Health Law

USA Today (12/3, Appleby) reports, "More than one million people in the Medicare drug program next year will pay almost the full price for certain brand-name drugs when they choose them over generics -- a move that advocates for patients say is not clearly spelled out by the government nor insurers." In addition, "for hundreds of targeted drugs, patients will pay a standard co-payment. They also will pay the difference in price between the brand- name medicine and the generic." According to Medicare, "about 10 percent of insurers will use the extra charge next year." The additional "charge applies to drugs such as Zocor (simvastatin), for cholesterol, and anti-depressant Zoloft (sertraline Hcl), whether bought at the pharmacy or by mail." Medicare's website "does not include the extra fees when calculating annual costs for beneficiaries. Instead, a footnote on the medications says they 'may be subject' to extra charges and suggests enrollees contact insurers."

The Wall Street Journal (12/2, Burton, Armstrong) reported, "The family of a California woman who went into respiratory arrest and died after neck surgery filed a lawsuit blaming her death on the use of a fast-selling bone-growth protein made by Medtronic Inc." The lawsuit "comes amid a Justice Department investigation and a separate U.S. Senate inquiry into use of the bone-growth product -- called Infuse Bone Graft -- for purposes not approved by the Food and Drug Administration." Currently, "The only type of spine surgery for which Infuse has been approved is a frontal approach to the lower backbone, known as the lumbar spine." In their lawsuit, the family contends that "a Medtronic salesman" allegedly urged that the patient's "surgeon use Infuse in her neck surgery even though such use wasn't FDA-approved." The patients' surgery, on Aug. 21, occurred "about seven weeks after the FDA had warned that Infuse in neck surgery had caused 'life-threatening complications.'"

The AP (12/2, Mohajer) reported, "A former employee of UCLA Medical Center pleaded guilty Monday to selling information from the medical records of celebrities and high-profile patients, including Britney Spears and Farrah Fawcett, to the National Enquirer." Lawanda Jackson pleaded guilty "to the felony charge of violating federal medical privacy law for commercial purposes." According to authorities, "Jackson worked as an administrative specialist at the UCLA hospitals...and in recent years began using her supervisor's password to access medical records inappropriately." Prosecutors said that before she resigned in July 2007, Jackson received "checks totaling at least $4,600" from the tabloid. She now "faces a maximum sentence of 10 years in prison, followed by three years of supervised release, and a $250,000 fine." Jackson's "sentencing is set for May." So far, the Enquirer faces no charges, but a U.S. attorney's spokesman said that "the role of the media is part of the investigation into the privacy breaches."

        "Inquiries this year by UCLA and the California Public Health Department" revealed that "Jackson personally had viewed the records of more than 1,000 patients since 2003," Modern Healthcare (12/2, Blesch) added. These investigations also found that "many employees had inappropriately accessed patient records over the course of several years." The "medical center has committed to a variety of steps to prevent breaches."

CQ (12/2, Ethridge) reports that former Obama campaign advisor, David Blumenthal, director of the Institute for Health Policy at Massachusetts General Hospital, and James Morone, chairman of political science at Brown University, wrote an article in the New England Journal of Medicine that recommended President-elect Barack Obama follow President Lyndon Johnson's lead on Medicare by quickly passing healthcare reform. To help pass Medicare legislation, Johnson "went so far as to underestimate its true cost and avoided projecting the legislation's economic impact so the bill could [pass] more quickly." Blumenthal and Morone wrote that Johnson decided "to expand coverage now and worry about how to afford it later." However, Obama faces a much bleaker economic situation than Johnson did. For a healthcare overhaul bill to succeed, Obama "will need to use much of his political capital, the authors noted. Johnson was victorious because he was personally committed to passing Medicare, and willing to spend money and energy as well as use his clout."

        Wasteful healthcare spending seen as "major test" for Obama. In the Wall Street Journal (12/2) Health Blog, Victoria Knight cites Gary Kaplan of Virginia Mason Medical Center who estimates that about half of the $2.3 trillion spent on U.S. healthcare "does nothing to improve health." Sorting out this wasteful spending in healthcare "is going to be a major test for President-elect Barack Obama who pledged during his campaign to cut the average American family's healthcare tab by $2,500."

        Obama may utilize massive email base to advance healthcare agenda. Bloomberg News (12/3) reports, "President-elect Barack Obama said he will tap into the millions of email addresses compiled during his campaign to help advance his agenda, particularly when it comes to potentially contentious issues such as healthcare." In an interview with Ebony magazine, Obama said, "If I'm trying to move healthcare reform through Washington, then the fact that we have 10 million people on an e- mail list who are ready and willing to get activated [will prove to be] incredibly powerful." Bloomberg News says that "the absence of broad public support helped doom the efforts of the last Democratic president -- Bill Clinton -- to overhaul the U.S. medical insurance system as interest groups picked apart the massive plan."

The AP (12/2) reported, "Federal regulators are taking steps to get medically unfit truck and bus drivers off the road after being accused for years of dragging their feet on the issue." States will now "be required to merge commercial truck and bus drivers' licenses with drivers' medical examination certificates into a single electronic record" under a measure "approved by the Federal Motor Carrier Safety Administration." The rule is geared toward making it "it easier to check whether drivers have met medical requirements to operate commercial vehicles." The new rule will allow states "three years to comply." In addition, "the administration has also proposed creating a registry of medical examiners qualified to award certificates to drivers." Those examiners "who fail to meet minimum standards could be barred from issuing fitness-to-drive certificates."

The AP (12/3, Eggert) reports, "Public health officials and doctors on Tuesday implored the Legislature to ban smoking inside bars, restaurants, and other workplaces before adjourning for the year, saying lives are at stake." Michigan Department of Community Health Director Janet Olszewski "sent a letter urging passage of smoking-ban legislation to all 148 members of the Legislature. Organizations representing physicians, medical students, and hospitals also wrote to lawmakers." To date, over "30 states have passed smoking bans, but Michigan legislators are at odds over carving out exemptions for some businesses." Specifically, "the Democratic-led House has passed legislation that would ban smoking at restaurants and bars, but exempt Detroit casinos, smoke shops, and others." Meanwhile, "the Republican-held Senate has voted to prohibit smoking at all workplaces with no exceptions." The two chambers must reach a consensus before the current law can be changed.

The New York Times (12/3, B1, Abelson), on the front page of its Business Day section, reports, "For these economically uncertain times, the UnitedHealth Group has a 'first of its kind' product: the right to buy an individual health policy at some point in the future even if you become sick." The product "is not actual medical insurance, but is aimed at people who may have insurance now but are worried they may lose it - and may not be able to obtain replacement insurance on their own," due to early retirement or medical sickness. After passing a medical review, policyholders "will pay 20 percent each month of the current premium on an individual policy to reserve the right to be insured under the plan at some point in the future." Some industry analysts say that the plan "may become obsolete" as there "is serious talk in Washington of having private insurers agree to offer individual coverage to anyone, regardless of their health status."

The U.S. News & World Report (12/2, Bedard) reported, "Concerns about major coverage and payment changes that Blue Cross and Blue Shield is imposing on some four million federal workers has prompted a House hearing this week." The "federal workforce subcommittee of the House Committee on Oversight and Reform" will discuss the changes with Blue Cross, "the Office of Personnel Management, as well as a doctor," on Wednesday. The insurer has been criticized for certain changes that "will cut coverage while raising costs" without "much notice to federal workers." Still, Blue Cross's "explanation of coverage" noted that "the changes coming to the new plan are not that radically different than what other insurance companies are imposing."

The AP (12/3) reports, "Health insurer Aetna Inc. spent $452,449 in the third quarter to lobby on several Medicare and Medicaid-related issues, according to a recent disclosure report." The insurer focused its lobbying efforts on "legislation involving Medicare prescription drug prices, physician reimbursements, Medicare Advantage funding cuts and the expansion and extension of the State Children's Health Insurance Program." And, in a separate article, the AP (12/3) reports, "Managed care company Cigna Corp. spent more than $341,435 in the third quarter lobbying on health insurance regulations and Medicaid and Medicare issues, according to a recent disclosure form." Cigna also lobbied "on legislation dealing with the children's health insurance and patient rights, as well as on mental health benefits, the long-term safety and effectiveness of medical devices and drugs, and tax matters."

Crain's Detroit Business (12/2, Greene) reported, "Critics of individual health insurance legislation supported by Blue Cross Blue Shield of Michigan held a press conference Tuesday in Lansing to explain why they are opposed to the bills." The proposed legislation would allow Blue Cross "to increase rates to individuals by 37 percent and 75 percent for seniors who purchase Medicare supplemental policies." Blue Cross would also be allowed to "charge 300 percent or more to seniors and those with disabilities than others." Blue Cross officials contend that the "legislative package is crucial for its survival." The insurer has projected a $166 million loss "this year on individual health policies, and projects to lose $264 million if nothing is done." But, "a coalition of seniors, the disabled and health insurers contend the bills are anti-consumer and are only designed to enhance Blue Cross' profits and monopoly." The bills are also opposed by "Michigan's HMOs...because they would add a new 'cherry-picking' tax on premiums that would raise rates on people purchasing commercial insurance."

NBC Nightly News (12/2, story 9, 2:15, Williams) reported, "A report [Tuesday] from the Institute of Medicine is taking a stand on a big and long-running problem in medicine." The organization "said that working for 30 consecutive hours creates an unsafe working condition, that is hazardous both to physicians and to the patients for whom they care."

        According to the New York Times (12/3, A23, Parker-Pope), the "national panel of medical experts proposed significant and costly changes for training new doctors in the nation's hospitals, recommending mandatory sleep breaks and more structured shift changes to reduce the risk of fatigue-related errors." This "experts' report...focused on the grueling training of medical residents." Notably, while "a series of changes, including limiting residents to an 80-hour workweek and 30-hour shifts," has been made in recent years, "the expert panel said those reforms were not enough," because "caps on work hours are often not enforced, and many residents still do not get enough sleep, putting doctors and patients at risk for fatigue-related mistakes."

        Therefore, in order "to improve patient safety," the panel members recommend that "medical residents...get at least five hours of sleep after working 16 hours," USA Today (12/3, Rubin) adds.

        The Washington Post (12/3, A6, Brown) added that the proposed "work rules for physicians-in-training...are considerably more restrictive than those that went into effect in 2003, but are widely violated." For instance, "a survey of about 4,000 interns found that in the first year those rules were in effect, 84 percent reported working shifts that violated them at least one month of the year." Meanwhile, "43 percent reported working more than 80 hours weekly." The AP (12/3), the Salt Lake Tribune (12/3, Rosetta), Modern Healthcare (12/3, Lubell), and Scientific American (12/3, Lite) also cover the story.

The U.K.'s Telegraph (12/2, Devlin) reported, "Writing for the British Medical Journal, Dr. David Kao from the University of Colorado warns that pressure to get drugs to market as soon as possible has shifted the focus away from patient safety." Drug "companies are keen to get their products on the shelves as soon as possible to maximise the profit that they can make before their patent" expires "and other companies can make generic versions of the medication." Furthermore, "patients are also anxious to receive the most advanced treatments quickly and there have been controversies about the length of time it takes drugs to be approved for use on the [National Health Service] after they have been passed by regulators." But, according to Dr. Kao, "giving large numbers of patients new drugs in a short space of time can expose them to unknown risks" and that "concerns have been expressed that deadlines for approving drugs have reduced the focus on safety."

The New York Times (12/3, B1, Abelson) reports on the front page of its Business Day section, "The Cleveland Clinic plans to announce this week it has begun publicly reporting the business relationships that any of its 1,800 staff doctors and scientists have with drug and device makers." The clinic's "complete disclosure of doctors' and researchers' financial ties" will be made "available on its website, www.clevelandclinic.org." The clinic's move is the "most recent part of a conflict-of-interest effort" that began when "some of its leading doctors came under fire several years ago when the news media disclosed some of their financial links." Since then, the Cleveland Clinic has reviewed "its conflict-of-interest policies and developed a formal system of tracking the business dealings of its doctors and researcher." The clinic's efforts were praised by Sen. Charles Grassley (R-Iowa), who "has brought Congressional scrutiny to the issue and introduced legislation that would require drug and device makers to divulge the payments they make to doctors."

Forbes (12/3, Ruiz) reports, "When Massachusetts expanded healthcare coverage to the uninsured in 2006, the goal was to provide residents with regular access to treatments and physicians. But, as demand increased, the system became overwhelmed." According to a recent report released by the Massachusetts Medical Society, there are "alarming barriers to doctor access. In an avalanche of disheartening statistics, the most worrisome included the three- to four-week delay to see certain specialists, and a 10 percent increase in the number of family physicians who have stopped accepting new patients." As a result, some medical experts say that, while it is laudable that over 439,000 Massachusetts residents have obtained health insurance since 2006, insurance without access to physicians is useless. And, "industry experts are concerned that legislators will repeat Massachusetts' unfortunate experience on a national level." Should this occur, it would have serious repercussions for patients, especially baby boomers, and residents of inner-city urban and rural communities.

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