Compounded drugs serve an important role in patient care particularly if there is not an FDA-approved drug that treats the patient’s ailment.  Compounding is typically governed by state board of pharmacy laws and therefore, compounded drugs can pose a higher level of risk to patients.  With that being said, the Food Drug and Cosmetic Act does restrict the compounding of drug products that are essentially copies of commercially available or approved drug products. 

This presentation will discuss FDA guidance documents related to the compounding of essential copies and the use of bulk drug substances.

Pharmacies live in a glass house. If a pharmacy is doing something it should not be doing, then someone knows about it. That “someone” can be a PBM, a government agency, or a whistleblower. It is acceptable for a pharmacy to work with a physician, hospital and other referral sources provided the arrangements are legally permissible. In doing so, the pharmacy needs to avoid crossing the line in which the arrangement violates the federal anti-kickback statute and other applicable federal and state fraud statutes. This program will address some of the arrangements that pharmacies and referral sources can legally enter and ways that those arrangements can go sideways and make a pharmacy subject of an investigation. This program will address hot button issues pharmacies need to avoid to better steer clear of investigations. The presentation will be presented by both Denise Leard and Bradley Howard.

Pharmacy Benefit Managers (or PBMS) process and pay prescription drug claims and are responsible for creating and updating a health plan’s formulary. These duties vest significant power in the PBM. Couple that with the ability to control who can be part of the PBM’s network, and the PBM is in the driver’s seat. It is important that pharmacies understand how a PBM works and what the pharmacy’s rights and responsibilities are in any relationship with a PBM.

This webinar will discuss how to work with a PBM to insure a good relationship.  It will also discuss steps to mitigate problems when the relationship goes awry. 

A state Board of Pharmacy has the responsibility to protect the consumers in its state and for this reason, has the power to close your pharmacy in an instant.  Therefore, it is important to understand the rules governing your pharmacy. But what happens if the Board of Pharmacy thinks your pharmacy isn’t complaint and wants to take a closer look?  Every pharmacy needs to have a plan in place to deal with potential problems. This program will discuss Board of Pharmacy investigations and strategies for responding to such investigations. 

Referral sources are key to growing a pharmacy’s business but in the healthcare industry, careful consideration must be given to regulatory guidelines. Often what is perfectly legal in another industry is not legal for a healthcare provider. This presentation will discuss the ins and outs of arrangements with referral sources.

This webinar will cover the most frequently asked pharmacy questions and will address various legal issues facing pharmacies.  Topics covered will include buying and selling a pharmacy, marketing, handling an FDA inspection, pharmacy diversion, responding to a state Board of Pharmacy complaint, and the most often raised topic of handling a PBM audit.

Physician relationships are key to succeeding in today’s competitive environment and pharmacies that work on building those relationships will flourish.  Unfortunately, because the government has chosen to regulate the healthcare industry this means that what is allowed in other industries may not be allowed in healthcare. The STARK Law is one of those regulations that changes the rules. The STARK law was put in place to prohibit overutilization by physicians by creating limits to a physician’s ability to refer designated health services such as outpatient prescription drugs to an entity in which the physician has a financial relationship. As a result, anytime a pharmacy has a financial relationship with a physician, the pharmacy must analyze its activities for compliance with STARK. STARK was first enacted in 1989 and over time the reimbursement models have evolved from almost exclusively fee for service to a value-based model. CMS has recently issued new guidance and exceptions to STARK that address value-based compensation models.

This program will discuss recently published STARK guidance that applies to relationships between pharmacies and physicians. Understanding this new guidance will be important to working with physicians as suppliers develop these key relationships.

With 78 million baby boomers retiring at the rate of 10,000 per day, the demand for prescription drugs and related pharmacy services will increase exponentially. Along with this increased demand will come increased scrutiny of pharmacies by government regulators, third-party payors (“TPPs”), and others. In order to successfully withstand this scrutiny, pharmacies need to be aware of the most important legal issues they will face in the upcoming months.

This program will discuss these hot-button issues and the steps that pharmacies should take to navigate them. Among other issues, this program will discuss (i) how to fill out PBM re-enrollment questionnaires; (ii) how to respond to a PBM audit; (iii) how to offer value-added services to patients without offering prohibited inducements; and (iii) providing consulting pharmacy services, EHR software, and other products and services to long term care facilities.

There are a number of terms that have recently entered the health care space’s vocabulary: data analytics, quality outcomes, performance measurements, and collaborative care. Collectively, these stand for the proposition that third-party payors no longer intend to pay for health care services that are provided in "silos." Said another way, payors expect health care providers (pharmacies, physicians, hospitals, SNFs, home health agencies, and DME suppliers) to work together to keep patients healthy. Payors expect providers to know what other providers are doing in treating a particular patient. This program will examine the ways that pharmacies can legally collaborate with hospitals, physicians, and other referral sources. Particular areas of focus are (i) preferred provider arrangements with other providers; (ii) medical director agreements with physicians; and (iii) agreements among providers to collect and share patient data so as to measure outcomes.  

Keeping up with ever-changing federal and state laws and third-party payer requirements may leave you wishing you had a psychic on staff; this program is the next best thing. Find out what are the challenges facing pharmacies and what steps you should take to address each challenge head-on. This presentation will discuss PBMs, payor audits, appropriate marketing activities, and other topics that affect pharmacies on a daily basis.  Don’t risk your fortune by being unprepared.

The DEA is responding to the opioid epidemic by increasing its inspection of DEA registered businesses.  The best defense in dealing with a DEA inspection is a good offense by complying with federal and state laws and regulations concerning controlled substances.  As DEA inspections are typically unannounced, the pharmacy must be prepared for an inspection at any time.  This program will review the federal laws and regulations governing pharmacy dispensing and other transfer of controlled substances, records that must be maintained by the pharmacy, steps to take in the event of theft or loss of controlled substances, and how to protect against diversion related to invalid prescriptions.  We will also discuss what to expect during a DEA inspection, steps the pharmacy should take during the inspection, and how to respond to any issues identified during an inspection.

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. 

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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.