State and Federal “Sunshine Acts” Shift KOL Marketing Tactics Historically, biological, pharmaceutical and medical device firms ("firms") marketed products to health care providers ("provider") through the provision of clinical information as well as a variety of promotional marketing programs which included various incentives such as free meals, free trips, free CME, free office supplies, honoraria, speaker fees, paid consulting agreements, etc., ("remuneration"). Undisclosed paid endorsements of firm products by key opinion leader (KOL) physicians at academic research institutions arguably resulted in inefficient utilization of products with concomitant resulting financial and/clinical harms to payers and patients. By making such remuneration "transparent", regulators will be able to identify and prosecute abusive and/or illegal remuneration practices by firms and academic KOLs will arguably be more likely to abide by applicable conflict of interest policies.
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Accountable Care Organization Clinical Integration Since its formation in 1965, Medicare has been the proverbial government manipulated “tail that wags the (private sector health care market) dog” in national health care reimbursement policy. Due to its sheer size and reach, Medicare (Parts A to D) dwarfs all other federal and state healthcare programs combined. Therefore changes affecting Medicare reimbursement and care delivery structure generally have had an immediate, profound, and transformative effect not just on Medicare, but also on private sector commercial insurance reimbursement practices as well. In this sense, Medicare has operated as a government run “incubator” for national healthcare reimbursement policies and structural market reforms. So in order to understand how healthcare has evolved to its present state, one also needs to understand how Medicare has and continues to transform the commercial healthcare industry.
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ALSCG Optimizing Your Return on Investment Life science organizations are turning to technology to address the shifting challenges of contract management, particularly with respect to controlling potential revenue leakage, safe‐guarding against compliance issues, and facilitating government reporting. Contemporary contract management solutions offer flexible and configurable capabilities that aid in harmonizing pricing guidelines and terms.
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Outsourcing Your Compliance Headache ‐ BPO Now that the complexities and operational challenges associated with healthcare reform have been recognized, and the life sciences industry gains more clarity around the regulations, many firms are taking time to review their internal infrastructures against government compliance requirements.
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ALSCG Revenue Contract Management System Implementations A multitude of business drivers are leading Life Sciences companies to evaluate and implement Revenue Contract Management (RCM) solutions. These include the need to ensure compliance in an ever‐changing regulatory landscape, a systematic approach to commercial and government contract administration and the need for business intelligence required to effectively evaluate and implement innovative contracting strategies.
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Staying Compliant with the Physician Payments Sunshine Act Eleven months after the Patient Protection and Affordable Care Act (PPACA) became law on March 23, 2010, the implementation challenges associated with health care reform continue. Unfortunately for the life sciences industry, the passage of PPACA’s Physician Payments Sunshine Act provisions did not standardize, curtail, or rationalize pre-existing state-specific aggregate spend reporting obligations.
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Healthcare Reform, Compliance, and Organizational Optimization As the US healthcare industry continues to mobilize with the arrival of the Patient Protection and Affordable Care Act (PPACA), life sciences manufacturers must not only prepare to comply with changing Federal legislation, but also consider how the process of compliance can best be leveraged to optimize their businesses.
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Leveraging CLM Automation for Competitive Advantage While many organizations have come to realize the importance of implementing more robust contract lifecycle management (CLM) solutions, many fail to realize the full potential benefits of such automation.
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