As reported on our sister blog, http://www.lifescienceslegalupdate.com/, Reliance Medical Systems, LLC, filed a complaint in the U.S. District Court for the Central District of California this week that seeks a declaration that an Office of Inspector General (OIG) Special Fraud Alert on physician-owned distributors (PODs) unfairly and unconstitutionally burdens First Amendment rights of free speech and due process. The complaint sets forth Reliance’s legal rationale in support of the lawfulness of the physician-owned model, and it characterizes the Fraud Alert as the result of a multi-year lobbying campaign by “Big Corporations” forced to compete with small physician-owned entities. For more details, see our full report.
CMS has released a report to Congress on “Recovery Auditing in the Medicare and Medicaid Programs for Fiscal Year 2011”. According to CMS, recovery auditors identified and corrected 887,291 claims amounting to $939.3 million in improper payments in fiscal year 2011; while most of the improper payments ($797.4 million) were overpayments, the auditors also were responsible for $141.9 million in underpayments being repaid to providers and suppliers. After considering all fees (including contingency fees), costs, appeals, and underpayments, the Medicare fee-for-service (FFS) Recovery Audit Program returned $488.2 million to the Medicare Trust Fund in FY 2011. CMS discusses procedural changes adopted to decrease the Recovery Auditors errors, and according to CMS, only 2.9% of all Recovery Auditor determinations were challenged and later overturned on appeal. The report notes that short-stay inpatient hospital admission issues represented a significant portion of the Medicare FFS error rate and also represent a large portion of FY 2011 overpayment collections. The report also includes, among other things, an update on the status of recovery audit contracting in the Medicare Advantage, Medicare prescription drug, and Medicaid programs, along with a RAC prepayment review demonstration. On a related note, CMS has posted a “Recovery Audit Program Myths” document, addressing such issues as claims denial rates and review criteria, presumably to combat persistent provider criticism of the program.
On February 11, 2013, the Obama Administration announced that anti-fraud efforts under the Health Care Fraud and Abuse Control Program (HCFAC) recovered a record-breaking amount of $4.2 billion in FY 2012. More specifically, in 2012 the Justice Department opened 1,131 new criminal health care fraud investigations involving 2,148 potential defendants, and a total of 826 defendants were convicted of health care fraud-related crimes. The DOJ also opened 885 new civil investigations, obtained settlements and judgments of more than $3 billion in FY 2012 under the False Claims Act, and collected nearly $1.5 billion in fines and forfeitures under the Federal Food, Drug and Cosmetic Act. Obama Administration officials emphasized that efforts to reduce fraud will continue to expand with new tools and resources provided by the ACA, including enhanced screening and enrollment requirements (which have eliminated nearly 150,000 ineligible providers from the Medicare rolls), increased data sharing across the government, expanded overpayment recovery efforts, and greater oversight regarding private insurance.
The Department of Justice recently announced that it secured a record $4.9 billion in settlements and judgments in civil fraud cases in FY 2012, including health care fraud recoveries totaling more than $3 billion. The Department notes that some of the largest recoveries during the year – representing nearly $2 billion -- involved false claims for drugs and medical devices under federally insured health programs (with an additional $745 million returned to state Medicaid programs). The Department also reports that in FY 2012, a record 647 qui tam/whistleblower suits were filed and a record $3.3 billion was recovered in such suits.
In light of a continued high rate of Medicare fee-for-service improper payments (8.6% in FY 2011), the GAO recently assessed the use of Medicare prepayment edits and CMS's oversight of Medicare Administrative Contractors (MACs) that process claims. In the report, "Medicare Program Integrity: Greater Prepayment Control Efforts Could Increase Savings and Better Ensure Proper Payment," the GAO estimates that while the use of prepayment edits saved Medicare at least $1.76 billion in FY 2010, it believes savings could have been greater if prepayment edits had been more widely used. For instance, the GAO found more than $100 million in Medicare payments that were inconsistent with a sample of three local coverage determinations (pertaining to monitored anesthesia care, parathormone, and noninvasive cerebrovascular studies) and that could have been identified using automated edits. The GAO also found weaknesses associated with CMS edit processes based on national policies, such as lack of specific time frames for implementing edits, flaws in the structure of some edits, and lack of centralized implementation. GAO recommends that CMS take a series of steps to strengthen its use of prepayment edits, such as implementing medically unlikely edits that assess all quantities provided to the same beneficiary by the same provider on the same day; encouraging more information sharing about effective edits, and assessing the feasibility of increasing incentives for edit use. HHS generally agreed with the recommendations.
A recent GAO report, “Medicaid Integrity Program: CMS Should Take Steps to Eliminate Duplication and Improve Efficiency,” points to a number of shortcomings in CMS Medicaid program integrity efforts. Among other things, the GAO found that Medicaid Integrity Group's (MIG) oversight and support activities had mixed results in achieving the goal of enhancing program integrity efforts. Moreover, the MIG’s hiring of separate review and audit contractors for its National Medicaid Audit Program was inefficient and duplicative. The GAO recommends that CMS: eliminate duplication by merging contractor functions, use comprehensive reviews to better target audits; work with states to ensure reliable reporting of their program integrity recoveries; discontinue state program integrity assessments that overlap other, more current data sources; and reevaluate its return on investment methodology.
On November 27, 2012, the HHS Office of Inspector General (OIG) released its fall Semiannual Report to Congress, which summarizes significant OIG enforcement, investigation, and audit activities for the period of April 1 – September 30, 2012, along with summary information for all of FY 2012. Most notably, the OIG reports approximately $6.9 billion in expected audit and investigative recoveries for FY 2012, consisting of $923.8 million in audit receivables and $6 billion in investigative receivables (of which $1.7 billion represents non-HHS investigative receivables, such as OIG’s work in states’ shares of Medicaid restitution). In addition, the OIG identifies approximately $8.5 billion in FY 2012 savings that result from legislative, regulatory, or administrative actions that were supported by the OIG’s recommendations (such as payment reforms for Part B drugs and biologicals adopted under the Modernization Act of 2003 and a variety of Medicare payment reductions impacting home health agencies, DME suppliers, and clinical laboratory services, among many others). In addition, for FY 2012 the OIG reports: exclusions of 3,131 individuals and entities from participation in federal health care programs; 778 criminal actions against individuals or entities that engaged in crimes against HHS programs; and 367 civil actions (including false claims and unjust-enrichment lawsuits filed in federal district court, civil monetary penalties settlements, and administrative recoveries related to provider self-disclosure matters). The report also highlights significant OIG accomplishments for this period, including various Medicare and Medicaid program reviews and Medicare Fraud Strike Force efforts that resulted in the filing of charges against 305 individuals or entities, 181 convictions, and $151 million in investigative receivables.
Hospitals Return Fire After Administration Warns Hospitals Against Gaming Payments through Electronic Health Records
In a letter to five major hospital associations on September 24, 2012, HHS Secretary Kathleen Sebelius and Attorney General Eric H. Holder, Jr., made sweeping generalizations about the improper utilization of electronic health record (EHR) technology to “game the system” to increase reimbursement. In a letter to the associations, Sebelius and Holder tout the benefits of EHR in coordinating care, improving quality, reducing paperwork, and eliminating duplicative tests, but warn that the technology also might facilitate fraud and abuse. Specifically, the letter cites “troubling indications” that some providers are using electronic health care technology to obtain payments to which they are not entitled, by such as by “cloning" medical records to inflate payments or “upcoding” the intensity of care or patient severity. The letter suggests hospitals may be using EHR to cut and paste together different medical records for a single patient, risking both medical errors and overpayments. The letter asserts that “[f]alse documentation of care is not just bad patient care; it's illegal.” Sebelius and Holder express their “resolve to ensure payment accuracy and to prevent and prosecute health care fraud.” To that end, the Administration is stepping up data mining and audits, including more extensive medical reviews to ensure that providers are coding evaluation and management services accurately. In addition to enforcement actions (including payment suspension where fraud is suspected), CMS will consider payment reductions as warranted reductions “to address inappropriate increases in coding intensity.” The letter, which followed a report in the New York Times regarding alleged hospital upcoding of evaluation and management codes, was sent to the American Hospital Association, Federation of American Hospitals, Association of Academic Health Centers, Association of American Medical Colleges, and National Association of Public Hospitals and Health Systems, is posted here.
In a rapid response, the American Hospital Association suggested that CMS shares the blame for a lack of clarity on hospital evaluation and management coding, noting “We have made numerous requests to the Centers for Medicare and Medicaid Services to develop national guidelines for the reporting of hospital emergency department and clinic visits. This is a request the AHA has made to CMS 11 times (starting in 2001) since the outpatient prospective payment system was first implemented.” AHA also rejected the need for more audits, saying, “What's needed is clearer guidance from CMS, not duplicative audits that divert much-needed resources from patient care.” The letter is posted at aha.org. The Association of Academic Health Centers, in a separate letter, also commented on the lack of coding guidance.
The Sebelius-Holder letter is emblematic of the rapidly-deteriorating relationship between providers and the federal government, as reimbursement and policy disputes are too often viewed through the lens of fraud. This relationship is likely to be further strained as Congress and the Administration negotiate alternatives to sequestration that could result in steeper Medicare and Medicaid reimbursement cuts.
Reed Smith’s Life Sciences Legal Update blog discusses a recent decision by the United States District Court for the Southern District of Ohio that may make it much harder for qui tam relators to rely upon stolen medical records or patient information in False Claims Act ("FCA") whistleblower actions. In the decision, Cabotage v. Ohio Hospital for Psychiatry, No. 11-cv-50 (S.D. Ohio July 27, 2012), the district court held that a registered nurse was not permitted to support her allegations of FCA violations by relying on confidential protected health information that she surreptitiously removed from the hospital where she was employed.
Fifth Circuit Upholds Ability of Government Employee Fraud Investigators to Bring Qui Tam False Claims Actions
Reed Smith's Global Regulatory Enforcement Law Blog recently featured a post on the Fifth Circuit’s ruling in United States ex rel. Little v. Shell Exploration & Production Co., in which the Court held that government employees are entitled to bring qui tam actions under the False Claims Act (FCA) – even if their federal job function is to investigate fraud on behalf of the government.