Category: Health Care Law

Centers for Medicare & Medicaid (CMS) Delays Auditing of “Two-Midnight” Rule

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The Centers for Medicare & Medicaid (CMS) announced this week it will delay Recovery Audit Contractor (RAC) audits of the “two-midnight” rule for 90 days. The 2014 Inpatient Prospective Payment System Final Rule, released in August 2013, finalized the “two-midnight” rule, under which hospital inpatient admissions that span at least two midnights presumptively qualify as appropriate under Medicare Part A, and hospital inpatient admissions that span less than two midnights (i.e., less than one Medicare utilization day) are presumptively inappropriate for payment under Part A.  When auditing medical necessity, the RACs would presume that the occurrence of 2 midnights after formal inpatient hospital admission indicates an appropriate in patient status for a medically necessary claim. If the occurrence of 2 midnights after formal inpatient hospital admission does not occur, government recovery auditors do not apply the same presumption and claims for such admissions receive a higher level of scrutiny.

As part of its announcement, CMS stated it will not, for a period of 90 days, permit government recovery auditors to review the medical necessity of inpatient admissions of one midnight or less between October 1, 2013 and December 31, 2013.

CMS’ frequently asked questions with its announcement can be found here.

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Diagnostic Laboratories Settles for $17.5 Million After Healthcare Whistleblowers’ Allegations of Medicare Fraud

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The Department of Justice announced yesterday that Diagnostic Laboratories and Radiology, the West Coast’s largest supplier of laboratory and X-ray services to nursing homes, will pay $17.5 million to settle whistleblower allegations that the California-based company violated the False Claims Act by giving kickbacks for referral of mobile lab and radiology services, which were subsequently billed to Medicare and Medi-Cal (California’s Medicaid program).  Diagnostic Labs allegedly took advantage of Medicare’s and Medi-Cal’s reimbursement systems by billing them at standard rates while secretly giving discounted fees to the participating nursing homes. According to the lawsuit, those fees were as much as 80 percent below the lab’s normal rates.

For inpatients, Medicare pays a fixed rate based on the patient’s diagnosis, regardless of specific services provided.  For outpatients, Medicare pays for each service separately.  Diagnostic Labs’ scheme supposedly enabled the nursing homes to maximize their profits for providing inpatient services by decreasing the cost of them.  It also allegedly allowed Diagnostic Labs to obtain a steady stream of lucrative, outpatient referrals that it could directly bill to Medicare and Medi-Cal.  This provision of inducements, including giving discounted rates to generate referrals, is prohibited by both federal and state law. By law, the discounts should have been passed along to the government programs.

The Medicare whistleblowers in this case were two former Diagnostic Lab employees, Jon Pasqua and Jeff Hauser, who said they were fired after reporting the secret discounts and kickbacks to the authorities. Hauser and Pasqua worked in the company’s sales office and said they tried to report the questionable discount practices to supervisors first, but were ignored. They then provided information to state and federal officials, and were subsequently fired from their jobs shortly before filing the healthcare fraud case in February 2010, according to their lawyers.

This settlement will resolve Hauser and Pasqua’s lawsuit, which was filed under the qui tam, or whistleblower, provisions of the federal and state False Claims Act. This act allows private citizens with knowledge of fraud to bring qui tam lawsuits on behalf of the US government. The individual filing the lawsuit is known as the relator, or whistleblower.  Healthcare whistleblowers, such as Hauser and Pasqua, serve an important role in exposing and eliminating healthcare fraud.

While it is true that whistleblowers take on a personal risk in these cases, it is still worthwhile for them to come forward with their information. Because qui tam whistleblowers help to eliminate government fraud, they receive a significant proportion of the lawsuit’s settlement for their efforts.

Together, Pasqua and Hauser will receive a total $3,755,500 as their share of the federal government’s recovery.

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Health Care Exchange Notices Required by October 1, 2013; However No Penalty for Not Providing

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The Affordable Care Act requires that employers provide employees with notice (Notice) about the health care exchanges (the federal government also refers to these as “marketplaces”). Nevertheless, some confusion prevails about what is actually required.

Employers Subject to the Notice Requirement

The Notice must be provided by all employers to which the Fair Labor Standards Act (FLSA) applies. In general, the FLSA applies to employers that have one or more employees who are engaged in, or produce goods for, interstate commerce. For most companies, a test of not less than $500,000 in annual dollar volume of business applies. However, the FLSA also specifically covers the following entities: hospitals; institutions primarily engaged in care of the sick, aged, mentally ill, or disabled who reside on the premises; schools for children who are mentally or physically disabled or gifted; preschools, elementary, and secondary schools and institutions of higher education; and federal, state and local government agencies. In addition, the FLSA will apply where an employee is engaged in interstate commerce, even if the activities do not rise to the requisite volume of business. Consequently, nearly all employers will be subject to the FLSA and, therefore, the Notice requirement.

Those who must receive the Notice are all employees of the employer, regardless of whether the employee is even eligible for the employer’s health plan.

When Must the Notice Be Provided?

The Notice must be given to all current employees by October 1, 2013. Individuals who begin employment after October 1, 2013 must be given the Notice within 14 days of their hire date. The Notice can be distributed to employees by first class mail or electronically, provided that the employer can meet Employee Retirement Income Security Act’s (ERISA) requirement for distribution of electronic notices (generally, this means that the employee has either consented to the electronic notice or utilizes a company computer as an essential function of their job).

What the Notice Must Include

Pursuant to the statute, the Notice must inform the employee of the existence of the health care exchange, describe the services the exchange provides, and how the employee can contact the exchange. In addition, the Notice must advise the employee that he or she may be eligible for a premium tax credit if the total allowed costs of benefits provided under the employer’s plan is less than 60 percent of such costs, that an employee who purchases exchange coverage may lose the employer’s contribution toward the cost of coverage and that the employee’s payment for exchange coverage will be on an after-tax basis.

The Department of Labor (DOL) has provided a model Notice for employers who offer health insurance and one for employers who do not offer health insurance to employees. The model Notices can be found here. Both model Notices go beyond the scope of the information an employer is required to disclose pursuant to the Affordable Care Act.

Employees Seeking Exchange Coverage Will Need Employer Information

Starting in early October when the insurance exchanges are supposed to “turn on,” employees seeking information about exchange coverage will need information about any coverage the employer offers. Employers are obligated by law to engage in that discussion and provide information. For example, a low income employee who is offered coverage by his employer may still be interested in seeing if alternative coverage is available from the insurance exchange that, when subsidized by tax credits, may be a better choice for the employee.

The model Notice for employers that offer coverage contains a Part B with boxes for the employer to check and lines to complete in which information about the employer’s plan is provided. Still further information can be provided on an optional page. Depending upon the employer’s circumstances, we have recommended edits to ease the administrative burden, to limit confusion by employees, to increase accuracy based on the employer’s own circumstances, and other changes.

No Fine for Failing to Provide Exchange Notices

On September 11, 2013, the DOL announced it will not impose a penalty on employers who do not distribute the Notice. Nevertheless, we recommend that Notice be given. The media has publicized this obligation such that employees who expect to receive the Notice but do not, may inquire or complain. Furthermore, while no penalty is currently imposed, the Notice is “required” and future guidance is likely to presume it has been given. It is also possible that future guidance will be issued that does impose the penalty for future failures to provide it. We believe the better approach in most situations is to provide the Notice, modifying it if necessary based on the employer’s own circumstances.

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Office of Federal Contract Compliance Programs (OFCCP) New Rules Target Veterans and Individuals with Disabilities

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Familiar with this?  It’s time to update your affirmative action plans.  For the women and minorities plan, you gather your applicant data, prepare spreadsheets and update your written materials to reflect new goals and changes in your recruiting sources.  For the veterans and individuals with disabilities plan, you update a bit and you’re done.  Starting early next year, however, the rules will change making updates more onerous for employers.  On August 27, 2013, the Office of Federal Contract Compliance Programs announced final rules for federal contractors regarding hiring and employment of disabled individuals and protected veterans and imposing new data retention and affirmative action obligations on contractors.  The rules are expected to be published in the Federal Register shortly and will become effective 180 days later.

The key changes include:

  • Benchmarks.  Contractors must establish benchmarks, using one of two methods approved by the OFCCP, to measure progress in hiring veterans.  Likewise, contractors must strive to hire individuals with disabilities to comprise at least seven percent of employees in each job group.  The OFCCP says these are meant to be aspirational, and are not designed to be quotas.
  • Data Analysis and Retention.  Contractors must document and update annually several quantitative comparisons for the number of veterans who apply for jobs and the number of veterans that they hire.  Likewise, for individuals with disabilities, contractors are required to conduct analyses of disabled applicants and those hired.  Such data must be retained for three years.
  • Invitation to Self-Identify.  Contractors must invite applicants to self-identify as protected veterans and as an individual with a disability at both the pre-offer and post-offer phases of the application process, using language to be provided by the OFCCP.  This particular requirement worries employers who know that the less demographic information they have about applicants, the better – especially when the application is denied.  Contractors must also invite their employees to self-identify as individuals with a disability every five years, using language to be provided by the OFCCP.

Additional information, including with respect new requirements such as incorporating the equal opportunity clause into contracts, job listings, and records access, can be found here (http://www.dol.gov/ofccp/regs/compliance/vevraa.htm) and here (http://www.dol.gov/ofccp/regs/compliance/section503.htm).

Contractors with an Affirmative Action Plan already in place on the effective date of the regulations will have additional time, until they create their next plans, to bring their plan into compliance.  However, whether they have a current Affirmative Action Plan or not, federal contractors should begin looking at these new rules now and take steps to ensure they are in compliance.

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Indicted—Not Once, But Twice! Former GlaxoSmithKline In-House Counsel, Lauren Stevens, Tells Her Harrowing Story And Hard Lessons Learned From Being Indicted

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Imagine, one of the worst things that could happen to any person, especially an attorney—being indicted.  This not only happened to former GlaxoSmithKline (“GSK”) Vice President and Associate General Counsel, Lauren Stevens (“Stevens”) once—but twice!  On November 8, 2010, a federal grand jury in the District of Maryland returned an indictment charging Stevens with one count of obstructing an official proceeding  in violation of 18 U.S.C. §1512, one count of falsification and concealment of documents in violation of 18 U.S.C. §1519, and four counts of making false statements in violation of 15 U.S.C. §1001. On March 23, 2011, the District Court dismissed the indictment without prejudice due to erroneous and prejudicial legal advice that the prosecutors gave to the grand jury.  However, on April 13, 2011, Stevens was indicated again, based on the same charges in the earlier indictment.  For more than 18 months, Stevens lived this harrowing ordeal, and eventually was exonerated of any wrong doing.  Stevens will discuss the events leading up to the indictment, the grueling court proceedings, and the lessons she learned at the National Association of Women Lawyers’ Ninth Annual General Counsel Institute on November 8, 2013 at the Intercontinental Hotel in New York City.

The indictments against Stevens arose out of a letter from the Food and Drug Administration (“FDA”) to GSK stating that it had information that GSK possibly promoted the use of Wellbutrin (a drug approved by the FDA to treat depression) for an unapproved use (namely, weight loss).  The FDA requested that GSK voluntarily provide numerous materials and information related to the promotion of Wellbutrin.

GSK assembled a team, led by Stevens, which included in-houseattorneys, a former FDA reviewer, and employees from GSK’s marketing, compliance, regulatory affairs and medical divisions, to respond to the FDA’s request.  GSK also retained an outside law firm to conduct an internal review and advise GSK how to respond to the inquiry.  Ultimately, GSK submitted six substantive letters, all signed by Stevens, in which she denied that GSK promoted Wellbutrin for an unapproved use and/or paid doctors to give promotional talks that included information on the unapproved use.  On December 17, 2010, the government filed a motion to bar Stevens from relying on the defense of advice of counsel on the basis that it was not a defense to a charge of violating 18 U.S.C. §1519 because, the government argued, the statute is not a specific intent crime.  That same day, Stevens filed a motion to disclose the government’s presentation to the Grand Jury relating to the advice of counsel defense.  She also filed two motions to dismiss Count II of the indictment.  In the first motion, Stevens sought dismissal for unconstitutional multiplicity and for failure to state an offense, arguing that Counts I and II violated her due process rights because they sought to impose multiple punishments for the same offense.  She also argued that the government’s case was legally flawed because the government did not allege that she altered or falsified any pre-existing documents.  In her second motion, Stevens sought dismissal of Count II on the basis that the charges were unconstitutionally vague.

On February 25, 2011, Stevens filed her opposition to the motion to exclude, arguing that where a defendant relies in good faith on the advice of counsel, she lacks the intent necessary to be found guilty of making false statements and obstructing justice, which required proof that she “knowingly” submitted false information.  She also argued that she met the prerequisites for asserting the defense because outside counsel was aware of all material facts as evidenced by over 350 drafts of the six response letters to the FDA and 1,300 pages of notes regarding the matter.

On March 23, 2011, the Court denied the government’s motion to prohibit Stevens from asserting the advice of counsel defense.  The Court then dismissed the indictment without prejudice due to erroneous and prejudicial legal advice the prosecutors gave to the grand jury.

On April 13, 2011, a federal grand jury re-indicted Stevens.  The trial commenced thirteen days later, and proceeded through May 6, 2011, at which time the government rested its case.  Stevens filed a Rule 29 Motion for Acquittal on the basis that the government failed to present evidence sufficient to prove beyond a reasonable doubt any of the six counts.  On May 10, 2011, the Court granted Stevens’ Motion and dismissed the indictment.  The Court determined that the government was given access to attorney-client privileged communications, which formed the basis of the government’s case, as the result of an erroneous decision by a Massachusetts magistrate judge that the communications were evidence of a scheme to perpetrate a crime of fraud.  However, the documents revealed a “studied, thoughtful analysis of an extremely broad request from the [FDA] and an enormous effort to assemble information and respond on behalf of the client.”  Although GSK’s responses may not have satisfied the FDA, they were sent to the FDA in the course of Stevens’ bona fide representation of a client and in good faith reliance on both external and internal lawyers for GSK.  The Court concluded: “the defendant sought and obtained the advice of counsel of numerous lawyers.  She made full disclosure to them.  Every decision that she made and every letter she wrote was done by consensus.”  Further, although some statements were not literally true, they were made in good faith which would negate the requisite element of intent required for the charged crimes.

Stevens learned many lessons from this ordeal including: (1) when hiring outside legal counsel, make sure they know all of the facts; (2) make sure other parties know you have hired outside counsel; (3) take clear, accurate notes, knowing they could end up in Court; and (4) be careful in correspondence with adverse parties.

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A Federal District Court in Florida Finds Hospital System Properly Terminated a Professional Services Contract for a Health Insurance Portability and Accountability Act (HIPAA) Breach

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The U.S. District Court for the Southern District of Florida found on June 20, 2013 that defendant Community Health Systems, Inc., and its affiliated hospital, Salem Hospital (collectively, “CHS”) properly terminated a Professional Services Agreement it had with Managed Care Solutions, Inc. (“MCS”) for breach of contract after determining that Nichole Scott, one of MCS’s employees, misappropriated Protected Health Information (“PHI”) from the hospital. Ms. Scott misappropriated PHI from the hospital’s patients including patients’ checks, credit card numbers and social security numbers.

The Business Associate Agreement (“BAA”) between CHS and MCS provided, among other things, that in the event MCS breached its obligations under the BAA, CHS could terminate both the BAA and the Professional Services Agreement. After CHS terminated the Professional Services Agreement with MCS as a result of Ms. Scott’s misappropriation of its patients’ PHI, MCS sued CHS for breach of contract. The Florida District Court granted CHS’s motion for summary judgment and dismissed the lawsuit.

The lesson from this case is that healthcare entities should have clear cross-default provisions in their Professional Services Agreements with their business associates and in their Business Associate Agreements that allow them to terminate the Professional Services Agreement or take other appropriate remedial action in the event of a breach by the business associate of its obligations under the Professional Services Agreement and/or under the Business Associate Agreement.

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Photocopiers – A Recurring Data Security Risk

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In a case that illustrates the data privacy risks associated with modern copiers, the United States Department of Health and Human Resources (HHS) has announced a $1,215,780 settlement with Affinity Health Plan, Inc. (Affinity), arising from an investigation of potential violations of the HIPAA Privacy and Security Rules.

This matter started when Affinity was advised by CBS Evening News that CBS had purchased a photocopier previously leased by Affinity.  CBS explained that the copier’s hard drive contained confidential medical information relating to Affinity patients.  As a result, on August 15, 2010, Affinity self-reported a breach with the HHS’ Office for Civil Rights (OCR).  Affinity estimated that the medical records of approximately 344,000 persons may have been affected by this breach.  Moreover, Affinity apparently had returned multiple photocopiers to office equipment vendors in the past without erasing the data contained upon the internal hard drives of those returned copiers.

After investigating this matter, OCR determined that Affinity had failed to incorporate photocopier hard drives into its definition of electronic protected health information (ePHI) in its risk assessments as required by the Security Rule.  Affinity also failed to implement appropriate policies and procedures to scrub internal hard drives when returning photocopiers to its office equipment vendors.  As a result, OCR determined that Affinity also violated the Privacy Rule.

In discussing this issue, Leon Rodriguez, Director of OCR, stated that, “This settlement illustrates an important reminder about equipment designed to retain electronic information: Make sure that all personal information is wiped from hardware before it is recycled, thrown away or sent back to a leasing agent…HIPAA covered entities are required to undertake a careful risk analysis to understand the threats and vulnerabilities to individuals’ data, and have appropriate safeguards in place to protect this information.”

In addition to the agreed upon settlement payment of $1,215,780, the settlement also requires the implementation of a Corrective Action Plan (CAP).  The CAP requires Affinity to use its best efforts to retrieve all hard drives that were contained on photocopiers previously leased by the plan that remain in the possession of the leasing agent, and take protective measures to safeguard all ePHI going forward.

Points to Consider

Affinity’s case demonstrates the risks presented by the modern copier – they are specialized computers that will store data and retain itindefinitely.  Thus, they pose a security risk for any company that processes and/or possesses personally identifiable information or proprietary information, such as trade secrets, research and development records, marketing plans and financial information.  Clearly, this risk applies to businesses regardless of specific business sector.

Therefore, when acquiring a copier, consider all options available to protect the data processed on that machine, typically through encryption or overwriting.  Encryption will scramble the data that remains stored on the copier’s hard drive.  Overwriting (or wiping) will make reconstructing the data initially on the drive very difficult.

Finally, anticipate the copier’s return to the vendor or other disposition.  Make sure that arrangements are made prior to the copier’s departure to effect the hard drive’s removal and secure disposition so as to make any data on it unusable to third parties.  Often vendors will provide such a service as will IT consultants.

Note that protecting sensitive information is a company’s ongoing responsibility.  Make sure that copiers are considered as part of any comprehensive data security or privacy policy (as are PCs, laptops, smart phones, flash drives and other electronic devices) to avoid an avoidable, but costly and embarrassing, data breach.

For additional information from the FTC on safeguarding sensitive data stored on the hard drives of digital copiers, click here.

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Health Care on the Hill: Week of September 9, 2013

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This week Congress returns to Washington, DC following their August recess and are jumping right back into legislative matters. Listed below are a few health-related hearings scheduled for this week.

Each Monday Capitol Health Record will be providing health-related highlights for the coming week.

Tuesday, September 10, 2013

10:15 a.m.
“PPACA Pulse Check: Part Two”
House Energy and Commerce Subcommittee on Health Hearing
2322 Rayburn House Office Building

Wednesday, September 11, 2013

2:00 p.m.
“The Threat to Americans’ Personal Information: A Look into the Security and Reliability of the Health Exchange Data Hub”
House Homeland Security Subcommittee on Cybersecurity, Infrastructure Protection, and Security Technologies Hearing
311 Cannon House Office Building

Thursday, September 12, 2013

10:00 a.m.
“Dental Crisis in America: The Need to Address Cost”
Senate Health, Education, Labor, and Pensions Subcommittee on Primary Health and Aging Hearing
430 Dirksen Senate Office Building

Thursday, September 12, 2013 and Friday, September 13, 2013

In addition to the above Congressional hearings, the Medicare Payment Advisory Commission (MedPAC) will be meeting in Washington, DC on Thursday and Friday to discuss recommendations regarding Medicare payment policies. MedPAC will meet at the Ronald Reagan Building and International Trade Center (1300 Pennsylvania Avenue, NW) from 9:30 a.m. to 5:15 p.m. on Thursday and 9:00 a.m. to 12:00 p.m. on Friday (agenda).

Amy Walker contributed to this article.

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A Continued Examination of Charitable Patient Assistance Programs Part Seven in a Series: Charitable PAPs: Donations and Transparency 2013-09-03

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In today’s challenging health care environment, Charitable Patient Assistance Programs (Charitable PAPs) have emerged to meet the needs of the nearly 30 million Americans that are underinsured and have difficulty paying out-of-pocket medical costs. As potential donors make strategic decisions to invest in Charitable PAPs, there are many elements that must be considered to ensure compliance with all applicable laws and regulations. For the previous alerts in the series, please refer here.

As Charitable PAPs are entrusted with donations to help patients, it is important that the organization is accountable to its donors and is in compliance with all relevant audit requirements. When considering a donation to a Charitable PAP, it is important to evaluate the organization’s commitment to regular and thorough independent, third-party reviews to verify program and financial transparency and to validate operations:

  • Does the organization undergo regular, independent financial audits? In most cases, non-profit 990s are prepared by an accredited and industry-recognized financial auditing firm typically named on the 990. Researching the firms can provide insight into the thoroughness of the audit.
  • Does the Charitable PAP agree to operate in a certain manner with its donors? Is compliance audited? It is possible to request copies of compliance audits to make sure the organization is adhering to applicable requirements and restrictions as outlined to donors.
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Top Whistleblower Settlements of 2013 – To Date

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The theme of the top whistleblower settlements to date in 2013 is, once again, health care fraud. Eight of the largest settlements involve fraud in the health care industry. This is indicative of the number of health care fraud cases being filed in recent years. According to the Department of Justice, since January 2009, over $10.3 billion has been recovered from health care fraud cases. This year, the focus seems to have particularly shifted to cases involving violations of the Anti-Kickback Statute and Stark law, which prohibit the giving of financial incentives for referrals or the use of particular pharmaceuticals or devices. Without further ado, here are the top whistleblower settlements of 2013 to date:

1. Ranbaxy USA Inc. ($500 Million)

Ranbaxy USA Inc., a subsidiary of Indian generic pharmaceutical manufacturer Ranbaxy Laboratories Limited, agreed to pay a total of $500 million to settle criminal and civil allegations filed against the company. Ranbaxy pleaded guilty and agreed to pay a criminal fine and forfeiture of $150 million. The civil settlement, which resolves False Claims Act violations, was for $350 million. Ranbaxy was accused of poor oversight and inadequate testing and maintenance of drugs manufactured at its facilities in Paonta Sahib and Dewas, India. This lead to false claims being submitted to numerous government agencies including the FDA, Medicaid, Medicare, TRICARE, the Federal Employees Health Benefits Program, the Department of Veterans Affairs, and USAID. The whistleblower in this case, former Ranbaxy executive Dinesh Thakur, will receive $48.6 million from the federal share of the civil settlement.

For more information about this settlement, read the DOJ press release.

2. C.R. Bard Inc. ($48.26 Million)

C.R. Bard Inc., a New Jersey-based corporation that develops, manufactures, and markets medical products, agreed to pay $48.26 million to resolve kickback allegations filed against the company. Bard was accused of submitting false claims to Medicare for brachytherapy seeds used to treat prostate cancer. According to the complaint filed in 2006, Bard paid illegal kickbacks in numerous forms to both physicians and customers who used the seeds to perform treatment for prostate cancer. The whistleblower in this case, Julie Darity, was a former Bard manager for brachytherapy contracts administration. She will receive $10,134,600 as her portion of the settlement.

For more information about this settlement, read the DOJ press release

3. Par Pharmaceutical Companies Inc. ($45 million)

Par Pharmaceutical Companies, Inc., one of the top five U.S. generic pharmaceutical companies, pleaded guilty to federal criminal charges and agreed to settle civil allegations involving the company’s promotion of the drug Megace ES. Par was fined $18 million and ordered to pay an additional $4.5 million in criminal forfeiture. The company will also pay $22.5 million to resolve the civil allegations. The civil suit accused Par of promoting Megace ES for non-FDA approved uses that were not covered by federal healthcare programs and of actively ignoring some of the negative side effects the drug has on various patient groups when promoting Megace ES. The settlement resolves three separate whistleblower lawsuits that were filed against the company. Two of the five whistleblowers in the cases, Mr. Michael McKeen and Ms. Courtney Combs will receive $4.4 million as their portion of the settlement. Any payments to the other whistleblowers, Ms. Christine Thomas, Mr. James Lundstrom, and Mr. Elliott, are unknown at this time.

For more information about this settlement, read our blog post.

4. Dr. Steven J. Wasserman ($26.1 Million)

This year, the Department of Justice announced one of the largest ever settlements with an individual under the False Claims Act. Florida dermatologist, Dr. Steven J. Wasserman agreed to settle allegations filed against him for $26.1 million. Dr. Wasserman was accused of performing medically unnecessary services and engaging in an illegal kickback scheme. Dr. Alan Freedman, the whistleblower in this case, was a pathologist at a company involved in the kickback operation. He filed his qui tam lawsuit in 2004 and will receive slightly over $4 million as his share in the settlement.  

For more information about this settlement, read our blog post. 

5. CH2M Hill Hanford Group Inc. ($18.5 Million)

CH2M Hill Hanford Group Inc. and its parent company CH2M Hill Companies Ltd. agreed to settle civil and criminal allegations relating to time card fraud for a total of $18.5 million. CH2M had a contract with the Department of Energy to manage and clean 177 large underground storage tanks that contained radioactive and hazardous waste at a nuclear site in Washington. CH2M employees allegedly regularly overstated the number of hours they worked on time cards submitted to the Department of Energy. As a result, CH2M was overpaid for more hours of work than were actually performed. The civil settlement was for $16.55 million. CH2M will also pay $1.95 million to resolve the criminal liabilities. To date, eight CH2M employees have pleaded guilty to engaging in the time card fraud. The whistleblower in this case, Carl Schroeder, was a former CH2M employee and one of the individuals who pleaded guilty to the scheme. The qui tam provisions of the False Claims Act bar whistleblowers from receiving a portion of the settlements if they are convicted for their role in the fraud scheme. Therefore, Mr. Schroeder will not receive a portion of this settlement.

For more information about this settlement, read the DOJ press release. 

6. American Sleep Medicine LLC ($15.3 Million)

The Department of Justice announced a $15.3 million False Claims Act settlement it reached with American Sleep Medicine LLC. American Sleep is a Florida-based company that owns and operates 19 diagnostic sleep testing centers across the country. Its primary business is to provide testing for patients who suffer from sleep disorders. American Sleep allegedly submitted false claims to Medicare, TRICARE, and the Railroad Retirement Medicare Program for tests that were performed by technicians who lacked the proper certification required by these agencies for reimbursement. The whistleblower in this case, Daniel Purnell, will receive about $2.6 million as his portion of the settlement.

For more information about this settlement, read the DOJ press release.  

7. Adventist Health System & White Memorial Medical Center
   ($14.1 Million)

This month, Adventist Health System and its affiliated hospital White Memorial Medical Center agreed to a $14.1 million settlement. The settlement was the result of a qui tam lawsuit filed against the companies accusing them of violating the Anti-Kickback Act and the Stark Statute. Of the $14.1 million, $11.5 million will go to the federal government and $2.6 million will go to California’s Department of Health Care Services. Adventist Health was allegedly improperly compensating physicians for patient referrals to White Memorial by transferring medical and non-medical supplies and other inventory to the physicians at less than fair market value. White Memorial was also accused of paying referring physicians at a rate above fair market value for teaching services at the family practice residency program. The whistleblowers in this case were Dr. Hector Luque and Dr. Alejandro Gonzalez, who were members and partners of White Memorial. They will collectively receive $2,389,219 as their portion of the settlement.

For more information about this settlement, read our blog post.

8. Cooper Health System ($12.6 Million)

Cooper Health System and Cooper University Hospital, a hospital and health care system in South New Jersey, agreed to a $12.6 million settlement that resolved allegations that Cooper engaged in an elaborate illegal kickback scheme. According to the complaint, Cooper created a sham advisory board to pay high-volume medical practices upwards of $18,500 each to attend four meetings over the course of a year with the true goal of encouraging medical practices to refer patients to Cooper. The whistleblower in this case, Dr. Nicholas L. DePace, is a prominent Delaware Valley cardiologist. Dr. DePace was invited to join the sham advisory board and, after attending one of the meetings, figured out Cooper’s true intentions. Dr. DePace’s whistleblower reward has not yet been determined.

For more information about this settlement, read our blog post.

9. Hospice of Arizona ($12 Million)

Three Arizona hospice companies, Hospice of Arizona LC, American Hospice Management LLC and American Hospice Management Holdings LLC, agreed to settle a False Claims Act lawsuit with the government for $12 million. In order for hospice care to be reimbursed by Medicare, patients are required to have a life expectancy of, at most, six months.The qui tam lawsuit, filed against the companies in 2010, accused the defendants of submitting false claims to Medicare for patients who did not need to be admitted to the Hospice of Arizona. Additionally, they were accused of submitting false claims by overbilling Medicare for some of the hospice’s services. Ellen Momeyer, the whistleblower in this action, was a former Hospice of Arizona employee. Momeyer will receive $1.8 million (approximately 15%) as her share of the settlement.

For more information about this settlement, read our blog post.

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