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

CMS has announced a July 18, 2011 public meeting to receive comments and recommendations from the public on the appropriate basis for establishing 2012 Medicare payment amounts for a specified list of new CPT codes for clinical laboratory tests.  Registration is required.  Background information will be posted on the CMS website prior to the meeting.  Immediately following this meeting, CMS will host a separate information session to discuss new genetic testing codes (a listing of the new genetic test codes for 2012 is included in the notice. While CMS is not accepting payment recommendations at this time for genetic testing, the agency “is open discussions to the public on recommendations going forward on how these codes should be addressed,” including clinical laboratory versus physician fee schedule assignment, current codes used to reflect test steps, and how various genetic tests are similar to/different from existing laboratory tests.

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This post was written by Paul Sheives. 

FDA will hold a public workshop on November 2, 2010 to seek input on best practices related to cell and gene therapy clinical trials in pediatric populations. A panel will discuss topics including: (1) evaluating cell and gene therapy products prior to initiating pediatric clinical studies; (2) identifying and minimizing risks associated with the administration of cell and gene therapy products in pediatric populations; (3) obtaining informed consent and assent; and (4) conducting continuing review of cell and gene therapy products in pediatric populations. Registration for the meeting closes on October 1, 2010.

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A House Ways and Means Health Subcommittee hearing examined efforts to promote the adoption of health information technology through Medicare incentives designed to encourage the meaningful use of electronic health records. Likewise, the House Energy and Commerce Health Subcommittee held a hearing on implementation of the Health Information Technology for Economic and Clinical Health (HITECH) Act, along with hearings on direct-to-consumer genetic testing, controlled substance monitoring, and prescription drug disposal. A Senate Health, Education, Labor and Pensions Committee hearing examined programs to promote treatments for rare and neglected pediatric diseases. The Senate Homeland Security and Governmental Affairs Committee held hearings on disaster medical preparedness and preventing and recovering Medicare payment errors.

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The Food and Drug Administration (FDA) is reviewing its policy of enforcement discretion regarding LDTs to assure the public that lab tests are safe and effective. To that end, the FDA is hosting a public meeting on oversight of Laboratory Developed Tests on July 19 and 20, 2010. The agency also will accept comments from stakeholders on "reasonable and effective regulation of LDTs" until August 15, 2010. The FDA "believes that a risk-based application of oversight to LDTs is the appropriate approach to achieve the desired public health goals.” The agency seeks comments from stakeholders on the issues that pose the greatest concern to the public health. After the meeting and public comment period, the "FDA will move forward expeditiously to develop a draft oversight framework for public comment.”

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Recent Congressional hearings include a Senate Special Committee on Aging hearing on dietary supplements, a House Energy and Commerce Committee hearing on “Developments in Synthetic Genomics and Implications for Health and Energy,” and a House Oversight and Government Reform Committee hearing on “Pediatric Over-the-counter Medication Recalls.” 

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On October 7, 2009, CMS published an interim final rule with comment period implementing sections certain provisions of the Genetic Information Nondiscrimination Act of 2008 (GINA) that prohibit discrimination based on genetic information in health insurance coverage and group health plans.  These interim final regulations are effective on December 7, 2009; comments will be accepted until January 5, 2010. In a related development, the Department of Health and Human Services (HHS), Office for Civil Rights, also published a proposed rule on October 7 that would modify the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy standards to implement GINA provisions addressing the privacy and confidentiality of genetic information and make certain other changes to the HIPAA privacy rule. Comments will be accepted until December 7, 2009.

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The HHS Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) is meeting on October 8 and 9, 2009 to review three SACGHS draft reports: a final draft report and recommendations on gene patents and licensing practices; a public consultation draft report on genetics education and training; and a revised draft paper on direct-to-consumer genetic testing.

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The HHS Secretary's Advisory Committee on Genetics, Health, and Society has published a notice soliciting comments on a draft report on “Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests.'' Comments will be accepted until May 15, 2009; comment submission information is available here.

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On May 6, 2009, MedCAC is meeting to focus on the desirable characteristics of evidence needed to evaluate screening genetic tests for Medicare coverage.

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The HHS Secretary's Advisory Committee on Genetics, Health, and Society is meeting on December 2 and 3, 2008 to review a preliminary draft report that addresses questions about whether gene patents and certain licensing practices are affecting patient access to genetic tests. The meeting will also address diagnostic laboratory standards and technology platforms and the role they are playing in innovation of genetic technologies. 

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