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    <recommendedItem id="20100101_19_377"
                     title="Advisory Panel Rates Genomic Cancer Tests"
                     score="0.009"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/Medicare/tb/18269?impressionId=1265786060595"
                     
      &lt;p&gt;Some genomic tests aimed at identifying patients most likely to respond to cancer drugs won a thumbs-up from a Medicare advisory panel, but others didn&apos;t make the grade.&lt;/p&gt;
&lt;p&gt;As part of a national coverage determination under way at the Centers for Medicare and Medicaid Services, members of the Medicare Evidence Development &amp;amp; Coverage Advisory Committee (MEDCAC) last week rated the clinical value of several pharmacogenomic cancer tests now available.&lt;/p&gt;
&lt;p&gt;The tests would be used to select patients for treatment with drugs including tamoxifen, irinotecan (Camptosar), trastuzumab (Herceptin), and imatinib (Gleevec).&lt;/p&gt;
&lt;p&gt;CMS has not previously decided whether such tests should be reimbursed by Medicare, although testing is already routine for some of these treatments.&lt;/p&gt;
&lt;p&gt;The FDA-approved labeling for trastuzumab requires such testing. Imatinib&apos;s approvals include chronic myeloid leukemia featuring the BCR-ABL &quot;Philadelphia chromosome&quot; mutation, although the label doesn&apos;t explicitly mention testing.&lt;/p&gt;
&lt;p&gt;&quot;CMS is aware that the body of evidence on the role of pharmacogenomic testing in cancer continues to evolve,&quot; according to the agency&apos;s notice of the meeting.&lt;/p&gt;
&lt;p&gt;&quot;Recognizing the rapid accumulation of such evidence, CMS seeks guidance from the panel to inform future coverage determinations. We want to ensure that Medicare beneficiaries have access to any demonstrated improved health outcomes of pharmacogenomic testing, and are protected from inaccurate or inappropriate pharmacogenomic testing that could compromise therapy or increase the risks of adverse events during therapy.&quot;&lt;/p&gt;
&lt;p&gt;MEDCAC panelists were asked to rate their confidence in the clinical utility of five tests and in the scientific evidence available for review.&lt;/p&gt;
&lt;p&gt;The five tests cover: &lt;ul&gt; &lt;li&gt;Polymorphisms in the CYP2D6 drug-metabolizing enzyme for breast cancer patients who are candidates for tamoxifen&lt;/li&gt; &lt;li&gt;Polymorphisms in the UGT1A1 gene for colon cancer patients considered for irinotecan treatment&lt;/li&gt; &lt;li&gt;Presence of HER/neu epidermal growth factor receptor expression in patients with breast cancer, indicating suitability for trastuzumab&lt;/li&gt; &lt;li&gt;Presence of the BCR-ABL mutation in patients with chronic myeloid leukemia who would be candidates for imatinib&lt;/li&gt; &lt;li&gt;Mutations in the K-ras gene for metastatic colorectal cancer patients eligible for cetuximab (Erbitux) or panitumumab (Vectibix)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The 15 panel members assigned values of one to five, reflecting low to high confidence, to each test. A score of two reflected medium-low confidence, while a four meant medium-high confidence.&lt;/p&gt;
&lt;p&gt;Most of the panelists agreed that the evidence underlying the tests for CYP2D6 and UGT1A1 polymorphisms was still too scant for an assessment of their clinical value. Mean scores for these tests were 2.07 and 1.83, respectively, with nearly all votes either a one or two.&lt;/p&gt;
&lt;p&gt;But MEDCAC members were more confident that the usefulness of the other three tests for diagnostic and monitoring purposes could be evaluated. Mean scores for those tests were all well above four.&lt;/p&gt;
&lt;p&gt;For the HER/neu, BCR-ABL, and K-ras tests, since members believed the evidence was adequate for assessment, MEDCAC also voted on whether their use actually would improve health outcomes in cancer patients.&lt;/p&gt;
&lt;p&gt;A third ranking provided the committee&apos;s views on whether the conclusions could be generalized to the Medicare population and patients in the community.&lt;/p&gt;
&lt;p&gt;Mean scores for those rankings were all also above four, indicating the panel&apos;s support for these tests as clinically beneficial.&lt;/p&gt;
&lt;p&gt;On the other hand, when asked whether there was enough evidence to assess the utility of the BCR-ABL test in detecting treatment failure, panelists didn&apos;t think so. Most of those votes were twos, and the mean was 2.47.&lt;/p&gt;
&lt;p&gt;CMS has not given a time line for deciding whether to approve Medicare coverage for the tests.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_369"
                     title="Administration Issues Mental Health Parity Rule"
                     score="0.009"
                     href="http://www.medpagetoday.com/Psychiatry/GeneralPsychiatry/tb/18258?impressionId=1265786060595"
                     
      &lt;p&gt;WASHINGTON  --  Under a proposed rule released by the Obama administration, patients in a group insurance plan who are being treated for mental illness or substance abuse may no longer be charged more than if they were receiving medical or surgical care.&lt;/p&gt;
&lt;p&gt;The Department of Health and Human Service (HHS), the Department of Labor, and the Internal Revenue Service issued an interim rule last week containing specific language necessary to enforce the bipartisan &lt;a href=&quot;http://www.medpagetoday.com/Psychiatry/GeneralPsychiatry/11169&quot; mce_href=&quot;http://www.medpagetoday.com/Psychiatry/GeneralPsychiatry/11169&quot; target=&quot;_blank&quot; title=&quot;Financial&amp;#8200;Bailout&amp;#8200;Carries&amp;#8200;Mental&amp;#8200;Health&amp;#8200;Parity&amp;#8200;Bill&amp;#8200;Through&amp;#8200;Congress&quot;&gt;mental health parity law passed by Congress in 2008&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;The law  --  called the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act  --  states that if a group health plan covers the treatment of mental illness or drug or alcohol abuse, the limits and financial requirements for these services can be &quot;no more restrictive&quot; than those that apply to medical and surgical benefits.&lt;/p&gt;
&lt;p&gt;That means an insurance plan cannot charge higher copayments, deductibles, and out-of-pocket expenses for mental health services than for treatment of physical illnesses.&lt;/p&gt;
&lt;p&gt;Companies with fewer than 50 employees in their group insurance plans are excluded from the law.&lt;/p&gt;
&lt;p&gt;&quot;The rules we are issuing today will, for the first time, help assure that those diagnosed with these debilitating and sometimes life-threatening disorders will not suffer needless or arbitrary limits on their care,&quot; said Kathleen Sebelius, secretary of HHS.&lt;/p&gt;

&lt;p&gt;The American Psychiatric Association (APA) issued a statement applauding the regulations.&lt;/p&gt;
    &lt;p&gt;&quot;Mental health parity was a major advance for the APA and for our patients living with mental illnesses,&quot; according to the group&apos;s president, Alan F. Schatzberg, MD. &quot;The APA will continue to work hard and submit the important feedback to the administration that is necessary to make sure our patients receive the care they need.&quot;&lt;/p&gt;
    &lt;p&gt;The statement also drew attention to some shortcomings in the regulations, which did not address provider networks and formulary development.&lt;/p&gt;
    &lt;p&gt;The APA intends to submit recommendations for these and other topics during the 90-day comment period.&lt;/p&gt;
    &lt;p&gt;The American Psychological Association also welcomed the regulations.&lt;/p&gt;
    &lt;p&gt;&quot;We are delighted that under these regulations consumers are protected from insurance discrimination to the greatest extent possible,&quot; according to its executive director for professional practice, Katherine Nordal, PhD, in a prepared statement.&lt;/p&gt;
    &lt;p&gt;The rule also requires a single deductible for mental health and medical/surgical coverage. Patients who are being treated for a mental condition at the same time as somatic condition often have to pay separate deductibles which can &quot;prevent access to mental health treatment,&quot; according to the psychologists&apos; group.&lt;/p&gt;
    &lt;p&gt;&quot;It is particularly significant that the regulation will ban health plans from imposing separate deductibles or setting separate out-of-pocket caps for mental health and medical/surgical services,&quot; the statement said. &quot;This is a big win for anyone seeking mental health treatment.&quot;&lt;/p&gt;
    &lt;p&gt;The 2008 law expanded greatly on the Mental Health Parity Act of 1996, which required parity only in lifetime and annual dollar limits. In practice, crtics say, insurers got around that prohibition by charging higher copayments for mental health services and by &quot;cherry-picking&quot; services that would and would not be covered.&lt;/p&gt;
    &lt;p&gt;The 1996 law also specifically excluded coverage parity for substance abuse treatment.&lt;/p&gt;
    &lt;p&gt;The new rule will take effect April 5, 2010.

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                     score="-0.007"
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