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MIXED NEWS ON FINALIZED MEDICARE DRUG FORMULARY

The Centers for Medicare and Medicaid Services (CMS) has released the final rules for the new Medicare prescription drug benefit, giving physicians and patients a better sense of what benefits to expect – and the picture is mixed.

Despite the testimony of AAN members and representatives from other medical societies, the final formulary plan is largely unchanged from the draft that many physicians say will leave gaps in drug coverage. One victory, according to an analysis by Powers, Pyles, Sutter, and Verville, the AAN Washington lobbying agency, is in epilepsy drugs: the guidelines now include a wider array of anticonvulsants, including some newer ones that were excluded originally. In November, Neurology Today reported on AAN efforts to get more specific neurology drugs included in the formulary guidelines that will be the framework for Medicare prescription drug benefit.

The formulary guidelines break drugs down into therapeutic categories – for example, anti-dementia agents or analgesics – and subdivide those into pharmacologic classes – such as reuptake inhibitors or opioid analgesics. Pharmaceutical benefits providers must include at least two drugs in each category or class in their Medicare plans. However, this system leaves ample room for important groups of drugs to be completely excluded; a plan could cover two tricyclic antidepressants while excluding selective serotonin reuptake inhibitors and norepinephrine reuptake inhibitors, for example.

The AAN recommended creating classes or therapeutic categories for many neurology drugs, to ensure their coverage – immunomodulators for multiple sclerosis, anti-spasticity drugs, anti-ALS agents, and statins for stroke, to name a few. Outside of epilepsy drugs and immunomodulators, none of these recommendations were implemented. “We gained on the epilepsy, but were disappointed in other areas such as MS and parkinsonism,” said John Gates, MD, President of the Minnesota Epilepsy Group and a member of the AAN Legislative Affairs Committee.

In response to criticism from the AAN and other medical societies, US Pharmacopoeia, the organization that created the formulary, added a list of 118 “formula key drug types” to the formulary plan, which subdivides the pharmacological classes to include commonly prescribed subclasses of drugs – nonsteroidal anti-inflammatories and triptans, for example. Some – although not all – of the neurology drugs the AAN sought to cover are included as formula key drug types. US Pharmacopoeia recommends that CMS require plans to include at least one of each formula key drug type, to ensure that the benefit will be adequate for seniors and will not discourage enrollment.

Seniors will have a choice of at least two prescription drug plans under the new Medicare benefit, which will begin in 2006.

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SURGEON GENERAL: TAKE MORE FOLIC ACID TO AVOID NEURAL TUBE DEFECTS

US Surgeon General Richard H. Carmona, MD, is encouraging women to prevent neural birth defects by taking sufficient folic acid part of his “Year of the Healthy Child” campaign. Pediatric neurologist Peter H. Berman, MD, praised the effort in an e-mail message: “Every effort to encourage women anticipating pregnancy to take folic acid should be encouraged.” Dr. Berman is a Senior Neurologist at Children's Hospital of Philadelphia and Professor of Neurology and Pediatrics at the University of Pennsylvania.

Marc P. DiFazio, MD, Chief of the Child and Adolescent Neurology Service at Walter Reed Army Medical Center in Washington, DC, concurred: “A simple, inexpensive treatment that is preventative is something that we should focus on, and I commend the Surgeon General on this initiative.” Insufficient folic acid intake in mothers can lead to neural tube defects in babies. However, women who take folic acid supplements before getting pregnant and early in a pregnancy can prevent 70 percent of these birth defects.

The Surgeon General recommends that all women of childbearing age take 400 micrograms of folic acid daily. Women with a family history of neural tube defects should take 10 times as much folic acid – 4 milligrams. Dr. DiFazio concurred, noting that some medicines, valproic acid for example, deplete folate and women then have to take more folate as well. However, he cautioned, “to give higher [folate] dosages, you would not want to take extra combined vitamin products, as some of the fat-soluble vitamins might be given in toxic doses in this case.”

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NIH CALLS FOR OPEN ACCESS TO RESEARCH

Figure. US Surgeon G...
Figure. US Surgeon G...
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The NIH released its first policy on public access to research publications in February, formally requesting that NIH-funded researchers submit their published papers to a central online database starting May 2. While the policy is couched as a request rather than a mandate, the NIH views participation in its publicly-available research database to be part of an investigators' commitment to the NIH.

The open access policy asks NIH-sponsored researchers to submit their published peer-reviewed findings to the NIH to be added to the National Library of Medicine's PubMed Central database. The findings would become publicly available no more than a year after publication, although the NIH is encouraging researchers to push to make their papers available earlier.

The policy was originally set to be released in January, but the NIH unexpectedly delayed the announcement until February. The NIH collection of free online journal content is posted here: www.pubmedcentral.nih.gov. Investigators who want to learn more about how the NIH's public access policy will affect their publications can visit: www.nih.gov/about/publicaccess/index.htm.

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COMMENTS INVITED ON NEW DEA PAIN MANAGEMENT GUIDELINES

The US Drug Enforcement Administration (DEA) has invited physicians to help redraft its guidelines on pain management, and two neurologists who specialize in treating pain have weighed in with Neurology Today on what they want to see the new guidelines address. While the DEA has stated that it will not draft new laws or regulations with the physician comments, it wants to clear up confusion physicians may have about how to prevent diversion of pain medications to illicit users or how to deal with patients who are suspected of abusing or diverting pain pills.

The DEA decided to revisit its guidelines on pain management after identifying inaccuracies in its current guidelines last November. The agency published a brief correction of the inaccurate information – available online here: www.deadiversion.usdoj.gov/fed_regs/rules/2004/fr1116.htm – and pledged to launch a thorough revision this year.

Misha-Miroslav Backonja, MD, Associate Professor of Neurology, Anesthesiology, and Rehabilitation Medicine at the University of Wisconsin-Madison, said that physicians who follow the pain treatment guidelines published by many medical societies should not run afoul of most of the DEA's November corrections. However, one phrase drew his attention: a proscription against prescribing an “inordinately large quantity” of controlled substances. “Who is to say what is inordinately large?” Dr. Backonja asked. In the new pain management guidelines, he said he would like to see this term better defined.

Charles Argoff, MD, Director of the Neurology Pain Service at North Shore University Hospital in Manhasset, NY, said he would like see the DEA articulate these and other points in its new guidelines: “We must know what we are required to document regarding a patient's history, problem, and past treatment before prescribing opiates; determine potential screening tools for identifying potential misuse; specify guidelines for follow-up with patients; and know what will happen if the doctor does everything possible to prevent misuse but it happens anyway.”

Neurologists have until March 21 to submit their suggestions or questions to the DEA. For more information on submitting comments to the DEA, visit www.deadiversion.usdoj.gov/fed_regs/rules/2005/fr0118.htm.

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FINAL NIH ETHICS RULES STRICTER THAN EXPECTED

Figure. Dr. Charles ...
Figure. Dr. Charles ...
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After more than a year of scrutiny and debate, the new NIH ethics guidelines have been released – and are more restrictive than those suggested last year by NIH Director Elias A. Zerhouni, MD. “I am confident that these new rules will prevent the recurrence of past abuses and will go a long way in preserving the historic role of NIH as the primary source of unbiased scientific health information for the country,” said Dr. Zerhouni in a press release.

Commenting on the new guidelines, Michael A. Williams, MD, said: “There were some media reports on the reactions of NIH scientists, and how angry everyone was at the scope and how radical a change it is, but at the same time, it was clear that this change was coming and there was enough variance in practice of a small percentage of employees that it had to come. The stake of the NIH reputation is so high that it was inevitable that it would be so strict.” Dr. Williams is Chair of the AAN Ethics, Law, and Humanities Committee and Assistant Professor of Neurology at Johns Hopkins University School of Medicine in Baltimore, MD.

The new rules restrict all NIH employees from being paid for certain types of employment – including consulting – by a variety of groups affected by NIH decisions: pharmaceutical and biotechnology companies, NIH grantee research institutions, and health care providers and insurers, to name a few.

This is more restrictive than Dr. Zerhouni's original outline, which would have permitted limited industry consulting relationships for some employees, for example. It also forbids high-level employees from owning stock in biotechnology and pharmaceutical industries or other bodies affected by NIH decisions, and limits such stock ownership for the rest of NIH employees. NIH employees will not be completely cut off from the academic and research community, however. They may still teach at universities, write books and review journal articles, and practice medicine, among other activities.

This may not be the last word on ethics at the NIH, however. The HHS is collecting public comments on the new regulations through April, and will use this information along with data from how the guidelines are implemented in the coming year to modify the regulations, if necessary.

Dr. Williams noted that there is an “interesting push and pull” between interaction with and independence from industry. “The NIH has a mandate to facilitate the commercialization of its findings,” so that industry and scientists should interact and companies will benefit financially from NIH research. It is when the benefits go to individuals that there are conflicts of interest, he said. The new NIH ethics guidelines are available online here: www.nih.gov/about/ethics_COI.htm.

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LEAVITT CONFIRMED AS HHS SECRETARY, SETS PRIORITIES

Figure. Dr. Michael ...
Figure. Dr. Michael ...
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Michael O. Leavitt became the new Secretary of HHS in January, replacing Tommy Thompson, who stepped down last year. Topping his list of priorities for the coming years is implementing the Medicare Modernization Act. Before his appointment, Mr. Leavitt was the Administrator of the Environmental Protection Agency (EPA).

In a speech to the Senate Finance Committee, Mr. Leavitt touched on several goals he has for his tenure as HHS Secretary. One challenge he noted will be restoring the somewhat tarnished reputations of some of the HHS divisions: the FDA is under fire for its handling of COX-2 inhibitors, the NIH is struggling with ethics issues surrounding employee involvement in industry consulting, and the CDC is still answering for last year's flu vaccine shortage. He mirrored the Bush administration's desire to increase the use of health care information technology, and also mentioned a need to reform Medicaid, which he called “flawed and inefficient.” Mr. Leavitt also came out in favor of medical liability reform.

Before he was appointed to the EPA, Mr. Leavitt was a three-time Governor of Utah. During his governance, he made some controversial changes to the state's Medicaid program that involved cutting benefits to mandatory Medicaid beneficiaries to expand coverage for non- mandatory beneficiaries. He was able to cover more children under the state's SCHIP program, increase immunization rates, and keep Utah's healthcare costs 25 percent below the national average.

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BUSH TEAM PUSHES E-PRESCRIBING, EMRS

New HHS Secretary Michael Leavitt announced plans to use Medicare to leverage e-prescribing into common practice, in January. Increasing the use of health care technology is high on President George W. Bush's domestic agenda this year.

Although e-prescribing will be voluntary for physicians and pharmacies, support for it will be mandatory for prescription drug plans participating in the Medicare prescription drug benefit. The HHS e-prescribing regulations will apply to communications regarding prescriptions, benefits, and eligibility that take place among pharmacies, doctors, and drug plans. Compliance to the new regulations is set to coincide with the start of the new drug benefit – January 1, 2006.

“We are committed to widespread use of e-prescribing as quickly as possible,” said Mark B. McClellan, MD, PhD, Administrator of the CMS, in a press release. The administration believes that putting e-prescribing standards into practice will speed their adoption, leading to safety benefits like fewer drug-drug interactions and errors caused by messy handwriting.

One of President Bush's campaign goals was to give electronic medical records (EMRs) to all Americans within a decade. In his 2006 budget, he requested $125 million for demonstration projects to hone health care information technology for the marketplace, and has asked to double this year's $50 million budget for technology projects.

©2005 American Academy of Neurology

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