False Claims Act Litigation—2012 Year In Review

Within the first year of CMS’ launch of a state-of-the-art predictive analytics technology, referred to as the Fraud Prevention System (FPS), the program generated leads for 536 new fraud investigations, provided new information for 511 pre-existing investigations, and triggered thousands of provider and beneficiary interviews to verify that legitimate items and services were provided to beneficiaries, according to CMS’ Report to Congress, “Fraud Prevention System–First Implementation Year.” CMS’ implementation of FPS has resulted in a shift in strategy going beyond a “pay and chase” approach to a more effective strategy that identifies fraud before payments are made, CMS said.

Even as CMS aggressively worked to minimize fraud in the Medicare and Medicaid programs, various types of health care compliance litigation relating to the False Claims Act were working their way through different courts. Below is a summary of some of the more significant decisions.

U.S. ex rel Parks v. Alpharma, 4th Cir., August 14, 2012. The trial court correctly ruled that a former sales representative for drug manufacturer Alpharma, Inc., had not made a prima facie case for retaliatory termination because the employer did not have notice that she might bring a lawsuit under the False Claims Act (FCA). The sales representative told her superiors that she was concerned that their marketing of Kadian, a morphine-based drug, might be for off-label use, but she never mentioned the possibility of FCA litigation.

Gonzalez v. Fresenius Medical Care North America, 5th Cir., July 30, 2012. A district court properly granted the motions for judgment as a matter of law filed by an end-stage renal disease (ESRD) service provider and a physician on the relator’s False Claims Act (FCA) claims. The relator’s claims that her employment was terminated because of her qui tam action were without merit since she did not produce evidence that her employer knew of the action and the employer showed good cause for her termination. The court correctly awarded attorney’s fees to the provider and physician from the relator’s counsel, who unreasonably and vexatiously multiplied proceedings.

USA ex rel Williams v. Renal Care Group, Inc., 6th Cir., October 5, 2012. The decision that a dialysis provider and its wholly owned subsidiary created their corporate structure to file false Medicare claims in order to take advantage of two separate Medicare billing structures applicable to end-stage renal disease (ESRD) patients was reversed in part and remanded in part for further consideration. The dialysis provider had sought clarification of federal laws regarding corporate structure and ESRD billing with the Health Care Financing Administration (HCFA), which was denied by the U.S. during the first two years of litigation. The district court’s ruling that the provider had violated the False Claims Act (FCA) was reversed because the U.S. did not show that the provider met all four elements of the FCA, and summary judgment was granted to the provider as the record indicated the provider did not knowingly present a false claim. The remainder of the claims against the provider were reversed and remanded for further consideration because the district court did not provide enough record on the claims at hand.

Thompson v. Quorum Health Service, LLC, 6th Cir., June 22, 2012. The jury verdict finding that Quorum Management Services (Quorum), a healthcare management company, fired an employee in retaliation for his filing a qui tam lawsuit was proper. To establish retaliatory discharge, the employee must prove that the employer took an adverse employment action with knowledge that the employee was engaged in protected activity. If the employer offers a business justification for the employment action, the employee may overcome that evidence by proving that the stated reason was a pretext. Quorum suspended Thompson shortly after learning that he had filed the qui tam action. The stated reason, Thompson’s failure to comply with Quorum’s Code of Conduct, was probably pretextual because of the timing of the adverse action and because there was no further investigation into his alleged violations, and the employer could not articulate the reason that it decided to raise the adverse action from suspension with pay to termination.

United States v. Castro-Ramirez, 6th Cir., February 13, 2012. There was sufficient evidence to support a physician’s conviction for Medicare fraud. The government submitted evidence that the physician signed Medicare forms authorizing physical and occupational therapy for many individuals who he never evaluated and gave pre-signed forms to a co-conspirator to fill out at a later date. There is also evidence that he recruited Medicare beneficiaries to join this fraud by giving them prescriptions for narcotics and other controlled substances, amounting to approximately 50,000 prescriptions to 479 “patients.” The evidence shows that the physician was involved for years in a coordinated and tiered conspiracy that enabled the physician and his co-conspirators to bilk Medicare and reduce the risk of detection. Accordingly, his conviction for conspiracy to commit health care fraud and launder money and eleven counts of health care fraud was affirmed.

U.S. ex rel. Goldberg v. Rush University Medical Center, 7th Cir., May 21, 2012. A federal district court improperly dismissed a qui tam action, which alleged that a hospital fraudulently billed Medicare because the allegations were not “substantially similar” to the disclosures in earlier government reports. A Government Accountability Office (GAO) report and physicians at teaching hospital (PATH) audits revealed that, generally, attending physicians failed to provide direct supervision of residents in teaching hospitals as required for Medicare reimbursement; however, these findings did not disclose a particular fraud by a particular hospital. The relators’ complaint described a specific kind of deception practiced by a specific hospital by highlighting the hospital’s practice of allowing teaching physicians to supervise multiple operations simultaneously. Although the general fraud had previously been disclosed, the realtors provided new and material information and qualified as the original source of the information in light of United States ex rel. Baltazar v. Warden. Accordingly, the district court’s dismissal was vacated and the case was remanded for review of the particular facts of the case.

Stop back tomorrow for a look at 2012 Affordable Care Act litigation.

Congress Passes Bill to Avoid “Fiscal Cliff,” With Medicare Doc Fix, Other Medicare/Medicaid Extensions

Congress on New Year’s Day passed the “American Taxpayer Relief Act of 2012,” the main purpose of which is stop the automatic tax increases and federal budget cuts that took effect on January 1, 2013. The legislation also includes several changes to the Medicare and Medicaid programs not directly related to the issues of tax increases and spending cuts, otherwise known as the “fiscal cliff.”

The bill passed by a vote of 89 to 8 vote in the Senate and 257 to 167  in the House.

The tax portion of the bill provides that income taxes will increase for families with income above $450,000 and individuals above $400,000, with increases also in the estate tax and capital gains tax for wealthier Americans.

Physician Medicare Reimbursement Fix

The legislation delays for one year a planned cut in Medicare payments for physicians. Physician Medicare payments are determined in part by the sustainable growth rate (SGR). The SGR was established by law in 1997 and is designed to limit the annual increase in physician payments to the annual increase in the U.S. gross domestic product. Each year, CMS announces a conversion factor that will increase payments if physician spending increases for that year are below the increase in GDP, or cut payments if physician spending increases are above the GDP increase. Every year since the SGR has been in effect physician payments have increased above the GDP increases, and every year CMS has announced cuts in physician payments for the next year. Only Congress can intervene to stop the payment cuts, which are cumulative and so have become potentially larger and larger each year.

The announced spending cut for physician payments was 26.5 percent for 2013 (77 FR 68891). Under this legislation, the conversion factor is set at zero, which means that physician Medicare payments will remain relatively unchanged for 2013. The extension of existing Medicare physician payments will cost about $25 billion over 10 years, according to the Congressional Budget Office.

For physicians providing multiple therapy services on or after April 1, 2013, and for which payment is made under the physician fee schedule, the 25 percent multiple procedure payment reduction is increased to 50 percent.

The floor for the geographic adjustment factors, which are used to modify the relative value of each procedure under the physician fee schedule, has been extended again until January 1, 2014.

For purposes of the mandatory physician quality reporting system, CMS shall treat an eligible professional as satisfactorily submitting data on quality measures if the eligible professional is satisfactorily participating in a qualified clinical data registry.

Documentation and Coding Adjustment For IPPS

The legislation amends the TMA, Abstinence Education, and QI Programs Extension Act of 2007 (P.L. 110-90) to make an additional adjustment to the standardized amounts used in determining payments made under the inpatient hospital prospective payment system (IPPS) based upon the HHS Secretary’s estimates for discharges occurring only during fiscal years 2014, 2015, 2016, and 2017 to fully offset $11,000,000,000 (which represents the amount of the increase in aggregate payments from fiscal years 2008 through 2013 for which an adjustment was not previously applied). The HHS Secretary shall not have authority to fully recoup past overpayments related to documentation and coding changes from fiscal years 2008 and 2009.

Overpayments

The legislation extends the period of time during which Medicare contractors can attempt to collect overpayments from providers from three years to five years.

Outpatient Therapy Services

The legislation extends the exceptions process relating to the cap on outpatient therapy services to December 31, 2013. It also extends the therapy cap to therapy furnished as part of outpatient critical access hospital services.

Radiology Services

The legislation limits Medicare payments for stereotactic radiosurgery, complete course of treatment of cranial lesions.

Diabetic Supplies

The legislation establishes new competitive prices for Medicare payment of diabetic supplies and eliminates overpayments for diabetic supplies.

Ambulance Services

Payments under the ambulance fee schedule for non-emergency transports for end-stage renal disease beneficiaries are reduced by 10 percent for services provided on or after October 1, 2013. The “temporary” increase in the ambulance fee schedule amounts for ground ambulance services originating in a rural or a rural census tract, added in 2004, are extended yet again until January 1, 2014. HHS also is required to prepare a study that analyzes data on existing cost reports for ambulance services furnished by hospitals and critical access hospitals, including variation by characteristics of such providers of services, and another study on the feasibility of obtaining cost data on a periodic basis from all ambulance providers of services and suppliers for potential use in examining the appropriateness of the Medicare add-on payments for ground ambulance services and in preparing for future reform of such payment system.

Advanced Imaging Services

Currently, Medicare payments for advanced diagnostic imaging services are reduced by 75 percent to reflect higher presumed utilization of imaging equipment. Under the legislation, this reduction increases to 90 percent.

Medicare Advantage

The coding adjustment applied to Medicare Advantage (MA) plan adjustments to better align MA payments with Medicare fee-for-service payments is changed from 1.3 to 1.5 percentage points for 2014, and from 5.7 to 5.9 percentage points for 2015 to 2018. The provision allowing specialized MA plans for special needs individuals to restrict enrollment is extended until January 1, 2015. The deadline after which CMS will no longer approve of any new cost plans under MA also has been extended to January 1, 2014.

ESRD Bundled Payments

The legislation requires CMS, for services furnished on or after January 1, 2014, to adjust payments relating to the end stage renal disease (ESRD) bundled payment rate to reflect changes in utilization of certain drugs and biologicals. In making reductions, CMS must take into account the most recently available data on average sales prices and changes in prices for drugs and biological reflected in the ESRD market basket percentage increase factor. The legislation also delays until January 1, 2016, implementation of oral-only ESRD-related drugs in the ESRD prospective payment system. HHS also must conduct an analysis by January 1, 2016, of the case mix payment adjustments relating to ESRD bundled payments, and make appropriate revisions to such case mix payment adjustments. The Government Accountability Office (GAO), no later than December 31, 2015, must prepare a report to Congress on how HHS has addressed implementation of payments for oral-only ESRD-related drugs in the bundled ESRD prospective payment system.

Medicare-Dependent Hospitals and Low-Volume Hospitals

The legislation extends the Medicare-dependent hospital program, which provides extra payments to certain rural hospitals, until October 1, 2013. It also extends through fiscal year 2014 the Medicare adjustment for payments to low-volume hospitals.

Medicare Improvement Fund

The Medicare Improvement Fund, established in 2008, has been defunded completely.

Medicaid Changes

The legislation adjusts the calculations for amounts that states receive for disproportionate share hospitals under Medicaid for fiscal years 2021 and 2022. Several programs under Medicaid have been further extended for one year. These include the Qualifying Individual program (through 2013), Transitional Medical Assistance (through 2013), and the “express lane” option for enrollment under both Medicaid and the Children’s Health Insurance Program (through 2014).

The FDA & New Zealand Agree to Recognize Each Other’s Food Safety Systems as Comparable

The FDA and New Zealand’s Ministry for Primary Industries have signed an agreement recognizing each other’s food safety systems as comparable to each other, according to an FDA news release. This is the first time that the FDA has recognized another country’s food safety system as comparable to its own.

 According to the memorandum of understanding, the systems recognition decision facilitates trade between the two countries by reducing the type and frequency of border checks and level and type of verification activities expected by the importers and exporters of food products from either country.

 Systems recognition involves reviewing a country’s food safety system to determine whether it provides a similar set of protections as the FDA’s. The FDA’s system recognition approach was pilot tested with New Zealand using the draft International Comparability Assessment Tool. The FDA’s comparability approach was the subject of a September 2012 Government Accountability Office report.

 The FDA is currently pilot testing a systems recognition process with Canada. Congresswoman Rosa DeLaura (D-Ct.), meanwhile, expressed concern that two pending agreements with Canada, the Regulatory Cooperation Council and Beyond the Border initiatives, could weaken American Food Safety standards. She cited a September beef recall in Canada that she called “the largest beef recall in history.”

 The agreement between the United States and New Zealand is available on the FDA’s website.