Hospitals sue CMS
over âTwo-Midnightâ Rule, pay cut accompanying regulation
In two related lawsuits filed April 14, the hospital industry challenged the
Department of Health and Human Services' âtwo-midnightâ 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 âinpatientâ for purposes of Medicare reimbursement.
The AHA's filing said that this ânew 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.â The August 2013 rule was for fiscal year 2014 payments.
In a statement from the AHA, the plaintiffs said hospitals âtake 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.â
In the statement, Rich Umbdenstock, president and chief executive officer of
the AHA, said that the two-midnight rule âundermines medical judgment and
disregards the level of care needed to safely treat patients.â He added,
âHospitals 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.â
A separate complaint filed April 14 takes aim at a payment cut that
plaintiffs said âwill cost the nation's hospitals more than $200 million
this year aloneâ (Am. Hosp. Ass'n v. Sebelius, D.D.C., No. 1:14-cv-00607 ,
The complaint said that CMS claimed, âwithout 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.â 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.
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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.
Visit Yahoo for the story.
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
HHCâs effort was recently recognized by the âECRI Instituteâ in Pennsylvania
with its â2014 Supply Chain Achievement Award,â which honors healthcare
organizations that demonstrate excellence in overall supply chain
âA centralized supply chain management system eliminates redundancies,
ensures more purchasing controls and maximizes HHCâs vast bargaining power
at a time HHC faces serious budget challenges,â said Antonio D. Martin,
HHCâs Executive Vice President and Chief Operating Officer. âBy
standardizing our methods of procurement and establishing an organized and
clinically-based supply chain structure, we can support quality healthcare
and control our costs.â
âEach 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,â said Martin. âThese 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.â
HHCâs 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. HHCâs 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
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.
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
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 Associationâs (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
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
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
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
"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
One doctor has already admitted guilt, been fined and given a suspended
sentence. He said he accepted ÂŁ100 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
Visit EIN News for the story.
announces FDA 510(k) clearance for the Kangaroo Feeding Tube with IRIS
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 patientâs
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 patientâs
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
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 â 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.
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 âexceptional
respondersâ 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 donât 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
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 NCIâs 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 âmelted
awayâ and didnât 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 studyâs lead investigator.
Genetic analysis revealed the patient carried a mutation in the TSC2 gene
that helped make her tumor susceptible to Novartis AGâs Afinitor, used for
kidney and breast cancer. The treatment works on a biological pathway called
mTor thatâs 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
wouldnât 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 tumorâs spread and growth. Still, most patients develop resistance
and the disease returns.
One patientâs dramatic results from a targeted therapy that doesnât 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
Visit Bloomberg for the article.