Overview and Analysis of the Proposed Federal Sunshine Regulations

On December 19, 2011, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule (the “Proposed Rule”) related to section 6002 of the Affordable Care Act, commonly referred to as the “Physician Payment Sunshine Act.” The Physician Payment Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare, Medicaid, or CHIP to report annually to the Secretary of the Department of Health and Human Services (“Secretary”) certain payments or other transfers of value to physicians and teaching hospitals. Additionally, applicable manufacturers and applicable group purchasing organizations (“GPOs”) must report certain information regarding the ownership or investment interests in them that are held by physicians or their immediate family members.

To learn more about this development regarding the Physician Payment Sunshine Act, please see the full post written by Elizabeth B. Carder-Thompson, Katie C. Pawlitz, Nancy E. Bonifant and Debra A. McCurdy on Reed Smith’s Health Industry Washington Watch blog.

OCR Launches Privacy and Security Audits

This post was written by Brad M. Rostolsky and Nancy E. Bonifant.

To implement the HITECH Act’s mandate for the Office for Civil Rights (OCR) to perform HIPAA audits, OCR has just announced that it is piloting a program to perform up to 150 audits of covered entities to assess privacy and security compliance. Audits conducted during the pilot phase are planned to begin with an initial 20 audits between November 2011 and April 2012. The remaining audits are scheduled to conclude by December 2012. All covered entities and business associates are eligible for audits; however, OCR has indicated that it is focusing on covered entities (range in type and size) in the initial phase. Business associates will be included in future audits.

During the pilot, every audit will include a document production and onsite visit, and will result in an audit report. OCR will notify a selected covered entity in writing and request documentation of the covered entity’s privacy and security compliance efforts. The covered entity must comply within 10 business days. OCR expects to notify selected covered entities between 30 and 90 days prior to the anticipated onsite visit. Onsite visits may take between three and 10 business days, and after fieldwork is completed, the auditor will provide the covered entity with a draft final report. Selected covered entities will then have 10 business days to review and provide written comments back to the auditor. The auditor will complete a final audit report within 30 business days after the covered entity’s response and submit it to OCR.

Should an audit report indicate a serious compliance issue, OCR may initiate a compliance review to address the problem. Significantly, OCR will not post a listing of audited entities or the findings of an individual audit that clearly identifies the audited entity.

A description of the pilot program is available at http://www.hhs.gov/ocr/privacy/hipaa/enforcement/audit/index.html

 

CMS and FDA Announce Parallel Review Pilot Program

This post was written by Susan Edwards, Elizabeth Carder-Thompson, Gail Daubert, Celeste Letourneau, and Debra McCurdy.

On Friday, October 7, 2011, the Centers for Medicare & Medicaid Services ("CMS") and the Food and Drug Administration ("FDA") (collectively, the "Agencies") announced they were soliciting nominations from sponsors of medical devices to participate in the Agencies’ parallel review pilot program. The Agencies officially published a Federal Register notice announcing the program October 11, 2011 (the "Notice"), with an effective date of November 10, 2011, although the Agencies began accepting nomination submissions October 7.

To read the full alert, which summarizes the Notice and discusses potential implications for manufacturers that may be considering participation in the pilot program, click here.

Prospects Unclear for CMS/FDA Proposed Parallel Review of Medical Products

This post was written by Susan A. Edwards, Elizabeth B. Carder-Thompson, Gail L. Daubert and Celeste A. Letourneau.

Notably absent from last month’s Department of Health and Human Services Semiannual Regulatory Agenda was any indication of where the Centers for Medicare and Medicaid Services ("CMS") and the Food and Drug Administration ("FDA") stand with respect to their notice with request for comments, issued last fall, on the proposed parallel review process for medical products. While CMS and FDA officials confirmed that they are currently reviewing comments submitted during the review period, they declined to speculate on when they intend to act. The comments submitted, however, provide insight into industry views on this important issue, including widespread discontent with the approval mechanisms currently available. We have undertaken a review of all of the comments submitted and extracted the eight main concerns cited in the following analysis.

Senate Finance Committee Report Inquires into Physician-Owned Distributors

This post was written by Joseph W. Metro, Gina M. Cavalier and Jouya Rastegar.

On June 9, 2011, Senator Orrin Hatch released a report by the Senate Finance Committee Minority Staff that outlines key concerns about Physician-Owned Distributors (“PODs”), specifically regarding the lack of regulatory oversight and clear guidance from the Department of Health and Human Services Office of Inspector General (“OIG”). The Committee Minority’s report, Physician Owned Distributors (PODs): An Overview of Key Issues and Potential Areas for Congressional Oversight, set forth findings of committee staff who spoke to over fifty people and reviewed thousands of pages of documents. In addition to the report, the Chairman and Ranking Members of the Senate Financial Committee, Special Committee on Aging, and Judiciary Committee sent letters on the same day to the Administrator for Centers for Medicare & Medicaid Services (“CMS”)and the Inspector General of Health and Human Services (“HHS”) requesting further inquiry into the concerns set out in the Senator Hatch’s report.

The crux of the Committee’s concern with PODs is the potential for fraud and abuse the Committee believes to be inherently found in PODs. Historically, implantable medical devices (these are what the report focuses on) have been sold to hospitals and surgery centers directly from the device manufacturers or through independent distributors. More recently, PODs have come into existence to buy the devices from manufacturers and sell them to hospitals or surgery centers. PODs are mostly comprised of small groups of physicians who create companies to distribute, and in some cases manufacture, medical devices for implantation in surgeries. The large majority of products sold by PODs are sold to hospitals where their own physician investors practice. This is where the concern stems from—physicians’ potential ability to profit through distribution markups on products they are selling through the PODs in which they are owners or investors, particularly where the PODs likewise solicit discounts from manufacturers based on preferred positioning or other “captive” volume.

The report: (1) explains the history of PODs and their business models; (2) describes the concerns for fraud and abuse; (3) highlights the regulatory environment in which they exist; and (4) concludes by outlining what the should happen to address concerns. The nature of PODs creates financial incentives for physician owners to use devices that yield personal financial return, which may implicate the federal anti-kickback statute’s prohibition on inducements to purchase or order items covered under federal health care programs. The report listed anecdotal and evidence-based reasons for concern, such as instances of surgeons performing eight to ten procedures on elderly patients despite the serious health risks, stories of surgeons redoing previous surgeries to use their own POD products, an analysis from the Quality Implant Coalition, a coalition of manufacturers of implantable medical devices, which showed claims data from one hospital indicating a 300 percent increase in spinal fusion surgery after a spinal product POD moved into the hospital’s area, and an April 2010 Journal of the American Medical Association study that found a fifteen-fold increase in the number of spinal fusion surgeries for Medicare patients from 2002-2007, the period during which PODs became a more prevalent business model. On the other hand, the report mentioned a paper written by a POD, which was presented at the American Association of Orthopedic Surgeons 2009 annual meeting, in which the POD asserted that its business model helped saved the hospital with which it was affiliated thirty-four percent over a two year-period—a total savings of over one million dollars.

The legal implications of the business of PODs have not been entirely clear because the regulatory environment in which they find themselves is murky. As highlighted in the Senate Finance Committee report, the OIG issued written guidance on the issue of PODs and expressed the need to carefully review and closely scrutinize these entities under fraud and abuse laws and its Special Fraud Alert relating to joint venture arrangements. Similarly, CMS has declined to regulate PODs under the Stark law. However, the Senate Finance Committee report indicated that there has been a lack of any recent or more specific guidance on this topic. Further the report noted that POD arrangements might implicate the Sunshine Act’s reporting requirements relating to manufacturer financial arrangements with physicians, for which HHS has not yet issued guidance.

The report, as well as the letters to the HHS Inspector General and CMS Administrator, call for several measures to address concerns: (1) further inquiring into and closely examining PODs and their current structures and activities; (2) providing additional regulatory guidance from OIG and/or Congress; (3) including the distribution model of PODs into CMS’ final definition of “applicable manufacturers,” in order to require PODs to fall under the Sunshine Act financial reporting requirements; (4) accounting for the POD business model when CMS promulgates the final Accountable Care Organization regulation to protect against abuses posed by PODs; and (5) developing recommendations for further actions.
 

HHS Issues Notice of Proposed Rulemaking Regarding the HIPAA Privacy Rules Standard for Accounting of Disclosures Requirements and Access Report

This post was written by Gina M. Cavalier and Brad M. Rostolsky.

Today the Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking implementing provisions of the HITECH Act related to accounting for disclosures of protected health information (PHI). Pursuant to the HITECH Act and its more general authority under HIPAA, HHS proposed to divide the Privacy Rule provisions related to an accounting into two separate individual rights: (1) an accounting and, (2) an access report.

With respect to an accounting, HHS proposes that individuals have a right to an accounting of disclosures of PHI in a designated record set made by a covered entity or a business associate: (i) for impermissible purposes, (ii) for public health activities, (iii) for judicial and administrative proceedings, (iv) for law enforcement purposes, (v) to avert a serious threat to health or safety, (vi) for military and veterans activities, and (vii) for workers compensation. The proposed compliance date for this provision is 180 days after the effective date of the final rule.

With respect to the access report, HHS proposes to provide individuals with the right to receive a report detailing who has accessed their electronic PHI in a designated record set maintained by a covered entity or its business associates. HHS proposes that covered entities and business associates provide individuals with a right to an access report beginning January 1, 2013, for electronic designated record set systems acquired after January 1, 2009, and beginning January 1, 2014 for electronic designated record set systems acquired as of January 1, 2009.

The proposed rule is posted here.

Comments are due in 60 days - August 1, 2011.

HHS Issues Notice of Proposed Rulemaking Regarding the HIPAA Privacy Rules Standard for Accounting of Disclosures Requirements

This post was written by Gina M. Cavalier, Vicky G. Gormanly and Brad M. Rostolsky.

Pursuant to the HITECH Act, covered entities and business associates must account for disclosures of PHI for treatment, payment and health care operations if the disclosures are through an electronic health record. This represents a significant change to the requirements under the current HIPAA Privacy Rule. The Department of Health and Human Services (HHS) will shortly publish a notice of proposed rulemaking to modify the Privacy Rule’s standard for accounting of disclosures of protected health information. An advance copy of the proposed rule is available here.

HHS proposes to expand the accounting requirements of the Privacy Rule to provide individuals with the right to receive an access report detailing who has accessed their electronic PHI in a designated record set. Accordingly, HHS proposes to revise an individual’s right to an accounting under the Privacy Rule by separately setting forth an individual’s right to (a) an accounting of disclosures and (2) an access report. HHS has also proposed other changes designed to improve the workability and effectiveness of the existing accounting of disclosures requirements.

 

Comments are due 60 days after the proposed rule is published in the Federal Register.

 

More to come...

HHS Announces First Ever Civil Money Penalty for Violations of HIPAA Privacy Rule

This post was written by Gina M. Cavalier.

Earlier today the Department of Health and Human Services' (HHS), Office for Civil Rights (OCR) announced the imposition of the first ever civil money penalty for violations of the HIPAA Privacy Rule. The penalty - which is $4.3 million - was assessed against Cignet Health of Prince Georges County, a health insurer. The underlying HIPAA violations include (1) failing to provide patients with access to their medical records, and (2) failing to cooperate with OCR's investigation into the failure to provide access. The HHS press release is available here.

To discuss this or any other HIPAA or data privacy/security issue, please contact Mark S. Melodia or Gina M. Cavalier.

New Jersey Seeks General Assistance Rebate Payments From Non-Participating Pharmaceutical Manufacturers

This post was written by Joseph W. Metro and  David E. Dopf .

The New Jersey Department of Human Services (“Department”) has sent letters to numerous pharmaceutical manufacturers demanding rebate payments under the Work First New Jersey General Public Assistance/Medicare Part D Wraparound Drug Rebate Program (“GA Rebate Program”). The Department is seeking to collect payments from manufacturers that have chosen not to participate in the GA Rebate Program and thus never entered into a GA Rebate Program agreement with the Department (“Rebate Agreement”). In addition, for some manufacturers that have entered into Rebate Agreements, the Department is now seeking payments for time periods prior to the effective dates of those Rebate Agreements.

The Department’s demand letters have uniformly provided the manufacturers with the option of requesting, within twenty (20) days from their receipt of the letter, either a pre-hearing conference for purposes of trying to resolve the payment dispute or a formal hearing before the New Jersey Office of Administrative Law (“OAL”). Manufacturers choosing to pursue a pre-hearing conference can still request a hearing before the OAL within twenty (20) days from the date of the pre-hearing conference if the dispute is not resolved.

We believe there are very strong arguments in support of the position that a manufacturer cannot be liable for payments under the GA Rebate Program in the absence of a Rebate Agreement covering the time period for which the payments relate. Please contact Joe Metro or David Dopf if you have any questions regarding the Department’s actions or would like assistance challenging the Department’s demand for payment.
 

Final HITECH Privacy and Security Rule Expected Soon

According to a senior health information technology and privacy specialist at HHS Office for Civil Right (OCR), regulations finalizing the July 14, 2010, proposed rule implementing many of the HITECH Act's privacy, security, and enforcement requirements could be published by the end of 2010 or in early 2011.   Additionally, OCR, developing a HITECH Act required "periodic audit" plan, which will be targeted to ensure that covered entities and business associates comply with the requirements of  the Privacy and Security Rules. 

We'll keep you posted as things progress . . .

Final Breach Notification Rule: HHS Back to the Drawing Board

The Department of Health and Human Services (HHS) has announced that its development of a Final Breach Notification Rule (currently, the rule is in interim final form) has been stalled, as the final rule was withdrawn from consideration of the Office of Management and Budget  in order for HHS to give further consideration to what the final rule should include.  HHS has remained relatively quiet regarding the development of a Final Breach Notification Rule, but has announced that it intends for a final rule to be published "in the coming months." 

New HITECH/HIPAA Proposed Rule Released Today

HHS has just released its proposed rule modifying the HIPAA Privacy, Security, and Enforcement Rules to implement the privacy, security, and certain enforcement provisions of subtitle D of the Health Information Technology for Economic and Clinical Health Act (Title XIII of the American Recovery and Reinvestment Act of 2009).  The advance version of the rule can be accessed here; the official version will be published July 14.  A press release should be available later this morning.

Pursuant to the announcement of the proposed rulemaking on the HHS Privacy website, the proposed modifications to the HIPAA Rules include provisions extending the applicability of certain of the Privacy and Security Rules’ requirements to the business associates of covered entities, establishing new limitations on the use and disclosure of protected health information for marketing and fundraising purposes, prohibiting the sale of protected health information, and expanding individuals’ rights to access their information and to obtain restrictions on certain disclosures of protected health information to health plans. In addition, the proposed rule adopts provisions designed to strengthen and expand HIPAA’s enforcement provisions.

Importantly, HHS has stated that the new HIPAA regulations will not be enforced until 180 days after the final rule has become effective. Comments will be due on or about September 13, 2010.

More to come . . . 

Reed Smith Health Care Reform Review: The Affordable Care Act - Analysis and Implications for DMEPOS Suppliers

This post was written by Debra A. McCurdy

In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act).  In this analysis, we concentrate on those provisions in the new law that will affect suppliers and manufacturers of durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS).

To read the full alert, click here.

Notes on the National Summit on Health Care Fraud

This post was written by Elizabeth Carder-Thompson.

Last week, in my capacity as president of the American Health Lawyers Association, I attended the first National Summit on Health Care Fraud, a joint undertaking by the U.S. Department of Health and Human Services and the U.S. Department of Justice. The conference brought together private sector leaders, law enforcement personnel, and health care experts as part of the Obama Administration’s coordinated effort to fight health care fraud. This was the first national gathering on health care fraud between law enforcement and the private and public sectors.

I.      Presentations and Trends

Leading the morning session, HHS Secretary Kathleen Sebelius vowed to “prevent, catch, and discourage fraudsters,” stating “Criminals – your days are numbered.” She promised an aggressive new fraud prevention focus, including enhanced Medicare Strike Force activities in a number of US cities, and continued coordinated, multi-agency initiatives under HEAT – the Health Care Fraud Prevention and Enforcement Action Team Secretary Sebelius also stated that, next week, the President’s budget likely will request an additional $1.7 billion in funding for fraud prevention and detection.

Attorney General Eric Holder disclosed that, in 2009, DOJ charged over 800 individuals in health care fraud cases, and obtained 580 convictions so far. DOJ also recovered billions of dollars in False Claims Act (qui tam) recoveries. He also promised that future fraud-busting efforts will include actively engaging the private sector (including Medicare beneficiaries recruited to serve on “Senior Medicare Patrols”), the insurance industry, and health care providers.

A panel comprised of representatives from CMS, FBI, OIG, DOJ, and others who have worked on what they call “the viral fraud cases in the Miami-Dade area” (i.e., spreading like a virus) told stories about the highly-aggressive and coordinated tactics and techniques they now employ. An Assistant United States Attorney who serves as the South Florida Health Fraud Coordinator, Luis Perez, said the days of prolonged subpoena productions, accountant analyses, extended research into cases, and deference to white collar defendants, are over: “We arrest everyone,” he said. His team of government agents and prosecutors seeks to bring the highest possible provable charges as offenses are committed, and then bring in additional evidence during the sentencing phase in order to seek upward adjustments under the Sentencing Guidelines to obtain maximum prison times.

The CEO of the Tufts Health Plan in Boston, James Roosevelt, highlighted anti-fraud tactics increasingly employed by private payers. For example, Tufts has hired Nick Messuri – formerly head of the Massachusetts Attorney General’s Medicaid Fraud Control Unit and a well-known, tough prosecutor in the state – as head of its antifraud group, which includes nine other attorneys. Tufts and other payers conduct their own clinical and other investigations relating to medical necessity, upcoding, miscoding, overutilization, outliers, illegal referrals, and more. Tufts currently has 128 open investigations, some of which are being conducted in cooperation with governmental entities to which it has made reports. 

II.      Investigative and Enforcement Predictions

During the afternoon, attendees were divided into discussion groups to consider such issues as effective law enforcement tactics, the role of states in fraud prevention, effective use of data, and more. A report on the break out-sessions will be published in the future, but some of the common themes I observed – and the future actions I predict – are as follows:

1) There will be heightened cooperation and more aggressive, coordinated enforcement in the public and private sectors to combat fraud, abuse, and waste. The main focus used to be Medicare fraud – now it is health care fraud across-the-board.

2) Increasingly, efforts will be directed at fraud and abuse prevention, and pre-payment scrutiny, rather than just focusing on “pay-and-chase” enforcement. CMS and private payers will be seeking to justify deviating from “prompt pay” requirements in the name of fraud and abuse prevention. A number of speakers commented that investment in health care fraud provides a multiple return – for DOJ, it was a $4 return for every dollar; for Tufts, a $7 return for every dollar; and for OIG, an $8 return for every dollar.

3) There will be increased attention paid to data coordination. Currently, Medicare, Medicaid, and private payers collect and maintain data in different ways, making utilization and other “pattern” comparisons difficult. This is going to change.

4) Governmental entities are directing their resources in a more data-driven and targeted way in order to identify fraudulent patterns. For example, they know that “fraudsters” who used to operate in Miami-Dade are moving up Route 95 into South Carolina and other states. Data shows that those who defrauded fee-for-service programs for a specific item or service, e.g., orthotics and diabetes supplies, are now moving to defraud Medicare Advantage plans. Providers sanctioned and excluded in one state are moving to another. Some of these schemes have worked in the past – but they will not in the future.

5) There will be greatly increased efforts to engage the general public – Medicare beneficiaries, their families, and others – in whistleblowing.

III.     What Does All of This Mean for the Future?

None of us committed to health care in America would countenance or want less than full punishment for “real” health care fraud. Unquestionably, many of the cases cited at the Summit fall in this category – billing for services not rendered, beneficiaries selling their Medicare numbers, false certifications by physicians for items of durable medical equipment, dental clinics pulling children’s teeth unnecessarily to obtain Medicaid payment, clinics billing for outmoded infusion therapy for HIV/AIDS patients, and more. I applaud aggressive and coordinated investigation and enforcement efforts to rid our system of these practices and their perpetrators, and the fraud-fighters in the government clearly are a very smart, very dedicated group 

I worry, however, that the zeal for health care fraud enforcement will inappropriately ensnare committed, compassionate health care providers, suppliers, and manufacturers. In our practice, we are increasingly seeing qui tam relators – whistleblowers – with dollar signs in their eyes, bringing questionable and even frivolous actions against their employers or former employers. We are seeing overburdened prosecutors taking years to make qui tam intervention decisions – while the relators continue to work and gather “data” at their employers’ places of business, to “support” their cases. 

I worry about Medicare contractors, eager to keep their contracts, trying a little too hard to prove to CMS that they are fraud-conscious. I have several supplier clients on 100% pre-pay Medicare review facing significant potential disallowances because a contractor decided for the first time to implement a technical Medicare manual provision about recording a specific date of service – when there is no question from the medical record that medically necessary, physician ordered, and readily documented services were in fact provided.

I worry about constitutional due process. One private insurance company representative at the Summit suggested that the government send announcements to all private payors when any qui tam cases are unsealed, so that the insurance companies can place “edits” on claims filed by the defendants, or at least pre-payment reviews – well before the case has been decided. I worry that the “arrest them all” enforcement mentality will harm the reputations and future livelihood of individuals not yet tried, who are later exonerated. 

There are no easy answers. At a minimum, though, in this rapidly-evolving investigative and enforcement environment, health care providers, suppliers, and manufacturers need to concentrate more than ever before on compliance. Moreover, their compliance efforts need to be real and not token ones, including comprehensive training, and internal auditing and monitoring with real consequences for employees and representatives falling short. The stakes are very high, and the so-called “radar screen” that companies used to joke about “flying under” now reaches all the way to the ground.

Reed Smith will continue to monitor developments with respect to health care fraud as the health care reform debate continues. In the interim, please contact Elizabeth Carder-Thompson in our Washington office if you have questions regarding this topic.

HHS Rule Implements HITECH Act Changes to HIPAA Enforcement

On Friday, October 30, 2009, the U.S. Department of Health and Human Services ("HHS") published an interim final rule and request for comments that implements certain HIPAA enforcement changes made pursuant to the HITECH ActConsistent with the provisions of the HITECH Act, the new rule amends the HIPAA enforcement regulations applicable to violations of each of HIPAA's Administrative Simplification Rules (i.e., Privacy Rule, Security Rule, Transactions and Code Sets Rules, Standard Unique Identifier for Employers (EIN Rule), and the Standard Unique identifier for Health Care Providers (NPI Rule)) by instituting the below categories of violations and tiered penalty scheme to HIPAA violations that occur on or after February 18, 2009. 

  • Unknown violations (i.e., if a person did not know and by exercising reasonable due diligence would not have known that a violation occurred): The penalty shall be at least $100 for each violation not to exceed $25,000 for all such identical violations during a calendar year, but may be no more than $50,000 for each violation not to exceed $1.5 million for all such violations of an identical requirement or prohibition during a calendar year.
  • Violations due to reasonable cause and not to willful neglect: The penalty shall be at least $1,000 for each violation not to exceed $100,000 for all such identical violations during a calendar year, but may be no more than $50,000 for each violation not to exceed $1.5 million for all such violations of an identical requirement or prohibition during a calendar year.
  • Violations due to willful neglect (and the violations have been corrected): The penalty shall be at least $10,000 for each violation not to exceed $250,000 for all such identical violations during a calendar year, but may be no more than $50,000 for each violation not to exceed $1.5 million for all such violations of an identical requirement or prohibition during a calendar year.
  • Violations due to willful neglect (and the violations have not been corrected): The penalty shall be at least $50,000 for each violation not to exceed $1.5 million for all such violations of an identical requirement or prohibition during a calendar year.

Furthermore, the interim final rule generally amends a covered entity's ability to employ an affirmative defense against an action seeking civil monetary penalties if (i) the covered entity did not have knowledge or constructive knowledge of the violation, and (ii) the violation was not due to reasonable cause and not willful neglect. HHS is also given the authority to waive a civil monetary penalty for violations due to reasonable cause and not willful neglect if the covered entity corrects the violation within 30 days of having knowledge that the violation occurred. 

Comments on this interim final rule will be considered if received by December 29, 2009.

White House Announces Funding for Medical Tort Reform Demonstration Projects

On September 17, 2009, the White House released a “Patient Safety and Medical Liability Reform Demonstration” Fact Sheet, which outlines a new $25 million Department of Health and Human Services initiative designed to help states and health care systems identify new models for managing medical liability claims. The three-pronged initiative will support competitive grants to states and health systems with a focus on the development, implementation and evaluation of alternatives to improve health care quality and patient safety while reducing medical liability.

The Funding Opportunity Announcement will be available within 30 days. The Agency for Healthcare Research and Quality will review applications and make award decisions in early 2010.

The evaluation of the initiative will be released publicly within 18 months of the end of the initiative. The evaluation will focus on short-term improvements in both patient safety and medical liability systems with an allowance for long-term assessment of improvements as well.