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.

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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. 

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Legal Guidelines for Waiver or Reduction of Medicare and Commercial Co-Payments

Pharmacies have an obligation to take reasonable steps to collect co-payments from Medicare beneficiaries. From the viewpoint of the OIG, it is important for the beneficiary to pay something. This causes the beneficiary to have “equity” in the process thereby making the beneficiary a wiser consumer of health care products and services. When a pharmacy routinely waives co-payments for Medicare beneficiaries … and particularly when the pharmacy advertises that it waives co-payments, then the OIG considers this to be a kickback, inducement, and a false claim. According to the OIG, the pharmacy can only waive a co-payment when the pharmacy has made a patient-specific decision to waive…..and that decision is based on the financial condition of the patient. Contracts with commercial insurers and state statutes impose substantially the same requirements on pharmacies that bill commercial insurers. In fact, PBMs are kicking pharmacies out of network when the PBMs conclude that the pharmacies are routinely waiving co-payments. This program will discuss the requirements imposed upon pharmacies to attempt to collect co-payments from Medicare beneficiaries and commercial patients, and the steps that the pharmacy should take before waiving a co-payment. 

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Compounding Pharmacies: Steps To Avoid Issues with the FDA, DEA, Pharmacy Boards, and Patent Holders

In light of the New England Compounding Center tragedy, the state boards are becoming more assertive and the jurisdictional powers of the FDA have increased. This program will discuss the rules and regulations that compounding pharmacies must currently follow. This program will “gaze into the crystal ball” and discuss the additional regulatory actions that will take place in the not-too-distant future. Separate and apart from governmental regulation, this program will discuss the rights of manufacturers that own drug patents and steps that the compounding pharmacy can take to avoid litigation from a manufacturer to enforce its patent rights.

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Purchasing a Pharmacy: State Lincense, DEA Permit, Medicaid Number, The NCPDP, and Other Regulatory Issues

When purchasing a pharmacy pursuant to an “asset sale,” there are a number of steps that must be fulfilled. The purchaser must obtain its own pharmacy license; until it does so, it can operate under the seller’s pharmacy license pursuant to a power of attorney. This program will discuss the many regulatory requirements that must be met in an asset purchase and the fewer regulatory requirements that must be met in a stock purchase.

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