340B Contract Pharmacy Agreement
Covered companies that opt for the use of contractual pharmacy decisions are required to register each contract pharmacy. Covered companies must register contract pharmacy agreements online for an open registration period after a written contract has been concluded. As noted earlier, program 340B requires drug manufacturers participating in Medicaid to provide discounts to certain health care providers known as “safe units” on prescription drugs. Part of the aim of this directive is to help companies in question to take advantage of the savings of these rebates to meet the health needs of the uninsured and the underinsured. Many 340B suppliers have agreements with “contract pharmacies” that issue discounted drugs on behalf of covered companies. These suppliers explain that contract pharmacies help them expand the reach of their services. The use of contract pharmacies has been blessed since the 1990s through HRSA`s sub-regulation. If a drug does not accumulate within a negotiated period (usually 90 days) to obtain a full size of the package, the EC pays the contract pharmacy (via TPA) the highest cost of the drug that the pharmacy should have paid. The result is always a loss for the EC. Yes, if something can go wrong. The EC should set specific parameters for the negotiation of agreements and, of course, the EC has final approval of each agreement and signs the final agreement that exists between the EC and the contract pharmacy.
Things are certainly being negotiated on your behalf, but at the time, opponents argued that the guidelines would not adequately describe the security measures that would combat major problems such as drug diversion and double rebates. Since then, there has been growing concern about what many see as a lack of supervision of contract pharmacies participating in the 340B program. A 2014 report by the Inspector General`s HHS office (OIG) found that the agreements of pharmacies complicated efforts to prevent diversions and duplication. We`re back with another 340B of mail. The 340B program has recently been a regular part of the blog in the context of the ongoing litigation that is being discussed here and here. Today, we wanted to give readers the details of an ongoing saga about another aspect of the 340B program – the growing presence of contract pharmacies in Area 340B and the recent efforts of pharmaceutical companies to contain this trend. This saga has shown a great back-and-forth between the drug industry, on the one hand, and 340B, suppliers, stakeholders and members of Congress, on the other. The agency that governs the 340B program – the Health Resources and Services Agency, hrsA – is stuck in the middle. In the meantime, suppliers are not waiting for Congress to address this issue. The National Association of Community Health Centers (NACHC) recently informed HHS of its intention to sue the agency if it does not intervene and sanction drug manufacturers until October 1. Readers of the blog find it strange that NACHC plans to sue HHS, rather than the drug manufacturers themselves.
This is due to a 2010 Supreme Court case – Astra USA Inc. v. Santa Clara County – in which there is no private right of action under Status 340B. Therefore, it is likely that the suppliers would have to sue HHS/HRSA to seek an action by Mandamus – that is, an injunction in which the government declares a non-discretionary duty of action, and the plaintiff has no other recourse. However, it is not entirely clear what the non-discretionary duty is to act, given that contract pharmacies are not mentioned in 340B status. The TPA filters the recipes of the CE patients of the switch for each mandated pharmacy.