340B Drug Pricing Program
Our group of experienced attorneys have years of experience in handling all forms of health care matters from compliance to criminal defense.
Our firm has experience handling both compliance-based programs and self-reporting programs such as those found in the 340B Drug Pricing Program. If you have any questions or need compliance help with 340B Drug Pricing Program, contact our experienced attorneys.
What is the “340B Drug Pricing Program?”
When drug manufacturers supply drugs to a nonprofit or a hospital, they need to provide discount prices on drugs. The federal government enacted the 340B Drug Pricing Program to both regulate the price of drugs to hospitals and nonprofits. The other thing under 340b is a refund program where drug companies will get reimbursed by the deferral government for the reduced prices.
How Can I Participate in the 340B Drug Pricing Program?
If you are a drug manufacturer and you actively are selling drugs to other companies, you might have to enter into this program. You would need to offer reduced prices but what is important is making sure you are getting the reimbursement for the reduced price.
What Legal Problems Can Arise Through This Program?
When you are accepting funding for this program, you need to make sure you can show that you are giving a reduced price for the drugs. If you end up receiving money for the program but do not reduce the price you might end up having to forfeit all of your proceeds from the program. Compliance with the law is the main focus for 340b to make sure that you do not face reimbursement.
How Can I Avoid Problems Related to Pricing Programs?
When you are accepting funds through the 340B Drug Pricing Program, you need to make sure you are in compliance with the law. Contact our experienced attorneys to work with you to make sure you are in compliance whenever you enter into the 340B Drug Pricing Program. Compliance involves our review of your policies and procedures as well as help to draft any legal documents you need.
What Does Compliance Entail?
Compliance is an essential component of most health-related industries, and it is no different with the 340B Drug Pricing Program. When you enter into this program, you need to find out what hospitals and nonprofit organizations qualify for a discount. The discounts provided are usually for underserved and low-income areas.
How Can We Help You with Compliance?
Our team of dedicated health care law specialist are well versed in all areas of the law. Part of what we do is work in compliance. 340B Drug Pricing Program is a complicated program so we will work with you to form contracts and to keep you up to date with all the changing law in this area.
The specialized form of 340B Drug Pricing Program compliance is extremely important because it is so complicated. Our attorneys will work through the law with you to create a plan of action that is geared best to fit your needs as a supplier while making sure you are in compliance.
What Do You Have to Gain from Participation in the 340B Drug Pricing Program?
The reason why you want to participate in this program is to be able to serve underprivileged areas, but even more so it is to make money through the federal rebate program. When you offer the lower price on prescriptions, the federal government gives out money to your company to compensate for the reduced prices.
Getting paid through a reimbursement scheme might also reduce the risk of non-payment to a degree as well. When the stipend drugs are given out you have an almost 100% guaranteed form of payment through the federal government as opposed to if you operate with hospitals on a lien base payment plan.
What is an HRSA Audit?
When you participate in the 340B Drug Pricing Program you sometimes will have to deal with audits that work to try and find if the correct amount of money was given out based on the needs of the hospitals and the discounts that are given. These audits come in the form of an HRSA final report that is given to your company to show how much money is owed back after the audit.
Can You Fight Your HRSA Final Report?
Yes, if you get an HRSA Final Report, you have a 30 day time period to appeal internally to HRSA the amount that is owed back after the audit. Our firm can help you to prepare an appeal to this report to try and save you as much money as possible. Repayment under these actions can be fought, and if we are successful, you may not have to pay as much or even any amount following an audit.
What Do Repayments Look Like?
When you have to make a repayment following an HRSA report you will have to work between the manufactures and providers to come to some negotiated conclusion. The amount to repay ultimately is not set by the federal government but as a negotiation between the provider and each manufacturer.
What Should You Do?
If you need any help with 340B Drug Pricing Program compliance or negotiations, you should contact our experienced attorneys to help you through this process. We have experience in handling all forms of health care law including compliance.
Our experienced attorneys know just how important it is for you to stay in compliance to avoid legal troubles so we will work hard for you to ensure compliance. If there are any problems with your contract that lead to legal troubles, we will also be able to defend against any charges you may face.