Government Affairs Issues
There are a variety of issues either currently impacting, or poised to impact healthcare distributors and their hospital, extended care, and physician/alternate site customers. To learn more about the issues below please call HIDA's Government Affairs team at (703) 549-4432 or email them at hidagovaffairs@hida.org.
Advocacy
Pedigree (Supply Chain Integrity)—Pedigrees, or tracking requirements, are intended to ensure the safety and integrity of the pharmaceutical supply chain, a multi-step distribution process that ensures providers and patients receive the wide-range of life-saving medical-surgical products they require. HIDA supports the implementation of a federal requirement that will allow non-ADR, licensed distributors, to provide pedigree information back to the last ADR in the supply chain who purchased the product directly from the manufacturer.
Competitive Bidding (DME) — The Medicare Modernization Act of 2003 requires Medicare to replace the current DME payment methodology for certain Part B items with a competitive bidding process. HIDA supports a competitive bidding program that permits any willing provider to participate in the program as long it meets Medicare enrollment and participation requirements, and is willing to accept the payment rate established through competitive bidding.
Monitoring
Seasonal Flu Vaccine—Access to the seasonal flu vaccine is critical to the public health and each year HIDA works with Congress, federal officials, state agencies and legislatures, and industry partners to protect and improve the flu vaccine supply chain.
Unique Device Identification—The Food and Drug Administration Amendments Act of 2007 (FDAAA) mandates the establishment of a Unique Device Identification System for all FDA regulated devices. The FDA is developing draft regulations to implement these requirements. HIDA supports a program that would help ensure product integrity; however criteria must be established to ensure that this program will be implemented in the most cost effective and practical way possible.
Licensure—Currently 36 states have licensure requirements that medical-surgical products distributors must adhere to in order to deliver prescription drugs, devices, and medical equipment to healthcare providers. HIDA supports a clear, uniform, and reasonable oversight system for medical-surgical products distributors.
Gift Disclosure— Several Federal and State lawmakers are seeking gift disclosure rules for drug companies and their pharmaceutical sales representatives. Some legislation inadvertently regulates medical products distributors, when increasing manufacturer-to-provider transparency is the original intent. HIDA supports language that excludes distributors from disclosure requirements.
Vendor Credentialing—Vendor credentialing refers to the practice of patient care centers implementing requirements that vendors must satisfy to enter or work in the healthcare institution. HIDA supports the establishment of effective credentialing criteria to reduce duplication and cost inflation.
Emergency/Pandemic Preparedness— Medical product distributors play a pivotal role in emergency preparedness. Distributors are among healthcare’s first responders during natural disasters, biological events, and other adverse scenarios. HIDA has taken a proactive role in educating both the government and distributors in the value of advance planning.
Health Information Technology—Health IT enables doctors to instantly access medical records at the point of care and elsewhere. HIDA has an interest in Health IT's impact on the medical products supply chain and its role in advancing medical safety and efficiency.
Medicare Reimbursement—Medicare reimbursement rates have an enormous impact on beneficiary access to life-saving medical products. Changes in Medicare reimbursement rates can adversely affect the spending levels within the Acute, Physician and Extended Care market segments that HIDA members serve.
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