type: other

jurisdiction: US

text: b"Department of Health and Human Services\n OFFICE OF\n INSPECTOR GENERAL\n\n\n\n CMS\xe2\x80\x99S IMPLEMENTATION OF\n SAFEGUARDS DURING FISCAL\n YEAR 2006 TO PREVENT AND\n DETECT FRAUD AND ABUSE\n IN MEDICARE PRESCRIPTION\n DRUG PLANS\n\n\n\n\n Daniel R. Levinson\n Inspector General\n\n October 2007\n OEI-06-06-00280\n\x0c Office of Inspector General \n\n http://oig.hhs.gov\n\nThe mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452,\nas amended, is to protect the integrity of the Department of Health and Human Services\n(HHS) programs, as well as the health and welfare of beneficiaries served by those\nprograms. This statutory mission is carried out through a nationwide network of audits,\ninvestigations, and inspections conducted by the following operating components:\n\nOffice of Audit Services\nThe Office of Audit Services (OAS) provides all auditing services for HHS, either by\nconducting audits with its own audit resources or by overseeing audit work done by others.\nAudits examine the performance of HHS programs and/or its grantees and contractors\nin carrying out their respective responsibilities and are intended to provide independent\nassessments of HHS programs and operations. These assessments help reduce waste,\nabuse, and mismanagement and promote economy and efficiency throughout HHS.\n\nOffice of Evaluation and Inspections\nThe Office of Evaluation and Inspections (OEI) conducts national evaluations to provide\nHHS, Congress, and the public with timely, useful, and reliable information on\nsignificant issues. Specifically, these evaluations focus on preventing fraud, waste, or\nabuse and promoting economy, efficiency, and effectiveness in departmental programs.\nTo promote impact, the reports also present practical recommendations for improving\nprogram operations.\n\nOffice of Investigations\nThe Office of Investigations (OI) conducts criminal, civil, and administrative\ninvestigations of allegations of wrongdoing in HHS programs or to HHS beneficiaries\nand of unjust enrichment by providers. The investigative efforts of OI lead to criminal\nconvictions, administrative sanctions, or civil monetary penalties.\n\nOffice of Counsel to the Inspector General\nThe Office of Counsel to the Inspector General (OCIG) provides general legal services to\nOIG, rendering advice and opinions on HHS programs and operations and providing all\nlegal support in OIG's internal operations. OCIG imposes program exclusions and civil\nmonetary penalties on health care providers and litigates those actions within HHS.\nOCIG also represents OIG in the global settlement of cases arising under the Civil False\nClaims Act, develops and monitors corporate integrity agreements, develops compliance\nprogram guidances, renders advisory opinions on OIG sanctions to the health care\ncommunity, and issues fraud alerts and other industry guidance.\n\x0cE X E C U T I V E S U M M A R Y\n\xce\x94 E X E C U T I V E S U M M A R Y\n\n\n\n\n OBJECTIVE\n To determine the extent to which the Centers for Medicare & Medicaid\n Services (CMS) implemented safeguards during fiscal year (FY) 2006 to\n prevent and detect fraud and abuse in Medicare prescription drug plans\n (PDP).\n\n\n BACKGROUND\n CMS is responsible for safeguarding the Medicare Part D program\n against fraud and abuse. CMS is statutorily required to perform\n financial audits of PDPs contracted to provide drug benefits to Medicare\n beneficiaries. Beyond this requirement, CMS holds considerable\n discretion in structuring safeguards for the program. In total, we\n identified six major safeguard activities conducted by CMS: a complaint\n process, data-monitoring activities, financial audits, monitoring PDP\n sponsor compliance with contract requirements, oversight of PDP efforts\n to reduce fraud and abuse, and providing education and guidance to a\n number of stakeholders on fraud and abuse identification. CMS\n contracted with one Medicare Prescription Drug Integrity Contractor\n (MEDIC) in FY 2006 to perform some of these functions, including\n complaint investigation.\n\n To identify the status of safeguard implementation and to provide an\n early assessment of progress, we reviewed documents provided by CMS\n and the MEDIC describing and documenting current and planned\n efforts during FY 2006 and conducted a series of structured interviews\n with CMS and MEDIC staff. Although our focus was on PDPs, some of\n the concerns raised may also be applicable to Medicare Advantage\n Prescription Drug Plans and the Retiree Drug Subsidy.\n\n\n FINDINGS\n CMS implemented safeguard activities throughout FY 2006;\n however, further development or application of these activities is\n needed\n Some of CMS\xe2\x80\x99s safeguards have been functioning since enrollment\n began, while others were implemented in a limited capacity or had not\n yet begun. For example, the complaint process has been in place since\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS i\n\x0cE X E C U T I V E S U M M A R Y \n\n\n\n November 2005, but other safeguards, such as data analysis for fraud\n detection, had not yet begun by the end of FY 2006. Compliance audits,\n an important tool for monitoring PDP sponsor compliance, had not\n begun, but CMS staff underwent extensive preparations, including\n protocol development and staff training. CMS reported that initial\n preparation for financial audits began in FY 2006, with the first audits\n expected to begin in January 2008. CMS issued initial guidance for\n PDP compliance plans and is conducting education initiatives; however,\n the slow release of two important guidance documents raises concern.\n In FY 2006, CMS relied largely on complaints to identify potential\n fraud and abuse in the Medicare Part D program; however, not all\n complaints were investigated timely\n During the first year of the program\xe2\x80\x99s operation, CMS relied largely on\n complaints to identify potential fraud schemes and abusive practices.\n Fraud complaints are handled by the MEDIC, which evaluates the\n merit of each complaint, conducts investigations, and makes referrals to\n law enforcement, as appropriate. At the end of our data collection,\n 24 percent of the 6,132 complaints that the MEDIC had received were\n open cases, apparently the result of insufficient staff. In addition, CMS\n does not track Medicare Part D fraud and abuse complaints made to\n 1-800-MEDICARE, nor does it know if these callers actually follow\n through with instructions to make additional calls to the MEDIC\n hotline.\n Limits to legal authority, jurisdiction, and CMS\xe2\x80\x99s ability to monitor\n enrollees switching plans complicate CMS\xe2\x80\x99s efforts to safeguard\n Medicare Part D PDPs\n We identified three impediments to the effective oversight of Medicare\n Part D, specifically in the areas of financial auditing, Part D marketing,\n and utilization management. For example, CMS does not have the legal\n right to go onto the premises of pharmaceutical benefit managers to\n verify that plans accurately report all remuneration and must rely on\n PDP sponsors to include sufficient requirements in their own contracts.\n Further, CMS has limited authority over insurance brokers, one of the\n most frequent subjects of fraud complaints. Lastly, coordination of\n information between plans about beneficiaries suspected of\n inappropriate utilization had not occurred because the plan sponsors\n have concerns over the Health Insurance Portability and Accountability\n Act of 1996 privacy laws.\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS ii\n\x0cE X E C U T I V E S U M M A R Y \n\n\n\n\n RECOMMENDATIONS\n To ensure that CMS\xe2\x80\x99s program integrity safeguard activities are\n implemented in a manner that is sufficient to protect the Medicare\n Part D program, we recommend that CMS:\n Develop a comprehensive safeguard strategy for Medicare Part D\n PDPs with specific activities and target dates and ensure that all\n activities are progressing in a timely manner. CMS should develop a\n comprehensive strategy with specific activities and target dates and assign\n staff to follow up on progress. Further, CMS should make Medicare Part\n D safeguard activities a sufficient priority in the budgeting process to\n support their timely and effective administration.\n\n Ensure that all fraud complaints receive proper attention. CMS should\n have a process in place to monitor the number of open complaints and\n take action if backlogs occur. Additionally, CMS should investigate\n options to immediately transfer fraud complaints submitted to 1-800-\n MEDICARE to the appropriate MEDIC.\n Address legal concerns that may impede program integrity efforts.\n Specifically, CMS should: (1) require PDP sponsors to include standard\n wording regarding requirements for record retention and accessibility\n within subcontractor contracts, (2) enforce appropriate sanctions for\n plans whose brokers violate permissible marketing practices, and\n (3) utilize the MEDICs as intermediaries for PDPs to share information\n about their beneficiaries suspected of inappropriate utilization.\n\n\n AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL\n RESPONSE\n In its comments to the draft report, CMS responded that many of its\n ongoing activities already satisfy our recommendations. It further\n stated that the report does not fully explain the immense workload\n required for CMS to develop and administer the benefit in its first year\n and indicated that processes and procedures have improved over time.\n CMS additionally reported several advances in this safeguard strategy\n that occurred after the end of our data collection period (FY 2006). We\n revised the draft report, as appropriate, based on these comments. CMS\n did not indicate whether it concurred with our recommendations. We\n ask that, in its final management decision, CMS indicate whether it\n concurs with our recommendations and what steps, if any, it will take to\n implement them.\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS iii\n\x0c\xce\x94 T A B L E O F C O N T E N T S\n\n\n\n EXECUTIVE SUMMARY ....................................i\n\n\n\n\n INTRODUCTION........................................... 1\n\n\n\n\n FINDINGS ................................................. 8 \n\n CMS implemented safeguard activities in FY 2006 . . . . . . . . . . . . 8 \n\n\n CMS relied largely on complaints . . . . . . . . . . . . . . . . . . . . . . . . . 12 \n\n\n Legal authorities, jurisdiction, and monitoring enrollees . . . . . . . 14 \n\n\n\n\n R E C O M M E N D A T I O N S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 \n\n Agency Comments and Office of Inspector General Response . . . . 19 \n\n\n\n\n A P P E N D I X E S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 \n\n Appendix A: Medicare Part D Benefits and Operation. . . . . . . . . 23 \n\n\n Appendix B: Agency Comments. . . . . . . . . . . . . . . . . . . . . . . . . . . 25 \n\n\n\n\n A C K N O W L E D G M E N T S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 \n\n\x0c\xce\x94 I N T R O D U C T I O N\n\n\n OBJECTIVE\n To determine the extent to which the Centers for Medicare & Medicaid\n Services (CMS) implemented safeguards during fiscal year (FY) 2006 to\n prevent and detect fraud and abuse in Medicare prescription drug plans\n (PDP).\n\n\n BACKGROUND\n This inspection is an early implementation review of CMS\xe2\x80\x99s efforts to\n prevent and detect fraud in Medicare Part D PDPs. A separate Office of\n Inspector General (OIG) inspection, \xe2\x80\x9cPrescription Drug Plan Sponsors\xe2\x80\x99\n Compliance Plans,\xe2\x80\x9d addressed efforts made by the plans themselves.1\n Medicare Part D Prescription Drug Program\n The Medicare Prescription Drug, Improvement, and Modernization Act\n of 2003 (MMA) established the Medicare Part D prescription drug\n program. Effective January 1, 2006, this program provides an optional\n outpatient prescription drug benefit, which is available to all 42 million\n Medicare beneficiaries.2 3 Beneficiaries generally have the option to\n enroll either in a stand-alone PDP for their drug coverage and receive\n all other benefits through traditional Medicare fee-for-service or enroll\n in a Medicare Advantage plan and receive all Medicare benefits,\n including drug coverage, through managed care.4\n The MMA required an aggressive implementation schedule for the\n Medicare Part D benefit. In the approximately 2 years between passage\n of the law and the effective date of Medicare Part D coverage, CMS and\n plan sponsors were conducting implementation activities, including the\n development of procedures, data systems, and infrastructure to carry\n out all necessary functions. Applications for the first PDPs were due in\n March 2005 and beneficiaries began electing coverage in\n November 2005. As of July 2006, approximately 24 million Medicare\n\n\n\n 1 OEI-03-06-00100. \n\n 2 Social Security Act \xc2\xa7 1860D-1. \n\n 3 Centers for Medicare & Medicaid Services, \xe2\x80\x9cMedicare Enrollment: National Trends\n\n 1966-2005.\xe2\x80\x9d Available online at \n\n http://www.cms.hhs.gov/MedicareEnRpts/Downloads/HISMI05.pdf. Accessed on March \n\n 22, 2006. \n\n 4 CMS, Final Rule, \xe2\x80\x9cMedicare Prescription Drug Benefit,\xe2\x80\x9d 70 Fed. Reg. 4194 \n\n (January 28, 2005). \n\n\n\n\nOEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 1\n\x0cI N T R O D U C T I O N \n\n\n\n beneficiaries were enrolled in a Medicare Part D drug plan.5 A\n summary of the benefit and its operation is included in Appendix A.\n\n During 2006, the first full year of the benefit, expenditures totaled more\n than $47 billion.6 To implement the program, CMS received $1 billion\n for startup costs to be used in FYs 2004 and 2005.7 Of that $1 billion,\n CMS used 44 percent for education and outreach, 5 percent for payroll\n expenses, and the balance primarily for information technology\n improvements.8 It is unclear what portion of the $1 billion was\n dedicated to program integrity efforts. In addition, CMS received a one-\n time increase of $100 million from the Deficit Reduction Act (DRA) of\n 2005 for Medicare program integrity activities conducted during FY\n 2006. 9 A portion of these funds was allocated to activities designed to\n protect Medicare Part D from fraud and abuse. Future funding sources\n for Part D program integrity activities have yet to be determined.\n Program Integrity Staff and Medicare Prescription Drug Integrity Contractors\n Numerous groups within CMS have responsibility for overseeing\n aspects of Part D administration, including the Center for Beneficiary\n Choices, the Office of the Actuary, and the Office of Financial\n Management. However, the Medicare Modernization Act Integrity\n (MMAI) group within the Office of Financial Management\xe2\x80\x99s Program\n Integrity Group is focused specifically on fraud prevention and detection\n in Part D. The MMAI group conducts training, reviews regulations, and\n provides guidance to the Department of Health and Human Services on\n what fraud-related vulnerabilities exist and how they should be\n addressed. It is also responsible for overseeing the Medicare\n Prescription Drug Integrity Contractors (MEDIC).\n\n\n\n 5 Center for Medicare & Medicaid Services, \xe2\x80\x9cMedicare Advantage, Cost, PACE, Demo, \n\n and Prescription Drug Plan Contract Report \xe2\x80\x93 Monthly Summary Report.\xe2\x80\x9d September \n\n 2006. Available online at \n\n http://www.cms.hhs.gov/PrescriptionDrugCovGenIn/02_EnrollmentData.asp. Accessed\n\n on October 18, 2006. \n\n 6 \xe2\x80\x9c2007 Annual Report of the Boards of Trustees of the Federal Hospital Insurance and \n\n Federal Supplementary Medical Insurance Trust Funds,\xe2\x80\x9d p. 5. Available online at \n\n http://www.cms.hhs.gov/ReportsTrust Funds/downloads/tr2007.pdf. \n\n Accessed on July 24, 2007. \n\n 7 Public Law 108-173 \xc2\xa7 1015. \n\n 8 Centers for Medicare & Medicaid Services, \xe2\x80\x9cBudget Facts.\xe2\x80\x9d February 7, 2005. Available \n\n online at http://www.cms.hhs.gov/apps/media/ press/release.asp?Counter=1350. Accessed \n\n on May 30, 2006. \n\n 9 Deficit Reduction Act \xc2\xa7 5204 amending Social Security Act \xc2\xa7 1817(k)(4)C. \n\n\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 2\n\x0cI N T R O D U C T I O N \n\n\n\n MEDICs are private firms with which CMS contracts to perform fraud\n prevention and detection activities, including complaint tracking and\n investigation and data mining. Only one MEDIC contract was awarded\n for work conducted during FY 2006 and that contract was awarded on a\n reduced-scope basis. CMS attributed this decision to funding\n limitations. That MEDIC provided the staff dedicated to investigating\n prescription drug fraud complaints during the first year of the Medicare\n Part D benefit. Three regional MEDICs and a data-focused MEDIC\n were each awarded 1-year contracts in September 2006 (after release of\n the DRA funds) with operations beginning in December 2006.\n Fraud and Abuse Strategy\n CMS is responsible for preventing and detecting fraud and abuse in\n Medicare Part D. However, the only activity statutorily required of\n CMS is to conduct financial audits of one-third of the plans each year.10\n Beyond that, CMS exercises considerable discretion in safeguarding the\n program. CMS\xe2\x80\x99s publicly announced plans to combat fraud and abuse\n in Medicare Part D include a range of prevention and detection\n activities; however, the complete strategy has not been laid out as a\n single comprehensive plan. Accordingly, we analyzed CMS\xe2\x80\x99s various\n press releases and guidance documents to identify CMS\xe2\x80\x99s safeguard\n activities.\n\n In an October 2005 press release, CMS announced that it would be\n \xe2\x80\x9cexpanding its efforts in fighting fraud and abuse in Medicare [Part D]\n by using state of the art systems and expertise to prevent problems\n before they occur.\xe2\x80\x9d11 It further discussed a general three-pronged\n approach to safeguarding the Medicare Part D program which includes:\n (1) implementing new and innovative techniques to monitor and analyze\n data to help identify fraud; (2) working with key partners, such as law\n enforcement and consumer groups; and (3) providing tips for\n beneficiaries to protect themselves. In this same press release, CMS\n announced the selection of eight MEDICs that would then be eligible to\n bid on contracts for future MEDIC work. Also in October 2005, CMS\n released a document titled \xe2\x80\x9cPart D Oversight Strategy for\n\n\n\n 10 Social Security Act \xc2\xa7 1860D-12(b)(3)(C).\n 11 CMS Fact Sheet: The New Medicare Prescription Drug Program: Attacking Fraud\n and Abuse. October 7, 2005. Available online at\n www.cms.hhs.gov/apps/media/press/release.asp?Counter=1693. Accessed on\n November 20, 2006.\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 3\n\x0cI N T R O D U C T I O N\n\n\n Contractors/Industry.\xe2\x80\x9d12 This document states that oversight \xe2\x80\x9cwill be\n data driven to the extent possible\xe2\x80\x9d and identifies four functions that will\n feed into oversight: contractor management, auditing, compliance and\n enforcement, and the functions performed by MMAI and the MEDICs.\n\n\n SAFEGUARD ACTIVITIES\n We have defined safeguard activities as any activity or process that is\n able to prevent or detect fraud and abuse, as some activities identified\n as safeguards are not designed explicitly for that purpose. From CMS\xe2\x80\x99s\n press releases, the oversight strategy document, and interviews with\n CMS staff, we identified the following six major types of safeguard\n activities:\n 1. Complaint Process\xe2\x80\x94This process involves the intake, tracking, and\n investigation of fraud complaints. Complaints may arise from\n beneficiaries, pharmacists, plan staff, or any other person with a fraud\n complaint pertaining to Medicare Part D. Complaints provide a source\n of direct information about potential fraud.\n 2. Data Monitoring\xe2\x80\x94Data monitoring describes the use of data systems\n to assess transactions and look for anomalies that might suggest fraud.\n This includes automated data edits, trend monitoring, and data mining.\n 3. Financial Audits\xe2\x80\x94Financial audits verify that plan-reported financial\n data are credible and accurate. The MMA specified that a financial\n audit should be conducted on one-third of all Medicare Part D plans\n each year. Financial audits could cover a wide range of topics and\n would potentially reveal problems that may result in overpayment to\n plans, including misrepresentation of bids, underreporting of rebates,\n and inaccurate prescription drug event data.\n 4. Monitoring PDP Sponsor Compliance\xe2\x80\x94CMS conducts a number of\n monitoring activities designed to oversee the operation of PDPs. If\n problems are identified through these activities, CMS can implement\n intermediate sanctions or terminate a PDP contract. The activities\n include account management activities, compliance audits, and\n operational safeguards.\n\n\n\n\n 12 Centers for Medicare & Medicaid Services, \xe2\x80\x9cPart D Oversight Strategy for\n Contractors/Industry.\xe2\x80\x9d October 24, 2005.\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 4\n\x0cI N T R O D U C T I O N \n\n\n\n \xe2\x80\xa2\t Account management\xe2\x80\x94CMS account managers act as a nerve center\n into which all types of PDP information feeds and are tasked with\n educating PDP sponsors on new, revised, or misunderstood policies.\n They hear complaints from the PDPs about CMS operations and\n receive regular reports about beneficiary complaints and PDP-\n reported data.\n\n \xe2\x80\xa2\t Compliance audits\xe2\x80\x94CMS staff use compliance audits to measure\n PDP sponsors\xe2\x80\x99 adherence to 14 broad elements that are required of\n them.13 These audits are designed to ensure that plans have\n management controls in place to enable all necessary functions,\n including beneficiary enrollment and claims processing.\n\n \xe2\x80\xa2\t Operational Safeguards\xe2\x80\x94A wide range of management controls\n used in the routine operation of Medicare Part D have both a\n primary role in administration of the benefit and a secondary role of\n fraud prevention and detection. Two examples of operational\n safeguards are the bid review and the formulary and benefit\n review.14 15\n 5. Oversight of PDP Efforts To Reduce Fraud and Abuse\xe2\x80\x94As part of the\n contract to administer PDPs, CMS requires PDPs to have in place\n effective fraud control programs and recommends some specific\n\n\n 13 The 14 elements addressed in the audit protocol are: (1) Enrollment and\n Disenrollment; (2) Provider Communication; (3) Marketing and Beneficiary Information;\n (4) Privacy and Confidentiality; (5) Drug Utilization Management, Quality Assurance,\n and Electronic Prescribing; (6) Pharmacy Access; (7) Formulary, Transition Process, and\n Pharmacy & Therapeutics Committee; (8) Medication Therapy Management;\n (9) Coordination of Benefits/True-Out-of-Pocket Costs; (10) Compliance Plan;\n (11) First-Tier and Downstream Contracts/Maintenance of Records; (12) Claims\n Processing and Payment; (13) Grievances, Coverage Determinations, and Appeals; and\n (14) Licensure and Solvency.\n 14 The actuarial aspect of the bid review process is conducted by CMS\xe2\x80\x99s Office of the\n Actuary. CMS staff and contractors review bids to determine whether the assumptions\n underlying financial projections are appropriate and reasonable. Included in this review\n is a detailed statistical analysis to identify outlier values in the bid components. When\n outliers are identified, a more thorough review is initiated and values are substantiated\n prior to approval. Some specific aspects of the review may enable CMS to identify\n inappropriate cost manipulation tactics that could affect total Part D costs.\n 15 CMS conducts a formal review to ensure that a PDP\xe2\x80\x99s formulary and benefit structure\n meet minimum specifications, ensuring that beneficiaries have access to a full range of\n medications. The formulary review process is an automated process that checks for these\n specifications. If the formulary does not pass the review, CMS returns the formulary to\n the plan for revision. A similar process is used to ensure that the plan\xe2\x80\x99s benefit package\n matches its formulary. For example, if a plan\xe2\x80\x99s benefit package indicates a certain\n number of cost tiers, the formulary must show drugs available in each of the tiers.\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 5\n\x0cI N T R O D U C T I O N \n\n\n\n activities to identify potential fraud and abuse.16 With the ability to\n monitor drug transactions and implement utilization controls that could\n serve as an alert for fraud, PDPs are uniquely situated to identify fraud\n committed by beneficiaries or pharmacies.\n 6. Education and Guidance\xe2\x80\x94CMS has an initiative to educate\n beneficiaries about potential fraud schemes and how to protect\n themselves. Training for law enforcement, CMS staff, and other\n Government agencies is also designed to address fraud issues\n developing in Medicare Part D.\n\n\n SCOPE\n This review describes the implementation status of CMS safeguard\n activities related to stand-alone PDPs during FY 2006. We did not\n describe safeguard activities conducted by the PDPs themselves. As the\n prescription drug benefit is still new, we also did not seek to determine\n the effectiveness of the safeguards that are in place or planned. We also\n excluded issues of data integrity and security, which is being addressed\n by a separate OIG inquiry. Although our focus was on PDPs, some of\n the concerns raised may also be applicable to MA-PDs and the Retiree\n Drug Subsidy.17 18\n\n\n METHODOLOGY\n We reviewed a variety of documents and conducted a series of\n interviews with CMS and MEDIC staff to determine the\n implementation status of safeguard activities at the time of our review.\n Document Review\n We reviewed publicly available documents as well as internal\n documents provided to us by CMS and the MEDIC. Documents\n included press releases, guidance documents, standard operating\n procedures, budget documents, contracts, and training materials.\n\n\n\n\n 16 42 CFR \xc2\xa7 423.504(b)(vi)(H). \n\n 17 Medicare Advantage plans offer a complete range of health benefits including hospital\n\n and physician coverage. They may choose to offer an additional prescription drug benefit \n\n through Medicare Part D. \n\n 18 The Retiree Drug Subsidy encourages private employers to provide Part D benefits to \n\n their retirees by subsidizing the cost for Medicare-eligible beneficiaries. \n\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 6\n\x0cI N T R O D U C T I O N\n\n\n Interviews\n We conducted 19 interviews, either in person or by telephone, primarily\n during August and September 2006. These interviews were with CMS\n staff in the Office of Financial Management, the Center for Beneficiary\n Choices, and the Office of the Actuary. Our discussions addressed\n specific program integrity issues involved in various operations of the\n Medicare Part D program.\n Site Visit\n We conducted a site visit with the Enrollment and Eligibility MEDIC,\n Delmarva Foundation, in Easton, Maryland. Delmarva Foundation was\n the only MEDIC in operation at the time of our data collection. During\n this visit, we interviewed managers and senior staff regarding their\n contracting process, operations, and perspectives on fraud\n vulnerabilities. Additionally, we observed the intake of beneficiary\n complaints to the MEDIC fraud hotline by telephone operators, toured\n the facility, and observed the use of the MEDIC\xe2\x80\x99s data systems. We also\n reviewed documentation of the complaint statistics, standard operating\n procedures, and training sessions conducted by MEDIC staff.\n Direct Observation\n Several internal management systems were demonstrated for us by\n both CMS and the MEDIC. At CMS, we observed several modules of\n the Health Plan Management System (HPMS) in use, including bid\n review, formulary submission and review, plan benefit package review,\n and compliance audits.19 During the MEDIC site visit we observed use\n of the Complaint Tracking Module of HPMS, as well as internal MEDIC\n complaint-tracking and data analysis systems. We also used the\n MEDIC\xe2\x80\x99s complaint-tracking data to determine the overall number of\n complaints.\n Standards\n This study was conducted in accordance with the \xe2\x80\x9cQuality Standards for\n Inspections\xe2\x80\x9d issued by the President\xe2\x80\x99s Council on Integrity and\n Efficiency and the Executive Council on Integrity and Efficiency.\n\n\n\n\n 19 The HPMS is a Web-enabled information system that supports the ongoing operations\n of the Medicare Advantage and Part D programs by facilitating electronic communication\n between CMS and plans.\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 7\n\x0c \xce\x94 F I N D I N G S\n\n Some aspects of CMS\xe2\x80\x99s strategy to\nCMS implemented safeguard activities throughout safeguard Medicare Part D have\n FY 2006; however, further development or been operational since enrollment\n application of these activities is needed began in November 2005. Others\n were implemented in a limited\n capacity or had not yet begun. Below are descriptions of each of the six\n safeguard activities, i.e., complaint process, data monitoring, financial\n audits, monitoring PDP sponsor compliance, oversight of PDP efforts to\n reduce fraud and abuse, and education and guidance, and their\n implementation status as of the end of FY 2006.\n Complaint Process\xe2\x80\x94Complaint investigations resulted in 312 referrals\n related to the \xe2\x80\x9c$299 Ring\xe2\x80\x9d scam and 122 other fraud referrals\n The process to handle complaints has been in place since November\n 2005. Generally, complaints are submitted through a public number\n (1-800-MEDICARE) and are routed to regional staff for followup and\n resolution. However, complainants that suggest fraud are advised to\n call to the MEDIC, which receives calls through a toll-free hotline\n number (1-877-7SAFERX) that is dedicated to complaints about\n potential Part D fraud. The MEDIC is responsible for evaluating the\n merit of fraud complaints and conducts investigations to determine\n whether referrals to law enforcement agencies or State insurance\n commissions are appropriate. Shortly after the end of the fiscal year,\n the MEDIC had investigated 1,421 complaints and made 434 fraud\n referrals.20 Specifically, the MEDIC referred 38 cases to OIG, 80 cases\n to State insurance commissioners, and 4 cases to local or State law\n enforcement.21 Additionally, the MEDIC referred 312 cases for a\n particular type of fraud, known as the \xe2\x80\x9c$299 Ring\xe2\x80\x9d scam. The \xe2\x80\x9c$299\n Ring\xe2\x80\x9d scam involved a scheme whereby perpetrators called potential\n enrollees and requested bank account numbers to withdraw payment\n for enrollment into a nonexistent PDP.\n Data Monitoring\xe2\x80\x94Neither CMS nor the MEDIC had conducted any significant\n data analysis for fraud detection purposes\n Data-driven fraud detection was mentioned in multiple press releases\n as a critical part of CMS\xe2\x80\x99s fraud control strategy. However, those efforts\n have been slow to materialize. Electronic systems were put in place to\n ensure proper formatting and logical consistency in Part D claims data\n\n\n 20 The MEDIC complaint descriptors reflect complaints received until October 30, 2006.\n 21 A case referral may include numerous individual complaints.\n\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 8\n\x0cF I N D I N G S \n\n\n\n and controls were put in place to ensure that the extra benefits for low-\n income enrollees are designated appropriately. However, no significant\n data analysis had been conducted specifically to detect or prevent fraud\n and abuse.\n\n CMS staff reported that they did not expect to begin these efforts\n immediately and that efforts were further delayed by a lag in data\n submissions. The data lag occurred because it took time for the PDPs to\n submit claims data properly, a consequence of a complex and quickly\n designed system. Additionally, CMS experienced some data problems\n during the early phases of implementation. One example is that some\n beneficiaries appeared to be incorrectly enrolled in two PDPs\n simultaneously, allowing drug transactions to be billed to the incorrect\n PDP. This problem was eventually resolved, but the process of\n correcting those errors did not begin until August 2006.\n\n Another barrier to conducting data analysis was the lack of a\n centralized data repository. In September 2006, CMS contracted with\n Electronic Data Systems to be the One Program Integrity System\n Integrator (One PI). The One PI will warehouse Medicare data for\n prescription drugs, physician services, and inpatient care, among other\n data. This contract represents a significant step towards the use of\n data-driven fraud detection methods, but no actual data analysis is\n expected until the summer of 2007. When operational, this group will\n be responsible for using data analysis techniques to uncover fraud,\n waste, and abuse. It will also offer powerful data analysis tools and\n make data accessible to CMS program integrity staff and other\n appropriate parties via a Web-based portal.\n Financial Audits\xe2\x80\x94CMS let a contract to develop the financial audit program\n just before the end of FY 2006, with an expectation that the first audits will\n begin in January 2008\n The final reconciliation between CMS and the PDP sponsors is scheduled\n to begin in September 2007, following the June 30, 2007, deadline for\n PDPs to submit rebate information. CMS staff do not plan to begin\n conducting financial audits until the reconciliation is complete, which\n means that the earliest financial audits will likely begin in January 2008.\n These first audits will be designed to verify financial data for plan year\n 2006.\n\n CMS is required to conduct audits on one-third of Medicare Part D\n organizations, including PDPs, each year. However, the one-third audit\n requirement does not specify that CMS audit every plan within a 3-year\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 9\n\x0cF I N D I N G \nS\n\n\n period or any other timeframe. Therefore, it is conceivable that some\n plans would not be audited during the Part D program\xe2\x80\x99s initial 3-year\n period.\n\n In addition, CMS staff expressed concern that funding limitations may\n constrain the depth and/or breadth of the audits. Although CMS took a\n significant step in preparation for the audits by hiring a contractor in\n September 2006 to develop the audit process and protocols, further and\n more costly steps are still needed. By September 2007, CMS expects to\n have a final audit process and protocol, including thresholds for audit\n findings and timelines for conducting audits, but still needs to hire and\n train additional contractors to conduct the audits. The number of staff\n required has not yet been determined but will likely be significant and\n costly. For the financial audits to proceed as planned, CMS will need to\n identify them as a high priority when making budget decisions.\n Monitoring PDP Sponsor Compliance\xe2\x80\x94Efforts to monitor PDP sponsor\n compliance are in place, but compliance audits have been delayed\n Although routine account management activities and operational\n safeguards were in place prior to the first beneficiary enrollment period,\n compliance audits had not started as of the end of FY 2006. CMS staff\n have, however, undergone extensive preparations for conducting\n compliance audits. Audit protocols have been developed and many staff\n at CMS are reportedly trained and ready to begin the audit process.\n Compliance audits were scheduled to begin in the summer of 2006 but\n were delayed because the data system that enables CMS to schedule\n and track compliance audits encountered technical problems. Staff\n anticipated that the first audits would be conducted in early 2007.\n Oversight of PDP Efforts to Reduce Fraud and Abuse\xe2\x80\x94CMS issued\n requirements for PDP sponsors\xe2\x80\x99 fraud, waste, and abuse compliance plans\n As a part of their contracts, PDP sponsors must agree to implement fraud\n control programs.22 CMS issued guidelines to PDP sponsors before the\n benefit began and then updated guidance with the release of the initial\n chapter (issued as chapter 9) of its \xe2\x80\x9cPrescription Drug Benefit Manual\xe2\x80\x9d in\n April 2006. This chapter describes specific requirements for PDP\n sponsors\xe2\x80\x99 fraud, waste, and abuse compliance plans which address\n primarily basic infrastructure.23 Specific fraud detection activities are\n\n\n 22 42 CFR \xc2\xa7 423.504(b)(vi)(H). \n\n 23 Centers for Medicare & Medicaid Services, \xe2\x80\x9cPrescription Drug Benefit Manual,\xe2\x80\x9d \n\n chapter 9.\n\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 10\n\x0cF I N D I N G S \n\n\n\n recommended but are not required. CMS expected that PDPs would\n incorporate CMS guidance into their compliance plans by January 2007.\n An OIG report, \xe2\x80\x9cPrescription Drug Plan Sponsors\xe2\x80\x99 Compliance Plans,\xe2\x80\x9d\n found that although all PDP sponsors had a plan to detect, correct, and\n prevent fraud, waste, and abuse in place by January 1, 2006, few PDPs\n addressed all of CMS\xe2\x80\x99s recommendations for specific fraud and abuse\n detection activities.24\n Education and Guidance\xe2\x80\x94Many education efforts were under way, but the\n slow release of two key documents raises concern\n By the end of FY 2006, CMS and the MEDIC had conducted numerous\n training sessions for beneficiaries, PDP sponsors, and law enforcement\n entities. Other educational efforts included advisory opinions, direct\n mailings, training, and conferences. These efforts contribute to\n beneficiary protection, as well as information sharing between law\n enforcement groups working on Medicare Part D integrity issues.\n\n Despite these efforts, the delayed release of two critical documents\n raises concern. First, although CMS makes most of its Medicare Part D\n guidance materials available on the Internet, the agency has not yet\n completed the \xe2\x80\x9cPrescription Drug Benefit Manual.\xe2\x80\x9d As of the end of FY\n 2006, five chapters had been released in final form, including the\n following: 2, \xe2\x80\x9cPart C and D Marketing Guidelines,\xe2\x80\x9d 3, \xe2\x80\x9cPDP Enrollment\n and Disenrollment Guidance,\xe2\x80\x9d 9, \xe2\x80\x9cFraud Compliance Plans,\xe2\x80\x9d\n 14, \xe2\x80\x9cCoordination of Benefits,\xe2\x80\x9d and 18, \xe2\x80\x9cGrievances, Coverage\n Determinations, and Appeals.\xe2\x80\x9d As a result, PDP sponsors are expected\n to cull the information about Medicare Part D requirements from a\n variety of letters and guidance documents. Second, CMS\xe2\x80\x99s only\n Medicare Part D fraud alert issued during the first year of the program\n took several months to release. The alert regarded the \xe2\x80\x9c$299 Ring\xe2\x80\x9d\n scam. A consumer alert was released in June 2006, but the fraud alert,\n which is intended to be an early alert for law enforcement entities and\n PDP sponsors, had not been released by the end of the fiscal year.25\n CMS staff explained that the delay was due to CMS\xe2\x80\x99s writing, editing,\n and clearance process, as well as its perception that the warning was\n most pertinent during periods of plan marketing and open enrollment,\n which occurred in November 2006.\n\n\n\n 24 OEI-03-06-00100. \n\n 25 The fraud alert was released in November 2006. \n\n\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 11\n\x0c F I N D I N G S \n\n\n\n\nIn FY 2006, CMS relied largely on complaints to With aspects of CMS\xe2\x80\x99s fraud protection\n program not in place at the time of our\n identify potential fraud and abuse in the\n review, CMS relied largely on complaints\n Medicare Part D program; however, not all\n to identify potential fraud schemes and\n complaints were investigated timely abusive practices in the first fiscal year of\n Medicare Part D operation. CMS staff\n described complaints as an effective fraud and abuse protection tool,\n indicating that beneficiaries are frequently vocal about their\n experiences and often report suspected wrongdoing. Further, CMS staff\n suggested that some types of fraud are best identified by beneficiaries\xe2\x80\x99\n reporting directly on their experiences.\n Although complaints are a valuable source of information, we noted two\n weaknesses in the complaint process. First, the MEDIC was battling a\n sizeable number of open complaint cases deemed worthy of\n investigation, and second, Medicare Part D fraud complaints submitted\n to 1-800-MEDICARE are not tracked, allowing for the possibility of\n missing important information from valid fraud complaints.\n Shortly after the close of FY 2006, 24 percent of the 6,132 complaints\n received by the MEDIC were open, most of which required further\n investigation\n At the time of our data collection, a single MEDIC (Delmarva\n Foundation), contracted to focus on enrollment and eligibility fraud in\n the early months of Medicare Part D operation, was responsible for\n tracking and investigating all fraud complaints and referring cases of\n merit to law enforcement. The MEDIC conducted complaint intake and\n triage on 6,132 complaints received during FY 2006.26 The triage\n process is used to determine a priority level for further investigation\n and helps to ensure that the most serious fraud complaints are quickly\n identified.27 A few complaints are quickly referred to an enforcement\n agency without ever being investigated by the MEDIC, and many others\n are quickly closed or referred to the PDP because it is clear that fraud is\n not the issue. The remaining complaints are considered \xe2\x80\x9copen\xe2\x80\x9d until the\n case is referred to and accepted by law enforcement or closed as a result\n of insufficient evidence.\n\n\n\n\n 26 The MEDIC complaint data reflect complaints received through October 30, 2006.\n 27 The triage process involves evaluating each complaint on five criteria: patient abuse,\n geographic scope of impact, monetary impact, ability to prosecute, and pattern of fraud.\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 12\n\x0cF I N D I N G S \n\n\n\n Shortly after the end of FY 2006, the MEDIC had 1,475 open complaints\n in various stages of investigation. These included complaints awaiting\n review, active investigations, and cases in the preliminary stages of\n referral to law enforcement agencies. Of these, almost half had been\n open for at least 150 days and a few had been open for 300 days or more.\n\n The significant number of open complaints appears to be the result of an\n insufficient number of investigative staff. The first MEDIC contract\n funded only primary activities, such as complaint intake and\n investigation, forcing the MEDIC to reduce its original plan for the\n range of efforts employed and resources dedicated to fighting fraud.\n Although the MEDIC maintained all complaint intake activities, only\n three full-time and three part-time investigative staff were assigned to\n conduct follow-up investigations. Staff at CMS and staff at Delmarva\n Foundation were optimistic that, with the addition of the three regional\n MEDICs beginning operations in December 2006, the number of open\n complaints would be dramatically reduced.\n Medicare Part D fraud and abuse complaints submitted to 1-800-MEDICARE\n are not logged or tracked\n Both 1-800-MEDICARE and 1-877-7SAFERX are publicized phone\n numbers, but 1-800-MEDICARE is designed as a resource to answer\n general questions and receive all types of Medicare complaints,\n including Medicare Part D fraud complaints. In contrast, 1-877-\n 7SAFERX is dedicated to complaints about Medicare Part D fraud.\n Although the customer service representatives at 1-800-MEDICARE\n enter most complaints into the Complaint Tracking Module of HPMS,\n Medicare Part D fraud complaints are not entered. When Medicare\n Part D fraud is suspected, the customer service representative advises\n the caller to call the MEDIC at 1-877-7SAFERX. CMS does not track\n how many people have been advised to call the MEDIC, nor does it\n conduct any followup to ensure that the complainant actually called the\n MEDIC. To the extent that callers are not following through with calls\n to 1-877-7SAFERX, valid complaints could be slipping through the\n cracks.\n\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 13\n\x0c F I N D I N G S \n\n\n\n\nLimits to legal authority, jurisdiction, and CMS\xe2\x80\x99s Despite the operation of six types\n ability to monitor enrollees switching plans of safeguard activities, we\n identified three impediments to\n complicate CMS\xe2\x80\x99s efforts to safeguard\n the effective oversight of Medicare\n Medicare Part D PDPs\n Part D, specifically in the areas of\n financial auditing, Part D marketing, and utilization management.\n Although these impediments are not insurmountable, they do make\n CMS\xe2\x80\x99s Medicare Part D oversight responsibility more difficult to fulfill.\n CMS has limited ability to verify that direct and indirect remuneration are\n accurately reported by PDP sponsors\n After the plan year has ended, PDPs must report to CMS all outstanding\n financial information, including direct and indirect remuneration.\n Remuneration received by PDP sponsors may reduce the PDP sponsor\xe2\x80\x99s\n cost of providing Medicare Part D drugs. Such remuneration includes\n manufacturer or pharmaceutical benefit manager rebates, chargebacks,\n discounts, goods in kind, or grants. Remuneration is deducted from PDP\n losses (or added to PDP profits) for the year and may have a significant\n impact on the final payment reconciliation between CMS and PDP\n sponsors, because it directly affects the amount of money that CMS will\n reimburse or recoup from PDPs. Underreporting remuneration could\n result in significant losses to the Medicare Part D program. The onus is\n on PDPs to accurately and completely report this information. However,\n CMS\xe2\x80\x99s ability to check the veracity of this self-reported data is limited to\n financial audits, and auditors will be faced with the difficult task of\n identifying any remuneration that is not reported by PDPs or their\n subcontractors.\n Additionally, CMS staff do not currently have the legal authority to go\n onto the premises of the pharmaceutical benefit managers to verify the\n flow of goods and money. Instead, CMS must rely on PDP sponsors to\n include sufficient requirements in their own contracts with subcontractors.\n Regulations require that a PDP sponsor \xe2\x80\x9cagrees to require all related\n entities, contractors, or subcontractors\xe2\x80\x9d to allow CMS access to documents\n and information for the purpose of audits.28 However, if the PDP sponsors\n fail to include sufficient access provisions in their contracts with\n subcontractors, the regulations afford CMS no direct regulatory authority\n to independently access information.\n\n\n\n 28 42 CFR \xc2\xa7 423.505(i)(2).\n\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 14\n\x0cF I N D I N G S \n\n\n\n CMS has limited authority over insurance brokers, one of the most\n frequent subjects of fraud complaints\n Brokers are paid a commission to enroll eligible beneficiaries into a\n plan. Brokers may represent any number of PDPs and receive different\n commissions based on which plan is selected by the beneficiary.\n Dishonest brokers may inappropriately steer potential enrollees to\n particular plans by providing false or limited information. Some of the\n most egregious complaints received to date involve brokers enrolling\n beneficiaries without their consent. Because brokers assist in boosting\n enrollment numbers, plans have few incentives to rein in dishonest\n brokers. CMS requires that plan subcontractors, including brokers,\n comply with all Medicare Part D regulations, but this proves difficult to\n enforce with respect to brokers for several reasons. First, if CMS learns\n that a broker is not in compliance with Part D marketing and\n enrollment requirements, it cannot take direct corrective action against\n the broker itself. Rather, CMS would have to take enforcement actions\n against the PDP sponsor who contracted with the broker. Second,\n because brokers are regulated by State insurance commissions, the\n MEDIC must refer alleged broker misconduct to the appropriate State\n insurance commission and rely on it to take corrective actions against\n the broker. Third, privacy restrictions contained in the Health\n Insurance Portability and Accountability Act of 1996 (HIPAA)\n necessitate that the MEDIC obtain consent from the enrollee before\n sharing case-specific information with the State insurance commission.\n With the cases that have been referred, the MEDIC experienced delays\n and sometimes difficulty getting such consent.\n Overutilization of drugs for the purpose of personal drug abuse or selling\n prescription drugs for profit poses a significant cost risk to Medicare\n Part D; however, plans are limited in their ability to monitor suspect\n enrollees\n Although the inappropriate costs per individual may be small, the\n suspected widespread nature of this type of fraud poses a significant\n risk to the program. The MEDIC staff is aware of approximately 60,000\n persons who were identified by State Medicaid programs because they\n demonstrated unusual drug utilization patterns prior to their transition\n to Medicare Part D. Some State Medicaid programs conducted routine\n data checks to identify potentially inappropriate utilization by\n individuals, known as \xe2\x80\x9coverutilizers,\xe2\x80\x9d and took steps to control their\n drug access through management structures, such as prior\n authorizations and pharmacy restrictions. Information about specific,\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 15\n\x0cF I N D I N G S \n\n\n\n known overutilization risks in State Medicaid programs was not\n transferred to PDPs when the Medicare Part D benefit began. Thus,\n PDPs must conduct their own analysis to identify these risks. PDPs\n face further difficulty in developing and maintaining knowledge about\n potential overutilizers because most beneficiaries are able to change\n plans every year and Medicare/Medicaid dually eligible beneficiaries are\n able to change plans every month. PDPs and the MEDIC have\n interpreted HIPAA privacy provisions as prohibiting communication\n about suspected overutilizers. As such, plans must develop a new\n utilization profile for an enrollee each time the enrollee changes plans.\n HIPAA provisions allow PDPs to communicate about beneficiaries\n suspected of inappropriate behavior, as long as each PDP currently has\n or previously had a relationship with the beneficiary in question.\n However, there is currently no mechanism by which PDPs can identify\n which other PDPs have or previously had a relationship with a\n beneficiary.\n\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 16\n\x0c\xce\x94 R E C O M M E N D A T I O N S\n CMS is making progress towards fulfilling its plans for preventing and\n detecting fraud and abuse in PDPs; however, some activities were not\n fully implemented by the end of FY 2006. CMS staff report that some\n activities would have been premature or point to funding and data\n limitations as a rationale for delays. Although we recognize the short\n timelines and significant challenges that CMS faced in rapidly\n implementing the Medicare Part D program, the impact on beneficiaries\n as well as the large magnitude of outlays (i.e., $47 billion in 2006) call\n for commensurate safeguard activities. In an effort to continue\n improving CMS\xe2\x80\x99s safeguard strategy, we recommend that CMS:\n Develop a comprehensive safeguard strategy for Medicare Part D PDPs with\n specific activities and target dates and ensure that all activities are\n progressing in a timely manner\n CMS had begun implementation activities in all safeguard areas, but\n CMS staff could not provide timelines for final implementation. CMS\n should develop a comprehensive written strategy document with specific\n activities and target dates and assign staff to follow up on progress.\n This document should serve as a management tool to coordinate\n different CMS groups that may have a role in safeguarding Medicare\n Part D PDPs and aid in identifying areas that may not be adequately\n protected by the safeguards that are in place. It should also be used as\n a prompt to notify appropriate senior staff if implementation activities\n fall behind schedule. Further, CMS should make Medicare Part D\n safeguard activities a sufficient priority in the budgeting process to\n support their timely and effective administration. Of foremost concern\n are commencement of the financial audits, sufficient MEDICs to\n investigate fraud complaints, and the pursuit of innovative data-driven\n techniques to identify potential fraud and abuse.\n Ensure that all fraud complaints receive proper attention\n As the number of MEDICs and staff assigned to investigate complaints\n increases, CMS should have a process in place to monitor the number of\n open complaints and take action if backlogs occur. Additionally, CMS\n should investigate options for customer service representatives to\n directly transfer fraud complaints received by 1-800-MEDICARE to the\n appropriate MEDIC.\n\n\n\n\nOEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 17\n\x0cR E C O M M E N D A T I O N S \n\n\n\n Address legal concerns that may impede program integrity efforts\n Three concerns in particular require attention:\n\n Require PDP sponsors to include standard wording regarding requirements for\n record retention and accessibility within subcontractor contracts.\n\n Verification that PDPs report all remuneration is intrinsically difficult.\n For this reason, it is critical for CMS to have full access to primary\n documentation about remuneration, including that maintained by a\n pharmaceutical benefit manager or other subcontractor. Further, CMS\n should not be limited in its ability to access critical information because\n only general or nonspecific requirements are included in subcontractor\n contracts. The standard wording should include provisions for (1) CMS\n accessing information directly from subcontractors; (2) timelines for\n both records maintenance and accessibility; (3) special circumstances,\n such as terminated contracts; and (4) penalties for noncompliance with\n records access provisions. Further, the inclusion of this language\n should be verified through either the financial audits or compliance\n audits.\n Enforce appropriate sanctions for PDPs whose brokers violate permissible\n marketing practices.\n\n The prevalence of complaints from FY 2006 indicates that improper\n broker marketing practices pose a significant risk for the Part D\n program. Although CMS may be unable to directly penalize brokers\n who are conducting illegal marketing practices, the PDPs have ultimate\n responsibility for their subcontractors.29 CMS guidance requires PDPs\n to monitor the performance of subcontractors, including marketing\n practices. CMS Part D regulations also require that PDP subcontractor\n contracts include a provision allowing CMS or the PDP to take\n corrective action if either CMS or the PDP determines that the\n subcontractor is not performing satisfactorily.30 CMS should be vigilant\n in its oversight of insurance brokers and ensure strong enforcement of\n Part D marketing standards.\n\n\n\n\n 29 42 CFR \xc2\xa7 423.505(i). \n\n 30 42 CFR \xc2\xa7 423.505(i)(4)(ii). \n\n\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 18\n\x0cR \tE C O M M E N D A T I O N S \n\n\n\n Utilize the MEDICs as intermediaries for PDPs to share information about their\n beneficiaries suspected of inappropriate utilization.\n\n Currently, there is no way for information about extreme or unusual\n utilization by a particular beneficiary to be communicated between the\n beneficiary\xe2\x80\x99s prior PDP to his or her next PDP. Allowing the MEDICs\n to act as repositories of information about beneficiaries suspected of\n fraud would improve PDPs\xe2\x80\x99 ability to identify and monitor drug-seeking\n and drug-selling behavior. Further, early identification of these\n individuals would limit the effectiveness of a beneficiary switching\n plans to avoid targeted actions by the PDPs to prevent fraud. In\n implementing this activity, CMS should explore whether this\n recommendation can be addressed by revising MEDIC contracts.\n\n\n AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL\n RESPONSE\n In its comments to the draft report, CMS did not indicate whether it\n concurred with our recommendations, but did provide comments\n regarding each recommendation (see Appendix B). CMS responded that\n many of its ongoing activities already satisfy our recommendations. It\n further stated that the report does not fully explain the immense\n workload required for CMS to develop and administer the benefit in its\n first year and indicated that processes and procedures have improved\n over time. In its technical comments, CMS reported several advances in\n its safeguard strategy that occurred after the end of our data collection\n period (FY 2006). The advances CMS reported include:\n \xc2\x83\t continued progress towards commencement of the financial\n audits. Audits are still scheduled to begin by the end of calendar\n year 2007;\n \xc2\x83\t successful negotiations to allow MEDICs sufficient access to\n PDP data so that data-driven fraud detection activities can\n begin;\n \xc2\x83\t improvement in processing complaints timely. Specifically, CMS\n reported that of 5,286 complaints received by the MEDICs\n between December 2006 and June 2007, only 2 are older than 30\n days;\n \xc2\x83 commencement of routine PDP compliance audits in February\n 2007;\n \xc2\x83 issuance of a self-assessment tool to assist PDPs in improving\n their fraud, waste, and abuse compliance plans; and\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 19\n\x0cR \tE C O M M E N D A T I O N S\n\n\n \xc2\x83\t release of four new chapters of the Prescription Drug Benefit\n Manual.\n\n Comprehensive safeguard strategy\n\n Regarding our recommendation to develop a comprehensive safeguard\n strategy with specific activities and target dates, CMS stated that the\n MEDIC task orders and Umbrella Statement of Work (USOW) are\n CMS\xe2\x80\x99s comprehensive safeguard strategy for the Part D program.\n Additionally, CMS responded that the broader strategy for fighting\n fraud, waste, and abuse is the three-pronged strategy. Although OIG\n agrees that the task orders and USOW provide an important framework\n for enacting many safeguard activities, these documents are specific to\n the MEDIC activities and do not address the broad coordination that is\n needed between different groups within CMS that each have a role to\n play in safeguarding Medicare Part D. With regard to CMS\xe2\x80\x99s three-\n pronged strategy, the documents we reviewed lacked the details,\n deliverables, and timelines that would extend its use from a broad\n strategic concept to a useful management tool. Therefore, we continue\n to recommend that CMS create a comprehensive safeguard strategy\n that includes specific activities across the range of its existing and\n planned program integrity efforts and tie these activities to target dates\n so that implementation progress can be monitored, strengths can be\n identified, and delays can be addressed.\n Fraud complaints\n\n Regarding our recommendation to ensure that all fraud complaints\n receive proper attention, CMS stated that ensuring all complaints are\n addressed promptly is a top priority. CMS also expressed concern that\n our draft report misrepresented the MEDIC\xe2\x80\x99s activities in responding to\n complaints but acknowledged early difficulties with the volume of\n complaints. Further, CMS stated that the three MEDICs contracted for\n FY 2007 would be sufficient to fully investigate and resolve fraud\n complaints.\n\n Because of CMS\xe2\x80\x99s concern that we misrepresented the MEDIC\xe2\x80\x99s\n activities in responding to complaints, we made revisions to avoid\n characterizing open complaint cases as a \xe2\x80\x9cbacklog\xe2\x80\x9d and to more fully\n describe the status of the open cases at the time of our data collection.\n However, the number of open cases and the time that some cases\n remained open suggest that the complaint process is susceptible to\n backlogs. Consequently, OIG continues to recommend that CMS devote\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 20\n\x0cR E C O M M E N D A T I O N S\n\n\n sufficient resources to ensure that all fraud complaints receive proper\n attention, including implementing a system to monitor the complaint\n caseload for potential backlogs.\n\n CMS also stated that it will explore the feasibility of transferring Part D\n fraud calls from 1-800-MEDICARE directly to the MEDIC hotline and\n that, until a decision is made, 1-800-MEDICARE customer service\n representatives will remain responsible for making determinations as\n to whether calls should be sent to MEDICs. We clarify that the intent of\n this recommendation is to ensure that once a fraud complaint is\n identified, complainants should be directly connected to the MEDIC,\n rather than being advised to call the MEDIC hotline. We expect that\n customer service representatives will continue to be responsible for\n identifying which calls should be directly connected to the MEDIC.\n Address legal concerns\n\n Regarding our recommendation to pursue legal authority to obtain\n records directly from subcontractors and to explicitly require\n subcontractors to retain their documents, CMS stated that it currently\n has authority to obtain records from subcontractors and that\n requirements for record retention already exist. OIG interprets the\n existing authority as being dependent on the inclusion of sufficient\n contractual language by PDP sponsors within their subcontractor\n contracts. We modified this recommendation to more specifically\n address this underlying concern.\n\n Regarding our recommendation to enforce appropriate sanctions for\n PDPs whose brokers violate permissible marketing practices, CMS\n described its authority and a range of potential sanctions it is able to\n impose in the event of noncompliance with marketing guidelines.\n\n Regarding our recommendation to utilize the MEDICs as intermediaries\n for PDPs to share information with each other about suspected fraud,\n CMS stated that it will evaluate the possibility and potential\n implications of having the MEDICs serve as the intermediaries for PDP\n data.\n Request for final comments\n\n We ask that, in its final management decision, CMS indicate whether it\n concurs with our recommendations and what steps, if any, it will take to\n implement them.\n\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 21\n\x0c\xce\x94 A P P E N D I X A\n\n Medicare Part D Benefits and Operation\n Medicare Part D benefits are provided by private insurers, either in the\n form of a stand-alone PDP or as part of a comprehensive Medicare\n managed care plan, known as a MA-PD. PDP plans provide Medicare\n beneficiaries access to prescription drugs for low monthly premiums and\n copayments. The MA-PD plans include hospital and physician\n insurance, as well as the prescription drug benefits. For 2006, there\n were 1,429 PDPs and 1,314 MA-PDs.\n\n Medicare Part D plans provide coverage that is at least actuarially\n equivalent to a defined standard benefit. The defined standard benefit\n in 2006 provided coverage in four progressive phases: (1) a $250\n deductible; (2) beneficiary coinsurance of 25 percent of drug costs\n between $250 and $2,250; (3) coverage gap with the beneficiary\n responsible for all drug costs between $2,250 and $5,100; and\n (4) catastrophic coverage with a beneficiary coinsurance of 5 percent for\n all drug costs over $5,100. Most drug plans offered in 2006 opted for an\n alternative benefit structure, but the defined standard benefit still\n serves as the baseline. Although beneficiary-paid premiums and other\n cost sharing cover approximately 25 percent of the program\xe2\x80\x99s expected\n cost, the remaining 75 percent is drawn from the Medicare Trust Fund.\n Medicare Part D Program Operations\n Managing the Medicare Part D program requires many coordinated\n activities. For each year, prospective sponsors must submit an\n application demonstrating that all qualifications will be met, including\n an acceptable formulary. CMS staff review the applications and\n formularies to determine an intent to comply with program\n requirements. Accepted applicants may then submit bids, which\n include the benefit designs and attestations that the benefit is\n actuarially equivalent to the defined standard benefit; the expected\n costs of the program; and any cost utilization controls that will be\n employed. Once the bid is deemed acceptable, a contract is let with the\n plan sponsor and the private organization agrees to abide by all\n Medicare Part D regulations.\n\n Plans may begin marketing activities the October prior to the beginning\n of the plan year. All marketing materials must either use standardized\n language that is on file with CMS or have CMS review the materials for\n accuracy and appropriateness. Open enrollment begins on\n November 15, which allows enrollees to select a plan or change their\n plan designations. Enrollees may evaluate plan options by their use of\n\n\nOEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 22\n\x0cA P P E N D I X A \n\n\n\n\n\n premiums, deductibles, and copays; the drugs allowed through the\n formularies; restrictions that may be placed on drug utilization; and the\n benefit designs to determine which plan best accommodates their needs.\n Several resources are available to assist beneficiaries in making their\n selections, including the Web-based plan finder and 1-800-MEDICARE\n staff. Some enrollees with low income qualify for additional financial\n assistance to cover the costs of premiums, deductibles, and copays.\n Enrollees that are dually eligible for Medicare and Medicaid will be\n automatically assigned to plans if they do not select plans themselves.\n\n Once the plan year begins, enrollees are entitled to the prescription\n drug benefits offered by their selected plans. The plans record each\n pharmacy transaction and report summary information about the\n transaction to CMS. The information reported to CMS is called the\n Prescription Drug Event and is used for a year-end reconciliation. The\n plans, however, hold the primary responsibility for tracking each\n beneficiary\xe2\x80\x99s total drug costs and out-of-pocket expenses. Beneficiary\n drug costs and out-of-pocket expenses (formally called true-out-of-\n pocket, or TrOOP) determine when the beneficiary enters particular\n phases of the benefit. Specifically, total drug costs determine when a\n beneficiary enters the coverage gap and TrOOP determines when the\n catastrophic benefit begins.\n\n CMS pays plans prospectively; however, certain payments are\n reconciled after the end of the plan year. CMS\xe2\x80\x99s payments to plans\n include: (1) a risk-adjusted prospective payment for each beneficiary\n enrolled, each month; (2) a subsidy to account for the lower premiums,\n deductibles, and copayments offered to qualifying low-income enrollees;\n (3) reinsurance for a portion of drug costs incurred by plans during the\n catastrophic coverage phase; and (4) a payment adjustment (positive or\n negative) for a predetermined risk-sharing agreement. The\n reconciliation process does not begin until plans have fully disclosed\n their direct and indirect remuneration, e.g., rebates, due approximately\n 6 months after the end of the plan year. Consequently, payments are\n not fully adjudicated until several months after the plan year, at a\n minimum.\n\n\n\n\nOEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 23\n\x0c\xce\x94 A P P E N D I X B\n\n\n Agency Comments\n\n\n\n\nOEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 24\n\x0cA P P E N D I X B\n\n\n\n\nOEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 25\n\x0cA P P E N D I X B\n\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 26\n\x0cA P P E N D I X B\n\n\n\n\n OEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 27\n\x0c\xce\x94 A C K N O W L E D G M E N T S\n\n This report was prepared under the direction of Kevin K. Golladay,\n Regional Inspector General for Evaluation and Inspections and\n A. Blaine Collins, Deputy Regional Inspector General for Evaluation\n and Inspections in the Dallas regional office.\n\n Amy Ashcraft served as the team leader for this study, and Tom\n Browning served as the lead analyst. Central office staff who\n contributed include Linda Abbott.\n\n\n\n\nOEI-06-06-00280 SAFEGUARDS TO PREVENT AND DETECT FRAUD AND ABUSE IN MEDICARE PRESCRIPTION DRUG PLANS 28\n\x0c"


type: caselaw

jurisdiction: EU

text:
 18.4.2009
 BG
 Официален вестник на Европейския съюз
 C 90/24
 Решение на Първоинстанционния съд от 4 март 2009 г. — Associazione italiana del risparmio gestito и Fineco Asset Management/Комисия
 (Дело T-445/05) (1)
 (Държавни помощи - Схема за помощи, приведена в изпълнение от италианските власти в полза на някои предприятия за колективно инвестиране в прехвърлими ценни книжа, специализирани в притежаването на акции на дружества с ниска или средна капитализация - Решение, с което помощта се обявява за несъвместима с общия пазар - Жалба за отмяна - Пряко и лично засягане - Допустимост - Задължение за мотивиране - Селективен характер на мярката - Задължение за възстановяване)
 2009/C 90/38
 Език на производството: италиански
 Страни
 Ищци: Associazione italiana del risparmio gestito (Рим, Италия) и Fineco Asset Management SpA (Рим) (представители: адв. G. Escalar, адв. G. Cipolla и адв. V. Giordano, avocats)
 Ответник: Комисия на Европейските общности (представители: г-н V. Di Bucci и г-н E. Righini)
 Предмет
 Отмяна на Решение 2006/638/ЕО на Комисията от 6 септември 2005 г. относно схемата за държавни помощи, която Италия възнамерява да приведе в изпълнение в полза на някои предприятия за колективно инвестиране в прехвърлими ценни книжа, специализирани в притежаването на акции на дружества с ниска или средна капитализация, които се котират на регламентирани пазари (ОВ L 268, 2006 г., стр. 1).
 Диспозитив
 1)
 Отхвърля жалбата.
 2)
 Осъжда жалбоподателите да заплатят съдебните разноски.
 (1) ОВ C 48, 25.2.2006 г.


type: contracts

text:
 Avis juridique important
 |
 E1994A1231(07)
 PROTOCOL 6 on the legal capacity, privileges and immunities of the EFTA Surveillance Authority
 Official Journal L 344 , 31/12/1994 P. 0072 - 0074
 PROTOCOL 6 on the legal capacity, privileges and immunities of the EFTA Surveillance Authority PART I THE EFTA SURVEILLANCE AUTHORITY Article 1The EFTA Surveillance Authority shall possess legal personality. It shall in particular have the capacity to contract, to acquire and dispose of movable and immovable property, and to be a party to legal proceedings.Article 21. Within the scope of its official activities, the EFTA Surveillance Authority shall have immunity from jurisdiction and execution, except:(a) in so far as it has expressly waived such immunity in a particular case;(b) in respect of a civil action by a third party for damage arising from an accident caused by a vehicle or other means of transport belonging to or operated on behalf of the EFTA Surveillance Authority or in respect of a traffic offence involving such means of transport;(c) in the event of the attachment, pursuant to a decision by the administrative or judicial authorities, of the salaries and emoluments, including pension rights, owed by the EFTA Surveillance Authority to a Member, an official or other servant or a former Member, official or other servant;(d) in respect of a counterclaim directly connected with judicial proceedings initiated by the EFTA Surveillance Authority.2. The property of the EFTA Surveillance Authority, wherever located, shall be immune:(a) from any form of requisition, confiscation or expropriation;(b) from any form of sequestration and administrative or provisional judicial constraint, except in the cases provided for in the preceding paragraph.Article 3The archives of the EFTA Surveillance Authority and all documents belonging to it or held by it shall be inviolable wherever located.Article 41. Without being restricted by financial controls, regulations or moratoria of any kind the EFTA Surveillance Authority may:(a) hold funds or currency of any kind and operate accounts of any currency;(b) freely transfer its funds or currency from one country to another or within any country and convert any currency held by it into any other currency.2. In exercising its rights under paragraph 1 of this Article the EFTA Surveillance Authority shall pay due regard to any representations made by any State Party to this Protocol and shall give effect to such representations in so far as it is considered possible to do so without detriment to the interests of the EFTA Surveillance Authority.Article 51. The EFTA Surveillance Authority, its assets, income and other property shall be exempt:(a) from all direct taxes; the EFTA Surveillance Authority shall not, however, claim exemption from rates, taxes or dues which are in fact charges for public utility services;(b) from customs duties and prohibitions and restrictions on imports and exports in respect of articles directly imported or exported by the EFTA Surveillance Authority for its official use. Articles imported under such exemption shall not be sold in the territory of the State into which they were imported except under conditions agreed with the Government of that State;(c) from customs duties and prohibitions and restrictions on imports and exports in respect of its publications.2. When purchases or services of substantial value and necessary for the exercise of the official activities of the EFTA Surveillance Authority are made or used by the EFTA Surveillance Authority and when the price of such purchases and services includes taxes or duties, the State Party to this Protocol that has levied the taxes or duties shall take appropriate measures to grant exemption from such taxes or duties or to provide for their reimbursement, if they are identifiable.Article 61. The EFTA Surveillance Authority shall enjoy in the territory of each State Party to this Protocol, for its official communications, treatment not less favourable than that accorded by the Government of that State to any other comparable international organization, in the matter of priorities, rates and taxes for posts and telecommunications and press rates for information to the press and radio.2. No censorship shall be applied to the official correspondence and other official communications of the EFTA Surveillance Authority.3. The EFTA Surveillance Authority shall have the right to use codes and to dispatch and receive correspondence by courier or in sealed bags, which shall have the same immunities and privileges as diplomatic couriers and bags.PART II THE MEMBERS, OFFICIALS AND OTHER SERVANTS OF THE EFTA SURVEILLANCE AUTHORITY Article 71. The Members of the EFTA Surveillance Authority, the officials and other servants thereof shall enjoy the following privileges and immunities:(a) immunity from jurisdiction, even after they have left the service of the EFTA Surveillance Authority, in respect of acts, including words written or spoken, done by them in the exercise of their function. This immunity shall, however, not apply in the case of a traffic offence committed by a Member, official or other servant, nor in the case of damage caused by a vehicle or other means of transport belonging to or driven by him;(b) inviolability for all their official papers and documents;(c) exemption from all obligations in respect of national service, including military service;(d) together with members of their families forming part of their households, exemption from all measures restricting immigration and from aliens' registration formalities;(e) together with members of their families forming part of their households, the same facilities as to repatrition, in time of international crisis, as are normally accorded to staff members of international organizations;(f) the same treatment in respect of currency and exchange regulations as is normally accorded to staff members of international organizations;(g) exemption from all national income tax on their salaries and emoluments paid to them by the EFTA Surveillance Authority, excluding pensions and other similar benefits paid by the EFTA Surveillance Authority. The States Parties to this Protocol reserve the right to take those salaries and emoluments into account when assessing the amount of tax to be applied to income from other sources.2. The EFTA Surveillance Authority shall specify the classes of officials and other servants to whom paragraph 1 applies and shall inform the EFTA States of its decision. The names of the officials and other servants included in these classes shall regularly be made known to the EFTA States.Article 8In addition to the privileges and immunities provided for in Article 7 (1), the Members of the EFTA Surveillance Authority shall enjoy:(a) immunity from arrest and detention, except when found committing, attempting to commit or just having committed an offence;(b) immunity from civil and administrative jurisdiction and execution enjoyed by diplomatic agents, except in the case of damage caused by a vehicle or other means of transport belonging to or driven by him;(c) full immunity from criminal jurisdiction, except in a case of a traffic offence caused by a vehicle or other means of transport belonging to or driven by him, subject to subparagraph (a);(d) the same customs facilities as regards his personal luggage as are accorded to diplomatic agents.PART III MEMBERS OF ADVISORY BODIES AND EXPERTS Article 91. Members of advisory bodies assisting the EFTA Surveillance Authority in its work shall enjoy the following privileges and immunities while performing their duties for the EFTA Surveillance Authority or carrying out missions on its behalf:(a) immunity from jurisdiction, even after the termination of their mission, in respect of acts, including words spoken or written, done by them in the exercise of their functions; this immunity shall not apply, however, in the case of a traffic offence committed by a member of an advisory body, nor in the case of damage caused by a vehicle or other means of transport belonging to or driven by him;(b) inviolability for all their official papers and documents;(c) exemption from all measures restricting immigration and from aliens' registration formalities;(d) the same treatment in respect of currency and exchange regulations as is accorded to the representatives of foreign governments on temporary official missions.2. Paragraph 1 shall also apply to experts on missions while performing their duties on behalf of the EFTA Surveillance Authority as well as to representatives of the Commission of the European Communities and the EC Member States who participate in the work of the advisory bodies referred to in paragraph 1.PART IV GENERAL PROVISIONS Article 101. The EFTA Surveillance Authority has a duty to waive its immunity in all cases where reliance upon it would impede the course of justice and it can be waived without prejudicing the interests of the Authority.2. Privileges and immunities are granted to the Members, officials and other servants in the interests of the EFTA Surveillance Authority and not for the personal benefit of the individuals themselves. The EFTA Surveillance Authority shall have the right, and is under a duty, to waive the immunity of a Member, official or other servant in any case where, in its opinion, the immunity would impede the course of justice and could be waived without prejudice to the interests of the Authority.Article 11No State Party to this Protocol shall be obliged to accord the privileges and immunities referred to in Article 7 (1) (c), (d) and (e) to its own nationals or permanent residents.Article 12The provisions of this Protocol shall not prejudice the right of each State Party to this Protocol to take all precautionary measures necessary in the interest of its security.Article 13If any State Party to this Protocol considers that there has been an abuse of a privilege or immunity conferred by this Protocol, consultations shall be held between the State and the EFTA Surveillance Authority to determine whether any such abuse has occurred, and, if so, to ensure that no repetition occurs. A State which considers that any person has abused any privilege or immunity granted to him under this Protocol may require him to leave its territory.


text:
 21.7.2012
 LV
 Eiropas Savienības Oficiālais Vēstnesis
 C 217/26
 Prasība, kas celta 2012. gada 22. maijā — Micrus Endovascular/ITSB — Laboratorios Delta (“DELTA”)
 (Lieta T-218/12)
 2012/C 217/55
 Valoda, kādā sagatavots prasības pieteikums — angļu
 Lietas dalībnieki
 Prasītāja: Micrus Endovascular LLC (Wilmington, Amerikas Savienotās Valstis) (pārstāvis — B. Brandreth, Barrister)
 Atbildētājs: Iekšējā tirgus saskaņošanas birojs (preču zīmes, paraugi un modeļi)
 Otra procesa ITSB Apelāciju padomē dalībniece: Laboratorios Delta Lda (Queluz, Portugāle)
 Prasītājas prasījumi
 —
 atcelt Iekšējā tirgus saskaņošanas biroja (preču zīmes, paraugi un modeļi) Apelāciju otrās padomes 2012. gada 6. marta lēmumu lietā R 244/2011-2 un
 —
 piespriest atbildētājam atlīdzināt prasītājai izdevumus, kas tai radušies Apelāciju padomē un Vispārējā tiesā
 Pamati un galvenie argumenti
 Kopienas preču zīmes reģistrācijas pieteikuma iesniedzēja: prasītāja
 Attiecīgā Kopienas preču zīme: vārdiska preču zīme “DELTA” attiecībā uz precēm, kas ietilpst 10. klasē — Kopienas preču zīmes reģistrācijas pieteikums Nr. 6655906
 Iebildumu procesā pretstatītās preču zīmes vai apzīmējuma īpašniece: otra procesa ITSB Apelāciju padomē dalībniece
 Pretstatītā preču zīme vai apzīmējums: starptautiskas grafiskas preču zīmes “DELTA PORTUGAL” reģistrācija Nr. 131374 attiecībā uz precēm, kas ietilpst 5. klasē; Portugāles grafiskas preču zīmes “DELTA PORTUGAL” reģistrācija Nr. 140578 attiecībā uz precēm, kas ietilpst 5. klasē; reģistrēta firma “LABORATORIOS DELTA” Nr. 23113
 Iebildumu nodaļas lēmums: iebildumus apmierināt
 Apelāciju padomes lēmums: apelācijas sūdzību noraidīt
 Izvirzītie pamati: Padomes Regulas Nr. 207/2009 8. panta 1. punkta b) apakšpunkta pārkāpums


type: legislation

text:
 Avis juridique important
 |
 52000PC0640
 Förslag rådets förordning om upphävande av förordning (EG) nr 2151/1999 beträffande införande av ett förbud mot flygningar mellan gemenskapens och Förbundsrepubliken Jugoslaviens territorier med undantag av Republiken Montenegros och Kosovoprovinsens /* KOM/2000/0640 slutlig */
 Förslag RÅDETS FÖRORDNING om upphävande av förordning (EG) nr 2151/1999 beträffande införande av ett förbud mot flygningar mellan gemenskapens och Förbundsrepubliken Jugoslaviens territorier med undantag av Republiken Montenegros och Kosovoprovinsens (framlagt av kommissionen)MOTIVERINGTill följd av de val som nyligen ägt rum har i Jugoslavien uppstått en ny politisk situation som präglas av en tydlig förändringsvilja. När de politiska förhållandena så medger kan det bli nödvändigt att upphäva förbudet mot flygningar avseende Jugoslavien för att bidra till stärkandet av demokratin och rättsstaten.Syftet med detta förslag till förordning är att omsätta denna avsikt i gemenskapens rättsordning.FörslagRÅDETS FÖRORDNINGom upphävande av förordning (EG) nr 2151/1999 beträffande införande av ett förbud mot flygningar mellan gemenskapens och Förbundsrepubliken Jugoslaviens territorier med undantag av Republiken Montenegros och KosovoprovinsensEUROPEISKA UNIONENS RÅD HAR ANTAGIT DENNA FÖRORDNINGmed beaktande av Fördraget om upprättandet av Europeiska gemenskapen, särskilt artikel 301 i detta,med beaktande av gemensam ståndpunkt XXXXXX [1] av den XX oktober 2000 antagen av rådet på grundval av artikel 15 i Fördraget om Europeiska unionen, beträffande flygningar mellan gemenskapens territorium och delar av Jugoslaviens territorium (Serbien),[1] EGT Lmed beaktande av kommissionens förslag [2], och[2] EGT C [...], [...], s. [...].av följande skäl:(1) Till följd av de nyss hållna valen har i Jugoslavien uppstått en ny politisk situation som präglas av en tydlig förändringsvilja; under dessa omständigheter skulle upphävandet av förbudet mot flygningar mellan gemenskapen och Jugoslavien kunna bidra till stärkandet av demokratin och rättsstaten.HÄRIGENOM FÖRESKRIVS FÖLJANDE.Artikel 1Förordningarna (EG) nr 2151/1999 [3] och (EG) nr 607/2000 [4] skall upphöra att gälla.[3] EGT L 264, 12.10.1999, s. 3.[4] EGT L 73, 22.3.2000, s. 4.Artikel 2Denna förordning träder i kraft samma dag som den offentliggörs i Europeiska gemenskapernas officiella tidning.Denna förordning är till alla delar bindande och direkt tillämplig i alla medlemsstater.Utfärdad i Bryssel denPå rådets vägnarOrdförande


text:
 115 HR 2098 IH: Second Amendment Defense Act of 2017
 U.S. House of Representatives
 2017-04-14
 text/xml
 EN
 Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
 I115th CONGRESS1st SessionH. R. 2098IN THE HOUSE OF REPRESENTATIVESApril 14, 2017Mr. Perry introduced the following bill; which was referred to the Committee on the JudiciaryA BILLTo eliminate the authority of the executive branch to further restrict the conduct of individuals
 in relation to firearms or ammunition.
 1.Short titleThis Act may be cited as the Second Amendment Defense Act of 2017. 2.Elimination of executive authority to further restrict conduct of individuals in relation to firearms or ammunitionNo officer or employee of the Federal Government may take any action that would result in a limitation on the conduct of an individual in relation to a firearm or ammunition that is more restrictive than the limitations on the conduct that are in effect as of January 3, 2016.


text:
 3.4.2017
 EL
 Επίσημη Εφημερίδα της Ευρωπαϊκής Ένωσης
 C 104/50
 Προσφυγή-αγωγή της 17ης Ιανουαρίου 2017 — Barnett κατά ΕΟΚΕ
 (Υπόθεση T-23/17)
 (2017/C 104/70)
 Γλώσσα διαδικασίας: η γαλλική
 Διάδικοι
 Προσφεύγουσα-ενάγουσα: Inge Barnett (Roskilde, Δανία) (εκπρόσωποι: S. Orlandi και T. Martin, δικηγόροι)
 Καθής-εναγομένη: Ευρωπαϊκή Οικονομική και Κοινωνική Επιτροπή
 Αιτήματα
 Η προσφεύγουσα-ενάγουσα ζητεί από το Γενικό Δικαστήριο:
 —
 κυρίως, να ακυρώσει την απόφαση της 21ης Μαρτίου 2016, η οποία λήφθηκε σε εκτέλεση της αποφάσεως του Δικαστηρίου Δημόσιας Διοίκησης της 22ας Σεπτεμβρίου 2015 και με την οποία απορρίφθηκε η υπαγωγή της προσφεύγουσας στην ευεργετική ρύθμιση της πρόωρης συνταξιοδοτήσεως χωρίς μείωση των συνταξιοδοτικών δικαιωμάτων της·
 —
 επικουρικώς, να υποχρεώσει την Ευρωπαϊκή Οικονομική και Κοινωνική Επιτροπή σε καταβολή στην προσφεύγουσα-ενάγουσα ποσού 207 994,14 ευρώ για την υλική ζημία την οποία υφίσταται, πλέον τόκων υπερημερίας, υπολογιζόμενων από την ημερομηνία κατά την οποία κατέστησαν απαιτητά τα οφειλόμενα ποσά, με επιτόκιο το καθοριζόμενο από την Ευρωπαϊκή Κεντρική Τράπεζα (ΕΚΤ) για τις κύριες πράξεις αναχρηματοδοτήσεως, προσαυξημένο κατά τρεισήμισι ποσοστιαίες μονάδες, καθώς και κατ’ αποκοπήν ποσού 25 000 ευρώ για την ηθική βλάβη την οποία υφίσταται·
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 σε κάθε περίπτωση, να καταδικάσει την Ευρωπαϊκή Οικονομική και Κοινωνική Επιτροπή στα δικαστικά έξοδα.
 Λόγοι και κύρια επιχειρήματα
 Προς στήριξη της προσφυγής-αγωγής της, η προσφεύγουσα-ενάγουσα προβάλλει τρεις λόγους.
 1.
 Ο πρώτος λόγος αντλείται από παράβαση του άρθρου 266 ΣΛΕΕ, καθόσον η καθής-εναγόμενη δεν έλαβε υπόψη το σκεπτικό της αποφάσεως του Δικαστηρίου Δημόσιας Διοίκησης της 22ας Σεπτεμβρίου 2015, Barnett κατά ΕΟΚΕ (F-20/14, στο εξής: απόφαση του ΔΔΔ, EU:F:2015:107), κατά τη λήψη των μέτρων εκτελέσεως. Ειδικότερα, από την αιτιολογία της προσβαλλομένης αποφάσεως προκύπτει ότι η καθής-εναγόμενη δεν εφάρμοσε τα προβλεπόμενα στις γενικές διατάξεις εφαρμογής (ΓΔΕ) κριτήρια προκειμένου να προβεί στη φερόμενη επανεξέταση της υποψηφιότητας της προσφεύγουσας-ενάγουσας. Σε κάθε περίπτωση, η προσβαλλόμενη απόφαση δεν θεραπεύει τη διαπιστωθείσα από το Δικαστήριο Δημόσιας Διοίκησης παρανομία, δηλαδή τον μη ορισμό του συμφέροντος της υπηρεσίας στις ΓΔΕ της ΕΟΚΕ.
 2.
 Ο δεύτερος λόγος αντλείται από το ότι η προσβαλλόμενη απόφαση πάσχει από πρόδηλα σφάλματα εκτιμήσεως του συμφέροντος της υπηρεσίας το οποίο φέρεται ότι υπήρχε το 2013.
 3.
 Ο τρίτος λόγος, ο οποίος προβάλλεται επικουρικώς, αντλείται από την αναρμοδιότητα της ΕΟΚΕ να λάβει νέα απόφαση σχετική με την πρόωρη συνταξιοδότηση χωρίς μείωση των συνταξιοδοτικών δικαιωμάτων κατόπιν της καταργήσεως του άρθρου 9, παράγραφος 2, του παραρτήματος VIII του ΚΥΚ, με τον κανονισμό 1023/2013 του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου, της 22ας Οκτωβρίου 2013, για την τροποποίηση του κανονισμού υπηρεσιακής κατάστασης των υπαλλήλων της Ευρωπαϊκής Ένωσης, καθώς και του καθεστώτος που εφαρμόζεται στο λοιπό προσωπικό της Ευρωπαϊκής Ένωσης (ΕΕ 2013, L 287, σ. 15). Ως εκ τούτου, λόγω της διαπιστωθείσας με την απόφαση του ΔΔΔ παρανομίας, η προσφεύγουσα-ενάγουσα στερήθηκε οριστικώς της δυνατότητας να υπαχθεί στην επίμαχη ευεργετική ρύθμιση. Για τον λόγο αυτό, επιβάλλεται η πλήρης αποζημίωσή της.


type: wikipedia

text:
Η Διεθνής Ολυμπιακή Επιτροπή (ΔΟΕ, αγγλικά: International Olympic Committee, IOC, γαλλικά: Comité International Olympique, COI) δημιουργήθηκε από τον Δημήτριο Βικέλα και τον Πιερ ντε Κουμπερτέν το 1894 για να αναβιώσει τους Αρχαίους Ολυμπιακούς Αγώνες που πραγματοποιούνταν στην Ελλάδα.
 Η ΔΟΕ διοργανώνει τους Ολυμπιακούς Αγώνες. Αποφασίζει επίσης για την εισαγωγή ή την κατάργηση ενός αθλήματος από το πρόγραμμα των Ολυμπιακών αγώνων. Οι αγώνες της Ολυμπιάδος γιορτάζονται κάθε 4 χρόνια (θερινοί) ενώ οι χειμερινοί το 3ο έτος της Ολυμπιάδας. Οι πρώτοι θερινοί εορτάστηκαν το 1896 στην Αθήνα, ενώ οι πρώτοι χειμερινοί το 1924 στο Σαμονί (Chamonix) της Γαλλίας.
 Οργάνωση
 Η Σύνοδος της ΔΟΕ
 Η Σύνοδος της ΔΟΕ είναι η γενική συνέλευση των μελών της ΔΟΕ. Πραγματοποιείται μία φορά το χρόνο κατά τον οποίο κάθε μέλος έχει μία ψήφο. Είναι το ανώτατο όργανο της ΔΟΕ και οι αποφάσεις της είναι οριστικές.
 Έκτακτες σύνοδοι μπορούν να συγκαλούνται από τον Πρόεδρο ή μετά από γραπτή αίτηση τουλάχιστον του ενός τρίτου των μελών της.
 Μεταξύ άλλων, οι αρμοδιότητες της Συνόδου είναι:
 Να εγκρίνει ή να τροποποιήσει τον Ολυμπιακό Χάρτη.
 Να εκλέγει τα μέλη της ΔΟΕ, τον Επίτιμο Πρόεδρο και τα επίτιμα μέλη.
 Να εκλέγει τον Πρόεδρο, τους Αντιπροέδρους και όλα τα άλλα μέλη της Εκτελεστικής Επιτροπής της ΔΟΕ.
 Να εκλέγει τη διοργανώτρια πόλη των Ολυμπιακών Αγώνων.
 Η Εκτελεστική Επιτροπή της ΔΟΕ
 Η εκτελεστική επιτροπή της ΔΟΕ αποτελείται από τον Πρόεδρο, τέσσερις αντιπροέδρους και από άλλα δέκα μέλη. Όλα τα μέλη της Εκτελεστικής Επιτροπής της ΔΟΕ εκλέγονται από τη σύνοδο, σε μυστική ψηφοφορία, με πλειοψηφία των ψηφισάντων. Η Εκτελεστική Επιτροπή της ΔΟΕ αναλαμβάνει τη γενική συνολική ευθύνη για τη διαχείριση της ΔΟΕ και τη διαχείριση των υποθέσεών της.
 Η Σύνοδος της ΔΟΕ εκλέγει, με μυστική ψηφοφορία, τον Πρόεδρο της ΔΟΕ μεταξύ των μελών του, για θητεία οκτώ ετών, άπαξ ανανεώσιμη για μια θητεία τεσσάρων ετών. Ο πρόεδρος της ΔΟΕ, Τόμας Μπαχ, εξελέγη για θητεία οκτώ ετών στις 10 Σεπτεμβρίου 2013. Ο Μπαχ θα είναι υποψήφιος για επανεκλογή το 2021.
 Πρόεδροι της ΔΟΕ
 Διετέλεσαν οι:
 1894 - 1896 Δημήτριος Βικέλας
 1896 - 1925 Πιέρ ντε Κουμπερτέν
 1925 - 1942 Ανρί ντε Μπαγιέ Λατούρ
 1946 - 1952 Σιγκφριντ Εντστρομ
 1952 - 1972 Έιβερι Μπράντεζ
 1972 - 1980 Λόρδος Κιλάνιν
 1980 - 2001 Χουάν Αντόνιο Σάμαρανκ
 2001 - 2013 Ζακ Ρόγκ
 2013 - Τόμας Μπαχ
 Ελληνική Εκπροσώπηση
 Δημήτριος Βικέλας (1894-1899): 1ος και μοναδικός Έλληνας πρόεδρος της ΔΟΕ
 Αλέξανδρος Μερκάτης (1899-1925): μέλος
 Γεώργιος Αβέρωφ (1926-1930): μέλος
 Νικόλαος Πολίτης (1930-1933): μέλος
 Άγγελος Βολανάκης (1933-1963): μέλος
 Ιωάννης Κετσέας (1946-1965): μέλος
 Κωνσταντίνος Β ́ της Ελλάδας (1963-1974): επίτιμο μέλος
 Πύρρος Λάππας (1965-1980): μέλος
 Επαμεινώνδας Πετραλιάς (1975-1977): μέλος
 Νικόλαος Νησιώτης (1978-1986): μέλος
 Νίκος Φιλάρετος (1981-2005): μέλος
 Λάμπης Νικολάου (1986-2015): επίτιμο μέλος (από το 1986 έως το 2005 ήταν το τελευταίο χρονικό διάστημα που η Ελλάδα είχε 2 Αθάνατους στη ΔΟΕ)
 Σπύρος Καπράλος (2019-): μέλος
 Παραπομπές
 Εξωτερικοί σύνδεσμοι
 Επίσημη ιστοσελίδα


text:
 19.3.2011
 ET
 Euroopa Liidu Teataja
 C 89/11
 Eelotsusetaotlus, mille on esitanud Upper Tribunal (Tax and Chancery Chamber) (Ühendkuningriik) 12. jaanuaril 2011 — The Commissioners for Her Majesty’s Revenue & Customs versus Philips Electronics UK Ltd
 (Kohtuasi C-18/11)
 2011/C 89/20
 Kohtumenetluse keel: inglise
 Eelotsusetaotluse esitanud kohus
 Upper Tribunal (Tax and Chancery Chamber) (Ühendkuningriik)
 Põhikohtuasja pooled
 Kaebuse esitaja: The Commissioners for Her Majesty’s Revenue & Customs
 Vastustaja: Philips Electronics UK Ltd
 Eelotsuse küsimused
 1.
 Kui liikmesriik (nt Ühendkuningriik) arvab oma maksubaasi hulka teises liikmesriigis (nt Madalmaad) registreeritud ja seal maksuresidendiks oleva äriühingu kasumi ja kahjumi ulatuses, mis hõlmab Madalmaade äriühingu Ühendkuningriigis paikneva püsiva tegevuskoha äritegevuse kaudu Ühendkuningriigis teeninud kasumit, siis kas Ühendkuningriik piirab ELTLi artiklis 49 (endine EÜ artikkel 43) sätestatud liikmesriigi kodaniku asutamisvabadust Ühendkuningriigis sellega, et takistab Ühendkuningriigi mitteresidendist äriühingu Ühendkuningriigis paikneva püsiva tegevuskoha poolt Ühendkuningriigis teenitud kahjumi ülekandmist Ühendkuningriigi äriühingule kontsernisisese maksuvähendusena, juhul kui kahjumi kõik osad või mis tahes muu arvesse võetav summa „vastavad summale/on esindatud summas, mille saab äriühingu või isiku mujal kui Ühendkuningriigis teenitud kasumi pealt (mis tahes ajavahemiku eest) välismaise maksuna maha arvata või muul viisil arvesse võtta” — st, et Ühendkuningriigis paikneva püsiva tegevuskoha poolt Ühendkuningriigis teenitud kahjumit on lubatud üle kanda üksnes juhul, kui on selge, et nõude esitamise ajal ei saa teha mahaarvamisi mõnes muus riigis väljaspool Ühendkuningriiki (sh teises liikmesriigis (nt Madalmaades)), kusjuures loa andmiseks ei peeta piisavaks ka seda, et maksusoodustust, mida teistes riikides oleks olnud võimalik saada, tegelikult ei taotletud, ega ka olukorda, kus teises riigis ei ole võimalik kohaldada Ühendkuningriigi residendist äriühingu Ühendkuningriigis teenitud kahjumi ülekandmisele võrdväärseid tingimusi?
 2.
 Kui see on nii, siis kas saab seda piirangut põhjendada:
 a)
 üksnes kahjumi topeltkasutamise takistamisega või
 b)
 üksnes liikmesriikidele antud maksustamispädevuse tasakaalustamise vajadusega või
 c)
 liikmesriikidele antud maksustamispädevuse tasakaalustamise ja kahjumi topeltkasutamise vältimise vajadusega?
 3.
 Kui see on nii, siis kas piirang on sellis(t)e põhjendus(t)ega proportsionaalne?
 4.
 Kas ELi õiguse kohaselt peab Ühendkuningriik juhul, kui Madalmaade äriühingu õigustele seatud piirang ei ole põhjendatud, või siis ulatuses, milles piirang ei ole proportsionaalne ühegi õigustusega, pakkuma Ühendkuningriigi äriühingule õiguskaitset, näiteks andma talle õiguse taotleda kasumi pealt kontserni maksusoodustust?