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DETAILED SUMMARY OF AFFORDABLE HEALTH CARE FOR AMERICA ACT <br />biosimilar product must have no clinically meaningful differences in safety, purity or potency from the <br />reference product, and may not be licensed until at least 12 years after the date that the brand-name <br />product was licensed. <br />Physician Payment Sunshine. Requires manufacturers or distributors to electronically report to the <br />HHS OIG any payments or other transfers of value above a $5 de minimis made to a "covered <br />recipient" (physician, physician group practice, other prescribers, pharmacy or pharmacist, health <br />insurance issuer, group health plan, pharmacy benefit manager, hospital, medical school, sponsor of a <br />continuing medical education program, patient advocacy or disease specific group, organization of <br />health care professionals, biomedical researcher, group purchasing organization.) Requires hospitals, <br />manufacturers and group purchasing organizations to report the nature of ownership arrangements by <br />physicians. Failure to report is subject to civil monetary penalties from $1000 to $10,000 (max <br />$150,000 per year) per payment, transfer of value, or investment interest not disclosed; penalties for <br />knowing failure to report range from $10,000 to $100,000 per payment, not to exceed $1,000,000 in <br />one year or .1% of revenues for that year. <br />Comparative Effectiveness Research (CER). Creates a new Center at the Agency for Healthcare <br />Research and Quality, supported by a combination of public and private funding that will conduct, <br />support and synthesize CER. An independent stakeholder Commission makes recommendations to the <br />Center on research priorities, study methods, and ways to disseminate research. The Commission has <br />its own source of funding and is responsible for evaluating the processes of the Center and is <br />authorized to make reports directly to Congress. A majority of the Commission members would be <br />required to be physicians, other health care practitioners, consumers or patients. The blended bill <br />contains improved protections to ensure that subpopulations are appropriately accounted for in <br />research study design and dissemination. The bill contains protections to prevent the Center and <br />Commission from mandating payment, coverage or reimbursement policies. In addition, the bill <br />contains protections to ensure that research findings are not construed to mandate coverage, <br />reimbursement or other policies to any public or private payer, and clarify that federal officers and <br />employees will not interfere in the practice of medicine. <br />Reducing Waste, Fraud, and Abuse <br />Increases funding by $100 million annually for the Healthcare Fraud and Abuse Control Fund to fight <br />Medicare and Medicaid fraud; improves provider and payment screening to prevent fraud and abuse <br />before it occurs; creates enhanced oversight for Medicare and Medicaid programs at risk of fraud and <br />abuse; creates new penalties for providers and suppliers that defraud federal health care programs; <br />partners with the private sector to reduce waste and abuse by requiring that all Medicare and <br />Medicaid providers establish compliance programs to reduce waste, fraud, and abuse. <br />Prevention & Wellness <br />Creates a grant program to help small and mid-sized employers begin or strengthen workplace <br />wellness programs. These grants will assist in improving the health of our nation's workforce and will <br />reduce employer health care costs. Participating employers must offer the programs to all employees <br />Prepared by the Committees on Ways & Means, Energy & Commerce, and Education & tabor 8 <br />October 29, 2009 <br />31 <br />