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G-2 Conference Laboratory Report

LAB INSTITUTE 2002

REPORT

 

29 October 2002

 

 

It gives me great pleasure to report on Lab Institute 2002.  My report will be brief, since I was able to get handouts of all attended sessions, and include them with this report.  I tried my best to diversify my sessions to correlate with topics that I thought were within AMT’s domain of interest. They included: 1). The Critical Role of Diagnostics in Bioterrorism Defense – “Scary”!, 2). Reducing Errors in the Clinical Lab, 3).  Lab Payment and Coverage Outlook in 2003 and Beyond, 4). Lab Regulatory Policies and Initiatives, 5). CLIA Compliance and Enforcement Update, 6). Getting The Final Word On ABN’s., 7). Compliance Countdown for HIPPA Requirements in 2003, and finally, I attended a non-program evening session by CLMA to discuss “Do We Need A Clinical Laboratory Federation?  Since I have already reported the results and actions coming out of this meeting, I won’t do so in this report. A capsule summary of the above sessions follows:

 

  • The Critical Role of Diagnostics In Bioterrorism Defense – Speaker: George Poste, PhD.

 In improving our biodefense capabilities, the biggest single point of leverage available today is to enhance the speed with which infected individuals are detected and infectious agent(s) are identified, according to Dr. Poste.  Because it is unlikely that we will anytime soon have the necessary drugs and vaccines to counter many of the agents that could be used against us, he concluded that new diagnostic tools would need to establish the appropriate containment measures.

 

  • Reducing Errors In The Clinical Lab – Speaker: Stan Schofield

 

The discussion included how to design an Error Reduction Program, based on best practices available today.  The necessary components of such a program were described: goals and possibilities, essential policies and how organizational assessments should take place. The workshop concluded with an active case study from the speaker’s laboratory by which he illustrated how errors were detected and what policy, program and staff actions were required to reduce the errors.

 

  • Lab Payment & Coverage Outlook: What’s Ahead in 2003 & Beyond – Speakers:  Thomas Gustafson, PhD., Barton McCann, MD., John McLaughlin, Richard Naples, Mark Synovec. MD., and G. Gregory Raab, ESQ., moderator. 

 

Over the past decade the clinical laboratory sector has seen remarkable growth in the range and complexity of diagnostic tests, and patient management has become more effective because of greater speed and precision in test measurement.  At the same time, the industry has seen lower per-unit costs due to increased automation and test refinement.  Remarkably, though test results influence the majority of clinical decisions, spending for laboratory procedures nationwide is a miniscule percentage of total health expenditures.  Notwithstanding these important developments, the use of diagnostic tests by medical professionals today is often driven more by third-party payer insurance policies revolving around coverage, coding and reimbursement issues than it is by considerations of clinical usefulness.  Speakers during this session explored critical policy issues that directly influence the availability and provision of medically indicated laboratory testing services.

 

  • Playing Politics With Medicare:  Congressional & White House Election-Year Strategies – Speaker:  Morton Kondrache.

 

Many political commentators believe both parties are playing election-year politics with medicare. Republicans insist on reforming Medicare to give Seniors a choice of insurance plans, while Democrats charge this will force them into HMOs.  Democrats look on Medicare as a key factor in their 2002 election strategy, and most polls indicate that the public trusts Democrats more than the GOP by a substantial margin on such domestic issues as health and prescription drugs.  In contrast, polling shows that “war”  issues favoring Republicans, have been ascendant in the public’s mind in recent weeks, but voters say “domestic” issues will decide how they cast their ballots.

 

  • Lab Regulatory Policies & Initiatives:  Issues and Answers – Speakers:  Denis Garrison, Jackie Sheridan-Moore, Bernard Statland, MD, PhD., Judy Yost, and Hope Foster, Esq., moderator.

 

This panel presentation took up a number of significant regulatory changes under medicare affecting laboratory providers that are scheduled to take effect this fall, including final implementation of national coverage/payment policies for 23 frequently ordered tests and mandatory use of new standard Beneficiary Notice formats.  CMS officials responsible for these two regulatory initiatives presented the latest implementation details and related information to help labs comply with these changes.  In this regard, pay particular close attention to the handout on this topic.  Speakers also addressed the latest CLIA regulatory and enforcement developments as well as FDA action regarding GLIA categorization of lab tests and regulation of genetic testing.

 

  • CLIA Compliance & Enforcement Update – Speakers:  Brenda Kohn, Esq., and Jeffrey Sherrin, Esq.

 

This clinic examined several key CLIA enforcement issues from the perspective of both CMS and the defense.  Among the issues: problems that commonly lead to CLIA enforcement, the process that will be followed to resolve such problems, how labs should address proposed sanctions, the range of sanctions available and under what circumstances they will be imposed, hearings and resolving enforcement proceedings.  Participants also gained an in-depth understanding of how the government handles CLIA deficiencies and what strategies labs can employ to reduce their risks.

 

  • Compliance Countdown For HIPPA Requirements in 2003 – Speaker:  Richard Marks, Esq.

 

This clinic focused on HIPPA’s security requirements as they apply to covered entities, because security is the framework within which all HIPPA privacy and transaction requirements are implemented.  Simply, if covered entities cannot, in the statute’s words, “ensure “ security, then privacy measures are a hollow gesture, and HIPPA transactions are vulnerable to a world of mischief.  Mike McCarty gave a good presentation on HIPPA at this past year’s annual meeting, and would be interested in getting the attached handout of this particular presentation.

 

In summary, I think that I covered a lot of ground at the Lab Institute, rekindled many old lab friendships, and served AMT to the best of my abilities .Since I live right on the edge of this great City and location, I ask for AMT to call on me at any time to assist them in any way, small or big.  Thank you one and all for the opportunity to serve you.

 

 

Best Regards,

Bill Robbins, MT(AMT)