Category: Health Care Law

Update on Government Shutdown's Impact on Trade

Katten Muchin

The ongoing federal government shutdown is impacting a wide variety of import and export trade activities. While the situation remains fluid as each agency executes its contingency plans, below is a summary of the current impact on trade.

Customs and Border Protection (CBP): The majority of CBP employees are exempt from the furlough as being deemed essential to the country’s security. Most of those exemptions are related to the agency’s ongoing revenue collections. Currently, ports are maintaining their normal hours of service. CBP also seems to be accepting and processing protests, although with some delays. However, CBP appears to have stopped processing ruling requests or responding to any court documents due to the shutdown. Among the CBP personnel not exempted from furlough are technicians and program managers. As a result, certain additional CBP activities, such as bonds and licensing and processing FDA refusals, may also be impacted.

Food and Drug Administration (FDA): FDA continues to perform entry review and to address high-risk recalls, civil and criminal investigations, and other critical public health issues. However, FDA has furloughed personnel as well, resulting in entry review delays. The agency is giving priority to perishable entries, defined as merchandise expiring within 30 days, and to any lifesaving medical product. The agency has generally ceased routine establishment inspections, monitoring of imports, notification programs such as those involving food contact substances and import formula, and its laboratory research activities.

International Trade Commission (ITC): ITC has shut down its investigative activities, including antidumping and countervailing injury investigations and reviews, and intellectual property rights infringement investigations and ancillary proceedings. The schedules and deadlines for all investigative and pre-institution activities are being tolled and all hearings and conferences have been postponed. In addition, ITC’s website is down, so information such as the online Harmonized Tariff Schedule is not available.

International Trade Administration (ITA): ITA’s website—including the online steel licensing system—is down. The agency recommends sending an email to steel.license@trade.gov for manual processing of license requests for shipments that do not have a steel license. Enforcement and Compliance (formerly, Import Administration) intends to uniformly toll all administrative deadlines related to the administration of US antidumping and countervailing duty laws for the duration of the shutdown. These include deadlines for preliminary and final determinations in antidumping and countervailing duty investigations and administrative reviews and deadlines for all actions by parties to these proceedings.

Bureau of Industry and Security (BIS): BIS is no longer accepting advisory opinion requests, classification requests (CCATS), encryption reviews, encryption registrations or export license applications. Similarly, BIS will not issue any final determinations. The SNAP-R application on BIS’s website is not available and will not reopen until the shutdown ends. All pending export license applications, commodity classification requests, encryption reviews, encryption registrations and advisory opinion requests will be held without action by BIS until the shutdown ends. Applicants may request emergency processing of export license applications for national security reasons.

Department of Agriculture (USDA): USDA’s website is down. The Animal and Plant Health Inspection Service (APHIS) is operating in the ports, but personnel will not be available for the renewal and authorization of notifications or permits.

Alcohol and Tobacco Tax and Trade Bureau (ATTTB): ATTTB has halted its regulatory functions, noncriminal investigative activities and audit functions. But it will ensure that all tax remittances are processed because these functions have been deemed necessary for safety and protection of property.

As Congress continues to debate the necessary appropriations to fund the government’s operations, the trade community should expect further impact on trade operations.

Article By:

of

Action Steps NOW To Comply With The Affordable Care Act

Womble Carlyle

Although the one-year delay in the effective date of the pay-or-play provisions of the Affordable Care Act (“ACA”) (until January 1, 2015) gives employer-sponsored health plans more time to prepare for those requirements, many ACA provisions will take effect on January 1, 2014. Employees are asking for information regarding these changes and the Department of Labor is already including ACA requirements in its benefit plan audits. The target keeps moving. Here is what you need to do NOW to ensure that your health plan is in compliance on January 1, 2014 and that you are prepared for what’s coming: 

  • Distribute the required Notice informing your employees about their coverage options by October 1, 2013 and to all new hires after October 1, 2013.
  • Determine if your plan will have “grandfathered” status in 2014.
  • Confirm that required plan design changes are in effect for 2014, including:
  • Elimination of annual limit on essential health benefits.
  • Elimination of pre-existing condition exclusions for new enrollees.
  • Limiting waiting period for enrollment to 90 days.
  • Elimination of restrictions related to participation in clinical trials (non-grandfathered plans only).
  • Conform cost-sharing provisions to ACA requirements (non-grandfathered plans only).
  • Provide coverage for ACA “essential benefit” categories (insured plans in individual and small group markets only).
  • Timely provide updated Summaries of Benefits & Coverage.
  • Develop strategies on how to use the rest of 2013 and 2014 to plan for ACA provisions that will go into effect in 2015, including (1) pay-or-play provisions, such as determination or confirmation of applicable larger-employer status and how to determine full-time employee status; and (2) reporting requirements.
  • Consider alternative options to continuing to provide health care coverage for your various categories of employees.
  • Implement cafeteria plan changes related to ACA and repeal of DOMA.
  • Bring wellness programs into compliance with ACA.
  • Prepare to pay ACA reinsurance fees (self-insured plans only).
  • Make sure you are complying with the final HIPAA rules concerning “protected health information” that went into effect on September 23, 2013.

The Government Shut Down and Its Impact on Public Health

MintzLogo2010_Black

In the early morning of October 1, 2013, the U.S. federal government officially went dark. The shutdown came in the aftermath of the Senate’s decisive vote to reject a House plan that would have kept the government funded for several more months but delayed implementation of key portions of the Affordable Care Act (ACA) for one year.

The impact of the shutdown will be felt across all healthcare sectors as many federal employees face furloughs of unknown duration. In particular, the Department of Health and Human Services (HHS) announced in its Contingency Staffing Plan that over half of its employees will be furloughed. HHS’s Plan is based upon federal guidance that allows agency programs to continue only if they either do not rely on annual appropriations, or they involve the safety of human life or the protection of property.[1] According to HHS, the following programs and services will continue:

  • Funding for Medicaid and the Child Health Insurance Program will continue uninterrupted because funding has already been set aside for these programs.
  • Funding for Medicare will likewise continue uninterrupted but only in the short term. If the political impasse stretches beyond several weeks, the program could be disrupted by the reduction in HHS staff.
  • The Centers for Medicare & Medicaid Services (CMS) will continue to implement the ACA, “including coordination between Medicaid and the Marketplace, as well as insurance rate reviews, and assessment of a portion of insurance premiums that are used on medical services.”[2]
  • State and federal health insurance exchange programs will open as planned, though it is not clear how the information technology (IT) that underpins the exchanges will function since they are operated by government contractors.[3]
  • The National Institute of Health (NIH) will continue to provide patient care for current NIH Clinical Center[4] patients
  • The Food and Drug Administration (FDA) will be able to operate only for “vital activities” such as high risk recalls and other “critical public health issues.”
  • Substance Abuse and Mental Health Services Administration will continue programs such as the Suicide Prevention Lifeline using the balance of available grants.
  • Other programs supported through mandatory funding such as the Centers for Disease Control and Prevention (CDC) Global HIV/AIDS Program will continue.

However, several programs important to public health will be disrupted if a congressional compromise cannot soon be reached. For example:

  • Outside of matters related to “imminent threats to the safety of human life or protection of property,” CMS, FDA, NIH and other federal agencies will not publish regulations or other guidance during the shutdown.
  • CMS will not fund task forces that work to prevent healthcare fraud and abuse, and will scale back on Medicare provider audits.
  • The CDC seasonal influenza program, which tracks flu outbreaks and certain infectious diseases, will come to a halt.
  • No new patients will be admitted to the NIH Clinical Center. NIH-funded researchers may continue to work for as long as their money holds out but additional funds will not be released during the shutdown.
  • The FDA will not be able to support much of its food safety activities, such as routine inspections and public notification programs. The FDA’s laboratory research and some compliance and enforcement activities will be suspended.
  • No action will be taken on any grants related to medical research, improvement of the healthcare system, and monitoring of substance abuse programs.

Although providers can take comfort in the fact that Medicare and Medicaid program reimbursement will proceed, a government shutdown for any period of time beyond three or four weeks could impede certain critical administrative functions, such as Medicare claims processing, and therefore impact their pocketbooks. Likewise, while substantial ACA implementation will continue, long term furloughs could affect certain components of the law (such as the exchanges) because they depend on government employees to help run the IT component, among other aspects of the program. Thus, the magnitude of the shutdown’s impact will depend on how long it endures.

*Copyright 2013, American Health Lawyers Association, Washington, DC. Reprint permission granted.

[1]/ Opinion of the Office of Legal Counsel, Department of Justice, Government Operations in the Event of a Lapse in Appropriations, 1995 WL 17216091 (Aug.16, 1995) at pp. 3-4: see also, Effect of Appropriations for Other Agencies and Branches on the Authority to Continue Department of Justice Functions During the Lapse in the Department’s Appropriations, 19 Op. O.L.C. 337, 1995 WL 917146 (Dec. 13, 1995).

[2]/ Contingency Staffing Plan, pp.2-3.

[3]/ CMS has not publicly stated whether the IT contracts are already issued and funded.

[4]/ The NIH Clinical Center is the agency’s research hospital.

Federal Government Shutdown

DrinkerBiddle

For the first time in 17 years, the federal government has officially shutdown.  Late last night, the Administration released a memo to all federal agencies advising them to execute their contingency plans (an agency-by-agency list is available here).

Yesterday the Senate passed a bill that would fund the government through November 15, 2013, but would make no changes to the Affordable Care Act (ACA).  (More information on the Senate vote is available here.)  Last night, by a vote of 228-201, the House passed legislation that would keep the government open through December 15, 2013, but would delay the ACA’s individual mandate requirement and would eliminate health insurance subsidies for Members of Congress, Congressional staff, the President, the Vice President, and political appointees.  By a vote of 54-46 the Senate voted to table, or kill, the legislation.

Following the latest Senate action, the House voted to formally request a conference committee with the Senate.  (Conference committees are joint House-Senate committees that are created to resolve disagreements between the House and Senate versions of a given bill.)  House Speaker Boehner (R-OH) appointed the following members to the conference committee:  House Majority Leader Cantor (R-VA-7), Ways and Means Chairman Camp (R-MI-4), House Budget Committee Chairman Ryan (R-WI-1), House Appropriations Chairman Rogers (R-KY-5), Representative Frelinghuysen (R-NJ-11), Representative Crenshaw (R-FL-4), Representative Carter (R-TX-31), and Representative Graves (R-GA-14).  House Democrats have not appointed conferees.  The Senate voted to table the request for conferees.

While the House and Senate cannot seem to agree on terms to fund the entire government, both chambers have passed H.R. 3210, legislation that would provide payment through the government shutdown for members of the Armed Forces (including reserve personnel) and civilian Department of Defense (DoD) employees and contractors whom the DoD Secretary determines are providing support to members of the Armed Forces.  The legislation passed the House by a unanimous vote, the Senate passed the bill by a voice vote, and was signed into law by President Obama last night.

At this point, both the House and the Senate appear at a stalemate.  Until Members of Congress can reach some agreement, the government shutdown will remain in place.  We will continue to update this blog as events unfold.

 of

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

vonBriesen

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.

Article By:

 of

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

tz logo 2

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.

 of

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

Michael Best Logo

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.

Article By:

 of

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

DrinkerBiddle

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.

Article By:

 of

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

NAWL_logo-logotype_CMYK

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.

Article By:

 of

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

Dickinson Wright Logo

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.

Article By:

 of