About 2.2 million people, or more than one in every four Americans who signed up for private health coverage under President Barack Obama’s healthcare reform law, have inconsistent data in their applications that could lead to them losing coverage in isolated cases, officials said. Republicans, who have made the law known as Obamacare a top issue for November’s midterm congressional elections, pounced on the disclosure as fresh evidence that it poses an unworkable burden for Americans. But officials denied that the data issues rise to the level of problem enrollments, saying consumers in many cases included data on income, citizenship and immigration that is more up to date than federal records show.

 

I thought our readers should know this information since we often give antibiotics either preop or intraop.

Authors: Schweizer ML et al., JAMA 2014 May 21;

The mean attributable cost of surgical site infections in the Veterans Affairs system in 2010 was $11,876.

With today’s emphasis on improving healthcare quality while decreasing cost, understanding the true costs of surgical site infections (SSIs) is important. Using data from the Veterans Affairs Surgical Quality Improvement Program and the Veterans Health Administration (VHA) Decision Support System, investigators performed a retrospective cohort analysis to assess SSI-associated costs among patients who underwent inpatient surgery at Veterans Affairs hospitals.

Between October 2009 and September 2010, 54,233 patients underwent surgery at any of the 129 hospitals involved; 1756 of them (3%) developed SSIs (superficial in 74%, deep in 26%). Risk factors for SSIs included emergency surgery, recent heavy alcohol use, diabetes, chronic obstructive pulmonary disease, and congestive heart failure. The risk-adjusted costs were 1.43 times higher for all patients with an SSI (1.25 and 1.93 times higher for patients with superficial and deep SSIs, respectively) than for patients without an SSI. The estimated increase in costs was $11,876 for SSIs overall ($7003 for superficial and $25,721 for deep infections). If the hospitals with SSI rates higher than the 50th percentile reduced their rates to those of institutions at the exact 50th percentile, the VHA could save an estimated $13,198,865 annually.

Comment

The authors acknowledge limitations of the study — for example, including only a 30-day postoperative follow-up period, which would limit the detection of SSIs in patients receiving implants (including joint prostheses), not including cardiac surgery patients, and using data from Veterans Affairs hospitals (where patients are generally sicker and more likely to be male than those in a private hospital). Still, these findings will be of great benefit in considering the cost-benefit of various approaches to SSI prevention.

 

This is important for our readers because so many of our followers work in the ICU beside just surgery.

Authors: Binney ZO et al., Crit Care Med 2014 May 42:1074

Investigators describe a process by which ICU patients were transferred successfully to inpatient hospice care.

In the U.S., 10% to 20% of patients admitted to an intensive care unit (ICU) will die in the ICU. Many critical care teams have partnered with palliative care providers to deliver outstanding end-of-life care in the ICU. However, transitioning critically ill patients from the ICU to hospice care is relatively rare. In this study, investigators retrospectively examined a program in which patients were transferred from an ICU to an inpatient hospice unit (IHU) in two academic medical centers within the same healthcare system.

During 6 months, 167 patients were transferred from the ICU to the IHU; 99 missed opportunities for transfer also were identified. Patients who were not transferred were less likely to have received palliative care consultations and more likely to have required mechanical ventilation or vasopressors, although IHU admission criteria did not exclude such interventions. An estimated 585 ICU days might have been avoided if all opportunities for transfer were realized.

Comment

Collaboration between palliative care and critical care providers has yielded progressively nuanced end-of-life care in the ICU. Transition to inpatient hospice care might confer added benefit, because hospice provides resources that rarely are available in an ICU, including prolonged bereavement support for families. Although we need to examine the long-term effect of ICU-to-hospice transfers, they clearly are feasible and might improve patient and family care as well as lower hospital costs.

 

Authors: Kim JB et al., J Am Coll Cardiol 2014 Jun 3; 63:2280

Overall mortality risk was 50% higher in patients who underwent off-pump versus on-pump coronary artery bypass grafting.

Compared with on-pump coronary artery bypass grafting (CABG), off-pump surgery offers potential advantages of reduced bleeding, reduced need for transfusion, and superior neurocognitive outcomes. However, few studies have compared long-term survival with each strategy.

In the current study, investigators compared all-cause mortality in 2333 patients who underwent off-pump CABG and 2570 patients who underwent on-pump surgery between 1989 and 2012 at a single center in Korea. Compared with the on-pump group, rates of diabetes, hypertension, and single-vessel coronary artery disease (CAD) were higher in the off-pump group. Mean ejection fraction was also slightly higher in the off-pump group, but age, sex, and prevalence of left-main CAD were similar between the two groups. More distal anastomoses were performed in the on-pump group (mean, 3.7 vs. 3.0), but more arterial grafts were used in the off-pump group.

All-cause mortality was similar between the two groups at 30 days and 1 year but increased more in the off-pump group during long-term follow-up (median, 6.4 years). Using propensity-matched adjustment, overall mortality risk was nearly 50% higher with off-pump versus on-pump CABG (mortality rates, 22% vs. 17%; hazard ratio, 1.48; 95% confidence interval, 1.14–1.90).

Comment
In this large, retrospective comparison, on-pump CABG was associated with better long-term survival compared with off-pump CABG. These findings are consistent with results of smaller studies and meta-analyses. Possible explanations for the better outcome with on-pump surgery include more-complete revascularization, superior graft patency for technical reasons (not assessed in this study), and the higher mortality observed in patients who crossed over from off-pump to on-pump surgery.

Since we need surgeons this obviously has a major effect on your anesthesia practice.

Although surgeons play a large role in caring for patients under accountable care organization (ACO) models, Medicare-approved ACOs haven’t paid attention to them, according to a new study in Health Affairs.

Researchers analyzed the experiences of 59 Medicare-approved ACOs using a survey and conducting in-depth interviews with senior leaders at four Pioneer and Medicare Shared Saving Program models. Thirty of the 59 ACOs responded to the survey.

They found that ACOs—which included integrated delivery systems, independent practice associations, multispecialty groups, primary care partners and physician-led organizations–have given little attention to surgical care and instead focus on coordinating care for patients with chronic conditions and reducing hospital readmissions and emergency department visits.

“Surgery was clearly not part of the strategic plans of any of the case study sites,” lead author James M. Dupree, a former health policy fellow at the American College of Surgeons who now is a urology surgery fellow for Baylor College of Medicine, wrote. “Tellingly, not a single interviewee could say–or would even guess–how much of their ACO’s total expenditures were attributable to surgery.”

The broader survey findings also indicated a lack of focus on surgery. Eighty-eight percent said they “didn’t know” how much of their total spending was attributable to surgery. And 86 percent rated the goal of reducing unnecessary surgery as very low, low or medium priority. Only 10 percent ranked it high or very high.

Researchers said ACOs will not achieve their desired cost savings and quality improvements by limiting their focus on managing chronic illnesses, readmissions and ED visits. Success may depend on their ability to increase the integration of care–especially managing patients with complex conditions who often require surgical care.

Surgeons, they said, can work directly with primary care doctors to ensure patients receive appropriate but not overly complex preoperative workups. In turn, primary care physicians can work to ensure the chronic conditions associated with poor perioperative outcomes are managed well before surgery. Furthermore, they said surgeons can help patients improve physical function after surgery and reduce readmissions by consulting with home care or rehabilitation facilities to help manage post-perative issues remotely.

“ACO administrators, policy makers, and surgeons need to be aware of these findings, because they have the potential to affect practice patterns and referral streams for surgical patients, the care provided to ACO patients, and the success of ACOs themselves,” the study concludes.

Cloud-based software services provider athenahealth has released its 2014 PayerView Report, which leverages the company’s data to provide insight into provider-payer relationships and ranks healthcare payers based on various metrics.

Denial rate is one of those metrics. According to the report, here are the 10 payers with the lowest percentages of claims requiring backend rework.

1. Blue Cross Blue Shield of Oregon — 2.9 percent

2. Premera Blue Cross of Washington — 3.1 percent

3. HealthPartners — 3.1 percent

4. Blue Cross Blue Shield of Rhode Island — 3.2 percent

5. Healthsource (a Cigna subsidiary) — 3.4 percent

6. Medicare Part B of Oregon — 3.4 percent

7. Capital BlueCross of Pennsylvania — 3.5 percent

8. US Family Health Plan — 3.5 percent

9. Medicare Part B of Arkansas — 3.6 percent

10. Tufts Health Plan — 3.6 percent

The FDA has approved the first mucoadhesive buccal film therapy for the maintenance treatment of opioid dependence, the manufacturer announced on Friday. Bunavail — a combination of buprenorphine and naloxone — should be used along with counseling and psychosocial support.

The manufacturer says that this mode of delivery is more potent and therefore requires half the dose of the currently marketed sublingual formulation (Suboxone). This “may help to reduce the potential for misuse and diversion and potentially lessen the incidence of certain side effects,” the company says.

The FDA has approved Eloctate, a new prophylactic treatment for children and adults with hemophilia A. The infusion is long-acting and will decrease the number of doses required, with an infusion needed every 3 to 5 days (rather than three times weekly or every other day).

Eloctate consists of the coagulation factor VIII molecule linked to a protein fragment (Fc), which makes the therapy last longer in the patient’s blood.

In a clinical trial of some 160 males aged 12 and older with severe hemophilia, Eloctate effectively treated, reduced, and prevented bleeding episodes. Additionally, it was effective in controlling perioperative bleeding.

The U.S. uninsured rate held steady at a record low of 13.4 percent in May, according to a recent Gallup poll.

The uninsured rate appears to have leveled off after monthly declines in the wake of the Patient Protection and Affordable Care Act’s major provisions taking effect. It remains to be seen whether the uninsured rate will stay steady, go up or decrease further before the next open enrollment period begins in November for the PPACA health insurance exchanges, according to Gallup. The uninsured population could also continue to shrink if more states opt to expand their Medicaid programs.

Here are 22 statistics on the change in the uninsured rate overall and for various subgroups between the fourth quarter of last year and the latest survey, which included more than 30,400 Americans and was conducted from April 1 to May 31 as part of the Gallup-Healthways Well-Being Index.

Percentage of U.S. Uninsured

                                 Quarter 4 2013                                    April 1 through May 31, 2014

All adults                                  17.1                                                                 13.4

Ages 18 to 25                  23.5                                                                  19.1

26 to 34                                  28.2                                                                   23.9

35 to 64                                  18                                                                           13.2

65 and older                           2                                                                     2

White                                11.9                                                                            8.9

Black                                  20.9                                                                     14.7

Hispanic                                38.7                                                                         33.1

Less than $36,000 in household income30.7                                                 24.7

$36,000 to $89,999                                11.7                                               8.6

$90,000+                                                5.8                                                   3.9

Hospitals across the country are struggling to deal with a shortage of one of their essential medical supplies. Manufacturers are rationing saline — a product used all over the hospital to clean wounds, mix medications and treat dehydration. Now drug companies say they won’t be able to catch up with demand until next year.

That leaves San Francisco General Hospital’s materials manager, Reid Kennedy, in a fix. Kennedy is in charge of managing all the gloves, bandages, bedpans and IV solutions for all the medical floors, emergency room and operating room.

He first got a call last year from his vendor telling him they might not be able to deliver his full order.

“We were put on notice that it was going to be tight,” he said.

Then things got worse in January. The flu season hit much harder than expected, and sick people flooded into hospitals. Saline bags flew off the shelves to treat dehydration, and demand far outstripped supply.

“The flu season knocked us out as an industry,” Kennedy said. Though hospital administrators say the shortage hasn’t affected the quality of patient care, Kennedy uses the word “crisis” to describe the shortage.

But can salty water really be that hard to come by? Kennedy pays $1.57 per bag. Why can’t drug companies just whip up some more?

“To make one of these drugs is very complex, even though the drug itself is simple,” said Valerie Jensen, the director of the drug shortage program at the Food and Drug Administration. “It takes about three weeks to make one batch of normal saline from start to finish.”

She says the key challenge is making sure saline products are sterile. More than 30 steps and a range of supplies are involved in producing sterile saline. Jensen says FDA inspectors have reason to keep a close eye on any drug injected intravenously. She says they’ve found some nasty things in IV drugs: bacteria, mold, glass particles.

“These are issues that absolutely would be a safety risk for patients,” she said.

That’s why the FDA sets strict quality standards for the facilities that manufacture saline and other IV drugs. But the agency has to find a delicate balance between safety and supply.

Some suppliers suggest keeping up with the FDA’s standards is too onerous and may be playing a part in the shortage.

“A lot of variables came together to create this,” said Scott Crandall, director of medical supply contracts at Novation, a group buying organization in Texas that manages contracts for San Francisco General and 2,000 other hospitals across the country. He’s been hearing from manufacturers that increased FDA scrutiny is interfering with drug production.

“During the last year, all suppliers had issues in their facilities where they had to correct certain things the FDA found,” Crandall said.

Some of those corrections were serious. Hospira, one manufacturer of saline, issued a recall earlier this year because of leaks in its saline bags. Before that, Baxter, another manufacturer, found particles in its saline vials and had to recall four lots. Both companies say the recalls had no bearing on the current shortage.

Flu Season Causes Headaches

But Crandall says inspections and maintenance require shutting down machines. And when machines aren’t operating, less saline is getting shipped. Last winter, he says maintenance closures “slowed production down, 10 to 20 percent.”

So the industry was already behind when the flu season hit.

The procurement director for a group of dialysis centers says his supplier, Baxter, told him the main problem was winter weather. Snow and ice storms in the Midwest were delaying trucks headed for California.

“As the weather got worse, we began to see more and more back-order issues,” said Colin Carthen of Satellite Healthcare, which runs 70 dialysis centers across the U.S. Each patient comes in three or four times a week, and each time goes through one to two liters of saline to clean the blood and prevent clotting. At the worst of the shortage, Carthen realized the health of 6,000 patients depended on the administrative magic tricks he could perform behind the scenes.

“I called up a clinical person that I knew, and said, ‘Well, what happens if we run out of saline?’ Because I was really afraid,” he remembers. “And they were just like, ‘Yeah, it gets ugly, fast.’”

Carthen says he’s lucky that didn’t happen. Every day, he spent hours on the phone with suppliers and clinical staff, juggling and rerouting supplies so everyone had enough.

Keeping the Supply from Drying Up

Hospitals have developed new clinical protocols to conserve supplies during the shortage. Nurses at San Francisco General are using smaller saline bags when possible, and transitioning patients who still need hydration to drink water from cups a little sooner than they did in the past. Kennedy has spent hours talking with pharmaceutical and clinical staff about when to use these conservation measures, to make sure there is enough saline to go around.

“Pie is a good analogy. Now I’m going to use 16 slices of pie instead of eight slices of pie, and I’ll be able to feed 16 people instead of eight,” he said.

The FDA is trying to mitigate the shortage by importing saline from Spain and Norway. But FDA economist Marta Wosinska says that’s not a sustainable solution, since those countries have to supply their own hospitals.

“There is no spot market. You can’t buy it like pork bellies or grains or oil. You cannot go on a marketplace and order a certain amount,” she said.

U.S. companies also don’t have the capacity to ramp up production. They only have so many machines, and a lot of them are tied up producing other essential drugs. Building new facilities is hardly an option.

“We’re talking about hundreds of millions of dollars and it would take three to five years,” Wosinska said.

The drug companies don’t face any real penalties if they don’t come through with saline supplies. Contract loopholes release them from paying any fees to their customers if a drug shortage is industry-wide, as this one is.

Both Baxter and Hospira, the top two saline producers in the country, say they are doing all they can to maximize production. Each points a finger at the other for contributing to the shortage.

“We saw increased demand amid decreased product availability from competitors as the main driver,” a Baxter spokesman wrote in an email.

A Hospira spokesman countered: “Hospira began seeing stronger demand for its saline products in late 2013 when another manufacturer began to experience manufacturing issues.”

Hospira reported a 20 percent increase in U.S. net sales of its injectable drugs between January and March, citing “increased volume due to competitor supply issues,” in its latest quarterly financial report.

“The Most Expensive Drug Shortage in History”

The burden ultimately falls on hospitals, clinics, and dialysis centers to come up with their own workarounds. And all that staff time adds up. Hospitals spend $216 million a year on the labor costs of managing drug shortages, according to Erin Fox, a professor at the University of Utah College of Pharmacy.

Now that the industry has indicated the saline shortage will extend through the end of the year, Fox estimates this will be the most expensive drug shortage in history.

“IV fluids impact almost every single patient and every single floor. That means you have to educate and get a message out to multiple groups of people rather than a selected group, like for an anesthesia drug or a cancer drug,” Fox said.

For now, the actual cost of saline is steady. Hospitals are protected under contracts that keep prices locked through next year. But Novation’s Scott Crandall says that is very likely to change when those contracts expire.

“The suppliers have already signaled to the market that they plan on increasing price significantly,” he said. “And when I say that, it could double and triple in some aspects.”

Fox says that would be far better than the current situation.

“It is far cheaper for hospitals to pay $3 a bag for saline and have a consistent and quality product — not recalled due to contaminants, or leakage,” she said, “than it is to potentially delay elective surgeries or make workarounds that change weekly or daily due to inconsistent supply.”