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March 22, 2016
FDA proposes ban on most powdered medical gloves
The U.S. Food and Drug Administration has announced a proposal to ban most powdered gloves in the United States. While use of these gloves is
decreasing, they pose an unreasonable and substantial risk of illness or injury to healthcare providers, patients and other individuals who are
exposed to them, which cannot be corrected through new or updated labeling.
The proposed ban applies to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s
glove.
Powder is sometimes added to gloves to help make it easier to put them on and take them off; however, powdered gloves are dangerous for a
variety of reasons. In particular, aerosolized glove powder on natural rubber latex gloves, but not on synthetic powdered gloves, can carry proteins
that may cause respiratory allergic reactions.
Although powdered synthetic gloves do not present the risk of allergic reactions, these devices are associated with an extensive list of potentially
serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions, which are bands of fibrous scar
tissue that form between internal organs and tissues. These side effects have been attributed to the use of glove powder with all types of gloves.
As these risks cannot be corrected through new or updated labeling, the FDA is moving forward with the proposal to ban these products, which – if
finalized – would ultimately remove them from the marketplace completely.
In making the determination that these products are dangerous and present an unreasonable and substantial risk, the FDA considered all available
evidence, which included a thorough review of the available scientific literature and comments received on a February 2011 Federal Register Notice.
In addition, given the critical role medical gloves play in protecting patients and healthcare providers, the FDA also conducted an economic analysis
that showed a powdered glove ban would not cause a glove shortage and the economic impact of a ban would not be significant.
The proposed rule is available online at www.regulations.gov for public comment for 90 days.
Visit the FDA for the announcement.
New GHX supply chain product data report reveals continued growth in key healthcare segments in 2015
Global Healthcare Exchange, LLC (GHX) released fourth quarter 2015 data on distributed sales in both Medical Surgical (med-surg) and Clinical
Laboratory (clin-lab) product segments in healthcare.
The new GHX Market Intelligence “By the Numbers” quarterly report reported that the med-surg segment grew 4.4 percent in 2015 to $34.8B in
volume and 4.7 percent growth to $9.1B in the fourth quarter compared to fourth quarter 2014 ($8.7B). Clin-lab decreased 1 percent to $1.92B in the
fourth quarter compared to results in fourth quarter 2014 ($1.94B), but overall experienced 7.0 percent growth in 2015 to $7.5B in volume.
The newly released GHX Market Intelligence quarterly market reports are based on data from the top 20 U.S. healthcare distributors, representing
75 percent of all distributed healthcare sales in the United States. This represents $40B+ invoice dollars and 100M invoice lines of distributed sales
for medical surgical and clinical laboratory products and supplies annually.
The complete fourth quarter 2015 Clinical Laboratory Segment and Medical Surgical Segment reports are available at GHX Market Intelligence.
For more information, visit GHX.
HSCA applauds FDA for authorizing expedited review of new generic drug applications for ‘sole source’ products
Healthcare Supply Chain Association (HSCA) President and CEO Todd Ebert, R.Ph., released the following statement about the U.S. Food and
Drug Administration’s (FDA) decision to begin prioritizing abbreviated new drug applications (ANDAs) for generic drugs with only one manufacturer,
sometimes known as “sole source” products:
“We applaud the FDA for taking this important first step to expand patient access to critical generic medications. Expediting the review and approval
process for generic drugs with only one manufacturer will help increase competition in the market, mitigate generic drug price spikes, and alleviate
future drug shortages.
“The Healthcare Supply Chain Association and our member GPOs have a unique line of sight into the causes of generic price spikes, and we are
committed to reducing costs and increasing competition and innovation in the market. We have worked with Congress, FDA, and industry
stakeholders to adopt practical solutions, including review prioritization, to help address generic price spikes.
“While the FDA decision to authorize expedited review of sole-source product applications will help foster competition in the generic drug market,
there is more to be done to ensure generic medications are accessible and affordable to healthcare providers and patients who rely on them. We
encourage Congress and FDA to prioritize review of generic drugs with two or fewer manufacturers, or where a price spike has already occurred,
particularly in the generic injectable market. We look forward to continuing to work with bipartisan leaders from the Senate HELP and Special Aging
Committees, as well as the FDA, on other solutions to generic drug access.”
Visit HSCA for the release.
Accuracy concerns on testing device for blood-thinning drug
Dr. Gary Goldstein, a Florida internist, knew something was wrong with a blood-testing device in his office when, all of a sudden, it began giving out
odd results. The device, an INRatio monitor by Alere, is crucial to helping doctors manage patients on warfarin, a blood-thinning drug. When he
checked the INRatio’s results against those from an outside laboratory and found they did not match, he got worried and called Alere. Then, he said,
after sensing a lack of interest from the company, he filed a report about the event with the Food and Drug Administration.
Dr. Goldstein was not alone. Since the INRatio and a later model, the INRatio2, were cleared for use in 2002, the FDA has received more than 9,000
reports of malfunctions with the products, and more than 1,400 reports of injuries, according to an analysis in December by the Public Citizen Health
Research Group, a consumer organization. Reports of injuries associated with the INRatio devices are far higher than similar products on the
market, a review of FDA records shows.
The device’s problems also led last fall to a new analysis of a large drug trial that relied on the INRatio to monitor patients.
These reports, in addition to a series of FDA warning letters and recalls, have raised questions among doctors and public health experts about why
the device remains on the market. Neither the FDA nor Alere have yet said publicly that the device appears to malfunction.
The INRatio and other similar devices measure the blood’s clotting ability and have been welcomed by many doctors and their patients who take the
drug warfarin, a blood-thinning drug that requires careful monitoring. Instead of sending blood samples to an outside laboratory, doctors can learn
with the prick of a finger if warfarin is working properly.
The stakes are high: Too little warfarin and patients could suffer a stroke, but too much and they could bleed to death.
Public records show that problems began to arise with the INRatio only a few years after it went on the market. In 2005 and 2006, the FDA issued
two warning letters to HemoSense, the device’s maker at the time. The letters argued that the company had failed to act on complaints that the
devices were giving erroneous results.
The FDA was receiving thousands of reports of malfunctions and injuries. The INRatio was associated with 1,451 injury reports, according to an
analysis of adverse-event reports to the FDA By contrast, CoaguChek, the market leader that is made by Roche, logged 95 injury reports over the
same period.
Visit the New York Times for the story.
Income, gender and payer status strongly impact readmissions, study finds
A new study published in the March/April edition of the Journal for Healthcare Quality, evaluated readmission rates from approximately 15 million
inpatient, all-payer discharges across more than 600 diverse hospitals. The study found that factors such as income, gender, age and payer status
all showed a strong statistical significance in predicting readmissions within 30 days.
Specifically, it suggests that the odds for heart attack patients being readmitted were: 17% higher for women than men; and 24% higher for Medicare
patients versus those with commercial insurance.
In addition, the lower the income and older an individual, the more likely they were to be readmitted. These findings suggest that readmission rates
are closely linked to a patient’s socioeconomic status.
The enactment of the Affordable Care Act led to reduced payments for hospitals with readmission rates exceeding an expected level. However, the
Centers for Medicaid & Medicare Services’s (CMS’s) readmission penalty policy does not account for the major socioeconomic factors this research
demonstrates are contributing to readmissions.
A separate Premier analysis of federal FY 2015 readmissions program results on the association of the readmission reductions on hospital cohorts
found that disproportionate share hospitals (DSH) hospitals are less likely to avoid a readmissions penalty than non-DSH hospitals. The analysis
controlled for other hospital characteristics, including teaching status, urban location, and size of facility.
Premier’s study also identified the top five disease states driving risk adjusted readmission rates:
1.
Heart failure (20%)
2.
Chronic obstructive pulmonary disease (18%)
3.
Renal failure (17%)
4.
Sepsis (17%)
5.
Pneumonia (12%)
Furthermore, chronic and comorbid conditions were significant predictors for a readmission. Heart attack patients with diabetes or renal failure had a
42% higher chance of readmission. Discharge status also plays a key role, with heart attack patients discharged to a nursing home having a 43%
higher chance of a readmission when compared to those that are sent home.
Variables from the research to risk adjust for readmissions are embedded into Premier quality analytics and services, enabling providers to view their
individual hospital results and pinpoint potential opportunity areas. The ability for providers to predict the financial impact of federal payment
programs based on clinical outcomes is essential. Establishing an effective quality cycle management strategy can help providers generate change.
The study is available at the Journal of Healthcare Quality.
Acetaminophen won't help arthritis pain, study finds
Acetaminophen, commonly known as Tylenol in the United States, isn't an effective choice for relieving osteoarthritis pain in the hip or knee, or for
improving joint function, a new study finds.
Although the drug rated slightly better than placebo in studies, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) or
diclofenac are better choices for short-term pain relief, the researchers said.
"Regardless of dose, the prescription drug diclofenac is the most effective drug among painkillers in terms of improving pain and function in
osteoarthritis," said lead researcher Dr. Sven Trelle. He's co-director of clinical trials at the University of Bern in Switzerland.
The new report was published in The Lancet.
The current research included information from 74 trials published included more than 58,000 patients. The studies compared how well various
doses of acetaminophen and seven different NSAIDs relieved arthritis pain.
The researchers found that acetaminophen was slightly better than an inactive placebo. But they added that taken by itself, acetaminophen has no
role in treating osteoarthritis, regardless of dose.
The maximum daily dose of diclofenac -- a prescription pain reliever -- was the most effective treatment for pain and disability, the new study
showed. The researchers also found diclofenac was better than the maximum doses of NSAIDs, including ibuprofen, naproxen (Aleve) and celecoxib
(Celebrex).
In addition to not helping with pain, one expert pointed out that acetaminophen can also be dangerous. The new report was published in The Lancet.
Visit NIH for the report.
UnitedHealth unit signs deal with Walgreens to grow in-store prescriptions
OptumRx, the pharmacy benefit manager of UnitedHealth Group Inc., said that it had signed an agreement with Walgreens Boots Alliance that is the
first step in a strategic relationship with the pharmacy chain.
Walgreens, which has 8,200 pharmacies, will fill 90-day prescriptions for OptumRx customers at its mail delivery prices, starting Jan. 1, 2017,
OptumRx said. Mail delivery prices are typically lower, sometimes by as much as one-third, than what pharmacies charge in stores.
The model puts OptumRx on more equal footing with its two largest competitors, CVS Health — which is made up of pharmacies and a pharmacy
benefit manager — and St. Louis County-based Express Scripts Holding Corp., which has a similar pharmacy program, one Wall Street analyst said.
OptumRx Chief Executive Mark Thierer said in an interview that he expected the relationship to extend into using OptumRx data as well as the
bigger Optum division’s care delivery assets, urgent care and behavioral health services.
Visit St. Louis Today for the article.
How Medicare drug plans hope to follow private sector lead
Aetna and Cigna inked deals in early February with drugmaker Novartis that offer the insurers rebates tied to how well a pricey new heart failure drug
works to cut hospitalizations and deaths. If the $4,500-a-year drug meets targets, the rebate goes down. Doesn’t work so well? The insurers get a
bigger payment.
In another approach, pharmacy benefit firm Express Scripts this year began paying drugmakers a special negotiated rate for some cancer drugs —
to reward the use of the medicines for the specific cancers for which they have the most demonstrated effectiveness.
Those are examples of the kind of private sector efforts the Obama administration hopes to borrow as it tests a handful of payment strategies in
Medicare. The results could lead to a profound shift in how the Centers for Medicare & Medicaid Services spends $20 billion a year for drugs under
Part B, which are those given in doctors’ offices and hospital outpatient centers. Many cancer treatments are provided that way, as are some
treatments for rheumatoid arthritis, macular degeneration and other medical conditions.
Under a proposed rule, different methods would be tried in selected geographic areas over a five-year test period. Some of these experiments would
begin this year, with others added in 2017. The proposal faces two months of public comment.
Dubbed “value-based pricing,” such largely unproven ideas are the latest tactics being tried to slow growth in prescription drug spending amid rising
public alarm about drug prices.
Here are four concepts the government is investigating:
1) Cut drug reimbursements for doctors and outpatient hospital centers.
Many drugs covered under Medicare Part B are first purchased by a physician office or outpatient center, then dispensed to patients. Once billed,
Medicare pays the healthcare provider the average sales price plus 6 percent for costs associated with the purchase and storage of the medications.
For example, a doctor or clinic would receive an add-on fee of $6 when a $100 drug is purchased, or $300 for a $5,000 treatment. In the private
sector, that practice — called “buy and bill” — is being reduced. Instead, specialty pharmacies — often connected with pharmacy benefit
management companies — purchase the drugs, then deliver them to doctors’ offices. The management companies, paid by insurers for their
services, negotiate prices with drugmakers.
2) Level payments.
In the private sector, insurers sometimes set benchmarks, often called “reference prices,” for services patients generally can shop around for, such
as a hip or knee replacement or colonoscopies. The California Public Employees Retirement System insurance plans, for example, saw that the cost
of joint replacements varied widely among hospitals, then set a cap of $30,000 for a joint replacement. If patients chose hospitals that charged more,
they had to pay the difference. The move was credited with saving millions in its first two years, and most of it came from the more-expensive
hospitals lowering prices.
Medicare plans to apply this model to its payments to doctors and outpatient centers for some medicines that are all in a similar class of drugs. For
example, it might select one price for all injectable treatments for knee pain caused by osteoarthritis. That rate would be paid even when centers use
higher-cost products.
3) Tie payments to effectiveness.
Under Medicare’s proposal, drugmakers would agree to offer rebates that link the final price of their products to results achieved by patients. Just
what those results would be — improved health, fewer hospitalizations or some other measure — would be spelled out up front. There are more than
300 such “risk-sharing” agreements currently in place, according to a University of Washington School of Pharmacy database.
4) Cut patients’ out-of-pocket costs.
To get patients to take important medications, such as statins after a heart attack, some insurers, including Aetna, have reduced or eliminated
patient copayments for specific treatments. Other insurers have experimented with similar incentives for other conditions, such as asthma or
diabetes. They generally found that reduced payments made patients more likely to continue taking their medications.
In Medicare Part B, patients are responsible for 20 percent of the cost of their drugs — unless they have a supplemental insurance policy that covers
such copayments. Medicare proposes to cut or eliminate those payments for certain drugs considered most effective or valuable.
Medicare is soliciting suggestions in its public comment phase as to which drugs might be the best candidates for the test.
Visit Kaiser Health for the report.