Tuberculosis treatment requires medication and monitoring

Tuberculosis (TB) continues to be a problem in the United States, particularly among at-risk populations. The groups at highest risk for TB include people living with someone who has active disease, and those with a lowered immune response, such as HIV patients.

“Every medical center in our region has tuberculosis on its risk assessment list, that is, its list of potential issues to monitor on a continuing basis,” says Stephen Parodi, MD, chief of infectious disease for Kaiser Permanente, Northern California. “We make it a priority to ensure that patients at risk for infection with TB are screened for latent infections.”

The region includes 20 medical centers serving 3.1 million members. Dr. Parodi says the plan encourages screening for those who have been incarcerated or have a history of IV drug use and has educated primary care physicians and pediatricians to screen for TB.

“We saw a significant surge in TB cases when the HIV epidemic first hit; since then we’ve seen a leveling off,” he says. “In terms of epidemiology, it’s interesting to note that many cases we’re now seeing are in foreign-born individuals. We live in a global world, and we need to be aware that constant vigilance and aggressive, early recognition of latent and active disease will prevent further spread.”

Most people infected with tuberculosis don’t have any symptoms. When a patient is positive for latent TB, the clinician looks at the risk factors and determines (based on criteria from the Centers for Disease Control) whether the person is a candidate for preventive medicine.

“Preventive medicine is a lot easier than treating the active form of the disease,” Dr. Parodi says. “With latent disease we can treat with one drug, as opposed to active disease, where we typically have to use a minimum of four drugs initially.”

Patients who develop active TB experience symptoms such as weight loss, fever, night sweats, cough, chest pain and bloody sputum.

“Until susceptibility results are available, empiric initial treatment for active TB should include four drugs: isoniazid, rifampin, pyrazinamide and ethambutol,” says Mark Abramowicz, MD, editor-in-chief of The Medical Letter on Drugs and Therapeutics, a non-profit newsletter that critically appraises drugs. “When susceptibility to isoniazid, rifampin and pyrazinamide has been documented, ethambutol can be omitted.”

DIRECT PATIENT OBSERVATION NEEDED

One of the greatest problems in TB treatment today is the emergence of drug-resistant strains of the bacteria.

“Poor adherence to TB therapy is the most common cause of treatment failure, and can lead to drug resistance,” says Dr. Abramowicz. “Medical Letter consultants recommend that most patients, including those with disease due to drug-susceptible strains, take drugs for active TB under direct observation.”

At Kaiser, patients with active TB are monitored closely, typically with a monthly office visit. Kaiser physicians sign the orders for directly observed therapy, which is provided by the county public health department.

“We provide medications, lab testing to monitor potential side effects, symptom assessments, and imaging, x-rays or CT scans as needed,” Dr. Parodi says. “Protocols differ from jurisdiction to jurisdiction in terms of exactly who gets directly observed therapy, but in our experience, most counties are aggressive. If there is an identified case of active, potentially contagious TB, that person is receiving directly observed therapy.”

Extensively drug-resistant TB is a form of the disease caused by strains that are resistant to all the most effective anti-TB drugs. The World Health Organization reports that 41 countries have cases of extensively drug-resistant TB, including the United States.

“Confirmed multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis should be treated with directly observed therapy in collaboration with a clinician familiar with management of these conditions,” says Dr. Abramowicz. “Regimens for these conditions must include at least four drugs to which the organism is susceptible; the duration of therapy usually should be 18 to 24 months.”

In recent years, researchers have made considerable progress toward developing new medications that could treat tuberculosis more effectively. Eleven new medications from seven different drug classes are currently in clinical trials for tuberculosis.

“The medications that are farthest along are antibiotics called fluoroquinolones, which have the potential to shorten the duration of therapy,” says Eric Nuermberger, MD, associate professor of medicine and international health at Johns Hopkins School of Medicine, who is on the faculty of Hopkins’ Center for Tuberculosis Research. “Current medications require six to nine months; we hope fluoroquinolones will reduce that to four months. Four phase II studies of fluoroquinolones are currently underway, and we should have an answer in about two years.”

Fluoroquinolone drugs are already on the market in the United States for acute conditions such as community-acquired respiratory tract infections and urinary tract infections.

Of the medications that are being developed solely for tuberculosis, the one that’s furthest along is TMC207, developed by Tibotec.

According to a recent study in The New England Journal of Medicine, when researchers added TMC207 to a standard regimen for multidrug-resistant tuberculosis, a significantly higher proportion of patients had negative sputum cultures at two months.

Elaine Zablocki has been reporting on healthcare for more than 20 years. She is based in Oregon.

This article is based on information supplied by The Medical Letter (www.medicalletter.org), a non-profit organization that publishes newsletters offering critical appraisals of new drugs and comparative reviews of older drugs. The Medical Letter is independent of the pharmaceutical industry and supported entirely by subscription sales. Institutional site license inquiries can be sent to info@medicalletter.org [info@medicalletter.org]

#1 Priority for Your Front Office Team

A surgeon can be the best surgeon in the area or the world, for that matter. But, if his/her front office isn’t doing its job right, this expertise means nothing. It’s the equivalent of having the best quarterback on the field, but the front line can’t block, the running back can’t run and the receivers can’t catch. A team simply can’t win, with only one effective player. So how effective is your team?

As in football, a front office must know the drills and apply them daily. First, they need good people skills. It’s a MUST that they always put the patient first. As the saying goes, “if Mama ain’t happy, ain’t nobody happy!” How does this apply to your patients? Think about it, if your staff mishandles an issue in the front office, they’ve not only upset the patient, but the patient’s family/friends and everyone sitting in your front office, i.e. other patients and potential customers. If you can do one thing for your staff, teach them how to handle difficult situations. First, train them to live and breathe the two rule standard as an initial reaction to a disgruntled patient: “Rule #1 – The patient is always right, Rule #2 – If the patient is wrong, refer to Rule #1.” By making the patient feel that they are right, the anger and emotions surrounding the situation are diffused immediately. Second, in resolving a patient issue, take them to a private area and work through the patient’s issue in a positive manner. If a staff member has done something wrong, require that the staff resolving this issue with the patient do 4 things: (1) admit wrong doing, (2) openly acknowledge what was done incorrectly, (3) apologize for the mistake, and (4) come up with an action plan that you will implement immediately to ensure this doesn’t happen again. If your staff does this, it’s a guarantee that your patients will come back, as well as become life-long customers and most importantly, tell their family and friends of the great experience they had at your office and/or surgery center and what a top notch ophthalmologist you are.

The second most important duty of front office staff is how they treat each other. The Golden Rule is always a good place to start. This rule is “treat others, as you would like them to treat you.” If you instill this in each and every one of your people and let them know that you expect them to live this daily, your personnel issues will be minimal. In the last year, one of cataract outsourcing team members violate this rule. Rather than treat it as an isolated incident and address with only this particular staff, the supervisor gathered the entire group together the day after the episode and presented them with a one page statement. He read it out loud and had discussions with them what this meant on an individual level, as well as a team. He went over points about how our society, as a whole, has become less professional and respectful of each another. They discussed this and it was agreed that the team needs to work harder in making sure these types of behaviors/attitudes don’t permeated their work environment. They discussed how they could have handled the situation differently. In the end, the supervisor, along with each staff member, signed this document acknowledging their pledge to treat each other professionally and with the utmost respect, at all times.

Another aspect of front office service applies to your facility staff. If you haven’t already done so, you need to encourage, promote, and require your facility staff to treat your office staff with the upmost respect and view them as a key customer. In addition, they need to do the same for all surgeon users’ office staff. Your people must view these groups of people as key customers, i.e. same top notch customer service, as the staff gives the patients. Granted not all physician offices have the greatest customer service-oriented people working their front desks. But, encourage your staff to look beyond this and to keep reminding themselves that a surgeon’s staff is the gatekeeper of the facility’s patients. Again, if these key people are happy, I’ll guarantee you the facility case load will increase.

Finally, your staff needs to be dutiful in completing the tasks of scheduling, pre-certing, registering, preparing patient for surgical protocol and expectations, billing and collecting payments. However you might remind them that if poor customer service exists and/or prevails, there will be no need to pre-cert, register, etc…, as customers will be non-existent. Therefore, the #1 priority must always be customer service to both external and internal customers.

Quality Models

Five years ago, Aetna and several large employers confronted Virginia Mason Medical Center in Seattle over how much it was charging for treatment of migraine, severe acid reflux and narrowed aortic valves, and other conditions. Virginia Mason, a not-for-profit hospital system that employs about 400 salaried physicians, took the message to heart.

Working with the employers and Aetna, doctors and staff began to re-engineer care protocols. For example, the system ensured back pain patients same-day access to a physical therapist and physical medicine physician and sharply reduced medically unnecessary MRI tests and physical therapy visits. From 2004 to 2007, the changes yielded a 50% reduction in lost employee work days due to back pain, almost $2 million in cost savings and high patient satisfaction scores.

Following the overhaul, however, Virginia Mason’s spine clinic was losing revenue because of fewer billed tests and services. To offset the loss, Aetna boosted reimbursement for appropriate physical therapy sessions. With the higher payments and the greater volume of patients it could handle under the more efficient system, Virginia Mason covered its costs—while payers achieved a significant net savings.

President Obama and health policy experts have specifically touted integrated delivery systems, such as Virginia Mason, Geisinger Health System, the Mayo Clinic and others, as national models for innovation. Dartmouth University researchers have found, for instance, that Mayo spends one-third to one-half less than other top hospitals to care for similar patients with equal or better results.

Geisinger has gotten so much attention from politicians that it reportedly hosted tours for more than 70 visiting payers and providers last month.

Leaders of integrated delivery systems say the model won’t work just anywhere. It’s challenging to build a culture of high quality and low costs through contractual relationships. Independent delivery markets don’t have the dynamic of salaried doctors and instead must manage the powerful fee-for-service forces.

Robert S. Mecklenburg, MD, medical director of the Center for Health Care Solutions at Virginia Mason, says his system’s experience shows how health plans and employers can benefit from collaborating with an integrated hospital-physician group. But, he adds, moving away from fee-for-service to payment models that reward better patient outcomes, higher patient satisfaction and lower costs is key.

“[Innovative providers] want to be paid for value,” he says. “That’s very important in straightening out U.S. healthcare.”

Mayo Clinic CEO Dr. Denis Cortese describes integrated systems as having high levels of physician engagement, teamwork, connectivity and greater use of industrial efficiency and quality controls. All this is hard to achieve in contracted networks.

At the same time, experts say, non-integrated systems haven’t felt the pressure—or been given the financial incentive—to change because payers have been slow to revamp payment methods to encourage coordinated delivery. The current fee-for-service model simply rewards greater volume of services.

So far, Dr. Mecklenburg says, no health plans have agreed to pay Virginia Mason based on actual patient outcomes, except on a temporary experimental basis. He believes the system should realize a positive margin when it meets its quality targets.

“You won’t get system reform without changing the reimbursement dynamics,” says Andrew Webber, president of the National Business Coalition on Health in Washington, D.C. “I’m sure the leaders of integrated delivery systems are frustrated with the current payment system.”

ALIGNMENT OF INCENTIVES

At the state level, Massachusetts, with its individual mandate, now is eyeing a shift from fee for service to bundled payments to control spiraling costs.

In line with that, Blue Cross & Blue Shield of Massachusetts continues to leverage its Alternative Quality Contract with episode-based global payments, which pushes providers to work together on improving patient outcomes and cost-effectiveness, according to Jim Conway, senior vice president of the Institute for Healthcare Improvement in Cambridge.

The alternate contract sets specific outcome measures provider groups must achieve in managing patients with chronic conditions. For the first few years, provider groups won’t face financial penalties as long as they meet the process standards, but down the line, they’ll take a financial hit if they don’t meet the outcome targets.

“It took a while for the first hospital and physician group to sign up,” Conway says. “But now a lot of people are signing up because they see this as the direction the industry is going—away from fee for service to a system that takes care of overall global health.”

In other parts of the country, Blue Cross & Blue Shield of Minnesota also has started paying providers for care of the whole patient rather than for specific services, Conway says.

Self-insured employers are testing new reimbursement approaches as well.

Members of the Colorado Business Group on Health are paying providers additional reimbursement on top of fee-for-service payment to manage the care of diabetics and other patients with chronic conditions, according to Webber. They’re using a program developed by the Bridges to Excellence industry partnership. Similarly, the Employers Coalition on Health in Rockford, Ill., is experimenting with paying providers a bundled case rate for patients with chronic conditions, using the PROMETHEUS Payment System, of which Bridges to Excellence is the operational partner.

Webber says health plans and employers should offer financial incentives to patients to get their care from integrated systems, taking advantage of emerging value-based benefit designs.

“There will be opportunities to say to patients, ‘We’re willing to reduce your premium share if you’re willing to participate in more integrated, high-performance delivery systems,’” he says. “I think more and more consumers would be willing to join more closed-panel systems if they could reduce their premium share. Then we can reward high-performance providers in two ways: with payment differentials and with more patients.”

HOME TEAMS

Some health plans and employers around the country are working with provider organizations—and even small physician practices—to support the emerging patient-centered medical home model.

In the model, a primary care physician leads a team of allied health professionals to provide or facilitate each patient’s care needs, including self-care and prevention. The team uses data to proactively manage care for its entire patient population as well.

The Geisinger Health System in Pennsylvania and Group Health Cooperative, a Seattle nonprofit health plan that employs salaried doctors, have reported that their medical home pilots have reduced emergency room use and preventable hospital admissions, improved outcomes for chronic care patients and boosted patient satisfaction. They’re expanding the model to all primary care sites, but it’s costly to properly staff, train and equip practices to become effective medical homes. The practices must be adequately reimbursed to cover the extra patient management services and the forgone fees for service.

Health plans and Medicare have moved slowly on implementing the model, waiting to see evidence of cost savings and quality improvement.

“The medical home is a very important element, and we need to reward primary care doctors, because this can move us toward more integration of care,” Webber says.

Beyond the medical home initiative, Geisinger Health System has taken another step in aligning payment. The not-for-profit system, which includes three hospitals, a multispecialty group practice with 700 doctors and a health plan, is beginning to re-engineer care protocols, starting with coronary artery bypass surgery. Its payment methodology for the re-engineered services, called ProvenCare, bundles comprehensive care for the procedure at a fixed price, instead of piecemeal services and costs. Essentially, by bundling services and paying a flat rate, some risk is shifted to the provider, so it’s in the provider’s interest to deliver the best care, not more care.

Geisinger and its doctors identified 40 factors that produce the best outcomes for bypass operations and built a checklist that ensures those best practices are performed every time. Since its redesign went live early in 2006, Geisinger reports markedly improved patient outcomes for bypass surgery, including a 44% reduction in the 30-day readmission rate, a 21% reduction in patients with any complications, and a 55% reduction in re-operations for bleeding.

Geisinger similarly has redesigned care for hip replacement, interventional cardiology procedures, cataract surgery, obesity surgery and perinatal care.

Duane Davis, MD, chief medical officer of Geisinger Health Plan says Geisinger has gotten a “marketing buzz” out of ProvenCare. Employers like the fact they pay once for the product, just like for other goods and services. But surprisingly, no other health plans have taken Geisinger up on its ProvenCare guarantee deal, except for Geisinger’s own plan. Dr. Davis says he isn’t sure why that’s the case.

“That’s stupid,” says Jeff Goldsmith, a veteran industry forecaster based in Charlottesville, Va. “If a provider group is organized well enough to give you a guarantee they won’t have to readmit, I would rush to sign a contract like that. Maybe some attitudes need to change.”

Goldsmith says that health plans and provider organizations are leery about working together on global payment contracts because of the disastrous experiences with capitated contracts back in the 1990s. Many physician groups and hospitals formed joint ventures to accept these fixed-fee deals and suffered big losses. New structures aim to even out the economics with gainsharing.

WATER UNDER THE BRIDGE

However unfortunate, private practice is collapsing, and more hospitals are employing doctors and creating their own multispecialty, integrated delivery systems. That, Goldsmith says, will allow hospital systems to manage care with their employed doctors. Likewise, health plans may be ready to return to working with provider groups to manage their patient populations because current cost-control methods, such as external utilization review and patient cost-sharing, aren’t sufficient.

“I can’t tell you whether that mindset has changed and whether plans have decided they’ve run out of tricks and are ready to return to working with providers in a constructive way,” Goldsmith says.

Scott Armstrong, president of Group Health Cooperative, says, “our whole industry is in the process of trying to come up with an answer to how health plans can work with providers. How can [global payment] create alignment around common goals? We have to overwhelm the skepticism based on bad experiences in the past.”

Even beyond that, however, Geisinger’s Dr. Davis says it’s going to take time to make healthcare better and cheaper. While integrated systems like his offer important lessons, there are no “big bang” solutions. The primary care medical home is a good place for health plans to start aligning payment incentives for improved care.

“There’s a huge opportunity for the insurance industry to use its skill sets and work in partnership with the clinical side to coordinate very fragmented care,” he says. “If we don’t figure out how to do primary care and coordination better, in the long run, payers will lose anyway.”

While private-industry payers can work on reducing fragmentation, government-supported coverage continues to face budget challenges. As a result, even the highest quality, most efficient providers stand to lose further reimbursement as rates decline.

The Mayo Clinic announced early last month that its Rochester, Minn., clinic, which has treated patients from the Midwest and West, will only accept Medicaid beneficiaries from Minnesota and the four states that border it. Meanwhile, its Arizona location no longer accepts Medicare for patients seeking primary care at its Glendale facility after reviewing results from a two-year pilot project. Mayo leaders made the decisions to limit service based on the low payment rates in Medicare and Medicaid.

Encourage depression screening for all pregnant women

The Incidence Of Depression runs high, and the utilization growth of antidepressants is a testament to this common condition. Unfortunately, pregnant women who also need to manage depression present a chronic-care challenge for doctors and health plans.

Between 14% and 23% of expectant moms experience depressive symptoms, according to the American Psychiatric Association (APA) and the American College of Obstetrics and Gynecologists (ACOG). Treatment with antidepressants for pregnant women is a bit tricky, prompting discussion about whether to prescribe and whether women already taking the drugs should continue their regimen despite being pregnant.

“The Management of Depression During Pregnancy: A Report from the American Psychiatric Association and The American College of Obstetricians and Gynecologists,” published in Obstetrics & Gynecology (September 2009) andGeneral Hospital Psychiatry (September/October 2009), weighs the risk and benefits of different treatment options for depression. The new guidelines should serve as a call to obstetricians to look for signs of depression in their patients.

The organizations’ guidelines for pregnant women currently on medication for depression include:

Psychiatrically stable women who prefer to stay on medication may be able to do so after consultation between their psychiatrist and ob-gyn to discuss risks and benefits;

Women who would like to discontinue medication may attempt tapering and discontinuation if they are not experiencing symptoms, depending on psychiatric history;

Women with recurrent depression or who have symptoms despite their medication may benefit from psychotherapy;

Women with severe depression (with suicide attempts, functional incapacitation or weight loss) should remain on medication; and

If a patient refuses medication, alternative treatment and monitoring should be in place, preferably before drug discontinuation.

The study also makes recommendations for pregnant women not on medication for depression, saying risks and benefits of treatment choices should be evaluated and discussed, including factors such as stage of gestation, symptoms, history of depression and other conditions and circumstances (smoking, difficulty gaining weight, etc.).

Nishendu Vasavada, MD, clinical associate professor, Department of Psychiatry at the University of Texas Southwestern Medical Center in Dallas, says it is not unusual for women to be on antidepressants when they get pregnant but cautions against their use in the first trimester.

“It is generally safer to take antidepressants after the first trimester,” he says, recommending the lowest possible dose and the use of Class C drugs. “Women should talk with their providers and find out as much as they can about medication choices to make the best decisions.”

Rajni Lad, MD, medical director at CBHNP, a behavioral health managed care company, agrees and notes added support is beneficial.

“The therapist is able to assess a member’s condition and related issues, oversee medication regimens and communicate with the obstetrician,” he says. “We can determine if a member should remain on an antidepressant once she is pregnant and when it is safe to stop taking the drug. We generally don’t prescribe drugs for depression during a woman’s first trimester, but provide other support.”

CBHNP partnered with its sister company, AmeriHealth Mercy Health Plan, a Medicaid managed care plan in Pennsylvania, in implementing the Perinatal Depression Pilot Program in November 2008. Nurse case managers at AmeriHealth Mercy screen women for depression by phone using a validated set of questions designed for a pregnant population. Those at high-risk (15% on average) are referred to CBHNP behavioral health specialists for evaluation and appropriate interventions.

“While the member is on the phone, a nurse case manager arranges an appointment with a mental health provider to ensure these women receive timely attention. The nurse not only coordinates care but follows the member’s progress, recommends appropriate resources and conducts follow-ups,” says Lawrence Kay, MD, senior medical officer for the health plan. “Access for these women is the most critical issue.”

As of September, 125 women have been screened, nine referred to a behavioral health provider and two to an outpatient clinic.

SPECIAL DELIVERY

After developing a set of healthcare reform principles, King County (Washington State) incorporated them into a Maternal and Child Behavioral Health Pilot, a four-year program that identifies and treats depression in low-income, pregnant women, mothers and their young children. These populations are more likely to suffer from depression and are less likely to obtain treatment due to poverty, lack of community support and substance abuse.

New data presented by the APA illustrate that Medicaid beneficiaries are more vulnerable to depression than other populations. They are more than five times less likely than privately insured patients to attend the recommended three follow-up visits with their physician (5% vs. 29%) in the 12 weeks following diagnosis and a prescription for an antidepressant; less likely to stay on medication for more than 60 days (35% vs. 55%); and half as likely as the privately insured to have their antidepressants augmented or changed—despite equal access to antidepressants.

The pilot, operating in eight ethnically diverse King County safety-net clinics, rests on the evidence that the best way to reduce the negative impact of depression is through early diagnosis and treatment. Anne Shields, manager, community and school partnerships, Public Health, Seattle and King County, notes that screening and follow-up are rare among the low-income population with more attention being paid to children’s health rather than their mothers’.

The pilot’s primary goals are:

Improve mental health outcomes in low-income children through increased access for their mothers to depression screening and treatment;

Improve mental health treatment through the implementation of standardized treatment protocols in primary care; and

Improve primary care providers’ ability to reduce the risk of mental health problems and treat conditions suffered by mothers and children.

Shields says the pilot is guided by the five essential elements of an evidence-based model for depression care known as IMPACT: 1) A PCP works with a care manager to implement a treatment plan. 2) A depression care manager educates the patient about depression, supports medication therapy, coaches patients and monitors their symptoms. 3) The care manager and PCP gain access to a designated psychiatrist. 4) Care managers measure depressive symptoms at the beginning of and throughout treatment, using the PHQ-9 (Patient Health Questionnaire), which evaluates the presence and severity of patients’ depression symptoms. 5) Treatment is adjusted based on clinical outcomes.

“PCPs often don’t know how to screen for depression and don’t have the time, but a care coordinator can serve as an extension of the PCP with the time and skills to offer the best intervention,” Shields says. “It’s easy for a PCP to lose sight of follow-up. One of the best things about our program is access to a psychiatrist who knows how to prescribe appropriate medications for pregnant women, ensure that they are safe to use, provide oversight and change regimens if necessary.

The results are noteworthy. More than 97% of enrolled mothers have been screened at least once for depression using the PHQ-9 tool. All the clinics screen pregnant patients during their prenatal visits; some also have developed successful protocols to screen mothers during their children’s visits. Finally, 75% of women on caseload have participated in numerous follow-up activities, including phone calls, clinic visits and support groups.

CHANGING MOODS FOR MOMS

Shoshana Bennett knows only too well the risks of depression related to pregnancy. As a clinical psychologist in Bodega Bay, Calif., she has learned from her own experiences.

“Obstetricians aren’t trained in mood disorders,” she says. “Every pregnant woman should be screened at least once during the first trimester to make sure she isn’t clinically depressed. Women are most vulnerable when they are pregnant but often depression is dismissed as ‘just being pregnant.’ If a woman has trouble sleeping or has no appetite, she may have feelings of anxiousness but is afraid to say anything for fear of being prescribed an antidepressant. Or if she is already taking one, there is a chance she could experience a relapse if her doctor decides to terminate the drug.”

Bennett recommends counseling first and medications second as well as communication between the obstetrician and a mental health specialist.

“Depression can affect the fetus so if symptoms are affecting a woman’s life, she shouldn’t white knuckle it, but instead use appropriate treatment,” she says.

According to Consumer Reports Best Buy Drugs, 60% to 70% of people with depression don’t receive the treatment they need.

Mari Edlin is a frequent contributor to MHE. She is based in Sonoma, Calif.

We’re All In This Together

As a physician, Reed Tuckson, MD, has seen his share of suffering. He specifically recalls a hospital patient he treated who had congestive heart failure and diabetes. The woman was discharged home, but many social services in her community had been cut, leaving her without meal delivery, transportation or health aid.

When Dr. Tuckson saw her again, she was in the emergency room, septic and malnourished with decubitus ulcers. She had missed every one of her follow up appointments. Medical science could certainly help treat her conditions, however, what the woman truly needed was support beyond the scope of medicine alone.

Dr. Tuckson, who today serves as executive vice president and chief of medical affairs for UnitedHealth Group, believes optimal healthcare delivery requires pulling the pieces of medical and social services together in a comprehensive way, “so that lovely, wonderful woman is not in a wheelchair at two in the morning, unable to breathe, hungry and in pain.” He says the experience with that particular patient still resonates with him.

During his first week on the job with UnitedHealth Group in 2000, he listened in on telephone support calls between care coordinators and plan members and heard them working to solve complex health and social issues not unlike those of his former hospital patient. As he listened in, he heard the insurer’s resources at work. He says the mission to improve health of populations as well as individuals is what drives him.

“The highest level of our mission requires us to find the common connection with the missions of the other stakeholders, because none of us can do alone what actually has to be done on behalf of each individual person,” Dr. Tuckson says. The insurer’s role—which he believes is generally misunderstood by those outside of the industry—is one of collaboration with providers, employers, patients and policymakers. Insurers have experience with the types of value determinations and cost-effectiveness strategies that many are insisting on to reshape the healthcare system overall.

Making Decisions

Dr. Tuckson believes the industry must be more explicit about what patient-centered healthcare delivery should look like and how it should function, then share the vision beyond the purview of its own ranks. That vision isn’t clear enough now to influence change. In order to generate a meaningful conversation that might lead to improvements in the system, the nation must take a long hard look at making choices and engaging consumers, he says.

“What’s so frustrating about the health reform debate in Washington,” he says, “is that it is so completely uninformed about the real issues: How do we make decisions that are personally appropriate that advance our chance for affordable access for the services that we need as individuals—both medical services and medically necessary social services?”

For example, preventive medicine, which many believe can lead to reduced costs and improved health if encouraged more widely, is often dependent on community situations. And the issues are twofold. First, an individual’s community environment plays a role in health. Lack of affordable and healthy food, unsafe neighborhoods and negative media images create inherent challenges to healthy lifestyles. Also, a lack of health clinics to deliver needed prevention can compound the problem.

It’s unreasonable to expect individuals in traditionally underserved populations with little optimism for the future to make healthy lifestyle choices a priority. Many skip preventive health services because they are struggling simply to get a hot meal on the table each night, Dr. Tuckson says.

“If gunshots are ringing through your community, it is very difficult to think about going jogging in the evening or planting a community garden, if there’s no actual earth in which to plant,” he says. “Those are real challenges that are stated the most dramatically.”

It Can Be Done

United Health Foundation, which was established by UnitedHealth Group in 1999, has committed $23 million to four community health centers in Miami, New Orleans, New York City and Washington, D.C., since 2003. Published studies from the George Washington University Medical Center have documented that these clinics, which are located in medically underserved communities, provide high-quality care that equals or exceeds care provided in the private sector, based on national quality benchmarks without risk adjustment.

The clinics have transformed from “centers of last resort to centers of choice,” according to Dr. Tuckson, who serves on the foundation’s board. In September, the university reported that three of the clinics had exceeded the national average of 30% for the percentage of diabetes patients with blood pressure under 130/80 mm Hg. New York (46%), Miami (40%) and New Orleans (39%) beat the benchmark. The same three also exceed the national average of 73% for the percentage of patients with diabetes receiving at least one LDL-cholesterol test—Miami reached 84%, New York reached 82%, and New Orleans reached 98%.

Through innovation, the clinics have been able to serve patients with chronic conditions who need a high level of comprehensive care. There’s no reason why the model of care, which has been able to make the most of scarce resources, should be limited to just one project, one population or to a certain type of coverage category, Dr. Tuckson says.

“The lessons we learn from the health centers ought to be applied to the rest of society and vice versa,” he says.

When considering underserved populations, he also says it’s important to recognize that absolutely every person in every community has a set of unique issues—medical and social—that require multidimensional responses from the healthcare system overall. Individualizing care for each person has become an emerging trend that complements the opportunity for managing care from a population perspective, regardless of what that population might be.

“When it comes to healthcare, it is exceedingly important to realize we’re all in it together,” he says. “The sense of ghetto-izing or segregating certain people, ethnicities or cultures is becoming inappropriate.”

Bringing It All Together

Three emerging factors are accelerating the ability for health plans to push comprehensive care forward:

Improved data analytics now afford opportunities to identify members with a variety of health needs;

Improved health data can also indicate the health needs proactively and with greater specificity; and

Consumerism is increasing members’ engagement levels in their health.

Certainly much of what enables comprehensive care stems from technology, but the tools still have yet to provide for true integration of care delivery among the healthcare silos. While the pace of such progress is frustrating, Dr. Tuckson says the partnership among payers, providers and other stakeholders is helping to overcome the siloed infrastructure more than ever before. The idea of integrated delivery of care has been talked about conceptually for more than a decade, but only now is the healthcare industry beginning to stitch the fragments together, he says.

For example, medical home projects nationwide are bringing care teams together and offering appropriate reimbursement for coordinated clinical approaches. The coordinated approaches are supported by data analytics that provide a snapshot of the comprehensive health needs of each individual person, he says.

“Putting that data into the primary care physician’s office as part of their traditional clinical capabilities and working in partnership allows for more comprehensive management of the individual,” he says. “That’s the next area. That will be defined, obviously, by how fast we can move the health information technology infrastructure.”

UnitedHealth Group launched a patient-centered medical home pilot in February in which it provides technology, infrastructure and care-coordination support to select primary care physicians in Arizona. There are more than 100 medical home pilots underway nationally, and tracking the data over time will inform plans’ future strategies.

Financial Footing

While furthering integrated care, population management and individualization is all well and good, the benevolent side of the mission only tells half the story. Healthcare has become an economic strategy in the United States. The bleak statistics of runaway costs on pace to reach $4 trillion are repeated so often that average Americans have begun to recite them by heart.

Dr. Tuckson says legitimate value determinations are needed to evaluate the relative cost and quality of medical procedures, drugs and devices. Once the value picture is sketched out with some degree of quantification, the individual member or patient is enabled to make clinically and economically smart care choices with his or her providers.

“There has to be a way in which people and society choose what they want and what they are willing to afford within the reality that there has to be controls,” he says. “The easiest part of that conversation would be that people should have access to care that works and is cost-effective. That ought to be a given, however, we also know we have a very suboptimal research infrastructure available to answer that question for expensive and increasingly important interventions, especially given the pace of discovery.”

The genius of America’s inventors and scientists has produced a difficult dilemma in which medical advances that save lives, improve quality of life and reduce pain and suffering also create an unaffordable inflationary spiral. New and improved treatments don’t come cheap. Likewise, the discrete evaluation of emerging procedures and products might prove that each has merit but fails to judge each one’s merit against comparable treatments.

Comparing the effectiveness of treatments head-to-head through scientifically sound research—comparative effectiveness research (CER)—has become cx. Federal health agencies have just begun to dole out $1.1 billion in stimulus funding for CER.

According to Dr. Tuckson, CER will also need to be taken a step further to create protocols in real-world clinical practice based on research results. He says CER funding is promising but it’s not likely to produce the scope of research needed nor the speed at which it must be delivered to improve the health of Americans affordably. His plea is that stakeholders fight “so much harder for the research infrastructure that delivers the answers to these questions.”

Clinical Expertise

Once the federally sponsored CER begins drawing conclusions, specialty societies, such as the American Academy of Pediatrics for example, could then take a lead role in translating research into best practices then in communicating the guidance to physicians. Specialty societies will need more support for that to happen, however, because they currently don’t have the resources to turn that kind information around in a timely manner.

“It is terribly inappropriate to leave those kind of choices to our industry, uninformed by the best of our nation’s clinical science expertise,” Dr. Tuckson says. “At United, we put our money where our mouth is by putting money into these societies, but with the level of scale that’s needed, no one company can do this by itself.”

He says he is “deeply saddened” when health insurers use their experience to make value decisions, then are criticized for it. Other stakeholders need to be involved, and he says he looks forward to having honest conversations at the national level to address the shared goals of value determinations and controlling the rising cost trends.

No one wants their insurer to exclude any service from the benefit package, Dr. Tuckson says, but on the other hand, no one is pleased by the amount of waste and misuse of services that are prevalent in the U.S. system. The fundamental contradiction of these two attitudes have become more evident in recent policy discussions. It makes for a frustrating process when trying to bend the cost curve and design benefits appropriately.

That’s why Dr. Tuckson believes when it comes to healthcare, everyone is in it together. No matter what operational challenges health plans must confront, sensible contracting, providing affordable access, and maintaining dynamic partnerships with providers and community organizations remain the plans’ responsibility.

“All pieces of that puzzle must all work together,” he says. “And we have to be part of that, acting on behalf of the needs of the person. If we lose sight of that, we do so at our peril.”

Reed Tuckson, MD, on…

The politics of health reform

“Health reform is talked about almost as if it were a political football game, and you’re either on one side or you’re on another. People use terms—public plan, health exchange, single payer—and that sort of lets you know if you’re on this team or that team…I refuse to be on any of those teams. It’s silliness.”

Holding down costs

“You have to get at controlling the inflation of unit costs for physician and hospital reimbursement. You have to get at the issue of appropriateness in the access to services and controlling waste and inefficiency in the delivery.”

Health insurers as stakeholders

“We in our industry clearly understand what it means to try to control unit costs and be fair to the hospitals and physicians who are delivering the care. We absolutely understand what it means to try and take the waste out of the system and all the challenges that come from doing that every day. We also know the anger and the frustration that occurs when you do it. We bring a set of experiential knowledge that is essential when trying to find solutions to problems, more so than anyone.”

Health insurance exchanges

“The health insurance exchange concept today as discussed is a philosophical placeholder for a political or social agenda, as opposed to being something that everyone understands what it means, how it would work and the ways in which it is going to deal with the two fundamental issues on the table: How will it deal with unit cost pricing and how will it deal with utilization and the control of utilization of healthcare services?”

Expansion of Medicaid

“Expanding Medicaid, public insurance, is an important part of the mosaic. It will take a mosaic to achieve our goals, and public insurance is going to be very important in that regard, just as private insurance will be important in that regard.”

Insurers being called ‘dishonest’

“When it comes to health and human survival, this is a profound social ethic that requires and demands the best of all of us. To deliberately and mean-spiritedly deny the participation and challenge the ethical integrity of a major stakeholder in the solution to this problem is to do potential violence to the opportunity for optimal solutions and thereby optimal health of the nation.”
Reed Tuckson, MD, UnitedHealth Group, Executive Vice President and Chief of Medical Affairs
Reed Tuckson, MD, has more than 25 years of experience in healthcare leadership and has been a member of several bipartisan federal advisory committees on genetics, infant mortality, children’s health, violence, radiation testing and healthcare reform. Previously he served as senior vice president for professional standards for the American Medical Assn. In February, Black Enterprise named him one of the “100 Most Powerful Executives in Corporate America.” He earned a bachelor’s degree in zoology from Howard University and his medical degree from the Georgetown University School of Medicine.

We’re All In This Together

As a physician, Reed Tuckson, MD, has seen his share of suffering. He specifically recalls a hospital patient he treated who had congestive heart failure and diabetes. The woman was discharged home, but many social services in her community had been cut, leaving her without meal delivery, transportation or health aid.

When Dr. Tuckson saw her again, she was in the emergency room, septic and malnourished with decubitus ulcers. She had missed every one of her follow up appointments. Medical science could certainly help treat her conditions, however, what the woman truly needed was support beyond the scope of medicine alone.

Dr. Tuckson, who today serves as executive vice president and chief of medical affairs for UnitedHealth Group, believes optimal healthcare delivery requires pulling the pieces of medical and social services together in a comprehensive way, “so that lovely, wonderful woman is not in a wheelchair at two in the morning, unable to breathe, hungry and in pain.” He says the experience with that particular patient still resonates with him.

During his first week on the job with UnitedHealth Group in 2000, he listened in on telephone support calls between care coordinators and plan members and heard them working to solve complex health and social issues not unlike those of his former hospital patient. As he listened in, he heard the insurer’s resources at work. He says the mission to improve health of populations as well as individuals is what drives him.

“The highest level of our mission requires us to find the common connection with the missions of the other stakeholders, because none of us can do alone what actually has to be done on behalf of each individual person,” Dr. Tuckson says.

The insurer’s role—which he believes is generally misunderstood by those outside of the industry—is one of collaboration with providers, employers, patients and policymakers. Insurers have experience with the types of value determinations and cost-effectiveness strategies that many are insisting on to reshape the healthcare system overall.

Making Decisions

Dr. Tuckson believes the industry must be more explicit about what patient-centered healthcare delivery should look like and how it should function, then share the vision beyond the purview of its own ranks. That vision isn’t clear enough now to influence change. In order to generate a meaningful conversation that might lead to improvements in the system, the nation must take a long hard look at making choices and engaging consumers, he says.

“What’s so frustrating about the health reform debate in Washington,” he says, “is that it is so completely uninformed about the real issues: How do we make decisions that are personally appropriate that advance our chance for affordable access for the services that we need as individuals—both medical services and medically necessary social services?”

For example, preventive medicine, which many believe can lead to reduced costs and improved health if encouraged more widely, is often dependent on community situations. And the issues are twofold. First, an individual’s community environment plays a role in health. Lack of affordable and healthy food, unsafe neighborhoods and negative media images create inherent challenges to healthy lifestyles. Also, a lack of health clinics to deliver needed prevention can compound the problem.

It’s unreasonable to expect individuals in traditionally underserved populations with little optimism for the future to make healthy lifestyle choices a priority. Many skip preventive health services because they are struggling simply to get a hot meal on the table each night, Dr. Tuckson says.

“If gunshots are ringing through your community, it is very difficult to think about going jogging in the evening or planting a community garden, if there’s no actual earth in which to plant,” he says. “Those are real challenges that are stated the most dramatically.”

It Can Be Done

United Health Foundation, which was established by UnitedHealth Group in 1999, has committed $23 million to four community health centers in Miami, New Orleans, New York City and Washington, D.C., since 2003. Published studies from the George Washington University Medical Center have documented that these clinics, which are located in medically underserved communities, provide high-quality care that equals or exceeds care provided in the private sector, based on national quality benchmarks without risk adjustment.

The clinics have transformed from “centers of last resort to centers of choice,” according to Dr. Tuckson, who serves on the foundation’s board. In September, the university reported that three of the clinics had exceeded the national average of 30% for the percentage of diabetes patients with blood pressure under 130/80 mm Hg. New York (46%), Miami (40%) and New Orleans (39%) beat the benchmark. The same three also exceed the national average of 73% for the percentage of patients with diabetes receiving at least one LDL-cholesterol test—Miami reached 84%, New York reached 82%, and New Orleans reached 98%.

Through innovation, the clinics have been able to serve patients with chronic conditions who need a high level of comprehensive care. There’s no reason why the model of care, which has been able to make the most of scarce resources, should be limited to just one project, one population or to a certain type of coverage category, Dr. Tuckson says.

“The lessons we learn from the health centers ought to be applied to the rest of society and vice versa,” he says.

When considering underserved populations, he also says it’s important to recognize that absolutely every person in every community has a set of unique issues—medical and social—that require multidimensional responses from the healthcare system overall. Individualizing care for each person has become an emerging trend that complements the opportunity for managing care from a population perspective, regardless of what that population might be.

“When it comes to healthcare, it is exceedingly important to realize we’re all in it together,” he says. “The sense of ghetto-izing or segregating certain people, ethnicities or cultures is becoming inappropriate.”

Bringing It All Together

Three emerging factors are accelerating the ability for health plans to push comprehensive care forward:

Improved data analytics now afford opportunities to identify members with a variety of health needs;

Improved health data can also indicate the health needs proactively and with greater specificity; and

Consumerism is increasing members’ engagement levels in their health.

Certainly much of what enables comprehensive care stems from technology, but the tools still have yet to provide for true integration of care delivery among the healthcare silos. While the pace of such progress is frustrating, Dr. Tuckson says the partnership among payers, providers and other stakeholders is helping to overcome the siloed infrastructure more than ever before. The idea of integrated delivery of care has been talked about conceptually for more than a decade, but only now is the healthcare industry beginning to stitch the fragments together, he says.

For example, medical home projects nationwide are bringing care teams together and offering appropriate reimbursement for coordinated clinical approaches. The coordinated approaches are supported by data analytics that provide a snapshot of the comprehensive health needs of each individual person, he says.

“Putting that data into the primary care physician’s office as part of their traditional clinical capabilities and working in partnership allows for more comprehensive management of the individual,” he says. “That’s the next area. That will be defined, obviously, by how fast we can move the health information technology infrastructure.”

UnitedHealth Group launched a patient-centered medical home pilot in February in which it provides technology, infrastructure and care-coordination support to select primary care physicians in Arizona. There are more than 100 medical home pilots underway nationally, and tracking the data over time will inform plans’ future strategies.

Financial Footing

While furthering integrated care, population management and individualization is all well and good, the benevolent side of the mission only tells half the story. Healthcare has become an economic strategy in the United States. The bleak statistics of runaway costs on pace to reach $4 trillion are repeated so often that average Americans have begun to recite them by heart.

Dr. Tuckson says legitimate value determinations are needed to evaluate the relative cost and quality of medical procedures, drugs and devices. Once the value picture is sketched out with some degree of quantification, the individual member or patient is enabled to make clinically and economically smart care choices with his or her providers.

“There has to be a way in which people and society choose what they want and what they are willing to afford within the reality that there has to be controls,” he says. “The easiest part of that conversation would be that people should have access to care that works and is cost-effective. That ought to be a given, however, we also know we have a very suboptimal research infrastructure available to answer that question for expensive and increasingly important interventions, especially given the pace of discovery.”

The genius of America’s inventors and scientists has produced a difficult dilemma in which medical advances that save lives, improve quality of life and reduce pain and suffering also create an unaffordable inflationary spiral. New and improved treatments don’t come cheap. Likewise, the discrete evaluation of emerging procedures and products might prove that each has merit but fails to judge each one’s merit against comparable treatments.

Comparing the effectiveness of treatments head-to-head through scientifically sound research—comparative effectiveness research (CER)—has become cx. Federal health agencies have just begun to dole out $1.1 billion in stimulus funding for CER.

According to Dr. Tuckson, CER will also need to be taken a step further to create protocols in real-world clinical practice based on research results. He says CER funding is promising but it’s not likely to produce the scope of research needed nor the speed at which it must be delivered to improve the health of Americans affordably. His plea is that stakeholders fight “so much harder for the research infrastructure that delivers the answers to these questions.”

Clinical Expertise

Once the federally sponsored CER begins drawing conclusions, specialty societies, such as the American Academy of Pediatrics for example, could then take a lead role in translating research into best practices then in communicating the guidance to physicians. Specialty societies will need more support for that to happen, however, because they currently don’t have the resources to turn that kind information around in a timely manner.

“It is terribly inappropriate to leave those kind of choices to our industry, uninformed by the best of our nation’s clinical science expertise,” Dr. Tuckson says. “At United, we put our money where our mouth is by putting money into these societies, but with the level of scale that’s needed, no one company can do this by itself.”

He says he is “deeply saddened” when health insurers use their experience to make value decisions, then are criticized for it. Other stakeholders need to be involved, and he says he looks forward to having honest conversations at the national level to address the shared goals of value determinations and controlling the rising cost trends.

No one wants their insurer to exclude any service from the benefit package, Dr. Tuckson says, but on the other hand, no one is pleased by the amount of waste and misuse of services that are prevalent in the U.S. system. The fundamental contradiction of these two attitudes have become more evident in recent policy discussions. It makes for a frustrating process when trying to bend the cost curve and design benefits appropriately.

That’s why Dr. Tuckson believes when it comes to healthcare, everyone is in it together. No matter what operational challenges health plans must confront, sensible contracting, providing affordable access, and maintaining dynamic partnerships with providers and community organizations remain the plans’ responsibility.

“All pieces of that puzzle must all work together,” he says. “And we have to be part of that, acting on behalf of the needs of the person. If we lose sight of that, we do so at our peril.”

Reed Tuckson, MD, on…

The politics of health reform

“Health reform is talked about almost as if it were a political football game, and you’re either on one side or you’re on another. People use terms—public plan, health exchange, single payer—and that sort of lets you know if you’re on this team or that team…I refuse to be on any of those teams. It’s silliness.”

Holding down costs

“You have to get at controlling the inflation of unit costs for physician and hospital reimbursement. You have to get at the issue of appropriateness in the access to services and controlling waste and inefficiency in the delivery.”

Health insurers as stakeholders

“We in our industry clearly understand what it means to try to control unit costs and be fair to the hospitals and physicians who are delivering the care. We absolutely understand what it means to try and take the waste out of the system and all the challenges that come from doing that every day. We also know the anger and the frustration that occurs when you do it. We bring a set of experiential knowledge that is essential when trying to find solutions to problems, more so than anyone.”

Health insurance exchanges

“The health insurance exchange concept today as discussed is a philosophical placeholder for a political or social agenda, as opposed to being something that everyone understands what it means, how it would work and the ways in which it is going to deal with the two fundamental issues on the table: How will it deal with unit cost pricing and how will it deal with utilization and the control of utilization of healthcare services?”

Expansion of Medicaid

“Expanding Medicaid, public insurance, is an important part of the mosaic. It will take a mosaic to achieve our goals, and public insurance is going to be very important in that regard, just as private insurance will be important in that regard.”

Insurers being called ‘dishonest’

“When it comes to health and human survival, this is a profound social ethic that requires and demands the best of all of us. To deliberately and mean-spiritedly deny the participation and challenge the ethical integrity of a major stakeholder in the solution to this problem is to do potential violence to the opportunity for optimal solutions and thereby optimal health of the nation.”

Implantable Miniature Telescope (IMT)

The IMT is a micro-sized precision telescope, about the size of a pea, that is implanted in one eye in an outpatient surgical procedure conducted under local anesthesia. The IMT provides magnification of 3.0X or 2.2X, depending on the IMT model used. A magnified image is projected over a wide field of the retina to improve the ability to recognize images that were previously either difficult or impossible to see. The IMT is implanted in one eye of patients who present with untreatable late-stage AMD (end-stage AMD). The telescope provides central vision, while the non-implanted eye provides peripheral vision.

Stephen Lane, M.D., principal investigator at Associated Eye Care, Stillwater, MN who implanted six IMTs in VisionCare’s Phase I trial, commented, “We are excited about the potential the IMT provides for improving visual acuity and the quality of life for individuals with severe AMD. We are encouraged with the results produced in the Phase I trial and look forward to studying the IMT in a larger patient population in this Phase II/III evaluation.”

“We see many patients in the clinic with advanced AMD for whom we have no real viable treatment options. The IMT technology may give ophthalmologists a method of improving vision and function in the more than 500,000 U.S. patients who have bilateral permanent vision loss due to macular degeneration,” said vitreo-retina disease specialist and Phase I investigator, Baruch D. Kuppermann, M.D., Ph.D., University of California, Irvine.

Fourteen patients were implanted with the IMT in the Phase I trial. Patients were monitored for safety and efficacy. One year after implantation, the majority of patients gained three or more lines (a doubling) of distance or near visual acuity and improvement in their activities of daily living. The most common complication was transient inflammation.

Patients at over 25 leading medical universities and ophthalmic centers into its US Phase II/III pivotal trial for untreatable end-stage AMD and Stargardt’s macular dystrophy.

In a presentation to the joint meeting of the American Academy of Ophthalmology (AAO) and the European Society of Ophthalmology (SOE) in New Orleans, LA, on October 23-26, 2004, VisionCare reported that the ongoing Phase II/III trial was assessing the safety and efficacy of the IMT. Phase I trial results demonstrated that one year after implantation, 77% (10/13) of patients gained two or more lines of distance or near visual acuity and 62% (8/13) of patients gained three or more lines (a doubling) of visual acuity as measured on a standard (ETDRS) eye chart. The most common complication was transient inflammation.

On October 19, 2005, Paul Sternberg, M.D. and Henry Hudson, M.D., announced positive results from VisionCare’s Phase I/III clinical trials of the IMT. After one year, subjects showed a mean improvement of over 3 lines in both distance and near visual acuity. 90% exceeded the primary endpoint of the trial with a 2-line improvement. Significant improvement in quality of life and daily living activities was also measured. A 2-year follow-up has revealed no serious safety issues. In July 2006, however, the company suffered a setback when the IMT was voted down for approval by an FDA advisory panel.

The November 2006 issue of Ophthalmology (Volume 113, Issue 11, Pages 1895-2134) published an article titled “Implantable Miniature Telescope for the Treatment of Visual Acuity Loss Resulting from End-Stage Age-Related Macular Degeneration” (Hudson HL, Lane SS, Heier JS, Stulting RD, Singerman L, Lichter PR, Sternberg P, Chang DF, IMT-002 Study Group) which detailed the results from the IMT002 trial. 217 patients at 28 U.S. investigational sites had severe vision loss due to the characteristic central blind spot caused by end-stage macular degeneration. The publication reports 90% of patients met or exceeded the protocol-specified primary efficacy endpoint of visual improvement, defined as a 2-line gain in either distance or near vision on the study eye chart. The protocol stated the endpoint would be achieved if at least 50% of patients met this target.

At 1 year after the telescope implantation procedure, 67% of patients achieved a 3-line (doubling of vision) or greater improvement in their study eye distance visual acuity, compared with 13% of unimplanted fellow eye controls. Approximately 25% of telescope-implanted eyes achieved a 5-line or greater improvement in visual acuity, compared with 2% of fellow eyes. Loss of 3 lines or more was encountered in 1.6% of implanted eyes, compared with 3.1% of fellow eyes. Secondary efficacy outcome measures suggest improvement in patients’ vision-related quality of life and activities of daily living. On the National Eye Institute 25-item Visual Function Questionnaire, patients improved significantly from baseline (range 7 to 14 points) in 7 of 8 relevant vision-specific and psychosocial subscales, including General Vision, Social Functioning, and Dependency. Corneal endothelial cell density, a safety endpoint, was reduced 20% from preoperative at 3 months and 25% at one year (compared with the 17% protocol-specified target).

Patients enrolled in the study were at least 55 years of age and had central vision loss caused by disciform scars (end-stage wet AMD) or geographic atrophy (advanced dry AMD). Exclusion criteria included active choroidal neovascularization (wet AMD) or treatment of wet AMD in the preceding six months. Patients with early-stage AMD, mildly visually impairing AMD, or unilateral affection were not eligible.

The IMT002 trial was a prospective, open-label, multicenter clinical trial conducted under an investigational device exemption from the U.S. Food and Drug Administration (FDA). Patients averaged 76 years of age. The telescope prosthesis was generally well tolerated in the eye. 206 of the 217 enrolled patients had the device successfully implanted in their study eye, while 11 patients received a standard intraocular lens due to an aborted procedure. The most common complications or adverse events included transient intraocular pressure, transient corneal edema, iris prolapse, and inflammatory deposits on the device. There were 2 cases of corneal decompensation. The published results were published online at www.ophsource.org/periodicals/ophtha/article/PIIS016164200600933X/abstract.

On December 28, 2007, Optolight Vision Technology (now called VisionCare Ophthalmic Technologies, Inc.) announced success from implantation of a second generation of the IMT, called the Lipshitz macular implant (LMI). The LMI is named for its inventor, Dr. Isaac Lipshitz, who also developed the IMT.

Researchers at Dr. Agarwal’s Eye Hospital and Eye Research Centre, Chennai, India, investigated visual and surgical outcomes of the intraocular mirror telescopic intraocular lens implanted in patients with bilateral macular pathology and visual acuity worse than 20/200 in whom vision improved with a ×2.5 external telescope preoperatively. They reported that the LMI may be an effective solution for optical rehabilitation of patients with ARMD or other macular pathology by increasing the central image on the retina while preserving peripheral vision. The abstract of this research was published online at www.sciencedirect.com.

In November 2008, the American Journal of Ophthalmology* published two-year results from the Phase II/III IMT002 trial showing substantial visual acuity improvement in end-stage AMD patients. The study device has received CE Mark approval in Europe and is currently investigational and under regulatory review by the U.S. Food and Drug Administration.

The publication details the two-year safety profile of the device and found rates of cornea endothelial cell loss, while higher than conventional small-incision anterior segment eye surgery, were consistent with anterior segment procedures employing more similar incision sizes required for telescope implantation. According to one co-author of the study, the risks of surgery are outweighed by the benefits.

“The published data show improved visual acuity in end-stage AMD patients that was maintained over two years — a three-line improvement that we have previously shown makes a real impact on our patients’ independence and quality of life,” said Henry L. Hudson, M.D., lead author for the IMT002 study and retina specialist at Retina Centers, P.C. in Tucson, AZ.

For more information on the research, see www.visioncareinc.net or call (408) 872-0526.

*Hudson HL, Stulting RD, Heier JS, Lane SS, Chang DF, Singerman LJ, Bradford CA, Leonard RE; IMT002 Study Group. Implantable Telescope for End-Stage Age-related Macular Degeneration: Long-term Visual Acuity and Safety Outcomes. Am J Ophthalmol. 2008: 146; 664-673.

15 Medicare/Medicaid Anti-Kickback and Fraud and Abuse Statute Cases Making Headlines in 2009

This is a short summary of 15 anti-kickback and fraud cases and investigations that have made headlines in 2009.  The situations involve a range of participants including hospitals, device companies, physicians, payors and other suppliers.

1. Medtronic whistle-blower suit. A lawsuit filed by two former Medtronic employees of the company’s Memphis-based spine business accused 120 leading spine surgeons across the country and 18 medical device distributors of promoting “off-label” use of the Medtronic product Infuse, which is used in spine surgery to promote bone growth between vertebrae. The product is approved by the FDA for use in the lower back but was allegedly being used in neck surgeries by a number of spine surgeons. Although off-label use of the product is not illegal, the plaintiffs claimed that the defendants took a total of $8 million in consulting fees for promoting the product in 2006. A Massachusetts federal judge dropped the suit in March, ruling that the case did not constitute a whistle-blower suit and blocked an amended complaint by the defendant. However, a civil suit is still active in federal court.

2. Orthopedic device maker anti-trust/anti-kickback suit. A lawsuit against Zimmer, Stryker and three other orthopedic device manufacturers accused the device makers of driving the McCulloughs, a family of commissioned salespeople for a competitor of the defendants, out of business. The McCulloughs claimed the defendants provided kickbacks to orthopedic surgeons for using their products over competitors. A federal judge dismissed the antitrust case against the Zimmer and Stryker in March, stating that the plaintiffs lacked standing to bring an antitrust action and lacked insufficient evidence for racketeering charges, which the suit also alleged. The three other device manufactures named in the suit, DePuy, Smith & Nephew and Biomet, previously settled with the McCulloughs.

3. Federal oversight of orthopedic device makers ends. The U.S. Attorney’s office ended 18 months of federal oversight of orthopedic device manufacturers Zimmer, Depuy, Biomet, Stryker and Smith & Nephew in March. The federal oversight resulted from charges by the U.S. Attorney’s office in 2007 that the device makers violated anti-kickback statutes by paying tens of thousands of dollars to surgeons as incentives to use their products. The companies avoided prosecution by agreeing to new corporate compliance procedures and federal monitoring. Zimmer, DePuy, Biomet and Smith & Nephew remain subject to the terms of separate agreements entered into with the OIG until 2012.

4. NueroMetrix kickback allegations. In February, medical device maker NeuroMetrix agreed to pay $3.7 million as part of a deferred prosecution agreement for federal allegations from the U.S. Attorney’s office that it gave kickbacks to physicians. The allegations accused NeuroMetrix of paying physicians in the form of free boxes of disposable biosensors for use with the company’s NC-stat System to encourage the physicians to recommend the device to colleagues. NeuroMetrix also allegedly asked physicians to seek reimbursement using a higher valued CPT code under certain circumstances when physicians performed a nerve conduction study using the NC-stat System. Of the $3.7 million, NeuroMetrix agreed to pay $1.2 million as a criminal penalty after admitting that it provided the free biosensors; the remaining $2.5 million in civil damages will settle the kickback and fraudulent up-coding allegations. Under the deferred prosecution agreement, NeuroMetrix will not be prosecuted in connection with the illegal kickbacks if the company complies with the obligations of the agreement for a term of 36 months.

5. Illinois radiology centers kickback suit. Fourteen radiology centers in Illinois that allegedly paid illegal kickbacks to doctors in exchange for referrals agreed to pay a total of $1.2 million to settle a lawsuit filed by the Illinois Attorney General in January. The case, which was filed in 2007, alleged that the radiology centers entered into sham “lease” agreements with doctors under which the doctors paid a reduced rate for MRI and CT scans, charged the patient’s insurance carriers a higher rate and then pocketed the difference. The lawsuit asserted that the defendants’ actions violated the Consumer Fraud and Deceptive Business Practices Act, as well as Illinois’ anti-kickback law, the Insurance Claims Fraud Prevention Act.

6. UnitedHealth Group class action suit. UnitedHealth Group, the nation’s second largest health insurer, agreed to pay $350 million to resolve a class action lawsuit with the American Medical Association and the Medical Society, the State of New York and the Missouri State Medical Association in January. The suit alleged that UnitedHealth’s wholly-owned subsidiary, Ingenix, rigged the databases that health insurers rely upon to set the “reasonable and customary” rates they charge for out-of-network physician fees so that providers and health plan member were underpaid for these services. The company also settled a separate investigation into these practices by the New York Attorney General for $50 million in January. UnitedHealth admitted no wrongdoing in conjunction with either investigation.

7. Medicaid fraud suits against New York hospitals. Seven hospitals in New York were accused in January of fraudulently billing Medicaid for more than $50 million for alcohol and substance abuse treatment even though the hospitals lacked a state license to provide this treatment. The lawsuits, brought by the New York State Attorney General and U.S. Attorney Benton Campbell, also claim that four hospitals — Columbia Memorial Physicians Hospital Organization in Hudson; Long Beach Medical Center; New York Downtown Hospital; and St. Joseph’s Medical Center in Yonkers — allegedly paid kickbacks to Missouri-based SpecialCare Hospital Management Corp. to get more patients into drug treatment programs. The suit also accused Queens’ Parkway Hospital, which closed in 2008, of trying to bribe homeless patients to participate in a detox program. The other defendants are the former Our Lady of Mercy in the Bronx and Benedictine Hospital in Kingston. The state settled for $4.5 million with Our Lady of Mercy, now run by Montefiore Medical Center, which denied all wrongdoing.

8. Florida HIV clinic Medicare fraud scheme. The owners and operators of two Miami medical clinics named Medcore Group and M&P Group of South Florida, and a phlebotomist at one of the clinics, were charged and plead guilty in January of conspiring with others to submit approximately $5.3 million in fraudulent claims to Medicare. The defendants admitted that they entered into kickback arrangements with Medicare beneficiaries whereby the beneficiaries were paid every week in exchange for their Medicare billing information, thus allowing the clinics, which claimed to specialize in the treatment of HIV-positive patients, to submit fraudulent bills. The defendants also admitted that none of the Medicare beneficiaries needed the injection and infusion treatments administered and billed to Medicare by the clinics. Four additional co-defendants in the case did not plead guilty and stood trial in March. All four co-defendants, which included two physicians, were found guilty.

9. Texas medical supply companies’ Medicare fraud scheme. Rhonda Fleming, who owned several Houston-based medical supply companies and a Medicare billing firm, and her two business associates were convicted by a federal jury in April of healthcare fraud, conspiracy to defraud Medicare and wire fraud. The three were found to have participated in a $36 million Medicare fraud scheme and face sentences of up to 20 years in prison for each count.

10. Biomet spinal product sales investigated. The U.S. attorney’s offices in Massachusetts and West Virginia began investigating Biomet, a leading orthopedic device manufacturer, for improper sales, promotion and billing by its spinal device unit, EBI, in January. The company allegedly promoted the off-label use of its spine stimulation devices, which resulted in fraudulent Medicare and Medicaid billing. The federal probe in West Virginia stemmed from a whistle-blower lawsuit alleging that a West Virginia surgeon implanted the devices in clinical research without asking for the consent of the patients. The complaint also alleges that on 15 occasions, a representative of the EBI unit was in the operating room while the spinal products were used for off-label proposes. The Massachusetts investigation may have stemmed from another whistle-blower suit from March 2005 which claimed Biomet was improperly billing bone-growth stimulators as devices that must be purchased rather than rented. Biomet denies both allegations.

11. Yale-New Haven Hospital settles Medicare fraud allegations. Yale-New Haven (Conn.) Hospital agreed to pay $3.77 million in March to settle an investigation by the U.S. Attorney’s Office, District of Connecticut, in response to allegations by CMS that it billed Medicare for inflated charges related to infusion therapy, chemotherapy and blood transfusion services. Authorities claimed that the organization billed Medicare for multiple units of these services when the program only allows payments for a single unit of infusion therapy and chemotherapy administration per patient, and one unit of blood transfusion per day. The hospital also disclosed, under the OIG’s Provider Self-Disclosure Protocol, that it had inadequately documented claims pertaining to services provided in its oncology infusion services in patients’ medical records, including dispensing medication and conducting laboratory studies without written orders signed by a physician; the protocol encourages such voluntary disclosure. Under the settlement, Yale-New Haven Hospital did not admit liability.

12. Illinois physician pleads guilty to fraud. James Durham, MD, of Benton, Ill., pleaded guilty in April to charges that he overcharged Medicare and Medicaid for services while president of Franklin (Ill.) Rural Health Care Clinic. Dr. Durham was accused of instructing employees to bill Medicare and Medicaid for services not covered by the payors. In total, Dr. Durham improperly charged Medicare for $42,503 and Medicaid for $145,388 between Jan. 1, 2003, and May 31, 2006. Dr. Durham faces possible prison time and a $100,000 fine and will be sentenced in July.

13. WellCare settles Medicaid fraud allegations. WellCare, a Tampa, Fla.-based health insurer, agreed to pay $80 million in May to settle allegations that it defrauded Florida’s Medicaid program. The U.S. Attorney’s Office in Tampa accused WellCare of submitting fraudulent charges to Medicaid and Florida Healthy Kids Corp., which cost the programs around $40 million. Under the agreement, WellCare agreed to a civil forfeiture of $40 million and an additional $40 million in restitution to Medicaid and Healthy Kids. In addition, WellCare agreed to implement new reporting policies, institute corporate financing governance programs and retain and pay an independent monitor to ensure compliance.

14. Houston’s Methodist Hospital settles Medicare fraud charges. The Methodist Hospital in Houston agreed to pay $9.9 million in March to settle allegations that it improperly increased charges to Medicare patients. The allegations brought by the Dept. of Justice against the hospital claimed that Methodist inflated charges for inpatient and outpatient care to receive outlier payments — supplemental reimbursement to hospitals to pay for care when it is unusually high — that it should not have received. The hospital denied the allegations.

15. Synthes settles kickback inquiry. Synthes, maker of the ProDisc artificial spinal disk, settled an inquiry in May by the New Jersey Attorney General, which accused the device maker of failing to disclose financial conflicts of interest for doctors researching its products. The Attorney General accused Synthes of compensating physicians who were testing the ProDisc for recommending its use to patients with company stock. Synthes agreed to disclose any future payments or investments held by doctors involved in researching its products through its Web site and will pay $236,000 to reimburse the Attorney General’s office for its investigation.

This article originally published @ Becker’s ASC Review.

Standardizing Electronic Documentation Using a Perioperative Nursing Language

Our places of work and homes are abuzz with new terms: toxic assets, monetary policy and stimulus packages. While the current state of the economy is to many a relatively new development: cost containment, productivity and revenue struggles are not new to healthcare. Consider the dizzying predicament for healthcare professionals when economic issues are mixed with industry issues such as safety, quality, evidence-based care and pricing transparency. Adding regulations offering incentives for the “meaningful use” of electronic health records (EHR) and the clinical care environment transitions into a tense, high-pressure conflict between actual care, documentation and data collections.

In the midst of this conflict and pressure is the professional nurse. No doubt, nurses affect clinical care and patient outcomes. A report studying the effects of nurse-to-patient ratio validated a strong correlation with reducing patient morbidity and mortality.¹

However, healthcare organizations, especially perioperative areas, have difficulty with data collection, integrity and retrieval that provides the basis for operational and clinical decisions. Poor or inconsistent data restrains the allocation of appropriate resources or tools to develop a scientific foundation for an evidenced-based nursing practice model.

Increasingly, healthcare and the perioperative environment are going digital. With this transformation, there is a need to provide rigorous standards that promote safe patient-centered care. A market survey of over 200 perioperative units in healthcare facilities and ambulatory surgery centers (ASCs) revealed many wanted, or had some version of, the Perioperative Nursing Data Set (PNDS) in their documentation, but did not know how to incorporate it into their plan of care. Additionally, the respondents were unsure if their documentation met standards or regulatory requirements due to the complex regulatory environment and the difficulty of maintaining the frequent updates.²

Clearly, healthcare organizations need to identify the critical factors to be employed when developing an information infrastructure and the tools to quantify efficient, cost-effective quality care. By applying a standardized perioperative language, the clinical environment has a mechanism to aggregate consistent data representing patient-centered care. The American Medical Informatics Association (AMIA) also offers additional guidance for selection and implementation of an information system to promote a national infrastructure for healthcare:

• Establish a local, regional and national health information exchange (HIE) to ensure that health information is available whenever and wherever needed
• Create standards, policies and practices that foster security, confidentiality, transparency and public trust
• Identify health terminologies and classifications allowing health data to be uniform and consistent across information systems
• Link information related to individuals in order to ensure the validity and integrity of health data for care and research
• Develop decision making and other knowledge management tools in order to permit delivery of individualized, evidence-based care
• Develop appropriate and secure linkages between EHRs and the public health surveillance systems.³

The PNDS is foundational to this effort as it meets an essential point of the information infrastructure criteria by providing clear, consistent and precise terminology, and definitions for clinical problems (nursing diagnoses), nursing interventions and patient outcomes, and reflect perioperative nursing practices.⁴ The PNDS is not a standard of care, but a structured vocabulary allowing the aggregation of clinical information across the perioperative continuum of care. In a standardized perioperative framework, the PNDS is associated with practice standards, accreditation criteria and regulatory requirements to facilitate efficient and safe patient care, while staying current with changes in healthcare. Throughout the healthcare system, initiatives to promote patient safety, improve outcomes and report consistently on quality metrics are gaining considerable momentum. Congress has directed the Centers for Medicare and Medicaid Services (CMS) to put into place a reporting system for ASCs to track quality by the end of this year, with financial penalties for those failing to submit the required data.⁵

Responding to this heightened emphasis on quality reporting will not be easy. Compliance with the Joint Commission or other accreditation standards is another concern for ASCs. Automating documentation in the clinical setting can greatly improve the ability to meet these goals. Information systems not only satisfy regulatory demands, it also reduces inefficient manual processes.

Healthcare organizations do not want to re-invest in a new surgical information system but want collected data to be used more efficiently for benchmarking and quality initiatives. A standardized data framework that overlays the existing user information documentation system and standardizes perioperative documentation and nursing workflow will help guide decision making for patient-centered care. Such a framework enables hospital decision makers and nurses to:

Guide safer care by integrating:

• The Association of periOperative Registered Nurses’ (AORN) Perioperative Standards and Recommended Practices
• Regulatory and mandatory reporting requirements
• Accreditation standards
• PNDS
• Consistent, standardized communication.

Guide effective care by:

• Enabling evidenced-based clinical decisions
• Providing information to develop protocols
• Integrating current regulatory requirements, accreditation criteria and national standards
• Promoting nurse-sensitive interventions and plan of care.

Drive efficient care by:

• Returning nurses from the conference room to the operating room
• Reducing nurse documentation time
• Facilitating perioperative staff training by
• Training new orientees
• Orientating temporary staff.

The framework should complement rather than replace any information technology (IT) vendor system, focusing on standardizing the perioperative content of the EHR, nursing documentation and functionality with surgical information systems. There are four general categories of technology that should be considered when purchasing any new IT application:

• Presentation – what is seen on the screen
• Workflow – how information is proceeded and sequenced
• Reference files – tables and files of predetermined values, such as allergy types or patient positions
• Data – where patient-level information is stored

With this framework, healthcare organizations can standardize the perioperative content for workflows and reference files.

Workflows should be standardized across both the perioperative continuum (pre-admit to post operative recovery) and throughout the nursing cycle (assessment, nursing diagnosis, desired outcome, implementation, evaluation and actual outcome)

Reference files should be created by the organization implementing the system. The framework provides a comprehensive and detailed list of standardized reference files scalable to any organization.

So how does all of this represent patient-centered care?

1. It does not require more documentation; it is transparent to the user
2. It integrates national standards, recommended practices and regulatory requirements across all phases of perioperative care
3. It employs PNDS as the universal perioperative language with associated data elements reflecting nursing interventions
4. It reflects nursing workflow in the entire plan of care, assessment, implementation, evaluation and patient outcomes
5. Enables data to be used for benchmarking, both internally and externally
6. It supports national mandatory reporting measures (e.g., Surgical Care Improvement Project measures) by utilizing continued documentation of the assessment findings throughout all phases of perioperative care
7. It supports the submission of required CMS quality data.

References

1. J. Needleman, PI Buerhaus. Nurse Staffing Levels and Quality of Care in Healthcare Organizations. The New Eng J of Med May 30, 2002, No. 22, Vol 346:1715-1722
2. CSC market survey conducted on behalf of AORN from 8-1-2008 thru 9-30-2008.
3. D. Detmer. AMIA recommendations for achieving a national infrastructure for HIT and  informatics to President-Elect Obama. January 7, 2009. http://www.amia.org/files/ObamaLetter_January2009.pdf. Accessed April 3, 2009.
4. C. Peterson, ed. Perioperative Nursing Data Set Revised 2nd ed. Denver: CO: AORN, INC; 2007:9-15.
5. Centers for Medicare & Medicaid Services (CMS). 2008Deficit Reduction Act (DRA) 2005 (c). http://www.cms.hhs.gov/HospitalAcqCond/. Accessed April 3, 2009.

Sharon Giarrizzo-Wilson, RN, BSN/MS, CNOR, is a perioperative nurse specialist, in Clinical Informatics for AORN. Julie Hammersley, RN, is a senior manager in the Perioperative practice at CSC. Louise Kenney, RN, is a senior manager in the Perioperative practice at CSC. Barbara Ripollone, RN, is a partner and the solution leader for the Perioperative/Supply Chain practice at CSC.

Infection Prevention in Outpatient Healthcare

Pathogenic organisms are like international travelers with unrestricted passports; they can flourish everywhere, even in the ambulatory care setting, which traditionally has a very low infection rate.

“As the boundaries between all segments of the continuum of care (inpatient, ambulatory, long-term) continue to blur, the priorities for each are becoming more closely aligned,” says Sue Barnes, RN, BSN, CIC, national leader of infection prevention and control/patient safety at Kaiser Permanente. “For this year, I would say that the most problematic pathogen is Clostridium difficile, due to the increasing virulence, incidence and associated morbidity and mortality. This pathogen is directly related to antibiotic use and contaminated environmental surfaces that are present in all three care settings.”

Barnes says there are several urgent infection prevention-related issues at work in healthcare settings; the first is adequate resourcing for infection prevention in all segments of the care continuum, especially this year with the new burden of mandatory reporting of infection rates. “Although this will help the drive to zero infections eventually, in the short term (the reporting) is only serving to divert already constrained infection control staff from infection prevention activities, in order to create reports,” Barnes says. The second is environmental cleaning and disinfection, specifically supporting reducing Clostridium difficile infection transmission. The third is finding a way to automate infection surveillance, which is directly related to the aforementioned lack of staffing and resources.

Barnes says that no matter the care setting, there are several critical best practices relating to infection prevention that are appropriate: hand hygiene and appropriate glove use; environmental cleaning and disinfection; and respiratory etiquette (covering your cough with mask, tissue and cleaning hands frequently).

Infection prevention should move to center stage in the outpatient setting because more surgical procedures are being handled in ambulatory care facilities than ever before. According to a new study, “Ambulatory Surgery in the United States, 2006,” from the Centers for Disease Control and Prevention (CDC) the number of outpatient surgery visits in the United States increased from 20.8 million visits in 1996 to 34.7 million visits in 2006.

Campos-Outcalt (2004) notes, “It is easy to overlook the potential for spreading infectious diseases in the outpatient setting. Relying on healthcare workers to practice good hygiene is unlikely to be enough. This public health battle must employ a comprehensive plan for clinic design, involving staff in setting and enforcing policies, and repeatedly emphasizing the importance of good hygiene.”¹ Campos-Outcalt encourages outpatient facilities to institute and enforce policies on respiratory hygiene and hand hygiene, as well as immunize all staff members, and be on alert for potentially contagious patients.

A number of high-profile outbreaks of hepatitis have grabbed headlines in recent years, including breaches in infection control techniques and unsafe injection practices that exposed more than 40,000 patients to hepatitis at an endoscopy center in Las Vegas in 2007. Unsafe injection practices have also been cited at freestanding centers in Nebraska, New York, Michigan and North Carolina.

In the last decade, more than 60,000 patients in the United States were asked to get tested for hepatitis B virus (HBV) and hepatitis C virus (HCV) because healthcare professionals in settings outside hospitals failed to follow basic infection control practices, according to a study by the CDC.² This first full review of all the CDC investigations over the past 10 years of healthcare-associated viral hepatitis outbreaks appeared in the Jan. 6, 2009 issue of Annals of Internal Medicine.

“This report is a wake-up call,” says John Ward, MD, director of CDC’s division of viral hepatitis. “Thousands of patients are needlessly exposed to viral hepatitis and other preventable diseases in the very places where they should feel protected. No patient should go to their doctor for healthcare only to leave with a life-threatening disease.”

Kathy Warye, CEO of the Association for Professionals in Infection Control and Epidemiology (APIC), in a prepared statement issued earlier this year, observed, “APIC is very concerned by the mounting number of cases in which clinicians in ambulatory care settings failed to follow safe injection practices, causing outbreaks of serious infections and endangering the lives of patients. These outbreaks were preventable and should never have occurred. Consumers seek healthcare services to get better and should not be exposed to unnecessary risk.”

In the United States, transmission of HBV and HCV while receiving healthcare has been considered uncommon. However, a review of CDC outbreak information revealed a total of 33 identified outbreaks outside of hospitals in 15 states, during the past decade: 12 in outpatient clinics, six in hemodialysis centers and 15 in long-term care (LTC) facilities, resulting in 450 people acquiring HBV or HCV infection. Patients were exposed to these potentially deadly diseases because healthcare personnel failed to follow basic infection control procedures and aseptic technique in injection safety. Reuse of syringes and blood-contamination of medications, equipment and devices were identified as common factors in these outbreaks.³

“More and more patients in the United States receive their healthcare in outpatient settings,” says Denise Cardo, MD, director of CDC’s Division of Healthcare Quality Promotion. “To protect patients, infection control training, professional oversight, licensing, innovative engineering controls and public awareness are needed in these healthcare settings.”

CDC officials say the report shows the need for ongoing professional education for healthcare providers, as well as consistent state oversight in detecting and preventing the transmission of bloodborne pathogens in healthcare settings.

Warye advises, “With an increasing amount of care being delivered in outpatient settings, more patients will be put at risk unless clinicians are adequately educated and consistently adhere to infection prevention measures. Clinics should also be concerned about new and more virulent pathogens, such as MRSA, which can be transmitted in outpatient settings and take a hard look at how they are addressing infection prevention overall.”

“The (hepatitis C) outbreak in Las Vegas (in 2008) was an opportunity for every ASC to review their policies on IV medication administration as well as all infection control policies,” says Carol Imes, RN, MPA, CNOR, director of nursing at Mentor Surgery Center in Mentor, Ohio. “I used this situation to educate my staff on best practices as well as unsafe practices. The reality is that ASCs have a very low infection rate — less than 1 percent.”

Having said that, however, Imes cautions, “With the rise in drug-resistant infections, I think that ASCs will see more infections. We are accepting higher-risk patients with obesity, diabetes, cardiovascular problems — including hypertension and circulatory problems — who may be more prone to infections, and we never know exactly to what environment we are sending our patients. We have some advantages in ASCs that include much shorter length of stay and contact with fewer people who might contribute to infections. I also think that ASCs take infections very seriously and analyze each case thoroughly to see if there are trends or if changes are needed in protocols. New required quality measures will reinforce what ASCs already do. Focus on administering IV antibiotics within one hour of incision may help decrease infections, but that is not always easy to do. Handwashing is one key to lowering infections.”

Imes encourages ASCs to pay close attention to environmental cleaning and follow the 2008 “Guideline for Disinfection and Sterilization in Healthcare Facilities” from the CDC. “I just printed these guidelines and I will be reading them over the next couple of weeks. I hope that they will not negate my feelings on some sacred cows that we have buried many years ago (e.g., we do not require shoe covers; we do not wash our OR floors after every case unless there is blood or body fluids on it; and allowing staff to wash their own scrubs). We have lacked sound scientific evidence on many of our surgical practices, and I have found no increase in our infection rates after eliminating these sacred cows.”

The CDC says it is working to address the patient safety challenge in the outpatient setting through a number of efforts, including:

• Improving viral hepatitis surveillance, case investigation and outbreak response, such as support for health departments to thoroughly investigate all individuals identified to have HBV or HCV infection
• Strengthening the capacity of state and local viral hepatitis prevention programs
• Augmenting the CDC’s National Healthcare Safety Network, the national surveillance system for tracking healthcare-associated infections, to collect outpatient setting information
• Partnering with the Hepatitis Outbreaks’ National Organization for Reform (HONOReform), a patient advocacy foundation, to create patient and provider education materials
• Continued improvement of injection safety practices through educational outreach efforts with professional nursing and anesthesiology organizations;
• Working with partners in the dialysis and other care communities to promote safe care practices
• Working with regulators and professional societies to strengthen licensure and accreditation processes with emphasis on safe injection practices

References

1. Campos-Outcalt D. Infection control in the outpatient setting. J Fam Practice. Vol. 53, No. 6. June 2004.
2. Thompson ND, et al. Nonhospital healthcare–associated hepatitis B and C virus transmission: United States, 1998-2008. Ann Intern Med. Vol. 150, No. 1. Pages 33-39. Jan 6, 2009.
3. Kuehn BM. Poor infection control fuels hepatitis in non-hospital healthcare facilities. JAMA. 2009;301(6):589.

Next Page »