Health Law

The Washington Post (12/9, HE1, Jenkins) reports on the front of its Health section that there is "a growing concern among policymakers and healthcare experts who" believe there may be "a shortage of family medicine doctors and geriatricians to care" for the country's 44 million Medicare beneficiaries. In fact, "healthcare experts and advocates for...elderly say the problem is partly a reflection of how worried physicians are about changes in reimbursement rates from the federal government. Some physicians say they are afraid of accepting new Medicare patients and discovering later that the amount they receive for treating them will be decreased." In addition, many cite "the slow pace of reimbursement and the layers of paperwork it requires." Meanwhile, a study published last week showed that "nearly 30 percent of the 2.6 million Medicare beneficiaries seeking a new primary-care physician between September 2007 and October 2008 had trouble finding one, up from 25 percent in 2005."

The AP (12/9) reports that, according to a study published in the Jan. 15, 2009 issue of the journal Cancer, "state laws meant to keep teens out of indoor tanning booths haven't made a dent." For the study, researchers from the American Cancer Society conducted "telephone surveys of more than 1,100 youths ages 11 to 18. The surveys were" performed "in 1998 and 2004 in the 48 continental states." In 1998, "eight states...had new or fairly new laws to restrict minors' access to indoor tanning." But, "each of the laws allowed young people to use tanning parlors provided they had some form of parental consent." The investigators found that in the eight states with indoor-tanning laws, approximately "eight percent of youths used indoor tanning in both 1998 and 2004 -- no change over the six years."

        "That's a worrisome trend, because ultraviolet radiation, whether from the sun or indoor tanning facilities, has been linked to skin cancer, the most common malignancy in the United States, with one million new cases in 2008," HealthDay (12/8, Doheny) added. The authors conjectured that "enforcement issues probably explain why the restrictions aren't working." Study author Vilma Cokkinides, Ph.D., explained, "One study [evaluated by the researchers] looked at enforcement and found poor compliance." She said that children "'were able to bypass the restriction,' either by lying about their age, or because the establishment didn't ask, she said." Cokkinides and colleagues called for "more stringent legal measures and more education...to reduce indoor tanning by minors." Dermatologist Elizabeth K. Hale, M.D., spokeswoman for the Skin Cancer Foundation, said that "indoor tanning bed use should be prohibited for those under 18."

        According to MedPage Today (12/8, Phend), the authors suggested that "physicians redouble efforts to inform parents about 'the short-term and long-term skin cancer risks associated with the use of indoor tanning.'" Recently, "one large meta-analysis found a 75 percent higher melanoma risk among individuals who started using sunbeds before age 35." In addition, indoor tanning can accelerate "aging of the skin," as well as alter "immune system function," and cause "photo-induced medication reactions," the investigators noted. To date, "many organizations support legislation to limit minors' access to indoor tanning facilities. The World Health Organization has called for outright restriction of use by individuals under age 18."

The New Jersey Law Journal (12/9, Gottlieb) reports, "Two litigators who have been arguing about the breakup of their firm for two years are squabbling now over shares of a proposed $2.45 million fee in a class action settlement with Horizon Blue Cross Blue Shield." The class action suit is aimed at "getting Horizon to increase benefits for eating-disorder patients." In November, Bruce Nagel "made an agreement with Horizon to ask U.S. District Judge Faith Hochberg to approve a settlement that would provide $1.18 million to both" his own clients, as well as those of David Mazie, his ex partner, "and hundreds of other insureds whose eating-disorder benefits had been limited in the past," without telling Mazie. The deal also "called for Nagel's firm, Nagel Rice, to be class counsel." Still, Mazie "agreed to support the proposed Horizion pact," and even though Nagel said "the settlement was off" on Nov. 28, Mazie contends "there was a deal and he wants the judge to enforce it." Mazie also "wants the judge" to "appoint his firm co-lead class counsel."

The AP (12/8) reported, "AstraZeneca PLC and Bristol-Myers Squibb Co. said Monday they plan to extend their international deal to co-develop -- and ultimately sell -- a new diabetes drug to include Japan."

        The drug, dapagliflozin, which may regulate "the reabsorption of glucose in the kidney, is one of two investigational drugs under joint development by the companies," the Philadelphia Inquirer (12/8) added. The treatment "is in phase III clinical trials in several countries, including the United States, as a once-daily treatment for Type 2 diabetes. It is in phase II clinical trials in Japan." In addition, "the two companies also are collaborating on saxagliptin, which they would market as Onglyza. It's a DPP-4 inhibitor being studied in clinical trials as a once-daily therapy." The drugmakers "submitted a new-drug application to the Food and Drug Administration on June 30, and a marketing authorization application to the European Medicines Agency on July 1 for saxagliptin."

In the Wall Street Journal (12/8) Health Blog, Jonathan Rockoff wrote, "Sen. Ted Kennedy (D-MA) is giving up his perch on the powerful Judiciary Committee to concentrate on overhauling healthcare." Sen. Kennedy said that he expects "to lead a very full agenda in the next Congress, including working with President Obama to guarantee affordable healthcare, at long last, for every American." Rockoff noted that Sen. Kennedy's move is "another sign that President-elect Obama and Congressional Democrats plan to make healthcare reform an early priority."

Healthcare IT News (12/8, Manos) reported, "Howard Dean, Chairman of the Democratic National Committee (DNC), former Governor of Vermont has predicted that President-elect [Barack] Obama will get his healthcare reform plan passed in stages, not in one fell swoop." Speaking at "the eHealth Initiative's Fifth Annual Conference" Dec. 4, Dean said that healthcare reform must "proceed at a pace of comfort for the American people." Dean explained that "under a universal healthcare system," the Centers for Medicare and Medicaid Services "will have to step up to an increased load," which will require incremental changes. He noted that because "most Americans...like the care they are getting from their doctors," convincing them that "they can keep it" is a concept that "is critical to getting support for change." Dean also said that "healthcare IT will be a big part of cutting costs in an Obama healthcare reform plan," and that "small doctor practices" should receive "help financially to purchase the IT," or "they will become disenfranchised."

CQ (12/8, Armstrong) reported incoming House Energy and Commerce Chairman Henry Waxman, in a speech Monday sponsored by the Prescription Project, "promised to immediately take-on health care and energy overhauls."  On healthcare, Waxman "echoed" other top Democrats, saying he would take his cues from the Obama administration.  Waxman said that "although he would not give up his role as a watchdog, he wants to write health care legislation that is politically achievable."  Waxman prefers a "passable" bill that "secures the goal of universal coverage, [includes] sensible controls on cost and assurances of quality care."

        Waxman, "best known for his seemingly daily oversight hearings on everything from Blackwater to baseball," used his first health policy speech "to let congressional greenhorns know that, yes, he does know something about healthcare, and no, his recent role as omnipresent overseer doesn't mean his skills are poorly matched to the heavy duty demands of healthcare legislating," CQ (12/8) editor John Reichard added.  Waxman noted his legislative accomplishments as chairman of the Energy and Commerce Health Subcommittee, which he called "one of the most productive subcommittees in the Congress" between 1979 and 1994.

The Hill (12/9, Young) profiles Senate Finance Committee ranking member Chuck Grassley's senior aide Mark Hayes who "is one of a handful of senior Republican aides who could wield considerable influence over how" healthcare reform "advances, or fails to."  According to Hayes, "Republicans are prepared," and "the GOP is more sensitive to health reform as a political issue and more knowledgeable about the policy."  An "early test of whether Democrats and Republicans can play nice on health reform will be" SCHIP reauthorization.  Hayes said, "How Congress approaches SCHIP will have implications for whether bipartisan healthcare reform can get done in 2009.  If a lengthy, protracted and partisan SCHIP debate is the kickoff to the healthcare debate of the year, that will make a bipartisan, comprehensive proposal less likely."

The AP (12/8) reported, "It's been three years since New Hampshire started screening medical malpractice cases before trial, but it's hard to say whether the new system is a success." Cases are screened by panels that are "led by a retired judge and include a doctor and lawyer." The panel votes "in favor of the plaintiff or the doctor," and if the panel's decision is "a unanimous ruling either way," it is "given to a jury if the case goes to trial." While physicians and their lawyers contend that the screening process "saves money and time by encouraging settlements," attorneys who represent "injured patients say the system doesn't work because lawyers are preparing as much for the panel hearings as they do for trials." Furthermore, the state has "no way to tell whether cases are being resolved faster...because more than half of the" suits "filed after the new system began" are unresolved. A meeting has been scheduled for January by the head of the superior court system "to discuss changing the process."

HealthDay (12/8, Edelson) reported, "An electronic prescribing system that tells doctors which drugs are the least expensive can save millions a year," according to study published in the Archives of Internal Medicine.

        Medscape (12/8, Barclay) explained that researchers "conducted a prepost study with concurrent controls using 18 months of administrative data from October 1, 2003, to March 31, 2005, to compare the change in the proportion of prescriptions for three formulary tiers before and after e-prescribing began." With this "data, they developed multivariate longitudinal models to estimate the specific effect of e-prescribing, after adjustment for baseline differences between intervention and control prescribers. Using average medication costs by formulary tier, the investigators estimated potential savings."

        MedPage Today (12/8, Fiore) reported that "more than 1.5 million patients filled 17.4 million prescriptions during the study period. In a multivariate analysis, the" investigators "found that e-prescribing corresponded to a 3.3 percent increase (95 percent CI 2.7 percent to 4.0 percent) in tier-1 prescribing," while "tier 2 prescriptions decreased 1.9 percent (95 percent CI -2.5 percent to -1.3 percent) and tier 3 prescriptions dropped 1.5 percent (95 percent CI -1.8 percent to -1.1 percent). ... E-prescribing with formulary decision support accounted for 20 percent of total prescriptions. At that level, the technology could result in annual savings of $845,000 per 100,000 patients. Furthermore, "higher levels of e-prescribing would increase the savings. Projected savings could be $3.91 million per 100,000 patients per year," the investigators added.

Healthcare IT News (12/8, Merrill) reported, "President-elect Barack Obama released 'a few key parts' of his economic recovery plan for 'both Wall Street and Main Street' in a radio address aired on Dec. 6." With regard to healthcare IT, Obama discussed "plans for a 'sweeping effort to modernize and upgrade'" by ensuring "that our hospitals are connected to each other through the Internet." In doing so, the new administration will "roll out $10 billion per year for five years to help physicians and other providers adopt healthcare IT." Obama stated that his team "will make sure that every doctor's office and hospital in this country is using cutting edge technology and electronic medical records" in order to "cut red tape, prevent medical mistakes, and help save billions of dollars each year." He noted that patients' records will be "available when needed, but also confidential under patient control."

Healthcare IT News (12/8, Merrill) reported that "four Federally Qualified Health Centers (FQHC) in Montana are poised to connect electronically," as "Riverstone Health, which operates the largest FQHC in the state, serving residents in the Yellowstone valley area," plans "to implement a unified electronic medical records (EMR) and practice management (PM) solution from Westborough, Mass.-based eClinicalWorks." Through the link, healthcare workers "will have greater access to patient information and the ability to coordinate care across" the state. Furthermore, "Riverstone Health official's say the EMR/PM solution will help to meet the stringent reporting and billing requirement that apply to its FQHCs, as well as to ensure there is no interruption in the funding that supports patient care." Notably, the "project is being funded through a High Impact Health Information Technology grant by the U.S. Department of Health and Human Services Health Resources and Services Administration."

The Charlotte (NC) Business Journal (12/8) reported, "Blue Cross and Blue Shield of North Carolina will offer free generic prescription drugs to about 1 million members during the first half of next year." The insurer will allow "some members [to] waive their copays on generic prescriptions." Members of "Blue Advantage...and Medicare supplement customers" will be required to "meet an annual prescription deductible" first, before using the copay waiver. The program "is also available to many members who receive coverage through their employers" and to "members of self-funded employer groups...if their employer group has a pharmacy benefit through Blue Cross and has chosen to participate in the program."

        The insurer "will evaluate the impact of the program in June," WWAY-TV (12/9) Wilmington reports on its website. Blue Cross "may extend the program beyond the six month trial period" to "everyone across the board" if it sees "more people taking their medicine."

The New York Times (12/9, Rabin) reports that data released from the Agency for Healthcare Research and Quality indicate that the "number of hospital patients with bedsores has risen dramatically over a 14-year period, leading to longer, more expensive hospital stays." Specifically, "some 503,300 patients admitted to U.S. hospitals in 2006 suffered from a bedsore that developed either before or during their stay." That estimate "was 281,300 in 1993, representing an increase of 78.9 percent." While the report "did not explain why bedsores had become so much more frequent, an official with the American Hospital Association speculated that the increase may be due to rising numbers of very frail, elderly patients arriving in hospitals." Yet, "it's also possible that greater attention to bedsores by hospital staff has led to improved record-keeping and a more accurate accounting of their numbers."

Life Sciences Law

The AP (12/9, Alonso-Zaldivar) reports, "It could have been the world's first prescription pistol. The single-bullet Palm Pistol set the Internet abuzz with speculation that Medicare might even pay for the elderly and disabled to pack heat." However, on "Monday the Food and Drug Administration (FDA) said the Palm Pistol doesn't have a shot of being listed as a medical device, and revoked the registration issued to its inventor only last week." In a statement, the FDA said that the agency "has determined the product is not a medical device." According to the product's inventor, Matthew M. Carmel, "the elderly and disabled are easy targets for criminals, and the Palm Pistol could be an equalizer. Shaped like an oval, it fits in your palm" and "the barrel sticks out through" users' fingers, who then, "instead of pulling a trigger...push down on a button with [their] thumb."

The New York Times (12/9, D6, McNeil) reports that a "major limitation on journalists covering global health is the cost: getting to a story can mean airfare to Africa or Asia, hotels, Jeep rentals, satellite phones, translators, sometimes even armed guards." Although "many news organizations are cutting back," the Bill and Melinda Gates Foundation is stepping in to support such efforts. In fact, "last week, 'The NewsHour With Jim Lehrer' received a Gates Foundation grant of $3.5 million to help its correspondents produce 40 to 50 reports over three years on malaria, AIDS, tuberculosis, measles, neglected diseases, and other global health issues," monies that "came with 'no strings.'" While "this is the foundation's most overt financing of health journalism," it is "not the first." Meanwhile, "because fictional plotlines may be even more persuasive," the foundation "gave $1.4 million to a University of Southern California program that advises television and film writers on medical issues."