Findings came after OIG audited the Healthcare Integrity and Protection Databank
Adverse actions taken by federal healthcare regulators against clinical pathology laboratories and other healthcare providers have not been reported to a public database as required by law. That is the finding of the Office of the Inspector General (OIG), based on its study of the information contained in the Healthcare Integrity and Protection Data Bank (HIPDB).
During its audit of the HIPDB, the OIG determined that the Centers for Medicare and Medicaid Service (CMS) failed to report disciplinary actions it took against medical laboratories and other providers to the Healthcare Integrity and Protection Data Bank (HIPDB). According to the OIG’s recently-released report, CMS’s Division of Laboratory Services was responsible for many of the omissions.
Clinical Laboratory Actions Should Be Listed in the HIPDB
The HIPDB is a national database of adverse actions taken by federal agencies against “healthcare practitioners, providers and suppliers,” who are defined in the OIG report as medical doctors, laboratories, clinics, nursing homes, managed care facilities, prescription drug plans and durable medical equipment (DME) suppliers.
Federal lawmakers mandated the database as a way to lower patient risk by helping healthcare organizations make better informed hiring decisions, and to prevent physicians and other healthcare providers who have had their licenses revoked—due to fraud, abuse or incompetence—from practicing in other states.
Under federal law, CMS is required to report to the HIPDB various types of disciplinary actions taken against healthcare providers—which they did, in part. Among the disciplinary actions CMS failed to report to the HIPDB is “revocations and suspensions of laboratory certifications.”
The OIG report revealed that,
- “None of the 148 adverse actions imposed against laboratories in 2007 and the 30 adverse actions imposed against managed care and prescription drug plans between January 1, 2006, and July 31, 2009 (the last action was effective March 7, 2009), had been reported to the HIPDB at the time of our review.
- “None of the adverse actions against durable medical equipment (DME) suppliers taken after 2008 had been reported to the HIPDB. However, as of April 30, 2009, the HIPDB contained 5,125 adverse actions against DME suppliers imposed from 1998 through 2008. According to the officials with whom we spoke, as a cost-saving measure, CMS is no longer reporting adverse actions taken against DME suppliers to the HIPDB.
- “None of the 45 nursing homes terminated from participating in Medicare from 2004–2008 were reported to the HIPDB until 2009, well after the required reporting timeframe.”
It turns out that CMS incorrectly believed it was complying with the laws contained within the Social Security Act by reporting only those adverse actions related to fraud and abuse. However, The Social Security Act does not limit the type of adverse reactions CMS is required to report.
OIG Declared That CMS Should Have Reported All Adverse Actions
The OIG stated that CMS should have been reporting all adverse actions, regardless of circumstances or status. In addition, CMS reported nothing on cases that were under appeal during the time period reviewed in the OIG report (2001-2009).
In an agreement with the OIG, CMS has “described planned efforts to report adverse actions imposed against nursing facilities, laboratories, and DME suppliers, including working with HRSA to develop technical procedures and educating staff and contractors about HIPDB reporting.” The HRSA (Human Resources and Services Administration) administers HIPDB through a “memorandum of understanding” with the OIG.
It remains to be seen how this will affect clinical laboratories, pathology groups, and other healthcare providers. At a minimum, because of the OIG’s agreement with CMS, it can be expected that the Healthcare Integrity and Protection Data Bank will contain a more complete list of those medical laboratories for which CMS has taken disciplinary actions and/or suspended or revoked licenses.
Clinical laboratory managers and pathologists should interpret these developments as a renewed emphasis on transparency and accurate reporting of healthcare provider performance by federal agencies. In fact, they may want to more regularly check this database to see if any medical laboratories to which they refer specimens have received some form of adverse action by CMS.