The first drug transparency law was passed in Vermont nearly a decade ago. Since then, more than 20 other countries have introduced their own requirements for transparency of drug prices. These laws promote transparency by requiring pharmaceutical companies to report prescription drug prices, sometimes even by informing purchasers in advance of expected increases in drug prices. Non-compliance carries significant legal penalties, and some states have already begun aggressively enforcing the law, with defaulting companies having to pay six- or seven-figure penalties for late reporting or non-reporting. The Department collected data from businesses according to the following categories: Risks: Inconsistencies between state and federal reports Disclosure report data is self-reported to the Department by drug and medical device manufacturers registered in Excel spreadsheet files, with specific formatting and data elements required by the Department. Implications for pricing strategies. As more and more countries develop price transparency rules, manufacturers should be aware of their pricing strategy and its implications from a legal and public perspective. Future regulations can influence future business decisions and pricing strategies. In addition, in order to stay below the legal reporting thresholds, manufacturers may need to consider adjusting their pricing strategies. Government legislation on price transparency is not uniform across states and requires careful analysis of each requirement to understand the intricacies and reasonable assumptions required for compliant reporting. To ensure compliance in each state where their products are sold, manufacturers need to pay attention to changes in each state`s laws.
However, keeping track of updates for different states can be a tedious task. To assist pharmaceutical companies in this task, Buchanan`s experienced compliance team at the FDA proactively monitors these updates to help companies not only comply with state guidelines, but also stay informed of updates to state legislation. Complex and evolving reporting requirements. Reporting requirements are complex, rapidly evolving and often include penalties for non-compliance. Resource constraints may limit a manufacturer`s ability to actively monitor newly enacted or improved legislation and understand the details of each reporting obligation. Manufacturers may be fined if they fail to report certain information, fail to provide information in a timely manner, or fail to provide complete information. This may require a thorough legal and operational assessment of reporting obligations. Most aggregated issuing States have a much broader list of covered beneficiaries and a greater number of activities to report. We have compiled a table with states that have different requirements than the Federal Sunshine Act. In addition, some states expect companies to take additional steps beyond price reporting.
For example, Oregon requires special registration under its Drug Price Transparency Act, and registrars are expected to pay a $400 annual evaluation bill subject to late fees — even if no notification of new drugs or price increases is triggered by that state`s law. In 2019, the state of Maryland created the MD Prescription Drug Affordability Board to protect state residents, state and local governments, health care providers, and more from the high cost of prescription drugs. In 2021, Maryland passed another bill creating the “Prescription Drug Affordability Fund” and directed the MD Prescription Drug Affordability Board to assess fees ($1,000 per year) against manufacturers, distributors, freight forwarders and pharmacy benefit managers registered with the MD State Board of Pharmacy. This website currently contains data reported to the Ministry of Drug and Medical Device Manufacturers from 2009 to 2016. From a policy perspective, companies should consider identifying challenges and tracking resources devoted to meeting government transparency obligations after the implementation of federal solar radiation in case there is an opportunity to change government requirements. Seeley believes states like Minnesota, which are almost entirely covered by federal reporting requirements, are most likely to use the federal system. Manufacturers: Manufacturers are required to report to the FDA if they become aware that any of their devices have caused or contributed to death or serious injury. (Key terms are defined in 21 CFR 803.3.) Instructions for completing the required Form 3500A are available.
Manufacturers must also report to the FDA if they determine that their device malfunctioned and would likely cause death or serious injury or contribute to it if the malfunction were to recur. For more information, refer to the Medical Device Notification Guidance Document for Manufacturers. VT still has the only total food ban for their prescribing doctors if they “practice regularly in Vermont,” which is a bit left to the company`s interpretation. It becomes difficult to know if a licensed physician in Vermont actually practices in a surrounding state. Affected manufacturers and GPOs subject to the reporting requirements of the states of Vermont, Massachusetts, Minnesota, the District of Columbia, Louisiana, and California should be aware that certain state requirements for reporting gifts or payments may be advanced. Seeley noted that most, but not all, companies will use the federal government`s right of first refusal and withdraw what they report separately. However, the law does not prejudge all aspects of government requirements for disclosure of payments to physicians and other health professionals. Many states have found that it is in their best interest to take legislative action to curb rising drug prices and reduce their annual drug spending. This momentum is expected to continue in the coming years. As public and legislative scrutiny of drug prices continues and more states introduce and pass laws, it will be important for pharmaceutical manufacturers to understand the requirements and impact on their current and future operations. Deloitte Risk & Financial Advisory works with manufacturers to support policies and standard operating procedures, accurate and timely reporting, and reasonable assumptions.
We also contribute to ongoing reporting, including the development of a government drug price transparency system and tools that include pricing information to run pricing scenarios and generate the reports required for reporting. Our solutions include: While a user facility is not required to report a device malfunction, it may voluntarily notify the FDA of such product issues through MedWatch, the FDA`s safety information and adverse event reporting program.
Comments are closed.