Biocept announces a provider agreement with Alliance Global FZ to market and distribute Biocept’s Target Selector liquid biopsy tests in the United Arab Emirates and select countries in the Middle East, North & Sub-Saharan Africa, and Southeast Asia region. All diagnostic testing services under this agreement will be performed in Biocept’s San Diego-based CLIA-certified laboratory with Alliance Global having responsibility for sales, marketing, distribution, and reimbursement of the Company’s liquid biopsy platform. Additional terms of the agreement were not disclosed.
Friday, July 13, 2018
InflaRx initiated at buy at BMO
BMO Capital analyst Matthew Luchini initiated InflaRX (IFRX) with an Outperform rating and a price target of $45. The analyst notes that the company’s IFX-1 “could be a best-in-class treatment for hidradenitis suppurativa” skin diseas, with initial data suggesting a “better clinical profile” than Humira. Luchini adds that the strength of IFX-1’s Phase IIa data de-risks the ongoing Phase IIb trial, also stating that “IFX-1’s targeting of C5a could be an advantage over emerging competitor avacopan” made by ChemoCentryx (CCXI).
Advaxis shares gain as FDA lifts clinical hold on its drug trial
Shares of the biotech company Advaxis Inc. ADXS, -8.27% surged 68% in premarket trade on Friday after the Food and Drug Administration lifted a clinical hold on the company’s phase 1/2 study for a cancer drug combination. The clinical hold was put in place in March after a patient death following “acute respiratory failure after nine months of combination therapy,” the company said; it will now implement new measures to detect these types of events early. The trial is testing a combination of Advaxis’ axalimogene filolisbac, a listeria-based immunotherapy, and Astrazeneca’s durvalumab AZN, +4.29% for patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer. Company shares have dropped 29.5% over the last three months, compared with a 5.4% rise in the S&P 500 SPX, +0.87% and a 2.3% rise in the Dow Jones Industrial Average DJIA, +0.91%
J&J verdict likely to increase attention on lawsuits, says Credit Suisse
After a Missouri jury on Thursday ordered Johnson & Johnson to pay $4.69B to 22 women who alleged the company’s talc-based products, including its baby powder, contain asbestos and caused them to develop ovarian cancer, Credit Suisse analyst Vamil Divan said the large number of ongoing litigations are gaining the attention of investors and is not expected to slow. Given the number of cases related to both talc and mesh and the size of the potential verdicts, Divan says it is “challenging” to put reasonable ranges on what J&J’s ultimate liability may end up being, though he notes that J&J has been able to overturn many of the cases and has appealed all of the unfavorable verdicts. Divan maintains an Outperform rating and $151 price target.
Thursday, July 12, 2018
Breast Cancer Surgeons Slow to Adopt ‘Major’ Practice Changes
Despite guidelines from as far back as 2012 stating that axillary lymph node dissection (ALND) is no longer needed in certain early-stage breast cancer patients, most surgeons said they would still likely perform the more involved procedure, a survey study found.
For patients with clinically node-negative breast cancer and ≤2 sentinel nodes with macrometastasis, 49% of surveyed surgeons said they would “definitely or probably” recommend ALND in a patient with macrometastasis in a single node, reported Monica Morrow, MD, of the Department of Surgery at Memorial Sloan Kettering Cancer Center in New York City, and colleagues.
“Although avoidance of axillary dissection has been shown to be safe in high-quality studies, half of surgeons still do it routinely,” Morrow told MedPage Today. “This practice is most common among surgeons not doing a lot of breast cancer, indicating a quality gap.”
And 62.6% of surgeons said they would also opt for ALND if two sentinel nodes had macrometastasis.
“Z0011 clearly demonstrated axillary dissection was not necessary for those two scenarios,” said Morrow.
First presented at a meeting in 2010, the American College of Surgeons Oncology Group Z0011 trial changed practice, revealing that ALND was no better than sentinel node biopsy (SNB) alone in terms of locoregional recurrence or survival among clinically node-negative breast cancer patients with metastases in one or two sentinel nodes. Following breast-conservation surgery, patients also received whole-breast radiation therapy (RT). Guidelines from both the National Comprehensive Cancer Network and the American Society of Clinical Oncology have both reflected the results of the trial since shortly after its publication in 2011.
“This issue needs to be addressed through targeted, clear education,” said Morrow. “These findings were considered very controversial by some when first published, but are now confirmed in other studies and with longer follow-up, and this needs to be made clear to non-specialist surgeons.”
The current study in JAMA Oncology invited 488 surgeons from July 2013 to August 2015 to participate in a survey of five clinical scenarios meant to tease out their acceptance of evidence-based guidelines for use of ALND.
In all, 376 responded, 359 of whom filled out the clinical scenario portions of the surveys completely. Mean participant age was 53.7, and most were men (73.7%). A total of 37.8% of respondents were from low-volume centers, treating 20 breast cancer cases or fewer in the year prior to the survey. The rest were high-volume surgeons, with 29.8% seeing 21 to 50 cases and 28.7% seeing more than 50 in the prior year. Surgeons were found by searching data from the Surveillance, Epidemiology, and End Results (SEER) sites in Georgia and Los Angeles.
In multivariable analysis, surgeons were found to be have a significantly lower propensity to use ALND if they had a higher volume of breast cancer cases in the previous year:
- 21-50 cases: -0.19, 95% CI -0.39 to 0.02
- >51 cases: -0.48, 95% CI -0.71 to -0.24
“The finding that surgeons have been slow to adopt major practice changes is not new,” wrote Sara H. Javid, MD, and Benjamin O. Anderson, MD, both of the University of Washington in Seattle, in a commentary that accompanied the study.
“What will shift surgeon behavior toward higher quality, evidenced-based practices? It has long been recognized that making people aware of their own performance relative to peers can successfully improve the quality of their work,” Javid and Anderson wrote. “With increased visibility of one’s own performance relative to peers and evidence-based standards of practice, combined with the support of a respected credentialing body, such as the American Board of Surgery, toward the delivery and measurement of care, meaningful change is plausible.”
Other factors associated with a significantly lower propensity to use ALND included surgeon recommendation of a minimal margin width:
- 1-5 mm: -0.10, 95% CI -0.43 to 0.22
- no ink on tumor: -0.53, 95% CI -0.82 to -0.24
And participating in a tumor board:
- 1%-9%: -0.25, 95% CI -0.55 to 0.05
- >9%: -0.37, 95% CI -0.63 to -0.11
While ALND does reimburse at a higher rate, Morrow said she does not believe this to be “the major driver” of non-acceptance of Z0011.
“For so many years, removal of axillary nodes was considered an important part of local control and cure, and it is difficult for some to accept the concept that in the era of modern systemic therapy in patients getting breast RT as part of breast-conserving surgery that this is no longer true,” she said. “At the time we surveyed the surgeons in our study the 10-year results of Z0011 were not published, so a small proportion may have been waiting for those to be available.”
But, said Morrow, the main reason is likely that the Z0011 trial represented “a true change in our beliefs about breast cancer management and was very controversial initially.”
The study was funded by a grant from the National Cancer Institute.
Morrow and co-authors disclosed no conflicts of interest, nor did Javid and Anderson.
LAST UPDATED
Primary Source
JAMA Oncology
Secondary Source
JAMA Oncology
2019 Proposed Medicare Fee Schedule Announced
With great fanfare, officials at the Centers for Medicare & Medicaid Services (CMS) on Thursday announced a number of proposed initiatives in the 2019 Medicare physician fee schedule that they say will ease administrative burdens on providers.
“I spent part of the last year traveling the country and visiting clinicians in different care settings,” CMS administrator Seema Verma said on a conference call with reporters. “One thing we heard time and time again is that time spent on paperwork is time away from patients … We heard too many stories about provider burnout. It became clear to me that if we were going to be serious about improving quality and access for patients, we have to improve the lives of providers on the front lines.”
More E/M Documentation Options
One example of this push is several proposed documentation changes aimed at cutting the burden on physicians who provide evaluation and management (E/M) services. These include giving providers the following options:
- Documenting office/outpatient E/M visits using medical decision-making or time instead of applying the current 1995 or 1997 E/M documentation guidelines
- Using time as the governing factor in selecting visit level and documenting the E/M visit, even if counseling or care coordination dominates the visit
- Focusing documentation on what has changed since the last visit or on pertinent items that have not changed, rather than re-documenting information, provided the physician reviews and updates the previous information
- Reviewing and verifying certain information in the medical record that is entered by ancillary staff or the beneficiary, rather than re-entering it
CMS is also proposing to streamline the E/M coding system itself by having “new, single blended payment rates for new and established patients for office/outpatient E/M level 2 through 5 visits and a series of add-on codes to reflect resources involved in furnishing primary care and non-procedural specialty generally recognized services,” the agency said in a fact sheet posted on its website.
This change includes a “minimum documentation standard” for a level 2 visit “where Medicare would require information to support a level 2 CPT visit code for history, exam and/or medical decision-making in cases where practitioners choose to use the current framework, or, as proposed, medical decision-making to document E/M level 2 through 5 visits,” CMS said.
“In cases where practitioners choose to use time to document E/M visits, we propose to require practitioners to document the medical necessity of the visit and show the total amount of time spent by the billing practitioner face-to-face with the patient,” the fact sheet continued. Although physicians might want to include additional information for clinical or legal reasons, “we would only require documentation to support the medical necessity of the visit and associated with the current level 2 CPT visit code.”
The agency estimated that making these changes to E/M coding will save providers 51 hours per year, an amount that Verma said was “one of the most significant reductions in provider burden undertaken by any administration.”
Changes in Part B Drug Payments
The agency also is proposing to change the way it pays for new drugs that physicians administer under Part B of the Medicare program. Under the current system, during the first two quarters that a new drug is on the market, Medicare pays the physician the drug’s wholesale acquisition cost (WAC) plus a 6% fee to cover office overhead and the cost of administration. CMS is proposing to cut the payment to WAC plus 3%, “so the payment amount more closely matches the actual cost of the drug,” Verma said.
After the first two quarters, reimbursement for the new drug would revert to the current system, which pays doctors the average sales price of the drug plus an additional 6%.
CMS also is proposing changes to Medicare’s Merit-Based Incentive Payment System (MIPS), which is used by physicians who aren’t participating in an advanced payment model such as an accountable care organization. The MIPS program requires providers to submit data on six quality measures of their choice. “We’re proposing to remove process-based measures [from MIPS],” Verma said. “Many of these measures are ‘topped out'” — that is, almost all providers are reporting that they’re doing very well on them.
“We’ve heard from doctors that using these measures is really just measuring processes and doesn’t focus on improving patient outcomes,” she continued. CMS’s proposal “would remove 34 measures from the program immediately while continuing to focus on patient safety, saving providers collectively an estimated 26,313 hours, or more than $2.3 million in 2019.”
On the advanced payment model side, CMS is seeking to drop 10 measures for accountable care organizations “that aren’t driving toward improved quality,” Verma added.
Increasing Telemedicine Use
The agency also is trying to increase the use of telemedicine. “Under this proposal, Medicare will start paying for virtual check-ins, meaning patients can connect with their doctor by phone or video chat,” she said. “Many times [that will] get them the care they need and avoid unnecessary costs in the system. This is not intending to replace office visits, but rather to augment them and create new access points for patients.” The proposed rule also would allow for payment when the doctor reviews an image that a patient texts to the office.
One area that Verma did not discuss on the call was the overall percentage increase in the amount that Medicare was reimbursing physicians. Last year, Medicare increased overall payments to physicians by 0.41%. This year, payments will increase by $0.3 billion — that includes a 0.25% increase as mandated in this year’s Bipartisan Budget Act, minus 0.12 percentage points to account for some changes in relative value units.
The proposed rule also lists the fee schedule’s final conversion factor — the amount that Medicare’s relative value units are multiplied by to arrive at a reimbursement for a particular service or procedure under Medicare’s fee-for-service system. That figure is $36.05, up slightly from last year’s conversion factor of $35.99.
Half of Parents Use Cell Phones While Driving with Young Children in the Car
A new study from a team of researchers at Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania School of Nursing (Penn Nursing) found that in the previous three months, about half of parents talked on a cell phone while driving when their children between the ages of 4 and 10 were in the car, while one in three read text messages and one in seven used social media.
The study also found a correlation between cell phone use while children were in the car and other risky driving behaviors, such as not wearing a seat belt and driving under the influence of alcohol whether or not children were present in the car.
The findings were published in the Journal of Pediatrics.
Crash fatalities and injuries caused by distracted driving constitute a public health crisis in the U.S., resulting in about one in four motor vehicle crashes. Previous research suggests that causes of distracted driving by parents and caregivers include talking on hand-held or hands-free cell phones or using phones to text, email, or access the Internet.
Researchers wanted to identify specific factors associated with cell phone-related distracted driving in parents and caregivers of children between the ages of 4 and 10.
“Technology has become increasingly intertwined with our daily lives,” said lead author Catherine McDonald, PhD, RN, FAAN, a Senior Fellow with CHOP’s Center for Injury Research and Prevention and an Assistant Professor of Nursing in the Family and Community Health Department at Penn Nursing. “The results from this research reinforce that risky driving behaviors rarely occur in isolation, and lay the groundwork for interventions and education specifically aimed at parents who drive with young children in their cars.”
The study was conducted using an online sample of 760 adults from 47 U.S. states. The respondents had to be at least 18 years old, a parent or routine caregiver of a child between the ages of 4 and 10, and had driven their oldest child between those ages at least six times in the preceding three months.
In the preceding three months, 52.2 percent of parents had talked on a hands-free phone while driving with a young child in the car, while 47 percent had done so with a hand-held phone. The study also found that 33.7 percent of parents read text messages while 26.7 percent sent text messages while driving with children. Social media also contributed to distracted driving, with 13.7 percent of respondents reporting using social media while driving with children.
The study also looked at child restraint system (CRS) use for children in the same age group. The study found that 14.5 percent of parents did not consistently use their typical CRS when driving with their children. Drivers who did not consistently use their typical CRS were more likely to engage in cell phone use while driving.
Finally, the study looked at parent and caregiver risky behavior associated with driving, including not wearing a seat belt as a driver and driving under the influence of alcohol, whether or not their children were in the car. The researchers saw a direct correlation between a history of driving under the influence and increased likelihood of all types of cell phone use while driving with children in the car. All cell phone-related distracted driving behaviors other than talking on a hands-free phone increased if a person did not always wear their seat belt while driving with children.
“When clinicians are discussing child passenger safety with families, they can use the opportunity to ask and educate about parental driving behaviors such as seat belt use and cell phone use while driving,” McDonald said. “This type of education is especially pivotal today, as in-vehicle technology is rapidly changing and there is increased – and seemingly constant – reliability on cell phones. However, it is also important to note that even parents who did not engage in risky behaviors, such as not wearing a seat belt as a driver or driving under the influence of alcohol, still used their cell phones while driving.”
McDonald said that future studies are needed to understand if unsafe distracted driving behaviors by parents influences their children as they become young drivers in the future.
The authors would like to acknowledge the National Science Foundation (NSF) Center for Child Injury Prevention Studies at the Children’s Hospital of Philadelphia (CHOP) for sponsoring this study and its Industry Advisory Board (IAB) members for their support, valuable input and advice. This material is also based upon work supported by the National Science Foundation under grant number EEC-1460927.
McDonald et al, “Factors Associated with Cell Phone Use While Driving in a Survey of Parents and Caregivers of Children ages 4-10 Years,” Journal of Pediatrics, online July 12, 2018.
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