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Current Themes in Enforcement § Theme #1: Increased and continued
Government emphasis on financial fraud and abuse, governmental waste and transparency.
§ Theme #2: Increased reliance on whistleblowers, audits, corporate compliance programs, internal investigations, and self-monitoring.
Key Statistics § In FY 2011, approximately $3.03 billion was recovered
by the Government under the False Claims Act through civil settlements and judgments.
§ Of the $3.03 billion recovered, approximately $2.4 billion
involved recoveries for alleged fraud with respect to federal health care programs
§ Qui Tam relators (whistleblowers) earned in excess of
$532 million in share awards in FY 2011 – the highest annual recovery ever, exceeding the awards in FY 2010 by almost $150 million.
Recent Cases/Settlements U.S. v. Patel (5th Circuit, Aug. 2012)
The Fifth Circuit recently affirmed the conviction of a cardiologist of 51 counts of health care fraud. The court also affirmed his sentence which included a 10-year prison term, a $175,000 fine, and a $387,511 restitution order. The indictment alleged that the cardiologist defrauded Medicare, Medicaid, and private insurers by seeking reimbursement for “medically unnecessary” cardiac procedures such as angioplasty and stent placements.
Recent Cases/Settlements U.S. v. Patel (5th Circuit, Aug. 2012) cont.
In addition, two Louisiana hospitals previously settled lawsuits over the cardiologist’s work. In October 2006, Our Lady of Lourdes Regional Medical Center paid $3.8 million to settle a false claims lawsuit and another $7.4 million to settle a class action lawsuit by hundreds of the cardiologist’s former patients. Similarly, in January 2008, Lafayette General Medical Center agreed to pay $1.9 million to settle allegations that it defrauded federal and state health care programs by billing for medically unnecessary cardiology procedures as well as $1.8 million to settle over 100 malpractice cases filed by the cardiologist’s former patients.
Recent Cases/Settlements Christ Hospital (Cincinnati, OH, July 2012)
Christ Hospital paid approximately $1.8 million to settle a whistleblower lawsuit that claimed a cardiologist billed Medicare for vascular tests without reading them. The whistleblower was the former medical director of vascular lab services and claimed that tests for up to 8,000 patients were not properly reviewed. The whistleblower said that he was forced to file a claim because hospital administrators ignored warnings about the tests and patients were being put at risk.
Recent Cases/Settlements HCA Inquiry (July 2012)
HCA executives recently disclosed that in July the civil division of the U.S. Attorney’s office in Miami requested information on reviews assessing the medical necessity of interventional cardiology services provided at 10 of its hospitals, located largely in Florida. HCA’s Florida hospitals provide about 20% of the company’s revenue. Less than a day after the company disclosed the investigation, the New York Times published a story reporting on numerous internal reviews that turned up a widespread pattern of unnecessary cardiology procedures being performed at many of HCA’s hospitals.
Recent Cases/Settlements
Peninsula Regional Medical Center (Salisbury, MD, Aug. 2011)
PRMC agreed to pay $1.8 million to the Government to settle allegations that it was aware of, and failed to prevent medically unnecessary cardiac stent procedures by a staff cardiologist, after PRMC’s senior leadership failed to follow up on complaints of cath lab staff about such procedures. The cardiologist was criminally prosecuted and convicted of 6 health care fraud offenses involving the stents, including falsifying patient records, performing unnecessary procedures, and billing federal health care programs and private insurers for these procedures.
Recent Cases/Settlements Hamot Medical Center (now UPMC Hamot) (Erie, PA, Oct. 2010)
A former cardiologist of PA cardiology group filed a complaint (which named 5 cardiologists, the group, and UPMC Hamot as defendants) alleging that from at least 2001 to 2005, the defendants performed unnecessary diagnostic and interventional cardiac catheterization procedures and other vascular surgical procedures, and that they improperly billed or overbilled the Government for services rendered. From April 2004 through February 2005, the cath lab activity records show that the defendant cardiologists performed 4,408 catheterizations on patients, which was double the number of catheterizations performed by other members of the group.
Recent Cases/Settlements St. Joseph Medical Center (Baltimore, MD, Dec. 2010)
St. Joseph’s settled with the Government for $22 million relating to an employed cardiologist allegedly implanting unnecessary stents in 585 patients over a 2 ½ year period from 2007 through 2009. St. Joseph’s self-reported this alleged medically unnecessary stent activity to the Government and also to the affected patients. The settlement also involved resolution of allegations that St. Joseph’s paid illegal kickbacks to the offending cardiologist’s group by paying in excess of fair market value for the group’s practice and paying compensation to the cardiologists above fair market value.
New Tools to Fight Fraud and Abuse § At the end of July, CMS opened a new $3.6 million
Command Center § The Command Center groups experts from all different
areas – clinicians, data analysts, fraud investigators, and policy experts – into the same room to build and improve the Government’s sophisticated new predictive modeling system, also known as the fraud prevention system.
§ The intended result is for investigations that used to
take days and weeks to be done in a matter of hours.
Updates from the JCAHO Conference on PCI Overuse
Marc E. Shelton, M.D., F.A.C.C., F.E.S.C.
President – Prairie Cardiovascular Governor – ACC Illinois Chapter
Internal & External Case Peer Review:
Moving Targets
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National Summit on Overuse Elective Percutaneous Coronary Intervention Group
Definition of Elective Coronary Intervention (PCI): For the purposes of the Overuse Summit, the panel determined that elective PCI is defined as a scheduled outpatient or observational stay procedure for a patient not requiring pre-hospitalization for treatment of their coronary disease. It was agreed that approximately 90% of patients / procedures for Elective PCI may fall into this definition. STEMI / N-STEMI and Unstable Angina (AU) do not fit within the definition of Elective PCI.
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Discussion of Overuse / Inappropriate Use: The indications classified by the Appropriate Use Criteria (AUC) can form the basis of what is considered inappropriate / overuse of elective PCI. The AUC incorporated five clinical elements and by consensus of expert panel determination of appropriate, uncertain, or inappropriate use were determined. • Five elements of Appropriate Use Criteria (AUC) include:
• Clinical presentation • Symptom severity • Ischemia severity • Extent of medical therapy • Extent of coronary anatomical findings
on angiography
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Scope of the problem: PCI remains a commonly used and costly medical intervention. In the U.S. in 2011, there were 325,000 PCI procedures performed on Medicare recipients, of which approximately 50% were done as elective procedures. According to National Cardiovascular Data Registry (NCDR) data, (Q2012) suggests that 6% of elective procedures are done "inappropriately" applying AUC criteria. This is reduced from 12% on the initial NCDR AUC data (Q42011). Accreditation for Cardiovascular Excellence (ACE) data estimates 8% of procedures are inappropriate.
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Chan, et al., reported the following for non-acute indications: 72,911 PCIs (50.4%) were classified as appropriate, 54,988 (38.0%) as uncertain, and 16,838 (11.6%) as inappropriate. The majority of inappropriate non-acute PCIs were performed in patients with no angina (53.8%), low-risk ischemia on non-invasive stress testing (71.6%) or suboptimal (</ = 1 medication) anti-anginal therapy (95.8%).
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Furthermore, an underestimation of Elective PCI may exist because:
• Databases are relatively new; ACE accreditation (2010). • NCDR registry is voluntary and has only recently started a program to adjudicate submissions. Important aspects regarding Overuse / Inappropriate Use • Rely on peer-review to make sure that cath reports are accurate. • Need to leave room for clinical decision making; not all patients fit into the usual clinical criteria. • There is a need for a standardized template for the cath report that is necessary for judging appropriateness and includes the AUC criteria. • Need to familiarize / educate hospitals, cath labs, and physicians with the existence of appropriate use criteria.
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Comments from the Advisory Panel • Need to leave room for clinical decision making; not all patients fit into the usual clinical criteria. • Need to account for the "style of some physicians;" those that admit everyone with chest pain and may also be a result of the way the patient looks at their issue of chest pain and their discomfort with it. Can't shift the severity of disease to more severe, just to look good. • There needs to be shared decision making and patient-centered care.
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Comments from the Advisory Panel • Standardization of documentation. Need identified by ACC, SCAI. Not all hospitals use standardized formats. Goal is to streamline process and suggest one of the tools that are available. Encourage elements that should be on a template report. • Identify situations where there is evidence of patient harm and overuse. • Use of AUC criteria, which includes the presence of two anti-angina agents for the treatment of angina.
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Current existing interventions that address appropriateness of elective PCI: • National Cardiovascular Data Registry (NCDR) or Regional Northern New England Cardiovascular Data Registry (NNECVDB) and/or Statewide databases (NY, MA) submission • Accreditation for Cardiovascular Excellence (ACE) or agency accreditation • Appropriate Use Criteria (AUC) • Society for Cardiovascular Angiography (SCAI) ToolQit, which will soon have AUC tool online • Blue Cross Blue Shield of Michigan Cardiovascular Consortium PCI Quality Improvement Initiative (BMC2 PCI).
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Proposed Interventions to address overuse / inappropriate use
Proposal #1 Encourage standardized reporting in the cath lab / interventional report • Development of a standardized template including the five AUC criteria:
• Clinical presentation • Symptom severity • Ischemia severity • Extent of medical therapy • Extent of coronary anatomical findings on angiography
• Use of a second "time-out" during the procedure to ensure that appropriate documentation regarding the indications for the Elective PCI is addressed. • Need for a formal external or internal case review on a periodic basis. • Submission to reasonable database and external film review of random cases.
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Additional comments from Advisory Panel: • SCAI tool kit will have electronic toolkit where
you can plug in patient data and will tell you whether appropriate or inappropriate → beta testing → should be available in the next six weeks.
• May include ACE certification with re-certification.
• Need to create a unique certification program from payers / regulators / CMS / accreditors with implication for financial, accreditation, public reporting, and payment issues need to drive this to gain leverage.
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Proposal #2
Encourage standardized analysis / interpretation of non-invasive testing with emphasis on ischemia • Development of a standardized report for non-invasive testing including the following:
• Radiation safety; • Mandatory appropriate use criteria; • Mandatory standardized reporting including the extent
of the severity of ischemia. • Development of criteria for stress testing; both for the referral process as well as the interpretation of the test.
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Additional Comments from Advisory Panel: • Need incentives for qualifying ischemia; if you used standardized reports, then you would have information on the extent of the ischemia. • Encouraged standardized analysis and interpretation. • Objectify stress testing imaging.
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Proposal #3 Focus on informed consent and allowing for patient knowledge / understanding of the benefits / risks of PCI • Documentation on the informed consent (in standardized language) and include that the patient may need dual anti-platelet therapy for a specified length of time. • Propose that every facility that provides Elective PCI has the ability to get surgical input when the need arises e.g., patients with high SYNTAX scores, etc.
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Additional Comments from the Advisory Panel: • Need for surgical input for those patients with a high SYNTAX score even for hospitals with on-site surgery facilities. • For facilities without surgical capabilities, the need for surgical input (teleconferencing, etc.) needs to be provided for patients who may be a candidate for revascularization.
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Proposal #4
Public / professional education • Increase awareness of the issue of Elective PCI overuse / inappropriate through education. • Dissemination of information from the Summit on the issue of overuse / inappropriate use to organizations with an interest in this area (AHA, etc.) with an emphasis on the use of standardized templates for PCI reports as well as non-invasive testing.
