January 5, 2011
CMS program identifies $371.5 million in improper Medicare payments in three states
The Centers for Medicare & Medicaid Services (CMS) announced that $371.5 million in improper Medicare payments has been collected
from or repaid to health care providers and suppliers as part of a demonstration program using recovery audit contractors (RACs) in
California, Florida and New York in 2007. Nearly $440 million has been collected since the program began in 2005.
The RAC demonstration program, created by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), is
designed to find and correct improper Medicare payments paid to health care providers participating in fee-for-service Medicare. Medicare
processes more than 1.2 billion Medicare claims annually, submitted by more than one million health care providers, including hospitals,
skilled nursing facilities, physicians and medical equipment suppliers. Errors in claims submitted by these health care providers for services
provided to Medicare beneficiaries can account for billions of dollars in improper payments each year.
Approximately 96 percent of the improper payments identified by the RACs in 2007 were overpayments collected from health care providers;
the remaining 4 percent were underpayments repaid to health care providers. The types of inadvertent errors leading to improper payments,
found by the RACs, include the following examples: A health care provider bills Medicare for conducting three colonoscopies on the same
patient on the same day; Payments are made for services that are coded incorrectly, for example Medicare is billed for a certain procedure
but the medical record shows that a different procedure was actually provided; A health care provider is paid twice because the provider
submitted duplicate claims; or A claim is paid using an outdated fee schedule.
The RAC demonstration is a key tool CMS uses to assure payments to health care providers are accurate and proper and that the number of
errors in Medicare claims continues to decline. Medicare calculates the error rate, the amount of incorrect claims that are submitted by
healthcare providers, as part of the Comprehensive Error Rate Testing (CERT) program. Since CMS began the program, the error rate
dropped from 14.2 percent in 1996 to 3.9 percent in 2007. This decline in improper payments reflects CMS‟ efforts to target erroneous claims
processing, inaccurate billing and errors by health care providers. For more information on the RAC program and to view the FY 2007 Status
Document, visit: http://www.cms.hhs.gov/RAC
Blood thinner might be tied to more deaths
Amid indications that more people may have died or been harmed after being given a brand of the blood thinner heparin, federal drug
regulators said Thursday that they had found “potential deficiencies” at a Chinese plant that supplied much of the active ingredient for the
Baxter International, which makes the brand of heparin associated with the problems, and buys supplies from the Chinese plant, announced
that it was expanding a recall to include virtually all its heparin products. Though Baxter produces much of the heparin used in the United
States, regulators said the other major supplier would be able to meet the demand.
The Food and Drug Administration said the number of deaths possibly associated with the drug, made from pig intestines, had risen to 21
from 4. But it cautioned that many of those patients were already seriously ill and that the drug might not have caused their deaths.
The FDA emphasized that it had yet to identify the root cause of the problem, and that it had not concluded that the Chinese plant was
responsible. The agency also said it was investigating two Chinese wholesalers, also called consolidators, that supplied crude heparin to the
Chinese plant, Changzhou SPL, as well as those that sold raw ingredients to the consolidators.
The New York Times reported Thursday that at least one of the consolidators received supplies from small, unregulated family workshops
that scraped mucous membrane from pig intestines and cooked it, eventually producing a dry substance known as crude heparin.
Scientific Protein Laboratories, a Wisconsin company that is the majority owner of the Chinese plant, issued a statement Thursday saying
the FDA‟s finding did not represent its final determination as to whether the plant complied with federal regulatory rules. S.P.L., the statement
said, is committed to finding the root cause of the adverse reactions.
The FDA admitted this month that it had violated its own policy by failing to inspect SPL, located west of Shanghai, before the factory began
shipping the heparin ingredient to Baxter in 2004. China‟s drug agency also did not inspect the plant.
Last week, the FDA sent inspectors to the plant. Among the potential problems they found was a failure to properly follow the steps for
identifying impurities and deficiencies related to manufacturing equipment. According to a redacted inspection report released by the agency,
the SPL plant appeared to have made at least some heparin with “material from an unacceptable workshop vendor.” The vendor was not
Erin Gardiner, a spokeswoman for Baxter, said the company was reviewing the FDA‟s report. “We expect S.P.L. to respond to those
observations thoroughly and promptly,” Gardiner said. “The observations are important and need to be addressed promptly but they are not
necessarily indicative of the root cause.”
The FDA‟s concern about heparin had previously centered on Baxter‟s multidose vials, but on Thursday Baxter agreed to voluntarily recall
not only the multi-dose vials but also single-dose vials and a diluted solution of heparin used to keep blood clots from forming in intravenous
lines. There have been no adverse reaction reports involving the latter product, called Hep-Lock heparin flush products. The only heparin
products made by Baxter that are still on the market are premixed bags of intravenous solutions, the FDA said.
The FDA estimates that more than one million multidose vials of heparin are sold per month in the United States, about half of which are
manufactured and distributed by Baxter. At first, the agency said it believed that four people had died after allergic reactions to the drug. On
Thursday, officials said as many as 17 more people may have died, but they described the links to heparin as more tenuous. The adverse
reactions have included decreased or low blood pressure and fast heart rate. Not all of them are known to involve Baxter products, but the
drug agency did not issue warnings involving any other products. (NY Times)
FDA licenses new hemophilia treatment
The U.S. Food and Drug Administration has licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects
approximately 15,000 individuals, almost exclusively males, in the United States. The new treatment, called Xyntha Antihemophilic Factor
(Recombinant) Plasma/Albumin Free, is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Factor
VIII, known as an anti-hemophilic factor, is missing or decreased in patients with hemophilia A.
Xyntha is licensed for the control and prevention of bleeding, which can occur spontaneously or after an accident or injury in patients
diagnosed with hemophilia A. Xyntha is also licensed to help prevent surgical bleeding in this patient population.
Xyntha is manufactured using recombinant DNA techniques that enable scientists to create new DNA strands with specific traits, such as the
capacity to produce a specific protein.
To make Xyntha, genes from Chinese Hamster Ovary cells (CHO) are modified to produce factor VIII. These CHO cells are free from known
infectious agents, and Xyntha undergoes an additional process of viral inactivation. Also, the culture in which the cells are grown is free of
any human or animal material.
In clinical trials, Xyntha was shown to be effective at preventing or controlling bleeding, including preventing bleeding in surgery, for
hemophilia A patients. Generally, the most frequently reported adverse reaction was headache. For those receiving Xyntha to prevent
bleeding in surgery, the most frequently reported adverse reaction was fever. Most adverse reactions reported in either study were
considered mild or moderate in severity. Xyntha is manufactured by Wyeth Pharmaceuticals Inc., located in Philadelphia.
New York strengthens emergency preparedness with Cardinal Health ventilators
Cardinal Health, a global provider of products and services that improve the safety and productivity of health care, announced an order by
the New York Department of Health, for its public health preparedness program. As part of an expanding statewide plan to maintain
emergency response readiness, New York has purchased more than 1,850 portable ventilators from Cardinal Health over the past two
Cardinal Health has already shipped 850 of its Laptop Ventilators Series 1200 (LTVs) in „GoPack‟ configuration to New York state. GoPacks
contain ventilators, accessories, tubing and other supplies to immediately deploy for use in emergency situations. GoPacks improve
readiness and simplify warehouse storage.
Cardinal Health is also working with other states to upgrade their emergency operations. Last year, the company supplied 2,400 ventilators
to California for its emergency preparedness initiatives and assisted the Governor‟s Office of Emergency Services in responding to wildfires
in southern California. Today, more than 5,500 LTVs are in state emergency care programs.
The LTV 1200 Series ventilator is a portable, light-weight, high-acuity ventilator that is optimally designed for emergency and disaster
situations. Among its numerous features, the LTV Series Ventilator offers an intuitive "in-the-field" user interface, individualized air pressure
and volume controls settings and internal oxygen blending. In addition, it can be powered from a variety of sources, including an internal and
external battery and an automobile auxiliary power outlet.
USDA rejects 'Downer' cow ban
Agriculture Secretary Ed Schafer told Congress yesterday that he would not endorse an outright ban on "downer" cows entering the food
supply or back stiffer penalties for regulatory violations by meat-processing plants in the wake of the largest beef recall in the nation's history.
Appearing at a Senate Appropriations subcommittee hearing, Schafer said the department is investigating why it missed the inhumane
treatment of cattle at the Westland/Hallmark Meat Co. in Chino, CA, including workers administering electric shocks and high-intensity water
sprays to downer cows, those too sick or weak to stand without assistance.
The secretary announced interim steps such as more random inspections of slaughterhouses and more frequent unannounced audits of the
nearly two dozen plants that process meat for federal school lunch programs. But he deflected calls from Sen. Herb Kohl (D-Wis.), the
subcommittee chairman, for the government to ban all downer cows from the food supply, increase penalties for violators and require
installation of 24-hour surveillance cameras in processing plants.
"The penalties are strong and swift, as we have shown," Schafer said. "Financially, I don't see how this company can survive. People need to
be responsible and, from USDA's standpoint, they will be held responsible. . . . They broke the rules. That does not mean the rules are
wrong. I believe the rules are adequate."
The hearing came 11 days after Agriculture officials ordered the recall of 143 million pounds of beef processed by Westland/Hallmark,
including 37 million pounds that had gone to school lunch and other public nutrition programs. No illnesses have been linked to the recalled
J. Patrick Boyle, president of the American Meat Institute, a trade association, called the Westland/Hallmark plant "an anomaly, an extreme
circumstance." Government regulations prohibit slaughtering cattle for food if the animals cannot stand or walk on their own. An inspecting
veterinarian had said the Hallmark cattle were healthy enough to be used for food, but they subsequently collapsed. Federal regulations
require that such animals be reexamined by a veterinarian and slaughtered separately, but that apparently was not done, officials said. Cows
that cannot stand up are supposed to be kept out of the food supply in part because they may be infected with bovine spongiform
encephalopathy (BSE), or mad cow disease. The disease is extremely rare in the United States, but of the 15 cases documented in North
America, most in Canada, the majority have been traced to downer cattle.
The Humane Society, which believes all downers should be banned, sued the USDA this week over that policy, calling it a "dangerous
loophole." "We need a rigorous inspections program because reckless behavior by a single company can have national and global
implications," Wayne Pacelle, the group's president, told the Senate panel. "How many other crises, recalls and public scares can we tolerate
before we adopt an unambiguous policy of combating mad cow in the food supply? We need a bright line on this." (Washington Post)
Novation hosts Kimberly Clark’s hospital-acquired infection education & awareness tour bus
Today, Friday, Feb. 29, Novation, the healthcare contracting services company of VHA Inc., University HealthSystem Consortium (UHC) and
Provista, LLC, is hosting an education and awareness event. Employees from Novation and local medical organizations will learn about
hospital-acquired infections (HAIs), including methicillin-resistant Staphyloccus aureus (MRSA), what they are, how they spread and how to
combat them. Participants will climb on board Kimberly Clark‟s (KC) HAI education and awareness tour bus and experience interactive
technology, informal instruction and Web-based workstations. The all-day awareness and education event supports Novation‟s ongoing
commitment to provide member health care organizations with comprehensive information and access to leading infection control products
and solutions. At the event, visitors will receive information about HAIs. In addition, local medical personnel will attend three free educational
sessions regarding hospital-acquired infections. The Kimberly Clark bus will be touring locations in the US offering HAI education at
numerous sites including the AORN Congress in March.
Cosmetic products may cause fatal infections in critically ill patients
Healthy consumers can handle the low levels of bacteria occasionally found in cosmetics. But for severely ill patients these bacteria may
trigger life-threatening infections, as patients in the intensive care unit at one Barcelona hospital discovered after using contaminated body
moisturizer. The Burkholderia cepacia bacteria outbreak is detailed in the open access journal, Critical Care. Five patients suffered from
infection including bacteremia, lower respiratory tract infection and urinary tract infection associated with the bacterial outbreak in August
2006. Skin care products sold in the European Union are not required to be sterile, but there are limits to the amount and type of bacteria
that are permitted.
The Hospital Universitari del Mar, Universitat Autònoma de Barcelona‟s routine infection control surveillance pinpointed the unwelcome
bacteria in five patients‟ biological samples. Researchers tested a number of environmental samples, and discovered that moisturizing body
milk used in the patients‟ care was a B. cepacia reservoir. Tests on sealed containers of the moisturizer confirmed that the bacteria had not
invaded the product after it had been opened, but that it was contaminated during manufacturing, transportation or storage.
“This outbreak of nosocomial infection caused by B. cepacia in five severely ill patients supports a strong recommendation against the use
cosmetic products for which there is no guarantee of sterilization during the manufacturing process,” says study author Francisco Álvarez-
Lerma. B. cepacia is a group or “complex” of bacteria that can be found in soil and water. They have a high resistance to numerous
antimicrobials and antiseptics and are characterised by the capacity to survive in a large variety of hospital microenvironments. These bugs
pose little medical risk to healthy people. However, those with weakened immune systems or chronic lung diseases, particularly cystic
fibrosis, may be more susceptible to B. cepacia infection. B cepacia is a known cause of hospital infections.
Cerner Corporation and Hill-Rom partner to connect intelligent hospital beds to the electronic medical record
Cerner Corporation and Hill-Rom, an operating company of Hillenbrand Industries, announced that they have formed a strategic relationship
to integrate their technologies to improve and coordinate healthcare delivery, featuring Hill-Rom intelligent hospital beds that communicate
directly with the Cerner Millennium healthcare computing platform.
Efforts in the first stage of the partnership are focusing on the integration of Hill-Rom‟s intelligent bed systems, such as VersaCare and
TotalCare, with the Cerner Millennium system. Utilizing the Cerner CareAware global device connectivity architecture, the intelligent bed is
able to feed data, including patient weight, bed rail position and head elevation, to the Cerner Millennium system. Access to real-time
information and automation of labor-intensive tasks not only furthers safety initiatives, but also allows clinicians to spend more time with
In addition, the relationship is expected to expand to integrate the Cerner CareAware architecture with other Hill-Rom IT solutions such as
nurse call, asset management and NaviCare Patient Flow. Likely integrations include Hill-Rom‟s asset management software and the Cerner
CareAware architecture to provide an enhanced solution to a hospital‟s asset tracking needs, including asset tracking, utilization
management and reduction of cross-contamination events. Integration with NaviCare Patient Flow and Nurse Call would complement the
Cerner Smart Room, Cerner‟s solution to improve patient care and clinician efficiency through advanced technology, by providing clients with
enhanced communication, real-time patient tracking and intelligent task management for clinical operations.
In 2007, Cerner launched its Medical Device Certification Program, designed to facilitate the integration of information generated by medical
devices into the EMR. A first of its kind in the industry, this program allows Cerner to work directly with medical device companies like Hill-
Rom to develop drivers to seamlessly connect medical devices to the EMR.
Lexmark showcases how smart MFPs accelerate benefits of key healthcare IT initiatives at HIMSS
Lexmark International Inc. is attending the Healthcare Information and Management Systems Society (HIMSS) conference to present
solutions and services that complement key IT initiatives such as Electronic Medical Records (EMRs) and physician order management to
quickly enhance clinician productivity and patient safety.
Lexmark will demonstrate its cost-effective document capture solutions that help healthcare facilities automatically scan documents into EMR
management systems and easily integrate with a hospital‟s existing IT infrastructure. The solutions are part of Lexmark‟s healthcare
solutions and services suite which also features:
Documents on demand replaces preprinted forms with intelligent bar coded forms to automate antiquated workflow processes prevalent in
nursing stations, helping customers bridge from a paper-based environment to digitally-enabled processes.
Lexmark Queue & View solution utilizes the power of Lexmark multifunction products (MFPs) and proven physician order management
software to eliminate time consuming, error prone faxing. An onscreen view of the order queue enables fast, accurate follow through. STAT
orders are automatically routed to the top of the queue and pertinent patient information is read directly from a barcode on the order so no
additional processing is required to index the order for the queue.
Through its Distributed Fleet Management (DFM) services, Lexmark provides healthcare enterprises with managed printing services, giving
them complete visibility and control over their distributed printing environment.
The Lexmark Clinical Assistant is a Lexmark X646dte monochrome laser MFP, pre-loaded with configurable healthcare-specific applications
to simplify clinical workflow processes with a single touch of an icon on the user-friendly Lexmark eTask touch screen, without special
training. See www.lexmark.com/healthcare
Philips aligns healthcare informatics business to simplify the flow of patient data throughout the hospital
Royal Philips Electronics announced a new structure for its Healthcare Informatics business to align its entire portfolio of clinical information
solutions including patient monitoring, enterprise and clinical image management, anesthesia information, women‟s health information, and
cardiology information systems. The realignment will allow Philips to meet the clinical workflow and information needs demanded by its
clinical customers. At the same time, this allows Philips to harmonize clinical systems with the infrastructure and integration needs required
by informatics customers.
Patient Monitoring is evolving from reactive displays of vital sign information to rich clinical decision support solutions that are predictive and
preventative. These solutions must provide value to clinical customers while seamlessly integrating to the healthcare institution‟s
infrastructure and electronic health record (EHR).
“Integrating Patient Monitoring into Healthcare Informatics enables us to find synergies between our software competencies and monitoring
solutions recently strengthened by the acquisitions of XIMIS, Emergin and VISICU,” said Oran Muduroglu, CEO, Healthcare Informatics, for
Philips Healthcare. “Philips‟ innovation in IT simplifies workflow and provides easy access to all relevant information for more informed
diagnosis and decision-making. By better managing the flow of data through the continuum of care, healthcare organizations can significantly
impact operations and focus more effort on their core business: taking care of patients.”
Artromick aligns with McKesson to enhance medication safety at the patient's bedside
Artromick, a developer of medication management and healthcare technology solutions for the long-term and acute care markets, today
announced an exclusive referral agreement with McKesson Automation, Inc., a division of McKesson, the world's largest healthcare services,
automation and information technology company. Artromick is now McKesson's vendor of choice for hospitals that need effective, easy-to-
use, point-of-care mobile computing solutions to deliver its CarePoint ConnectT software.
Offered exclusively from McKesson, CarePoint Connect fully integrates a hospital's bar-code point-of-care (BPOC) system and Pharmacy
Information System (PIS) with the AcuDose-Rx automated dispensing cabinets on a mobile medication cart, right at the patient's bedside.
This unique integration software gives nurses "anywhere/anytime" access to key clinical information; reduces dispensing time at the
medication cabinet by quickly identifying the location of each patient's medications; ensures accuracy and saves nurses time on medication
administration and clinical documentation, all of which enable more time for direct patient care.
Hospitals can choose from among Artromick's extensive line of mobile computing solutions, including its latest workstation, the new NX10
Mobile Computing Workstation. This point-of-care computing cart is a flexible, light-weight and cost-effective solution that helps hospitals
achieve their patient safety goals.
Optimal Solutions and Metro Health partner to improve patient care and satisfaction
Optimal Solutions Inc., a software engineering firm based in Wyoming, MI, announced its partnership with Metro Health. Metro Health has
implemented Optimal Solutions‟ eVideon interactive patient television system to dramatically improve the patient experience.
The introduction of the eVideon healthcare solution coincides with the opening of the newly constructed Metro Health Hospital where
eVideon performs a critical role in delivering personalized information and entertainment to patients and staff. With eVideon, patients, visitors
and staff have access to a wide variety of digital media, including digital TV, commercial-free satellite radio, DVD-quality newly-released
movies and professional development.
eVideon delivers a confidential and completely personalized patient and visitor experience. Whether in need of a hip replacement, or
undergoing care for a recent heart attack, patients will find the system is tailored to their individual medical condition, unique needs,
prescribed educational material and entertainment preferences.
“The benefits of eVideon transcend simple entertainment and education,” according to Jeff Ingle, president of Optimal Solutions. “Patients
expect more from today‟s healthcare facilities. eVideon can enhance staff productivity and increase a patient‟s feelings of independence and
control over the bedside experience, which in itself can promote a sense of wellness. eVideon also offers entertainment options similar to
what patients enjoy at home. That‟s a level of convenience that can create a strong preference among patients toward a particular healthcare
facility.” See http://www.evideon.com/.