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Pharmacy Regulatory & Compliance Attorney

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Lawyers for Federal & State Regulatory Issues

Protect Your Pharmacy and Ensure its Compliance for Continued Success

Pharmacy compliance and regulation are complex but very necessary. These guidelines provide protections for public health and safety. Non-compliance can hurt the individuals whom pharmacies are operating to help, and failing to follow regulations can lead to significant legal trouble for pharmacy owners.

The continued business of your pharmacy depends on its compliance with the regulations and laws that govern pharmacists and businesses. If your pharmacy is under suspicion of noncompliance or is at risk of being sued, you want to contact an attorney as soon as possible. An effective attorney can help you defend against accusations, manage state or federal investigations, and work to maintain an operational business. A regulatory attorney is also capable of helping pharmacy companies review their compliance policies before legal and financial issues arise.

The attorneys at Boesen & Snow Law in Arizona have experience in pharmacy law and business law. They will assess your case and help you understand how to identify the solutions to your problem. These attorneys have more than 75 years of combined experience in healthcare and business management laws. Boesen & Snow is located in Arizona and helps clients nationwide ensure they are following the laws and regulations of their state. When it is well done, regulation compliance can keep your patients safe and ensure your company is successful.

Federal Agencies that Oversee Pharmacy Compliance

Federal compliance and regulation are largely governed by the following agencies:

1.   The Food and Drug Administration (FDA) oversees the drug supply chain and its safety and security.

The FDA, the Food, Drug & Cosmetic Act (FDCA) and myriad statutes and regulations work to ensure that drugs are safe and effective for patients. Manufacturers, distributors, and pharmacies all have a responsibility to  follow the drug laws and regulations. This includes determining the state licensure and federal registration of suppliers while having USP compliant policies for drug storage. A FDA regulatory attorney can help create policies to ensure compliance.

2.   The Drug Enforcement Administration (DEA) oversees the regulation and management of controlled substances.

Under the Controlled Substances Act (CSA), controlled substances have to be tracked and secure. Pharmacies must have plans in place for inventory and security of each of their controlled substances and, in some cases, human growth hormone (a non-controlled drug regulated by the DEA). Pharmacies, that stock and dispense controlled substances, must also be registered with the DEA and ensure registration renewal to remain in business. A regulatory and compliance attorney with intimate knowledge of state and federal controlled substance rules can help you understand all the necessary aspects of complying with the DEA and state-specific requirements.

3.   The Environmental Protection Agency (EPA) oversees the removal of hazardous waste.

The Resource Conservation and Recovery Act (RCRA) requires safe disposal of hazardous pharmacy materials, and pharmacies must ensure they follow those regulations to keep others and the environment safe. Not all drugs require hazardous disposal. It’s important that pharmacies know what is expected of them and have the necessary policies and training in place.

An attorney who is well-versed in federal regulation and compliance can help pharmacies understand the requirements. This can help ensure a safer business and limit liabilities.

The Potential Risks to Your Pharmacy’s Monetary Growth

Pharmacy business owners should always be aware of how failure to comply with laws and regulations can affect the growth and revenue of the pharmacy.

PBMs

Many pharmacies contract with Pharmacy Benefit Managers (PBMs). PBMs contract compliance and audit responses can be a nightmare to manage. In addition, they may impose direct and indirect remuneration fees, generic effective rate clawbacks, brand effective rate clawbacks, and other costly dollar recoupments. PBMs often profit on their audits of pharmacies. This results in costly losses for your pharmacy. It’s important to have an attorney to effectively defend and litigate against these actions when necessary.  ENGAGE A LAW FIRM EARLY IN THE AUDIT PROCESS.  The first, and sometimes last, chance to protect you pharmacy occurs in the initial audit response.

Most PBMs own their own specialty pharmacies and often prevent you from joining an preferred network. Our attorneys will fight for your access into these preferred pharmacy networks, and review contracts and other documents that make up these transactions.

Incorporating Outsourcing Facilities

Outsourcing Facilities are registered by the FDA as a result of  the addiction of Section 503B of the Food Drug & Cosmetic Act (FDCA). The rules governing 503B Outsourcing Facilities are strict. Navigating pharmacy compounding requirements while layering in current Good Manufacturing Practices (cGMP) can be daunting.  The pharmacists and attorneys at Boesen & Snow have experience running 503Bs and keeping them compliant.  New guidance by the FDA that appears to allow 503A pharmacies to receive and dispense medications from 503Bs can be risky if you do not know how each of the states regulates 503Bs working with 503As.

Beneficiary Inducement

Beneficiary inducement is the practice of offering discounts or benefits to patients or third parties, especially if the patient is receiving federal benefits. It is important to refrain from improperly inducing the dispensing of prescriptions to patients. Beneficiary inducements for government third-party-payors and for all patients in so-called “All Payor States” can lead to a risk for receiving a civil monetary penalty (CMP) or criminal charges. The penalties range from $2,000 to $100,000 depending on type of fraud or abuse and whether the government can prove intent to defraud. It’s important to protect your business from these financial liabilities.

Consult with a lawyer to determine how to construct and monitor the facility and design compliance of your pharmacy. An attorney can help prevent these legal penalties before they happen and protect you and your company in the event they occur. Additionally, agencies that impose penalties will take into account the compliance programs at work when deciding on sentencing.

Other Compliance Concerns

Just like any other health care provider, pharmacies and pharmacists have other regulations they must follow. This includes:

  • Billing Compliance: Pharmacies must bill correctly and keep required records, whether their billing is done through a third party or in the company. There are essential safeguards necessary to ensure billing compliance.
  • Fraud Prevention: This includes preventing fraud through inaccurate billing and fraud through inadvertent acceptance of invalid prescriptions.
  • Business Regulation: Pharmacy compliance also includes following regulations for employment, marketing, and other business practices.
  • Monitoring Continued Compliance: Maintaining compliance in a pharmacy doesn’t end with the creation of policies. As a pharmacy, it is your responsibility to ensure compliance is continuous and the policies are effective.

Pharmacy Regulatory Compliance

Your pharmacy and pharmacists must comply with all laws that regulate the dispensing of controlled substances. This includes federal laws and the laws specific to your state.

Noncompliance can result in fines and the suspension or revocation of your pharmacy license. If your pharmacy has been suspected of noncompliance with:

  • HIPAA/HITECH
  • Third-Party Payor contracts
  • Compounding compliance
  • Recordkeeping compliance
  • Third-Party Payor contract compliance
  • Fraud, Waste, and Abuse accusations
  • Medicare, or other federal payor provider compliance
  • Pharmacy, compounding, or limited drug distribution pharmacy regulation

Contact our office at (602) 900-8562 or email us by filling out this online contact form. It’s better if you work with a qualified attorney quickly to help protect your license and your business.

Legal Obligations of Pharmacists and Pharmacy Technicians

In addition to pharmacy and business compliance, pharmacists and pharmacy technicians have several legal requirements they must follow. This includes:

  • Maintaining accurate prescription records
  • Correctly dispensing medications to patients
  • Clearly and accurately providing patients with information about medication, including mandatory counseling and counseling recordkeeping requirements
  • Supervising the supply of medication and the supply chain for which you participate as a trading partner
  • Continuous Quality Assurance/Continuous Quality Improvement compliance
  • Medication error and Quality Related Event documentation and handling
  • Patient Safety Organization interactions

Medication errors can harm patients. Ensuring that pharmacists are aware of their responsibilities is part of a comprehensive compliance program.

Compliance Programs

An attorney can help you implement a compliance program that fits with state and federal guidelines. Generally, this includes:

  • Clearly written policies for conduct and compliance
  • Employees in charge of compliance
  • Employee training and education on the importance of compliance with regulations
  • Communication between a business, its employees, and patients
  • Enforcing, monitoring, and self-auditing for regulatory compliance
  • Partnership with a federally-qualified Patient Safety Organization (PSO)

These guidelines can be made specific for your pharmacy’s safety and needs.

An Attorney Helping You with Every Part of the Process

Federal and state regulations can be overwhelming, especially when you’re trying to keep your business afloat. At Boesen & Snow, we want to help you with that goal and protect you from legal and financial liability throughout the process. We understand how complicated compliance is because we’ve been in your shoes. Our attorneys want to provide you with comprehensive support in any of the following areas:

  • Corporate, federal, and state compliance
  • HIPAA, ARRA, and HITECH audits and regulatory compliance
  • Compliance with anti-kickback laws
  • Compliance with physician-ownership and referral laws (e.g., Stark Laws)
  • Audits and investigations
  • Licensure, credentialing, and background checks
  • Fraud and abuse compliance
  • Workers’ compensation and wage and hour laws
  • Employment law compliance
  • Billing and claims processing

Our attorneys have years of experience working in pharmacies and other health care providers  dealing with complex business law. This makes our team uniquely qualified to help your pharmacy remain profitable and compliant.

Boesen & Snow Law: Setting Your Pharmacy Up for Success

When you run a pharmacy, you need an attorney and legal team who understands the unique needs of your practice. Contact the team at Boesen & Snow to see how we can help your company flourish.

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