A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards
November 15, 2012
New Test Reimbursement Bill Introduced
Representative Peter Roskam (R-IL) introduced legislation, H.R.6446, the Improving Diagnostic Innovations Act of 2012, which would create a process for increasing Medicare payments for new laboratory tests. Under the legislation, the Department of Health and Human Services (HHS) would take into consideration a number of factors when using the gap-fill process to set payment rates for new laboratory tests. Among the factors CMS would be required to take into account include:
- The tests impact on patient care;
- The resources needed to develop, validate and perform the test;
- Medicare claims data;
- Laboratory charges to patients;
- Private insurance rates; and
- Other factors specified by HHS.
Congressional Bill Would Punish Medicare Auditors
Representative Sam Graves (R-MO) recently introduced legislation, H.R.6575, the Medicare Audit Improvement Act of 2012, which would increase the accuracy and transparency of the recovery audit contractors (RACs) program. Created under Medicare Modernization Act of 2003, RACs are directed by Congress to identify fraud and abuse within the Medicare program and recoup overpayments. RACs are permitted to keep a portion of the overpayments they recover.
Doctors Get Another Chance to Avoid Medicare e-Prescribing Penalty
Doctors who were unable to meet Medicare electronic prescribing requirements will have a second chance to claim a hardship exemption and prevent the 2013 e-prescribing penalty from reducing their Medicare pay.
The Centers for Medicare & Medicaid Services will allow physicians and other eligible health professionals an additional window of time in which to file hardship exemptions, indicating to the agency that a 1.5% penalty should not be applied to all Medicare rates next year, officials said. Any physician who did not request an exemption by the original due date, June 30, now can file a hardship application by Jan. 31, 2013.
Clinical Quality Measures for 2014 MU
The Centers for Medicare & Medicaid Services (CMS) has published the final 2014 clinical quality measures (CQMs) for eligible professionals and eligible hospitals seeking to attest for meaningful use. Beginning in 2014, the reporting of clinical quality measures will change for all providers. Electronic health record (EHR) technology that has been certified to the 2014 standards and capabilities will contain new CQM criteria. Eligible professionals (EPs), eligible hospitals and critical access hospitals will report using their respective new 2014 criteria – regardless of whether they're taking part in participating in Stage 1 or Stage 2 meaningful use.
Decisions Doctors Must Make to Avoid Medicare Penalties
A physician’s decision not to report Medicare quality measures or participate in paperless prescribing and health record programs in 2013 will be a costly one in the long run. The programs have been voluntary for the past several years. However, federal laws require Medicare rates eventually to be reduced for physicians who do not participate in the physician quality reporting system as well as the electronic health records and e-prescribing incentive programs. The reason why 2013 is such a critical year for doctors is that Medicare officials are using it as a benchmark for future penalties in all of these programs. The American Academy of Family Physicians estimates that participating in these initiatives next year could save a physician $19,000 in avoided penalties. Successfully reporting quality measures and achieving meaningful use of an EHR in 2013 will prevent a doctor’s Medicare rates from being reduced by 3.5% in 2015 for noncompliance.
The American Hospital Association filed suit against the U.S. Department of Health and Human Services (HHS) for refusing to meet its financial obligations for hospital services provided to some Medicare patients. The AHA was joined in the suit by four hospital systems in states including Michigan, Missouri and Pennsylvania. At issue is the Administration’s refusal to reimburse hospitals for reasonable and necessary care when the government in hindsight believes that such care could have been provided in an outpatient facility or department instead of in the inpatient portion off the hospital itself.
Physician Fee Schedule
The CY 2013 PFS final rule with comment period was placed on display at the Federal Register on November 1, 2012. The final rule with comment period addresses changes to the physician fee schedule, payments for Part B drugs, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services.
Cleveland Clinic: Top 10 Innovations Announced
"Our list gives you the flavor of where health care is going," says Chris Coburn, executive director of Cleveland Clinic Innovations. It is the Clinic's corporate arm, responsible for creating companies using the health system's research in medical technology.
- Bariatric surgery for diabetes control
- Neuromodulation therapy for cluster and migraine headaches
- Mass spectrometry for bacterial identification
- Novel medications for advanced prostate cancer
- Handheld optical scan for melanoma
- Femtosecond laser cataract surgery
- Ex-Vivo Lung Perfusion system
- Modular devices for treating complex aneurysms
- Breast tomosynthesis
- Medicare Better Health Rewards Act
Not a Surprise for Pathologists: Study Determines Doctors Fail to Follow Up on as Many as 60% Clinical Laboratory Test Results
Researchers looked at how physicians in ambulatory settings followed up on the results of medical laboratory tests Studies performed in the United States show that, for ambulatory patients, doctors fail to follow up on as many as two-thirds of medical laboratory test results and up to one-third of radiology reports! A recent review of 19 of these studies also showed that these failures resulted in serious lapses in patient care.
It was researchers at the University Of New South Wales (UNSW) who undertook a systematic review of evidence of failure to follow up on diagnostic test results and how this impacted ambulatory patients. The review was the first of its kind, internationally, according to a story published on UNSW’s Australian Institute of Health Innovation (AIHI) website.
Lab Orders and HIEs
Certification Requirements Needed to Transmit Lab Orders
A recent posting on Michigan Health Connect indicates that while this state-wide HIE is handling 820,000 lab results per month, it is only handling about 5000 orders per month. This 160-fold disparity highlights the issues with trying to use HIEs for bidirectional lab communications. Lab results distribution is a relatively straightforward problem for an HIE. The format standards are relatively mature, and technology exists for routing data through a network to the correct ordering provider, based on identifiers in the message itself. The results may or may not be mapped to a standard vocabulary; many EHRs have not made this a requirement for lab data. However, with LOINC adoption increasing, result code mapping will also become a straightforward exercise.
Standardizing orders is much more difficult, because it’s not just a data routing and formatting problem. Most EHRs don’t create a complete order that’s ready to send to the lab. And many legacy Lab Information Systems don’t accept unsolicited inbound orders, because they require manual patient registration before the order can be accepted.
In a paper published in the European Journal of Human Genetics, Robert Cook-Deegan of Duke University; James Evans of the University of North Carolina, Chapel Hill; and lawyers John Conley and Daniel Vorhaus of Robinson, Bradshaw & Hinson assert that by operating a proprietary database of gene-disease associations, Myriad is denying researchers, physicians and patients access to "basic scientific and medical information" that would improve their knowledge of variants linked to cancer and enable more accurate diagnoses. Myriad's proprietary database "is probably the major factor in explaining the company's ability to interpret VUS result more successfully than others," the authors of the EJHG paper assert.
NY State Department of Health Guidelines Assist Labs Developing NGS-Based Cancer Assays
The New York State Department of Health this summer released guidelines laying out the requirements for the development and validation of next-generation sequencing-based cancer diagnostic tests in New York laboratories, its first set of recommendations pertaining specifically to NGS.
The guidelines, which cover somatic variant detection for molecular oncology testing, were issued in August by the department's Clinical Laboratory Evaluation Program, or CLEP, which monitors the quality of testing conducted by clinical laboratories and blood banks in the state as well as out-of-state labs that accept clinical samples from New York.
As they become better developed and more widespread, non-invasive prenatal genetic tests may get caught up in the furor over abortion in the US and, to a lesser extent, in Europe, writes the University of California Hastings College of the Law's Jaime King in Nature. She argues that the US Food and Drug Administration, needs to develop a regulatory framework for such tests and help educate the public about the tests and what they can determine.
Cholesterol Tests May Not Hinge on Fasting
Any doctor will tell you: For accurate results, you must fast for at least eight hours before a lipid profile, the blood test for cholesterol, lipoproteins and triglycerides. But now a study published in Archives of Internal Medicine suggests that fasting is probably unnecessary. Two Canadian scientists studied records of more than 200,000 people who completed at least one lipid profile during a six-month period at a laboratory in Calgary, Alberta. They recorded their fasting times before the test, and compared the readings according to the amount of time the patients fasted.
HIV Tests at the Dentist Could Reduce Disease Spread
Some dentists not only check your teeth, but also take a swab along your gum line to test for HIV. And a new way of offering the test may boost its acceptance in patient's eyes, dentists say. Dentists hope the practice can reduce the number of people who are infected with HIV and don't know it, and in turn, decrease disease spread.
Rapid Flu Tests Not Always Accurate
Most rapid influenza diagnostic tests (RIDTs) perform well when viral concentrations in a sample are high, but accuracy declines at lower concentrations, researchers found.
Of 11 FDA-cleared rapid tests that were commercially available during the 2011-2012 flu season, most detected viral antigens in samples with the highest concentrations, according to Roxanne Shively, MS, of the Department of Health and Human Services (HHS), and colleagues. Detection varied, however, when the viral concentrations in a sample were lower, the researchers reported in the Nov. 2 issue of Morbidity and Mortality Weekly Report. And one rapid test -- SAS FluAlert Influenza A from SA Scientific -- did not consistently detect the pandemic H1N1 virus or other influenza A viruses even at high concentrations.
Home Pregnancy Tests may Detect Men's Cancer
If you've been near social media or on the Internet, you may be aware of the buzz over posts claiming a teenage boy took a home pregnancy test as a joke, received a positive result, and wound up being diagnosed with testicular cancer. CNN interviewed a girl who identified herself as a friend of the 17-year-old, but was not able to independently confirm the posts. However, it's true home pregnancy tests can detect some types of testicular cancer in men, experts say - but the tests would not be useful as a screening tool.
Tablet-based Technology Gauges Surgical Blood Loss
Developers tout algorithm as way to reduce transfusions.
An optical scanner for Apple’s iPad tablet computer reliably estimates blood loss during surgery, according to a pilot study evaluating the technology in both experimental and clinical settings.
More precise measurement of blood loss during surgery could provide better information to maintain hemodynamic stability of the patient and to help anesthesiologists determine, in real time, if and when to start a transfusion, Siddarth Satish, MS, a chemical engineer, and his colleagues reported at the 2012 annual meeting of the American Society of Anesthesiologists.
SpinChip Combines Microfluidics and Centrifuge for Rapid Blood Analysis
New technology being developed by scientists in Norway may bring rapid blood testing directly to the bedside. The SpinChip, invented by Stig Morten Borch of Norway’s SINTEF research center, uses a centrifuge to spin a small microfluidic chip that separates a blood sample into solid and liquid components that then undergo chemical reactions within the chip’s narrow channels. Within minutes of activating the centrifuge, an optical sensor reads the results of the reactions and provides output to the clinician.
Blood Tests Predict Level of Enzymes That Facilitate Disease Progression in Atherosclerosis, Osteoporosis, Cancer
Predicting how atherosclerosis, osteoporosis or cancer will progress or respond to drugs in individual patients is difficult. In a new study, researchers took another step toward that goal by developing a technique able to predict from a blood sample the amount of cathepsins - protein-degrading enzymes known to accelerate these diseases - a specific person would produce. This patient-specific information may be helpful in developing personalized approaches to treat these tissue-destructive diseases.
"We measured significant variability in the amount of cathepsins produced by blood samples we collected from healthy individuals, which may indicate that a one-size-fits-all approach of administering cathepsin inhibitors may not be the best strategy for all patients with these conditions," said Manu Platt, an assistant professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.
By studying a specific part of the male DNA, it may be possible to refine the interpretation of PSA tests. This would reduce the risk of men being treated for prostate cancer unnecessarily. The findings have been presented in a thesis by Christel Björk at Lund University, Sweden, who has carried out the study with her colleague Hannah Nenonen, supervised by researcher Yvonne Lundberg Giwercman.
A PSA test measures the level of PSA (prostate-specific antigen) in the blood, and raised PSA can signal an increased risk of cancer; however, this is not the case for everyone. The problem is that there is no good way to separate those with naturally high levels of PSA from those at increased risk of prostate cancer. "If we know that a man has a naturally high level of PSA, this can be taken into account in a PSA test, and the patient may be able to avoid arduous treatment with a risk of side-effects", says Christel Björk, a doctoral student at the Department of Clinical Sciences, Lund University.
Bacteria Test Could Prevent Deadly Infections in Newborns
Researchers have developed a small cartridge that can identify harmful microbes in a newborn or the mother. It is extremely easy to use and does not require much clinical microbiological expertise. The health worker simply adds a sample from the baby, mother, or both, and waits ten to fifteen minutes for the result. This simple, cheap and rapid test gives health care professionals useful data so that they can decide quickly what treatments to recommend.
When a baby is born, they move from the protection of the womb to an environment with literally trillions of microscopic organisms.
Detecting Biothreats, Faster and Cheaper
CDC Scientists at the Texas Biomedical Research Institute (TBRI) have created a fast and efficient way of developing tests for potential bioterror agents. The technique, published (November 5) in Scientific Reports, quickly identifies antibodies that recognize bacterial toxins or viral proteins in a few days, using simple equipment found in most facilities around the world. This technique is “more suitable for resource limited laboratories” than traditional methods that require expensive equipment like chromatography systems, said Kim Janda, a chemist from the Scripps Research Institute, who was not involved in the study. “I think it will find ample use in other laboratories in the future.”
Harvard Researchers’ New DNA Barcoding May Give Pathologists Expanded Capabilities in Fluorescence Microscopy
Scientists at Harvard University’s Wyss Institute for Biologically Inspired Engineering have developed a new DNA, barcoding technique. The fluorescence microscopy approach has significant implications for the imaging community. Beyond imaging, however, pathologists will be able to use this same technology when evaluating tissue specimens. The new method could enable simultaneous imaging of many different types of molecules in a single cell, according to Peng Yin, Ph.D., Associate Professor of Systems Biology at Harvard Medical School and Core Faculty Member at Wyss Institute. The developers expect the method to provide researchers with a richer, more accurate view of cell behavior than is possible using current techniques.
Veredus Laboratories Launches Powerful Multiplexed Molecular Diagnostic Lab-on-Chip Targeting Global Threat of Multi-Drug-Resistant Tuberculosis
Singapore, Veredus Laboratories, a supplier of molecular diagnostic tools, has launched VereMTBTM, a multiplexed molecular diagnostic chip capable of fast and accurate detection of Mycobacterium Tuberculosis Complex (MTBC) and its mutations, as well as 9 other clinically relevant non-tubercular mycobacterium. These mutations are responsible for resistance to multiple drugs and are reinvigorating the global spread of Tuberculosis.
The Association for Molecular Pathology held its 2012 Annual Meeting on Genomic Medicine October 25-27 at the Long Beach Convention and Entertainment Center in Long Beach, Calif.
There was a clear shift in focus at this year's conference. As AMP executive director Mary Steele Williams pointed out, many sessions last year explained what next-generation sequencing is. This year, more people are talking about results in utilizing next-gen sequencing for patient management. In "Surveillance for the Molecular Laboratory," Barry Kreiswirth, PhD, and Ari Robicsek, MD, discussed ways that molecular pathology tools can be utilized to identify outbreaks, monitor strains and resistance, and ultimately, catch outbreaks early to prevent further spread.
IBM to Send Watson to Medical School
Cleveland Clinic and IBM are partnering to increase the use of the Watson supercomputer in medical training. IBM researchers will work with Cleveland Clinic faculty and students to enhance Watson's Deep Question Answering technology for medicine.
IBM officials say Watson's ability to analyze the meaning and context of human language – and quickly process information to piece together evidence for answers – can help clinicians, nurses and medical students uncover knowledge buried within huge volumes of information.
Simple Eye Tests Accurately Identify Schizophrenia
Using a series of simple eye tests to identify abnormal eye movements may help clinicians to distinguish patients with schizophrenia from those without, new research suggests.
A study of almost 90 patients with schizophrenia and almost 90 of their healthy peers showed that tests focusing on viewing patterns could detect eye-movement abnormalities associated with the disorder. And in one combined data model, the tests correctly discriminated between the 2 groups with 98.3% accuracy.
Biomarkers for Adult B-acute Lymphoblastic Leukemia Identified
New insight into the aggressive behavior of certain adult B-acute lymphoblastic leukemias has provided researchers with a potential new prognostic biomarker and a promising new therapeutic target. The research, conducted by Ari Melnick, MD, associate professor of medicine and director of the Raymond and Beverly Sackler Center for Biomedical and Physical Sciences at Weill Cornell Medical College, and colleagues was published in Cancer Discovery, a journal of the American Association for Cancer Research.
Key Molecule Could Reveal Many Cancers Early On
A technique for monitoring high levels of a protein found in many pre-cancerous cell types – including breast, lung and skin cancer – could be used to detect cancer early. Their lab study, funded by Cancer Research UK, suggests that the same approach could potentially be used to detect precancerous breast cells, deliver radiotherapy to destroy tumors and monitor the effectiveness of treatment. The approach makes use of a protein called gamma-H2AX as a marker for DNA damage in an early stage of cancer development.
Women may be able to better gauge their own fertility based on the age their mother went through the menopause, a study has concluded. Women whose mothers had an early menopause had far fewer eggs in their ovaries than those whose mothers had a later menopause, a Danish team found. Women with fewer viable eggs have fewer chances to conceive. The study, of 527 women aged between 20 and 40, was reported in the journal Human Reproduction.
Monoclonal Antibody Boosts Cholesterol Reduction
Adding a monoclonal antibody that blocks the breakdown of lipid receptors to atorvastatin therapy further reduces low-density lipoprotein (LDL) cholesterol levels in patients with primary hypercholesterolemia, show study findings. The combination of the antibody, dubbed SAR236553, and 80 mg atorvastatin resulted in twice as many patients reaching a target LDL cholesterol level of less than 100 mg/dL as did with atorvastatin and placebo, and more than five times as many obtaining levels under 70 mg/dL.
Extra Chromosome 21 Removed From Down Syndrome Cell Line
University of Washington scientists have succeeded in removing the extra copy of chromosome 21 in cell cultures derived from a person with Down syndrome, a condition in which the body’s cells contain three copies of chromosome 21 rather than the usual pair. The targeted removal of a human trisomy, they noted, could have both clinical and research applications.
Mapping the Brain's 'Symphony'
NIH Director Francis Collins takes to his new blog to discuss the Human Connectome Project, an NIH-funded effort to map all the neural connections in the human brain.
"Given that a typical human brain contains 100 billion neurons, each with about 10,000 connections, this sounds like an impossible task," Collins notes, but he adds that it's already been done on a much smaller scale for the roundworm Caenorhabditis elegans, which has a nervous system comprising around 300 neurons and 7,000 connections.
Study Shows Vitamin D Levels in Women With Health Conditions Drop Substantially in Winter
Women with health conditions ranging from arthritis to diabetes are significantly more likely to be deficient in all-important vitamin D in the winter than in the summer. That is the finding of a study presented at the 2012 American Society for Clinical Pathology (ASCP) Annual Meeting in Boston. Doctors have long known that almost everyone’s vitamin D levels drop in the winter, particularly if they live in the northern part of the country, but new research suggests that vitamin D inadequacy is associated with specific health conditions. This suggests that extra intervention may be required to maintain optimum levels.
Individuals in families characterized by longevity tend to have low levels of 25(OH) vitamin D, Dutch researchers found. Offspring of parents who lived into their 90s had significantly lower levels of 25(OH) vitamin D compared with controls (64.3 nmol/L versus 68.5 nmol/L, P=0.002), according to Diana van Heemst, PhD, of Leiden University Medical Center in the Netherlands, and colleagues. They also were less likely to carry a common genetic variant that is associated with increased levels of the vitamin (P=0.04), the researchers reported online in CMAJ.
Daily Multivitamin Won't Halt Cardiovascular Disease, Study Says
A daily multivitamin has no effect on the incidence of cardiovascular disease and related conditions in men, according to a large study published in the Journal of the American Medical Assn. The study, conducted by researchers at Harvard Medical School and the Harvard School of Public Health, used data from the Physicians’ Health Study II, which has been tracking the effects of multivitamin use in over 14,000 physicians age 50 and above from 1997 until 2011. The PHS-II is the only large, long-term, placebo-controlled clinical trial of multivitamin use conducted to date, allowing its investigators to ask questions about any number of potential health impacts of multivitamins on older men; in a paper published last month, data from the PHS-II showed that daily multivitamin use slightly reduced the risk of cancers in men.
HPV Vaccine Uptake for Adolescent Males Extremely Low
Very few parents had their adolescent sons vaccinated for human papillomaviruses (HPV) in the year after its approval. Moreover, the willingness of parents to have their sons vaccinated appeared to decline over time. These findings were reported at the American Public Health Association (APHA) 140th Annual Meeting.
Study Identifies Patients Most Willing to Use Personal Health Records
Surprisingly, age, income and education aren’t the determining factors in who wants — and who doesn’t want — access to records online.
As physicians face pressure to have their patients access, share or download their records online, the most likely candidates for use of personal health records are those patients who perceive that they have a high health literacy rate. A study in the Fall edition of Perspectives in Health Information Management found that of those who were willing to use a personal health record, 65% self-reported a high health literacy level. For those who were not willing to use a PHR, 38% self-reported a high level of health literacy.
The research was conducted on behalf of a small medical practice in Central Florida that was contemplating the implementation of a PHR. Researchers from the University of Central Florida in Orlando surveyed 562 patients. They hypothesized that age, income and education levels influenced a patient’s willingness to use a PHR, but it turned out that those made no differences in who would, or wouldn’t, be willing to access one.
Source: http://www.ama assn.org/
Health IT Mandates, Costs Force Doctors to Leave Small Practices
Many doctors are leaving private practices to join large health care organizations, such as hospitals, partly due to the IT costs of implementing electronic health record systems, according to a new report by Accenture, a consulting firm. For the Accenture survey, called "Clinical Transformation: New Business Models for a New Era in Health Care," more than half of the doctors polled, or 53 percent, mentioned electronic health record (EHR) requirements as a reason for abandoning a private practice and seeking employment in a large health organization.
Washington orthopedic surgeon Vincent Desiderio doesn’t mind flipping through folders. His Spring Valley office has seven filing cabinets full of patient charts, some as thick as two inches. Despite feeling the federal government’s push to move to electronic medical records, Desiderio, who has been in practice for more than 30 years, likes his paper file system and may retire before he’s convinced to switch.
“I think that electronic medical records are the future — there is no doubt the industry is going to go paperless,” he said. “But I don’t want to go through an extensive revamping of how I see patients.” Desiderio isn’t the only one who would rather stick with a traditional system than take part in medicine’s digital revolution, which would take him months to transition into — and cost plenty.
Laboratory Reports for More Than 6000 Missing
Memorial Hospital has discovered that laboratory reports containing a certain amount of health information for 6,400 patients are missing. The laboratory reports are used for processing billing and charges for laboratory services, not for clinical care. There is no evidence the missing records have been disclosed to or used by unauthorized individuals.
Md. Hepatitis C Infection Linked to Hospital Worker Accused of Tampering with Needles
Health officials say a Maryland resident’s hepatitis C infection is closely related to infections linked to a traveling hospital worker accused of tampering with needles. The Department of Health and Mental Hygiene said that molecular testing performed at the Centers for Disease Control and Prevention linked the Maryland resident, who was a patient of the Baltimore VA Medical Center.