Gavel & Pestle Podcast

Title: Darshan Kulkarni on Amazon Pharmacy In 2017, Darshan Kulkarni PharmD, MS, Esq., predicted that Amazon would soon disrupt the pharmaceutical industry on the Gavel & Pestle Podcast. Three years later, his eerily accurate predictions are unfolding before us. On this special episode of Gavel & Pestle, the FDA regulatory lawyer, author, professor, and speaker returns to pass the baton to the podcast's new host Brooke Kulusich. They discuss Amazon Pharmacy's potential to singlehandedly reshape the pharmaceutical supply chain, its implications for patient health data and drug prices, and the future of pharmacy from drone delivery to Alexa pharmacists.  Listen to Darshan's predictions here.  Follow Gavel & Pestle on Twitter here.  Contact us today for a Gavel & Pestle Podcast appearance at publisher@pharmacypodcast.com. See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

“If you think compliance is expensive, try non-compliance.”  -Former U.S. Deputy Attorney, General Paul McNulty On this episode of Gavel and Pestle, Natalia Mazina, Esq., regulatory counsel at Mazina Law and founder of RxPolicy, joins host Brooke Kulusich to share her expertise in pharmacy compliance, third-party payer audits, and pharmacy benefit manager (PBM) disputes. They discuss the most common compliance mistakes that pharmacies make, the REAL implications of the Rutledge v. PCMA decision, and how independent pharmacies can think outside-the-box in their approach to PBMs. Follow Gavel & Pestle on Twitter here.  Contact us today for a Gavel & Pestle Podcast appearance at publisher@pharmacypodcast.com. See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

We welcome our newest host, pharmacy student at the University of Pittsburgh School of Pharmacy ‘22 Ms. Brooke E. Kulusich Brooke mentions: "Throughout pharmacy school, my passion for patient care has remained the driving force in my career. I have gained a deep appreciation for the vital role of pharmacists in the community and have been inspired to scale my impact beyond the individual patient level. As one of the most highly-regulated industries, pharmacy presents a unique opportunity to engage clinicians in shaping policies that carry our profession forward. Through Gavel & Pestle, I hope to share my passion for the intersection of healthcare and the law and look forward to learning alongside our audience through conversations with experts. As a third-year student pharmacist, I am interested in a career in pharmacy law or association management that would enable me to leverage my patient care experiences to advance policy decisions and improve patient access to care. Upon graduation, I hope to pursue a clinical or commercial role in a healthcare, government, private sector or public sector leadership position."  Contact us today for a Gavel & Pestle Podcast episode appearance.  Today's episode is sponsored by CEimpact:   https://www.ceimpact.com/marketplace  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

On this episode of the Gavel & Pestle Podcast, Darshan talks about the last mile of drug delivery and the challenges faced by patients getting their medications on time. In the last mile, the efficacy of a medicine must still be maintained, but managing and controlling the delivery can be an issue. The cost of technology to monitor may not be justified given that the value of the medicines being shipped to the final destination might be much lower than the value that was initially bulk shipped from the manufacturer. In this article we will explore the challenges of deploying technology and the circumstances under which tech can be used to cost-effectively manage and control the last mile delivery of medicines.  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

The Purdue College of Pharmacy is proud to present BoilerWoRx: a multidisciplinary response to public health needs in Indiana, initially focusing on the opioid epidemic. BoilerWoRx is a strategic mobilehealth initiative that will bring vital services to communities across Indiana. The BoilerWoRx program, in partnership with the Tippecanoe County Health Department and the Lafayette Transitional Housing Center, will be hosted their first event on Saturday, April 21, 2018 at Lafayette Transitional Housing at the Howarth Center in Lafayette, Indiana.  The BoilerWoRx team will provide counseling, education, training, drug disposal and Hepatitis A immunizations. This event is open to everyone so come out and learn more about BoilerWoRx. See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Darshan and Major talk about 23 & Me Data collected and it's potential ramifications to our privacy.  "Embedded in our genetic code is all kinds of sensitive data that could be compromising in the wrong hands without genetic privacy protections, the information stored in our genes might be used to discriminate against us or send us targeted ads. For these reasons, some have said we should skip out on consumer DNA tests if we value our privacy. Last week, after the FDA gave DNA testing company 23andMe the greenlight to offer consumers disease risk assessments, there was a new wave of warnings. “The product isn't really a kit...the product is you,” Popular Science wrote after the announcement. Others have speculated that the company's long-term goals include selling your data for advertising purposes. Let's be clear here. 23andMe definitely is selling your data to third party companies, research institutions and nonprofits. But it is not selling your genetic data to those entities in order for them to sell you things. It is selling de-identified, aggregate data for research, if you give them consent." From original article, by Kristen V. Brown:  https://gizmodo.com/23andme-is-selling-your-data-but-not-how-you-think-1794340474  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Darshan talks about the Telemedicine effect on modern healthcare. The term telehealth includes a broad range of technologies and services to provide patient care and improve the healthcare delivery system as a whole. Telehealth is different from telemedicine because it refers to a broader scope of remote healthcare services than telemedicine. See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Major & Darshan with the Gavel & Pestle Podcast talk about 'Patient Centricity' and being aware of the patient's experience and their pharmacy healthcare provider.  Contact Darshan:  https://www.linkedin.com/in/darshankulkarni/  @DarshanTalks  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Gavel & Pestle Podcast host Darshan KulKarni talks with Emmanuel Fombu, MD, MBA (Manny) the author of the best selling book titled, The Future of Healthcare: Humans and Machines Partnering for Better Outcomes Emmanuel Fombu, MD, MBA, is a physician, author, speaker and healthcare executive turned Silicon Valley entrepreneur. As a medical futurist and 2017 winner of the prestigious New York City Health Business Leaders Boldest Digital Health Influencer Award, Dr. Fombu champions the potential for the internet of things, artificial intelligence and machine learning to revolutionize the healthcare industry. https://www.emmanuelfombu.com/  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Telepharmacy is the delivery of pharmaceutical care via telecommunications to patients in locations where they may not have direct contact with a pharmacist. It is an instance of the wider phenomenon of telemedicine, as implemented in the field of pharmacy. Darshan Kulkarni, host of the Gavel & Pestle Podcast and VP Regulatory Strategy & Policy with Synchrogenix interviews Timothy Youkhana President with Scaled Enterprise Solutions about telepharmacy opportunities for pharmacy business.  Telepharmacy services include drug therapy monitoring, patient counseling, prior authorization and refill authorization for prescription drugs, and monitoring of formulary compliance with the aid of teleconferencing or videoconferencing. Remote dispensing of medications by automated packaging and labeling systems can also be thought of as an instance of telepharmacy. Telepharmacy services can be delivered at retail pharmacy sites or through hospitals, nursing homes, or other medical care facilities. The term can also refer to the use of videoconferencing in pharmacy for other purposes, such as providing education, training, and management services to pharmacists and pharmacy staff remotely. ABOUT --Scaled Enterprise Solutions https://ses.healthcare/about/  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Darshan & Major with the Gavel & Pestle Podcast returns to talk about the Amazonification of Healthcare.  Dr. Kulkarni is the Principal Attorney at the Kulkarni Law Firm. He provides regulatory and legal advice to pharmacies and other FDA regulated entities and their service providers. He speaks and regularly advises on current legal and compliance related matters including the physician payment sunshine act, clinicaltrials.gov, the False Claims Act, the Anti-Kickback Law and other developments of laws and regulations that affect the life sciences industry and compounding facilities. Contact: darshan@conformlaw.com #Amazonification  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Gavel & Pestle Podcast host - Darshan and Major discuss the opioid epidemic and the pharmacist's role.     Contact:    Darshan Kulkarni, Pharm.D, MS, Esq. The Kulkarni Law Firm 2929 Arch Street, Suite 1700  Philadelphia, PA 19104-7327 Twitter: @FDALawyers Subscribe for more news here See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

The Pharmacy profession and the business of pharmacy continues to face dramatic changes and challenges. We continue to see how pharmacy contributes value to the overall healthcare industry and will determine its ongoing success. A key component of our transformation through pharmacy will the effective use of technology, specifically artificial intelligence.  This podcast episode is an interesting conversation with "Gavel & Pestle Podcast" host Darshan Kulkarni VP Regulatory Strategy & Policy & Principal Attorney with The Kulkarni Law Firm.  Kulkarni Law Firm 2929 Arch Street, Suite 1700 Philadelphia, PA 19104 darshan[at]conformlaw.com Office Number: 215-948-8183 See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

About the Pharmacy Podcast Network: In 2009 Todd S. Eury launched the pharmacy industry's first podcast about the Business of Pharmacy dedicated to pharmacist professionals called the ‘Pharmacy Podcast Show'. In 2011, Eury's podcast evolved and in the fall of 2014, several pharmacists joined the podcast publication and the Pharmacy Podcast Show was transformed into the Pharmacy Podcast Network.  As a podcasting 1st in history, the audio-blog publication is the U.S. Healthcare System's largest network of podcasts dedicated to the profession of pharmacy with 23 co-hosts developing content for 15 different podcasts segmented on different topics like healthcare law, technology, medical cannabis, senior care, and pharmacogenomics. The Pharmacy Podcast Network has a collective listener base of about 67,000 and has personalized podcast publications for national associations like the American Society of Consultant Pharmacists and the National Association of Specialty Pharmacy. We embed the podcasts into our sponsors web-environments or they can set up a new page on their site dedicated to the podcasts.  Be sure to see our series sponsor's landing pages:  McKesson Technologies: https://marketing.mckesson.com/2017-MPTS-Pharmacy-Podcast-Series.html Cardinal Health: http://pharmacypodcast.com/podcast_tags/cardinal-health/ H. D. Smith: https://www.hdsmith.com/news-events/podcasts CVS Health: http://pharmacypodcast.com/podcast_tags/cvs-health/ Majority of our podcast episodes are between 17-25 minutes (purposely for the average commute)  With 25 leading co-hosts for 15+ different podcast segments, the PPN develops new content daily for our corporate sponsors including CVS Health, McKesson, Cardinal Health, RxSafe, KeyCentrix, R.J. Hedges & Associates, ASCP, and the NASP.  The folllowing podcasts are part of the PPN: https://soundcloud.com/pharmacy-podcast/sets  Pharmacy Leaders  Pharming Your Career  the Medical PotCast  the Gavel & Pestle Podcast  Specialty Pharmacy Podcast in collaboration w/ the NASP  SenioRx Radio in collaboration w/ the ASCP  the Fit Pharmacist  Pharmacy Inspection Podcast  PolitiTalkRx  PGX for Pharmacists  Pharming Your Career Pharmacy Compliance Guide  the Nontraditional Pharmacist  Income Outcomes Show  Pharmacy Future Leaders  Pharmacy Technician Podcast Please take a look at our co-host intelligence source here, you should be part of this team:  http://pharmacypodcast.com/cohost/ Sincerest thanks to our Listeners & Sponsors,  Thank you.  Todd S. Eury - Founder | Publisher  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Gavel & Pestle Podcast host Darshan Kulkarni, PharmD, JD talks about the importance of understanding regulations on marketing and advertising anything about medical marijuana.  Advertisements are not Exempt  Don't Wing It  FDA Ads  Disease Awareness Product Awareness  Product Claims Advertisement  FDA Listing of Advertising Guidances https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064956.htm FDA and Marijuana: Questions and Answers https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm     See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Medical Marijuana State Laws https://medicalmarijuana.procon.org/view.resource.php?resourceID=000881 29 Legal Medical Marijuana States and DC  Marijuana State Laws – Summary Chart from ProCon.org 1.Alaska 1998 Ballot Measure 8 (58%)  1 oz usable; 6 plants (3 mature, 3 immature)  2.Arizona 2010 Proposition 203 (50.13%)  2.5 oz usable; 12 plants  3.Arkansas 2016 Ballot Measure Issue 6 (53.2%) 3 oz usable per 14-day period 4.California 1996 Proposition 215 (56%)  8 oz usable; 6 mature or 12 immature plants  5.Colorado 2000 Ballot Amendment 20 (54%)  2 oz usable; 6 plants (3 mature, 3 immature)  6.Connecticut 2012 House Bill 5389 (96-51 H, 21-13 S)  2.5 oz usable  7.Delaware 2011 Senate Bill 17 (27-14 H, 17-4 S)  6 oz usable  8.Florida 2016 Ballot Amendment 2 (71.3%) Amount to be determined 9.Hawaii 2000 Senate Bill 862 (32-18 H; 13-12 S)  4 oz usable; 7 plants  10.Illinois 2013 House Bill 1 (61-57 H; 35-21 S)  2.5 ounces of usable cannabis during a period of 14 days  11.Maine 1999 Ballot Question 2 (61%)  2.5 oz usable; 6 plants  12.Maryland 2014 House Bill 881 (125-11 H; 44-2 S)  30-day supply, amount to be determined  13.Massachusetts 2012 Ballot Question 3 (63%)  60-day supply for personal medical use (10 oz)  14.Michigan 2008 Proposal 1 (63%)  2.5 oz usable; 12 plants  15.Minnesota 2014 Senate Bill 2470 (46-16 S; 89-40 H)  30-day supply of non-smokable marijuana  16.Montana 2004 Initiative 148 (62%)  1 oz usable; 4 plants (mature); 12 seedlings  17.Nevada 2000 Ballot Question 9 (65%)  2.5 oz usable; 12 plants  18.New Hampshire 2013 House Bill 573 (284-66 H; 18-6 S)  Two ounces of usable cannabis during a 10-day period  19.New Jersey 2010 Senate Bill 119 (48-14 H; 25-13 S)  2 oz usable  20.New Mexico 2007 Senate Bill 523 (36-31 H; 32-3 S)  6 oz usable; 16 plants (4 mature, 12 immature)  21.New York 2014 Assembly Bill 6357 (117-13 A; 49-10 S) 30-day supply non-smokable marijuana  22.North Dakota 2016 Ballot Measure 5 (63.7%) 3 oz per 14-day period 23.Ohio 2016 House Bill 523 (71-26 H; 18-15 S)  Maximum of a 90-day supply, amount to be determined  24.Oregon 1998 Ballot Measure 67 (55%)  24 oz usable; 24 plants (6 mature, 18 immature)  25.Pennsylvania 2016 Senate Bill 3 (149-46 H; 42-7 S)  30-day supply  26.Rhode Island 2006 Senate Bill 0710 (52-10 H; 33-1 S)  2.5 oz usable; 12 plants  27.Vermont 2004 Senate Bill 76 (22-7) HB 645 (82-59)  2 oz usable; 9 plants (2 mature, 7 immature)  28.Washington 1998 Initiative 692 (59%)  8 oz usable; 6 plants  Washington, DC 2010 Amendment Act B18-622 (13-0 vote)  2 oz dried 29.West Virginia 2017 Senate Bill 386 (74-24 H; 28-6 S)  30-day supply (amount TBD) See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Is Amazon Your Next Pharmacy? This is a 3 part series from the Gavel & Pestle Podcast with Darshan Kulkarni, Pharm.D, MS, Esq. PART 1 HERE PART 3 of 3 Where's Amazon fit in? Are they just a potential wholesaler? What about the PBM Play? And how does their warehouse leverage play into the bigger picture? Gavel & Pestle Podcast Darshan Kulkarni, Pharm.D, MS, Esq. The Kulkarni Law Firm 2929 Arch Street, Suite 1700 Philadelphia, PA 19104-7327 Office Number: 215-948-8183 Twitter: @FDALawyers See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Is Amazon Your Next Pharmacy? This is a 3 part series from the Gavel & Pestle Podcast with Darshan Kulkarni, Pharm.D, MS, Esq. PART 2 of 3 There are many different types of pharmacy, and other places where a trained pharmacist may work. This includes: community pharmacy hospital pharmacy clinical pharmacy industrial pharmacy compounding pharmacy consulting pharmacy ambulatory care pharmacy regulatory pharmacy home care pharmacy Where's Amazon fit in? Are they just a potential wholesaler? What about the PBM Play? And how does their warehouse leverage play into the bigger picture?  Gavel & Pestle Podcast Darshan Kulkarni, Pharm.D, MS, Esq. The Kulkarni Law Firm 2929 Arch Street, Suite 1700 Philadelphia, PA 19104-7327 Office Number: 215-948-8183 Twitter: @FDALawyers See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Interview with Jocelyn Paonita, who is the founder of The Scholarship System, a 6-step process that helps families pay for college with scholarships and avoid student loan debt. She has helped families secure over $805,350 in scholarships with her online course. Everyone's leadership road is a little different; tell us what you are doing now and how you got there. She created a system to not only work full-time as an entrepreneur, but helping others afford college. What are some of the misconceptions students have about getting scholarships? Many students say “I will never get that scholarship”. What would you tell them? Jocelyn talks about making sure to wait for the rejection to come rather than rejecting oneself outright. We have three groups in our listener base: students who are going to be in pharmacy school, graduate students in pharmacy school, and parents with children who will be going to school. Starting with the parents, how can they tell their kids to fill out scholarship applications at 16? She gives great details about these three larger categories. Have you had any professional (nursing, medical, pharmacy) school scholarship applicants? What is your expertise in these types of scholarships? Jocelyn tells us specifically how these types of scholarships might be a little different. Where does scholarships start with a high school student and can you tell me a little about scholarship season? She outlines the best time to start looking for scholarships. Is there any advantages an on-campus student could have by talking to people in getting scholarships and do you have any negotiation tips? Jocelyn outlines some key tactics on campus and off. What is the best way to contact you? http://thescholarshipsystem.com Jocelyn has a lot of free stuff, like the free essay writing guide, free webinar and the three-step writing method that makes essay writing so much less painful and more creative. This podcast was sponsored by "Memorizing Pharmacology: A Relaxed Approach" https://www.amazon.com/Memorizing-Pharmacology-Approach-Tony-Guerra/dp/1329898443   See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Is Amazon Your Next Pharmacy? This is a 3 part series from the Gavel & Pestle Podcast with Darshan Kulkarni, Pharm.D, MS, Esq. PART 1 of 3 The Drug pipeline. A drug pipeline is the set of drug candidates that a pharmaceutical company has under discovery or development at any given point in time. This involves various phases that can broadly be grouped in 4 stages: discovery, pre-clinical, clinical trials and marketing (or post-approval). Gavel & Pestle Podcast Darshan Kulkarni, Pharm.D, MS, Esq. The Kulkarni Law Firm 2929 Arch Street, Suite 1700  Philadelphia, PA 19104-7327 Office Number: 215-948-8183 Twitter: @FDALawyers See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

First time pharmacy buyers must be careful when buying a pharmacy. An ill-advised pharmacy purchaser may find himself purchasing a headache, and a prepared pharmacy purchaser may find herself getting a better deal than originally anticipated. The first 2 major questions to answer before beginning the process is to determine the type of pharmacy to purchase and the way you intend to purchase it. 503A v 503B Is there adequate space Compounding within state v out of state Patients in state v out of state Large volume compounding v small volume compounding Sterile v non sterile Licenses DEA Pharmacy State Board One board? Multiple boards FDA NABP/NCPDP number (National Association of Boards of Pharmacy (NABP) to obtain a NABP/NCPDP number so that you may bill third-party payers.) NPI number (The National Plan and Provider Enumeration System (NPPES) to apply for a NPI number for the pharmacy and, if applicable, for the pharmacists who will be providing patient care.) Recommended Agreements Agreements with various insurance providers Lease on facility Building/store lease In-store vending machines, such as copiers or photo-processing kiosks Collection service contracts, such as water, utility or phone Business or franchise contracts with third parties, such as UPS or the United States Post Office Building and/or parking lot maintenance contracts Drop-ship vendors for front-end products Direct accounts with suppliers of gifts, cards and so on Pharmacy automation equipment Pharmacy services, such as compounding Regulations Have SOPs in place Training required for SOPs Laws of Interest HIPAA FCA Anti-Kickback Advertising and coupons Fraud Audit the pharmacy All prescriptions have valid prescriptions Billing concerns Some recommended clauses Indemnification Stock purchase v asset purchase License use/continuation of contracts Ownership of issues like name etc State v area of focus Non Compete/ Non Disparagement Likely involves some amount of employment by previous owner Deal Exhaustion is a real thing!! Darshan Kulkarni, Pharm.D, MS, Esq. The Kulkarni Law Firm 2929 Arch Street, Suite 1700 Philadelphia, PA 19104 Office Number: 215-948-8183 Twitter: @FDALawyers See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Retired X-Wing Fighter, Force User, Lawyer, and Pharmacist Darshan Kulkarni strikes back to the Gavel & Pestle Podcast Universe to share his advice for selling your pharmacy business. ---May the Force be with You!  Preparation Consider a self audit Consider a data room Have a HIPAA agreement in place Have clear financial data available for viewing for at least 3-5 years Make sure employment agreements for all key employees are done Be open to owner financing But have clear deliverables and A very clear exit strategy - how do you get your money if he doesnt pay? Looking at appropriate valuation There are quick and dirty strategies 3x Gross sales Online calculators Ask others what they have paid for similar sales Consider an actual valuator Is there any present or threatened litigation? Are there any pending or expected audits? During the Sell Have a clear timeline, but an ultra aggressive timeline will doom your relationship from the start How will the money be paid? How much immediately How much after a certain period of time (e.g. costs come through, reimbursement comes through etc) What kind of promises do they expect? E.g. Business continues same way After the Sell How long and for how many hours do you need to work with/for them? Fraud can come back to be highly problematic Kickbacks Billing Lack of Rx So how can I help? Darshan@conformlaw.com  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

The latest Gavel & Pestle Podcast focuses on - 3 Tips for Buying a Pharmacy Pharmacy Buyers must be careful when buying a pharmacy. An ill-advised pharmacy purchaser may find himself purchasing a headache, and a prepared pharmacy purchaser may find herself getting a better deal than originally anticipated. The first 2 major questions to answer before beginning the process is to determine the type of pharmacy to purchase and the way you intend to purchase it. 503A v 503B Is there adequate space Compounding within state v out of state Patients in state v out of state Large volume compounding v small volume compounding Sterile v non sterile   Licenses DEA Pharmacy State Board One board? Multiple boards FDA NABP/NCPDP number (National Association of Boards of Pharmacy (NABP) to obtain a NABP/NCPDP number so that you may bill third-party payers.) NPI number (The National Plan and Provider Enumeration System (NPPES) to apply for a NPI number for the pharmacy and, if applicable, for the pharmacists who will be providing patient care.)   Recommended Agreements Agreements with various insurance providers Lease on facility Building/store lease In-store vending machines, such as copiers or photo-processing kiosks Collection service contracts, such as water, utility or phone Business or franchise contracts with third parties, such as UPS or the United States Post Office Building and/or parking lot maintenance contracts Drop-ship vendors for front-end products Direct accounts with suppliers of gifts, cards and so on Pharmacy automation equipment Pharmacy services, such as compounding   Regulations Have SOPs in place Training required for SOPs   Laws of Interest HIPAA FCA Anti-Kickback Advertising and coupons Fraud Audit the pharmacy All prescriptions have valid prescriptions Billing concerns   Some recommended clauses Indemnification Stock purchase v asset purchase License use/continuation of contracts Ownership of issues like name etc State v area of focus Non Compete/ Non Disparagement Likely involves some amount of employment by previous owner   Deal Exhaustion is a real thing!! Darshan Kulkarni, Pharm.D, MS, Esq. The Kulkarni Law Firm 2929 Arch Street, Suite 1700  Philadelphia, PA 19104 Office Number: 215-948-8183 Twitter: @FDALawyers See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Gavel & Pestle Podcast host - Darshan Kulkarni talks about the effects of non-compliant pharmacies and pharmacy law.  Due to the meningitis outbreak caused by NECC's products, FDA Commissioner Margaret Hamburg, MD, was twice called to testify before Congress. She explained that the FDA is inadequately empowered to regulate these compounding pharmacies. Most recently, Commissioner Hamburg revealed that inspections by the agency have found appalling conditions in other compounding pharmacies. Inspections carried out from February through April have documented rusty tools, bare-handed employees handling drugs, and black particles in “sterile” solutions. According to the commissioner, these unacceptable conditions cause significant risks to public health.   As a result of the meningitis outbreak and subsequent findings, several bills have been proposed in Congress to improve regulation of compounding pharmacy. Some proposals would let the current structure continue as is, while others would require pharmacies to register and operate as manufacturers. While the former approach ignores the tragedies that occurred, the latter seemingly may take regulations too far. Darshan Kulkarni has extensive experience handling complex regulatory affairs related to pharmaceuticals, biopharmaceuticals, and medical devices. Darshan can identify FDA compliance risks and work with your organization to develop proactive strategies to mitigate these risks. By working with us as your FDA attorney and regulatory consultant, you earn change management skills and the education to develop the right global regulatory strategies for you. eMail: darshan@conformlaw.com Phone: 215-703-7842 1001  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Gavel & Pestle Podcast host -Darshan Kulkarni, PharmD, MS, Esq - provides insight on Off-Label indication and illegal promotion of drugs. What you don't know can get you thrown in jail or millions in fines.   Providing Coverage for Off-label Prescriptions While off-label promotion is the purview of the Justice department, certain off-label prescribing is for all intents and purposes sanctioned by behemoth entities such as Medicare, and guided by national compendia. In 1993, a portion of the Omnibus Reconciliation Act legally required Medicare to cover an off-label use of a cancer drug if it is in the drug compendia, or is supported by peer-reviewed articles in certain journals outlined by Medicare. References: BioWorld Perspectives http://www.bioworld.com/content/label-use-fine-line-between-illegal-promotion-and-useful-information  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Darshan Kulkarni, JD, PharmD, discusses the impact of NonAdherence: Successful treatment of disease with prescription medicines requires consistent use of the medicines as prescribed. Yet research shows that medicines commonly are not used as directed. Nonadherence to medicines is a major health care cost and quality problem, with numerous studies showing high rates of nonadherence directly related to poor clinical outcomes, high health care costs, and lost productivity. The cost of nonadherence has been estimated at $100 billion to $300 billion annually, including costs from avoidable hospitalizations, nursing home admissions, and premature deaths.i Adherence to therapy is especially important for management of chronic diseases, such as diabetes, heart disease and cancer. Chronic disease affects nearly one in two Americans and treating chronically ill patients accounts for $3 out of every $4 spent on medical care. Many researchers have found that poor adherence among patients with chronic conditions persists “despite conclusive evidence that medication therapy can substantially improve life expectancy and quality of life. References: Avella's Mobile App Adherence Case Study on improving medication adherence in HIV patients using mobile health tools: https://info.avella.com/mobile-app-casestudy  ID-Cap is a powerful platform for in-body communications http://etectbio.com/ The challenge of patient adherence https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1661624/ LiquidHub: http://www.LiquidHub.com  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

We return to the Gavel & Pestle Podcast with Darshan Kulkarni, PharmD, MS, Esq. to discuss the sensitive topic of Whistleblowers in healthcare & pharmacy. What is a Whistleblower? A whistleblower is effectively an individual who has witnessed or been part of an unethical or illegal process, often against their will as a condition of employment, and decides to submit the incriminating evidence to the proper authorities. Whistleblowers begin the indictment process in cases that are criminal. Whistleblowers are not just restricted to the private sector, but the dynamics of retaliation from cases arising from the public sector can be different. Congress understands the precarious situations that whistleblowers are in and have established legislation for retributive protection.   Cases in the private sector are covered by The Corporate and Criminal Fraud Accountability Act and are enforced by the U.S. Department of Labor. A subset of the Zarbanes-Oxley Act of 2002, the law allows whistleblowers to enjoin the government in any civil claim that the Attorney General will advance to prosecution. The legislation essentially protects employees of publicly-traded companies from the employer and criminalizes retaliation.  In addition to employee protections, the law requires employers to establish a company policy and reasonable protocol to allow whistleblowers an opportunity to present situations occurring within the company that may have been overlooked in normal operations. Conditions of the legislation also require attorneys to become whistleblowers in the event of illegal activity.   The Equal Employment Opportunity Act provides additional protection for cases involving discrimination and retaliation, effectively giving a discriminated individual more legal leverage. The legal protections of remedies in this legislation allow for protections in legal standing for the witness of a discriminating act as well as the victim if the employer retaliates against the informant. Dr. Kulkarni is the Principal Attorney at the Kulkarni Law Firm. He provides regulatory and legal advice to pharmacies and other FDA regulated entities and their service providers.  He speaks and regularly advises on currently legal and compliance related matters including the physician payment sunshine act, clinicaltrials.gov, the False Claims Act, the Anti-Kickback Law and other developments of laws and regulations that affect the life sciences industry and compounding facilities.  He has worked as a pharmacist for more than 14 years in multiple capacities, including hospitals, retail pharmacies, managed care, and has even participated as a clinician in clinical trials.   See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

How has Twitter impacted your pharmacy business? Josh Lurie, Partner & Member of Board of Directors of Symplur joins the podcast to help our pharmacy industry discover the untapped power of Symplur Signals. Quoting an article from June 15, 2016 “Tech Republic” columnist Jason Hiner writes, “From the 1980s until the past several years, when people heard about breaking news via word-of-mouth they typically turned to network news such as Fox or CNN. Today, they turn to Twitter. A recent Pew Research study found that 62% of US adults now get news from social media, up from 49% in 2012.” I am one of these people who will access my Twitter account before any direct news source because it's faster, more sincere, and provides a diverse perspective on the same topic or news story. There's no other organization better positioned to demonstrate the power of Twitter in healthcare than Symplur. With their well-designed “Healthcare Hashtag” Project launching in 2011, Symplur has been researching thousands of hashtags (subject matter) specific to our healthcare industry, scientific research, patient trends, CDC reports, and industry conference interactions, to name a few. Symplur Signals promotes deep understanding of healthcare as seen by patients, doctors and other stakeholders with real-time access to insights from over a billion healthcare social media data points. The richness of data here is mind boggling and if you're not seeing the value yet, be sure to check out Symplur for yourself. Take the specialty pharmacy industry for example. Genentech's Avastin is a cancer medication that interferes with the growth and spread of cancer cells in the body. The anti-cancer drug is used to treat a certain type of brain tumor, and certain types of cancers of the cervix, kidney, lung, colon, and rectum. If specialty pharmacies researched specific hashtag keywords using Twitter such as #CervicalCancerthey could quickly find articles, physicians, insurance providers, and most importantly patients participating in a worldwide conversation about Cervical Cancer. Not only could these patient-care providers reach out to these patients directly through Twitter but strategically could become a digital health industry subject matter expert within that specific subject-topic or hashtag. The Pharmacy Podcast Show will be publishing a series on leveraging the power of healthcare hashtags, which will include a fascinating interview with Symplur executives. Be sure to subscribe to the show and reach out to learn how your Pharmacy business can see a significant benefit using Twitter. See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

Pharmacy Podcast Show co-Host Erin Albert, PharmD, JD, interviews Aaron Moore, PharmD, JD, with The American Society for Pharmacy Law (ASPL) which is an organization of attorneys, pharmacists, pharmacist-attorneys and students of pharmacy or law who are interested in the law as it applies to pharmacy, pharmacists, wholesalers, manufacturers, state and federal government and other interested parties.   ASPL is a nonprofit organization with the purposes of Furthering knowledge in the law related to pharmacists, pharmacies, the provision of pharmaceutical care, the manufacturing and distribution of drugs, and other food, drug, and medical device policy issues; Communicating accurate legal educational information; and Providing educational opportunities for pharmacists, attorneys, and others who are interested in pharmacy law.  2016 Developments in Pharmacy Law Seminar XXVII November 10 – 13, 2016 Hilton Austin Austin, Texas http://www.aspl.org/meetings Director Erin Albert Myers and Stauffer, LC Work:  317-846-9521 ealbert@mslc.com Director Aaron Moore Salsbury, Clements, Bekman, Marder & Adkins LLC Work:  410-539-6633 amoore@scbmalaw.com See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

In the 2nd installment of the 'GAVEL & PESTLE PODCAST' with host Darshan Kulkarni we discuss employee rights, the employer's options, trade secret law, and Baked Beans. Gavel & Pestle Podcast - on Twitter Let's Roll that Beautiful Podcast Footage! Darshan Kulkarni - on Twitter  FDA Reg & Compliance Attorney | Visiting Professor | Author | International Speaker Editorial & Advisory Board Member  NOTICE:  All content provided on this "Pharmacy Podcast Network" audio-blog is for informational purposes only. The owner of this podcast makes no representations as to the accuracy or completeness of any information on this show or found by following any link on this site.  See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices

From the founder of the Pharmacy Podcast Show, Todd Eury releases today the Gavel & Pestle Podcast Show with host - Darshan Kulkarni. The Gavel & Pestle Podcast is the fusion of Law and Pharmacy.  Darshan is a PharmD and Lawyer who's focused on providing legal, regulatory, and clinical assistance to pharmaceutical and biopharmaceutical products, especially starting at the point of post-IND assistance through commercialization of the product.  Darshan helps US based and international companies manage the myriad of regulations from FDA, HHS, OIG, US Attorney's Office, DOJ, etc. as are applicable to the discovery, manufacture, and sale of pharmaceutical and biopharmaceutical products. He also has legal, clinical, teaching, and regulatory backgrounds assisting pharmaceutical companies and their service providers ranging from 1 person consultants to multi-billion dollar, multi-national pharmaceutical companies in US-related legal, regulatory, and compliance activities.   See omnystudio.com/listener for privacy information. Learn more about your ad choices. Visit megaphone.fm/adchoices