Good morning to all from Washington, DC. Today OIG posts two reports and news about enforcement actions. As always, you can use the links provided to go directly to the new material. ------------------------------------------------------------------------------ Scientific Disagreements Regarding Medical Device Regulatory Decisions (OEI-01-10-00470) http://go.usa.gov/d9U WHY WE DID THIS STUDY FDA plays a critical role in ensuring the safety and effectiveness of medical devices and other products. At the Center for Devices and Radiological Health (CDRH), a series of scientific disagreements received media attention between 2008 and 2010. In these instances, CDRH reviewers and their managers disagreed over whether medical devices under review met applicable review standards. In October 2009, CDRH issued new policies and procedures for resolving internal scientific disagreements related to regulatory decisions. HOW WE DID THIS STUDY We surveyed CDRH managers and reviewers, requesting that they identify scientific disagreements that occurred during the fiscal year 2008-2010 period. We then reviewed the administrative files related to 36 reported scientific disagreements for the same period. We also surveyed respondents about their awareness of and training on CDRH's new policies and procedures for addressing scientific disagreements. WHAT WE FOUND Of the 36 reported scientific disagreements, 3 occurred after October 2009, and the new procedures were used to resolve them. The nature and resolutions of these 36 disagreements varied widely. Scientific disagreements often involved multiple issues, and most of their resolutions did not lead directly to the approval or clearance of devices. Most administrative files related to scientific disagreements contained required documentation, although accountability for file completeness is unclear. In addition, not all of CDRH's managers and reviewers have received training on the new procedures. CDRH also faces broader challenges in identifying and resolving scientific disagreements because of uncertainty about regulatory definitions and processes and staff perceptions about expressing differences of opinion. WHAT WE RECOMMEND We recommend that FDA: (1) Define more clearly its requirements for documenting and resolving scientific disagreements, (2) Train all reviewers and managers on the new policies and procedures for resolving scientific disagreements, and (3) More clearly assign accountability for the contents of the administrative files of all submissions. FDA concurred with our three recommendations. ------------------------------------------------------------------------------ Risk Adjustment Data Validation of Payments Made to PacifiCare of Texas for Calendar Year 2007 (Contract Number H4590) (A-06-09-00012) http://go.usa.gov/d9m Based on our sample results, we estimated that PacifiCare of Texas (PacifiCare) was overpaid approximately $115.4 million in 2007 because the diagnoses that it submitted to CMS for use in CMS’s risk score calculations did not always comply with Federal requirements. CMS uses the Hierarchical Condition Category (HCC) model (the CMS model) to calculate risk-adjusted payments. Medicare Advantage (MA) organizations, including PacifiCare, identify the diagnoses relevant to the CMS model and submit them to CMS. CMS categorizes the diagnoses into HCCs and uses the HCCs and demographic characteristics to calculate a risk score for each beneficiary. CMS then uses the risk scores to adjust the monthly capitated payments to MA organizations for the next payment period. PacifiCare did not have written policies and procedures for obtaining, processing, and submitting diagnoses to CMS. Furthermore, PacifiCare’s practices were not effective in ensuring that the diagnoses it submitted to CMS complied with Federal requirements. We recommended that PacifiCare (1) Refund to the Federal Government $183,000 in overpayments identified for the sampled beneficiaries; (2) Work with CMS to determine the correct contract-level adjustment for the projected $115.4 million of overpayments; (3) Implement written policies and procedures for obtaining, processing, and submitting valid risk adjustment data; and (4) Improve its current practices to ensure compliance with Federal requirements. PacifiCare disagreed with our findings. ------------------------------------------------------------------------------ June 4, 2012; U.S. Department of Justice Los Angeles Physician Assistant Found Guilty for Role in $18.9 Million Medicare Fraud Scheme http://go.usa.gov/yWn ------------------------------------------------------------------------------ June 4, 2012; U.S. Attorney; District of New Jersey Health Care Practitioner Pleads Guilty to Accepting Cash Kickbacks for Patient Referrals http://go.usa.gov/yWn ------------------------------------------------------------------------------ June 4, 2012; U. S. Attorney; Eastern District of Virginia Intensive In-Home Therapy Provider Sentenced to 24 Months for Health Care Fraud http://go.usa.gov/yWn ------------------------------------------------------------------------------ State Enforcement Actions Updated http://go.usa.gov/pqp ------------------------------------------------------------------------------ That’s all we have for today. If we can be of any further assistance, please send an Email to public.affairs@oig.hhs.gov Make it a great day! Marc Wolfson – Office of External Affairs
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OIG Posts 2 Reports & News about Enforcement Actions - 6/5
