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The aim is to strengthen clinical research in Europe in a number of areas with unmet medical needs. Specific actions under clinical trials listed in this work programme (especially under investigator-driven clinical trials) will have a major European added value into translating research to clinical practice. The objective is increasing therapeutic options for patients, stimulating the implementation of best practice in all Member States (MS) and in establishing the basis for a coherent programme addressing the issue of personalized medicine and improved therapeutic outcomes. Lifestyle factors (nutrition, environment, stress, smoking, alcohol and drug intake, exercise, etc.) have a. | AUTHENTICATED U.S. GOVERNMENT INFORMATION z GPCT Vol. 77 Friday No. 218 November 9 2012 Part II Department of Health and Human Services Centers for Medicare Medicaid Services 42 CFR Parts 413 and 417 Medicare Program End-Stage Renal Disease Prospective Payment System Quality Incentive Program and Bad Debt Reductions for All Medicare Providers Final Rule 67450 Federal Register Vol. 77 No. 218 Friday November 9 2012 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare Medicaid Services 42 CFR Parts 413 and 417 CMS-1352-F RIN 0938-AR13 Medicare Program End-Stage Renal Disease Prospective Payment System Quality Incentive Program and Bad Debt Reductions for All Medicare Providers AGENCY Centers for Medicare Medicaid Services CMS HHS. ACTION Final rule. SUMMARY This final rule updates and makes revisions to the end-stage renal disease ESRD prospective payment system PPS for calendar year CY 2013. This rule also sets forth requirements for the ESRD quality incentive program QIP including for payment year PY 2015 and beyond. In addition this rule implements changes to bad debt reimbursement for all Medicare providers suppliers and other entities eligible to receive Medicare payment for bad debt and removes the cap on bad debt reimbursement to ESRD facilities. See the Table of Contents for a listing of the specific issues addressed in this final rule. DATES Effective Date These regulations are effective on January 1 2013. Applicability Date The regulations setting forth the reductions in Medicare bad debt pursuant to section 3201 of the Middle Class Tax Extension and Job Creation Act of 2012 Pub. L. 112-96 are applicable for cost reporting periods beginning October 1 2012. FOR FURTHER INFORMATION CONTACT Michelle Cruse 410 786-4533 for issues related to ESRD. Heidi Oumarou 410 786-7942 for issues related to the ESRD market basket. Anita Segar 410 786-4614 for issues related to the QIP. Kellie Shannon 410 786-0416 for information regarding .