POLICY BRIEFINGS


GAO Reports on Price Disparities of Federal Drug Related Programs


A Government Accountability Office (GAO) report requested by Senator Tom Coburn (R-OK) was released in which the agency found that, for a sample of 78 high use and high expenditure brand name and generic drugs, Medicare Part D pays 32% more than Medicaid and that the Department of Defense (DOD) pays 60% more than Medicaid per unit. The differential was said to be mainly related to the amount of post-purchase price adjustments, e.g. refunds, rebates, or price concessions by drug manufacturers, which ranged from 15% for Medicare Part D, 31% for DOD and nearly 53% for Medicaid.


HHS Makes Disaster Preparedness Awards


HHS announced, pursuant to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (P.L. 113-5), that it has approved FY 2014 grants totaling $228.5 million for the hospital preparedness program and $611.8 for the Public Health Emergency Preparedness program. HHS said the funds were jointly awarded to encourage further cooperation between health care and public health systems to respond to emergencies and manage public health on a daily basis.


FDA Issues Policies for Compounding Pharmacies


Pursuant to the provisions of P.L. 113-54, the Drug Quality and Security Act (DQSA), the FDA issued final and interim draft guidance documents as well as a proposed rule. Under the proposed rule the FDA would revise the list of drugs that may not be compounded by compounders or outsourcing facilities because they have been withdrawn or removed from the market after they were found to be unsafe or not effective. The final guidance document describes the interim policies that require implementing regulations of the DQSA and the policies the agency will follow in regulating compounding entities under the new law. The draft interim guidance document describes the agency’s expectations regarding compliance with current good manufacturing practice requirements for facilities that compound human drugs and register with the agency as outsourcing facilities.


Upcoming Health-Related Hearings and Markups


House Energy and Commerce Health Subcommittee: will hold a hearing titled “21st Century Cures: Modernizing Clinical Trials.” 10 a.m., 2123 Rayburn; July 9.

Senate Special Aging Committee: will hold a roundtable discussion titled “Improving Audits: How We Can Strengthen the Medicare Program for Future Generations.” 2:15 p.m., 216 Hart; July 9.

House Oversight and Government Reform Subcommittee on Energy Policy, Health Care and Entitlements: will hold a hearing on Medicare management. 10 a.m., 2154 Rayburn; July 10.

House Veterans’ Affairs Committee: will hold a hearing titled “Service Should Not Lead to Suicide: Access to VA’s Mental Health Care.” 9:15 a.m., 334 Cannon; July 10.

House Energy and Commerce Health Subcommittee: will hold a hearing titled “21st Century Cures: Incorporating the Patient Perspective.” 10 a.m., 2322 Rayburn; July 11.



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