Technology has made the exchange of information easier than ever. But that ease comes with a price. HIPAA was put in place to ensure that health care providers who maintain protected health information (PHI) take steps to protect the PHI in its possession from unauthorized use. Failure to do so can result in significant fines and penalties. Despite a covered entity’s best efforts, unauthorized disclosures do happen—opening Pandora’s box. Once Pandora’s box is open, a covered entity must immediately take steps to mitigate the damage. This webinar will discuss proactive steps that can be taken to prevent a breach, and in the event of a breach, what must be done to comply with HIPAA.

There is an old saying: “Possession is 9/10ths of the law.”  At the end of the day, the PBM possesses the pharmacy’s money.  If the PBM withholds payment at the outset or recoups payments at a later time, then this poses a headache for the pharmacy.  Recoupment of payments results from post-payment audits.  That is, the PBM asks the pharmacy for documentation that justifies claims (i) previously submitted by the pharmacy and (ii) paid by the PBM.  If the PBM determines that the documentation does not support the claims, then the PBM will seek recoupment.  It is critical that the pharmacy know how to properly respond to an audit to reduce the risk of recoupment.  This webinar will discuss the steps that the pharmacy should take when it is notified of a PBM audit.  The steps that will be discussed will include (i) understanding what it is that the PBM is looking for; (ii) whether it is appropriate to request that the scope of the audit be narrowed and, if so, how to make such a request; (iii) whether it is appropriate to request an extension of time to submit documents and, if so, how to make such a request; (iv) if patient documentation is deficient, then how the pharmacy may be able to rehabilitate the documentation before submitting it; (v) how to organize documentation before it is submitted; (vi) how to succinctly draft an explanatory cover letter to go with the documentation when it is submitted; (vii) how to supplement documentation after initial submission; and (viii) verbal and written discussions that the pharmacy can have with the PBM following submission of documents with the goal of influencing the results of the audit. 

When a pharmacy goes to sell, it is not just buyers who are investigating. Smart sellers are coming to the table with a clear understanding of their business’s competitive position in the market, a realistic asking price, and knowledge of a potential buyer’s suitability well before they sit down to negotiate. This program will discuss the specifics of preparing for the purchase and/or sale of a pharmacy, specifically: (i) what a buyer looks for in acquiring a pharmacy and (ii) how a pharmacy can make itself more attractive to a group of buyers. Prospective buyers will learn to ask the right questions related to product/payer mix, referral source issues, licensing and permits, audit risks, and other legal matters. Sellers will learn which action steps can make their business more attractive in the marketplace including cleaning up sloppy books and tax records, dealing with payor issues, patient files, employment matters, and organizing material contracts in preparation for the transaction. This program will also discuss the different types of transaction structures (stock v. asset) and how these structures may dictate the preparation process for buyers and sellers. 

PBMs have tremendous power and are essentially accountable to no one. Capitol Hill is beginning to take notice of this and legislative changes will likely occur in the future. However, Congress moves at a glacier’s pace and so it will be several years before pharmacies start seeing legislative relief. Until then, pharmacies have to deal with PBMs as they are. PBMs have tremendous discretion in deciding which pharmacies they will allow in their network, which pharmacies will be denied re-enrollment, which pharmacies will be kicked out of the network…and which pharmacies to audit. This webinar will focus on audits. In particular, the webinar will discuss the “hot button” issues that trigger audits. These include: (i) billing pattern that is different from those of comparable pharmacies; (ii) changes in billing pattern; (iii) waivers and reductions in patient copayments; (iv) use of 1099 independent contractor marketing reps; (v) dispensing of large quantities of compounded drugs; and (vi) shipment of drugs via mail-order. This webinar will discuss steps that pharmacies can take to reduce the chances of being audited. Lastly, the webinar will discuss the steps that pharmacies should take to respond to PBM audits.

PBMs are truly the “Alpha dogs.” As unfair as it may be, PBMs have a great deal of discretion in deciding which pharmacies they will allow in network, which pharmacies will be denied re-enrollment, and which pharmacies will be kicked out of network. This program focuses on the “hot button” issues that PBMs are focusing on…and that serve as the basis for denying re-enrollment and removing from the network. These issues include routine waiver or reduction of copayments, engaging in mail-order beyond a certain threshold, engaging in questionable marketing practices, and engaging in questionable billing practices. This program will discuss practical steps that the pharmacy can take to avoid these problems.

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.