Today’s Federal Register included the notice that CMS and the FDA are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the sponsor and both CMS and FDA agreed to a parallel review. The intent of establishing a parallel review process is to reduce the time between FDA market approval and the CMS national coverage determinations (NCDs). 

CMS and FDA have solicited comments specifically about what products would be appropriate for parallel review, what procedures should be developed, how a parallel review process should be implemented, and other operational issues.  The notice also reveals that CMS and FDA intend to establish a pilot program for parallel review of medical devices. 

This notice comes on the heels of a CMS-FDA memorandum of understanding that was released this summer that enables the agencies to share data for a variety of decision-making purposes.

The trend in increasing collaboration between CMS and the FDA will have significant implications for coverage and reimbursement decisions and will require stakeholders to develop joint strategies for approaching both agencies. 

Comments on the parallel review are due on December 16, 2010.

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Last week, the White House announced President Obama’s recess appointment of Donald Berwick as CMS Administrator. Dr. Berwick is a pediatrician and professor at Harvard University and the founder the Institute for Healthcare Improvement. He launched the“100,000 Lives” campaign to reduce the number of deaths attributable to medical errors in hospitals. He has previously served as Vice Chair of the U.S. Preventive Task Force, member of the Board of Trustees of the American Hospital Association, Chair of the National Advisory Council of AHRQ. Dr. Berwick was sworn in on July 12.   

The Constitution provides an exception to the Senate confirmation process for nominations. When the Senate is in recess, the President may make a temporary appointment known as a “recess appointment” without Senate approval. President Obama is making the appointment during a recess in the middle of a session, so Dr. Berwick’s appointment will expire at the end of the following session or at the end of the first session of the 112^th Congress. President Obama has made 15 recess appointments, not including Donald Berwick.

Senate Minority Leader Mitch McConnell, along with Republican Senators John Barrasso, Pat Roberts and Tom Coburn have objected to President Obama’s move noting that confirmation hearings had not been scheduled to allow for consideration of the nominee. Senate Finance Committee staff have responded to the announcement noting that Republicans have urged Leadership to expedite Dr. Berwick’s confirmation hearing and hold his hearing before Supreme Court Justice nominee Elena Kagan’s hearing.    

Republicans on the Senate Finance Committee sent a letter to Chairman Baucus requesting a hearing on the appointment of Dr. Berwick. The letter requests a chance for Dr. Berwick “to present his qualifications for the position in the usual process” so as not to create “a shadow over his legitimacy and authority to serve as Administrator during a critical time for CMS.”  Republican members of the House Ways and Means Committee also urged a hearing with Dr. Berwick.

The Office of Management and Director Peter Orszag has announced that his last day at his post will be July 30.  President Obama announced that he will appoint Jack Lew as the new OMB Director. Mr. Lew currently serves as an aide to Secretary of State Hillary Clinton and previously worked as the budget director for former President Bill Clinton. Given the current budget deficit, the new OMB Director will certainly continue the focus on reducing the deficit.         

The Chairmen of the National Commission on Fiscal Responsibility, former Republican Senator Alan Simpson of Wyoming and Erskin Bowles, former chief of staff to President Bill Clinton, spoke to the National Governor’s Association and relayed that Congress must examine any and all proposals to contain entitlement programs, particularly Medicare and Medicaid. The Commission is required to develop a plan by December 1 to reduce the deficit. 

Prior to the August recess, the Senate is expected to consider the “Small Business Lending Fund Act” (H.R. 5297), which was introduced by Rep. Barney Frank (D-MA) to address the impact of the financial crisis on small businesses. The Senate will also consider the House-amended war supplementing spending bill before it adjourns. The House amended the Senate-passed bill to include Senator Herb Kohl’s (D-WI) legislation, the “Preserve Access to Affordable Generics Act,” which would ban agreements between brand name and generic drug manufacturers. Senator Kohl has called such agreements “one of the most egregious tactics used to keep generic competitors off the market leaving consumers with unnecessarily high drug prices.” The Generic Pharmaceutical Association, however, expressed opposition to the amendment noting that such agreements have, at times, allowed generic drugs to come to market before the patents of the name brand drugs expire.

Last night, the White House announced that President Obama has decided to make a recess appointment for Dr. Donald Berwick to serve as CMS Administrator. 

Dr. Berwick is a pediatrician and professor at Harvard University and the founder of the Institute for Healthcare Improvement. He launched the “100,000 Lives” campaign to reduce the number of deaths attributable to medical errors in hospitals.  He has previously served as Vice Chair of the U.S. Preventive Services Task Force, a member of the Board of Trustees of the American Hospital Association, and Chair of the National Advisory Council of the Agency for Healthcare Research and Quality (AHRQ).

The Constitution provides an exception to the Senate confirmation process for nominations. When the Senate is in recess, the President may make a temporary appointment known as a “recess appointment” without Senate approval. President Obama is making the appointment during a recess in the middle of a session, so Dr. Berwick’s appointment will expire at the end of the following session or at the end of the first session of the 112^th Congress. 

President Obama has made 15 recess appointments, not including Dr. Berwick.

Senate Minority Leader Mitch McConnell (R-KY), along with Senators John Barrasso (R-WY), Pat Roberts (R-KS) and Tom Coburn (R-OK), objected to President Obama’s move and noted that confirmation hearings were not scheduled to allow for consideration of the nominee. Senate Finance Committee staff responded that Republicans have urged Leadership to expedite Dr. Berwick’s confirmation hearing and hold it before Supreme Court Justice nominee Elena Kagan’s hearing.

The Patient Protection and Affordable Care Act requires the Secretary to establish Accountable Care Organizations (ACOs), which will enable care coordinate among providers, by January 1, 2012. ACOs that meet quality targets and reduce the costs of their patients by coordinating items and services under Medicare Part A and Part B are rewarded with a share of the savings they achieve. Physician groups, hospitals, nurse practitioners and physician assistants, and others can participate in ACOs.

The Centers for Medicare and Medicaid Services (CMS) has relayed that while specific quality performance standards will be determined by the Secretary, ACOs will be measured on clinical processes and outcomes of care, patient experience, and utilization of services. 

In a Frequently Asked Questions document, CMS stated that the Agency will host an Open Door Forum this summary and will post details of the session by June 11 on its website: http://www.cms.gov/OpenDoorForums/05_ODF_SpecialODF.asp#TopOfPage.  A Notice of Proposed Rulemaking is expected to be released in the fall.