New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:    

  • Health Reform Update. Congress returns next week from its August recess, starting a critical period for the fate of health reform legislation. After a turbulent summer of town hall meetings and public wrangling regarding the scope of reform, President Obama will address a joint session of Congress on September 9, 2009 to discuss in more detail his vision for the legislation.
  • Regulatory Developments. HHS and the FTC have issued rules on notification of health information breaches. The FDA has issued proposed rules that would require manufacturers and other covered entities to report adverse drug, biological, and device events electronically. The FDA also has reopened its public comment period on ways the agency can enhance the transparency of FDA activities and decisionmaking. HHS has adjusted for inflation the maximum civil money penalty amounts for violations of the confidentiality provisions of the Patient Safety and Quality Improvement Rule. HRSA has published a final notice on how certain children’s hospitals can participate in the 340B program.
  • Other HHS Developments.  The White House has announced almost $1.2 billion in funding to help hospitals and other providers use electronic health records, and CMS has issued guidance to states on Recovery Act funding for electronic health records. CMS has delayed implementation of a controversial new policy on DMEPOS “consignment closets” or “stock and bill” arrangements. CMS has made announcements on Medicare coverage for H1N1 vaccine and on value-based purchasing demonstrations. Guidance has been issued on surety bonds for DMEPOS suppliers. AHRQ is seeking public comment on a series of white papers on patient registries. 
  • OIG & GAO Reports. The OIG has issued reports on Medicaid fraud data, Medicare payment for power wheelchairs, and ambulance transportation for SNF residents. The GAO has reported on Medicare physician payments for services provided together. 
  • Looking Ahead. Upcoming health industry events include FDA meetings on medical device post-approval studies and prescription drug risk information, CMS educational events regarding DMEPOS competitive bidding, an HHS meeting on gene patents and licensing, and CMS meetings on Medicare coverage issues.
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