This webinar is provided to give the participant an understanding of the current landscape of compounding pharmacies, common compliance concerns, and areas of greatest risk. In addition, the presenters will provide information regarding common liability insurance gaps and how compounding and specialty pharmacies can prevent product and professional liability exposures.

When a person intends to buy … or sell … a pharmacy, there are a number of documentation and regulatory issues that must be addressed.  First, the seller must take a number of steps to make itself more “attractive.”  The buyer and seller need to decide whether the transaction will be an “asset” sale or a “stock” sale.  The parties will need to engage in the normal transactional steps: mutual nondisclosure agreement, letter of intent, stock purchase agreement/asset purchase agreement, and other closing documents.  The buyer will need to engage in three types of due diligence: financial, corporate and regulatory.  And the parties will need to meet a number of regulatory requirements such as submitting change of ownership notifications.  This program will discuss all of these (and other) issues associated with the purchase and sale of a supplier.

It would be nice if pharmacies operated in the real world —the world inhabited by auto parts stores and widget manufacturers. Unfortunately, pharmacies are not in the real world. They are in Alice in Wonderland where up is down, down is up, and every day they climb through the proverbial rabbit hole. In this alternative universe, pharmacies are subjected to numerous federal and state anti-fraud statutes and regulations. What would be perfectly acceptable in the auto parts world may be a felony in the health care world. This webinar will discuss the many anti-fraud statutes and regulations that the pharmacy must follow. More importantly, this webinar will teach the pharmacy how to recognize fraud landmines so that the pharmacy does not step on them. Examples of these fraud landmines include: (i) routinely waiving co-payments pursuant to a sham patient subsidy program; (ii) participating in sham clinical studies; (iii) paying commissions to marketing companies; and (iv) entering into improper arrangements with physicians and other referral sources.

This is a hot area in terms of enforcement actions brought by the Department of Justice, Office of Inspector General, and CMS contractors. When purchasing Internet leads, it is critical that the pharmacy not violate the Medicare anti-kickback statute. When communicating with leads, it is equally as critical that the pharmacy not violate the telephone solicitation statute and state and federal do-not-call statutes. Unfortunately, most Internet lead companies are clueless regarding the anti-kickback statute and the do-not-call statutes. Sadly, too many pharmacies and other providers are equally clueless. This webinar will discuss what a contract (between a pharmacy and an Internet lead company) should look like and will discuss what the pharmacy can and cannot do in contacting leads.

It is perfectly acceptable for the pharmacy to provide services to its patients that the pharmacy’s competitors do not provide. This is good business. These are classified as value-added services. On the other hand, when a pharmacy offers something of value to induce a prospective customer (a Medicare beneficiary) to buy something from the pharmacy (as opposed to buying something from the pharmacy’s competitor), then this may result in a prohibited inducement in violation of the beneficiary inducement statute and the Medicare anti-kickback statute. The line between a value-added service and a prohibited inducement can be unclear. This webinar will discuss the difference between value-added services and prohibited inducements and how the pharmacy can be aggressive in providing great services without crossing the line.

Notwithstanding the New England Compounding Center tragedy and several subsequent negative headlines, the demand for compounded drugs is continuing to increase. This is because physicians and patients recognize that for certain ailments, commercially available drugs are inadequate. And yet while the demand is increasing, there is also an increase in the challenges facing compounding pharmacies. This webinar will discuss the current state of federal law as it relates to compounding; the webinar will also give examples of state law that address compounding. The webinar will describe marketing programs that are legally acceptable…and those programs that should be avoided. The webinar will talk about the types of arrangements that compounding pharmacies can have with physicians and other referral sources and those that should be avoided. Lastly, the webinar will discuss (i) the steps that a compounding pharmacy should take to prepare itself for the State Board of Pharmacy and FDA inspections and (ii) how to respond to such inspections. 

ACHC Specialty Pharmacy Accreditation Top Deficiencies 

Join Greg Stowell, Senior Manager of Education & Training, as he goes over the Top Deficiencies for ACHC Specialty Pharmacy Accreditation and tips to staying compliant. 

Download the slides here.

Ask The Expert - HDDP Certification

Join, Jon Pritchett, Associate Director of Pharmacy for PCAB and Rad Dillion, USP 800 expert and Pharmacy Surveyor for PCAB as they answer some of your questions about our HDDP program.

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Patient Protection and Affordable Care Act: Its Specific Impact on Pharmacies

In “A Perfect Storm,” the crew of the Andrea Gail was trapped in the collision of a Nor’easter and a hurricane. The pharmacy profession is trapped in its own version of a perfect storm: audits, increasingly stringent documentation requirements, aggressive PBM actions, and the Affordable Care Act (otherwise known as “Obamacare”). This program will discuss the specific provisions of the ACA that impact pharmacies. These include provider screening; disclosure requirements; offsets of payments to providers with the same tax ID number; reporting and returning overpayments; and enhancement of the False Claims Act. More importantly, the program will present proactive steps the pharmacy can take to comply with these requirements.

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Lifeblood of the Successful Pharmacy: Marketing, Joint Ventures, and Arrangements with Referral Sources

• The legal parameters that must be followed when implementing a marketing program and entering into joint ventures and arrangements with referral sources
• The Medicare anti-kickback statute
• The Stark physician self-referral statute
• The beneficiary inducement statute
• The telephone solicitation statute, safe harbors, OIG fraud alerts, and state anti-fraud statutes
• Medical director agreements with physicians, joint ventures with hospitals and other providers, subsidizing a physician’s travel expenses to a conference, utilization of employee liaisons, and avoiding “sham” clinical studies
• Avoiding arrangements with marketing companies
• Utilization of W-2 employee marketing reps (rather than 1099 independent contractor marketing reps)

Download slides here.