Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

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

• Regulatory Developments -- The FDA has issued two final rules designed to expand access to investigational drugs for treatment use and clarify when patients can be charged for investigational drugs. The FDA also has announced a program setting deadlines for companies to respond to certain inspectional observations for those responses to be considered by the FDA when deciding whether to issue warning letters. CMS has corrected a number of recent Medicare payment rules. HHS is delegating to the Office for Civil Rights the authority to administer and enforce the HIPAA Security Rule. HHS also has announced how it calculating the higher federal matching funds available under the American Recovery and Reinvestment Act of 2009 (ARRA). 
• Other CMS Developments -- CMS has opened registration to all suppliers interested in participating in the Round 1 Rebid of the Medicare DMEPOS Competitive Bidding Program. CMS also has issued guidance on compliance standards for DMEPOS “consignment closets” or “stock and bill” arrangements," along with guidance to state survey agencies and Medicaid directors on a number of issues. CMS also has made a number of announcements regarding the Medicare Part D drug program and Medicare Advantage plans. 
• Other FDA Developments -- The FDA has announced steps it is taking to prevent non-compliant investigators and others from participating in new product development. The FDA also has announced FY 2010 drug and device user fee rates, and it is soliciting comments on draft guidance on genomic biomarkers.  
• Legislative Developments – Lawmakers continue to work to develop health reform legislation. In other areas, the Senate has confirmed the NIH Director, and panels have taken action on funding for HHS, along with whistleblower protection legislation and a bill to strengthen requirements for federal agencies to report and correct overpayment errors. 
• Odds & Ends -- The HHS OIG has issued reports on State Medicaid Fraud Control Units, nonphysicians performing physician services, DME in nursing homes, and pressure-reducing support surfaces. The Federal Trade Commission is delaying until November 1, 2009 enforcement of its Identify Theft Red Flags Rule. The Agency for Healthcare Research and Quality has announced plans to solicit contracts for comparative effectiveness research projects and has updated its "Methods Guide for Comparative Effectiveness Reviews."
• Looking Ahead --Upcoming health industry events include a national provider conference call on the 2009 Physician Quality Reporting Initiative, an FDA Workshop on prescription drug risk information, a series of events to help suppliers prepare for the upcoming Medicare DMEPOS competitive bidding program, and a meeting of the HHS Secretary’s Advisory Committee on Genetics, Health, and Society.