Category: Administrative & Regulatory

Your Face is for Sale! The 4 Most Interesting Things About the Proposed Update to Facebook’s Governing Documents

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If you use Facebook (and you likely do, if only to play some game that apparently involves crushing large amounts of candy), then you received an email last week informing you that Facebook is proposing changes to its Data Use Policy and Statement of Rights and Responsibilities.  The proposed changes are largely in response to the $20 million settlement, approved last month by a federal judge, of a class action brought against Facebook in response to its use of user names and photos in “Sponsored Stories”.

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In January 2011, Facebook implemented the Sponsored Stories advertising mechanism, which turned user “likes” into product endorsements.  The claim argued that Facebook did not adequately inform its users that profile photos and user names would be used by advertisers to recommend products and services.  The claim also argued that Facebook inappropriately did not give users the ability to opt out of the Sponsored Stories advertising feature and allowed the use of the likeness and photos of minors who, the claimants argued, should have automatically been opted out of the program.  Arriving just days after the approval of the settlement, the proposed changes include an interesting mix of responses and clarifications.  These are the most noteworthy:

Your face is for sale.  Under the approved settlement, Facebook agreed to pay $20 million and give its users greater “control” over the use of information by advertisers.  Facebook did not, however, agree to let its users opt out of allowing advertisers to use information entirely.  Under the revised Statement of Rights and Responsibilities, each user gives Facebook permission to use his or her name, profile picture, content and information in connection with commercial, sponsored or related content.  Facebook further clarifies that this means that businesses or other entities will pay Facebook for the ability to display user names and profile pictures.

  • Kids, be sure to ask your parents’ permission.  By using Facebook, each user under the age of 18 represents that at least one parent or guardian has agreed to Facebook’s terms, including the use of the minor’s name, profile picture, content and information by advertisers, on that minor’s behalf.
  • Your profile photo is fair game for facial recognition scanning.  Facebook scans and compares pictures in which you are tagged so that when your friends post more photos of you, it can suggest that they tag you.  The updated Data Use Policy makes it clear that your profile photo will be scanned for this purpose as well.
  • There’s a renewed emphasis on mobile phone data.  The updated policies make it clear that Facebook and, in certain cases, third-party integrated applications, will have access to a broad array of mobile data.  This includes the use of friend lists by third party mobile applications to advertise mobile applications used by an individual’s friends.  Whereas Facebook encountered substantial difficulty in implementing Sponsored Stories and similar advertising mechanisms, Facebook’s program of allowing mobile applications to market themselves as “Suggested Apps”has been a bright spot for the company’s bottom line.  Moreover, Facebook has signed on to an agreement with California Attorney General Kamala Harris that mobile applications constitute “online services” and, as such, are governed by the same disclosure and transparency regulations applicable to websites.  The clarifications related to mobile devices and applications suggest that Facebook intends to further develop the use of mobile data as a revenue stream without risking the same type of legal action.

Facebook’s proposed revisions remain open for public comment.   While the proposed revisions are unlikely to stoke the kind of furor that past changes have inspired, they remain an interesting display of the developing give-and-take between consumers and online service providers who provide a “free” service in exchange for the right to use and monetize personal data.

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WildTangent Files its Supreme Court Certiorari Petition in Patent Infringement Case – Part 1

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In September of 2009, Ultramercial, Inc. sued WildTangent, Inc., Hulu and YouTube in the Central District of California for alleged patent infringement of U.S. 7,346,545 (the ’545 patent).  The ’545 patent claims trading advertisement viewing for access to content over the Internet.  The Abstract of the ’545 patent reads:

The present invention is directed to a method and system for distributing or obtaining products covered by intellectual property over a telecommunications network whereby a consumer may, rather paying for the products, choose to receive such products after viewing and/or interacting with an interposed sponsor’s or advertiser’s message, wherein the interposed sponsor or advertiser may pay the owner or assignee of the underlying intellectual property associated with the product through an intermediary such as a facilitator.

Claim 1 of the ’545 patent is more detailed:

1. A method for distribution of products over the Internet via a facilitator, said method comprising the steps of:

a first step of receiving, from a content provider, media products that are covered by intellectual-property rights protection and are available for purchase, wherein each said media product being comprised of at least one of text data, music data, and video data;

a second step of selecting a sponsor message to be associated with the media product, said sponsor message being selected from a plurality of sponsor messages, said second step including accessing an activity log to verify that the total number of times which the sponsor message has been previously presented is less than the number of transaction cycles contracted by the sponsor of the sponsor message;

a third step of providing the media product for sale at an Internet website;

a fourth step of restricting general public access to said media product;

a fifth step of offering to a consumer access to the media product without charge to the consumer on the precondition that the consumer views the sponsor message;

a sixth step of receiving from the consumer a request to view the sponsor message, wherein the consumer submits said request in response to being offered access to the media product;

a seventh step of, in response to receiving the request from the consumer, facilitating the display of a sponsor message to the consumer;

an eighth step of, if the sponsor message is not an interactive message, allowing said consumer access to said media product after said step of facilitating the display of said sponsor message;

a ninth step of, if the sponsor message is an interactive message, presenting at least one query to the consumer and allowing said consumer access to said media product after receiving a response to said at least one query;

a tenth step of recording the transaction event to the activity log, said tenth step including updating the total number of times the sponsor message has been presented; and

an eleventh step of receiving payment from the sponsor of the sponsor message displayed.

As you can see, there are 11 method steps recited in Claim 1, so it is a very detailed claim and it cannot be summarized in a sentence or two.

The history of the case is not easy to summarize either.  In short, the District Court found that the subject matter of the patent was not patent eligible and dismissed the district court action before interpreting the claims.  In 2011, the Federal Circuit reversed the District Court decision, but the Supreme Court vacated the Federal Circuit’s decision in 2012 based on its recent opinion in Mayo v. Prometheus.  And in June of 2013 the Federal Circuit again reversed the District Court decision, leading to WildTangent’s Petition for Writ of Certiorari filed last week.

WildTangent’s cert petition is attached.  I will be discussing the petition and the ongoing patent eligibility battle in more detail in future posts.

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Treasury Department Recognizes All Legal Marriages for Tax Purposes

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On August 29, 2013, the Treasury Department issued Revenue Ruling 2013-17, Internal Revenue Bulletin 2013-38, which states that same-sex couple legally married in jurisdictions that recognize their marriage will be treated as married for ALL federal tax purposes. As a result, legally married same-sex couples are treated the same as legally married opposite-sex couples for federal tax purposes if the state of ceremony of their marriage recognizes same-sex marriage even if their state of residence does not recognize same-sex marriage.

This Ruling has significant impact for legally married same-sex couples and their tax advisors. However, it does not impact state law rules regarding the definition of marriage and may complicate income tax filings for same-sex couples legally married but living in a state that does not yet recognize their marriage, like Wisconsin and Illinois.

Background Leading Up to the Ruling

The Defense of Marriage Act (DOMA) was enacted by President Clinton in 1996. Section Two of DOMA says states do not have to recognize same-sex marriages performed in other states. Section Three of DOMA defined marriage for all federal purposes as only between one man and one woman.

On June 26, 2013, in Windsor v. United States (Windsor), the United States Supreme Court held that Section Three of DOMA was unconstitutional. Therefore, any same-sex married couple that lives in a state that recognizes same-sex marriage is to be treated the same for all purposes as any other married couple, and thereby are entitled to all of the 1,138 rights and privileges under federal law that are granted to married persons, which includes federal tax law.

Section Two of DOMA was unaffected by Windsor. Therefore, a same-sex couple that marries in one of the thirteen states that recognizes same-sex marriage who then moves to one of the thirty-seven states that does not recognize same-sex marriage would not be treated as married if the state of residence determines whether a couples is considered married, as opposed to the state of ceremony determining if a couple is married.

Absent guidance from the Treasury Department, a same-sex couple legally married in a recognition jurisdiction who then move to a state that does not recognize same-sex marriage, would most likely not be treated as married for federal tax law purposes. This is because the majority of federal tax laws are determined by a couple’s state of residence, not the state of ceremony of their marriage.

State of Ceremony Versus State of Residence

Consider the following examples to illustrate Windsor and this Ruling:

Britney and Jason are married in a drive-through chapel by an Elvis impersonator in Las Vegas and then go home to California. Their opposite-sex marriage is recognized for federal tax law purposes in California (and all other states) because California recognizes legal Nevada marriages. Sadly, Britney and Jason’s marriage only lasted 55 hours.

Mitchell and Cam are a same-sex couple married in New York (New York being a state of ceremony that recognizes same-sex marriage) and move back to Milwaukee (Wisconsin being a state of residence that does not recognize same-sex marriage). Prior to the Revenue Ruling, Mitchell and Cam are not married for federal law purposes, even though their marriage would be recognized if they stayed in New York. This is because Article Two of DOMA says that Wisconsin does not have to recognize New York marriages.

After the Revenue Ruling, with an effective date after September 16, 2013, Mitchell and Cam in Wisconsin will be treated as married for federal tax law purposes just like Britney and Jason in California. Mitchell and Cam will be able to utilize all federal tax laws Britney and Jason would be able to utilize (if Britney and Jason had respected the sanctity of their marriage).

Federal Tax Impact of Ruling

As a result of the Revenue Ruling, regardless of a couple’s state of residence, if they are married in a state that legally recognizes their marriage, the couple will be entitled to the following federal tax law benefits (among others): filing status as married filing jointly, claiming personal and dependency exemptions, taking the standard deduction, employee benefits, contributing to an IRA, spousal rollovers of IRA’s, unlimited marital deduction for estate and gift tax purposes, gift tax splitting, and estate tax exemption portability.

The Revenue Ruling does not apply to registered domestic partnerships, civil unions, or similar formal relationships recognized under state law that are not considered “marriage” under state law.

Legally married same-sex couples must file their 2013 income tax returns as either “married filing jointly” or “married filing separately.” They may also, but are not required to, file amended returns for open years (generally 2010, 211, and 2012) to be treated as married for federal tax law purposes.

Also, if an employee purchased health insurance coverage from their employer on an after-tax basis for their same-sex spouse, they may now treat the amounts paid for that coverage as pre-tax and excludable from their income, and file amended returns for a refund for open years. Further, if their employer paid Medicare and Social Security tax on those taxable benefits to the employee, the employer may file for a refund for both the employee and employer portions of those overpayments for open years.

Continuing Issues in Non-Recognition States

As of August 30, 2013, the District of Columbia and thirteen states (California, Connecticut, Delaware, Iowa, Maine, Massachusetts, Maryland, Minnesota, New Hampshire, New York, Rhode Island, Vermont, and Washington) recognize same-sex marriage. Therefore, clients who get married in those states or have employees who get married in those states, but subsequently reside in a non-recognition state, need to be aware of the new federal tax law benefits and obligations.

Even though married same-sex couples may now file as “married filing jointly” for federal income tax purposes, states like Wisconsin and Illinois that do not recognize same-sex marriage would still require those couples to either file as single or as married filing separately on their federal returns. This is because most state income tax forms use federal income tax amounts as the starting point for preparing the state return, and most state returns require the federal return to be attached to the state return. Without further guidance from state tax authorities, this could complicate income tax filings for same-sex married couples in non-recognition states.

Estate, gift, and generation skipping transfer tax laws now treat all legally married same-sex couples the same as opposite-sex couples, but, like opposite-sex couples, the Revenue Ruling does not mitigate the need for same-sex married couples to prepare estate plans. Many property law issues are driven by whether someone is classified as a “spouse” under state law, including who inherits under intestacy and other survivorship rights, all of which can be controlled by a will or trust in non-recognition states (like Wisconsin and Illinois). Finally, some states (like Illinois) have state estate and gift tax exemptions that are lower than the current federal estate and gift tax exemptions, which requires careful estate tax planning for all married couples, be they opposite-sex or same-sex.

The impact of Windsor and how same-sex couples are recognized for federal and state laws is a fast changing arena, and additional federal and state guidance will be required.

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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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Michigan Cardiology Settlement of Medicare and Medicaid Fraud Allegations

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On July 10, 2013, United States Attorney Barbara L. McQuade announced a $4 million settlement between Allegiance Health d/b/a W.A. Foote Memorial Hospital, Jackson Cardiology Associates, P.C., Jashu R. Patel, M.D. and the U.S. Government.  The U.S. Department of Justice collaborated with the Birmingham, Michigan law firm, Vezina Law, PLC, in pursuing this action against the Jackson, Michigan based defendants.

According to allegations brought against the defendants in 2008, Foote Memorial Hospital, Jackson Cardiology Associates, and Dr. Patel knowingly billed Medicare, Medicaid, and other federal health care programs for medically unnecessary cardiovascular procedures and tests, including, but not limited to, stress tests, cardiac catheterizations, cardiac stents, and peripheral angiography procedures.

The lawsuit was filed in the United States District Court for the Eastern District of Michigan under the qui tam provisions of the Federal and State False Claims Acts.  Both False Claims Acts allow private individuals with knowledge of fraud against a government program to file lawsuits on the Government’s behalf.  If the case is successful, the private plaintiffs, known as relators or whistleblowers, are entitled to a percentage of the Government’s recovery.  The state and federal False Claims Acts both provide for recovery of three times the single damages incurred by the government as a result of the fraud, as well as civil monetary penalties of between $5,500 and $11,000 per false claim submitted and statutory attorney fees.

The relator in this case is Dr. Julie Movach, an independent contractor with Medical Practice and a physician board certified in internal medicine, cardiology, and echocardiography.  Dr. Movach released a statement explaining how important it is for her to deliver the best care to her patients and ensure that they do not undergo any unnecessary procedures.  When she realized that certain health care providers were more concerned with their personal financial well-being rather than the welfare of their patients, to the point that they would commit fraud against federal health care programs, Dr. Movach knew she must expose this corruption.  She took it upon herself to file a lawsuit against the defendants on behalf of the U.S. government.  Dr. Movach deserves our thanks and applause for her willingness to risk her livelihood in order to ensure people with genuine need can continue to receive assistance from Medicare and Medicaid.

In this case, the combined settlement was $4,150,988.31. The Foote Memorial Hospital settled the allegations with the federal government for $1,824.927.98 and with the State of Michigan for $126,060.33.  At the same time, Dr. Patel and Jackson Cardiology settled the allegations with the federal government for $2,200,000.00.  As the whistleblower, Dr. Movach will receive a 19% share of the overall settlement, which amounts to approximately $760,000 of the proceeds.

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Countdown to HITECH Compliance: How to Redistribute Your Notice of Privacy Practices

Poyner SpruillSeptember 23, 2013 is the fast-approaching compliance deadline for the final omnibus HIPAA/HITECH rules.  Many provisions required revisions to Notices of Privacy Practices (NPPs) maintained and distributed by covered entities.  The U.S. Department of Health and Human Services (HHS) has made clear that these changes are material.  As a result, covered entities must redistribute their NPPs shortly in order to meet HITECH’s requirements.  This alert describes the manner of redistribution dictated by HIPAA.

General Requirements

When revising NPPs, keep in mind that whether paper or web-based, HHS requires them to be accessible to all individuals, including those with disabilities.  Covered providers required to comply with Section 504 of the Rehabilitation Act or the Americans with Disabilities Act must also take steps to ensure effective communication with individuals with disabilities, including making the revised NPP available in Braille, large print, or audio.  HIPAA also requires NPPs to be written in plain language.

Changes to the NPP may not be implemented prior to the NPP’s new effective date, unless otherwise required by law.  Typically, any change to the practices described within the revised NPP may only be applied to PHI created or received after the effective date of the change.  All previous versions of the NPP and any acknowledgments of its receipt must be maintained for six years from the last effective date.

If You Are a Health Care Provider

For existing patients, you must make the revised NPP available upon request on or after the effective date of the changes (for most, this date will be September 23, 2013).  If you have a physical service delivery site (such as a clinic or hospital), you must have copies of the NPP available at the site for individuals to take with them upon request.  You also must post a copy of the NPP or summary of the revisions in a clear and prominent location, where it is reasonable to expect individuals to be able to read the posting.  You must ensure all new patients receive the revised NPP at the time of first service after the effective date of the changes.  The revised NPP must be made available on your website if you have one.  If patients have agreed to receive electronic notice of the NPP, you may e-mail the revised NPP to those patients.  You do not need to obtain acknowledgment of receipt from individuals, except for the initial distribution of the NPP provided at the first time of service.

If You Are a Health Plan

You must distribute the revised NPP to current plan participants.  If you post your NPP on a website, then you must post the revised NPP, or a description of the material changes, prominently on that website by the effective date of the changes.  You also must provide in your next annual mailing to participants either the revised NPP or information regarding material changes and how to obtain a copy of the NPP.  If you do not post your NPP on a website, then you must provide participants with the revised NPP or information about the material changes and how to obtain the revised NPP within 60 days of the material changes.  Note that all health plans also must continue to notify participants of the availability of the NPP and how to obtain a copy at least once every three years.

HHS has stated that if covered entities or health plans amended and redistributed NPPs prior to issuance of the final omnibus rule then they are not required to repeat the process, so long as the current NPP that was redistributed meets all the requirements in the final rule.  For all other covered entities, the NPP must be revised and effective by September 23, 2013, and redistributed as appropriate.

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Healthcare Fraud Case Results in $491 Million Settlement

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On July 30, 2013, Pfizer Inc., one of the world’s largest pharmaceutical companies, announced its finalized agreement to pay $491 million to the U.S. government in order to resolve accusations that the company and one of its subsidiaries defrauded the U.S. healthcare system.  Under the settlement, Pfizer will pay $257 million in order to resolve civil allegations that Wyeth Pharmaceuticals Inc., owned by Pfizer, engaged in illegal marketing that led to false claims being brought to Medicare and similar healthcare programs.  Pfizer will pay the other $234 million of the settlement in order to cover criminal fines and penalties.

According to allegations in the lawsuit, Wyeth Pharmaceuticals had illegally marketed a transplant drug named Rapamune for uses that had not been approved by the U.S. Food & Drug Administration (FDA).  Patients use Rapamune in combination with other drugs following kidney transplants.  However, Wyeth’s advertising campaigns advocated the drug for unapproved applications, such as use after liver, lung, heart, pancreas, and islet transplants.  According to a U.S. attorney, this type of off-label marketing endangers patients and erodes the population’s confidence in the FDA.  In 2002, the FDA required Wyeth to place a “black box warning,” the most stringent type of warning required by the agency, on the Rapamune product label.  This warning would advise people of the risks inherent in using Rapamune after liver transplants.  One year later, the FDA required a similar type of warning with regard to the use of Rapamune after lung transplants.  Nevertheless, claims up to 90% of Wyeth’s Rapamune sales were allegedly for “off-label” uses.

The $491 million settlement resulted from two qui tam lawsuits filed against Wyeth Pharmaceuticals Inc.  Under provisions of the False Claims Act, private citizens with knowledge of fraud committed against the government can file a qui tam lawsuit on behalf of the United States.  The individual filing the lawsuit is known as the relator or whistleblower.  Healthcare whistleblowers, such as the persons who brought the lawsuits against Wyeth, serve an important role in exposing and eradicating healthcare fraud.  Many whistleblowers have personal knowledge of deceptive practices because they work for the companies that submit false claims to the Government.  By relating their knowledge to the appropriate authorities, these individuals can assure that healthcare programs can achieve their intended benefits to Americans with the greatest need of federal assistance.

In the first case, the False Claims Act whistleblowers were Marlene Sandler and Scott Paris.  They jointly filed a lawsuit in Pennsylvania that alleged aspects of off-label marketing.  At the time, the Government declined to intervene and the relators commenced to litigate the case on their own.  Two years later, a second qui tam whistleblower, Mark Campbell, came forward.  Mr. Campbell is a former Wyeth sales representative who worked for the company for twenty years.  Throughout the tenure of his employment, he became aware of Wyeth’s off-label marketing practices.  After he filed his lawsuit against Wyeth in the U.S. District Court for the Western District of Oklahoma, the Department of Justice intervened in the Sandler and Paris action.  The Government then transferred the matter to the Oklahoma court and consolidated the two cases.  The three Medicare fraud whistleblowers have aligned their interests and cooperated to help the investigation into Wyeth’s actions.

Because the whistleblowers took on a personal risk in bringing allegations against their employer and they devoted their time in relaying information vital to the case, they will obtain a significant proportion of the settlement.  False Claims Act whistleblowers typically receive 15% to 25% of settlements.  That means that Ms. Sandler, Mr. Paris, and Mr. Campbell will all potentially receive millions of dollars from Pfizer Inc.

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What Does The Word “Natural” Mean, Anyway?

Mintz Logot’s 2 o’clock in the afternoon, you need a snack – maybe a granola bar, but which one? Does the package that boasts it is “100% Natural” win out over the one that is only “All Natural”?  Would you even consider one that is merely “Natural”? Well, don’t expect the U.S. Food and Drug Administration to help you decide anytime soon – they have left it up to the courts to grapple with.

Lawsuits against food companies alleging consumer fraud based on deceptive labeling have increased in the last few years.  Many of these lawsuits have been brought in the U.S. District Court in the Northern District of California, causing that court to be known as the “Food Court” (no, not the one at the mall).  One common bone of contention is the use of the word “natural” in food labeling.  “Natural” remains undefined by the U.S. Food and Drug Administration after a failed attempt to do so in 1991.  It reaffirmed its informal policy for use of the word “natural” on food labeling claims:

The agency will maintain its current policy . . . not to restrict the use of the term “natural” except for added color, synthetic substances, and flavors as provided in [21 CFR] §101.22.  Additionally, the agency will maintain its policy . . . regarding the use of “natural,” as meaning that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.  Further, at this time the agency will continue to distinguish between natural and artificial flavors as outlined in §101.22. See more here.

A typical claim in a lawsuit will contend that the use of the word “natural,” whether as “100% Natural,” “All Natural,” or something similar, is misleading if the product contains or was processed with a compound perceived by plaintiffs to be artificial or synthetic.  The problem in these lawsuits is that the term is undefined, and even FDA says that it is difficult to define a food product that is natural because it has likely been processed and is no longer a “product of the earth.”  This leaves fertile ground for plaintiff’s class action attorneys to bring claims against food companies for any use of the word.

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Health Care Reform Update – Week of August 26th , 2013

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Leading the News

CMS Announces Matching Agreements for Data Hubs

On August 21st, the Centers for Medicare and Medicaid Services (CMS) announced its most recent agreement with state entities for exchange data hubs. States are now required to report any suspected or confirmed loss of personally identifiable information within an hour of discovery to their designated Center for Consumer Information and Insurance Oversight (CCIIO) State Officer, who will then notify the relevant Federal agency. CMS has posted a draft of the reporting form and has asked for public comments to be submitted by September 20th.

Lawmakers Defend Critical Access Hospitals

On August 22nd, a bipartisan group of 20 Senators, led by Senator Tammy Baldwin (D-WI), sent a letter to Chairman Max Baucus (D-MT) and Ranking Member Orrin Hatch (R-UT) of the Senate Finance Committee defending critical access hospitals and challenging a report released last week by the Department of Health and Human Services (HHS) Inspector General which criticized hospitals participating in the Medicare Critical Access Hospital program.

Implementation of the Affordable Care Act

On August 16th, the Small Business Administration (SBA) and the Small Business Majority announced a new series of weekly webinars to help small business owners learn how the ACA will affect their businesses and their employees.

On August 19th, HHS announced that it will be partnering with the Young Invincibles for the Healthy Young America video contest.

On August 21st, seventy nine Republicans in the House of Representatives signed a letter to Speaker John Boehner (R-OH) and Majority Leader Eric Cantor (R-VA) urging them to de-fund the implementation and enforcement of the ACA in any relevant appropriations bill.

On August 21st, Republican members of the House Energy and Commerce Committee sent a letter to Treasury Secretary Jack Lew stating that they have not yet received a response to questions submitted for the record to Mark Iwry on August 2nd regarding the delay of the employer mandate.

On August 23rd, the IRS released proposed rules on the ACA’s small business tax credit, which will be available to employers with no more than 25 full time employees purchasing health insurance through the Small Business Health Options Program (SHOP) exchange.

Other HHS and Federal Regulatory Initiatives

On August 19th, an Oklahoma judge granted a temporary injunction against a state law that placed additional restrictions on access to Plan B One-Step pending the outcome of a lawsuit challenging the law. The new restrictions contradict FDA approval for unrestricted, over the counter sale of Plan B One-Step.

On August 19th, the Agency for Healthcare Research and Quality (AHRQ) announced Richard Kronick will replace Carolyn Clancy as the director of the agency. He is currently the Deputy Assistant Secretary for Planning and Evaluation in the Office of Health Policy.

On August 20th, the Centers for Disease Control (CDC) announced an award of approximately $75.8 million to all 50 states through the Epidemiology and Laboratory Capacity for Infectious Diseases Cooperative Agreement.

On August 22nd, the HHS Office of the Assistant Secretary for Planning and Evaluation released an issue brief which found that the percentage of office-based physicians who are accepting new Medicare patients has not changed significantly between 2005 and 2012, and is slightly higher than the percentage accepting new privately insured patients.

On August 23rd, Iowa Governor Terry Branstad (D) submitted a Medicaid expansion waiver to CMS, which will formally replace the previous Medicaid waiver for the Iowa Care program with the Iowa Health and Wellness Plan.

Other Congressional and State Initiatives

On August 19th, Congressman Charles Rangel (D-NY) and Senator Kirsten Gillibrand (D-NY) announced they will be introducing the Communities United with Religious Leaders for the Elimination of HIV/AIDS (CURE) Act of 2013.

Other Health Care News

On August 19th, the RAND Corporation released a report stating that the one year delay of the employer mandate will not substantially impact the ACA.

On August 20th, the Kaiser Family Foundation released its annual Employer Health Benefits survey, which found that premiums increased at modest levels, consistent with the last several years.

On August 21st, the Commonwealth Fund released their findings from their Health Insurance Tracking Survey, conducted from 2011 to 2013, which indicated that only 27% of 19 to 29 year olds are aware of the new health insurance marketplaces instituted by the ACA.

On August 22nd, Gallup released a poll which showed that while the number of Americans who approved or disapproved of the ACA remained steady, the number of people who had no opinion of the law increased from 4% in June to 11%.

Hearings and Mark-Ups Scheduled

The Senate and the House of Representatives are in recess until the week of September 9th.

Alyssa Franke also contributed to this article.

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Argentina Legal Highlights (Volume II, 2013)

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Latin American Region Enviromental Report, Second Quarter, 2013

Packaging Waste Management Bill Introduced in Chamber of Deputies

On April 11, 2013, a bill (No. 1859-D-2013; the “Bill”) was introduced in the Chamber of Deputies that would create a national, comprehensive packaging-waste management system. The Bill would apply to most packaging and packaging waste, and would regulate most entities that are involved with the packaging of products, the marketing of packaged goods, or the recycling or recovery of packaging waste. (Arts. 2, 7) A covered entity could comply with its responsibilities through one of two methods. (Art. 9) One option would allow it to pay a fee and participate in a provincially or municipally administered Packaging-Waste Management Program (Programa de Gestión de Residuos de Envases), which would set requirements for collection, transportation, temporary storage, processing, and recovery of packaging waste. (Arts. 10-23) Alternatively, a covered entity could administer its own government-approved Deposit and Return System (Sistema de Depósito, Devolución y Retorno). (Arts. 24-26) The Bill was referred to the committees on Industry, Natural Resources and Conservation of the Human Environment, and Budget and Finance.

Reference Sources (in Spanish):

Battery Waste Bill Introduced in Chamber of Deputies

On April 25, 2013, a battery waste management bill (No. 1859-D-2013; the “Bill”) was introduced in the Chamber of Deputies. The Bill would cover nearly all batteries, with the exception of industrial and car batteries. (Art. 2) Most of the obligations established by the Bill would fall on battery producers: i.e., manufacturers, importers, brand owners, and resellers. These companies would be responsible for collection and management of battery waste and required to implement one of the following waste-management options: (a) establishing their own Individual Battery Waste Management System (Sistema de Gestión Individual de Residuos de Pilas y Acumuladores ); (b) participate in an Integrated Battery Waste Management System (Sistema Integrado de Gestión de Residuos de Pilas y Acumuladores); or (c) establish a deposit-and-return system. (Art. 5) Regardless of the option chosen, approval of the Secretariat of Environment and Sustainable Development (Secretaría de Ambiente y Desarrollo Sustentable) would be required. (Arts. 6-8) The Bill would also set standards for battery collection, treatment, recycling, and disposal (Arts. 9-10), impose labeling requirements (Art. 15), and require equipment manufacturers to make battery removal easy (Art. 16). Under the Bill, as under current Argentine law, used batteries would be deemed hazardous by definition, and thereby subject to Argentina’s extensive restrictions on transport, storage and handling of hazardous wastes. (Art. 3)

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