Unique device identification
Premier strongly supports including the House-passed language in the final healthcare reform bill requiring the Food and Drug Administration (FDA) to promulgate regulations to create a unique device identification (UDI) system for medical devices within six months of enactment of healthcare reform.  UDI is the missing link to protect the safety of patients by improving processes for device recalls and corrections.  Unlike medications, and virtually every other product sold in the marketplace, medical devices cannot be identified in a systematic and consistent manner.  The resulting ad hoc approach results in increased clinical risks to patients, including implanting a defective, counterfeit or recalled product, inability to track the recipient of a faulty product (recalls) and inability to track adverse events appropriately.
 
Physician Payment Sunshine Act
Premier is pleased that provisions to increase the transparency of financial relationships between the industry and physicians by requiring manufacturers of drugs, devices or medical supplies to publicly report payments or other "transfers of value" to physicians are included in the bill.  We support the Senate's approach which requires drug, device, biologics or medical supply manufacturers to publicly report all payments of value to physicians and teaching hospitals.  It also requires manufacturers or group purchasing organizations to disclose ownership or investment interest (other than a publicly traded security and mutual fund) held by a physician.
 
Comparative Effectiveness
Premier applauds both the House and the Senate for including provisions to create a comparative effectiveness research entity to identify priority areas of comparative clinical research and oversee the conduct of this research.  Premier prefers the Senate approach, which would create an independent institute (neither an agency nor establishment of the federal government)-the Patient-Centered Outcomes Research Institute-that would be advised by expert advisory panels and a methodology committee and overseen by a board of governors.
Health Disparities
Premier strongly supports healthcare reform provisions aimed at reducing healthcare disparities and improving the health status of all population groups.  In particular, we support provisions in the Senate bill that would establish community transformation grants and market-based incentives in the exchanges to reward quality and reduce healthcare disparities, as well as the House provision that would create community wellness and prevention grants.  Both the House and the Senate bills include additional provisions that Premier urges you to retain in the final bill, including those that would:  create grants for cultural and linguistic competence; standardize data collection and reporting; elevate the Office of Minority Health and authorize it to work with community organizations to develop quality measures to evaluate the effectiveness of activities aimed at reducing healthcare disparities; and broaden the definition of health disparities to reflect other populations impacted by inequities.
 
Rural Health Clinics
Premier asks that you address what we believe to be an oversight in the legislation and include Rural Health Clinics, Federally Qualified Health Center Look-Alikes and Indian Health Services/Tribal Health Clinics in the provisions of the bills that currently include only one type of safety net clinic, Federally Qualified Health Centers (FQHCs).  All these safety-net providers are essential to providing services for poor and under-served patients and share most of the same policy needs as FQHCs.  It only makes sense that they be treated equally.
 
The Premier healthcare alliance looks forward to working with you to advance these healthcare reforms and to further refine the final healthcare reform package to ensure that it accomplishes the goals of improving healthcare quality while safely reducing costs.
 
Sincerely,

Blair Childs
Senior Vice President, Public Affairs