November 2, 2015
CMS finalizes 2016 Medicare payment rules for physicians, hospitals & other providers
The Centers for Medicare & Medicaid Services (CMS) issued final rules detailing how the agency will pay
for services provided to beneficiaries in Medicare by physicians and other healthcare professionals in 2016
that reflects the administration’s commitment to quality, value, and patient-centered care.
Payment rules for the 2016 calendar year for End-Stage Renal Disease Prospective Payment System, the
Hospital Outpatient Prospective Payment System, Home Health Prospective Payment System, and the
Physician Fee Schedule were all finalized this week.
Key policies finalized in the 2016 payment rules include:
- Finalizing the Home Health Value-Based Purchasing model. This model, authorized under the Affordable
Care Act, is designed to improve health outcomes and value by tying home health payments to quality
performance. All Medicare-certified home health agencies that provide services in Massachusetts,
Maryland, North Carolina, Florida, Washington, Arizona, Iowa, Nebraska, and Tennessee will participate in
this model starting January 1, 2016.
-Finalizing updates to the “Two-Midnight” rule. The rule clarifies when inpatient admissions are
appropriate for payment under Medicare Part A. This continues CMS’ long-standing emphasis on the
importance of a physician’s medical judgment in meeting the needs of Medicare beneficiaries by providing
clearer guidelines and a more collaborative approach to education and enforcement. This was part of the
Hospital Outpatient Prospective Payment System final rule. Visit here for Two-Midnight Rule fact sheet.
- Finalizing the End-Stage Renal Disease Quality Incentive Program. The End-Stage Renal Disease final
rule will apply payment incentives to dialysis facilities to improve the quality of dialysis care. Facilities that
do not achieve a minimum total performance score with respect to quality measures, such as anemia
management, patient experience, infections, and safety, will receive a reduction in their payment rates.
- Beginning the new physician payment system post the Sustainable Growth Rate (SGR) formula and
supporting patient- and family-centered care. This is the first final Physician Fee Schedule final rule since
the repeal of the SGR formula by the Medicare Access and CHIP Reauthorization Act of 2015
(MACRA). Through the final rule, CMS is beginning implementation of the new payment system for
physicians and other practitioners, the Merit-Based Incentive Payment System, required by the
legislation.
- Finalizing provision to empower patients and their families regarding advance care planning. Consistent
with recommendations from a wide range of stakeholders and bipartisan members of Congress, CMS is
finalizing its proposal that supports patient- and family-centered care for seniors and other Medicare
beneficiaries by enabling them to discuss advance care planning with their providers.
The CY 2016 OPPS/ASC final rule updates Medicare payment policies and rates for hospital outpatient
departments (HOPDs), ASCs, and partial hospitalization services provided by community mental health
centers (CMHCs), and refinements to programs that encourage high-quality care in these outpatient
settings.
Approximately 4,000 hospitals and 60 CMHCs are paid under the OPPS, while approximately 5,300 ASCs
are paid under the ASC payment system. The OPPS provides payment for most HOPD services, including
partial hospitalization services furnished by HOPDs and CMHCs. OPPS payment amounts vary according to
the Ambulatory Payment Classification (APC) group to which a service or procedure is assigned. The final
rule also includes important changes to the Two Midnight Rule effective beginning in CY 2016.
Visit CMS for the releases.
California doctor convicted of murder charges in overdose of patients
A Rowland Heights, CA, doctor was convicted of second-degree murder Friday in connection with the
overdose deaths of three patients, capping a landmark case that was closely watched by medical and legal
professionals across the country.
Dr. Hsiu-Ying “Lisa” Tseng, who prosecutors say is the first doctor convicted of murder in the United
States for recklessly prescribing drugs to patients, was accused of ignoring “red flags” about her
prescribing habits, including the overdose of a patient in her clinic and nine phone calls in less than three
years from authorities informing her that patients had died with drugs in their system.
As the jury's decision was read, Tseng cocked her head and listened, showing no emotion.
“The message this case sends is you can't hide behind a white lab coat and commit crimes,” Deputy Dist.
Atty. John Niedermann said afterward. “A lab coat and stethoscope are no shield.”
Jurors deliberated two weeks before reaching their verdicts. The eight-week trial included 77 witnesses
and more than 250 pieces of evidence as the prosecution argued that Tseng had plenty of warnings that
her prescription practices were dangerous.
Niedermann told jurors that Tseng agreed to give patients powerful narcotics without asking follow-up
questions even after some — including an undercover agent posing as a patient — told her about their
drug addictions.
Tseng's defense lawyer, Tracy Green, portrayed the doctor as overworked and too trusting of her patients.
After Friday's verdict, Green said her client was shocked by the conviction and plans to appeal. She said
prosecutors used a long list of charges involving other patients to unfairly portray Tseng as a reckless
doctor responsible for the three overdose deaths.
The verdicts could have a terrible ripple effect, she said. Green said she has received several calls from
cancer patients and others with terminal illnesses who said the prosecution of doctors like Tseng has led
other physicians to limit the amount of powerful painkillers they prescribe, even to those who have a
medical need for them.
Tseng was also accused of prescribing drugs to people with no legitimate need for the medications and
fraudulent prescribing for writing a man's name on prescriptions so his wife could double her pill count.
The jury found Tseng guilty of more than a dozen illegal prescribing counts.
Tseng's attorney argued that her client's actions weren't motivated by the money. Visit the Los Angeles
Times for the story.
ECRI Institute PSO releases deep dive on risks in coordinating patient care
Poorly coordinated care puts patients at risk for preventable events, such as medication errors, lack of
necessary follow-up care, and diagnostic delays and errors. These events can lead to repeat testing and
procedures, dissatisfying care experiences, preventable patient harm, and unnecessary hospital
readmissions.
ECRI Institute Patient Safety Organization (PSO), with experience analyzing more than 2 million adverse
events and near misses, focused its just-released 4th annual Deep Dive on care coordination issues
affecting patients primarily during an inpatient hospital admission and at discharge.
"Coordinating a patient's care among various providers and across multiple care settings—from a hospital
to a rehabilitation facility to the patient's home, or from a hospital to a skilled nursing facility—is a huge
challenge," says William M. Marella, MBA, ECRI Institute executive director of PSO Operations & Analytics.
"Several events from the analysis were particularly compelling in illustrating the importance of ensuring
that providers along the care continuum work together as a team and communicate among each other
about the patients' care."
ECRI Institute PSO found that the largest share of all the care coordination reports—whether inpatient- or
discharge-related events—involved medications or medication reconciliation failures. Laboratory testing
and diagnostic imaging incidents contributed to 20% of the inpatient care coordination events. The top
four contributing factors were: human factors; communication breakdowns; policies and procedures that
were either unclear or not in place; and limitations in staff qualifications.
ECRI Institute PSO analyzed 223 events reported by 38 facilities over three and a half years, starting in
September 2011 and ending in mid-January 2015. Visit ECRI for the report.
Off-site, hospital-owned EDs can apply for ASRH certification
Since the launch of the Acute Stroke-Ready Hospital (ASRH) certification program, The Joint Commission
has received calls from customers asking if their off-site hospital-owned emergency department (ED) is
eligible to apply for the program.
After conducting a literature review and discussions with accredited organizations that have off-site,
hospital-owned EDs, The Joint Commission has decided that effective Oct. 1, 2015, these sites are eligible
to apply for ASRH certification if the off-site emergency department meets the following:
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Owned and operated by a Medicare-participating hospital as a provider-based emergency
department
Shares the same Centers for Medicare & Medicaid (CMS) Certification Number (CCN) as the main
hospital
Was surveyed as part of The Joint Commission’s triennial accreditation survey
Medical staff and nursing personnel at the off-site location must be part of the organization’s single
organized medical staff and nursing services, respectively
The medical director of the off-site location is on the medial staff at the main hospital
Medical records of the off-site location are part of the hospital’s single medical record system
Meets all Emergency Medical Treatment and Active Labor Act (EMTALA) requirements
Meets all ASRH eligibility requirements (including 10 patients served)
Has the ability to meet the ASRH certification requirements
Visit Joint Commission for the announcement.
Another study ties memory lapses to later dementia
Subjective memory complaints (SMCs) are associated with cognitive impairment nearly two decades later
among older women, a prospective study of aging has demonstrated.
SMCs may be a very early symptom of an insidious neurodegenerative disease process such as
Alzheimer's disease, Allison R. Kaup, PhD, of the San Francisco VA Medical Center and University of
California San Francisco, and colleagues reported online in Neurology.
"We found that older women with subjective memory complaints were more likely to be diagnosed with
cognitive impairment -- mild cognitive impairment or dementia -- years to decades later," Kaup said in an
interview. "These findings suggest that memory complaints in older adults may be a very early symptom
of a cognitive decline process, and provide further evidence that SMCs in aging warrant close attention as
a possible early warning sign of future cognitive problems, even several years in advance."
But the researchers also conceded that, at present, there are no proven interventions to prevent or delay
cognitive decline in patients deemed at risk.
The study showed that women with SMCs 18 years before the diagnostic evaluation had 1.7 times greater
odds of receiving an impaired diagnosis, while women with SMCs 4 years before the diagnostic evaluation
had three times greater odds of receiving an impaired diagnosis.
Even those women who reported SMCs at only one point in time were at increased risk of cognitive
impairment, said Kaup and colleagues. What's more, patterns of persistent SMCs and incident SMCs over
time were both significantly associated with risk of cognitive impairment, they pointed out.
Another recent study found that older adults with SMCs who went on to develop MCI progressed to this
diagnosis an average of 9.2 years after they first endorsed SMCs, noted the investigators. This supports
the notion of a prolonged prodromal period between SMCs and the development of cognitive impairment,
they said.
If SMCs do signal an insidious disease process as it first emerges and continues to unfold, this could be
consistent with the long, prodromal period of AD, said Kaup and colleagues. During this period, amyloid
deposition is present many years before the clinical manifestation of objective cognitive impairment, the
investigators noted. Neuroimaging studies corroborate this possibility, they said.
Physicians should consider incorporating assessment of SMCs into their routine checkups of older patients.
A questionnaire administered in the waiting room, even when the patient's primary reason for presenting
to the clinic is not cognition, could be a useful and provider-friendly screening tool, said the investigators.
Visit MedPage Today for the study.
You probably have herpes, the WHO says
Two-thirds of the world's population under 50 has the highly infectious herpes virus that causes cold sores
around the mouth, the World Health Organization said on Wednesday, in its first estimate of global
prevalence of the disease.
More than 3.7 billion people under the age of 50 suffer from the herpes simplex virus type 1 (HSV-1),
usually after catching it in childhood, according to the WHO study. That is in addition to 417 million people
in the 15-49 age range who have the other form of the disease, HSV-2, which causes genital herpes.
HSV-1 normally causes mouth ulcers rather than genital infection, but it is becoming an increasing cause
of genital infection too, mainly in rich countries. That is because improved hygiene in rich countries is
lowering HSV-1 infection rates in childhood, leaving young people more at risk of catching it via oral sex
when they become sexually active.
HSV-2 can increase the risk of catching and spreading HIV, the disease that causes AIDS. Little is known
about any link between HSV-1 and HIV/AIDS, although it can lead to other serious complications such as
encephalitis.
"We really need to accelerate the development of vaccines against herpes simplex virus, and if a vaccine
designed to prevent HSV-2 infection also prevented HSV-1, it would have far reaching benefits," said Sami
Gottlieb, a WHO medical officer.
Nathalie Broutet, also a WHO medical officer, said the U.S. National Institutes of Health and companies
including GlaxoSmithKline Plc were involved in trials to determine whether a therapeutic or preventative
vaccine was preferable. Visit Reuters for the report.
Cleveland Clinic unveils top 10 medical innovations for 2016
Cleveland Clinic unveiled its 10th annual listing of the 10 most powerful medical innovations of the coming
year. The announcement closed the 2015 Medical Innovation Summit, which drew more than 1,600 people
to the Cleveland Convention Center for the summit’s 13th year.
Topping the list of the Top 10 Medical Innovations for 2016 are new, faster methods of creating vaccines,
a process for rewriting genetic code, and a water purification system for the developing world.
The breakthrough drug therapies, medical devices and public health initiatives were selected by a panel of
75 Cleveland Clinic physicians and scientists.
Here, in order of anticipated importance, are the Top 10 Medical Innovations for 2016:
1. Rapid Development of Epidemic-Battling Vaccines
Researchers are developing effective vaccines faster than ever to prevent epidemics. It’s an effort given
new urgency by the 2014 Ebola epidemic in Africa and of bacterial meningococcal (Meningococcal B)
outbreaks in the United States.
“The rapid scientific response to recent epidemics indicates that we’ve achieved a new level of
sophistication in the area of vaccine development,” says Steven Gordon, M.D., chair of the Department of
Infectious Disease at Cleveland Clinic. “It was a global effort involving thousands of people, aided by
information technology and instant communication.”
The most promising Ebola vaccine emerged in only 12 months. While not yet licensed for use in humans,
it’s expected to be available in 2016.
2. Genomics-based Clinical Trials
Genetic profiling offers new hope to people suffering fatal diseases, like cancer. By upending a 50-year-old
research model, genomic-based tests may increase the speed and flexibility of clinical trials and guide
desperate patients to the most promising experimental treatments.
“Patients are waiting too long to enter clinical trials for drugs that may or may not be effective for their
specific variation of cancer,” says Charis Eng, M.D., Ph.D., chair of the Cleveland Clinic Genomic Institute.
“End-stage cancer patients especially may not have that time.”
3. Gene Editing Using CRISPR
Once, altering the DNA of human embryos, or any organisms, was the stuff of science fiction. No more.
Thanks to a new, inexpensive technique called CRISPR, gene editing is being adopted in labs everywhere.
CRISPR, which stands for “clustered regularly interspaced short palindromic repeats,” is being touted as a
way to eliminate genetic diseases. It can identify and remove bad genes from a DNA strand for as little as
$30.
The impact of altered organisms on ecosystems remains unknown. What’s clear is that CRISPR’s impact
on the human population will be tremendous.
4. Water Purification System for Prevention of Infectious Disease
An estimated 700 million people worldwide are drinking unsafe water daily, according to the World Health
Organization. A new kind of waste treatment plant may offer an affordable solution. It has shown promise
converting human waste into clean drinking water while also generating electricity to run the machine.
The sewage processor costs about $1.5 million and is able to handle the waste of 100,000 people daily. It
is now being tested in Dakar, Senegal.
5. Cell-free Fetal DNA Testing
The desire to deliver healthy babies has created a $2 billion pregnancy wellness market. Yet for all the
books, diets and yoga classes, parents’ fears about genetic diseases remain poorly addressed.
Studies show that Cell-free Fetal DNA Testing more accurately predicts Down's and Edwards’s syndromes
than standard blood tests and ultrasounds. This testing will soon be widely available, bringing more
certainty to parents everywhere.
6. Cancer Screening via Protein Biomarker Analysis
In 2016, a new biomarker platform is hitting the market that should offer more accurate cancer
screenings and more chances of early detection.
Protein biomarker analysis focuses on changes in the structure of certain proteins circulating in the blood.
In contrast to examining genetic mutations, which can indicate the risk of cancer, the new tests give realtime information on cancer’s presence.
7. Naturally Controlled Artificial Limbs
In recent years, researchers have discovered that neural signals associated with limb movement can be
de-coded by computers, leading to computer-controlled artificial limbs.
More recently, they have demonstrated that sensors implanted in the brain can control prosthetic arms,
wheelchairs and even a full-body exoskeleton. Now researchers are working on making “brain-machine
interfaces,” BMIs, safer and cheaper with lower-cost robotic components.
The idea of brain-powered prosthetics has gone from “What if?” to “When?”
8. First Treatment for HSDD
Several medications address male sexual dysfunction, but what about a woman’s loss of sexual desire? In
2015, the FDA approved flibanserin, the first medication designed to treat female hypoactive sexual desire
disorder (HSDD), or loss of sexual desire in premenopausal women.
“This innovative medication is well-studied and it does help restore sexual desire in women who have
HSDD,” says Holly L. Thacker, M.D., director of Cleveland Clinic’s Center for Specialized Women’s Health.
“The medication is intended to restore a woman’s sexual desire to her personal baseline,” Thacker
cautions. “It is not an aphrodisiac.”
9. Frictionless Remote Monitoring
For people with diabetes, monitoring glucose levels traditionally requires periodic poking with needles.
That could come to an end with the development of a skin-top biosensor that measures insulin and reports
the results to both patient and doctor.
Needle-free glucose monitoring is only one example of remote health monitoring that is frictionless,
requiring almost no action from the patient.
Other frictionless remote monitoring devices in development include a bandage that reads sweat
molecules to diagnose pregnancy, hypertension or hydration. Frictionless remote monitoring puts vital
data in the hands of both patient and caregiver, effortlessly.
10. Neurovascular Stent Retrievers
With strokes, time kills brain cells. The blood clot must be removed within three to six hours to prevent
long term disability, brain damage or death.
For years, the only FDA-approved treatment has been a clot-busting drug that is not always effective,
which is why doctors are excited about neurovascular stent retrievers. Inserted into the body through a
catheter and threaded through the blood stream, the tiny, wire-caged device seizes the blood clot and
removes it. Studies found that stroke victims whose clots were removed via stent retriever had speedier
recoveries and improved chances of regaining independence.
Look for the device to become a tool in every stroke unit by the end of 2016.
A fuller explanation of the Top 10 Medical Innovations for 2016 can be found on the website of Cleveland
Clinic Innovations.
Visit Cleveland Clinic for the release.
Last call for submissions The Jeannie A. Akridge
Memorial Scholarship
A year ago Healthcare Purchasing News announced the
creation of The Jeannie A. Akridge Memorial Scholarship.
The Scholarship covers the tuition costs for one International
Association of Healthcare Central Service Materiel Management
(IAHCSMM) member to attend the annual conference. The
winner will receive $1000 to use towards his or her meeting
expenses.
Jeannie, Healthcare Purchasing News' Managing Editor for
nearly 11 years, lost her battle with breast cancer last
November, after the disease spread to other organs. She was
only 42. The Jeannie A. Akridge Memorial Scholarship is a
tribute to her memory.
Jeannie spent close to a decade working closely with the
association and its members, putting together the continuing
education program content that HPN continues to offer each
month. She also attended and reported on the annual
meetings. Jeannie made a difference to her family, friends,
colleagues and thousands of HPN readers. We will continue to
honor and remember her dedication to the healthcare industry
and educating healthcare professionals in CSSD.
Dec. 17, 1971-Nov. 4, 2014
HPN will select the award winner based on a short essay (300-1000 words) that describes how the
department that sterilizes surgical instruments makes a difference and why it is important to providing
safe healthcare.
Deadline for submissions is November 4, which commemorates the anniversary of Jeannie's passing.
Please send all submissions to krussell@hpnonline.com.
The winner may also share his or her scholarship with other team members who would like to attend next
year's IAHCSMM Annual Conference & Expo in San Antonio, TX, April 24-27, 2016.
HPN will announce the winner in late November.