This is the second installment of our two-part blog series covering the ever-changing requirements in State Pricing Transparency Reporting (SPTR). We began by reviewing trends in these complicated and varying state regulations. Today, we’ll examine best practices in compliance.

In this post, we’ll explore the best practice recommendations regarding compliance for SPTR. This can be a bit tricky, and there are a lot of moving pieces for active and proposed regulations. We’ve identified some initial early steps to make compliance smooth and efficient.

Registering proactively. For any state that requires it, register proactively and ensure points of contact are regularly maintained so the state is able to contact you with any questions or clarifications they may need. Ensure you understand what the state’s expectations are for registrations, some ask all manufacturers to register regardless of having to submit any reports while others require registration only when submitting reports.  Currently states that do not require registration until reports are due do not have any registration fees associated so there is no financial risk to be registered in their system even if not submitting reports in the near future. This will make completing future reporting obligations and requirements easier to complete.

Plan for the annual and ongoing fees. Certain states that do require all manufacturers to maintain an active registration regardless of report submissions such as Oregon, Texas, West Virginia, and Maine have annual fees associated – usually between $400 and $500 a year – that manufacturers should plan to pay for the foreseeable future along with various fees tied to submitting reports in state like Oregon and Texas. The fees are certainly not going anywhere, which gives manufacturers the chanceto budget for the fees required for at least a one- or two-year timeframe to make sure the funds will be available to complete the payments when needed.

Make your compliance teams aware. There are many nuances associated with reporting to states and the expectations from Manufactures continue to be refined. To minimize the chance of errors, make sure compliance teams, legal, and anyone else who works with complicated disclosures know what is being reported and who to reach out to for support.  When states release their reporting requirements with very nuanced data across multiple business areas, it can be a much harder lift to get things completed when resources outside the SPTR team aren’t sure why they have to pull the data. If you can coordinate across teams early in the reporting process or when new states define expectations it tends to make the data gathering process much smoother and reduces the risk of late reporting due to delays.  

Plan your work, work your plan. This is one that we tend to use as an internal motto at IntegriChain: make sure you have planned what needs to be done to the best of your ability then go back and use it as your guiding light on regular cadences. Try and forecast your reporting timelines as far as you can, get ahead of schedule, and know that if you have something due in three months, the initial report preparation should begin now and not later. Manufacturers want to be ahead of the curve, not let things come down to the wire to avoid last-minute fire drills. 

Documentation is key. This is critical in any compliance area but keeping a copy of any previously submitted reports will take the time up front and save significantly more in the long run. We mentioned that web portals do a fair job of noting what information was submitted, but local copies should be maintained as well in the event reports are submitted via email instead of a web portal. It is rare, except for some regular quarterly or annual reports, that manufacturers are preparing and submitting reports in one version. The reports typically need to be reviewed and approved by multiple teams inevitably resulting in multiple versions of the same report before a final version is submitted. In a similar sense, keeping a track record of what decisions are being made helps make future decisions easier if a similar situation arises. For example, having a log of which fields in each report were submitted, which were withheld, and which reports might not be completed at all will make the long-term success of your SPTR team much easier.

Lastly, make your list and check it twice. With all the state lists that are coming out, make sure that you are checking these lists and, unfortunately, checking them again a few days or weeks after the initial release. It is not uncommon for states to refine their lists a couple of weeks after the initial release of new products. The good news is that when those state lists are re-released, they tend to give manufacturers a little bit more time to complete the reports for the new products. 

Despite the complexity of the SPTR process, manufacturers can put best practices into place to lessen the burden on their team and organization. For more information on State Price Transparency Reporting, join us at the Drug Pricing Transparency Congress, May 16-17 in Washington DC. 

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About the Author

John Whitridge

John Whitridge

Director, Operational Consulting

John Whitridge has spent many years working with manufacturers in a consulting role before shifting his attention to growing his expertise in State Price Transparency Reporting at IntegriChain. His background includes successful project execution in many areas such as system implementation, managed care contracting, chargeback validation, and government pricing. He is currently overseeing a dedicated team of SPTR resources. John looks to expand the offering and opportunities to support manufacturers in the complex waters of compliance.