Medicare expands coverage for treating facial lipodystrophy syndrome in people living with HIV 

Health law surprise is page 1,617 demanding which drugs work

Page 1,617 of the 2,400-page law signed by President Barack Obama this week -- the most sweeping change to U.S. healthcare in 45 years -- sparked little of the debate surrounding the expansion of coverage to 32 million Americans or its tax on employees’ “Cadillac” insurance plans. Yet the 43-page measure tucked inside the bill may have a far greater effect on medical care.

The overhaul creates an institute, funded with $500 million or more annually, to spur studies of which drugs, devices and medical procedures work best. The boost for comparative-effectiveness research, as the field is known among health experts, will increase scrutiny on treatments used by millions of Americans, including cholesterol drugs led by Pfizer Inc.’s Lipitor and heart stents from Medtronic Inc., said John Sullivan, an analyst at Leerink Swann & Co.

The findings may add scientific rigor to doctors’ decisions sometimes influenced more by marketing, said Jeffrey Lerner of the ECRI Institute, a nonprofit that conducts such research. In a health overhaul attacked by critics as too pricey, it’s one of the few measures with a chance to rein in U.S. medical spending that soared to $2.5 trillion last year, Sullivan said. Comparative effectiveness will probably be “a headwind for the healthcare industry,” the Boston-based analyst said in a March 23 phone interview. “If research shows that less complex and maybe less expensive products and therapies work just as well, that is not good news” for the companies.

Comparative effectiveness is one of multiple tools in the law designed to pry savings from the system, said Peter Orszag, Obama’s budget director, in a March 23 telephone interview. The legislation also experiments with new payment systems for doctors, penalizes hospitals with high readmission rates and creates an independent commission to decide which treatments Medicare should pay for, he said.

The institute will be run by a 19-member board of governors with three representatives of drug, device and diagnostic- testing companies as well as patient advocates, doctors and the National Institutes of Health. The U.S. Comptroller General, a presidential appointee, must name the board within six months.

Its funding will start at $10 million this year and reach about $500 million in 2013 when money from Medicare and a new insurer tax kicks in, according to an estimate from the Brookings Institution, a Washington-based research center. The budget may increase if insurance rolls grow, Brookings estimates. The healthcare law focuses on studies that assess effectiveness rather than compare costs. It also bars Medicare, the U.S. government insurer for the elderly, from using the research as the sole grounds for denying reimbursement for medical products or procedures.

The research is likely to spur consolidation among healthcare companies, said Lerner, chief executive officer at the ECRI Institute based in Plymouth Meeting, Pennsylvania, which serves governments and hospital systems. Smaller manufacturers may not have the resources to rebut studies questioning a product’s value, he said by telephone. “When you compete against other technologies, you’re going to have to demonstrate scientifically that you measure up and that takes time and money and sophistication,” Lerner said.

Drugmakers, led by Pfizer, support the effort as “an important solution for better quality and ultimately better value in healthcare,” said Randy Burkholder, an associate vice-president at PhRMA, the industry’s trade group in Washington, in a telephone interview. Device companies agree, said David Nexon, an executive vice-president for the industry’s AdvaMed trade group. Device makers favor the legislation because it focuses on clinical effectiveness, rather than cost, and because manufacturers will be part of the decision-making, he said in a telephone interview. The research may speed use of technologies proven better than existing treatments, Nexon said.

The research will have to overcome a payment system that rewards doctors for the volume of care done, rather than its value, said Devon Herrick, a health economist at the nonprofit National Center for Policy Analysis in Dallas. “There’s really very little incentive for a physician or hospital to follow cost-effectiveness studies,” Herrick said. “Often what we consider to be waste, a hospital considers that revenue. Traditionally, doctors never had to know about the cost of the drugs they’re prescribing. Visit Bloomberg for the article.

Congress approves 'fixes' to healthcare law

Congress agreed Thursday to amend the nation's new healthcare law, concluding its long and contentious quest to pass major reforms, and prepared to head home for a two-week recess and to hear from skeptical voters about the legislation. The last legislative hurdle to clear before recess was a reconciliation bill that contained a number of "fixes" to the healthcare law, as well as an overhaul of the student loan program and expansion of Pell Grants. The measure was designed to proceed through Congress along a fast track, but it bogged down nevertheless.

Both parties think they are emerging from the healthcare debate in the stronger political position, going into midterm elections. Democrats are convinced that Americans will warm to the legislation once they have a chance to digest it and that the party will be rewarded for addressing a serious problem.

The "fixes" bill adopted Thursday would alter major provisions of the health law. Uninsured people would receive more-generous subsidies to buy coverage; federal funding of Medicaid would increase; and seniors would see the "doughnut hole" coverage gap disappear in their Medicare prescription drug policies. The amendments also speed up enactment of new insurance restrictions that will particularly benefit people with chronic medical conditions. And in six months, uninsured adults younger than 26 may be added to their parents' health plans.

Because the measure was written under special budget reconciliation rules, it was protected from a Republican filibuster. But it was vulnerable to GOP parliamentary challenges. Aides scrutinized every line of the 150-page addendum and finally identified two minor provisions, related to the student-loan section, that were deemed out of order. That forced the legislation back to the House for one last late-night vote. Visit the Washington Post for the article.

The Medicare donut hole: Now you're covered, now you're not

If you're older, a woman, and suffering from either dementia or diabetes, you are the most likely to be exposed to unsubsidized medication costs in the US. This is known as the coverage gap for enrollees of Medicare Part D – the US federal program which subsidizes the cost of prescription drugs for Medicare beneficiaries. According to Dr. Susan Ettner from UCLA, and her colleagues, these clinically vulnerable groups should be counseled on how to best manage costs through either drug substitution or discontinuation of specific, non-essential medications. This is important so that more essential medication is not discontinued with adverse effects on patients' health, for cost reasons only. Their findings have just appeared online in the Journal of General Internal Medicine.

In 2006, 3.4 million seniors signed up to a Part D plan which provides voluntary drug coverage to all Medicare beneficiaries. The plan was expected to improve adherence to drug regimens and health outcomes, via improved financial access to medications. However, the standard Part D benefit includes a coverage gap (or donut hole). After a Medicare beneficiary surpasses the prescription drug coverage limit, he or she becomes financially responsible for the entire cost of prescription drugs until the expense reaches another threshold – the catastrophic coverage threshold.

Researchers found that 16 percent of enrollees entered the gap, with nearly 3 percent entering the gap very early on, i.e. within the first 180 days. Of those who entered the gap, only 7 percent exited again. Women and patients with dementia and diabetes were the most likely to enter the gap. Other conditions also predisposed beneficiaries to gap entry, including end-stage renal disease, coronary artery disease, chronic obstructive pulmonary disease, mental health conditions, and congestive heart failure.

As an example, an average 67-year-old woman with diabetes and a typical set of comorbidities – hypertension, hyperlipidemia, coronary artery disease and depression – would have a 54 percent chance of falling into the Medicare Part D coverage gap and being exposed to the full cost of her medication. If she fell into the gap, she would have an 11 percent chance of exiting again, but in the meantime, she would have incurred more than $3,600 in total out-of-pocket drug expenses. The full-text article is published at SpringerLink.com.

Study finds surgical masks provided effective protection of healthcare workers against H1N1

The effectiveness of ordinary surgical masks as opposed to respirators in protecting healthcare workers against the 2009 H1N1 influenza virus has been the subject of debate. An observational study published in the April 1, 2010 issue of Clinical Infectious Diseases, suggests that surgical masks are just as effective as respirators in this regard.

Researchers analyzed the incidence of H1N1 among healthcare workers from April through August of 2009 at Tan Tock Seng Hospital in Singapore. A small percentage tested positive for H1N1 during this period. None had cared for any patients with H1N1 or worked in H1N1 screening areas of the emergency room. In all cases, transmission was believed to have occurred outside of patient care, when healthcare workers were in contact with roommates, the general public, and other sources.

From June 19 to July 21, healthcare workers at the hospital wore N95 respirators in the emergency room and an H1N1 isolation area. From July 22 to Aug. 31, surgical masks were used by workers in these areas. The incidence of H1N1 among workers remained low during both periods. Although the study was observational, the findings suggest that surgical masks and respirators did not differ in their effectiveness in preventing hospital staff from acquiring H1N1.

"What is more important than using high-filtration or respirator masks for known or suspected cases is to have a uniform policy, such as using surgical masks, when in close contact with all patients," said study author Brenda Sze Peng Ang, MD, of the Tan Tock Seng Hospital in Singapore. "This way, health care workers are protected from getting infected by patients not initially thought to have H1N1." Visit Chicago Journals for the article.

More doctors giving up private practices

A quiet revolution is transforming how medical care is delivered in this country, and it has very little to do with the sweeping healthcare legislation that President Obama just signed into law. But it could have a big impact on that law’s chances for success. Traditionally, American medicine has been largely a cottage industry. Most doctors cared for patients in small, privately owned clinics — sometimes in rooms adjoining their homes.

But an increasing share of young physicians, burdened by medical school debts and seeking regular hours, are deciding against opening private practices. Instead, they are accepting salaries at hospitals and health systems. And a growing number of older doctors — facing rising costs and fearing they will not be able to recruit junior partners — are selling their practices and moving into salaried jobs, too.

As recently as 2005, more than two-thirds of medical practices were physician-owned — a share that had been relatively constant for many years, the Medical Group Management Association says. But within three years, that share dropped below 50 percent, and analysts say the slide has continued. For patients, the transformation in medicine is a mixed blessing. Ideally, bigger healthcare organizations can provide better, more coordinated care. But the intimacy of longstanding doctor-patient relationships may be going the way of the house call.

The trend away from small private practices is driven by growing concerns over medical errors and changes in government payments to doctors. But an even bigger push may be coming from electronic health records. The computerized systems are expensive and time-consuming for doctors, and their substantial benefits to patient safety, quality of care and system efficiency accrue almost entirely to large organizations, not small ones.

In many ways, patients benefit from higher quality and better coordinated care, as doctors from various fields join a single organization. In such systems, patient records can pass seamlessly from doctor to specialist to hospital, helping avoid the kind of dangerous slip-ups that cost the lives of an estimated 100,000 people in this country each year.

The changes have increasingly put the public and private provision of healthcare at odds. In the Medicare and Medicaid program, the government sets most prices related to hospitalization and doctor visits. And so organized health systems are seen as a way to increase quality and lower costs, in part because salaried doctors may order fewer procedures than those in private practice.

The Centers for Medicare and Medicaid Services decided last year to cut reimbursements to cardiologists by 27 to 40 percent, depending on the type of practice. The Medicare savings in cardiology are to be used to pay more to primary care doctors, widely seen as under great financial strain. In the wake of the government decision, cardiology practices across the country began selling out to health systems or hospitals. Dr. Jack Lewin, chief executive of the American College of Cardiology, estimated that the share of cardiologists working in private practice had dropped by half in the past year. “And the remainder of those left are looking to move in that direction,” Dr. Lewin said. “This is all happening with or without reform passing.” Visit the New York Times for the article.

Retail clinics branch into chronic disease treatment

Retail clinics aren't just for strep throats any more; they'll also be managing diabetes and other chronic diseases. "It's a new service strategy," Sandra Ryan, CPNP, told attendees at a meeting on retail clinics sponsored by the Convenient Care Association and the Jefferson School of Population Health.

"We're evolving our clinic offerings," said Ryan, chief nurse practitioner officer for Take Care Health Systems, which operates retail clinics inside Walgreens pharmacies, "from episodic treatment to looking at how do we get more chronic disease management, how do we do more prevention, how do we do more screening?"

Most of the so-called retail clinics are located inside pharmacies or grocery stores (hence, the name) although a few are freestanding. Staffed primarily by nonphysician providers, they've generally treated acute illnesses such as colds, strep throat, and urinary tract infections; some have also provided vaccinations and sports physicals.

But that's going to be changing, according to Ryan. "We have recently done some research that showed that people are willing to be treated for high blood pressure, asthma, and high cholesterol" at retail clinics, she noted. "Knowing there's an unmet need for treatment and management of chronic conditions in the U.S., and knowing that the cost is increasing, we think retail clinics are on the forefront to meet that need."

Take Care has already begun its first steps in that direction in a few clinics, which are offering spirometry testing for asthma patients and HbA1c tests to screen for diabetes. The chain also is doing hypertension screening and diagnosis. Once patients are diagnosed with hypertension, "we are currently referring them out" for care, but the company is looking at becoming part of the hypertension management team, Ryan said.

Donna Haugland, chief nursing officer at MinuteClinic, which operates retail clinics inside CVS pharmacies, noted that about 11% of Americans have now visited a retail clinic at least once. She added that the cost of managing diseases such as diabetes, which affects 23 million people nationwide, "far surpasses acute illnesses."

"With fewer and fewer physicians going into primary care, we need more access sites to help control the chronic disease problem we're running into… We in the retail [clinic business] think we're perfectly positioned to help in the effort to combat chronic disease," said Haugland. "We can identify patients and get them into the healthcare system so they can begin care," she continued, "and then we can bring them back and help educate them. As they get into the system, we can send them back to primary care and work with primary care in an integrated healthcare system to boost standards of care."

Ryan said chronic disease visits would work differently than the short acute-care visits that make up the majority of retail clinics' business now. "Our model is built around 20-minute drop-in visits, so some of the restructuring [might involve] more scheduled appointments," she said. Since retail clinics have peaks and troughs in traffic, with busier times in the morning and afternoon, chronic disease visits -- which might be 30 minutes long -- would need to be scheduled at less busy times. Visit MedPageToday for the complete article.

Joint Commission to offer monograph on Tdap vaccinations

In an effort to help healthcare organizations implement or enhance tetanus, diphtheria and acellular pertussis (Tdap) vaccination programs for patients and healthcare workers, The Joint Commission is seeking healthcare organizations that are willing to share their approaches for implementing such programs to assist in the development of a monograph. Health care organizations of all types are invited to participate, including hospitals, long term care organizations, medical offices, community health centers, home care and others.

The new monograph will include examples of promising strategies that have improved vaccination rates for people ages 11-64.  Healthcare organizations that have established Tdap vaccination programs are encouraged to submit a description of their programs by April 26, 2010.

The monograph will be produced and published later this year in partnership with infection prevention and infectious disease leaders from the Association for Professionals in Infection Control and Epidemiology, Inc. (APIC), the Centers for Disease Control and Prevention (CDC), the Society for Healthcare Epidemiology of America (SHEA) and the National Foundation for Infectious Diseases (NFID). 

The Joint Commission, with an unrestricted educational grant from sanofi pasteur, will gather and review real-world examples of successful initiatives for implementing and enhancing Tdap vaccination programs. When finalized, the monograph will be available for free download on The Joint Commission’s public Web site.

Health care organizations wishing to submit promising practices should go to www.jointcommission.org. 

Medicare expands coverage for treating facial lipodystrophy syndrome in people living with HIV 

The Centers for Medicare & Medicaid Services (CMS) announced its decision to cover facial injections for Medicare beneficiaries who experience symptoms of depression due to the stigmatizing appearance of severely hollowed cheeks resulting from the drug treatment for Human Immunodeficiency Virus (HIV), effective immediately.

Facial lipodystrophy (LDS) is a localized loss of fat from the face, causing an excessively thin appearance in the cheeks. In some cases, facial LDS may be a side effect of certain kinds of medications (antiretroviral therapies) that individuals receive as part of an HIV infection treatment regimen. 

The facial LDS can leave people living with HIV looking gaunt and seriously ill, which may stigmatize them as part of their HIV-infection status. Individuals who take these medications and experience facial LDS side effects may suffer psychological effects related to a negative self-image. These effects may lead people living with HIV to discontinue their antiretroviral therapies. The new decision allows for treatment of individuals who experience symptoms of depression due to the appearance changes from facial LDS. 

The injections included are “fillers” that have been approved by the U.S. Food & Drug Administration (FDA) to be injected under the skin in the face to help fill out its appearance specifically for treatment of facial LDS.  Data show that these injections can improve patient self-image, relieve symptoms of depression, and may lead to improved compliance with anti-HIV treatment. The final decision is posted on the CMS Web site.