Health Law

CQ (3/4) reports, "Medicaid, the mainstay of long-term care financing in the United States, has seen a major shift in recent years toward funding care in homes and community-based programs rather than in nursing homes, according to testimony to be presented Wednesday at a Senate Special Committee on Aging hearing." Nursing homes accounted for 53 percent of the $113 Medicaid spent in 2007 "for care, including extensive help with such basic daily activities as eating, dressing, bathing, walking, and going to the bathroom." Some experts say "that many people prefer to get long-term care outside of the nursing home," but worry "that a shift to care outside the nursing home would increase rather than reduce costs."

USA Today (3/4, Weise) reports, "The Food and Drug Administration does not have the information, resources or recall ability necessary to adequately regulate dietary supplements," a Government Accountability Office report said. "The GAO listed a number of areas in which the FDA has little oversight. For example, supplement companies don't have to tell the FDA what products they sell or ingredients they use." The GAO "report also found that the FDA does too little consumer education on the safety and efficacy of dietary supplements. ... Unlike drugs, which must be approved for safety and efficacy before entering the market, dietary supplements marketed before 1994 are presumed safe." The agency "must demonstrate that a product presents a significant or unreasonable risk to the public to get it off the market."

        "Besides advising that the agency ask for more power from Congress to regulate supplements, the report recommended that the agency make sure consumers know that such products, unlike drugs, do not need agency approval and that their makers do not have to prove their safety and efficacy before they go on sale," the New York Times (3/4, B3, Singer) adds. In addition, "To improve oversight, the report recommended that the FDA seek authority to require supplement makers to register as [makers of specific supplements], provide lists of products and copies of product labels, and to disclose all reports of health problems -- not just hospitalizations and deaths, as they have been required to do since the end of 2007." In a written response, included with the report, the agency "agreed that it could better ensure the safety of dietary supplements if it received more comprehensive information about supplement companies, products, and health problems." However, "the agency also said that additional requirements could lead to information overload."

The Wall Street Journal (3/4, Dooren) reports, "The Food and Drug Administration will ask an outside panel of medical experts for advice on whether the agency should allow wider use of AstraZeneca PLC's Seroquel [quetiapine fumarate], which is currently approved to treat bipolar disorder and schizophrenia." The agency "said it would convene its Psychopharmacologic Drugs Advisory Committee on April 8 to discuss the safety and effectiveness of Seroquel for treating generalized anxiety disorder and major depression. The FDA said the safety issues at the meeting will focus on 'concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia,' a neurological disorder that can be caused by drug exposure."

The AP (3/3, Levy) wrote, "Pennsylvania Gov. Ed Rendell's (D) proposed assessment on health insurers faces long odds in the state Senate, a key lawmaker told a top Rendell aide." According to state Senate Appropriations Committee Chairman Jake Corman (R-Centre), "some insurers will see it as a tax that will drive them out of the state or that they will simply pass on to consumers." And, "any increase in premiums could possibly swell the ranks of the uninsured at a difficult economic time when people are unable to afford higher costs." Still, Public Welfare Secretary Estelle Richman "and state Insurance Commissioner Joel Ario are working with insurers to find ways they can pay the two percent assessment without raising premiums," while pointing out that "many other states charge similar assessments." Although Richman "is committed to meeting with lawmakers to respond to their concerns," the "assessment would be enforced broadly against health insurers in the state as a way fill a hole in the funding for the state's 1.9 million Medicaid enrollees."

In a front-page story, the Boston Globe (3/4, A1, Wangsness) reported that Sen. Charles Grassley (R-Iowa) has begun scrutinizing a "group of highly paid executives: leaders of nonprofit hospitals." According to a recent IRS survey, "nonprofit hospital presidents earned nearly $500,000 a year on average in salary and other benefits," and on Tuesday Sen. Grassley said "that he is concerned that such salaries may be too high and that the hospitals' boards of directors are not taking full responsibility for approving them. Grassley said he hopes to introduce legislation, possibly as part of a sweeping healthcare overhaul later this year that would put more pressure on boards to keep salaries in check." The senator must decide "whether to try to change the regulations to shift the responsibility to the hospital board to prove a salary is reasonable." Some hospital leaders, however, argue that "most hospital boards already follow a thoughtful and transparent process to determine executive compensation. They need to compete to keep talented leaders with the skills required to deal with community concerns, government regulations, and complicated payment relationships with doctors."

CQ (3/4, Kim) reports, "Rep. Linda T. Sanchez (D-CA) has introduced a bill that would make pre-dispute arbitration agreements between long-term care facilities and residents invalid and unenforceable." According to Sanchez, "Arbitration agreements are often buried in overly complicated contracts, and many consumers do not realize they are waiving their legal options. ... We have to protect families and seniors, and that includes giving them the tools they need to protect their full legal rights." Notably, the "American Health Care Association and the National Center for Assisted Living oppose the bill (HR 1237), arguing that pre-dispute agreements bring timely, less adversarial settlements, and help to prevent rising medical costs due to lawsuits, and allow staff to focus on patient care."

Modern Healthcare (3/3) reported, "Lawmakers who want to offer a 10 percent Medicare reimbursement increase for emergency department (ED) care are looking to health information technology adoption to offset that pay bump." In fact, one legislator pointed out that the "'billions of dollars' in savings anticipated under some of the health IT provisions in the stimulus law would offset the cost of boosting Medicare payments to emergency-care staff." The "Access to Emergency Medical Services Act" was reintroduced last week. The measure "asks the CMS to develop standards, guidelines, and measures to address boarding -- keeping patients in ER exam rooms or in the hallways when inpatient rooms aren't available -- and ambulance diversion." Most importantly, the "legislation would also provide a 10 percent reimbursement increase to emergency department staff, including on-call specialists who often don't get paid for emergency care." Notably, "ACEP is hoping that Congress will approve the legislation soon, as well as hold hearings on the access problems facing patients who visit emergency departments."

The New York Times (3/4, A14, Harris) reports, "Federal health officials and prosecutors, frustrated that they have been unable to stop illegal kickbacks to doctors from drug and device companies, are investigating doctors who take money for using these products." In the past, "prosecutors rarely pursued doctors because they believed that juries would sympathize with respected clinicians." In the near future, however, "officials plan to file civil and criminal charges against a number of surgeons who they say demanded profitable consulting agreements from device makers in exchange for using their products." According to the Times, this "move against doctors is part of a diverse campaign to curb industry marketing tactics that enrich doctors but increase healthcare costs and sometimes endanger patients. Taken together, the new measures are likely to transform the relationship between medicine and industry." Lewis Morris, chief counsel to the inspector general of the Department of Health and Human Services, said, "What we need to do is make examples of a couple of doctors so that their colleagues see that this isn't worth it."

The AP (3/4, Tanner) reports that some physicians are "asking patients to agree to what amounts to a gag order that bars them from posting negative comments online." The AP highlights one company that "provides doctors with a standardized waiver agreement. Patients who sign agree not to post online comments about the doctor, 'his expertise and/or treatment.'" The "company advises doctors to have all patients sign the agreements. If a new patient refuses, the doctor might suggest finding another" physician. Physicians "are notified when a negative rating appears on a website, and, if the author's name is known, physicians can use the signed waivers to get the sites to remove offending opinion." But, John Swapceinski, co-founder of RateMDs.com, said, "They're basically forcing the patients to choose between healthcare and their First Amendment rights." According to AMA President Dr. Nancy Nielsen, "online doctor reviews 'should be taken with a grain of salt, and should certainly not be a patient's sole source of information when looking for a new physician.'"

Life Sciences Law

The Wall Street Journal (3/4, B4B, Gryta) reports, "The prospect of new generic versions of expensive biologic drugs, as outlined in President Barack Obama's proposed budget last week, may be inevitable, but their development faces a long, tough road to realization." The "administration's budget proposes exclusivity for generic biologics that is 'generally consistent'" with the "five years of exclusivity" of small-molecule medications. If the legislation passes, "the Food and Drug Administration would determine the approval process for biologic drugs and may do so on a case-by-case basis, analysts say. Because of their complexity, many drugs may be biosimilars, or approved for the same uses but having their own brand name and not automatically substitutable for the original." In fact, "if generic biologics have their own brands, then pharmacists won't be able to substitute them for the original, which means that generic companies will be forced to market their version of the drugs to physicians."

USA Today (3/4, Rubin) reports that recent coverage of one mother's in vitro fertilization experience that resulted in the births of eight children "galvanized Americans, many of whom hadn't given much thought to the risks of multiple births, such as prematurity and low birth weight, which can cause health problems at birth and lifelong disabilities." The implantation of multiple embryos first gained popularity before 1999 because doctors were "eager to ensure their patients' success and boost their practice's pregnancy rates." But since the American Society for Reproductive Medicine "first issued guidelines on embryo transfer," the "rates of triplet and higher-order births have fallen." And, through "advancements in culturing embryos in the lab, doctors can offer many younger patients an excellent chance of conceiving with only a single embryo." Still, the California family has "sparked debate about whether the United States should follow the lead of Belgium and Sweden, whose laws restrict the number of embryos that doctors may transfer at a time." Already, "legislators in two states" -- Missouri and Georgia -- "have introduced bills to limit embryo transfers."

Bloomberg News (3/4, McQuillen) reports, "A bipartisan group of US lawmakers reintroduced legislation to overhaul patent litigation, claiming the changes are needed to push innovation in a faltering economy." Bloomberg noted that the "debate over patent policies has pitted the technology industry against drug and biotechnology companies including Pfizer Inc. and Amgen Inc." But with "Democrats controlling both houses of Congress and the White House, technology companies may have the upper hand. The drug industry has traditionally given more lobbying dollars to Republicans," according to the Center for Responsive Politics in Washington. The drug companies, "usually the plaintiffs in infringement suits, want the strongest possible protection for their patents, which cover inventions that they may spend years and hundreds of millions of dollars on to develop."

The New York Times (3/4, B3, Wilson) reports that "Sen. Charles E. Grassley (R-Iowa) on Tuesday asked the drugmaker Pfizer to provide details of its payments to at least 149 faculty members at Harvard Medical School." Sen. Grassley "also asked for any Pfizer email, faxes, letters or photos regarding Harvard medical students who have protested drug company influence." The senator, "in a letter to Pfizer, wrote that he was 'greatly disturbed' to read" a recent New York Times article "describing a Pfizer representative taking cellphone photographs of the medical students last October at a campus demonstration against industry influence." The Times adds that "the American Medical Student Association, in a national survey of medical schools last year, gave the Harvard Medical School an F grade for how well it controlled drug company payments to faculty members."

        Bloomberg News (3/4, Pollack) reports that "Grassley, the ranking minority member of the Senate Finance Committee, has probed whether doctors and research schools have properly disclosed links to drug and medical-device companies." A handful of schools "have reviewed or altered conflict-of-interest rules in light of the scrutiny."

Bloomberg News (3/4, Fisk) reports that "Johnson & Johnson and its Janssen Pharmaceutica unit must pay West Virginia $3.95 million for misleading doctors about the risks and benefits of...Risperdal [risperidone]," an atypical antipsychotic drug, "a judge ruled." The state's attorney general "sued Johnson & Johnson and its Janssen unit in 2004, claiming the companies violated the state's consumer protection act by claiming the drug was safer than similar medications." In September 2003, the FDA "required makers of atypicals to warn doctors that such drugs were associated with an increased risk of diabetes." In November of that year, "Janssen...sent out 'false and misleading' letters to doctors that downplayed the risks" associated with the drug, the judge said in his decision.

The AP (3/3) reports, "Vertex Pharmaceuticals Inc. said Tuesday it bought two hepatitis C drug candidates from ViroChem Pharma Inc., and plans to test the drugs in combination with its own drug candidate telaprevir." According to Vertex, "a combination of telaprevir and the two drugs might be more effective against hepatitis C than telaprevir alone. The company said it plans to start a clinical study combining telaprevir with one of the ViroChem drugs in the second half of 2009." The company "is conducting late stage trials of telaprevir, but the ViroChem drugs are in early clinical development."

USA Today (3/4, Biskupic) reports, "As the Supreme Court heard an important case about judicial independence Tuesday, justices appeared open to crafting a rule that could lead elected state judges to disqualify themselves from disputes involving big donors." Justice David Souter commented that "the system we have depended on up to this point is not working very well," while Justice Anthony Kennedy said, "Our whole system is designed to ensure confidence in our judgments."

        The Wall Street Journal (3/4, Bravin) reports, "The Supreme Court appeared to be deeply split over whether an elected state judge may rule on a case where one party spent $3 million to help get him elected." The judge who appeared to "hold the casting vote," Justice Anthony Kennedy, "showed some sympathy for the plaintiff's argument that the judge should have been forced off the case."

        The AP (3/4, Sherman) also covers the story, reporting that, "during lively arguments in a closely watched case from West Virginia, the court's four liberal justices and Kennedy all expressed support for a ruling that the Constitution's guarantee of a fair trial could require judges not to participate in a case in which there was a likelihood of bias." Bloomberg News (3/3, Stohr), the Washington Post (3/4, A6, Barnes) and the Charleston Gazette (3/4, Nyden) also covered the story.

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