Thu, 21 Apr 2011 09:44:40 GMT Health Provider Alert http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert 6b7022a0-dbc4-4f2d-b65f-09d54a443180 Fri, 08 Apr 2011 17:37:57 GMT Reporting and Repayment of Medicare and Medicaid Overpayments Must Be Made by May 22, 2010 Under Section 6402(a) of the Patient Protection and Affordable Care Act http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/Reporting-and-Repayment-of-Medicare-and-Medicaid President Obama signed the Patient Protection and Affordable Care Act ("PPACA") on March 23, 2010. Thus, the clock started running on one of the most urgent requirements imposed by that Act -- that Medicare and Medicaid overpayments be "reported and returned" within 60 days after they are "identified." PPACA §6402(a). 58ffc597-7888-449c-b3ce-ceb0a0a58cb1 Fri, 08 Apr 2011 17:37:57 GMT FTC Extends Enforcement Date of Red Flags Rule http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/FTC-Extends-Enforcement-Date-of-Red-Flags-1352287 The Federal Trade Commission (the "FTC") announced that it has postponed enforcement of the Red Flags Rule1 until November 1, 2009. ad34b6bf-c149-4082-bf4a-8553008741ad Fri, 08 Apr 2011 17:37:57 GMT FTC Extends Enforcement Date of Red Flags Rule to August 1 http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/FTC-Extends-Enforcement-Date-of-Red-Flags-Rule-to-August On April 30th, in a surprising move, the Federal Trade Commission (the "FTC") extended its deferral of enforcement of the Red Flags Rule until August 1, 2009. This marks the second extension by the FTC. The Red Flags Rule's mandatory enforcement date was originally November 1, 2008. However, the FTC suspended enforcement of the Rule until May 1, 2009. The FTC explained that this second extension is in response to ongoing questions from some sectors - particularly smaller entities that are subject to a low risk of identity theft that "continue to have questions and concerns about the specific obligations they must meet and the burden of complying with the rule."1 9434eb72-6934-4977-b908-634529ad9f91 Fri, 08 Apr 2011 17:37:57 GMT Getting in Compliance with the FTC Red Flags Rule as May 1st Enforcement Date Approaches http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/Getting-in-Compliance-with-the-FTC-Red-Flags-Rule-as-May In November 2007, the Federal Trade Commission (the "FTC") released a final rule that requires certain organizations to implement an identity theft prevention program.1 This rule is known as the Red Flags Rule since it requires financial institutions and creditors to look for "red flags" that signal possible identity theft. Despite opposition from the American Medical Association and several medical associations (collectively, the "AMA"), the FTC recently confirmed its position that physicians and other health care providers are likely to be considered creditors and subject to the Red Flags Rule. The FTC may impose civil penalties in the event of a knowing violation, which constitutes a pattern or practice of violations of the Red Flags Rule. In addition, State Attorneys General also have authority to recover damages for violations of the Rule, including costs and attorney fees. d34e424c-f07a-46b2-911a-1c79082594a3 Fri, 08 Apr 2011 17:37:57 GMT HHS OIG Identifies Potential Violation of Anti-Kickback Laws In Proposed "Block Lease" Arrangements Between Physician Groups http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/HHS-OIG-Identifies-Potential-Violation-of-Anti-Kickback On August 26, 2008, the Office of Inspector General of the Department of Health and Human Services ("OIG") issued an Advisory Opinion [click to download PDF] to a physician group practice, finding potential anti-kickback violations with the group's proposal to "block lease" space, equipment, and personnel to other referring physician groups. The Advisory Opinion continues the OIG's historical concern with joint venture arrangements involving parties with existing or potential referral relationships, as well as highlighting its concern regarding "block lease" arrangements. In this case, the particular clinical specialties involved happened to be urologists and a radiology/radiation therapy group - a combination concerning which CMS has also recently expressed Stark-based concerns. However, the questionable components of the proposed arrangement reflected in the OIG's analysis are equally applicable to other similarly situated physician groups with referral relationships. c202f91d-ecf1-4fdf-a761-228be2a7e261 Thu, 21 Apr 2011 09:34:04 GMT CMS Issues 2009 Proposed Physician Fee Schedule Rule: Proposed Changes Would Impact Anti-Markup Rule, Add New Stark Law Exception http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/CMS-Issues-2009-Proposed-Physician-Fee-Schedule-Rule On June 30, 2008, the Centers for Medicare & Medicaid Services ("CMS") released the Proposed Physician Fee Schedule ("PPFS") rule for Fiscal Year 2009. As in previous years, the 2009 PPFS includes significant proposed changes to Medicare payment policies, including proposed changes to the purchased diagnostic test, or anti-markup, rule and a new Stark Law exception. 9f02c206-1517-4c03-b7b8-4b930464ec86 Fri, 08 Apr 2011 17:37:57 GMT Two New FTC Hospital Merger Enforcement Actions: The FTC Seeks to Block Hospital Merger in Northern Virginia and Issues Order Requiring Merged Hospital in Illinois to Create Independent Negotiating Teams http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/Two-New-FTC-Hospital-Merger-Enforcement-Actions-The-FTC-1351927 During the last several weeks, the Federal Trade Commission ("Commission" or "FTC") has taken two significant antitrust enforcement actions affecting hospitals: (1) The initiation of a merger challenge seeking to block Inova Health System Foundation's ("Inova") acquisition of Prince William Health System, Inc., ("Prince William") and (2) The issuance of a final decision and order relating to Evanston Northwestern Healthcare Corporation's ("ENH") acquisition of Highland Park Hospital ("Highland Park"). These actions indicate that the FTC's hospital merger enforcement program is alive and well. 25ea3b4e-20d4-4a5f-a6d7-ab2f9cfabd74 Thu, 21 Apr 2011 09:34:52 GMT OIG “Open Letter” Delivers Welcome News to Health Care Providers http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/OIG-Open-Letter-Delivers-Welcome-News-to-Health-Care The Office of the Inspector General’s (“OIG’s”) April 15, 2008 Open Letter to Providers (the “Open Letter”) guarantees further benefits to health care providers that choose to disclose and cooperate under the OIG Provider Self-Disclosure Protocol (“SDP”), first established in 1998. The new benefits include not only the expeditious resolution of SDP matters, but also the OIG’s predisposition not to require a Corporate Integrity Agreement (“CIA”) or Certification of Compliance Agreement (“CCA”) following self-disclosure. 57e75506-d451-4868-af48-89f07770af63 Thu, 21 Apr 2011 09:35:52 GMT STARK II PHASE III: A Detailed Section-By-Section Analysis of the Long-Awaited “Final” Rule http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/STARK-II-PHASE-III-A-Detailed-Section-By-Section-Analysis The Crowell & Moring Health Care Group is pleased to provide our clients, colleagues, and friends with our legal analysis of the Stark II Phase III Regulations, recently published in the September 5, 2007 Federal Register. These new regulations present both welcome relief and unanticipated future challenges in the manner in which physician financial relationships with DHS entities are structured. Our goal in preparing this analysis was to create a thoughtful, practical, and "user-friendly" Stark Law resource that incorporates references to prior rulemaking as well as to the proposed 2008 Medicare Physician Fee Schedule Rule. We hope you'll agree that we have accomplished this goal. As always, please feel free to contact your regular Crowell & Moring attorney if you have any questions regarding the analysis, which can be accessed by clicking on the image or link below. d49b39cd-19bd-4ea9-8df1-c144b4db5dee Thu, 21 Apr 2011 09:37:47 GMT OIG Opines On Propriety of ED Call Coverage Arrangements http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/OIG-Opines-On-Propriety-of-ED-Call-Coverage On September 27, 2007, the Office of Inspector General (“OIG”) published Advisory Opinion No. 07-10, in which the OIG concluded that it would neither exclude from Federal health care program participation nor impose civil monetary penalties and other administrative sanctions on a non-profit medical center for paying physicians to provide on-call coverage and uncompensated care services in its emergency department, despite the potential for the arrangement to violate the Federal health care program anti-kickback statute, 42 U.S.C. §1320b-7b(b). 7770e686-82f7-4081-8c5a-5731c9d6c36d Thu, 21 Apr 2011 09:38:12 GMT Long-Awaited Stark Law Phase III Final Rule Released By CMS http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/Long-Awaited-Stark-Law-Phase-III-Final-Rule-Released-By On August 27, 2007, CMS released the final rule that constitutes the third phase (“Phase III”) of the long, drawn out rulemaking process relating to the Federal physician self-referral prohibition (the “Stark Law”). 44f8202c-ba6a-4170-8b76-4c8336fa16e8 Thu, 21 Apr 2011 09:39:08 GMT 2008 Physician Fee Schedule Proposes A Host of Stark Law Revisions - And It Isn’t Even Phase III… http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/2008-Physician-Fee-Schedule-Proposes-A-Host-of-Stark-Law CMS issued the Proposed CY 2008 Medicare Physician Fee Schedule on July 2, 2007 (the “Proposed Rule”). Not only does this Proposed Rule establish several physician payment reforms, it also proposes to dramatically revise the Stark Regulations in several significant ways. The timing and extent of the somewhat confusing combination of a) proposed changes, and b) requests for comment on whether certain other changes ought to be proposed, is somewhat surprising given CMS’s delay in issuing the long-awaited Stark II, Phase III regulations. Nonetheless, the suggested revisions set forth in the Proposed Rule, if implemented, will have physicians and health care entities scurrying to re-structure many longstanding relationships previously thought to be acceptable under Stark. c9151be6-73d7-415a-b8c4-2c6be9cc45b0 Thu, 21 Apr 2011 09:39:31 GMT OIG Advisory Opinion 07-05: How a Fair Market Value Deal Can Place Hospital-Physician Joint Venturers at Risk of Kickback Violation http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/OIG-Advisory-Opinion-07-05-How-a-Fair-Market-Value-Deal In an Advisory Opinion released June 19, 2007, (OIG Advisory Opinion No. 07-05), the Department of Health and Human Services Office of Inspector General (“OIG”) made clear its disdain for the partial sale of physician ownership interests in an existing ambulatory surgery center (“ASCs”) to a local hospital. 6ad2cb44-7dbd-45c2-9b5b-957713d761a3 Fri, 08 Apr 2011 17:37:57 GMT Hot Fraud and Abuse Issues for Medical Device Companies http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/Hot-Fraud-and-Abuse-Issues-for-Medical-Device Federal enforcement authorities are focusing on key fraud and abuse issues in the medical device industry -- safety-related reporting and fraud risks, kickbacks, device alteration and off-label marketing. A May 24 th presentation at a BNA audioconference by Virginia Gibson, chief of the Civil Division of the U.S. Attorney's Office for the Eastern District of Pennsylvania, outlined these risk areas. 92ba3345-e9eb-4ab8-8cbe-bba267e09a0f Fri, 08 Apr 2011 17:37:57 GMT Hospital Credentialing of Medical Device Sales Representatives – Increasing Legal Issues on the Horizon http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/Hospital-Credentialing-of-Medical-Device-Sales Legal concerns surrounding the credentialing of health care industry representatives (“HCIRs”) will continue to increase as more and more hospitals implement credentialing programs and those who already have programs increase the level of scrutiny given to applications. 80b5452b-7969-46e7-b497-8a9dfc257a2b Fri, 08 Apr 2011 17:37:57 GMT PRRB Rules In Favor of Hospital on Bad Debt Issue http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/PRRB-Rules-In-Favor-of-Hospital-on-Bad-Debt In a decision dated April 19, 2007, the Provider Reimbursement Review Board ("the Board") soundly rejected the "extrapolation policy" that had been applied to the bad debts of St. Francis Hospital of Greenville, South Carolina, in fiscal year 2000, stating: "The Intermediary's extrapolation policy has no foundation in law, regulations, or established audit standards, and its use as a final determination of allowable costs is improper." 1b8560f1-001b-488b-9ea1-74d9468a8104 Thu, 21 Apr 2011 09:39:51 GMT OIG Will Engage in Unannounced Site Visits to Ensure Compliance With CIAs http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/OIG-Will-Engage-in-Unannounced-Site-Visits-to-Ensure On April 23, the Department of Health and Human Services, Office of Inspector General (OIG), indicated that it will begin engaging in unannounced site visits to providers operating under corporate integrity agreements (CIAs). 6eb07611-a577-4f04-80eb-7d92ef6deb2e Fri, 08 Apr 2011 17:37:57 GMT Supreme Court Deals Set-Back to Whistleblowers http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/Supreme-Court-Deals-Set-Back-to-1351394 8973f458-5188-46f4-b7a4-8bc4763819e6 Thu, 21 Apr 2011 09:40:23 GMT CMS Extends Deadline For Publication of Final Stark II, Phase III Rule http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/CMS-Extends-Deadline-For-Publication-of-Final-Stark-II As expected, CMS announced today that it is extending the timeline for publication of the final rule implementing the Stark Law (the “Phase III Rule”) for one year. With this extension, the interim final rule issued on March 26, 2004 (the “Phase II Rule”) will remain in effect until March 26, 2008, at which time CMS will publish the Phase III Rule. 636db872-4af9-4b48-b625-22045f69bbda Fri, 08 Apr 2011 17:37:57 GMT CMS Takes a Step Back on Recently Published Guidance on the New IDTF Quality Standards http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/CMS-Takes-a-Step-Back-on-Recently-Published-Guidance-on 25fe6ab5-19d9-4e63-a1ac-88feff94da11 Thu, 21 Apr 2011 09:40:44 GMT CMS Letter to State Medicaid Directors Offers Much-Needed Guidance on DRA Employee Education Requirements http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/CMS-Letter-to-State-Medicaid-Directors-Offers-Much-Needed As most health care providers are by now well aware, Section 6032 of the Deficit Reduction Act of 2005 provides that, by January 1, 2007, every entity that receives or makes annual payments of at least $5,000,000 under a State Medicaid plan must not only (1) establish policies and procedures concerning federal and state false claims and whistleblower laws, as well as the detection and prevention of fraud, waste and abuse, but also (2) update its employee handbooks, if any, to reflect such policies and procedures. b83b03d3-d95c-40fb-a279-e6263ca91fdb Thu, 21 Apr 2011 09:43:32 GMT Out With Thompson - In With McNulty: Department of Justice Issues New Guidance to Prosecutors http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/Out-With-Thompson-In-With-McNulty-Department-of-Justice U.S.Deputy Attorney General Paul J. McNulty issued a Memorandum yesterday on the Principles of Federal Prosecution of Business Organizations (the "McNulty Memo"). The McNulty Memo expressly states that it supersedes and replaces guidance contained in the January 20, 2003 Thompson Memorandum on the same subject, as well as the October 21, 2005 McCallum Memorandum regarding Waiver of the Corporate Attorney Client and Work Product Protections. 877232fc-3556-4985-b601-42ba7cecbd73 Thu, 21 Apr 2011 09:43:53 GMT Ernst & Young Report to IRS Reveals Tax-Exempt Hospitals' Community Benefits Justify Their Tax Exemptions http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/Ernst-Young-Report-to-IRS-Reveals-Tax-Exempt-Hospitals In a November 27, 2006 report commissioned by the American Hospital Association and sent to the Internal Revenue Service, Ernst & Young determined that 132 tax-exempt hospitals that had previously responded to a May, 2006 IRS survey each met the community benefit standards set forth in Revenue Ruling 69-545. 82628162-bb01-46a5-9a63-bfa7ebf3c21a Thu, 21 Apr 2011 09:44:15 GMT New Hospital Conditions of Participation to Take Effect January 26, 2007 http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/New-Hospital-Conditions-of-Participation-to-Take-Effect The Centers for Medicare & Medicaid Services has published a final rule revising and updating the conditions of participation (“CoP”) requirements affecting medical staff, nursing services, medical record services, pharmaceutical services, and anesthesia services. 9254ae8c-8528-45c1-b091-867f55bc1a82 Thu, 21 Apr 2011 09:44:40 GMT CMS Comes Down Hard on State Medicaid Fraud Enforcement Efforts http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/CMS-Comes-Down-Hard-on-State-Medicaid-Fraud-Enforcement In a recent report, the Centers for Medicare and Medicaid Services (CMS) slammed the State of New York, which administers the largest Medicaid program in the nation, for having an ineffective Medicaid fraud and abuse program. 5b4c44a9-b630-4521-8a38-a1e8559149d6 Fri, 08 Apr 2011 17:37:57 GMT New Provider and Supplier Enrollment Requirements To Take Effect June 20, 2006 http://www.crowell.com/NewsEvents/AlertsNewsletters/Health-Provider-Alert/New-Provider-and-Supplier-Enrollment-Requirements-To-Take On April 21, 2006 the Centers for Medicare and Medicaid Services (“CMS”) published a Final Rule setting out CMS’ requirements for providers and suppliers to establish and maintain Medicare enrollment and billing privileges. The new regulations will be codified at 42 C.F.R. 424 Subpart P and will go into effect on June 20, 2006.