DGS Health Law Blog

OIG Allows for Cost Sharing Arrangement between Ambulance Providers and Municipal Dispatch

Lisa Edwards — Tue, 01 May 2012 09:43:16 -0700

Recently the OIG issued an advisory opinion in favor of a municipal fire department’s plan to share costs for dispatch-related EMS services with local hospitals’ ambulance providers. OIG explained that this arrangement did not warrant administrative sanctions, although it nonetheless has the potential to generate prohibited remuneration under the Anti-Kickback Statute if the requisite intent to induce referrals was present.

The city’s fire department administers the emergency medical services (“EMS”) component of the 911 dispatch system, including assisting with decisions on critical care for patients and ambulance transport destinations (the “Services”). Historically, the fire department was responsible for all of the costs associated with the Services. However, under the proposed arrangement, the local hospitals would bear a portion of the costs for personnel to administer the dispatch system. Specifically, the fire department would use data from the previous year on the costs for the Services and the number of scheduled tours to each hospital to determine each hospital’s pro rata share of the costs for the coming year.

The proposed arrangement implicates the Anti-Kickback Statute because it requires the hospitals—each potential referral recipients from the dispatch service—to pay a portion of the costs for the dispatch as a condition for providing EMS services in the city, some of which are reimbursable by Medicare and Medicaid. OIG concluded, however, that a number of factors helped to mitigate the risk of fraud and abuse.

First, OIG explained that the sharing of costs was part of a comprehensive scheme by the city to manage EMS services and that the arrangement would ensure that municipalities were flexible enough to organize local EMS systems efficiently and economically. Second, OIG determined that the arrangement would ensure that hospitals paid a proportionate share of the costs and therefore the hospitals would not be overpaying their referral sources. Third, the amount due from a particular hospital would not be tied, directly or indirectly, to the volume or value of referrals it received because the costs would be pro-rata based on the number of scheduled tours. Fourth, OIG found that the arrangement did not increase the risk of overutilization of services because it was limited to EMS and would not change the existing dispatch procedures. Finally, the arrangement would not have an adverse impact on competition because it would permit all hospitals in the area to participate in the dispatch system.

Notably, OIG emphasized that it might have found the arrangement improper if the hospitals were paying the city or fire department anything not directly related to the provision of EMS, such as free or reduced cost equipment.

Let the Audits Begin . . .

Erin McAlpin Eiselein — Thu, 10 Nov 2011 15:45:35 -0700

Following the mandate set forth in HITECH, OCR has just announced that it's piloting a HIPAA compliance audit program beginning this month in order to assess HIPAA compliance efforts. During this pilot phase, which is expected to last through December 2012, OCR will audit up to 150 covered entities from "as wide a range of types and sizes of covered entities as possible." At least for now, Business Associates will not be included in the pilot program. OCR has engaged KPMG LLP to conduct the audits, and has made public a sample initial notification letter.

Each audit will include a request for documents and information, a site visit, and a draft audit report. Covered entities will have the ability to comment on the auditor's report before its finalized. While OCR states that it primarily will be using the audit reports to help develop technical assistance and evaluate the efficacy of corrective action plans, OCR is retaining the right to initiate a compliance review to evaluate any serious compliance issues uncovered during this process. At the conclusion of the pilot program, OCR will "broadly share best practices gleaned through the audit process and guidance targeted to observed compliance challenges." What happens after the pilot program, however, remains to be seen.

Supreme Court Sides with Pharma on Prescription Data Mining

Lisa Edwards — Thu, 25 Aug 2011 16:27:00 -0700

The U.S. Supreme Court recently struck down a Vermont law restricting data mining of medical prescription information in Sorrell v. IMS Health. Although the Court ruled on this issue in June, it is an important opinion with widespread impact, and as this blog has addressed lower courts’ opinions on this issue in the past, it is notable that this question is now resolved.

The ruling, based on free speech grounds, allows pharmaceutical companies to purchase prescribing data and use that data to tailor marketing efforts to physicians. This data is commonly collected by pharmacies and sold to prescription drug intermediaries (“PDIs”), who then sell the information to prescription drug companies. The data generally contains information regarding the prescribing doctor and the medication itself and does not contain identifiable patient information.

The Vermont law directly prohibited the sale, licensing, or exchange of prescription data, and the state legislature advanced three objectives in passing the law: curtailing overprescription of drugs, controlling healthcare costs, and protecting physician privacy. The majority opinion by Justice Kennedy established that the law contained both a “content- and speaker-based restriction” on speech, which required the Court to apply “heightened judicial scrutiny” to assess its validity. Under this assessment, the Court rejected each of Vermont’s policy justifications and found the law unconstitutional because it was not narrowly tailored to these policies.

Of note, the Court’s use of “heightened” scrutiny is somewhat ambiguous under free speech precedent. Typically, commercial speech is evaluated under an “intermediate scrutiny” test established in Central Hudson; however, “heightened” scrutiny has also been loosely used as a synonym for “strict scrutiny,” which requires a tighter correlation between the regulated speech and the government’s objectives.

Critics of the opinion argue that state regulators will have “less latitude to make policy decisions” regarding healthcare data and that courts now have broad discretion to invalidate commercial regulations based on the effects on free speech. However, there may still be hope for existing and future data mining statutes, particularly if the restrictions specifically target important interests, such as patient privacy, and do not single out certain types of buyers and sellers of data. For example, a Maine data mining statute similar to Vermont’s is only triggered when a physician elects to opt-out of submitting prescriber data, thus making the law’s restrictions much narrower. A number of state statutes are currently pending review in light of the Court’s opinion in Sorrell.

To read the Court's opinion, click here.

Be Smart About Using Your Smart Phone in Practice: Understand and Manage the Risks Involved in Using Smart Phones and Tablets in Medical Practice

Jenna Butler — Tue, 19 Jul 2011 13:21:36 -0700

Thousands of people lose or have their smart phones and other portable devices stolen every day. While most people worry only about the irritation of replacing their phone in such a situation, when a health care professional loses a portable device containing patient information, the irritation of replacing the phone is the least of their worries. With the government handing out million dollar plus penalties for the mistreatment of patient information, now is the time to ensure your practice is best positioned to deal with the inevitable loss of a smart phone.

To view the presentation slides from speakers Erin McAlpin Eiselein, Partner at Davis Graham & Stubbs LLP, and Dr. Marion Jenkins, CEO of QSE Technologies, which were presented last Thursday, July 14th, at a seminar and cover best practices for health care providers who use smart phones and tablets in their medical practice, please click here. Learn how to minimize risk and avoid potential liability under the federal and state privacy and security laws so that the loss of a phone does not turn into the loss of your practice.

Improper Release of PHI Draws Criminal Indictment

Erin McAlpin Eiselein — Tue, 28 Jun 2011 15:10:46 -0700

A physician in Virginia has been criminally indicted and charged with three counts of violating HIPAA in connection with release of protected health information ("PHI") to a patient's employer. This criminal charge is unique in that it does not allege that the physician released the PHI for personal gain. Instead, the charges are based on the fact that improper release was made "under the false pretenses that the disclosure of said information was necessary . . . . " Specifically, the physician knew that the patient was not a serious and imminent threat to the safety of the public, but used that as a basis upon which to release the PHI to the patient's employer.

This indictment demonstrates that the government will pursue criminal charges if it disagrees with a health care provider's rationale for releasing PHI. Health care providers should continue to carefully adhere to their HIPAA privacy policies when releasing any PHI, and consult with legal counsel in the event that they are unsure whether a release of PHI is permitted under HIPAA.

OIG Posts Health Care Compliance Training Videos

Lisa Edwards — Tue, 07 Jun 2011 15:27:22 -0700

OIG recently posted a video of its Healthcare Fraud Prevention and Enforcement Action Team ("HEAT") training in Washington, D.C. on health care compliance and fraud prevention. The training provides guidance to health care providers, compliance officers, and their legal counsel regarding health care fraud and abuse requirements and the fundamentals of compliance programs, as well as tips on navigating CMS when facing compliance issues and the government's various health care fraud enforcement initiatives.

Vermont Moves One Step to Closer to a Single-Payer System

Erin McAlpin Eiselein — Thu, 26 May 2011 12:58:28 -0700

All eyes turned to Vermont today as Governor Peter Schumlin signed into law a bill creating a board to oversee the planning and development of a state-sponsored insurance plan, Green Mountain Care. With the stroke of a pen, Vermont became the first state to move significantly toward a single-payer insurance system. One hurdle standing in Vermont's way is the need to secure a waiver from PPACA, which won't be available until 2017 under current law. Although there appears to be support for moving that deadline up to 2014, it remains to be seen how strong that support really is.

Colorado Chosen by CMS to Develop Dual Eligible Integrated Care Model

Lisa Edwards — Mon, 02 May 2011 12:14:54 -0700

The new CMS Innovation Center, in cooperation with the Federal Coordinated Health Care Office, announced recently that it is partnering with fifteen states across the U.S. in an effort to design new approaches to better coordinate care for dual eligibile patients (i.e., those patients eligible for both Medicare and Medicaid).

Colorado and fourteen other states were each awarded up to $1 million to develop a model describing how the state would structure a patient-centered approach to coordinate care across primary, acute, behavioral health, and long-term supports and services for dual eligible individuals. This initiative is funded by the Affordable Care Act.

CMS has explained that the goal of this demonstration program is to identify delivery system and payment coordination models that eliminate duplication of services, expand access to care, and lower costs for dual eligibles. After federal review of the proposals, CMS will work with states to implement the plans that hold the most promise, eventually testing them and replicating them in other states.

For more information on this new initiative, see the CMS Innovation Center's announcement or CMS's website and press release.

Supreme Court Hears Pharma Data-Mining Dispute

Lisa Edwards — Mon, 25 Apr 2011 13:18:25 -0700

Tomorrow the United States Supreme Court will hear oral arguments regarding states' authority to limit uses by pharmaceutical companies of physician prescription records for marketing. We discussed this issue in November on a blog post when the Vermont data-mining restrictions were found unconstitutional as a violation of free speech. For more on this battle headed to the Supreme Court, see this article in the New York Times.

Proposed Regs for ACOs Leave Many Questions Unanswered

Lisa Edwards — Tue, 12 Apr 2011 16:19:29 -0700

On March 31, 2011 the Centers for Medicare & Medicaid Services (“CMS”) released the much-anticipated proposed regulations for the creation of Accountable Care Organizations (“ACOs”), which were published in the Federal Register on April 7. ACOs are a key component of the Patient Protection and Affordable Care Act (“PPACA”) and are referenced in PPACA as part of the Medicare Shared Savings Program. Section 3022 of the Patient Protection and Affordable Care Act, Pub. L. 111-148 (Mar. 23, 2010), codified at 42 U.S.C. 1395jjj. Following the launch of the ACO program on January 1, 2012, CMS expects 5 million Medicare beneficiaries to eventually receive care through an ACO.

ACOs are coordinated healthcare delivery systems in which provider reimbursements are tied to quality measures and overall reductions in the cost of healthcare. In theory, ACOs will be able to maximize value by using a patient-centered team approach to care. In the ACO model, providers regularly communicate and collaborate on various aspects of patient care, ensuring continuity and consistency in care delivery. This approach stands in stark contrast to many current delivery models in which providers operate in silos, often creating disjointed or uncoordinated patient care.

Structurally, an ACO will consist of a group of healthcare providers – physicians, physician groups, hospitals, and other suppliers of health services or provisions – contracting with each other and with CMS to provide comprehensive care for patients. While providers will still receive Medicare fee-for-service payments, the ACO will share in any savings it achieves for the Medicare program. At the same time, however, ACOs would be liable for any losses to Medicare. This “blended” reimbursement model eliminates incentives for overutilization inherent in a traditional fee-for-service system, yet also disincentivizes underutilization because some fee-for-service reimbursement remains.

What did the proposed regulations establish?

Broadly, the proposed regulations establish the ground rules for ACOs, although there are still many unknowns. Once formed, ACOs are subject to CMS approval and will be required to enter into a three-year contract. Among the many threshold requirements set forth are the following: each ACO must have at least 5,000 Medicare beneficiaries; ACOs must agree to datasharing provisions with CMS; and ACOs must have 50 percent of their primary care physicians using Electronic Health Records in compliance with the HITECH Act. ACOs must also have systems in place to track 65 quality metrics across five domains: patient care experience, care coordination, patient safety, preventative health, and at-risk population health.

In exchange for an ACO’s commitment to these provisions, the ACO can select one of two reimbursement “tracks.” In Track 1, the ACO will share in savings only for the first and second year of their CMS contract; in the third year, the ACO will share in both savings and losses. In Track 2, the ACO will share in savings and losses for the duration of the contract. For ACOs in either track, in order for savings to accrue, the ACO must achieve between 2.0 and 3.9 percent savings below the CMS-established benchmark. Each ACO’s precise savings target will be established by CMS on a sliding scale related to ACO size.

What is still to-be-determined?

Although the proposed regulations answer many questions regarding ACOs, there is still a significant amount of uncertainty regarding their functionality. In particular, stakeholders are anxious about how ACO provisions will work in the context of tax law, anti-trust law, Stark Law, the Anti-Kickback Statute (“AKS”), and other fraud and abuse law.

Thus far, CMS has proposed several waivers, exceptions, and safe harbors to deal with the panoply of healthcare laws implicated by ACO formation, financial arrangements, and reimbursement schemes. Although CMS acknowledges that to-date “no clear consensus has emerged on the scope of the waivers necessary to carry out the Medicare Shared Savings Program,” CMS has proposed to waive application of Stark and AKS insofar as the law applies to disbursements and distribution of shared savings within the ACO membership and the arrangement is otherwise compliant with the law or falls within an existing exception. CMS is actively seeking comment in regarding other types of waivers not yet contemplated in the proposed regulations. Specifically, CMS is interested in public perspectives on waivers that may be necessary to achieve compliance in the formation of an ACO, in pursuit of the ongoing goals of the ACO, in contracting with outside entities, and in distributing payments received from private payers.

To further inform public comment and the final regulations, CMS has engaged the Department of Justice (“DOJ”), the Federal Trade Commission (“FTC”), and the Internal Revenue Service (“IRS”) to issue guidance regarding their respective areas of enforcement. Although additional information is forthcoming, the DOJ and FTC have issued a joint statement addressing proposed anti-trust enforcement measures, and the IRS has released a notice regarding implications of the tax code for ACOs.

Conclusion

ACOs have the potential to transform healthcare delivery, and they are a key component in the federal government’s renewed focus on quality of care. However, in order for ACOs to achieve their potential, CMS must ensure ACO implementation is consistent with the policies and objectives of other laws targeting the healthcare industry. Absent increased predictability and certainty regarding application of these laws in the ACO context, healthcare providers and entities will be reluctant to engage in ACO transactions.

Letters Deceptively Solicit High Fees For State Filing

Lisa Edwards — Fri, 08 Apr 2011 15:31:37 -0700

Over the past few weeks, Nevada-based Corporate Controllers Unit, Inc. ("CCU") has been engaged in a mail solicitation scam regarding Colorado Secretary of State filing fees. CCU has sent thousands of letters to Colorado addresses, each of which claims a $225.00 "annual fee" is due for filing a company's periodic report with the state. The letter has generated confusion among business owners because it looks like an official government document. Its reliability is bolstered by citations to Colorado law, intimidating terms such as "noncompliant" and "delinquent," and a logo resembling a government seal. Despite these misleading apparent marks of credibility, CCU has no authority to solicit fees on behalf of any government agency.

Colorado Secretary of State Scott Gessler issued a warning Monday regarding CCU's deceptive mail solicitations. Secretary Gessler reminded business owners that although the state does require most entities to file periodic reports annually, the cost for most businesses is only $10.00. You can find additional information on this issue at the Colorado Secretary of State's website.

OCR Strikes Again: Mass General Pays $1 Million to Settle HIPAA Violations

Lisa Edwards — Thu, 24 Feb 2011 14:41:17 -0700

On the heels of the Cignet Health civil monetary penalty for $4.3 million only two days ago, the OCR has announced today that Mass General, one of the country's oldest and largest hospitals, has agreed to pay HHS $1 million to settle potential HIPAA violations. The incident leading to this settlement involved an employee who brought documents on the subway with her, as she intended to work on them at home. Unfortunately for Mass General, those documents contained PHI of 192 individuals and the employee accidentallty left the documents on the subway. In addition to the million dollar payment, Mass General also agreed to enter into a Corrective Action Plan, which requires the hospital to develop additional privacy policies and procedures, ensure that employees complete additional HIPAA training, and provide HHS with semi-annual reports for the next three years. The settlement agreement and Corrective Action Plan are available here.

It's a First - HIPAA Violation Costs Cignet Health $4.3 million

Erin McAlpin Eiselein — Tue, 22 Feb 2011 21:29:50 -0700

HHS imposed the first civil monetary penalty for a HIPAA violation against Cignet Health. The $4.3 million penalty arose from Cignet's failure to allow 41 patients access to their medical records. It was then exacerbated by Cignet's refusal to cooperate with the OCR's investigation. Cignet's willful neglect of its obligation to cooperate with the government investigation ultimately cost it $3 million on top of the $1.3 CMP imposed for the underlying access violation. Lest there be any lingering doubt, ignoring a government investigation won't make it go away!

Nationwide Medicare Fraud Busts

Lisa Edwards — Fri, 18 Feb 2011 08:54:59 -0700

As we have noted over and over again in previous posts, the federal government has significantly ramped up its Medicare fraud and abuse enforcement. This time the crackdown on false billing schemes was staggering. Yesterday, in the largest single-day health care fraud bust in U.S. history, the Medicare Fraud Task Force charged and arrested 111 people--including physicians, nurses, and health care company executives-who allegedly swindled the federal government out of more than $225 million. These arrests took place in 9 major cities across the country. More specifically, the claims against these health care professionals were for fraudulent claims for services that were never provided, kickback arrangements, money laundering, and identity theft. More details available in the HHS/DOJ press release.

For most providers, these types of crackdowns are of little concern because they are targeting the most egregious and blatant fraud and abuse, and the overwhelming majority of providers are not involved in such schemes. Events like this, however, should serve as a reminder to even the most cautious and upstanding providers that the federal government has become increasingly serious about health care fraud and abuse enforcement. Between these enforcement efforts and increased auditing of providers through RAC audits, providers that remain vigilant will have a certain advantage over those that are not.

Mobile Health

Wallis S. Stromberg — Tue, 08 Feb 2011 10:51:34 -0700

Here is an interesting article about the use of mobile telephone technologies in the future delivery of health care services.

OIG Unveils Most Wanted List

Erin McAlpin Eiselein — Sun, 06 Feb 2011 21:40:10 -0700

Showing a continued resolve to combat health care fraud and abuse, the Office of Inspector General (OIG) has launched a Most Wanted Fugitives List. In an effort to engage the public in fighting health care fraud and abuse, the list identifies more than 170 individuals alleged to have committed health care fraud-related crimes. According to the OIG's press release, the top ten individuals on this list have cost taxpayers over $124 million. This announcement comes on the heels of the January 24, 2011 joint announcement by the U.S. Departments of Justice and Health and Human Services that the federal government recovered more than $4 billion taxpayer dollars in fiscal year 2010 from it's health care fraud prevention and enforcement efforts. If the OIG's plan works and the public pitches in on the enforcement front as a result of the Most Wanted Fugitives List, 2011 could be another very busy year for the federal government's health care fraud and abuse team.

Florida Court finds PPACA to be unconstitutional

Wallis S. Stromberg — Mon, 31 Jan 2011 15:57:49 -0700

In a 78 page opinion issued today by the U.S. District Court in Florida,the Patient Protection and Affordable Care Act was found to be unconstitutional. The lawsuit was originally filed by the Florida State Attorney General immediately after PPACA became law, and 25 other state Governors or Attorneys General later joined as plaintiffs.

Judge Vinson, who ruled in the case, made it clear at the outset that this decision was not about health care or the health care system, but was really a case about federalism and the limitations on the powers of the federal government under the Constitution. The opinion contains a detailed review of the history of the Supreme Court's interpretations of the Commerce Clause of the Constitution, and then applies that foundation to the question of whether or not the statute's mandate for individuals to purchase health insurance is a permissible exercise of Congressional power. After lengthy analysis, Judge Vinson determined that it was beyond the scope of the commerce clause, as it was an attempt to regulate what was effectively individual "inactivity", that is to say a decision by an individual not to participate in commerce, rather than an "activity" related to interstate commerce. The Court wisely recognized that ultimately this is an issue that the Supreme Court must decide. The discussion of this question is, for someone with an interest in politics or the law, really quite fascinating.

After deciding that the section of PPACA mandating the purchase of insurance was unconstitutional, the Judge then looked at whether that section could be removed from the statute and still have the remaining provisions stand (the legal question of "severability"). After recognizing that a court's determination on severability requires an analysis of the purpose of the law and the Congressional intent as to the inclusion of the objectionable provision, Judge Vinson concluded that Congress would not have passed PPACA as written if it did not contain the individual mandate proovision. Therefore, as a result of the essential individual mandate being unconstitutional, the entire health reform law must also be found to be void. This is this first judicial opinion that found the unconstitutionality of the mandate invalidated the entire PPACA.

So what happens now? There have been four District Courts that have ruled in cases on PPACA so far, two upholding the individual mandate and two finding it to be beyond Congress's Constitutional powers. The Florida opinion is, in my opinion, the most complete legal analysis of the question out of these four. Other cases are still pending, so there may be more rulings yet to come. From the District Court level, cases move the the federal Circuit Courts of Appeal and from there to the Supreme Court. How long the process will take to be completed is uncertain, but it is likely that the Supreme Court could hear the matter in 2012.

Government Intensifies Health Care Fraud Enforcement Efforts

Lisa Edwards — Tue, 25 Jan 2011 09:15:16 -0700

Health care fraud and abuse enforcement is always on our minds and our clients' minds, but yesterday HHS and DOJ gave health care providers even more to consider when evaluating their own fraud and abuse compliance efforts.

HHS and DOJ announced the highest annual recovery amount ever from health care providers as a result of the federal government's fraud and abuse enforcement efforts. According to the annual Health Care Fraud and Abuse Control Program ("HCFAC") report released yesterday, the government’s health care fraud prevention and enforcement efforts recovered a staggering $4 billion from health care providers in fiscal year 2010.

This year's $4 billion recovery amount is up 50% from 2009. To further put this $4 billion into context, the HCFAC has returned $18 billion total to the Medicare Trust Fund since its inception in 1997. This increased recovery is due, at least in part, to the recently employed enforcement teams such as the Health Care Fraud Prevention & Enforcement Action Team ("HEAT") and the Medicare Fraud Strike Force. In addition to these criminal enforcement recoveries, the government also obtained more than $2.5 billion in civil health care matters brought under the False Claims Act, which is the largest in the history of the DOJ.

HHS also announced yesterday new rules authorized by PPACA (or the Affordable Care Act) that will further intensify the government's efforts to fight fraud, waste and abuse in Medicare and Medicaid. Not only does PPACA provide an additional $350 million for HCFAC activities, but the rules include new provider screening and enfocement measures and gives the government the authority to suspend payments to providers when credible allegations of fraud are being investigated. These provisions--particularly the suspension of payment during investigations--are likely to have a significant impact on providers in the coming years. These regulations take effect March 25, 2011.

Although these recovery amounts seem high compared to previous years, health care providers should expect that recoveries may increase even further in coming years with the government's sharpened focus on health care fraud and abuse.

DGS Health Law Blog Named a Top 50 Healthcare Industry Blog

Sara Kraeski — Thu, 13 Jan 2011 14:40:29 -0700

If you are a blogger, you know that maintaining rich, informative, relevant and timely blog content is a labor of love. That's why I'm so pleased to see that the DGS Health Law Blog has been named as one of the Top 50 Healthcare Industry Blogs by Health Nation. You can click here to see the full Health Nation article. Congratulations John, Barbara, Wally, Erin & Lisa!

OIG Collects $26 Billion in Health Care Fraud Recoveries and Savings

Lisa Edwards — Tue, 21 Dec 2010 14:20:07 -0700

The Department of Health & Human Services ("HHS") Office of Inspector General ("OIG") recently reported in its Semiannual Report that for fiscal year ("FY") 2010 it expected recoveries and savings of approximately $25.9 billion, which includes $3.8 billion in investigative receivables and $1.1 billion in audit receivables. The other $21 billion included in the total amount includes various cost-saving actions supported by OIG's recommendations in audits and evaluations. The FY 2010 expected recoveries and savings were more than FY 2009, when OIG reported savings and expected recoveries of $21 billion.

In addition, OIG reported exclusions of 3,340 individuals and entities from participation in Medicare or other federal health care programs in the 2010 fiscal year. OIG initiated 647 criminal lawsuits and 378 civil lawsuits against individuals and entities for violations of health care laws and regulations.

OIG focused particularly in the Semiannual Report on the successes of its Medicare Fraud Strike Force teams, which coordinate with federal, state, and local law enforcement to investigate health care fraud. The Strike Force participated in an unprecedented takedown in seven cities that resulted in charges against 94 doctors, health care company owners, executives, and others for more than $251 million in alleged false billing.

Another highlight of fraud enforcement in FY 2010 was the $520 million that AstraZeneca agreed to pay the government to settle alleged false claims violations for kickbacks it allegedly offered to doctors in connection with unapproved uses of AstraZeneca's drug Seroquel.