Health Law

The Los Angeles Times (12/30, Ornstein, Weber) reports, "California's failure to check the criminal backgrounds of health professionals extends well beyond nurses, encompassing tens of thousands of doctors, dentists, psychiatric technicians, and therapists." The state Department of Consumer Affairs "has identified 104,000...professionals from all levels of medical care to add" to the 195,000 "registered and vocational nurses" with "histories of violence, addiction, predatory behavior, or corruption" who were not vetted. The agency "now estimates that close to a third of the state's 937,100 licensed healthcare workers have not been screened through fingerprint checks," as "licensing boards maintain inconsistent rules about who must be fingerprinted and when." Fingerprints "are the primary tool that regulators can use to root out convictions." The agency indicated that "those who have not been fingerprinted include almost three-quarters of psychiatric technicians; nearly half of family therapists, social workers, and dentists; and 12 percent of physicians."

The Orlando Business Journal (12/30) reports, "Increased vigilance against Medicaid fraud by state agencies has prevented more than $100 million in Medicaid overpayments during the past three years, according to a joint report released Dec. 29 by the Florida Attorney General's office and the state Agency for Health Care Administration." The report indicated that "the Attorney General's Medicaid Fraud Control Unit recovered over $56.7 million during fiscal year 2007-2008, which includes court judgments, fines, and civil penalties." Meanwhile, "88 arrests were made, 62 of which resulted from Medicaid fraud investigations."

        According to WCTV-TV Florida (12/29, Biance), "the Medicaid Fraud Control Unit says Medicaid is the single largest allotment of money in Florida's budget, amounting to over $16 billion dollars."

In the Wall Street Journal (12/29) Health Blog, Sarah Rubenstein wrote, "Medicare is cracking down on medical-equipment suppliers that the agency says have been scamming the government." Durable equipment is "the area where Medicare is most vulnerable in terms of fraud," according to Kim Brandt, director of program integrity for the Centers for Medicare and Medicaid Services (CMS). Medicare is now requiring "most of these suppliers, which are already facing new requirements that they get accredited," to "obtain surety bonds." In doing so, "these companies will have to pay around $1,500 each in return a performance bond that guarantees Medicare up to $50,000 if the supplier doesn't ultimately meet its obligations to the agency," Brandt noted.

        "As of March 1 this year, new suppliers were required to be accredited by one of 10 organizations to ensure the suppliers had the skills to do such things as fit people to wheelchairs or make oxygen settings," Bloomberg News (12/29, Green) added. Brandt said that "all suppliers must be accredited by Oct. 1, 2009."

        Under the new requirement, "certain suppliers of durable medical equipment, prosthetics orthotics and supplies, or DMEPOS," must "post a bond by Oct. 2, 2009," Modern Healthcare (12/30, DoBias) notes. Meanwhile, "newly enrolling suppliers...must meet the requirement by May 4, 2009." CMS has also "revoked billing privileges for more than 1,100 medical equipment suppliers in Southern California and South Florida, and has suspended payments to a number of home-health agencies in the Miami-Dade, Fla., area."

The AP (12/30) reports that on Dec. 29, the Food and Drug Administration (FDA) "said they have approved the first new drug to treat prostate cancer in four years." The drug, degarelix, an "injectable treatment from privately held Ferring Pharmaceuticals, fights the cancer by lowering levels of testosterone, which promotes the growth of tumors in the prostate." According to the FDA, "patients treated with degarelix had testosterone levels comparable to those seen after the testes are removed." Other "prostate drugs in the same class as degarelix include AstraZeneca's Zoladex (goserelin) and Abbott Laboratories' Lupron Depot (leuprolide)."

        HealthDay (12/29) added that degarelix belongs "to a class of drugs called gonadotropin releasing hormone (GnRH) receptor inhibitors." Its reported side effects include "injection site reactions, hot flashes, weight gain, fatigue, and an increase in certain liver enzymes."

The AP (12/30) reports, "Salix Pharmaceuticals, Ltd. said Monday the Food and Drug Administration (FDA) denied approval for the company's ulcerative colitis treatment and said a new study would be needed for another application." Salix, however, released a statement that "it believes the current application for the balsalazide tablet is sufficient." The company is expected to meet "with the FDA to discuss its options, but does not plan on conducting an additional study."

        The drug at issue "is a stronger form of Colazal, a 700-milligram capsule of balsalazide," North Carolina's Triangle Business Journal (12/30) adds. Colazal "was Salix's best-seller until generic competition was introduced at the start of the year, almost wiping out sales of the brand-name medicine."

The New York Times (12/30, A15, Driehaus) reports, "Former Senator Tom Daschle, whom President-elect Barack Obama has" selected "to be secretary of Health and Human Services and director of the new White House Office of Health Reform," attended "a community meeting Monday where he got an earful about expenses that were too high and coverage that was too little." The meeting, held in Indiana, "was one of thousands on healthcare being held around the country...and the first attended by Mr. Daschle."

        The Washington Post (12/30, A3, Connolly) adds, "Even before taking office or introducing concrete policy proposals, the administration-in-waiting is moving to build public support around the broad notion that the US health system needs an overhaul." In doing so, "Obama is betting that the energetic, technology-savvy supporters who fueled his candidacy will act as a potent counter-balance to the traditionally powerful special interests that have defeated similar reform efforts." Chip Kahn, president of the Federation of American Hospitals, noted, however, that "this month's sessions are geared mainly toward Obama's core supporters; a group predisposed to embrace the effort." Meanwhile, one attendee said that "the gatherings are less about concrete policy solutions and more a demonstration that 'we're here, and we're ready to work.'"

        "Obama's transition team is asking people who log into their website...to set up their own community meetings to talk about healthcare, and then report back through the site," Bloomberg News (12/30, Marcus) notes. "At the end of the 90-minute session," Daschle said that Obama "will use the reports to help craft recommendations to Congress."

Business Insurance (12/30, Geisel) reports that residents of Massachusetts "who are not covered under a health insurance plan in 2009 face higher financial penalties" under new rules proposed by the Massachusetts Department of Revenue. Under the proposed new guidelines, "the maximum penalty next year for those with incomes exceeding 300 percent of the federal poverty level will be $89 for each month an individual does not have coverage, or $1,068 for a full year of noncompliance." This compares to the current penalty for noncompliance of "$76 a month, up to a maximum of $912 a year." For those "whose income is less than 150 percent of the federal poverty level," penalties do not apply, because "such individuals are eligible for free health-insurance coverage with premiums completely subsidized by the state." People can, however, "obtain an exemption from the penalty if they can prove that affordable health-insurance coverage is not available."

Oklahoma's Journal Record (12/30, Francis-Smith) reports that, following "years of trying to force health insurance companies to cover costs related to autism, state Sen. Jay Paul Gumm (D-Durant) responded with skepticism to the news that Blue Cross and Blue Shield (BCBS) of Oklahoma has decided to provide autism benefits" in a plan to take effect in 2010. In fact, Sen. Gumm "was first in line to file a bill for the 2009 legislative session to require health-insurance companies doing business in Oklahoma to provide autism benefits." Meanwhile, Oklahoma House Speaker Chris Benge (R-Tulsa) said that the BCBS "announcement is proof that when given the opportunity, the market works to encourage private companies...to provide services increasingly in demand within a community." For his part, however, Sen. Gumm "questioned what benefits will be included in" the BCBS plan, or "what therapies are covered."

The New York Times (12/30, A19, Hartocollis) reports on the "1,000 primary-care physicians" in New York City "who have given up their doctor's pens over the past year to collect the smallest details of their patients' lives in a database as part of a $60 million city health department project." Analysts "say it is the most ambitious government effort nationwide to harness electronic data for public-health goals like monitoring disease frequency, cancer screening, and substance abuse." While HMOs "already use electronic records to communicate," the city "is trying to connect the vast majority of medical practices, which have 10 or fewer doctors, particularly in poorer neighborhoods, in hopes that providing them access to a broader base of patient information...will help them make strides in preventive medicine." The Times notes that "the health department is providing subsidies for doctors to subscribe to the system and teams of trainers to support the transition."

The Charlotte (NC) Business Journal (12/29, Thomas) reported, "Carolinas Medical Center (CMC) expects the number of uninsured patients visiting its" emergency department (ED) "to climb in the next six months as the economic downturn hits home." The surge is expected to "take a financial toll," as "CMC and other hospitals are required by federal law to care for all" ED "patients, regardless of their ability to pay," and "charity-care costs are paid for out of operating revenue." And, because uninsured patients "often delay seeking treatment," they exacerbate "the need for care," increasing the cost. In response, CMC parent Carolinas HealthCare System is "adding free-standing emergency rooms to alleviate pressure on its main emergency department." Dr. Lee Benjamin, assistant professor of surgery and pediatrics at Duke University School of Medicine and a member of the American College of Emergency Physicians, noted that "fewer emergency rooms nationwide and an increasing number of patients -- many without health insurance," will have "a major impact on this already stressed system."

Modern Healthcare (12/29, DerGurahian) reported, "Hospitals in Alabama are struggling to make ends meet as they see a decline in admissions amid the current financial turmoil and pending cuts to Medicaid reimbursements, according to a survey by the Alabama Hospital Association." The survey included "chief executive officers from 84 facilities across the state," of which "more than half...said that the credit crunch has moderately or significantly impacted daily business." Notably, "half of the respondents saw a decrease in admissions based on projected levels over the past three months, and fewer elective procedures were performed." Meanwhile, "75 percent of executives said that bad debt and charity care increased." The "majority of survey respondents" indicated that "if the state's Medicaid program goes through with projected reimbursement reductions next year, hospitals will make more cuts to staff and services and reduce administrative costs."

Minnesota's Star Tribune (12/30, Yee) reports that patients with high-deductible health plans "are more likely to hold off getting care" early in the year "because they are paying out of pocket." But, "later in the year, some have paid enough to reach their deductible, and insurance kicks in." Insurance will then cover "most medical services -- whether at 80 percent, 90 percent, or completely -- until the deductible resets in the new plan year, Jan. 1 for most of them." During this time, patients will "cram in colonoscopies, hysterectomies, hernia surgeries, and knee replacements." And, "at a time when the weak economy is hurting the industry, medical groups say they are grateful for the bump in business." High-deductible health plans "with health-savings accounts were introduced in 2004" to help "slow the growth of medical spending." Meanwhile, "deductibles for traditional plans -- known as preferred provider organizations -- also have jumped, with a $1,000 deductible now the national norm, according to benefits consultant firm Mercer."

The Miami Herald (12/29, Dorschner) reported, "Vista, the Sunrise health insurer, announced Monday it has been awarded a three-year contract to be the sole health insurance carrier for employees of Broward public schools." The Florida school system's "eligible employees and their dependents" will "be able to choose among four health maintenance organization (HMO) plans and two preferred provider organizations." One option "will be an HMO plan" available to "dependent children from birth to 21 years old or up to age 25, if enrolled as a full-time student."

Life Sciences Law

In a front-page article, the New York Times (12/30, A1, Pollack), reports, "Experts say that most drugs, whatever the disease, work for only about half the people who take them," which means that "not only is much of the nation's approximately $300 billion annual drug spending wasted, but countless patients are being exposed unnecessarily to side effects." Therefore, there is a lot of "hope...riding on the promise of 'personalized medicine,' in which genetic screening and other tests give doctors more evidence for tailoring treatments to patients." But, "for all the potential, experts see some formidable obstacles on the path to the promised land of personalized medicine," including "drugmakers, which can be reluctant to develop or encourage tests that may limit the use of their drugs," and the fact that "insurers may not pay for tests, which can cost up to a few thousand dollars." Still, "despite all the obstacles, personalized medicine is coming."

The AP (12/30) reports, "Abbott Laboratories was sued by Bayer AG's HealthCare unit, which is demanding royalties on its top-selling product, the arthritis drug Humira (adalimumab)." The suit alleges that "the drug violates" Bayer's "patent issued in 1997 for antibodies against tumor necrosis factor, or TNF, and immune cell protein that is linked to inflammation." Bayer is not asking "to halt sales of Humira." Meanwhile, a spokesman for Abbott said that "Humira does not infringe Bayer's patent, and Abbott believes that Bayer's patent is invalid."

The AP (12/29) reported that on Dec. 29, Switzerland-based Novartis AG announced "it has licensed a potential vaccine for a type of herpes virus from US-based company AlphaVax, Inc." The Swiss drugmaker "said it is paying $20 million upfront to the North Carolina company to secure the right to a developmental vaccine for the cytomegalovirus, or CMV," a virus that "can seriously harm patients with weakened immune systems." According to Novartis, "the vaccine is expected to enter phase II clinical trials next year." Should it be "successful, it would be the first vaccine against CMV."

In its Health Highlights section, HealthDay (12/29) reported that on Dec. 26, Allergan, Inc. announced that "it had received the US Food and Drug Administration's blessing to market Latisse (bimatoprost), the first prescription medication that makes lashes grow longer, thicker, and darker." The drug "is applied to the base of the upper eyelid" once daily, and "the full effect is seen in 16 weeks. Once treatment is stopped, lashes will slowly return to normal, the company said in the release." Allergan, Inc. cautioned that "the medication should not be applied to the lower eyelid, and that any other part of the body that was exposed to Latisse might show hair growth." In addition, the company "noted that the eyelashes on each lid might not grow the exact same way."