340B Lawyers – Covered Entity and Contract Pharmacy Services

340B Attorney – Covered Entity and Contract Pharmacy Services

The Health Resources and Services Administration (HRSA) within the Department of Health and Human Services (HHS) oversees the 340B Drug Pricing Program, which is designed to expand access to lower-cost drugs to patients who need them most. Contract pharmacies work with 340B Covered Entities to provide discounted drugs to patients qualified under 340B. 340B lawyers can offer Covered Entities and contract pharmacy providers comply with complex regulatory requirements helping clients maintain eligibility in the program.

Legal Counsel for 340B Covered Entities & Contract Pharmacies

The attorneys at Boesen & Snow Law have more than 45 combined years of professional experience in healthcare and pharmacy law. Throughout our firm’s operation, we have assisted thousands of clients with all types of regulatory compliance issues, contract reviews, and various other legal services that enable them to continue operating with confidence. If you operate a Covered Entity or contract pharmacy under 340B, we can help your organization in various ways.

Our firm provides client-focused legal counsel in every case we accept. The healthcare and pharmacy industries are some of the most heavily regulated and it is vital for every healthcare organization to maintain compliance. We can help you understand the 340B Drug Pricing Program more clearly, allowing your organization to offer higher standards of patient care while minimizing expenses for your patients.

340B Lawyers — Covered Entity & Contract Pharmacy Services

When you choose Boesen & Snow Law to represent your business, you are investing in dedicated legal counsel who can assist you with 340B-related issues and contract pharmacy services. We can help you take full advantage of 340B, maintain your eligibility, and review any disputes that may arise with a contracted Covered Entity. Our firm excels at providing focused, results-driven legal counsel and contract pharmacy services your business needs to succeed.

340B Drug Pricing Program: Purpose, Eligibility, and Compliance

Healthcare is notoriously expensive for patients throughout the United States, and the 340B Drug Pricing Program aims to expand access to necessary medications at reduced prices for patients in without health insurance or are underinsured and usually reside in an underserved community. 340B is administered by the Office of Pharmacy Affairs within HRSA, and it requires drug manufacturers to provide medications to qualified Covered Entities at reduced prices.

If an organization wishes to participate in the 340B Drug Pricing Program, the Covered Entity needs to register with the HRSA and comply with all the program’s requirements. After an organization has enrolled in the 340B Drug Pricing Program, it will be assigned a unique identification number that all vendors must verify before any sale of 340B discounted medications.

The 340B Drug Pricing Program sets discounted prices for many brand-name drugs as a percentage of the drug’s average manufacturer price, and the program applies to generic drugs as well. Whenever a manufacturer offers a lower price for a specific drug, it is possible for the 340B to offer a larger discount. Many safety-net hospitals and other healthcare facilities serving low-income communities are eligible for the 340B Drug Pricing Program.

An eligible provider can purchase drugs at lower prices, which in turn offsets the cost of these drugs to patients. One of the main tenets of the program is to ensure access to necessary drugs for low-income and vulnerable communities, ensuring they can receive essential care without exorbitant costs. Providers can, in turn, reach more eligible patients and curb the cost of certain drugs, and both patients and providers benefit from the resulting savings.

Once a Covered Entity has enrolled in the 340B Drug Pricing Program, they must renew their eligibility every year. All 340B Drug Pricing Program participants must maintain 340B compliance, complete all recertifications on time, and have legally enforceable service agreements with contracted partners. 340B lawyers help their clients secure enrollment in the program and maintain compliance.

Legal Concerns for Contract Pharmacies

While many Covered Entities enrolled in the 340B Drug Pricing Program use their own in-house pharmacies, many others work with contract pharmacies to participate in this program and extend the associated benefits to their patients. When a healthcare provider partners with a contract pharmacy, they must have a legally enforceable service agreement that complies with all applicable state and federal laws.

One of the most vital components of any modern business is contract drafting and review, especially in the healthcare sector. If you operate a 340B contract pharmacy, it is vital to ensure that your service agreements with partnered healthcare organizations do not expose your operation to undue legal issues and maintain a clear professional relationship that can continue to serve your business and improve the quality-of-care patients in your community receive.

The attorneys at Boesen & Snow Law can help your organization with service agreement development and review, and we are keenly aware of the many legal disputes surrounding the 340B Drug Pricing Program that have arisen in recent years. For example, many drug manufacturers were limiting sales of certain drugs to 340B contract pharmacies and raised legal disputes against many Covered Entities in response to a massive uptick in claims for discounts.

When you choose Boesen & Snow Law to assist your organization with any 340B Drug Pricing Program-related legal issues, you will have a dedicated legal team ready to provide comprehensive support and guidance. We can help your organization enroll as a contract pharmacy under the 340B Drug Pricing Program, assist you in the development of your service agreements, and help resolve any related legal disputes that may arise.

Benefits of Contract Pharmacy Services from Boesen & Snow Law

Navigating the tremendous compliance requirements of the healthcare industry is a challenge for any pharmacy. Boesen & Snow Law can help your business in many ways, and our contract pharmacy services include:

• Advising clients with regard to compliance with the 340B Drug Pricing Program. We can help determine your eligibility, what to expect when it comes to vendor agreements and service agreements with contracted healthcare providers, and much more so you can take full advantage of the program’s benefits.
• Assisting clients in drafting all necessary 340B policies and procedures.
• Completing comprehensive reviews of 340B Drug Pricing Program compliance. We can identify issues that might lead to an audit or other legal disputes with vendors and/or contracted partners.
• Preparing for HRSA audits, including document collation and legal advice prior to an audit. Any type of audit from a federal organization can be daunting, and the requirements for complying with an audit can be disruptive to your business without legal representation you can trust on your side.
• Helping clients respond to manufacturer inquiries. Drug manufacturers have been at odds with healthcare providers and contract pharmacies with respect to the 340B Drug Pricing Program, and we have the experience necessary to resolve such issues for our clients.
• Negotiating and developing service agreements with local healthcare organizations. Contracts are an essential consideration for every business, but they are especially important for parties entering into any type of business contract within the extent of a federal program such as the 340B Drug Pricing Program.
• Legal oversight for Medicaid payment and billing policies that may affect your business.
• Responding to general 340B Drug Pricing Program-related questions, helping your organization understand your rights and responsibilities more clearly.
• Initial enrollment and re-enrollment procedures to maintain the ability to participate in the 340B Drug Pricing Program.
• Helping clients determine potential remedies when drug manufacturers and/or contracted partners violate the terms of any service agreement.
• Providing clients with strategic legal solutions that enable them to continue operations with confidence, ensuring they are prepared to handle any future legal disputes that may arise concerning their participation in the 340B Drug Pricing Program.

Every investment you make into your pharmacy business is crucial, and 340B lawyers can help clients navigate these decisions with peace of mind. When you choose Boesen & Snow Law as your legal counsel for any 340B Drug Pricing Program-related issue, you are investing in a dedicated team of legal representatives with more than 45 years of combined experience in healthcare and pharmacy law.

Our goal is to help run your business in full compliance with state and federal laws. Whether you encounter any issues with the Arizona State Board of Pharmacy, the HRSA at the federal level, or any other regulatory authority, we can assist you in defending yourself and ensuring full compliance so you can continue operations without fear of further legal vulnerability in the future.

During an initial consultation, our team can field any legal questions you have about the 340B Drug Pricing Program, your eligibility to participate in the program, or any legal issues you have already encountered. Our team not only has the legal experience you need on your side to navigate these cases with confidence but also extensive medical experience, positioning our firm as a leading choice for contract pharmacy services.

FAQs

Q: What Qualifies a Patient for the 340B Drug Pricing Program?

A: A patient can qualify for discounted 340B drugs as long as they are a patient of a Covered Entity as defined by HRSA and require critical care. A contract pharmacy will provide the drugs under the 340B Drug Pricing Program as required, potentially reducing the patient’s expenses significantly.

Q: What Does the 340B Drug Pricing Program Allow?

A: A Covered Entity under the 340B Drug Pricing Program may choose to provide outpatient prescription medications through its own in-house pharmacy, or it may work with a contract pharmacy to provide these medications to patients at reduced prices. Independent pharmacies, specialty pharmacies, chain-based pharmacies, and community retail pharmacies all qualify to become contract pharmacies if they meet the eligibility requirements of 340B.

Q: What Is the Final Rule for 340B?

A: The Final Rule aims to address repayment to qualified healthcare entities under the new terms of the 340B Drug Pricing Program. The HHS will repay every 340B hospital that was unlawfully underpaid between 2018 and 2022, with each affected hospital receiving a single lump sum. The Final Rule also recoups funds from any hospitals that unlawfully received increased rates for any non-drug services between 2018 and 2022.

Q: Is the 340B Drug Pricing Program Going Away?

A: No. While the 340B Drug Pricing Program became the subject of scrutiny due to lax enforcement and oversight, the recent Final Rule was implemented to address discrepancies regarding unlawful redistribution of payments that affected many US hospitals between 2018 and 2022. The 340B continues to operate, but there is a clear demand for greater oversight to prevent hospitals and contract pharmacies from profiting at the expense of patients.

Q: What Can 340B Lawyers Do for My Business?

A: If you operate a healthcare organization or a contract pharmacy, it is vital to understand your rights and responsibilities as defined by the 340B Drug Pricing Program. It’s possible to save a tremendous amount of money on critical medications and to alleviate healthcare expenses for patients with this program, and your 340B lawyers can help you understand the legal issues that affect your business most acutely.

The attorneys at Boesen & Snow Law have years of professional experience helping our clients with all types of healthcare and pharmacy law, and we provide various contract pharmacy services that can help maintain your eligibility with the 340B Drug Pricing Program. We can also help resolve any related disputes that arise. Contact us today to schedule a free consultation with 340B lawyers you can trust to protect your business.