continue to push prices higher and affect potential buyers.”

Notable market stats for August

New Listings decreased 9.8 percent to 1,014. Pending Sales were up 14.1 percent to 856. Inventory levels shrank 22.4 percent to 1,737 units, leading to a Months Supply of Inventory that dropped 25.0 percent to 2.4 months.

Prices continued to gain traction. The Median Sales Price increased 4.8 percent to $220,000, coming in just below July’s record-setting Median Sales Price of $222,000. Days on Market was up 3.2 percent – just a one day difference – to 32 days.

In Carbon County, the Median Sales Price dipped to $130,500. Closed Sales and Pending Sales climbed to 74 and 80, respectively. There was a decrease in Inventory, which came in at 334 units.

More on the Lehigh Valley’s Market Trends

As the premier source of real estate information in the Lehigh Valley, the Greater Lehigh Valley REALTORS® is pleased to provide in-depth data on the housing market. The research is collected from its Multiple Listing Service (MLS) that compiles data from over 2,500 REALTOR® members. Visit www.GreaterLehighValleyRealtors.com and visit the “Market Trends” page to learn more.

For the most current and accurate data, contact a REALTOR®.

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Lehigh Valley: HOTTER THAN EVER – The Lehigh Valley is Booming!

With a nationwide trend for living in neighborhoods where you can “walk to” shopping, eateries, and transit, everything old is new again. From baby boomers who grew up on the outskirts of Philadelphia who are moving back to revitalized urban-suburban cities like Bethlehem, Allentown, Easton, to the money-conscious millennials who find added lifestyle value and […]

With a nationwide trend for living in neighborhoods where you can “walk to” shopping, eateries, and transit, everything old is new again. From baby boomers who grew up on the outskirts of Philadelphia who are moving back to revitalized urban-suburban cities like Bethlehem, Allentown, Easton, to the money-conscious millennials who find added lifestyle value and benefits cities have to offer; developers are jumping on board to meet the challenge.

We also live in a world where e-commerce and consumer demand for overnight shipping has facilitated the need for storing goods and warehouses are popping up throughout the Lehigh Valley. Many properties currently used for farming were zoned for Industrial Uses decades ago, increasing their value in a competitive market. Since these vast parcels can accommodate the new mega warehouses that have grown from thousands of square feet—to millions, e-commerce, manufacturing and distribution giants including Amazon, Walmart, UPS, Fed Ex, and QVC/HSN, have already taken a piece of the pie in the Valley. This has also created jobs, and since people like to live near their workplace, it has created a demand for housing, single-family as well as apartments, in and out of the cities.

Since the Lehigh Valley offers close proximity to a large network of major roadways and interstates, it benefits both industry and residential communities, not to mention the need for retail and service space, medical facilities, school expansion, transit, and other community amenities.

To get a better comprehension of the project types being driven in response to economic development and lack of residential inventory, here are a few examples of projects Maser Consulting is engineering:

 

SunCup, City of Bethlehem
JVI, LLC

This manufacturing facility is located on Easton Road in the City of Bethlehem and includes the initial construction of a 178,579 sf manufacturing building on a 13.65-acre site. This project is located on a Brownfield that formerly was used by Bethlehem Steel and Mineral Fiber Specialties.  SunCup employs 53 employees for each shift and produces beverages for Institutional users.  Deliveries to this site utilize tractor-trailer deliveries from a PennDOT Highway and by train via a rail spur extension from the adjacent Lehigh Valley Rail Management line.

 

Lehigh Hills Apartments
The KRE Group

To meet the need for upscale residential apartments in the Lehigh Valley, The KRE Group is proposing to add to their existing portfolio of apartment developments with the upcoming construction of the Lehigh Hills project in Upper Macungie Township.  The KRE Group has developed similar projects at Madison Farms in Bethlehem Township and Spring View project in South Whitehall and Upper Macungie Townships. The 50+ acre site, currently being used for agriculture, is slated to contain a total of eight buildings (7 apartment buildings and a clubhouse) with 273 apartment dwelling units with typical appurtenant site improvements.  The proposed recreation amenities include a clubhouse, fire pit, tot lot, community gardens, dog run, pool, and open space areas.  The site was developed utilizing a conservation design approach and preserves 30 acres of woodlands, wetlands, and steep slope areas.

Conclusion

Different factors historically push urban sprawl and demographics. In today’s world, it’s technology, automation, and demand. According to the Lehigh Valley Economic Development Corporation (LVDEC), the Lehigh Valley region “…is one of the fastest-growing industrial markets in the country.” It is geographically positioned in the right place at the right time to reap the benefits that growth will continue to bring.

 

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Bio:     C. Richard Roseberry, PE, AICP
Principal/Geographic Discipline Leader, Civil/Site
Maser Consulting P.A. 

Mr. Roseberry has over 30 years of extensive experience in Municipal and Private Development engineering services. His diversified expertise in civil engineering includes roadway and utility design; site layout; permitting; sanitary sewer collection systems and rehabilitation; stormwater management; zoning and land use planning.

Mr. Roseberry is a certified instructor for the Pennsylvania Municipal Planning Education Institute, a Certified Public Works Manager, Licensed Wastewater Collection System Operator, LEED Green Associate, and is a licensed professional engineer in New Jersey, Pennsylvania, Delaware, West Virginia, Massachusetts, and Connecticut.

 

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Recession Proof Real Estate In a Year of Major Volatility is Anything Recession-proof?

Real estate investing CAN be recession-proof, believe it or not.  When choosing the right property, you need to take every detail into account.  Ask yourself these questions first… Why are you buying this? Do I expect passive income, retirement income, flip income, first home, second home, and at any point can the property be rented?  […]

Real estate investing CAN be recession-proof, believe it or not.  When choosing the right property, you need to take every detail into account.  Ask yourself these questions first… Why are you buying this? Do I expect passive income, retirement income, flip income, first home, second home, and at any point can the property be rented?  If the property has the ability to be rented easily at an affordable monthly rate and you are in the positive after all mortgages, insurance and taxes are paid, then you may pass GO.  (I mention this because situations change and there could be a time where you are unable to sell it, but the property would do fantastic as a rental)  Does the property need repairs and how much in repairs?  Have the major systems been replaced recently, such as the roof, furnace, and windows?  If the amount of repairs are minimal and all you need are some carpet, paint, and cosmetics, then this paves a positive path for you regardless of the reason you are purchasing.

What about the purchase price? Of course, that is the most important piece to all of this! Are you buying in the height of the market and paying a high premium, or are you buying on a downswing of the market?  To be honest what it really means is that when you buy real estate in a seller’s market and are paying a higher price than in a down market, you need to be mindful of why you are purchasing it and when you plan to sell the property.  If you plan on holding this property for some time and are going to rent it, remember your mortgage balance will be paid down through the rent you charge.  If you are planning to live in the home and sell in 5 or 10 years, you will need to sell it in a market identical to when you purchased it, if you bought it at a premium price, this is why timing is everything.  Keep in mind there are opportunities in every market, you just need to find them!  I have heard this saying over the years, and it does resonate with anything you invest in…. Buy Low, Sell High or Buy High, Sell High, simple concept right?

How is real estate recession-proof?

You need to be aware of your financial position with any purchase in real estate and always prepare for a market swing, if you do this you CAN create a recession-proof real estate. Yes, there will always be a fluctuation in the value, but if the property can be rented, you are still in the positive.  As you rent the property over several years and your mortgage balance is paid down, you will also have equity in the property.  If you purchased the property to live in or as a rental and you updated the property with your own money or the money you made as profit that will help gain equity in the property when you sell it at a later date.  If you purchase the property in a dip in the market and the value doubles when you sell in the right market, you again are in the positive.  It is all about how you purchase the property, that you make an educated decision and have a professional alongside you to guide you through the process.   Even in an upswing, you can make money in real estate.  Full disclosure you can make mistakes and lose money in a down market, which should not happen.  I will be honest and say it is not for everyone, and HGTV makes it look super easy!

At the end of the day always make decisions with your eyes wide open, educate yourself, choose your position wisely, and await the positive outcome!

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Give Until it Feels Good

As we near the end of the year, it’s time to drill down on the best charity for your personal or professional giving. You’ll be asked by many charities to help or donate, and in my view, the charity and its mission need to “speak to you.” The tax break is great, but giving of […]

As we near the end of the year, it’s time to drill down on the best charity for your personal or professional giving.

You’ll be asked by many charities to help or donate, and in my view, the charity and its mission need to “speak to you.” The tax break is great, but giving of your money (or time) should matter.  Here are some basics on how you can research and select the right charity for your giving.

Start by clarifying your values. 

What is important to me?

  • sick children?
  • the hungry or homeless?
  • endangered animals?
  • the environment?
  • big picture causes that have touched you or your family?

Does it matter if the charity is local, regional, or national?

Do you want to support a large or small charity?

Once you’ve answered those questions, it’s time to research charities that fit your values and goals. If Googling “charities to donate to” seems daunting, you can use websites to whittle down where you want to donate by cause or location. Some good resources are Charity Navigator (charitynavigator.org), GuideStar (Guidestar.org), and Great Nonprofits (GreatNonProfits.org).

Once you’re there, look at the charity’s description on one of these sites and compare it to what you see on their website.  Which ones speak to your heart?  You also want to look at it like a business.  Make sure those you’ve narrowed your focus on are legit.  Are they a 501c3?  If it’s not showing up on these charity checking sites, ask the organization you’re considering to see its “letter of determination.”  If it’s faith-based, ask to see an official listing in a directory for its denomination.  Reputable organizations will be transparent and willing to define their mission and have measurable goals.  You’re essentially being a savvy entrepreneur and using the same criteria to measure their work and the ROI.  Avoid charities that won’t share information or pressure you.   That goes for those that won’t take no for an answer, too.

For my company, we’ve tried to spread the wealth.  We support a variety of charities with monetary donations, but we spend time and donate services with the following.  Bear with us while we explain our criteria.

Local:  Pediatric Cancer Foundation Lehigh Valley (https://www.pcflv.org/)

This is a donation of time.  I serve on the Marketing Committee for PCFLV.  Countess Communications has also sponsored their annual walk.

 

Regional: Star Treatments (http://www.startreatments.org/)

This is a donation of money, time, and services.

The charity is based in Michigan but reaches the Tri-state area by helping sick children to get to and from their doctor’s appointments in luxury transportation.  We make a monthly donation plus donate video services.  We’ve met amazing families here in the Lehigh Valley and partnered with wonderful local supporters to do fundraising work for this one.  In fact, our next fundraising event features the fabulous magician, Denny Corby, and is being held on November 22 at the Barrister’s Club in Allentown (hint hint)! Event details are below.

 

National:  American Heart Association-Lehigh Valley (https://www.heart.org/en/affiliates/pennsylvania/lehigh-valley-northeast)

This is also a donation of time and services.

My husband and I both lost our Father’s to heart disease.  This was a no brainer, and we like the team that leads the local office.  I serve on the Heart Ball Committee, and we also produce the video that is shown at the annual Go Red luncheon each May.

While these are just a few of our personal picks, there’s an overwhelming amount of charitable organizations that deserve your time and money.  Finding and supporting a cause you care about doesn’t have to be overwhelming.  Once you find nonprofits that align with your values, you’re well on your way.

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The Economic Case for an Accurate Census Count

The United States Census Bureau has begun operations across the country for the 2020 Census. The Founding Fathers included the mandatory headcount in our Constitution because they valued evidence-based policy-making. The census began in 1790 as an innovative data gathering operation and continues today to serve as the foundational data set that informs business, economics, […]

The United States Census Bureau has begun operations across the country for the 2020 Census. The Founding Fathers included the mandatory headcount in our Constitution because they valued evidence-based policy-making. The census began in 1790 as an innovative data gathering operation and continues today to serve as the foundational data set that informs business, economics, and overall society. However, there are escalating concerns that the Census Bureau’s goal to count everyone once in the right place may be jeopardized by a number of factors leading into the decennial count. The threat of an inaccurate count is very concerning for American businesses, who rely on information derived from the census every day to make material decisions that create jobs and grow our national economy. As Howard Fienberg, vice president of Insights Association, stated in a recent Congressional hearing, “the trickle-down impact of an inaccurate 2020 Census would restrain or ruin American businesses for a whole decade.”

Why does the census matter for businesses?  The census is a crucial tool that provides information about the characteristics of the population that no other survey produces. Accurate data from the count is critical to informed decision-making in both the private and public sectors.

Specifically, the census provides businesses with vital demographic information about customers, the workforce, and the economic landscape that is used by companies of all sizes in every industry sector. Population data from the census helps companies assess concentrations of skilled workers, neighborhoods to open a new store or office, and what products to offer.

What exactly is at stake for the Lehigh Valley?  In Pennsylvania, we receive $39 billion each year from Federal allocations using census-derived data.  Funding supports programs ranging from investments in infrastructure and technology to supporting healthcare and education. In forecasts of low-response rates for the count, there are many areas of the Lehigh Valley in which 30% or more of a census tract are predicted to be unresponsive. For each person not counted, the Lehigh Valley loses $2,093 per person per year.  An undercount of the estimated 670,000 Lehigh Valley residents puts federal funding at risk, while also decreasing the amount of representation our community has in government. Current predictions show Pennsylvania losing one congressional seat after the 2020 census. Unfortunately, there is increased national risk of an inaccurate count due to underfunding of the Census Bureau, the launch of a new online platform, and an overall polarized social climate.

An undercount will impact the private sector dramatically on everyday decisions, and subsequently, have an impact on the lives of Lehigh Valley residents. For example, utility companies would not know where to site new cell towers, electric transmission lines, or water lines, so certain communities would go without enough coverage while others might end up unnecessarily over-saturated. To put it simply, without accurate census data, Lehigh Valley businesses can’t know what the Lehigh Valley needs.

What can Lehigh Valley businesses do? In the face of these challenges, the private, public, and nonprofit sectors all over the nation have stepped up. After all, there is no better return on investment than ensuring the Lehigh Valley has accurate data that businesses need, and the region receives the correct federal allocation of funding and is represented adequately in our government.

Below are ways in which the private sector can make an impact on the count:

  • Fill out the census, and encourage employees, customers, and residents to complete the census, too. Become an official partner with the Census Bureau to distribute information as a valued and trusted voice in the Lehigh Valley.
  • Consider joining one of the six different complete count committees, made up of local business, government, and nonprofit leaders, which have formed at the local and county levels to ensure that everyone is counted.
  • Contribute to the Lehigh Valley Community Foundation’s Census Equity Fund. The Lehigh Valley Community Foundation is providing funding, training, building awareness, and championing efforts across the Lehigh Valley to ensure an accurate count.

The 2020 census will have an impact on the local and national economy. If census data is not accurate or has limited quality, businesses may face challenges in making good decisions, which can affect their bottom lines and our communities for the next ten years.

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Telehealth: Are We Ready for Better Healthcare at a Lower Cost?

Healthcare, specifically its cost and equitable delivery, is perhaps the most significant domestic social and political agenda of our times. According to the Centers for Medicare and Medicaid (CMS)[1], healthcare-related costs was 17.9% of US GDP (~$3.5 trillion dollars) in 2017. In a recent analysis by Fortune[2] U.S. healthcare costs are projected to become 19.4% […]

Healthcare, specifically its cost and equitable delivery, is perhaps the most significant domestic social and political agenda of our times. According to the Centers for Medicare and Medicaid (CMS)[1], healthcare-related costs was 17.9% of US GDP (~$3.5 trillion dollars) in 2017. In a recent analysis by Fortune[2] U.S. healthcare costs are projected to become 19.4% of GDP by 2027. While we have the most innovative healthcare system in the world in terms of discovering new treatments, we are ranked 27th in the world when it comes to overall healthcare outcomes[3]. To put things in perspective, we have the most powerful military in the world, and it costs us only 3.1% of our GDP. There are a number of reasons contributing to this massive disparity between investments in research, cost of care and outcomes and parsing that is beyond the scope of this article.

So where are we headed into the future?  Is there any hope for us to get quality healthcare at a reasonable cost?

Telemedicine/telehealth represents a growing sector within healthcare which has the greatest promise to bend the cost curve while providing better health outcomes. It intends to transform the current paradigm of care delivery through innovative internet-enabled technologies. According to the New England Journal of Medicine, [4] Telehealth is defined as “the delivery and facilitation of health and health-related services including medical care, provider and patient education, health information services, and self-care via telecommunications and digital communication technologies. Live video conferencing, mobile health apps, “store and forward” electronic transmission, and remote patient monitoring (RPM) are examples of technologies used in telehealth.” While some draw parallels to the holographic doctor in the 1990s T.V. series Star Trek, telemedicine is no longer science fiction. An example of a deployed telehealth solution is Project ECHO (Extension for Community Health Outcomes) that is currently in 130 sites in the U.S. as well as in 23 countries. Started in New Mexico by Sanjeev Arora M.D. in 2003, the goal of project ECHO was to extend access to specialists in the care of patients in remote locations, especially in rural areas. This resulted in reducing wait-times to see some specialist from 8 months to 2 weeks while also lowering the cost burden on the healthcare system and dramatically increasing the health and satisfaction of patients![5]

In every instance where telehealth solutions have been deployed, access to care immediately becomes more equitable, easy to get to, and less expensive. More excitingly, over the long run, with data gathered from individual patients, dramatic improvements in health outcomes are possible as it enables personalized medicine through artificial intelligence and machine learning.

The vision of the Affordable Care Act, the largest change to our healthcare system in 30+ years, was to move our entire healthcare model away from fee-for-service to evidenced-based care. In this paradigm, digital health is a critical component – starting with electronic medical records to link payers, providers, and patients seamlessly with data. While a number of states and private payers are investing, innovating and deploying telehealth-based care, there are many social, political and legal barriers that are continuing to prevent telehealth from reaching its full potential of providing Americans with cost-effective quality healthcare. It is important to emphasize that the barriers are not in technology! Here are some.

Resistance from incumbents: The current healthcare system is a physician and provider (hospital, clinic) centric model. This model ensures that a patients’ visit is private, safe, and secure. A physician, in addition to looking at objective data such as lab results, vital signs, and other measurements, also relies on subjective cues that have been honed from decades of training. Telehealth platforms disrupt this normal physician-patient interaction. Furthermore, physicians need to be re-trained on how to interact with patients who are at a remote location. What kind of video streaming is needed? How to perform a virtual patient examination? How does one keep this private? What are the liabilities involved? These are some of the questions that are being raised and actively debated.

Non-uniform national legislation: Because of the hesitation among care providers towards adopting telehealth, policymakers are at a loss on structuring workable rules and legislation around telehealth. A number of state-level pilots are ongoing around the country to determine what works best. These are, however, very ad-hoc local attempts occurring through regional grants with a focus on care accessibility and not so much on savings to the payers. As a result, the data and the lessons learned are spotty and un-coordinated.

Poor re-imbursement: Because the various pilot studies are not measuring true costs and accurately capturing return on investments (ROI), current re-imbursements for telehealth are a miniscule fraction of a physical visit. Neither the physicians, providers, or telehealth technology delivery organizations are able to capture sufficient and sustainable revenue. While a remote visit does cost less than a physical visit, the providers have locked in costs with their current infrastructure that is required to support a traditional physical visit. As a result, unless reimbursements are made higher at least on the outset initially, there is a disincentive to adopt telehealth.

Individual preference: Without elaborating this extensively, some people prefer to have a physical visit no matter how easy, convenient, or cost-effective a virtual visit may be. This is especially true in the generation group that is not digital-natives. The problem is compounded because individuals with insurance do not see the full cost of care, and this lack of transparency does not create any incentives to change to a lower-cost delivery model.

There are a number of organizations, including ours (www.chromologic.com) that are working on making telehealth a reality by focusing on reducing the friction in adoption, access, and cost. We work directly with the U.S. Department of Defense to address their needs for easy and rapid enrollment and verification of wounded warfighters and civilians at the point of need using a unique and dual secured biometric scheme. This technology is also making access to telehealth solutions frictionless in multiple civilian care delivery settings in the Los Angeles area.

The promise of telehealth in terms of reducing cost for better care is real. The adoption can be accelerated once we have a more focused national-level effort that is based on evidence gathered from the multiple pilots that have occurred/occurring around the nation. It is this authors belief that we are at a tipping point where a radical shift towards telehealth centric healthcare system is inevitable. But in this current political climate, we may have to be patient.


 

[1] https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsHistorical.html

[2] https://fortune.com/2019/02/21/us-health-care-costs-2/

[3] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31941-X/fulltext#seccestitle160

[4] https://catalyst.nejm.org/what-is-telehealth/

[5] https://mhealthintelligence.com/features/is-project-echo-the-telemedicine-model-that-healthcare-is-missing

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Life Sciences: Understanding the basic differences between Validation and Calibration

The Life Sciences market is evolving at breathtaking speeds these days, and the rapid rise in product innovation and cell therapy technology across the life science market is calling for companies to have a more robust quality and compliance approach in order to meet regulation and produce safe and reliable products. Good manufacturing practice (GMP) […]

The Life Sciences market is evolving at breathtaking speeds these days, and the rapid rise in product innovation and cell therapy technology across the life science market is calling for companies to have a more robust quality and compliance approach in order to meet regulation and produce safe and reliable products.

Good manufacturing practice (GMP) regulators in the United States the European Union and other internationally recognized GMP regulators have sharpened their focus on quality and compliance practices. Driving this trend is a shift in regulatory thinking from quality-by-test to quality-by-design systems/processes with emphasis on the level of risk to product quality and patient safety.

There’s an increased emphasis by regulators in the Healthcare and Life Sciences (HLS) industry to comply with rules and regulations across all aspects of their business, such as development, design, equipment operation, processes, test methods, standard operating procedures, computerized systems, and data security amongst other things. Realizing there is an urgency for growth, leadership, and knowledge that can serve and grow with our ever-changing industry, I wanted to share some basic insights from within my profession that seem to come up more often as people enter the regulated space of the Life Sciences industry.  Validation, calibration, and qualification are extremely critical in Healthcare and Life Sciences processes. Understanding them is necessary in order to meet GMP guidelines.

I’m often asked; “What is the difference between calibration vs. validation – are they the same? Is one a subset of the other?”

“I am still struggling to separate the two from each other – Can you provide me with a definition of Calibration vs. Validation and how the two differ.”

At the most basic level, calibration indicates the error of an instrument and measurers for any lack of trueness by comparison against a reference standard and validation stands for a process of testing and documenting.

Many people in the Healthcare and Life Sciences industry know the terms, but not everyone is aware of the differences.

Just a little insight will help you understand the differences between them.

Validation is the documented act of demonstrating that a procedure, process, and activity will consistently produce results meeting predetermined acceptance criteria. Pharma & Biotech’s most common way of establishing evidence or documenting test results is through the implementation of Protocols. Protocols, such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), along with essential design and planning documents such as User Requirement Specification (URS) and Validation Master Plan (VMP) are the building blocks of the validation framework.

Why is this essential? ‘If it’s not written down, then it didn’t happen!’

The FDA requires establishing documented evidence that a specific process will consistently produce results meeting specifications and quality attributes. Without supporting documentation, one runs the risk of being out of compliance.

Calibration on the other hand specifically refers to measurement devices, instruments and tools that record, monitor, and control environmental conditions or parameters. Calibration can also be defined as a process that demonstrates a particular instrument or device to produce results within specified limits with reference to a traceable standard over a range of parameters. This process also includes the adjustment of an instrument to realign with the acceptable standard.

Taking measurements involving any GxP process requires calibration to ensure the accuracy of the measurement. Instruments that record, monitor, control critical environmental variables require calibration. Instrument calibration must be enforced on a regular basis to ensure reproducible results. GMPs require written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment.

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Understanding these generally basic concepts are an integral step to understanding quality assurance and the many different aspects of compliance in the Life Sciences industry. It all might seem like a long, drawn-out process, but there’s a good reason for it. If you can ensure your products perform consistently and meet all the requirements of the industry, the value of both the product and patient safety increases. Along with this increased value comes a greater need to understand that the work we do matters, and that helping Life Science organizations ensure compliance and consistency with current regulations when carrying out commissioning, validation and qualification projects in a safe and efficient manner ultimately leads to saving lives.

 

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Passing the Smell Test – How Does it Work When it Comes to Medical Marijuana

Other than the fact that all marijuana is a Schedule 1 drug under the Controlled Substances Act, and illegal at the federal level, there is nothing simple and straight forward about the law on marijuana use in Pennsylvania (or in any part of the country) right now.  From law enforcement to business owners, there is […]

Other than the fact that all marijuana is a Schedule 1 drug under the Controlled Substances Act, and illegal at the federal level, there is nothing simple and straight forward about the law on marijuana use in Pennsylvania (or in any part of the country) right now.  From law enforcement to business owners, there is a struggle to understand what is legal as courts and agencies are hard-pressed to keep up with the legalization of marijuana and the conflict between state and federal laws.

On April 6, 2016, Pennsylvania passed the Medical Marijuana Act (the “Act”) which legalized the use or possession of medical marijuana in the Commonwealth.  By February 15, 2018, medical marijuana was available for distribution at Pennsylvania dispensaries for patients who meet certain requirements.  Specifically, the patient has to have one of seventeen enumerated “serious medical conditions,” receive certification from a practitioner to acquire the marijuana from an approved dispensary in Pennsylvania and be in possession of a valid identification card issued by the Pennsylvania Department of Health at any time they are in possession of medical marijuana.  The patient must also be under the ongoing care of the practitioner who issued the certification during any in-person visit to the dispensary.  There is no reciprocity between the states, meaning that a patient must have a Pennsylvania certification to get medical marijuana from a Pennsylvania dispensary.

The Act confirms that medical marijuana may only be dispensed as a pill, oil, topical form (including gel, creams or ointments), vaporization or nebulization, tincture or liquid.  Smoking marijuana is not permitted by the Act.  Likewise, marijuana in edible forms, such as brownies, is illegal unless it is done to aid ingestion by the patient – the medical marijuana cardholder.    Despite these clear designations and protections under the Act for the legalized use of medical marijuana in Pennsylvania, the rest of the state’s legislation remains unchanged.

Recently in the case of Commonwealth v. Barr, the Honorable Maria L. Dantos of the Lehigh County Court of Common Pleas granted the Defendant’s motion to suppress evidence that claimed the  search of a vehicle by the police was improper since it was based upon the smell of burnt and raw marijuana through the open window of the vehicle and a passenger in the vehicle possessed a medical marijuana card.  In his defense, the Defendant produced an expert who testified that the odor of ingesting medical marijuana with a vaping pen was the same as the odor of smoking regular marijuana from an unlawful source.  The arresting officer admitted she was not aware that the odor was the same.  In rendering the decision, Judge Dantos highlighted that this search and subsequent arrest of the Defendant for possession of marijuana (amongst other charges) demonstrated the “clear disconnect between the medical community and the law enforcement community” with regard to the legalization of medical marijuana and found that the smell of marijuana alone does not provide law enforcement with probable cause to conduct a search.

This decision raises many questions for business owners and their interactions with their employees.  For instance, what happens when an employer encounters an employee who smells of marijuana but shows no evidence of any other impairment?  Will the smell of marijuana be enough to create the reasonable suspicion needed to demand a drug test?  Will the smell of marijuana potentially place an employer on notice of a possible disability?  Does the employer have to give the employee the opportunity to provide a legitimate medical reason for smelling of marijuana before it can take any employment action?  How do the answers to these questions change when the employee is in a safety-sensitive position?  There is little, if any, guidance from the courts on these scenarios; however, applying the reasoning in the Barr case, the smell test, alone, is likely not enough for an employer to take adverse employment action against its employee.

As these types of decisions continue to be made, the legal landscape surrounding marijuana use in Pennsylvania will only evolve.  Where do we go next?

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