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)

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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.

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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?

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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.

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Responding to PBM Re-Enrollment Applications, Request for Information and Contract Terminations

PBMs are integral to the pharmacy’s existence. The power possessed by PBMs is frustrating and unsettling. Nevertheless, it is reality. Particularly with the increase in the number of compounding pharmacies, PBMs are more intrusive and demanding than they have been in the past. This program will discuss the ways that PBMs are intruding on pharmacies. Examples are detailed re-enrollment/re-credentialing applications, requests for information pertaining to waiver/reduction of copayments, audits of claims, and termination of contracts. Equally as important, the program presents practical steps to completing re-enrollment/re-credentialing applications, responding to requests for information, responding to billing audits, and responding to a termination notice.

Download the slides here.