Pharmacy Edge by APPA

Issue

THE NEW NORMAL

DSCSA Compliance Tips Policy Matters

Five

June/2016

Pharmacy of the Month Diamond Pharmacy

I don’t know why....

U.S. Supreme Court Upholds Theory of False Claims Act Liability

What it’s like to attend West Point Military Academy?

Table of Contents Issue 04 / May, 2016

Presidents Message

Pharmacy of the Month: Diamond Pharmacy

THE NEW NORMAL DSCSA Compliance Tips Policy Matters

What it’s like to attend West Point Military Academy?

I don’t know why....

U.S. Supreme Court Upholds Theory of False Claims Act Liability

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Congratulations to our Instructor, Steffani for winning the APPA Pharmacy Technician of the Year 2016

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President’s message Joshua Pirestani

Dear Friends, The day is upon us where we celebrate with family and friends through fireworks and barbecues to celebrate the Independence of the United States. As grade school children, we are educated on the purpose of Independence Day and the important role the Declaration of Independence plays for our country. We learn who the founding fathers were and what it stood for. I can only speak for myself, but all the details of the Declaration of Independence have been replaced with other volumes of information of current events such as how to take advantage of social media! Joking aside, we are educated on why the Declaration of Independence was significant to us as a people, but what we don’t realize is how important it was to other countries besides the United States of America. Our founding fathers’ bravery not only showed the world that we should stand up towards the injustices of a government that no longer guaranteed us our natural rights, but it also helped us to get increased foreign assistance from France to become free. The Declaration of Independence also states, “We hold these truths to be self-evidence, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness.” As it relates to today’s world, it is because of these words that women and men of all races are treated equally. These words have paved the way for some of the civil rights to have passed. This is why the Declaration of Independence is significant, not just for men and women, but for every human being who has accepted the United States as their home.

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So when fifty innocent lives are taken, the worst mass shooting in US history, I cannot help but to be angry. The media has focused on the fact that these lives were “gay” lives because the shooting was in a gay nightclub in Orlando, Florida. More importantly, these were innocent lives. These were sons, brothers, friends, and maybe even fathers. These were individuals who, as President Obama stated, were at “a place of solidarity and empowerment.” Their lives, liberties, and pursuit of happiness were taken away by one individual. Not by an alien race where Will Smith comes with guns blazing, but by one human being. Times like these we are able to see the strength of our country, not necessarily through government retaliation, but through the outpouring of kindness and support of others. We will not let this act of terror define us, but let how we react to this hate and violence define the strength and resilience of our people. We at APPA, offer our thoughts and prayers to all those affected by the Orlando shooting and look forward to the day when mass shootings are no longer a headliner in our country. So what better way to recognize our hard working Americans than to recognize those that have made a difference in the pharmaceutical industry, than to feature an independent pharmacy as Pharmacy of the Month? As a pharmaceutical association, one of our missions is to acknowledge the accomplishments and outstanding services our industry professionals and businesses have contributed to the consumers and to the industry. In highlighting these independent pharmacies, we say thank you and hope that when you step into your pharmacy, you pay your gratitude for their hard work and professional advice! See who this July’s Pharmacy of the Month is!

August brings more great news for our members! APPA will be launching their business division to help serve our members with pre-negotiated rates for services to help you and your business grow. If you’re interested in helping our members grow by providing your services, please email us at info@joinappa.com. APPA is currently in negotiations in securing a venue for next year’s inaugural annual event, PharmaCon in the 2nd quarter of 2017. This event will primarily be for independent pharmacy owners, pharmacists and pharmacy buyers. Pharmacy techs and anyone who has an interest in pharmaceutical purchasing will be welcome. We have a limited number of exhibitor booth spaces and 30+ have already joined our interest list. If you are interested in exhibiting please send an email to info@joinappa.com. We expect to have over 800+ attendees during this two day event. These two days will be packed with events for professional growth and business development as well as some time to unwind and meet other professionals within the industry in a less-than formal setting! We will also acknowledge our Industry Awards winners. Stay tuned in the coming months for additional information! Pharmacy Edge has been in existence for five months now and has nearly quadrupled its readership from 342 readers to 1308 readers! Thank you all for your support and please share our magazine with your friends and colleagues for industry news! We, at APPA, wish you and yours a Happy and safe Independence Day! Regards, Joshua Pirestani

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By InfiniTrak

THE NEW NORMAL DSCSA Compliance Tips Policy Matters

What is my new normal? The newly enforced Food and Drug Administrationâ&#x20AC;&#x2122;s (FDA) Drug Supply Chain and Security Act (DSCSA) requires electronic tracking and tracing of all dispensed prescription drugs and requires a process for product verification in the event of a suspect product and mandatory reporting requirements. These latest regulations bring a new way of life and create a new normal when approaching compliance as a part of your day to day business practices. The best way to document standard operating procedures related to DSCSA is to adopt and document policies. 8

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Keeping a policy up to date and easily accessible to staff will bring you real protection and peace of mind! Developing your Policy and Procedure Manual for DSCSA compliance may seem like a daunting task, especially when considering all of the elements of the new law and what is required of you as a dispenser. A store policy clearly communicates to staff the standard operating procedures for any process, ensuring that all employees handle situations consistently. Adopting a policy is also an important risk management move because, if done properly, it verifies your standard business practices. Even if an employee makes mistakes, evidence of a clear policy and guidelines (which the employee may not have followed) will be helpful to lessen any potential fines or penalties. A clear policy combined with annual staff training is excellent protocol to show compliance with regulatory process requirements.

InfiniTrak, has been following the development of these DSCSA regulations since they began in 2013. When designing a software solution, they looked at the situation from the point of view of the dispenser - and independent pharmacies like yours, and created a tool to meet you needs. For example, InfiniTrak provides its customers with a template for a track and trace policy document to be created to meet each locationâ&#x20AC;&#x2122;s requirements. InfiniTrak is a cost-effective, easy to use software that will save you time and money, increase productivity, ensure full compliance, and provide the peace of mind that comes from knowing that all of your data is at your fingertips, when you need it. Contact us today to learn more about how you can electronically create and transmit FDA and other government reports as required, all in a cloud solution.

Questions regarding your store policy and your compliance plan?

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I don’t know why.... I don’t know why your insurance won’t cover your medication. I’m not a Jedi. All I do is electronically submit the prescription to your insurance. It either gives me a reject of “not covered” or the co-pay. It does not give me anything else but that. This is a question for your insurance. Call them.

don’t know why your co-pay is higher this time. I’m not a Jedi. I don’t have a crystal ball. All I do is electronically submit the prescription to your insurance. It just tells me what to charge you for a co-pay. It doesn’t tell me why it is more. This is a question for your insurance. Call them. I don’t know why your doctor hasn’t called back on your refill. I’m not a Jedi. I don’t have a crystal ball. I have no magic skills. All I do is fax over the refill request and wait to hear from them. Most doctors don’t even look at the faxes until the next day, so calling me an hour later is a waste of my time (and yours). If you can’t wait any longer, call your doctor. And by the way, at any time we have 20-30 faxes out to various doctors for various patients for various refill requests. We’re not personally watching over yours and standing by the fax machine waiting. But I do know why your prescription isn’t ready for pick up yet. You dropped it off less than FIVE MINUTES ago. I’m not a Jedi. I don’t have a crystal ball. I have no magic skills. I’m NOT the Wizard of Oz. It takes TIME to fill a prescription. We’re NOT McDonalds. Relax and calm down. Go have a Starbucks. We’ll have your Rx ready shortly.

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Watchdog

Pharmacy of the Month Diamond Pharmacy

Mark provided new perspective and energy, helping to improve, enhance, and add features that have led to an expansion of Diamond’s services.

ost people associate pharmacies as drug dispensaries. But those who depend on the knowledge and expertise of these professionals know that they are more than this simplistic and short-minded definition. General practitioners can diagnose what ails a person and recommend what is needed to cure the ailment, however it takes the in-depth knowledge of a pharmacist to be able to dispense the correct dosage, assess the suitability of the medication recommended for the patient as defined by their medical history, determine how prescribed medications will interact with their current medication regimen, and most importantly educate and relay life-saving information to their patients. We, at APPA, would like to highlight those professionals and pharmacists who go above and beyond by recognizing them as “Pharmacy of the Month.” This month we would like to acknowledge, Diamond Pharmacy Services. Diamond Pharmacy Services is the nation’s largest correctional pharmacy provider, servicing nearly a third of the nation’s inmate population and dispensing over 1,000,000 prescriptions per month to 48 states and is also Pennsylvania’s largest independently owned nursing facility pharmacy provider. Gilbert and Joan Zilner, both pharmacists, purchased the pharmacy in Indiana, Pennsylvania, in 1970. Today it remains family-owned, with Mark Zilner R.Ph., Gilbert and Joan’s son, lead-

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ing the organization as the Chief Operating Officer. Gilbert and Joan are still very active in the company and serve as the Vice President and President respectively. What started out as a small retail corner drug store in Indiana, PA has expanded to a state-of-the-art 135,000 square foot institutional pharmacy with three satellite locations, a FDA certified repackaging company (RemedyRepack), an institutional medical supply company, an IV infusion pharmacy, compounding pharmacy, a retail mail-order pharmacy (InnovaHealth), two retail pharmacies, a retail medical supply store, and a EHR software company (SapphireHealth). Foreseeing the needs of the customer and having a strong desire to provide the best products and services has pushed Diamond to the forefront of the industry. “We are a family owned business and we consider our employees and customers to be part of our family,” Mark Zilner said. “We try our very best to listen, observe, and be an active partner to our customers in an effort to best serve them and their patients.”

Sapphire, Diamond’s Electronic Health Records software company, which released an EHR for the corrections market, was the first of its kind for prisons created and owned by a pharmacy services company. Sapphire was formed from a vision to implement time-saving measures which would in turn allow medical staff to spend more one-on-one time with patients while clinically improving care. “As we work closely with our customers on a regular basis, we realized that there were many pain points with their current software, and we decided that we had the internal talent to develop a product that would provide better care to our patients while simplifying the process for our customers. That is how Sapphire was born. To this day it continues to evolve as we develop the product based on our customers’ feedback and requests,” explained Zilner. The innovative ideas and focus on customer quality care have made Diamond successful in its industry as well as garnering positive customer reviews. For this reason and for many more unlisted here, we have chosen Diamond Pharmacy Services as the Pharmacy of the Month for July! Thank you Diamond Pharmacy Services for all that you do!

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The Pharmacy Choice online network is collectively the most popular destination on the internet for pharmacy professionals.

The Pharmacy Choice online network consists of three primary web portals PharmacyChoice.com, RxSchool.com and RxCareerCenter.com. Each of these portals serves a specific purpose while leveraging the marketing power of the others. Combined, these portals are the most visited websites in the pharmacy industry.

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RxSchool offers the best Live Internet education available through the popular RxSchool Live seminar room. Our leading internet delivery solution provides pharmacy professionals with a convenient way to get quality live education that qualifies for live CE credit.

The Pharmacy Choice web portal provides pharmacists, pharmacy technicians, students and others in the pharmacy industry with the most comprehensive suite of web-based tools and information available, including drug information, industry news, career opportunities and educational programs.

Rx Career Center is home to the largest job board for pharmacy professionals. Job candidates can search career opportunities using a secure and confidential system. Employers have the ability to upload their open jobs and search résumés.

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What it’s like to attend West Point Military Academy?

The American Pharmacy Purchasing Alliance teamed up with Cadet Collin Cooley, son of Suzette DiMascio-Cooley, CEO of CSI Specialty Group, to get the inside scoop on what it’s like to attend West Point.

We would like to thank Suzette and her son Collin for their contribution to the insight regarding this elite and proud United States Military Academy.

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est Point was founded in 1802. It is an internationally recognized institution for academic, military and physical excellence. West Point is deeply rooted in the history of our Nation.

In a typical class there are 15-20 students. Very traditional setting complete with chalk boards for every cadet. Interviewer: Give us a little background on why you chose to attend West Point and what was the admission process like? Cadet Collin: The admission process to gain acceptance to West Point is a very strenuous process. On top of an application featuring essays, High School GPA, SAT scores, etc. – typical to a regular college application you have to conduct a medical exam, physical test and apply independently for a congressional nomination. The application window opens 1 March of your junior year and extends to 1 December of your senior year. I was fortunate enough to receive my nomination through Senator Marco Rubio, who I am currently interning with in Washington DC.

they drill twice a week) and all other intercollegiate D1 and Club teams practice every day and sometimes twice a day. After practice is over (around 1800-1830) we have dinner followed by a mandatory evening study period for the underclassmen. Depending on my homework load, I am usually asleep at 0000 to get reset for the next day.

Interviewer: Give us a rundown on what a typical week looks like at West Point. Cadet Collin: West Point’s schedule is very fast paced. On any given day I wake up around 0600, breakfast formation and breakfast at 0630, classes start at 0730 and run until 1200. We have a lunch formation at 1205 followed by lunch and an hour off where they pack in briefings and various events such as tutoring sessions, meetings, etc. and then two more class periods until 1600. After class we have mass athletics which depend on your team. Intramurals meet twice a week (and

All cadets have the opportunity to take leave on Thanksgiving, Christmas, and spring leave’ possibly in the summer depending on their training schedule. Aside from that, we can take pass on certain weekends and we get more passes as we become upperclassmen.

In a typical class there are 15-20 students. Very traditional setting complete with chalk boards for every cadet. West Point stresses academics but more so they look to develop the whole person concept of scholar, athlete, and leader.

Interviewer: What are you majoring in at West Point? Why did you choose that major? When do you graduate? Cadet Collin: Definitely difficult balancing but west point develops you into a master at time management. I also manage a 3.2 Academic GPA while studying business management. pharmacy edge

Interviewer: What sports do you play? Cadet Collin: I play Sprint Football (in the College Sprint Football League). I made the team in January. Aside from that, I took boxing class last semester and Military Movement (essentially modified gymnastics) this semester as well as intramural grappling. Interviewer: What is the best thing about attending West Point? Cadet Collin: The people. Everyone is very competitive, yet they are also willing to take time out of their days to help. The people I have met at West Point will no doubt be some of my best friends for the remainder of my life. I look forward to serving with all of them in the future. Interviewer: What would you say is by far the biggest obstacle you had to overcome at West Point? Cadet Collin: Toughest obstacle at West Point is adjusting to the schedule and all that is expected out of you. West Point encourages you to be highly responsible for yourself and those around you. Trying to balance academics with physical fitness and military efficiency is difficult for anyone

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but the only way to get through it is to grind throughout each day and work to get better every single day. Now I feel as if I have adjusted well and look forward to keep getting better this coming year. Interviewer: What are your plans after graduation? Cadet Collin: I plan on branching Armor or Infantry following graduation. Deciding what I branch is still a while out, but I feel confident that I want to go in Combat Arms while I serve. As for posts, my dream post is Vicenza, Italy! If not there Fort Carson, Fort Hood or Fort Drum would be ideal. Interviewer: What would you say to someone who was thinking about attending West Point? Cadet Collin: For anyone thinking about going to West Point my advice to you is this: GO! You will never regret it. Every day is a challenge and it isn’t easy, but if you live for working through a challenge and getting better every day, West Point is a great place for you. Go Army, Beat Navy!

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U.S. Supreme Court

Upholds Theory of False Claims Act Liability Practice Area / INDUSTRY: White coller litigation and government investigations; healthcare; corporate compliance

he False Claims Act defines “knowing” and “knowingly” to mean that a person has “actual knowledge of the information,” or “acts in reckless disregard of the truth or falsity of the information.” A misrepresentation about compliance with a statutory, regulatory or contractual requirement must be “material” to the Government’s payment decision in order to be a violation of the False Claims Act. The Court further clarified the meaning of “material” and how that materiality requirement should be enforced.

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SPECIAL EDITION: PHARMACY UNDER INVESTIGATION Pharmacy Podcast Episode 309

In the False Claims Act and other federal fraud statutes, “The term ‘material’ means having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property.” The Court noted that the materiality standard is demanding and does not cover “minor or insubstantial” non-compliance. Furthermore, to gauge materiality, the Court opined that courts should look at whether the: • Defendant knows the Government refuses to pay claims based on non-compliance with the particular statutory, regulatory or contractual requirement, therefore considered material; • Conversely, the Government pays claims in full despite its knowledge that certain requirements were violated, therefore it is strong evidence that the requirements are not material, and; • The Government regularly pays a claim in full despite actual knowledge that certain requirements were violated, and has signaled no change in position, that is strong evidence that the requirements are not material. “Defendants can be liable for violating requirements even if they were not expressly designated as conditions of payment,” the court said in an opinion authored by Justice Clarence Thomas. “What matters is not the label the Government attaches to a requirement, but whether the defendant knowingly violated a requirement that the defendant knows is material to the Government’s payment decision.” How does this ruling impact those who do business with the federal government? Enforcement of the False Claims Act is the government’s primary civil remedy to redress false claims for government funds and property and under government contracts. This case is considered to be one of the most significant and important False Claims Act cases in recent history and viewed as at least a partial victory for the federal government and whistleblowers. Those who do business with the federal government should take stock of their compliance programs by assessing their effectiveness to meet statutory, regulatory or contractual requirements.

“The False Claims Act has proven to be the government’s most effective civil tool to ferret out fraud and return billions to taxpayer-funded programs,” said Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. In fiscal 2015, the Department of Justice obtained more than $3.5 billion in settlements and judgments from civil cases involving fraud and false claims against the government. This is the fourth year in a row that the recoveries have exceeded $3.5 billion and brings the total recoveries from January 2009 to the end of fiscal 2015 to $26.4 billion. Of the $3.5 billion recovered last year $1.9 billion came from the healthcare industry for allegedly providing unnecessary or inadequate care, paying kickbacks to physicians and other providers to induce the use of goods or services, or overcharging for goods and services paid for by Medicare, Medicaid, and other federal healthcare programs. The $1.9 million reflects federal losses only. In many of the cases, additional millions of dollars was recovered for consumers and state Medicaid programs. The next largest recoveries were from government contracts. The government depends on contractors

Settlements and judgments in cases alleging false claims for payment under government contracts totaled $1.1 billion in fiscal year 2015.

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to feed, clothe, and equip the military for combat; for the military’s planes, ships and weapons; as well as to provide everything needed to fund domestic programs such as highways and other infrastructure projects. Settlements and judgments in cases alleging false claims for payment under government contracts totaled $1.1 billion in fiscal year 2015. The White Collar Defense Bar is already debating the impact of the newly defined materiality standard, opining what the Court described as a “new, rigorous standard of materiality,” as the impetus that will kick off a significant increase in whistleblower lawsuits, particularly by predatory plaintiff’s firms. Some are

saying it may massive amounts of litigation in light of the aggressiveness of the plaintiff’s bar and their solicitation of whistleblowers. The litigation will center on what “materiality” is and the “knowledge” of compliance by providers not only in healthcare, but government contracts as well. The one sure way to proactively combat a risk to your organization is to ensure you are in compliance with applicable laws and regulations and most importantly, have a robust compliance program that includes regular audits of its effectiveness. Failure to do so will be viewed as reckless disregard that will imply “knowledge” and thus satisfy the materiality standard to allege a false claim.

For more information on this subject matter, please contact one the following attorneys:

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Anthony j. Calamunci anthony.calamunci@fisherbroyles.com fisherbroyles.com

Amy L. Butler amy.butler@fisherbroyles.com

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Nicole H. Waid nicole.waid@fisherbroyles.com 202-906-9572

Carson Porter carson.porter@fisherbroyles.com 202.262.5784

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