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The US Supreme Court has agreed that Governor Jeb Bush cannot legislatively block a Florida woman's husband from removing her feeding tube and allowing her to die. The case, Jeb Bush v. Michael Schiavo, drew national attention when Governor Bush pushed “Terri's Law” through the Florida legislature, allowing the Governor to prevent Michael Schiavo from removing his wife Terri's feeding tube, despite court rulings permitting him to do so. In 2004, Neurology Today covered this continuing story in January (page 1) and November (page 49).

Mrs. Schiavo has been in a persistent vegetative state for 15 years, and in 2003 the courts gave Mr. Schiavo permission to end her life. This was the culmination of a five-year court battle between Mr. Schiavo and Terri's parents, who want to keep her alive, believing that she can improve with treatment. Mr. Schiavo contends that Terri would not want to be kept alive under these circumstances. Mrs. Schiavo, who at age 26 suffered a heart attack that caused extensive brain damage, did not have a living will or written instructions for her care in a case such as this.

Mr. Schiavo had the feeding tube removed, Terri's parents appealed to Governor Bush to intervene, and Terri's Law was born. Terri's Law allowed the governor to block Mr. Schiavo from removing Terri's feeding tube in this particular case. However, the Florida Supreme Court soon struck it down as a violation of the separation of the branches of government. Although Governor Bush appealed the decision to the US Supreme Court, the court declined to consider the case, thereby upholding the Florida court's decision.

This may not be the end of the story, though. Mrs. Schiavo's parents continue to pursue other avenues for keeping their daughter alive, including trying to have Mr. Schiavo removed as Terri's guardian, reports the New York Times.

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Senator Christopher Dodd (D-CT) believes the Food and Drug Administration (FDA) should have the authority to halt ads that endanger patient safety – and he plans to introduce the Patient Protection Act of 2005 to create an FDA Office of Patient Protection empowered to act on new research on drug safety – or against overzealous ads.

Some of the powers Senator Dodd envisions for the Office of Patient Protection are the authority to ban DTC ads it sees as causing safety concerns; to require new warning labels or additional safety research on approved drugs; to withdraw an unsafe product from the market; and to impose $10,000 daily fines for non-compliance. The director of the new office would report directly to the FDA commissioner, and would have an annual budget of $100 million.

Commenting on the proposed new office, Patricia Coyle, MD, Professor of Neurology at the State University of New York at Stony Brook School of Medicine, offered reserved praise for the concept. “The FDA is underfunded and undermanned, so anything that gives them more money and support is positive.” She also believes that more scrutiny of direct-to-consumer advertising is a good idea – as long as the FDA holds all companies to the same standards. However, she noted, the success of the Office of Patient Protection will “depend on the implementation and the people involved.”

She suggested that a central registry for drugs might also help to ensure patient safety. For a period of time after approval, all adverse drug events could be reported to the central registry for analysis. “I am not aware of such a registry,” she said. “In theory, adverse events should be reported, but it is not done in a formal way. A high profile registry that is marketed to physicians could make adverse event reporting standard and routine.” And, she noted, the FDA could mandate reasonable follow-up for approved drugs.

It remains to be seen whether the Patient Protection Act will make it to a vote, however. In a Republican-controlled Congress, no Republicans had endorsed it at press time.

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This year, advocacy groups, including the AAN Legislative Affairs Committee (LAC), are once again struggling to keep Medicare payments to physicians from going down while medical and practice costs go up. While it is still early in the game, physicians have an ally: the Medicare Payment Advisory Commission (MedPAC) has recommended a 2.7 percent increase in payments in 2006 in lieu of the 5 percent cut called for by the physician fee formula used by Medicare, according to an AMA analysis. “This is a very positive sign,” said AAN Federal Affairs Manager Mike Amery. “We need organizations like MedPAC that advise Congress to be on the side of physicians on this issue.” The MedPAC recommendation is non-binding, but Congress will consider it when they address payment rates.

For the past few years, the payment formula that determines how much physicians will be compensated for treating Medicare beneficiaries – which many physician groups, including the AAN, see as flawed – has recommended reductions in physician payments. In those years, physicians advocated for payments that increase along with costs, and Congress voted for last-minute fixes to prevent fee cuts and increase physician payments. These fixes have often delayed published fee schedules, frustrating physicians trying to decide whether they can afford to participate in Medicare for the coming year.

Even if Congress takes MedPAC's advice and prevents fee cuts in 2006, the root problem won't be solved – the physician fee formula calls for similar fee cuts for the next six years. The AAN and many other physician groups have been advocating for replacing the current formula with one that reflects changes in the price of medical services, not just changes in the economy, as the current one does.

Indeed, MedPAC has recommended that the current formula be replaced, although it has not thrown its weight behind a particular strategy. Mr. Amery reports that the LAC will continue to pursue a change to the physician fee formula, although it is an expensive proposition. Increasing Medicare payments and correcting the physician fee schedule are one of the top three legislative priorities for the AAN this year, and will be a priority at the AAN's Neurology on the Hill advocacy event May 24 and 25. Neurology Today will continue to report on this issue as it develops.

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Physicians involved in a class-action lawsuit accusing several HMOs of improper billing practices won a small victory when the US Supreme Court affirmed their class-action status. The Supreme Court refused to hear an appeal of a lower court's decision in favor of class action status, thereby allowing the trial to proceed.

The 900,000-plus physician plaintiffs contend that the HMOs broke the Employee Retirement Income Security Act and state prompt payment laws by violating their contracts, lying about not receiving bills, changing billing codes by downcoding or bundling, and holding the money for payment for 60 and 90 days. The HMOs named in the suit are Health Net, Humana, PacifiCare Health Systems, Prudential Insurance Co. of America, United Healthcare, and Well Point Health Networks. Aetna and CIGNA were also named in the original suit, but have settled with physicians out of court.

The trial, which will take place in a Florida district court, is scheduled for September 6.

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Calls for safe and legal prescription drug importation have grown louder, and this may be the year that legislative forces converge to pass an importation law. The Senate – long the stopping point for this legislation – will consider at least two importation bills, and Senate Majority Leader Bill Frist and the new Chairman of the Health, Education, Labor and Pensions (HELP) Committee, Senator Mike Enzi (R-WY), have pledged to hold a hearing on one of the bills by April. The House passed an importation bill by a wide margin last year.

The two bills come from sponsors with some weight – the Pharmaceutical Market Access and Drug Safety Act (S. 334) comes from the bipartisan team of Byron Dorgan (D-ND) and Olympia Snowe (R-ME) – and the Safe Importation of Medical Products and Other Rx Therapies Act (S. 184) is sponsored by Judd Gregg (R-NH), who serves on the Health, Education, Labor, and Pensions Committee and the Labor, Health and Human Services, and Education Appropriations Subcommittee.

Both bills would allow individuals, pharmacies, and wholesalers to import prescription drugs from FDA-approved pharmacies in Canada, Australia, Japan, and other industrialized countries. They both would extend the FDA's regulatory scope and responsibility to cover imported drugs, as well.

However, all the legislative work may come to naught if Canada decides to close its borders to drug exports. Canada's Health Minister Ujjal Dosanjh has vocally supported efforts by the Manitoba Pharmaceutical Association to crack down on exported prescriptions, citing safety issues. The Pharmaceutical Association is targeting “countersigned” prescriptions – foreign prescriptions that are signed by Canadian physicians with no relationship to the patient, for the express purpose of exporting drugs – by disciplining pharmacists that fill prescriptions countersigned by physicians that have not examined the patient.

Physicians, too, are being disciplined for countersigning prescriptions – at least ten have been sanctioned, the latest with a two-year suspension. Minister Dosanjh is expected to make changes to Canadian law that could further cripple the drug export market, according to the Canada's news service, Canadian Press.

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Medical liability reform – another AAN legislative priority – is receiving strong legislative support this year. President George W. Bush spoke out in favor of reducing frivolous lawsuits and capping non-economic damage awards. Several times in the last few years, Congress has considered legislation like that recommended by President Bush, but it has not passed a medical liability reform law. The House has passed medical malpractice reform bills while the Senate has not passed even one. The President has charged the legislators with passing a malpractice reform bill in 2005, and this is one of the top three legislative priorities for the AAN this year.

In a January speech, President Bush outlined the liability reform measures he supports, which mirror many of the recommendations of physician advocacy groups and the solutions that have been proposed in Congress. The President voiced his support for a $250,000 cap on non-economic damages and a division of liability for those found guilty of malpractice, so that physicians are penalized in proportion to their responsibility for the malpractice. President Bush also called for limits on lawyers' contingency fees, provisions to pay large awards over time instead of in a lump sum, and a statute of limitations on injury suits – reforms common in federal medical malpractice legislation. “The AAN is in agreement with the President's proposal,” said Mike Amery, AAN Federal Affairs Manager, “we just need to see legislation that results in reduced malpractice insurance rates, not just tort reform.” Medical liability reform will also be highlighted at the Neurology on the Hill advocacy event in May.

So is this the year for tort reform? Republicans have gained seats in both Houses of Congress, but Democrats, traditionally opponents of these tort reform measures, still have enough seats to block legislation. “The chances in the House are excellent,” explained Mr Amery, “it comes down to the Senate. The cry to pass this legislation is louder every year, and it has at least four more supporters in the Senate this year, so we are getting closer. We see more than 50 percent support for medical liability insurance reform in the Senate, so we just need to not have it filibustered.”

© 2005 American Academy of Neurology