Osterholm and colleagues noted that the best results appear to come from LAIV in young children but the Advisory Committee on Immunization Practices doesn't currently recommend it for them, rather than TIV. They also noted that the pandemic vaccine effectiveness "is not adequate for a pandemic setting where the antigen match is ideal and antigen drift has not occurred" -- as was the situation with the 2009/2010 pandemic. "The difference between 69% effectiveness and 90% effectiveness (or greater) will have a major public health effect in any pandemic that causes serious morbidity or increased mortality," they added. The restrictive selection criteria used by Osterholm and colleagues led to some differences from the most recent published review, according to Heath Kelly, MBBS, of the Victorian Infectious Diseases Reference Laboratory in Melbourne, Australia, and Marta Valenciano, DVM, of EpiConcept in Paris. That analysis, by the Cochrane group, estimated efficacy in healthy adults of 73% when circulating and vaccine strains are well matched and 44% when they aren't, Kelly and Valenciano noted in an accompanying comment article. The new findings "understandably" have led Osterholm and colleagues to join in calls for better vaccines, they said. But while such vaccines are being developed, Kelly and Valenciano added, "now might also be an appropriate time to use revised estimates of the most probable effectiveness of influenza vaccines to re-examine the effectiveness and cost-effectiveness of some policy options."


Experts Meet to Evaluate the State of Medication Adherence and Provide Real-World Solutions
A recent think-tank meeting at the Duke Clinical Research Institute reviewed the magnitude, prevalence, impact and cost of medication nonadherence. MeadWestvaco Corp.  and adherence experts including representatives from consumer groups, community health providers, academia, government officials and industry participated in a two-day meeting to evaluate the current status of the problem and provide recommendations for policy change to improve medication adherence and its impact on public health and medical costs.

Poor medication adherence is a growing national concern. Research shows that half of all patients in the U.S. do not take their medicines as prescribed, despite evidence that medical therapy prevents death and improves quality of life. Approximately 125,000 deaths per year in the U.S. are due to medication nonadherence with total cost estimates ranging from $100 - 300 billion per year. A recent World Health Organization report states that, because the magnitude of medication non-adherence and the scope of these sequelae are so alarming, more health benefits worldwide would result from improving adherence to existing treatments, than from developing new medical treatments.

The goal of the meeting was to raise national awareness of the adverse consequences of nonadherence, to propose practical strategies for disseminating evidence-based approaches in real-world clinical settings, and to delineate a broad role for electronic information technology.

"An important first step in the meeting was to evaluate the current evidence base for medication adherence," said William H. Shrank, MD, MSHS, division of pharmacoepidemiology, Brigham & Women's Hospital, Harvard Medical School. "While the total number of publications has increased, there are only a handful of rigorous trials on medication adherence interventions compared with the many thousands of trials for efficacy of individual medications."

Another complicating factor which surfaced is that the interventions for long-term medications tend to be exceedingly complex, labor intensive and costly. In addition, questions remain as to how these interventions would be feasibly executed and sustained. In the short-term, simple scalable adherence strategies should be more broadly used until they can ultimately become part of successful multifaceted and tailored interventions.

A recent study published in Clinical Therapeutics using Walmart pharmacy dispensing data from more than 3 million individuals found such scalable results when calendar blister packaging was introduced at the pharmacy for a once-daily solid oral dose cardiovascular medication. This study demonstrated that an adherence strategy of even small effect size at the individual level that is broadly implemented on a population level, could significantly leverage therapeutic efficacy and provide substantial cumulative public health benefit.

In putting forth their recommendations, the group identified assumptions for successful interventions including (1) developing a multi-faceted, tailored approach that addresses both health literacy and behavior; (2) shared and mutually agreed upon priorities and objectives for medication selection and management with the need for reciprocal flow of information among patients, caregivers and providers; and (3) regular on-going feedback regarding performance in achieving established treatment goals for patients and providers.

"Based on our experience of providing simple solutions to complicated issues, we look forward to continuing to work with this prestigious group in tackling one of healthcare's biggest issues," said Elizabeth Whalley Buono, BSN, RN, MBA, JD, vice president, Regulatory Affairs MWV Healthcare."

The group is proposing an ongoing alliance to continue to work together to frame the problems related to medication adherence and share methods for improvement. For the future, there is a continued need to examine both simple and complex interventions that are effective, easy to use and readily available - such as a toolbox for providers. Technology will also increase in use and will help individuals, but continued input from patients and providers is needed on how to best incorporate these advances in clinical care. Lastly, shifting provider reimbursement systems to reward them for achieving better patient outcomes as well as including medication adherence into performance measures can help incentivize providers to emphasize adherence during the medical visit.

Feds, States Close In on Listeriosis Outbreak
Federal and state health agencies have begun to identify the source of a multistate listeriosis outbreak that has resulted in at least two deaths. The agencies, including the FDA, the CDC, and state health departments, have found that the 15 patients affected by the outbreak strain had eaten whole cantaloupes that appeared to have all come from the Rocky Ford region of Colorado, an FDA statement said. Patients affected with listeriosis became ill on or after Aug. 15, and had an median age of 84 years, ranging from 38 to 96 years. The agencies are currently testing product and environmental samples. The outbreak has been reported in Colorado, Nebraska, Oklahoma, and Texas. The outbreak was caused by Listeria, bacteria that can be found in water, soil, some farm animals, and raw milk, as well as in ready-to-eat deli meat, hot dogs, meat spreads, products made from unpasteurized milk, refrigerated smoked seafood, and raw sprouts. The bacteria can survive and grow in the cold of a refrigerator. The FDA noted that the disease can be fatal in certain high-risk populations, including adults ages 60 and older, those with compromised immune systems, and patients with chronic medical conditions. Pregnant women with listeriosis may experience miscarriage, stillbirth, and other potentially serious or fatal effects in their newborns. "While the investigation into the source of the Listeria outbreak is continuing, it is prudent for people who are at high risk for Listeria infection to avoid consumption of cantaloupe," Chris Urbina, MD, chief medical officer and executive director of the Colorado Department of Public Health and Environment, said in a release. Additionally, the CDC advised consumers on its website to dispose of cantaloupes marketed as coming from the Rocky Ford region, to set refrigerators to 40 degrees F or below and freezers to 0 degrees F or below, and to rinse raw produce under running tap water before eating it.

New H1N1 Strain H3N2 Infected Two Children In Recent Months
The US Centers for Disease Control and Prevention (CDC) have made a startling announcement this week. Two children previously vaccinated for the H1N1 influenza virus have contracted a new strain named H3N2 in what is being called a virus "reassortment." The good news is both have been treated successfully, but what's next?

The viruses are similar but not identical to each other, but they are different from eight other H3N2 infections identified in people over the past two years because they both contain the so-called matrix gene from the pandemic H1N1 influenza strain. The new identified variant contains genes of the H3N2 swine influenza that has been circulating in North American pigs since 1998 as well as the gene from the pandemic virus H1N1, making it a kind of hybrid.

The infected boy had no direct contact with pigs, but his symptoms which included fever, cough, shortness of breath, diarrhea, and sore throat, began two days after he was cared for by someone who'd had direct contact with asymptomatic animals in the preceding weeks. The girl, on the other hand, had been to an agricultural fair where she had direct exposure to swine. Four days later, she was taken to the hospital with fever, nonproductive cough, and lethargy.

The CDC report states:

"Although reassortment between swine influenza and 2009 influenza H1N1 viruses has been reported in pigs in the United States, this particular genetic combination of swine influenza virus segments is unique and has not been reported previously in either swine or humans, based on a review of influenza genomic sequences publicly available in GenBank. Analysis of data submitted to GenBank via the U.S. Department of Agriculture (USDA) Swine Influenza Virus Surveillance Program subsequent to this case identified two additional influenza H3N2 isolates from swine containing the M gene from the 2009 influenza H1N1 virus. Genome sequencing is underway to completely characterize the genetic composition of these two swine influenza isolates."

The viruses in these two patients are resistant to amantadine and rimantadine, but are susceptible to the neuraminidase inhibitor drugs oseltamivir and zanamivir. Because these viruses carry a unique combination of genes, no information currently is available regarding the capacity of this virus to transmit efficiently in swine, humans, or between swine and humans. To detect human infections with animal influenza viruses more effectively, CDC and state and local health departments have strengthened laboratory and epidemiologic procedures to promptly detect sporadic cases such as these.

The CDC concludes:

"The lack of known direct exposure to pigs in one of the two cases described in this report suggests the possibility that limited human-to-human transmission of this influenza virus occurred. Likely transmission of swine-origin influenza H3N2 virus from close contact with an infected person has been observed in past investigations of human infections with swine-origin influenza H3N2 virus, but has not resulted in sustained human-to-human transmission. Preliminary evidence from the investigation of the Indiana case shows no ongoing transmission. No influenza illness has been identified, but if additional chains of transmission are identified rapid intervention is warranted try to prevent further spread of the virus."

Finding a Robust Urgent Care EMR – Peer Reviews
In cooperation with the AAUCM, KLAS Research is putting together a comprehensive review of EMR systems for urgent care centers.

Since the key findings from this research will be of interest, all healthcare providers who participate will receive a complimentary summary of the results.

Whether you utilize an EMR today, or are planning to purchase an EMR down the road, would you be willing to share some insight?

Please use this link to contribute your thoughts.  All responses are aggregated and appreciated.

CMS Proposes More Loopholes for E-Prescribing Penalty
The federal government will begin to penalize some physicians next year for not electronically transmitting their Medicare patients' prescriptions to pharmacies. At the same time, the government wants to help physicians avoid paying those penalties. In proposed policies for the 2012 Medicare Physician Fee Schedule (PFS) released earlier this month, the Centers for Medicare and Medicaid Services (CMS) unveils a plan to lower the bar for complying with its e-prescribing imperative, as well as giving physicians more time to do what it takes to avoid the penalty, euphemistically called a "payment adjustment." That adjustment for "unsuccessful" e-prescribers is 1% of PFS charges in 2012, 1.5% in 2013, and 2% in 2014. The penalties come alongside bonuses for successful electronic prescribers in Medicare: 2% of PFS charges in 2009 and 2010, 1% in 2011 and 2012, and 0.5% in 2013. In its new policy recommendations, CMS states that the criteria for incurring the penalty need not be identical to the criteria for earning the bonus. "In general, we believe that an incentive should be broadly available to encourage the widest possible adoption of electronic prescribing, even for low volume prescribers," CMS states. "On the other hand, we believe that a payment adjustment should be applied primarily to assure that those who have a large volume of prescribing do so electronically, without penalizing those for whom the adoption and use of an electronic prescribing system may be impractical given the low volume of prescribing." In addition, CMS said that physicians and other prescribers who qualify for the bonus "have sufficiently demonstrated their adoption and use of electronic prescribing technology and thus should not be subject to the payment adjustment in a future year."

Less Work Needed to Avoid Penalty Than to Earn Bonus
As with its incentive program for electronic health records (EHRs), CMS is waving financial carrots and sticks to encourage clinicians to e-prescribe for the sake of patient safety and cost control. Both the federal government and the healthcare industry define electronic prescribing as transmitting a script from a clinician's computer to a pharmacy's, as opposed to writing a script with software and either faxing it or printing it out for hand delivery. To receive the bonus for 2011, clinicians must generate at least 25 e-prescriptions on separate visits throughout the year, in conjunction with 56 particular billing codes for medical services, mostly having to do with evaluation and management. These codes must account for at least 10% of the clinician's Medicare allowed charges. In addition, clinicians must use a qualified e-prescribing software program. It takes less work to avoid the penalty than to earn the bonus. Physicians will see their Medicare reimbursement shrink by 1% in 2012, the first year for payment adjustments, if they failed to generate at least 10 e-prescriptions through the first half of 2011. The penalty will not apply to physicians who lack at least 100 claims involving the 56 billing codes through the first half of the year, lack prescribing privileges, or were not licensed practitioners as of June 30, 2011. In addition, physicians also can claim a hardship exemption if they practice in a rural area without sufficient high-speed Internet access, or where pharmacies do not receive electronic prescriptions. The penalty in 2013 currently depends on one's prescribing performance in 2011. If clinicians qualify for an incentive payment this year, they avoid the payment adjustment 2 years later. In May, CMS proposed 4 other hardship exemptions for the 2012 penalty and a longer deadline for claiming one. One new exemption widely praised by physicians involves the federal incentive program for EHRs, which requires participants to e-prescribe. Under the May proposals, clinicians who register for the EHR incentive program and adopt certified EHR technology would be exempt from the e-prescribing penalty in 2012. The comment period on these recommendations ends July 25. The CMS proposals released on July 1 would give clinicians a second chance to avoid penalties in 2013 and 2014. In case they failed to earn an e-prescribing bonus in 2011, clinicians also could escape the 1.5% reduction in 2013 if they report submitting at least 10 electronic prescriptions in the first half of 2012. In addition, these 10 prescriptions could be associated with any PFS billing code, not just the 56 codes required to earn the incentive. The same rules would govern the 2014 payment adjustment: The adjustment would not hit clinicians who earn a bonus in 2012 or report at least 10 electronic prescriptions in the first half of 2013, regardless of the services rendered during those visits.

Proposals Fail to Lower Bar Enough
The July proposals also apply 2 of the 4 new hardship exemptions from the 2012 penalty to 2013 and 2014; namely, the inability to e-prescribe because of local, state, or federal restrictions, and prescribing fewer than 100 scripts during a 6-month reporting period for payment adjustments. CMS did not recommend extending the exemption for clinicians who register in the EHR incentive program to 2013 and 2014, which was a decision that disappointed Steven Waldren, MD, director of the Center for Health Information Technology at the American Academy of Family Physicians. Preserving the exemption based on participation in the EHR incentive program "would definitely lower the bar" for clinicians seeking to avoid the e-prescribing penalty, Dr. Waldren told Medscape Medical News. He also said that CMS should have addressed the issue of physicians finding it difficult to verify with the agency that they are complying with e-prescribing requirements. As they stand, the proposed changes to the e-prescribing incentive program "lower the bar some," but nevertheless amount to "small potatoes," according to Dr. Waldren. The comment period for the July 1 proposal, posted on the Federal Register, ends on August 30. The draft regulations explain several ways to submit comments. More information on the e-prescribing incentive program, and on how to apply for an exemption, is available on the CMS Web site.

FDA Okays New Flu Vaccine
The FDA has approved the influenza vaccine formulation for the 2011 to 2012 flu season. The vaccine protects against the three most common strains of the virus based on disease surveillance. The strains selected for the 2011-2012 influenza season are: A/California/7/09 (H1N1)-like virus
A/Perth/16/2009 (H3N2)-like virus
B/Brisbane/60/2008-like virus

"Vaccination remains the cornerstone of preventing influenza," the FDA said in a statement, adding that 5% to 20% of the U.S. population develops influenza annually, which results in over 200,000 hospitalizations from related complications. Healthcare providers should also consider vaccination for their colleagues, staff, and family members, the FDA advised. In addition, the agency encouraged healthcare organizations to follow the Advisory Committee on Immunization Practices (ACIP) recommendations issued by the Centers for Disease Control. Although flu virus strains circulating during flu season may not perfectly match with those in the vaccine, vaccination may reduce disease severity and help prevent influenza-related complications, according to the FDA.

The vaccine is licensed under six manufacturers for the 2011 to 2012 flu season:
Afluria by CSL Limited
Fluarix by GlaxoSmithKline Biologicals
FluLaval by ID Biomedical
FluMist by MedImmune Vaccines
Fluvirin by Novartis Vaccines and Diagnostics
Fluzone, Fluzone High-Dose, and Fluzone Intradermal by Sanofi Pasteur

Fluzone Intradermal is the first influenza vaccine administered through a novel intradermal microinjection and was approved in May 2011.

New Concentration for Flu Drug
Oseltamivir (Tamiflu) oral suspension will be marketed in a new 6 mg/mL concentration to reduce prescribing and dosing errors, the FDA announced Monday. The new concentration is less likely than the 12 mg/mL one to become frothy when shaken, so accurate measurements are more likely, an FDA statement said. Measurements for the oral dosing device that comes with the medication will also be listed by volume -- milliliters -- instead of mass -- milligrams. In addition to the concentration and dose-measurement changes, the drug's label will also include a column for volume based on the new concentration and revised compounding instructions for pharmacies to create the 6 mg/mL oral suspension from capsules of oseltamivir should the manufactured oral suspension be unavailable, the statement said. The FDA noted in a statement that healthcare professionals should be aware that pharmacies may dispense either concentration during the 2011 to 2012 flu season, and that patients should be aware of the different concentrations to avoid dosing errors. Drug manufacturer Genentech offered a voluntary drug take-back program of the old concentration for wholesalers, distributors, and pharmacies, but the 12 mg/mL form will still be available in drug stockpiles and in the marketplace until the current supply is exhausted or expires.

Tdap Vax Okay for Older Patients
The FDA has cleared the tetanus, diphtheria, and pertussis (Tdap) vaccine Boostrix for use in adults age 65 and older, the agency announced. Boostrix was originally approved in May 2005 for kids and teens ages 10 to 18, then had the indication expanded in December 2008 to include adults ages 19 to 64. The CDC recently recommended that patients age 65 and older who have close contact with infants should get a dose of Tdap, particularly for its protection against pertussis. However, only single vaccines for tetanus or diphtheria were available to this age group. Adults should "get Tdap instead of their next regular tetanus booster -- the Td shot that is recommended for adults every 10 years," according to the CDC. Health officials say pertussis has been a concern among older individuals, as several outbreaks have occurred across the country. "Pertussis is a highly contagious disease, and outbreaks have occurred among the elderly in nursing homes and hospitals," Karen Midthun, MD, director of FDA's Center for Biologics Evaluation and Research, said in a statement. Preliminary CDC data for 2010 show more than 21,000 cases and 26 deaths due to whooping cough; 22 of these deaths were in children younger than a year old. The newest indication was approved on the basis of findings from a 1,300-patient trial of those 65 and older. Researchers found the vaccine led to sufficient antibody titers in this population, the FDA said.

Pill Mix-Ups Force Acetaminophen Product Recalls
Two drug manufacturers have recalled a number of products that contain acetaminophen because of mislabeling that could result in overdoses. Endo Pharmaceuticals recalled two lots of Endocet (oxycodone/acetaminophen) tablets, 10 mg/325 mg (100-count), after bottles from each lot were found to contain some 10 mg/650 mg formulation pills, a company statement said. Qualitest Pharmaceuticals recalled four lots of their generic butalbital, acetaminophen, and caffeine tablets, 50 mg/325 mg/40 mg (500-count) and four lots of their hydrocodone bitartrate and acetaminophen tablets, 7.5 mg/500 mg (1,000-count) after a bottle of the former was found with a label from the latter, a statement from the company said. The Qualitest recalls affect lots C0390909A, C0400909A, C0410909A, and C0590909B of the butalbital/acetaminophen/caffeine combination, and lots C0390909A, C0400909A, C0410909A, and C0590909B of the hydrocodone bitartrate/acetaminophen combo. The Endo recall affects lot numbers 402415NV and 402426NV. Patients can differentiate between the two Qualitest products by looking for a white, round-shaped tablet with "2355" debossed on one side on the butalbital/acetaminophen/caffeine tablets. In contrast, the hyodrocodone bitartrate/acetaminophen tablets are white with green specks, capsule-shaped, and debossed with "3594" on one side. In the Endocet formulations, the 10 mg/325 mg tablets are capsule-shaped, with an "E712" marking on one side and a "10/325" marking on the other. The 10 mg/650mg tablet is oval, with an "E797" marking on one side and "10" on the other. Accidental dosage of the three-drug Qualitest combination tablet may result in sedation, lightheadedness, dizziness, nausea, hypersensitivity, tremors, irritability, and difficulty sleeping, but patients may also experience withdrawal symptoms and worsening of pain if doses of the hydrocodone drug are missed. Patients who take the elevated dose of acetaminophen accidentally may experience liver toxicity or severe liver damage. Each company asked patients to stop using the affected product and return it to the manufacturer. Meanwhile, McNeil Consumer Healthcare had recalled yet another lot of Tylenol Extra Strength Caplets because of a musty odor. The recall affects 225-count bottles in lot ABA619 and includes 60,912 bottles.

Killer E. coli Strain Never Detected Before
The E. coli strain responsible for the deadly outbreak in Europe is a new bacteria that has never been seen before, the World Health Organization said Thursday. The agency said that preliminary genetic sequencing suggests the strain is a mutant form of two different E.coli   bacterium, with lethal genes that could explain why the Europe-wide outbreak appears to be so massive and dangerous. "This is a unique strain that has never been isolated from patients before," Hilde Kruse, a   food safety expert at the World Health Organization, said. She added that the new strain has "various characteristics that make it more virulent and toxin-producing." So far, the mutant E. coli strain has killed 17 people in Germany and one in Sweden, and sickened more than 1,500 others, including 470 who have developed a rare kidney failure complication.

But she cautioned that since people with milder cases probably weren't seeking medical help, officials don't know just how big the outbreak is. "It's hard to say how virulent (this new E. coli strain) is because we just don't know the real number of people affected," she said. The outbreak is already considered the third- largest involving E. coli in recent world history, and it may be the deadliest. Twelve people died in a 1996 Japanese outbreak that reportedly sickened more than 12,000, and seven died in a 2000 Canadian outbreak. In a statement on WHO's website Thursday, it said 10 countries in Europe had now reported patients with two diseases related to the bacteria: haemolytic uraemic syndrome (HUS) and enterohemorrhagic E. coli (EHEC). It said that as of May 31, nine of the patients in Germany had died of HUS and six of EHEC. "There are many hospitalized patients, several of them requiring intensive care, including dialysis," the statement said.

Two-thirds of patients in Hamb, Germany, were suffering from severe neurological  problems such as language difficulties and seizures. Cause 'still unclear' In addition to Germany and Sweden, Austria, Denmark, France, Netherlands, Norway, Spain, Switzerland and the United Kingdom have all reported cases. "All these cases except two are in people who had recently visited northern Germany or in one case, had contact with a visitor from northern Germany," the WHO statement said. "Numerous investigations are continuing into the cause of the outbreak, which is still unclear," it added. Two U.S. residents who recently traveled in northern Germany are also thought to become ill because of the outbreak, federal health officials said.

WHO said it was keeping countries informed and added that it was not recommending any t rade restrictions relating to the outbreak. The statement came shortly after Russia announced it was banning imports of raw vegetables from the European Union because of the E. coli outbreak. "A ban on the import of fresh vegetables from EU countries takes effect from this morning," the head of the consumer protection agency Gennady Onishchenko said, according to the Interfax news agency.

Russia had already banned imports of vegetables from Germany and Spain. No fatalities or infections have yet been reported in Russia. The European Union argued the Russian ban was disproportionate. Frederic Vincent, a spokesman for the EU's Health and Consumer Policy Commissioner John Dalli, said Thursday that the European Commission would write to the Russian Agency for the Supervision of Consumer Rights to demand further clarification of the ban. Meanwhile, Spain's prime minister slammed the European Commission and Germany for singling out the country's produce as a possible source of a deadly bacterial outbreak in Europe, and said the government would demand explanations and reparations. Jose Luis Rodriguez Zapatero told Spanish National Radio that the German federal government was ultimately responsible for the allegations, adding that Spain would seek "conclusive explanations and sufficient reparations."

CMS Eases E-Prescribing Rule
The Centers for Medicare and Medicaid Services (CMS) announced it would be more flexible in allowing doctors to phase in electronic prescribing technology. Under current rules, physicians who use a qualified e-prescribing system are eligible for an additional 1% in Medicare Part B payments in 2011 and 2012, and a 0.5% increase in 2013. Providers who fail to complete at least 10 paperless prescriptions using a qualified e-prescribing system between Jan. 1 and June 30, 2011 will receive a 1% cut in Medicare reimbursements in 2012, a 1.5% cut in 2013, and a 2% cut in 2014. Some providers are exempt from those penalties, including physicians in rural areas without sufficient high-speed Internet access, and those in areas without sufficient available pharmacies.

In a proposed rule announced Thursday, CMS added a few more exemptions, and said doctors who are unable to e-prescribe should apply for a "hardship exemption" before Oct. 1, using a new government website. CMS said physicians can chose a number of new reasons for not complying, including having limited prescribing activity during the six-month time frame; or residing in an area where regulations hinder e-prescribing, such as in places that prohibit paperless orders for narcotics.

But CMS isn't backing away from its commitment to moving the nation's medical system to a paperless operation, and CMS Administrator Donald Berwick, MD, extolled the virtues of modernizing prescriptions and patient records. "Adopting health information technology can save money, it can save time, and it can save lives," Berwick said in a Thursday call with reporters. The American Medical Association (AMA) applauded CMS's announcement to modify the e-prescribing penalty policy.

The announcement by CMS "reflects its understanding that physicians who are working to adopt e-prescribing and other health IT should not be unfairly penalized for practice patterns that do not fit neatly within the current, limited exemption process," said AMA President Cecil Wilson, MD, in a prepared statement.

FTC Should Consider Drug Production Capacity, Potential Shortages In Merger Review
U.S. Senator Herb Kohlsent a letter to Federal Trade Commission (FTC) Chairman Jonathan Leibowitz urging the FTC to consider the impact pharmaceutical company consolidation has on the nation's limited drug supply. Prompted by recent news reports that doctors and hospitals are struggling with an "unprecedented surge in drug shortages in the United States," Kohl suggested that the industry's capacity to produce vital medicines might have been hampered by a decade of industry consolidation. Kohl serves as Chairman of the Senate Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, which has oversight authority over the FTC.

In his letter to Leibowitz, Kohl writes: "Maintaining a competitive pharmaceutical market is the highest priority...While I recognize that often shortages are likely to have causes not related to these competition issues, antitrust enforcers - particularly when reviewing drug company mergers - must be cognizant of these shortages when applying antitrust law to the drug industry."

According to a May 2, Washington Post article, "[a] record 211 medications became scarce in 2010 -- triple the number in 2006 -- and at least 89 new shortages have been recorded through the end of March..."

Kohl also cites a 2009 prescription drug pricing study, authored by the Government Accountability Office (GAO), which contends "[f]ewer drug companies competing in a therapeutic class may lead to fewer prescription drugs being developed and sold within that class."

Full text of the letter attached and copied below.

The Honorable Jonathan Leibowitz



Chairman



Federal Trade Commission



600 Pennsylvania Avenue, NW



Washington, DC 20580

Dear Chairman Leibowitz,

I am writing with respect to the issue of shortages of prescription drugs vital to the treatment of many patients with serious medical conditions.

As you know, pharmaceutical industry consolidation in recent years has left fewer manufacturers for both branded and generic drugs. There have been at least nine major pharmaceutical mergers since 2000, most of them valued at over $ 40 billion each. Just two years ago, in 2009, for example, there were three major mergers - the $ 68 billion Pfizer/Wyeth merger, the $ 41 billion Merck/Schering Plough merger, and the $ 47 billion Roche/Genetech merger. And just a few weeks ago, two of the leading generic drug companies, Teva and Cephalon, announced their intention to merge, a transaction valued at $ 7.5 billion. The impact of this consolidation may be having a serious effect on the availability of prescription drugs.

Recently, the Washington Post reported that "[d]octors, hospitals and federal negotiators are struggling to cope with an unprecedented surge in drug shortages in the United States that is endangering cancer patients, heart attack victims, accident survivors and a host of other ill people." The article reported that a record 211 medications suffered shortages in 2010, triple the number in 2006. Rob Stein, "U.S. drug shortages threatening those whose lives depend on crucial remedies," Washington Post, May 2, 2011, p. A10.

As the article points out, this problem may be caused in part because of consolidation resulting from drug company mergers. As the number of drug manufacturers decline, there are fewer and fewer manufacturers of older and less profitable products, "meaning that when raw material runs short, equipment breaks down or government regulators crack down, the snags can quickly spiral into shortages."

I recognize that the pharmaceutical industry, as the FTC has noted, has undergone dramatic alterations in recent decades due to new legislation, drug substitution laws and an evolving health care field. Nonetheless, the mega mergers of the past decade may be contributing to these critical drug deficiencies. In a 2009 prescription drug pricing study, the GAO claims "[f]ewer drug companies competing in a therapeutic class may lead to fewer prescription drugs being developed and sold within that class."[1]

I therefore recommend that the FTC consider this issue when considering future drug company mergers, and take care to examine such mergers so that this problem is not exacerbated. The FTC should also examine any drug shortages to insure that they are not in any way created by any anticompetitive practices.

Maintaining a competitive pharmaceutical market is the highest priority, and these reports of drug shortages are very troubling to me. While I recognize that often shortages are likely to have causes not related to these competition issues, antitrust enforcers - particularly when reviewing drug company mergers - must be cognizant of these shortages when applying antitrust law to the drug industry.

Thank you for your attention to this matter.

Sincerely,



HERB KOHL



Chairman, Subcommittee on Antitrust, Competition Policy, and Consumer Rights







FDA Lays Out Rules for OTC Liquid Meds



The FDA's new guidance for companies that make over-the-counter liquid medications - such as cough syrups and cold remedies - calls for packaging with calibrated dosing devices to prevent accidental overdose. Most liquid medicines already come with a dosing device, such as a cup or a dropper, but the FDA would like every liquid drug sold over-the-counter to have a measuring device, according to a final guidance issued by the agency.Those dosing devices should be clearly marked with liquid units of measurement, such as teaspoon or tablespoon, and the unit of measurement on the cup or spoon should be the same unit of measurement listed on the directions for use. The dosing device should also not carry any unnecessary markings that might be confusing to the person measuring out the dose, and the markings should stand out enough so they aren't obscured once the liquid product is added. Several recent studies have indicated that children often receive improper doses of liquid OTC medicines because parents give them in household spoons, or because the included dosing devices are poorly marked. One study found that cups included with liquid medications were particularly prone to errors, with some 70% of parents putting more than 6 mL of liquid into a cup intended for dispensing 5 mL. "Accidental medication overdose in young children is an increasingly common but preventable public health problem," said Karen Weiss, MD, of FDA's Center for Drug Evaluation and Research's Safe Use Initiative, in a press release. Overdoses of acetaminophen are among the most frequent unintentional poisonings seen in emergency departments and can lead to acute liver failure. Following the FDA's announcement, the trade group Consumer Healthcare Products Association (CHPA), announced OTC drug manufacturers will no longer produce liquid acetaminophen in a concentrated dose for infants, and liquid acetaminophen products for children under 12 will be sold only in one concentration to avoid confusion and accidental overdose. Manufacturers will also be adopting syringes with dose restrictors for products intended for infants, the CHPA indicated, but cups will continue to be provided for older children.In 2008, the FDA held a public hearing where consumer groups and some pediatricians - including Joshua Sharfstein, MD, who was then Baltimore Health Commissioner and went on to become deputy commissioner of the FDA - called for the FDA to ban the sale of over-the-counter cough and cold medicines for young children. Industry groups argued that the drugs are safe for use in kids under 2 years old. Some at the meeting also complained about the confusing dosing and labeling on kids' cough and cold products. The FDA's new recommendation also lists tips that caregivers should follow when giving medicine to a child, including knowing the child's weight, the difference between a tablespoon and a teaspoon, and using the dosing tool that comes with the medicine.







Feds Issue Warning to Makers of Unapproved STD Products



The FDA and the Federal Trade Commission are cracking down on manufacturers of products that claim to prevent, treat, and cure sexually transmitted diseases. The agencies said they sent warning letters to a dozen companies that sell products that make claims for herpes, chlamydia, genital warts, HIV, and AIDS. The products are sold online and in stores and have not been evaluated by the FDA. Selling non-FDA approved products that make unsubstantiated treatment claims is illegal. The companies have 15 days to inform the FDA about the steps they're taking to comply with the law. If they fail to do that, the products may be seized and the companies could face criminal prosecution, according to the FDA. "These products are dangerous because they are targeted to patients with serious conditions, where treatment options proven to be safe and effective are available," said Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research in a prepared release. "Consumers who buy these products may not seek the medical attention they need and could spread infections to sexual partners. "There is no way of knowing how many people have ordered the unapproved STD treatments online, Howard Sklamberg, director of the FDA's Office of Enforcement told reporters on the press call. He also said the FDA doesn't know of any specific instances of a person being harmed by one of the products, nor of a person opting to order the product online instead of seeking medical treatment. Some of the products such as Herpaflor and Never an Outbreak for herpes, and C-Cure for chlamydia contain natural ingredients such as herbs and fungi.  Another herpes treatment, Medavir, touts that its ingredients are FDA-approved. One of the main ingredients - fluoride - is indeed FDA-approved, but not to treat herpes. Most of the "treatments" are available on websites that are peppered with patient testimonials and promises of a "money-back guarantee." "When it comes to health products, the Internet can be a toxic wasteland for consumers," said Richard Cleland, assistant director of the FTC's Division of Advertising Practices. Such websites appeal to consumers who don't want to face the embarrassment or costs of seeking medical treatment, but consumers should be on guard, the agency officials said. "Consumers and health professionals should be warned that there are no -- NO - over-the-counter or online drugs or dietary supplements [that] treat STDs," Sklamberg said. "Appropriate diagnosis and/or treatment of STDs can only occur under the supervision of a healthcare professional."







Potentially Salmonella Tainted Cucumbers Recalled In 9 US States



1,590 cartons of whole cucumbers possibly contaminated with Salmonella and distributed to nine states in the USA have been recalled by L&M Companies, Inc., according to the FDA (Food and Drug Administration). The company and the FDA stress that so far no illnesses linked to cucumber consumption have been reported.







Wholesalers in the following states received cartons with possibly contaminated cucumbers from L&M Companies between 30th March and April 7th:

• Florida - 591 cartons
• Illinois - 139 cartons
• Indiana - 30 cartons
• Mississippi - 420 cartons
• Nebraska - 92 cartons
• New York - 200 cartons
• Tennessee - 15 cartons
• Texas - 2 cartons
• Wyoming - 101 cartons

Although the risk of infection is small, L&M Companies says it is issuing this recall as a precaution. The company warns that some wholesalers may already have distributed the cucumbers on, possibly to other states.







L&M Companies says that businesses which still have the recalled product should remove and destroy it immediately. They are marked as "Nature's Delight", with lot number PL-RID-002990 printed on the side of the carton. Consumers who have the recalled product should not eat it and should contact the shop they bought it from to confirm whether it is included in this recall.







After the FDA had carried out an inspection of a random sample of cucumbers in a cooler at Four Seasons Produce of Central Florida, Inc. on 13th April, traces of bacteria were found. The FDA adds that the company is cooperating fully.







L&M Companies invites consumers and businesses to call the following number in case of any enquiries - 919-981-8003, 8am to 5pm, Monday to Friday.







Florida Bill Requires Walk-in Clinics to Post Prices



A bill that would require certain walk-in clinics to post their prices has been passed by the Florida House. The Health Care Price Transparency Act (HB 935) applies to urgent-care centers owned by hospitals and requires them to post the costs of their 50 most frequently-provided medical services on a 15-square foot sign. The bill also allows primary care providers who voluntarily post their prices to skip their continuing medical-education requirements for two years. A similar bill pending in the Senate (SB 1410) is called the Patient's Bill of Rights and Responsibilities.

 

Congratulations to Michael Mitry, M.D., Anne-Marie Levan, M.D. and Antonio Serrano, M.D., winners of the AAUCM Fan Us On Facebook contest!

FDA Approves Rapid C. Diff Test



A rapid, automated molecular test for Clostridium difficile in patients' stool samples has been cleared by the FDA, the agency announced. Sold by Cepheid, the polymerase chain reaction (PCR) test also determines if C. difficile organisms belong to the epidemic 027/NAP1/BI strain. This strain has been associated with especially severe infections in North America and Europe, the FDA said. However, this latter capability is for epidemiological surveillance purposes only, not to determine or monitor treatment, the agency cautioned.







FDA Okays First Dengue Fever Test



The FDA has cleared the first test to diagnose patients with signs and symptoms of dengue fever. The test, known as the DENV Detect IgM Capture ELISA, looks for dengue virus antibodies in blood samples of patients who are symptomatic for the fever. There are no tests currently cleared or approved by the FDA for direct detection of dengue virus. The new test's clearance was made possible through an alternate marketing path known as the de novo pathway, which allows for marketing of new devices that are low to moderate risk in use and that may not require premarket approval, an FDA statement said. The test should not be used on patients who are asymptomatic, the statement said. The agency warned that test results can be complicated by the IgM antibody response to dengue virus, which doesn't occur until three to five days after the fever's onset, meaning that the test may show a negative result despite infection. The test may also react to related viruses -- such as that responsible for West Nile disease -- but in U.S. testing results, patients that showed signs of dengue should be considered to show presumptive evidence of dengue, according to the agency.







A Judge Has Dismissed a Lawsuit Brought by the California Medical Association That Sought to Block a Physician Rating Program by Blue Shield of California



Blue Cross and Blue Shield of California, a not-for-profit insurer based in San Francisco, started its Blue Ribbon Recognition Program in 2010. The program recognizes physicians by awarding them a "blue ribbon" icon next to their name on the insurer's website. The California Medical Association asserted in the lawsuit that because the information is based on selective data, it doesn't accurately describe the quality of care physicians provide and that the blue ribbons are awarded only to lower-cost physicians. The data is developed and compiled by the California Physician Performance Initiative, a healthcare program of the Pacific Business Group on Health, an employer coalition. But Alameda County, Calif., Superior Court Judge Steven Brick dismissed the CMA's claims, agreeing with the insurer that the program is a protected form of speech that benefits consumers. Brick also wrote in his order that the plaintiffs did not provide evidence of physicians being harmed or having lost business because of the program. In a statement, the insurer called the ruling "a validation that Blue Shield has every right to recognize high performing physicians." The California Medical Association could not be immediately reached for comment.  







Pennsylvania Governor Says Medicaid Expansion Under Federal Health Law Unaffordable



Pennsylvania Governor Tom Corbett says the Medicaid expansion under the year-old federal health care law will be unaffordable for his state, and he's urging the courts to help states settle the matter. Gov. Corbett is waiting 'a few months' before deciding whether the state should start crafting a state insurance exchange. A lack of information on that law's requirements was a problem that Mr. Corbett testified about at a U.S. House committee field hearing. Corbett and two of his top aides who spoke to the committee warned of the unsustainable cost to the state's taxpayers, criticized the lack of competition in the insurance industry, and insisted that the federal government's inflexible rules prevent states from finding better, cheaper ways to improve health care. "Pennsylvania," Corbett said, "should be allowed the flexibility to run a Medicaid program that is not measured on whether it adheres to federal requirements, but whether it prevents illness, improves the effectiveness of medical treatment and benefits the taxpayers."







Virginia Bans Synthetic Marijuana and "Bath Salts"



Synthetic marijuana and bath salts that have been used to get a legal high now will land users in jail. Governor Bob McDonnell signed two bills outlawing the synthetic drugs, which have been implicated in overdose deaths and sicknesses nationwide. Possession is a misdemeanor, but distributing the drugs would be a felony and manufacturing them would be punishable by up to 30 years in prison. The bill's sponsor, Senator Mark Herring said, "I am pleased that Virginia has now joined at least 15 other states that have taken action to protect our citizens, particularly our young people, from these dangerous designer drugs."







FDA: Short-Term Use Of Low-Dose OTC PPIs Do Not Increase Risk Of Broken Bones



Short-term use of low-dose proton pump inhibitors sold without a prescription 'is unlikely' to lead to hip, wrist and spine fractures, the Food and Drug Administration said. Noting that a study showed patients at highest risk for fractures took high doses of prescription heartburn and acid-reflux treatments or used the drugs for at least a year, the FDA said that in May, over-the-counter and prescription heartburn drugs would need new warnings about broken bones. OTC versions of PPIs are marketed at low doses for 14-day courses, with a maximum of 3 courses per year. Although the agency stated that these characteristics make the risk of fracture unlikely, it acknowledged that patients may not follow label instructions on how long they should take the medication, sometimes on the advice of a clinician. The FDA said healthcare professionals should be aware of the risk for fracture if they are recommending use of OTC PPIs at higher doses or for longer periods of time than noted in the label.







2011 Main Residency Match



This data from the National Residency Matching Program details residencies and the numbers of docs going into each specialty.







Japan Reactor Crisis Triggers Run on Iodide Pills in L.A.



Faced with a run on potassium iodide pills in Los Angeles-area pharmacies - prompted by fears of radioactive particles drifting across the Pacific Ocean from Japan's stricken nuclear reactors - public health officials are asking for calm. Jonathan E. Fielding, MD, MPH, health officer for Los Angeles County, told reporters on a conference call that his department had learned that stocks of potassium iodide pills had run low in some pharmacies, with a few reporting that they had sold out entirely. The pills are used in radiation leakage situations to prevent carcinogenic iodine-131 isotopes from accumulating in the thyroid gland. Fielding said he and other public health authorities still believe that Californians faced "minimal risk of radiation exposure" from the Japanese nuclear facility, even though news reports indicated that a series of explosions had breached the containment building surrounding one reactor. "I want to stress that there is no reason to purchase potassium iodide at this time," he said. Fielding also urged those who had already bought the pills not to take them, as they can have adverse effects. He also stressed that officials were monitoring radiation levels continuously and would alert the public if levels rose enough to warrant concern, noting that the distance from Japan would guarantee several days of warning. "However, concern for personal safety and that of loved ones has prompted some to rush to pharmacies to purchase potassium iodide," Fielding said. He said the run on potassium iodide could complicate treatment for people who need it now for medical purposes. The substance is sometimes prescribed to treat potassium deficiency, Fielding noted. He pointed out that even if there were a radiation danger, potassium iodide pills are not a panacea. "Let's remember that when we're talking about potassium iodide, we're talking about one particular isotope," he said. "If there was a plume or something like that, there would be many [radioactive isotopes in the environment] ... there are many problem radionuclides that can come out of a reactor."







Florida Governor Nixes Drug Tracking Funds



The governor of Florida has turned down a $1 million offer from the maker of oxycodone (OxyContin) to help get its prescription drug tracking program off the ground. Purdue Pharmaceuticals made the offer, but Florida Gov. Rick Scott (R) wasn't interested in the money. Scott has made it clear that he wants to cut Florida's Prescription Drug Management Program (PDMP) altogether, citing concerns about patient privacy. At least 34 other states operate PDMPs, which are supposed to curb diversion and nonmedical use of prescription painkillers, as well as cut down on doctor-shopping, by keeping track of all prescriptions for pain medications. The program was authorized by Florida's state legislature in 2009, but never funded. It was long held up by a bidder protesting a database contract award until a Tallahassee judge cleared the way for it to move forward. Purdue said it would give $500,000 a year over two years to the nonprofit Florida PDMP Foundation, which was established to fund raise for PDMP operations. The nonprofit has raised $500,000 in donations and qualified for $800,000 in federal grants. Libby Holman, a spokesperson for Purdue, said the company has never funded a PDMP before. It does, however, sponsor drug abuse education programs such as the Partnership for a Drug-Free America. Florida is notorious for its drug mill problem. Last month alone, drug agents raided 11 pain clinics throughout the state, arresting 23 people and seizing $2.5 million in cash and cars, media reports said. According to federal data from 2006, the state is among those with the highest rates of overdose deaths - which are largely attributable to deaths from prescription painkillers - at 12.5 per 100,000 population. One advocacy group - the Florida Society of Pain Management Providers - has even called Florida "the 'destination state' for all those who abuse or supply abusers with controlled medications."







Court Decision Ends Red Flags Rule Dispute



A recent federal appeals court decision - which dismissed a suit focusing on the Federal Trade Commission's (FTC) so-called Red Flags Rule - "validates" its long-standing argument that physicians who bill after providing services are not subject to that rule as creditors, the American Medical Association (AMA) said Monday. In its Friday ruling, the U.S. Court of Appeals for the District of Columbia said in the American Bar Association v. FTC that Congress clarified who must comply with the Red Flags Rule when it passed a bill in December exempting physicians and lawyers. "The enactment [by Congress] of the Clarification Act moots this case," wrote Judge Harry Edwards in the court's opinion. "Because the new legislation has clearly altered the posture of the case, there is no longer a live 'case or controversy' before this court." Under the "Identity Theft Red Flags Rule," the FTC initially had said that professionals - such as healthcare providers - would need a written identity theft prevention program designed to detect the warning signs - or "red flags" - of identity theft in their day-to-day operations. The appellate court's decision "reinforces the intent of a new law clarifying the scope of the Red Flags Rule and helps eliminate any further confusion about the rule's application to physicians," said AMA President Cecil Wilson, MD, in a statement. The lawsuit filed by the Litigation Center of the AMA and the State Medical Societies, the American Osteopathic Association, and the Medical Society of the District of Columbia - and joined by 26 national medical specialty societies--will now formally end.







Hazelnuts Pulled over E. Coli Worry



The distributor of a number of nut products has recalled a number of bulk and consumer goods because of potential contamination of hazelnuts with Escherichia coli bacteria. DeFranco and Sons recalled seven products after the company received seven adverse event reports. The recalled products included:

• Sunripe 1-lb Large Hazelnuts, sell-by date of June 30, 2011
• Sunripe 1-lb Mixed Nuts, sell-by date of June 30, 2011
• Sunripe 2-lb Mixed Nuts, sell-by date of June 30, 2011
• "Season's Greetings" 4-lb gift pack of Imperial Mixed Nuts, sell-by date of June 30, 2011
• Sunripe 50-lb Imperial Mixed Nuts, no sell-by date listed
• Sunripe 50-lb Supreme Mixed Nuts, no sell-by date listed
• George Packing 50-lb Hazelnuts, distributed from Nov. 2, 2010 to Dec. 22, 2010

The various 50-lb bags that contain hazelnuts may have been repackaged or sold in bulk containers, a company statement said. The company has not found E. coli in its nut products to date, but said it is issuing the recall "out of an abundance of caution." All affected nut products were distributed in the U.S. and Canada from Nov. 2, 2010 to Dec. 22, 2010.

Indictment in Florida Against "Pill Mills"

AMA Wants to Ease Docs' Return to Clinical Practice



The American Medical Association has initiated a new effort to help physicians who have left clinical medicine return to active practice if they wish. Thousands of physicians leave clinical practice each year - often because of burnout, family responsibilities, or more lucrative employment opportunities in other areas. While many doctors later decide they want to treat patients again, they face a number of barriers. The biggest obstacles are the high cost of recertification and the lack of readily available information on procedures to do so, which vary by state and specialty. The AMA released a report calling for policy changes to make the reentry process more transparent and less costly. Primarily, the physician group wants to see more uniformity in requirements for relicensing and recertification. "National re-entry policy guidelines must be developed that are consistent and evidence-based," the AMA urged. "They should specify the length of time away from practice that necessitates participation in a re-entry process and how much clinical care constitutes active practice." The group also recommended that physicians in reentry programs be allowed to treat patients under supervision. Basing policies regarding physician re-entry on clear evidence is another necessary element, the AMA said. Among the 16 specific recommendations by the AMA were calls for research on "the relationship between time away from practice and maintenance of clinical knowledge," and on possible "alternative licensure tracks" with a limited scope of practice for returning clinicians. The AMA said it worked with the American Academy of Pediatrics and the Federation of State Medical Boards in developing the recommendations, which it describes as important to insure a future physician work force. "Demographic changes in the population (and in medicine itself), as well as the passage of health system reform, have led to increased awareness of the need for more physicians in certain disciplines and regions. Easing the re-entry process can help address this concern," the AMA report said. The AMA estimates that some 10,000 physicians could resume clinical practice annually if the way back were eased.







Improving the Affordable Care Act



On Jan. 19 the U.S. House of Representatives passed H.R. 2 legislation to repeal the Affordable Care Act (ACA). The legislation will now be sent to the U.S. Senate, where passage is not expected. The House is scheduled to debate H.R. 9, legislation that instructs the committees of jurisdiction to develop new legislation intended to replace the ACA. That legislation also is expected to pass.







Change Is Coming for the Healthcare Industry



A potential decline in physician office visits, record spending on health information technology, a total redesign of insurance markets, and the creation of accountable care organizations are among the health industry trends in store for 2011, according to a PriceWaterhouseCoopers report. The report authors used an online survey of 1,000 U.S. adults to assess consumer perspectives on health reform, healthcare usage, and payment for healthcare. Those surveyed represented a cross-section of the population in terms of insurance status, age, gender, income, and geography. The survey results were incorporated into the analysis given in the report. High Deductibles = Fewer Office Visits Health insurance deductibles for people in employer-sponsored plans rose an average of 77% between 2003 and 2009, while premiums for family coverage increased by 41%, the Commonwealth Fund recently reported. And that trend will continue in 2011, according to the report, by the Health Research Institute at PriceWaterhouseCoopers (PwC), a large accounting and consulting firm. In 2010, the most common plan had deductibles ranging from $400 to $999, according to PwC. As deductibles rise, patients will forgo medical care to avoid paying out-of-pocket costs. Couple the rising deductibles with the struggling economy, and patients are even more likely to skip doctors visits. "With more employees being squeezed with high-deductible plans and coinsurance, their increased cost sensitivity will push them to make hard decisions on how often to go to the doctor or what prescriptions to fill,"the report authors said. The first group to be affected will be doctors and drug companies, because consumers' first-dollar spending in health plans tends to be on office visits and medication. Fewer office visits will eventually trickle down and effect other medical services, such as lab tests and imaging scans, the study authors said. Health IT Health information technology (HIT) spending is likely to hit record highs in 2011 as providers beef up their HIT capabilities to comply with new government regulations, according to the report. Starting in 2011, hospitals and physicians can start collecting money for "meaningful use" of electronic health records (EHRs). The money comes from the 2009 economic stimulus bill, which authorized $19 billion to upgrade the nation's HIT capabilities and to provide incentive payments through Medicare and Medicaid to clinicians and hospitals when they use electronic health records. Stage one of meaningful use is that physicians be able to provide patients with paper copies of their health records, which would be a "sea change for patients," the authors said. Redefining Insurance The primary foci of the insurance industry in 2011 will be the medical loss ratio (MLR) -- which mandates the proportion of an insurer's revenue that must be spent on patient care as opposed to administrative expenses -- as well as the new health insurance exchanges. The Affordable Care Act (ACA) requires that, starting in 2011, insurers covering large groups must spend at least 85 cents per dollar of revenue on medical care or "activities that improve healthcare quality" (for small group and individual plans, they must spend 80 cents per dollar). Beginning in the second quarter of 2011, the federal government will provide grants to help establish insurance exchanges, and debate will intensify over what defines a qualified health insurer. According to the report, 13.8 million people are expected to enroll in health insurance exchanges in 2014. ACOs The healthcare reform law will create a new care model, called an accountable care organization (ACO), which already has insiders buzzing. Loosely defined, an ACO will be a group of providers that works together to treat a set number of patients, and splits the payments it receives for the care provided. Under the ACA, the government will begin offering providers the option of forming ACOs with the hope that the setup will improve patient care and save money. Starting in 2012, Medicare will pay ACOs using a "shared savings" design which pays bonuses based on meeting certain quality and cost-saving benchmarks. In other words, if providers in an ACO can reduce the cost growth of Medicare in their communities, they will receive cash rewards. The report authors warn that one of the biggest risks for ACOs will be managing a patient population and trying to keep the population healthy and enrolled in the ACO. When PwC asked survey respondents how likely they would be to stay within an ACO, half said they would always stay with a hospital or group of physicians if they knew that group was accountable for their care. "Providing incentives for patients to be a part of this accountability model could be the difference between profits and losses for an ACO," the report authors said.