Over the decades, there has been an uneasy truce between pharmacies and the FDA. Pharmacies are regulated by their state boards; the FDA steps in when it concludes that the pharmacy has crossed the line over into the manufacturing arena. However, the FDA is becoming increasingly aggressive in attempting to assert jurisdiction over pharmacies. There are several reasons for this with the main reason being the FDA’s concern that state pharmacy boards are not adequately overseeing compounding pharmacies. In addition, the New England Compounding Center tragedy has cast a spotlight on compounding pharmacies. This program will discuss the legal basis upon which the FDA can assert jurisdiction over pharmacies, the legal arguments against such an assertion of jurisdiction, existing and potential legislation that addresses the FDA’s authority over pharmacies, the steps that the pharmacy can take to prepare for an FDA inspection, and the steps that the pharmacy can take to respond to an FDA inspection/enforcement action.

Arrangements Between Pharmacies and Long-Term Care Facilities:  Landmines to Avoid – Let’s look at a comparison. Medicare “grew up with” 23 million of the Greatest Generation (World War II generation). We now have 78 million Baby Boomers who are retiring at the rate of 10,000 per day. With such a large aging population, utilization of long term care facilities will increase dramatically. This program will discuss how a pharmacy can properly enter into arrangements with skilled nursing facilities (“SNFs”) and custodial care facilities. Questions to be addressed include:  What types of “value-added” services can the pharmacy provide to the facility without violating the Medicare anti-kickback statute? What are the key provisions to be included in a Facility Services Agreement between the pharmacy and the facility?

Health care fraud and abuse cases continue to make headlines.  While those cases are not representative of most health care providers, they should at least cause some introspection into what “could” happen.  Not only is a compliance program important, but one that is effective could save an implicated organization millions of dollars and keep the doors open.  Whether you are part of a small family-owned pharmacy or part of a large chain organization, compliance should be part of your culture.  In the event of a compliance issue or concern, having a thorough and implemented compliance plan will mitigate any potential adverse effects.  While compliance plans are key in dealing with government investigations, there are other positive effects.  For example, having a compliance plan can help a pharmacy identify a problem well before the government or payor, allowing the pharmacy to take corrective action without being exposed to dire consequences.  This webinar will guide you through how to structure and implement a compliance program that will withstand scrutiny in the event of a compliance issue. 

CBD or Cannabidiol is extracted from hemp plants and has been touted as a cure for everything from minor aches and pains to being able to treat patients with diseases such as multiple sclerosis, Parkinson’s disease, and many others.  The passage of the federal Farm Bill, which allows for cultivation of hemp, has created increased interest in CBD and products containing CBD.  However, the legalities of CBD are not as straight forward as most people believe.  This webinar will discuss the laws and regulations that suppliers should understand before deciding to add CBD to the products it offers.

A month ago, it was business as usual for health care providers.  Things have rapidly changed due to COVID-19.  As health care providers, your businesses are the key to defeating this virus.  However, there are many uncertainties.  How do you take care of your patients?  Will reimbursement be affected?  What if you have an employee who tested positive or needs to stay home to care for a family member who has tested positive?  These and many other questions are addressed in The Families First Corona Virus Act (“Families First”) and the Coronavirus Aid Relief and Economic Security Act (“CARES Act”), which have been implemented by the federal government to help with this crisis.  This presentation will discuss the important sections of these pieces of legislation and will help you to understand how they will help your business thrive during these tough times. 

Description to follow.

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.

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.

Download the slides here.

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.

Download the slides here.

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.

Introduction to ACHC/PCAB's Hazardous Drug Designated Person Certification

Join us as we talk about ACHC/PCAB's first of its kind certification for a Hazardous Drug Designated Person (HDDP). USP 800 stipulates that each entity handling Hazardous Drugs (HDs) MUST identify a Designated Person (DP) to guide them through both initial implementation, and to ensure ongoing compliance.

The Designated Person is responsible for:

1) Creating and implementing procedures concerning HDs.
2) Performing a documented annual review of these Standard Operating Procedures (SOPs).
3) Monitoring compliance with these SOPs and relevant rules and regulations.
4) Ensuring worker training and competency for HDs.
5) Ensuring "environmental control" of areas where HDs are found and handled.
6) Overseeing facility monitoring, managing related documents, and acting on results, including incident reports concerning HDs.

This certification is designed to fully equip this person with the knowledge and tools needed to ensure your compliance with USP 800.

Download the slides here.

Infusion Suites: How to Properly Set Up and Operate

Increasingly, pharmacies are entering into infusion suite arrangements with physicians. If structured properly, such an arrangement is legal. But, as often is the case, the “devil is in the details.” This program will discuss how an infusion suite can legally be set up and what legal pitfalls to avoid. Questions to be addressed include:

• Can the pharmacy furnish the nurse or must the nurse be employed by the physician?
• Must the physician purchase the drugs from the pharmacy or can the pharmacy supply the drugs without requiring the physician to pay for them?
• What are the key provisions to be included in the Infusion Suite Management Agreement?

Download the slides here.

What Business Practices Will Get You Investigated: Hot-Button Issues For The Department of Justice

Health care fraud continues to be a top priority for the Department of Justice. Brown & Fortunato defends pharmacies that have criminal and civil cases brought against them by the DOJ. As such, B&F works closely with federal investigators and prosecutors. This program will share observations regarding how the DOJ is attacking the problem, and what the pharmacy can do if it is the target of an investigation. Nationwide, there are nine Medicare Fraud Strike Forces using data analysis techniques to uncover fraud. This program will discuss the types of activities by pharmacies that the DOJ is focusing on. The program will set out “nuts and bolts” steps that the pharmacy can take to reduce the risk of being targeted by the DOJ. Lastly, the program will discuss the steps that a pharmacy should take in the event that it finds that is the target of a DOJ investigation.

Download slides here.