Life Sciences

Medicare & Reimbursement Advisor Weekly, May 27th, 2009

Medicare & Reimbursement Advisor Weekly, May 27, 2009

<p><b>Inside:</b></p>
<p>Family influence heightened during clinical meetings</p>
<p>How far to push, how much to pull?</p>
<p>NAMs: Making your value case on the road</p>
<p>How far to push, how much to pull?</p>
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<p><b><i>Around the continuum</i></b></p>
<p><b>Family influence heightened during clinical meetings</b></p>

<p>On the weekends, I&#x2019;ve been doing some social work in nursing homes and acute care settings as a designee, assigned by facilities to assist families as an advocate and resource support. In this work, I have an opportunity to sit in on family meetings with case managers, discharge planners, medical directors, floor nurses, Medicare and commercial insurance staff, and pharmacists. Since April, I&#x2019;ve attended three family meetings at Kimberly Hall, a Genesis nursing home chain in Windsor, CT, and two meetings at Yale New Haven Hospital. A physician or medical director attended two of the five meetings, probably because two of the cases were clinically more severe (including one of a 65-year-old male in a persistent vegetative state). Generally, physicians and pharmacists do not attend these meetings.</p>

<p>Below are some observations from these meetings:</p>
<ul>
  <li>The meetings were held two weeks after admission (fairly typical).</li>
  <li>The director of nursing was not present, except in one case.</li>
  <li>Social services opened the meetings and handled all referral/home health questions.</li>
  <li>The unit nurse manager seemed to run the meetings.</li>
  <li>Nursing staff: Only one time was a floor nurse present.</li>
  <li>The family educated the nursing staff about signs and symptoms recently observed.</li>
  <li>The medical director/physician was typically unaware of the family&#x2019;s observations (multiple times).</li>
  <li>The family questioned side effects and the efficacy of drug regimen in four meetings.</li>
  <li>The nurse manager was always willing to recommend treatment options to the MD.</li>
  <li>Commercial insurance rep talked about how Anthem BC wanted the patient to be exhibiting goals or it would cut reimbursement and force the family to take the patient home or pay privately. Reimbursement in one case was cut by 22 days before the benefit was reached.</li>
  <li>The family wanted Medicare to pick up the benefit for a three-week period after the Anthem days were up. The nursing home said it would pay under Medicare Part A per diem, but would not, in this case, be able to try an expensive pharmacy regimen:</li>
</ul>
<ul>
  <li>For example, in the case of the 65-year-old, Yale&#x2019;s neurologist started the patient on a series of two- to three-day psycho stimulants (Ritalin, Amatadine, Sinimet, then Zoloft). With Zoloft, the order was written for 30 days. The nursing home followed the order, but after 25 days, the patient had not exhibited a benefit and had suffered side effects. The physician agreed to meet with a consulting neuro-psych pharmacist to discuss other options.</li>
</ul>
<ul>
  <li>The family ultimately urged the nurse manager to facilitate a meeting with the medical director and hospital physician. The meeting was held within four days by phone, with the family present.</li>
  <li>The family asked the MD at one meeting whether an additional &#x201c;full neuro workup&#x201d; could be done. It was ordered and conducted within 48 hours. &#x2014;BC, <a href="mailto:bcote@hcpro.com"><i>bcote@hcpro.com</i></a></li>
</ul>


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<p><b>How far to push, how much to pull?</b></p>
<p><i>Editor&#x2019;s note: Some of you have been asking about push/pull strategies lately. I thought this article written a couple years ago by our medical advisor, Michael Yanuck, MD, would be a good rerun. Dr. Yanuck&#x2019;s contact information appears on p. 3.</i></p>

<p>Once you have managed care&#x2019;s attention about your product, what can you do to ensure a successful approval process for your drug? Strategies vary; there are probably as many as there are managed care plans. The following are five strategies to consider.</p>

<p><b>1. Rebates. </b>They always look attractive on the surface, but the devil is in the details. Are your rebates linked to using all of your company&#x2019;s products? Are they based on favored tiering status? Are they based on exclusivity or certain volume targets? Whereas the pharmaceutical industry looks at these as essen- tial issues, many managed care plans look at rebates as roadblocks to getting products on the formulary. Many are beginning to shun the all-or-nothing rebate system, and this could adversely affect your entire product line. Also, companies are becoming more savvy about the net cost after rebate compared to other products, especially generics.</p>

<p>There are fewer classes of drugs today without a generic equivalent, which discourages the use of brand-name drugs, unless the net cost of these drugs is sufficiently competitive with the generics, allowing for tiering copayment differences.</p>

<p><b>2. Push/pull strategies. </b>Is your company ready to partner with managed care organizations (MCO) to help educate their doctors as to the advantage of your product in the market? Are MCOs willing to conduct continuing medical education programs on the disease topic without having them sound like commercials? Are they available to work with the plan to put together literature (e.g., comparative dosing data) that helps the physician switch to this new drug from the existing plan drug if the plan makes your drug the preferred option? Not all managed care plans pursue this strategy. Some want no help at all from pharmaceutical companies; others will solicit help to work together, especially if this is a major formulary change.</p>

<p><b>3. Adherence programs. </b>This approach is fast becoming the wave of the future, especially with high-cost medications (e.g., those for mental health; HIV; inflammatory disease, including asthma; and chronic conditions, such as hepatitis C). Plans are seeking compliance programs to ensure that the member is benefiting from taking the medication. If the medication is not being used, the member&#x2019;s lack of compliance and adherence may cause:</p>
<ul>
  <li>Resistance</li>
  <li>Expensive treatments to be less effective</li>
  <li>Longer treatment times</li>
  <li>Multiple courses</li>
  <li>Cure failures</li>
  <li>
Significant medical cost for increasing</li>
</ul>
<p>  physician visits, ER treatment, and</p>
<p>  hospital admissions</p>

<p>How can a pharmaceutical company help an MCO make sure that it is getting the bang for its expensive buck? One tip is to team up with one of the services that does reminder calls for patients.</p>

<p><b>4. Registries/data collection. </b>Is your company available to help with obtaining and processing plan data in disease-specific registries and helping the plan collect quality information, pay-for-performance data, or Health Plan Employer Data and Information Set details? This is not to say that MCOs must depend on a pharmaceutical company for this information, but a partner to help with this would benefit many small managed care plans. This information, of course, would have to be personal health information blinded to the pharmaceutical company to ensure privacy compliance.</p>

<p><b>5. Disease management (DM): </b>Support programs or literature that would comprehensively support a DM program. Many plans are looking for the best way to do DM. Some are employing passive programs to give the members literature about their condition. Other plans are trying the interactive approach, with a case manager making calls and doing one-on-one education of higher-risk members. Find out whether your company can fill gaps for plans. Some companies may embrace these ideas; others may hold pharmaceutical companies at arm&#x2019;s length.</p>

<p>Feel out your clients and see where they fit, and where you can do the most to help.</p>

<p><i>Editor&#x2019;s note: Dr. Yanuck is president of Michael Yanuck, MD, PA Medical Consulting. Contact him at </i><a href="mailto:myanuck@tampabay.rr.com"><i>myanuck@tampabay.rr.com</i></a><i>.</i></p>


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<p><b>NAMs: Making your value case on the road</b></p>
<p>Healthcare formulary decision-makers will increasingly review whether they can divide populations into effectiveness subgroups to test pharmaceutical interventions. Our survey in December 2007 of our pharmacy and medical formulary decision-makers suggested increased interest in models being used by groups such as the United Kingdom&#x2019;s National Institute for Health and Clinical Excellence (NICE) <i>(</i><a href="http://www.nice.org.uk/"><i>www.nice.org.uk/</i></a><i>).</i></p>

<p>If you want to claim that your product is cost-effective, be sure to justify the choice of your outcomes claim for product performance compared to performance claims for comparison products. To do so:</p>
<ul>
  <li>Identify key results of your competitors&#x2019; clinical papers</li>
  <li>Summarize the key results and present pooled summaries</li>
  <li>Match these against your own product</li>
</ul>

<p>U.S. managed care may begin to rely more heavily on probabilistic sensitivity analysis to evaluate claims that products are cost-effective. If several products in your class and those of your competitors&#x2019; fall into the more costly benefit category&#x2014;and clinical differentiation is minimal&#x2014;plans will want to know how probable it is that product A is more cost-effective compared to products B, C, and D, or product E in another therapeutic class.</p>

<p>Manufacturers are wise to model their own claims using this approach. This<b> </b>will allow you to test various pricing<b> </b>scenarios. Groups such as NICE mandate this type of analysis, and it is recommended in numerous reimbursement guidelines globally. This analysis will become a standard in cost-effectiveness claims because it gives healthcare decision-makers a way to deal with uncertainty and rank therapy interventions in terms of their willingness to pay.</p>

<p>Ask your plan customers the following:</p>
<ul>
  <li>Do you use probabilistic sensitivity analysis to evaluate cost-effectiveness?</li>
  <li>Are you considering using it?</li>
  <li>How can I help you evaluate cost- effectiveness for our product?</li>
  <li>What is your threshold in evaluating these claims? (A threshold is equal to the amount that the plan is willing to pay for additional benefits using your product on formulary.)</li>
</ul>

<p>Plans will increasingly rank products when they invest more money in a therapeutic class. Plans will select products for formulary based on how much the product costs per quality-adjusted life year. So plans are asking, &#x201c;If we move to therapy B, how much do we truly gain?&#x201d;</p>

<p><i>Editor&#x2019;s note: Adapted interview with Dr. Paul Langley of Maimon Research, LLC.</i></p>