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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 
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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.
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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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McKesson Applauds DOJ Policy Change on Opioid Quotas


McKessoc Corporation today praised the U.S. Department of Justice’s decision to exercise its authority to reduce opioid production if the agency believes a particular drug is highly diverted.
“We applaud this common-sense action by the Department of Justice. The annual opioid production quota determines the total amount of controlled substances that can be produced each year. That authority is significant as the nation struggles to address the current public health crisis around opioid addiction. This new rule calls on the Drug Enforcement Administration to carefully assess which drugs are being diverted – an important part of the effort to curb opioid misuse and abuse.”
In October 2017, McKesson called on the DEA to revise its annual production quota for opioids.
McKesson is deeply concerned by the impact the opioid epidemic is having on families and communities across the nation—and is committed to being part of the solution. The company has formed an independent foundation dedicated to addressing the crisis, to which McKesson contributed $100 million. The company is also advancing company initiatives aimed at preventing opioid abuse and has offered thoughtful public policy recommendations, including the Prescription Safety-Alert System (RxSAS) technology proposal.
To learn more about McKesson’s comprehensive efforts to address the opioid epidemic, please visit: www.McKesson.com/FightingOpioidAbuse.
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Fortis Healthcare’s Board Approves IHH Healthcare’s Takeover Offer


Malaysian private-hospital operator IHH Healthcare Bhd. (5225.KU) received approval to buy a significant stake in Fortis Healthcare Ltd. (532843.BY), one of India’s largest hospital operators, allowing the company to gain a foothold in India’s growing health care sector.
Fortis’ board has approved IHH’s plan to invest 40 billion Indian rupees ($583.6 million) via a preferential allotment to a wholly owned unit of IHH at 170 rupees a share, subject to approval of shareholders, Fortis said in a filing to the Mumbai Stock Exchange on Friday.
In a separate stock exchange filing to Bursa Malaysia on Friday, IHH said its unit, called Northern TK Venture Pte Ltd., entered into an agreement with Fortis for the proposed subscription of 235.29 million new Fortis Shares by way of preferential allotment representing some 31.1% of the total voting equity share capital of Fortis. This means IHH must make a mandatory general offer for the shares it doesn’t own to conform with India’s takeover rules.
IHH, the world’s second-largest health-care firm by market value after U.S.-based HCA Holdings Inc., outbid the only other competing offer from TPG-backed Manipal Health Enterprises Ltd., according to Fortis.
“The IHH proposal offers a more strategically and financially compelling proposition along with simplicity and certainty,” Ravi Rajagopal, chairman of the board of Fortis, said in a statement.
IHH, which counts Malaysia’s sovereign wealth fund Khazanah Nasional Bhd. as major shareholder, has expanded in Asia, Europe and the Middle East over the past five years. IHH’s expansion is driven in part by a growing affluent class that is willing to pay for better-equipped clinics and private hospitals.
IHH said on Friday that the proposals represent an opportunity for it to further expand its footprint in India, given India’s tremendous growth potential with rising demand for quality private health care.
“The proposals are expected to propel IHH to become a leading Pan-Indian hospital operator, operating more than 5,400 beds in 37 hospitals,” IHH said.
Fortis’ hospital chain consists of 45 healthcare facilities in India, Dubai, Mauritius and Sri Lanka, with a total of about 10,000 beds and 314 diagnostic centers, according to its website.
IHH will fund the deal via a combination of external borrowings and internally funds, according to IHH’s filing.
IHH added that the deal is expected to be completed in the fourth quarter of 2018 and isn’t expected to have any material effect on its earnings for this year.
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Iowa, Illinois investigating infections linked to McDonald’s salad


The Iowa and Illinois health departments said on Thursday that they were investigating cyclospora infections linked to salads at McDonald Corp’s restaurants.

McDonald’s shares fell 1.4 percent after-hours on Thursday.
The Illinois Department of Public Health said it had seen about 90 cases, and the Iowa Department of Public Health said it had recorded 15 cases.
In about one-fourth of the Illinois cases people reported eating salads from McDonald’s in the days before they became ill.
McDonald’s, the world’s largest restaurant chain, said in a statement that it had been in contact with public health authorities in both states.
It said that it had voluntarily stopped selling salads at the approximately 3,000 affected U.S. restaurants until it could switch to another lettuce blend supplier.
“We are closely monitoring this situation and cooperating with state and federal public health authorities as they further investigate,” the company said.
The parasite, cyclospora cayetanensis, infects the small intestine, typically causing watery diarrhea and frequent, sometimes explosive bowel movements. It is spread by ingesting food or water contaminated with feces and not directly from one person to another.
Several outbreaks have occurred in the United States in the past several years, especially during the summer months, that had been linked to imported fresh produce including raspberries, basil, snow peas, and lettuce.
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Select Medical, OhioHealth Expand JV


Select Medical announces an expansion of its joint venture agreement with OhioHealthto combine operations of 38 physical therapy centers throughout Central Ohio.
As part of the partnership, OhioHealth will be majority owner and Select Medical will serve as managing partner.
“We are honored to broaden our partnership with OhioHealth to deliver expanded outpatient rehabilitative patient care in Ohio,” says David S. Chernow, president and CEO of Mechanicsburg, Pa-headquartered Select Medical, in a media release.
Under the agreement, the combined outpatient rehabilitation services will include 22 NovaCare Rehabilitation centers, owned by Select Medical, and 16 OhioHealth centers.  All are currently operating in the region.
“This growing partnership underscores our mission to improve the health of those we serve,” comments Steve Markovich, MD, executive vice president, OhioHealth. “The addition of 22 NovaCare Rehabilitation centers to the existing OhioHealth network will allow patients to have better access to affordable, quality care in their communities.”
Select Medical and OhioHealth formed the initial joint venture in 2013 to operate OhioHealth Rehabilitation Hospital. The 44-bed hospital treats stroke, traumatic brain injury, and spinal cord injury patients, per the release.
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