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DAILY UPDATE

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April 16, 2014   Download print version

Hospitals sue CMS over ‘Two-Midnight’ Rule, pay cut accompanying regulation

Zebra Tech to buy Motorola Solutions' enterprise business

New centralized procurement process will cut costs and bring long-term savings to hhc

CMS proposes adoption of updated Life Safety Code

UK drug company Glaxo 'paid bribes to Polish doctors'

Covidien announces FDA 510(k) clearance for the Kangaroo Feeding Tube with IRIS Technology

Hepatitis C treatment cures over 90 percent of patients with cirrhosis

Cancer ‘miracle’ patients studied anew for disease clues


 

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Hospitals sue CMS over ‘Two-Midnight’ Rule, pay cut accompanying regulation

In two related lawsuits filed April 14, the hospital industry challenged the Department of Health and Human Services' “two-midnight” rule for inpatient admissions, which industry says imposes regulatory burdens that could compromise care for seniors.

In one complaint filed in the U.S. District Court for the District of Columbia, the American Hospital Association and other industry groups and individual hospitals challenged an August 2013 HHS policy for determining when a patient is an “inpatient” for purposes of Medicare reimbursement.

The AHA's filing said that this “new rule provides that a Medicare beneficiary is not an 'inpatient' unless the admitting physician expects that beneficiary to need care in the hospital for a period spanning two midnights.” The August 2013 rule was for fiscal year 2014 payments.

In a statement from the AHA, the plaintiffs said hospitals “take issue with the wholly arbitrary requirement that a physician must certify at the time of admission that a Medicare patient is expected to need care in the hospital for a period spanning two midnights to be considered an inpatient.”

In the statement, Rich Umbdenstock, president and chief executive officer of the AHA, said that the two-midnight rule “undermines medical judgment and disregards the level of care needed to safely treat patients.” He added, “Hospitals stand by a physician's decision on what care is appropriate for each patient. The two-midnight rule is misguided and we feel confident the court will agree.”

A separate complaint filed April 14 takes aim at a payment cut that plaintiffs said “will cost the nation's hospitals more than $200 million this year alone” (Am. Hosp. Ass'n v. Sebelius, D.D.C., No. 1:14-cv-00607 , filed4/14/14).

The complaint said that CMS claimed, “without setting forth its actuaries' reasoning or calculations--that the two-midnights rule and other related policy changes would result in a net increase in the number of inpatient hospital stays that Medicare covers under Part A.” Specifically, the CMS reduced payments by 0.2 percent across the board for beneficiary discharges occurring on or after Oct. 1, 2013, the complaint said.

The AHA said it is joined in the litigation by the Greater New York Hospital Association, the Healthcare Association of New York State, New Jersey Hospital Association and the Hospital & Healthcare Association of Pennsylvania. Individual hospital plaintiffs are Wake Forest University Baptist Medical Center, North Carolina; the Mount Sinai Hospital, New York City; hospitals that are part of Phoenix-based Banner Health; and Einstein Healthcare Network, Philadelphia. Visit BNA for the article.

 

 

Zebra Tech to buy Motorola Solutions' enterprise business

Barcode printer maker Zebra Technologies Corp said it would buy Motorola Solutions Inc's enterprise business, which makes rugged mobile computers, tablets and barcode scanners, for $3.45 billion in its biggest deal ever. The deal will allow Zebra, whose products help companies such as Amazon Inc track inventory and supply chains, to enhance its portfolio through a range of Internet-connected devices.

The business, which accounts for about a third of Motorola Solutions' total revenue, has suffered as clients delay orders and cut spending.

After the sale, Motorola Solutions will be left with its core government and public safety business. It will also retain its iDEN products portfolio, which is a part of its enterprise business.

About 4,500 Motorola Solutions' employees will join Zebra's workforce of about 2,600 as of January 25.

Zebra's rivals in its printing business include Hewlett-Packard, Epson and Lexmark, while Ubisense and AeroScout are among its competitors in the location tracking products business.

In October, Zebra launched Zatar, a Web-based software that allows companies to deploy and manage devices and sensors connected to the Internet, also called the "internet of things." Zebra acquired Hart Systems, which provides Web-based inventory management software to the retail industry, in December. (Reuters) Visit Yahoo for the story.

 

 

New centralized procurement process will cut costs and bring long-term savings to hhc

The New York City Health and Hospitals Corporation (HHC) announced the creation of a new centralized procurement system for goods and pharmaceuticals that will make purchasing more efficient and transparent, and will save HHC approximately $50 million in its first year.

HHC has combined the purchasing power of its integrated network of 11 hospitals, five long-term care facilities and dozens of community health centers to leverage better pricing for its 58,000 catalogued items -- from hospital socks and sutures to services like printing and snow removal -- that range in price from under a dollar to tens of thousands of dollars. It will also establish a limited, standardized list of products available for purchase by HHC facilities to reduce waste and duplication, while maintaining the ability to purchase high quality products preferred by clinicians.

HHC’s effort was recently recognized by the “ECRI Institute” in Pennsylvania with its “2014 Supply Chain Achievement Award,” which honors healthcare organizations that demonstrate excellence in overall supply chain management.

“A centralized supply chain management system eliminates redundancies, ensures more purchasing controls and maximizes HHC’s vast bargaining power at a time HHC faces serious budget challenges,” said Antonio D. Martin, HHC’s Executive Vice President and Chief Operating Officer. “By standardizing our methods of procurement and establishing an organized and clinically-based supply chain structure, we can support quality healthcare and control our costs.”

“Each product category, such as perioperative services, will be guided by a value analysis committee of physicians, nurses and key administrative staff who will evaluate product selections, focusing on quality, cost, service and outcomes,” said Martin. “These steps reduce waste and unnecessary variability in our purchasing practices while ensuring that clinical staff has timely access to quality products and all the supplies they need to properly care for patients.”

HHC’s new centralized purchasing system was fully operational in December. HHC expects to have 90 percent of its overall purchasing under the new system. About 40 percent of purchasing was previously done locally, based on individual facility needs. HHC’s operating budget in Fiscal Year 2013 was $6.7 billion, with annual purchases of goods and pharmaceuticals of approximately $500 million.

In Fiscal Year 2010, facing a projected $1.2 billion budget gap for Fiscal Year 2013, HHC created a plan that called for $600 million in cost containment and restructuring and $600 million in additional revenue from the City and Federal governments. Supply chain and procurement reforms were also identified as areas that could be targeted to meet a revised financial plan.

As part of the procurement initiative, a new centralized procurement office of approximately 70 purchasing agents was established at HHC, with most staff relocating from other facilities. No employees were laid off. Visit NYC for the story.

 

 

CMS proposes adoption of updated Life Safety Code

The Centers for Medicare & Medicaid Services (CMS) announced a proposed rule on the adoption of updated life safety code (LSC) that CMS would use in its ongoing work to ensure the health and safety of all patients, family and staff in every provider and supplier setting. The updated code contains new provisions that are vital to the health and safety of all patients and staff.

A key priority of CMS is to ensure that patients and staff continue to experience the highest degree of safety possible, including fire safety. CMS intends to adopt the National Fire Protection Association’s (NFPA) 2012 editions of the (LSC) and the Health Care Facilities Code (HCFC). This would reduce burden on healthcare providers, as the 2012 edition of the LSC also is aligned with the international building codes and would make compliance across codes much simpler for Medicare and Medicaid-participating facilities.

The Health Care Facilities Code contains more detailed provisions specific to healthcare and ambulatory care facilities. Adoption of this code would provide minimum requirements for the installation, inspection, testing, maintenance, performance, and safe practices of health care facility materials, equipment and appliances.

The new edition of the LSC applies to: hospitals, long term care facilities (LTC), critical access hospitals (CAHs), Programs for All Inclusive Care for the Elderly (PACE), religious non-medical healthcare institutions (RNHCIs), hospice inpatient facilities, ambulatory surgical centers (ASCs), and intermediate care facilities for individuals with intellectual disabilities (ICF-IIDs).

The proposed rule is currently on display at http://ofr.gov/inspection.aspx and will be published in the April 16,2014 Federal Register. The deadline to submit comments is June, 16, 2014. Visit here to download the pdf for the full report.

 

 

UK drug company Glaxo 'paid bribes to Polish doctors'

UK drug company GlaxoSmithKline is facing a criminal investigation in Poland for allegedly bribing doctors, BBC Panorama has discovered. Eleven doctors and a GSK regional manager have been charged over alleged corruption between 2010 and 2012. A former sales rep said doctors were paid to promote GSK's asthma drug Seretide.

The company said one employee had been disciplined and it was co-operating with investigations.

If the allegations are proved, GSK may have violated both the UK Bribery Act and the US Foreign Corrupt Practices Act. It is illegal for companies based in either country to bribe government employees abroad.

A former sales rep for GSK in the Polish region of Lodz, Jarek Wisniewski, said: "There is a simple equation," he said. "We pay doctors, they give us prescriptions. We don't pay doctors, we don't see prescriptions for our drugs. "

"It's a bribe," Wisniewski said, confirming that although on paper the payments were for educational services, the doctors understood very clearly that they must produce a certain number of prescriptions in return.

The Lodz public prosecutor found evidence in documents given to doctors by GSK to support claims of corrupt payments in more than a dozen different health centers where there was no evidence "patient education" had taken place.

One doctor has already admitted guilt, been fined and given a suspended sentence. He said he accepted £100 for a single lecture he never gave, but only under pressure from a GSK drugs rep.

The company said a GSK training program to help improve diagnostic standards and medical training in respiratory disease was run by doctors in Poland from 2010 to 2012.

A statement said: "These sessions were delivered by specialist healthcare professionals who, based on contracts signed with GSK, received payments appropriate to the scope of work as well as their level of knowledge and experience. The provision of sessions under this program was agreed with the Polish healthcare centers.

"Following receipt of allegations regarding the conduct of the programme in the Lodz region, GSK has investigated the matter, using resources from both inside and outside the company. The investigation found evidence of inappropriate communication in contravention of GSK policy by a single employee. The employee concerned was reprimanded and disciplined as a result.”

Visit EIN News for the story.

 

 

Covidien announces FDA 510(k) clearance for the Kangaroo Feeding Tube with IRIS Technology

Covidien plc announced U.S. Food and Drug Administration 510(k) Clearance for the Kangaroo feeding tube with IRIS Technology. This first-of-its-kind camera-equipped disposable feeding tube is designed to enhance patient safety by providing visualization for a procedure that is currently blinded.

The Covidien Integrated Real-time Imaging System (IRIS) technology streams a real-time video back to the Kangaroo IRIS monitor, providing visual information that can aid clinicians in identifying key areas of a patient’s anatomy. The system also enables medical professionals to save images from the live stream and make notes associated with the image.

Prior to availability of the Kangaroo feeding tube with IRIS technology, feeding tube placement was often done blindly. The risk associated with blind placement is the misplacement of the feeding tube into the patient’s airway, which can potentially cause a punctured lung or even death. The Kangaroo feeding tube with IRIS technology now gives sight where medical professionals were previously blind. For more information about the Kangaroo feeding tube with IRIS technology, please visit www.covidien.com/kangarooIRIS.

 

 

Hepatitis C treatment cures over 90 percent of patients with cirrhosis

Twelve weeks of an investigational oral therapy cured hepatitis C infection in more than 90 percent of patients with liver cirrhosis and was well tolerated by these patients, according to an international study that included researchers from UT Medicine San Antonio and the Texas Liver Institute. Historically, hepatitis C cure rates in patients with cirrhosis (liver scarring) have been lower than 50 percent and the treatment was not safe for many of these patients.

Hepatitis C virus is the No. 1 driver of cirrhosis, liver transplants and liver cancer in the United States, noted Fred Poordad, M.D., lead author on the study, which was released Saturday by The New England Journal of Medicine in conjunction with Dr. Poordad's presentation of the data at the International Liver Congress in London. UT Medicine is the clinical practice of the School of Medicine at The University of Texas Health Science Center at San Antonio, where Dr. Poordad is a professor of medicine.

Interferon previously was the only agent to show effectiveness against hepatitis C, but patients often relapsed and the therapy caused multiple side effects. The new regimen is interferon-free and consists of several agents — ABT-450/ritonavir, ombitasvir, dasabuvir and ribavirin. Twelve weeks after the last dose, no hepatitis C virus was detected in the bloodstream of 91.8 percent of patients who took the pills for 12 weeks. Among patients treated for 24 weeks, 95.9 percent were virus-free 12 weeks after the end of therapy.

The combination medication regimen is expected to be on the market as early as the end of 2014 or very early 2015. Visit eScience News for the study.

 

 

Cancer ‘miracle’ patients studied anew for disease clues

The history of oncology is rife with reports of patients with advanced cancer who staged miraculous recoveries. Now scientists are starting to use sophisticated DNA sequencing technology to determine if these “exceptional responders” carry gene variations that can lead to new treatment approaches, better targeted therapies or even the re-emergence of experimental drugs once deemed failures.

As many as 10 percent of patients respond well in clinical trials to experimental medicines that end up being rejected for approval by U.S. regulators, according to the National Cancer Institute. A handful of initial studies have already produced promising data showing why some patients have exceptional responses to drugs that don’t work for others.

Now, the National Cancer Institute and academic medical centers including Memorial Sloan-Kettering Cancer Center in New York, the Dana-Farber Cancer Institute and Massachusetts General Hospital in Boston, and the Broad Institute in Cambridge, MA, are collecting data to conduct a more complete survey of exceptional responders. The plan is to create a national database for researchers.

So far, about 100 exceptional responders have been identified by researchers poring through about 10 years of clinical trials, said Barbara Conley, associate director of the NCI’s Cancer Diagnosis Program. Starting in June, the agency will urge researchers and doctors nationwide to send in clinical data on these patients, she said.

In a study presented at the American Association for Cancer Research meeting in San Diego, researchers analyzed the case of a 57-year-old woman with advanced thyroid cancer who was the only patient in a drug trial who experienced almost a complete disappearance of her tumor. Her tumor “melted away” and didn’t start growing again for 18 months, something unheard of in this rare, aggressive disease that usually kills in five months, said Nikhil Wagle, an instructor at Dana-Farber and the study’s lead investigator.

Genetic analysis revealed the patient carried a mutation in the TSC2 gene that helped make her tumor susceptible to Novartis AG’s Afinitor, used for kidney and breast cancer. The treatment works on a biological pathway called mTor that’s linked to the mutation.

Now, researchers plan to screen other patients for mutations to the mTor pathway and enroll them in clinical trials using the drug. These patients wouldn’t be selected based on the type or placement of their tumors, but rather based on molecular profiling, Wagle said.

David Solit, director of the Center for Molecular Oncology at Memorial Sloan Kettering, was one of the first scientists to chase the case of an exceptional responder using whole genome sequencing, studying the same biological pathway as Wagle.

Two years ago, Solit investigated the case of a woman with advanced bladder cancer who was part of a 45-patient trial testing Afinitor. While the trial was considered a failure, the woman had a complete remission and is still alive four years later, he said.

An analysis found mutations that caused a loss of function in TSC1 and NF2 genes, suggesting a new direction for researcher interest in the mTor pathway and opening the possibility that other patients who carry those mutations would find similar success using Afinitor.

The research also can help refine the advances already made in targeted cancer treatments and immunotherapies. Unlike traditional chemotherapy, which kills healthy cells along with malignant ones, targeted therapies are designed to home in on specific biological aspects of cancer cells that promote a tumor’s spread and growth. Still, most patients develop resistance and the disease returns.

One patient’s dramatic results from a targeted therapy that doesn’t help others suggests another genetic feature may be involved. By identifying a mutation in an exceptional responder, researchers can then screen other patients to see if they have the same alteration, and give them the same drug. Visit Bloomberg for the article.