In This Issue...


The President and House Republicans Spar Over Fiscal Cliff

As the January 1st fiscal cliff deadline nears, the White House and House Republicans are beginning to outline their initial bargaining positions. If the two sides cannot reach agreement by New Year's, $1.2 trillion in across-the-board spending cuts will take effect. Also, without action, the Bush-era tax cuts will expire. 

The President's opening proposal to avoid the fiscal crisis proposes $1.6 trillion in new taxes on the rich and $400 billion in cuts to federal health and entitlement programs. In addition, he is seeking authority to raise the debt ceiling without congressional approval. House Republicans have already stated that the White House's proposal is a nonstarter. Releasing their own plan, the GOP would reduce the deficit by $2.2 trillion through $1.4 trillion in cuts and $800 billion in tax write-offs, including raising Medicare eligibility from 65-67. 

One short-term proposal for resolving the impasse is to delay the trigger by six months to give the two sides more time to reach a long-term agreement. If policymakers adopt such approach, any broad framework agreement is likely to include a combination of elements proposed by both sides. GAU will continue to report on White House and congressional efforts to avoid a fiscal cliff in subsequent editions.

Supreme Court Agrees to Rule on Gene Patents

The United States Supreme Court has agreed to rule on the question of whether human genes are patentable. The Court will resolve a point of contention arising from an August 2012 ruling by the Court of Appeals for the Federal Circuit (a federal court that specializes on patent cases) in the case of the Association for Molecular Pathology v. Myriad Genetics, Inc. In a 2-1 ruling, the Federal Circuit upheld Myriad's right to patent the BRCA1 and BRCA2 genes. The ACLU, along with a number of pathology groups, argue that this finding is at odds with the Supreme Court's May 2012 ruling in the case of Mayo v. Prometheus, which invalidated Prometheus' method claims. The Supreme Court will take up the case in spring 2013. For more information on the Supreme Court's decision, please go to the Myriad Website or the ACLU's site.

PCORI Board Revises Methodology Standards to Guide Research

The Patient–Centered Outcomes Research Institute (PCORI) Board of Directors (BoD) recently modified the methodology standards provided to stakeholders as a guide for conducting their research. The revised standards are available on the PCORI Web site.

HHS OCR Releases Guidance

The Department of Health and Human Services (HHS) Office of Civil Rights (OCR) released guidance answering common questions regarding the use of de-identified information under the Health Insurance Portability and Accountability Act (HIPAA). According to OCR, this document is intended to "assist covered entities to understand what is de-identification, the general process by which de-identified information is created, and the options available for performing de-identification." The guidance is available on the OCR Website.

FDA Announces Guidance Priorities for 2013

On November 26, 2012, the Food and Drug Administration (FDA) released a listing of the guidance it plans to work on in 2013. The "A-list," which represents the guidance the agency plans to complete, includes documents on:

  • In Vitro Companion Diagnostic Devices;
  • De Novo Classification Process;
  • The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications; and
  • Mobile Medical Applications.

The "B-list," which includes those documents the agency plans to release if resources permit, includes a guidance on Direct to Consumer Genetic Testing. Noticeably absent from both lists is any reference to the agency guidance documents regarding laboratory developed tests. A copy of the FDA notices is available on its Website.