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DAILY UPDATE

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October 31, 2014   Download print version

Hospital associations urge Genentech to cancel its new distribution policy for cancer drugs

Dignity Health to pay $37 million to settle overbilling claims

U.S. quarantines 'chilling' Ebola fight in West Africa: MSF

Ebola fear drives protective equipment frenzy in U.S., WHO says

Does milk do a body good? Maybe not, a new study suggests

Screen all infants, children and teens to help prevent sudden cardiac death, says CHOP cardiology expert

NIH-led study explores prevention of heart disease in HIV-infected people

New study reveals how quickly viruses contaminate buildings

Still time to nominate your CEO: Is your CEO a SURE winner?

 
 
 

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Hospital associations urge Genentech to cancel its new distribution policy for cancer drugs

Speaking on behalf of more than 5,000 hospital members nationwide, half a dozen prominent hospital associations took a united stand earlier this week against Genentech, Inc.’s recent decision to end traditional, wholesale distribution of three of its lifesaving cancer drugs: Avastin, Herceptin and Rituxan.

Citing concerns about supply chain security, the threat of counterfeiting and patient-safety, the pharmaceutical giant informed U.S. hospitals in September that they will only be able to purchase the drugs through six specialty distributors – a move hospitals say will severely hurt their ability to continue providing quality, cost-effective care to cancer patients.

In a letter addressed to Genentech’s Chief Executive Officer Ian Clark on Wednesday, the group said, “We believe this decision will add unnecessary costs to the delivery system and produce supply disruptions by requiring complicated new delivery procedures. It will have a major impact on access to care and will ultimately result in higher costs for cancer patients.”

The letter was signed by America’s Essential Hospitals, American Hospital Association, Association of American Medical Colleges, Catholic Health Association of the United States, Children’s Hospital Association and Federation of American Hospitals.

The group charges that forcing hospitals to purchase those drugs from specialty distributors means they would no longer receive the timely delivery, price and other cost benefits they currently get from wholesalers. This could result in disruptions in patient therapy, they said, as medications would no longer arrive via their daily wholesale orders, including on-time deliveries for next-day patient appointments. A drug shortage resulting from unexpected weather or other emergency-related delays, and having to rely on limited distributor locations, might also force hospitals to consider stockpiling the drugs, although few have the resources needed to do that.  

“A hospital may not be able to afford to keep a large supply of these drugs on hand and, thus, may not have the flexibility to provide treatment for new patients,” the associations noted, adding that without subsidizations from insurance companies and federal programs, hospitals will be forced to absorb other costs too.

For example, they said facilities would require more manpower to comply with the 340B Drug Pricing Program and also lose the current data they rely on from wholesale distributors to benchmark themselves against other organizations, compare drug pricing and ensure appropriate utilization – information they say is rarely provided by specialty distributors or delivered in accessible formats.

“Specialty distributors generally do not offer any product tracking services and hospitals must implement manual tracking, thereby diverting already scarce resources,” they told Clark, urging him to reverse the decision. “Given the steep financial pressures facing hospitals today, your surprise decision has sent a shock wave through the hospital community that will completely up-end pharmacy budgets, thereby compromising hospitals’ ability to continue to invest in patient care and other community health efforts.”

Visit AHA to read the letter.

 

Dignity Health to pay $37 million to settle overbilling claims

Dignity Health, a three-state hospital chain based in San Francisco, has agreed to pay the government $37 million to settle claims that it overbilled Medicare and a military health care program for years.

The Justice Department said Dignity, formerly known as Catholic Healthcare West, submitted bills for inpatient care at 13 of its 39 hospitals in California, Nevada and Arizona that should have been charged at less-expensive outpatient rates.

The bills covered elective cardiovascular surgeries for stents and pacemakers, and diagnostic procedures at the 13 hospitals from 2006 to 2010, and a spinal operation called kyphoplasty at four hospitals from 2000 to 2008, the Justice Department said. The bills were paid by Medicare and a military health program called Tricare.

The case arose as a whistle-blower suit filed in San Francisco by a former Dignity Health employee, Kathleen Hawkins, who will receive $6.25 million of the settlement, the Justice Department said.

“Hospitals that attempt to boost profits by admitting patients for expensive and unnecessary inpatient hospital stays will be held accountable,” Ivan Negroni, chief of the U.S. Health and Human Services Department’s inspector general’s office in San Francisco, said in a statement.

Dignity Health, one of the nation’s five largest hospital systems, said it was not admitting wrongdoing, but settled to avoid the expense of continued litigation.

“The billing disputes reflect widespread confusion in the healthcare industry on unclear federal standards for approving coverage of patient admissions,” the company said. “As a result, it is often challenging for physicians to ensure their documentation adequately reflects their decision-making.” Visit San Francisco Gate for the article.

 

U.S. quarantines 'chilling' Ebola fight in West Africa: MSF

Mandatory quarantines ordered by some U.S. states for doctors and nurses returning from West Africa's Ebola outbreak are creating a "chilling effect" on aid work there, the humanitarian aid group Doctors Without Borders said on Thursday.

In response to questions from Reuters, the group said it was discussing whether to shorten some assignments as a result of restrictions imposed by several states since one of its American doctors, Craig Spencer, was hospitalized in New York City last week with the virus.

"There is rising anxiety and confusion among MSF staff members in the field over what they may face when they return home upon completion of their assignments in West Africa," Sophie Delaunay, executive director of Doctors Without Borders in the United States, said in a statement emailed to Reuters.

Doctors Without Borders, also known by its French name, Médecins Sans Frontières, or MSF, is one of the main aid groups working in Guinea, Sierra Leone and Liberia, where the worst Ebola outbreak on record has killed nearly 5,000 people.

Some MSF workers have been delaying their returns to the United States and are staying in Europe for 21 days, Ebola's maximum incubation period, "in order to avoid facing rising stigmatization at home and possible quarantine," Delaunay said.

As a result, MSF is discussing whether to shorten some Ebola assignments from their current duration of four to six weeks. Aid workers typically begin and end their assignments in Brussels, the Belgian capital, a spokesman said.

Delaunay's comments on Thursday are the most substantive criticism of the rules since they were announced, suggesting they are eroding MSF's manpower and forcing American workers into temporary exile.

MSF says the policies have also created a misperception that healthcare workers are endangering the public, even though a person who does not have symptoms cannot spread the virus. Delaunay sent her statement in response to questions from Reuters about whether returning MSF workers were rearranging travel plans to avoid U.S. states with mandatory quarantines.

She did not say how many workers were choosing to delay their return or whether MSF was paying to accommodate them. MSF had already made a policy of asking its workers not to return to their regular jobs for 21 days after finishing an Ebola assignment. It pays them wages for that time.

Three other MSF aid workers have returned to the United States since last Friday via one of five airports approved for passengers who have recently been in West Africa. Those workers have not been quarantined, an MSF spokesman said.

Delaunay, the MSF director, also said there were fears among its non-American workers that other countries may follow the example set by some U.S. states.

Visit Reuters for the story.

 

Ebola fear drives protective equipment frenzy in U.S., WHO says

Fears about Ebola in the U.S. have prompted a surge in purchases of personal protective equipment in the U.S. as the World Health Organization seeks to ensure West African countries get priority, the agency said.

The WHO is in constant dialog with companies including DuPont Co. that make personal protective equipment, or PPE, to ensure supply to prevent health workers contracting Ebola, Edward Kelley, the WHO’s director for service delivery and safety, said at a briefing in Geneva today. The WHO is buying about 500,000 sets of PPE a month, he said.

“I’m an American, there’s a lot of fear in a number of different countries,” Kelley said. “My own country has had a massive rise in purchasing of PPE. We’ve been trying to prioritize the push toward making PPE available in the affected countries.”

There have been 13,703 cases of Ebola with 4,920 deaths worldwide, including four cases and one death in the U.S., according to WHO figures. The WHO published updated guidelines on the use of PPE that it said is the first systematic evidence review of what equipment should be used and how to use it.

Visit Business Week for the story.

 

Does milk do a body good? Maybe not, a new study suggests

Got milk? If you’re drinking it to prevent bone fractures or to boost your overall health, you might want to go back to the fridge and opt for a yogurt or a slice of cheese instead.

A new study in the journal BMJ casts doubt on the widely held view that milk can help adults ward off hip fractures and broken bones. After tracking more than 100,000 Swedish men and women for up to 23 years, the study authors saw no link between milk consumption and fracture risk. However, they did find that avid milk drinkers were more likely to die at younger ages than their counterparts who drank little to no milk.

The Dietary Guidelines for Americans advise everyone over the age of 8 to consume three cups of milk per day or the corresponding amount of yogurt, cheese or other dairy products. A new study finds that people who drank lots of milk were more likely to have bone fractures and to die at younger ages than people who drank less than one glass per day.

European countries offer similar suggestions. After all, milk is a convenient source of calcium, vitamin D and phosphorus, three nutrients that are important for bone growth.

However, the researchers, from the Uppsala University, the Karolinska Institute and the Swedish National Food Agency, wondered whether this advice was scientifically valid. No randomized clinical trials have shown that drinking milk causes the risk of fractures or premature death to fall, and observational studies that might reveal an association between milk and better health have had mixed results.

The research team cited another reason for their skepticism: D-galactose. This is produced by the body as it breaks down lactose, the sugar in milk. Studies in animals have shown that chronic exposure to the nutrient causes “oxidative stress damage, chronic inflammation, neuro degeneration, decreased immune response, and gene transcriptional changes,” they wrote.

In fact, when scientists want to mimic the effects of aging, they give animals shots or food containing D-galactose.

So the researchers turned to two large studies of Swedish adults. The Swedish Mammography Cohort included data on 61,433 women who answered questions about their diet between 1987and 1990. Among them, 38,984 answered a more detailed diet survey in 1997. In addition, the Cohort of Swedish Men contained data on 45,339 men who completed a diet questionnaire in1997. All of the study participants were tracked until death (as verified by Swedish health records) or until Dec. 31, 2010.

The results: Among the women, 17,252 suffered some type of fracture, including 4,259 who had a hip fracture. Drinking milk did not appear to reduce the risk; compared with women who drank less than one glass of milk per day, women who drank at least three glasses of milk per day were 16% more likely to have any fracture and 60% more likely to have a hip fracture.

In addition, the researchers calculated that the avid milk-drinkers were 93% more likely than their counterparts to die during the course of the study. Those who drank at least three glass of milk were 90% more likely to die of cardiovascular disease and 44% more likely to die of cancer compared with women who drank less than one glass of milk per day. Visit the Los Angeles Times for the study.

 

Screen all infants, children and teens to help prevent sudden cardiac death, says CHOP cardiology expert

While sudden cardiac death is undeniably devastating to a patient's family, friends and often to whole communities, cardiology experts disagree on whether to screen all U.S. children for underlying heart problems that put them at risk for a sudden cardiac arrest (SCA). A person suffering a SCA requires immediate interventions to survive.

A diverse group of uncommon congenital heart defects and genetic conditions may put a child in danger of SCA, and at least two-thirds of these defects and conditions can be identified by an electrocardiogram (ECG), the test that analyzes the heart's electrical function. Much of the current debate centers on the practicalities and cost of universal ECG screening.

Two clinicians offer opposing commentaries on the controversy in the August 19 issue of Circulation, the journal of the American Heart Association.

Victoria L. Vetter, M.D., MPH,  a pediatric cardiologist and medical director of Youth Heart Watch in the Cardiac Center of The Children's Hospital of Philadelphia, strongly advocates using ECGs to screen all newborns, children and teenagers in primary care facilities or in clinic or community settings. "Many of the conditions responsible for sudden cardiac arrest and death are subtle and not evident as they are genetically based and are silent until a sudden arrest occurs," said Vetter, "To prevent SCD, a predisposing disease condition must be identified and early intervention provided."

These medical interventions for high-risk individuals include medications, lifestyle modifications, and use of implantable defibrillators in a small minority of those affected.

Opponents of universal screening argue that it would be impossible to train sufficient clinicians to read the EGG results and that the test is cost-prohibitive. In the accompanying article in Circulation, Richard A. Friedman, M.D., MBA, of Cohen Children's Medical Center in Hyde Park, NY, contends that devoting scarce resources to a very rare condition using an inexact mass screening test costing billions of dollars is an unsound public policy.

Vetter responds that people can be trained to administer and interpret the screening ECG and that the cost per test is nominal. Furthermore, she says, gaps in evidence about the utility of ECGs for screening should be addressed by further research, rather than dismissing its potential value.

Currently, cardiac screening is required in most states only for high school athletes prior to participating in school sports, but does not include an ECG. However, says Vetter, screening only high school athletes misses almost 48 million students who don't participate in organized high school team sports or who are younger than 14 years of age. The failure to use an ECG decreases the number of true abnormalities identified.  "Activity increases the risk of SCA, and whether in an organized sport or regular play, activity is a constant in children and teenagers," she added.

For more information, visit PRNewswire.

 

NIH-led study explores prevention of heart disease in HIV-infected people

The National Institutes of Health has launched a clinical trial to assess the effects of aspirin and cholesterol-lowering drugs, or statins, on preventing cardiovascular disease in people with long-term HIV infections. This group, which includes people on antiretroviral therapy (ART) as well as “elite controllers” who can limit the virus without ART, have a higher risk of developing heart disease and stroke compared to the general population. The study is funded by NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

“With the remarkable success of antiretroviral therapy, people living with HIV have a near-normal life expectancy,” said NIAID Director Anthony S. Fauci, M.D. “However, as this population ages, non-infectious complications such as cardiovascular disease begin to arise. We need to study the effects on the immune system of drugs normally prescribed for these conditions to ensure that they are beneficial for HIV-infected individuals.”

Researchers have long speculated that the enhanced risk of heart disease and stroke in people with long-term controlled HIV infections is associated with drug toxicity, immune defects and chronic inflammation. This study will specifically examine the role of chronic inflammation and allow researchers to observe how drug-related changes influence the levels of virus.

“Elite controllers and people on ART have elevated levels of clotting factors and blood markers that indicate inflammation and an active immune response,” said Irini Sereti, M.D., chief of the HIV Pathogenesis Unit in the NIAID Laboratory of Immunoregulation, which leads the clinical trial. “Over time, these factors likely contribute to an enhanced risk of cardiovascular disease, so if we can lower the levels of these factors with aspirin or statins, then maybe we can lower the risk of disease, too.”

The study, which is currently recruiting, will enroll elite controllers and people on ART who have not taken aspirin or statins during the past six months. The participants will be monitored for three months to establish baseline levels of clotting and inflammatory agents in their blood. Afterward, participants will be assigned randomly to either a regimen of aspirin or atorvastatin for nine months. The researchers will monitor clotting and inflammatory markers from blood samples and use MRI scans to measure the thickness of blood vessels in the neck.

For more information, visit ClinicalTrials.gov using the identifier NCT02081638.

 

New study reveals how quickly viruses contaminate buildings

Researchers at the University of Arizona, Tucson, recently revealed the results of a new study on viral contamination, presenting their findings at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in September. In response to the study, Clearstream, LLC, a diversified provider of environmentally friendly antimicrobial products and services, proposes proactive, technologically advanced measures to kill germs and prevent microbial transmission.

To determine the speed and extent of virus contamination in health care facilities, office buildings and hotels, the University of Arizona research team examined the transmission of bacteriophage MS-2 – a harmless tracer virus that is similar to the human norovirus in terms of its shape, size and resistance to disinfectants. The researchers applied the bacteriophage to one or two commonly touched surfaces, such as a doorknob or tabletop, at the beginning of the day. Then at various intervals throughout the day, they sampled dozens of surfaces (including light switches, countertops, handles, phones and computer equipment) to see if the virus was present. Their findings showed that within two to four hours, the virus had contaminated 40 percent to 60 percent of the sampled surfaces.

A second phase of the study examined the effectiveness of disinfectants in preventing transmission of the virus. “The results show that viral contamination of [surfaces] in facilities occurs quickly, and that a simple intervention can greatly help to reduce exposure to viruses,” reported researcher Charles P. Gerba of the University of Arizona.

The scientists recommended using a disinfectant registered by the Environmental Protection Agency (EPA) in combination with hand hygiene to prevent the spread of viruses. While the study specifically examined the use of disinfecting wipes containing quaternary ammonium compounds (QUAT), organizations can choose from a range of EPA-registered disinfectants and antimicrobial surface treatments – including Clearstream mPact products and services – to combat the spread of viruses.

Clearstream offers an array of products together with the mPact line of antimicrobial products and services including select product technologies that are approved by the EPA and by the Food and Drug Administration (FDA). They are formulated to reduce the risk of cross-contamination from a variety of sources, including an extensive and growing compendium of viruses, bacteria, mold, mildew, fungi, algae and yeast. There are two key steps in the mPact antimicrobial system – first, clean and disinfect with a biocide and second, treat targeted substrates with a long term (bound) static antimicrobial surface protection technology.

Clearstream’s first step begins with their mPerial detergent/disinfectant. mPerial disinfects and sanitizes surfaces to eliminate a broad spectrum of bacteria, fungi and viruses. It is proven effective against many viruses including, but not limited to, the norovirus (Norwalk virus), HIV-1, and bacteria such as E-coli, Salmonella, and Methicillin Resistant Staphylococcus Aureus (MRSA).

The second step, mPale Antimicrobial with ÆGIS Microbe Shield, is a surface-protection technology that renders offending microbes inactive without chemical poisons. Its unique design allows the formula to bond with virtually every porous, non-porous, organic or inorganic surface, providing non-toxic, non-leaching, long-term protection that will not persist in the environment.

Clearstream is currently in contact with the UN, the World Health Organization, Doctors Without Borders, US AID, the US Military, and Samaritans Purse in an effort to help reduce the suffering from the Ebola Virus in West Africa.

For more information, visit http://www.thinkclearstream.com/

 

 

Still time to nominate your CEO: Is your CEO a SURE winner?

As the healthcare industry debates whether hospital or health system CEOs really know and care about the supply chain, Healthcare Purchasing News readers know the truth: A small, but blossoming group of them do.

In fact, HPN has profiled nearly three dozen of them during the last decade.

Under a reform-minded healthcare industry, supply chain-minded CEOs are emerging as integral leaders and supporters of their organizations’ long-term success.

This motivated HPN to launch its annual search for "supply chain-focused CEOs” 10 years ago. We identify and profile supply chain-enlightened men and women to share their insights with you. Since 2005, you’ve helped us do that. To date, we’ve featured of 32 of them. Visit the HPN Hall of Fame to read their stories.

We’re now issuing another open call to nominate noteworthy hospital presidents/CEOs for HPN’s 2015 "S.U.R.E. Award for Supply Chain-Focused CEOs" to recognize chief executives who support, understand, recognize and empower the supply chain department to achieve bottom-line savings and top-line revenue.

You can help by recommending worthy candidates for recognition in our January 2015 edition. Just e-mail us the reasons how and why your CEO deserves the spotlight with no more than a couple of paragraphs for each of the four S.U.R.E. categories listed above that comprise the "SURE" acronym. Please describe how and why he or she supports, understands, recognizes and empowers the materials management department and its top executives.

For your nomination to qualify, please be sure to comply with the following rules:

1. Any nomination must be original and exclusive to HPN and not have been submitted – either original or edited – to any other publication or online media outlet currently or within the previous year.

2. GPO and distributor support is commendable, but we’re looking for internally- driven details beyond GPO- and distributor-driven contributions, including outsourcing operations to a GPO or distributor.

3. Any nominated executive (or nominator) must be willing to share relevant basic financial details with our readers – specifically annual revenues, annual expenses and annual purchasing volume.

4. Only administrators/CEOs are eligible for consideration – not COOs or executive/senior vice presidents.

Help us share the stories of these remarkable CEOs in our January 2015 edition so that the industry may learn from them and be inspired.

E-mail us your nominations by Friday, November 7, to editor@hpnonline.com.