Gavel & Pestle Podcast

Is Amazon Your Next Pharmacy? PART 1 --Pharmacy Podcast Episode 483

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
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Buying Your First Pharmacy - Gavel & Pestle Podcast - Pharmacy Podcast Episode 481

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.
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3 Tips for Selling a Pharmacy - Pharmacy Podcast Episode 446

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 
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3 Tips for Buying a Pharmacy - Pharmacy Podcast Episode 426

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.
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Detrimental Effects of Noncompliance: Pharmacy Law - Pharmacy Podcast Episode 396

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 
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Drug Benefits: Off-label indication & illegal promotion

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 
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The Billion Dollar Non-Adherence Factor - Gavel Pestle Podcast 355

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 
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What You Need to Know about Whistleblowers - Pharmacy Podcast Episode 341

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.  
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The Untapped Data Analytics Power of Symplur - Pharmacy Podcast Episode 339

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.
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American Society for Pharmacy Law (ASPL) - Pharmacy Podcast Episode 337

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
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