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The forecast for transparency just turned cloudy.

Key Messages

  1.  Tucked into the latest opioid law are changes to the Sunshine Act.
  2. Beginning in 2022, drug and device companies now must report transfers of value to advance practice nurses and physician assistants.
  3. CMS also awarded a contract to analyze Open Payments data over the next five years.
  4. All drug and device should review both their Sunshine Act systems AND their reported payments BEFORE CMS comes knocking at the door.
  5. Contact us to see how we can help.

Since its passage in 2010, both the Federal Sunshine Act and the Centers for Medicare and Medicaid Services (CMS) have been roundly criticized both for not going far enough to include all prescribers of drugs and devices and for taking a lax stance towards compliance.  Now all that is about to change.

Last week Congress passed, and the President signed in to law the Fighting the Opioid Epidemic with Sunshine Act of 2018.  At the same time, Policy & Medicine reported that CMS awarded a five-year contract to Econometrica, Inc.  The deal is to research and analyze Open Payments data.

New Reporting for Advance Practice Nurses & Physician Assistants

The original Sunshine Act narrowly focused on only physicians and teaching hospitals.  Other practitioners with prescribing powers were excluded.  States, including Massachusetts, Minnesota, and Vermont, went further to include other prescribers who were not doctors.

The new law adds physician assistants.  It also adds advanced practice nurses meaning nurse practitioners, nurse midwives, nurse anesthetists, and clinical nurse specialists.

Although tied to fighting the opioid epidemic, the law also comes at a time when Congress is grappling with the high drug prices.  The original Sunshine Act gave an incomplete picture.  It did not capture what drug and device companies were doing with non-doctor prescribers.

The Impact for Drug & Device Companies

With the changes, drug and device companies must revisit the data capture process to make sure they collect data on physician assistants and advanced practice nurses in ALL 50 states.

Previously, companies only had to capture that data in CERTAIN states.  Even if a company were lucky enough to have data for all states, the quality of that information where states did not require disclosure is likely weak.

It is not just the federal rules that are changing, but the state rules too.  Under the Sunshine Act, states can only ask for more information if it is DIFFERENT from Open Payments data.  For those states that asked for and got data about physician assistants and advanced practice nurses, they can no longer ask for it.  It is preempted. Companies must now change all those reports and the states must issue new templates.

CMS Open Payment Data Analysis Contract

The original Sunshine Act gave CMS the power to audit Open Payments Data.  However, CMS has never made use of that mandate.  This was due in part due to how CMS viewed its Sunshine Act role.  CMS viewed itself as the database keeper and not the enforcer.  To fill the gap, the HHS OIG  has suggested at various conferences that they would take on the enforcer role, but it never happened.

Now CMS has engaged  Econometrica to perform data analysis on Open Payments data.  We believe this is the first step to conducting Open Payments audits.

Targeting Payments

Companies should treat the recent interest in Open Payments information as a sign to get their data in order BEFORE the questions start.  Both CMS and some prosecutors (e.g., the Insys case) are looking at the completeness and accuracy of the data.  

The stakes are high. Liability is not just limited to the fines from CMS but includes potential criminal exposure to the people involved in “signing” the reports saying they were right.

Therefore, now is the time to review both the processes to collect and report the data and the past data provided to CMS.  Contact us to see how we can help.