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Friday, August 3, 2018

CDC: E-Cigarette Sales in the United States Climb As Prices Fall


There was a large increase in sales of electronic cigarettes (e-cigarettes) and related products in the United States in recent years as their prices fell, according to a study published online Aug. 2 in the U.S. Centers for Disease Control and Prevention’s Preventing Chronic Disease.
Teresa W. Wang, Ph.D., from the CDC in Atlanta, and colleagues found that average monthly sales of such products rose 132 percent from 2012 to 2017.
During the same period, “average monthly prices significantly decreased in 39 states for rechargeables, in 31 states for disposables, in 20 states for pre-filled cartridges, and in eight states for e-liquids,” the authors write. “Overall, U.S. e-cigarette unit sales generally increased as product prices decreased.”
In related news, U.S. Food and Drug Administration officials have said that the agency is preparing a new product standard for e-cigarettes. The FDA has a number of concerns about e-cigarettes, including harmful chemicals they might contain and the risk they could get young people addicted to nicotine.

Uncompensated-care audits coming in fall


Now that hospitals’ uncompensated-care claims affect how much the federal government pays them, the industry is bracing for heightened scrutiny of its reporting.
This is the first fiscal year of a three-year phase-in during which the CMS will use hospitals’ charity care and bad debt, together known as uncompensated care, to calculate their disproportionate-share hospital payments. Those payments used to be based mostly on how many Medicaid, dual-eligible and disabled patients hospitals served, but the Affordable Care Act included the switch under the assumption that more people would gain coverage under Medicaid and subsidized plans.
“It was really looked at as a threat before, for lack of a better term, but now it’s being implemented,” said Brian Green, a director with accounting firm RSM and co-leader of its regulatory practice, on the impending audits.
The CMS pledged to scrutinize hospitals that show a high ratio of uncompensated care to total operating costs, but emphasized in its final 2019 acute-care hospital inpatient prospective payment system rule last week that its audit protocols are confidential. The agency did reveal it expects to begin audits this fall. That means hospitals will have to walk a thin line between not leaving claims on the table and potentially being accused of claiming too much if they’re audited, said Christopher Kenny, a partner with King & Spalding who specializes in healthcare.
“You’re left in a bit of a quandary where if you don’t claim everything you feel you are entitled to claim, you are going to potentially be left with a smaller share of the (uncompensated-care cost) pool,” he said. “But at the same time … are they going to claim that some providers were overly aggressive in what they claimed? Who knows.”
Tim Wolters, director of reimbursement at Citizens Memorial Hospital in Bolivar, Mo., said he thinks the new method is a fairer way to determine uncompensated-care payments. It prevents hospitals in states like his that did not expand Medicaid from receiving lower uncompensated-care payments, which happened under the old formula.
“Hospitals had no choice in the matter; we had to play the cards dealt to us,” he said. “So to punish the hospital just because the state legislature didn’t expand Medicaid, that makes no sense.”
Even in New York, a state whose expanded Medicaid program now covers more than 6 million people, executives with the country’s largest public health system say they also support the change. That’s because NYC Health & Hospitals serves roughly 400,000 uninsured patients a year, most of whom weren’t counted under the old formula.
“That measure we think more accurately reflects our proportion of care provided to uninsured patients rather than using the Medicaid and (Supplemental Security Income) days as a proxy,” said Linda DeHart, the system’s assistant vice president for reimbursement.
The American Hospital Association says it’s worried that hospitals won’t report their uncompensated care accurately because of a lack of clear instructions. The trade group asked the CMS to delay the use of the S-10 worksheet, the section of the Medicare cost report where hospitals report uncompensated care, in calculating DSH payments until fiscal 2019, rather than the current fiscal year. The CMS declined, but it agreed to use the three-year phase-in approach the AHA recommended.
Erika Rogan, the AHA’s senior associate director of policy, wrote in an email that hospitals need more education on how to accurately complete the S-10s.
The AHA also asked the CMS to implement a stop-loss policy to protect hospitals set to lose more than 10% of their DSH payments in a given year as a result of transitioning to the S-10. The AHA estimates nearly 18% of hospitals will fit that bill in fiscal 2019. In its final rule, the agency declined to implement such a policy. A CMS spokesman did not return a request for comment.
The S-10 is relatively new to hospitals, and there’s some evidence that the amounts reported on the form aren’t always accurate. A 2017 CMS-commissioned study by Dobson DaVanzo & Associates compared uncompensated-care data reported on S-10 forms with numbers reported on Internal Revenue Service Form 990s between 2011 and 2013. The study found that although the data were highly correlated, there were big differences in what hospitals reported between the measures. For more than half of the hospitals, for example, the difference between the uncompensated care reported on the two forms was around 40%.

medicaid expansion by state 2018

Commenters on the CMS’ proposed rule noted that hospitals reported uncompensated-care costs that ranged from 0.14% to 250% of total revenue.
NYCH&H’s DeHart said while she agrees there’s room for improvement, the CMS has discussed using the S-10 worksheet for quite some time.
“Whatever flaws there may be related to the reporting instructions or the fact that they haven’t been audited, our understanding is that it’s still a better proxy for measuring what the intent of this funding is, which is to support hospitals providing uninsured care,” she said.

Know your hospital’s policy

One thing’s for sure: Hospitals must strictly adhere to their own financial assistance policies, which is the key factor that auditors will examine, Kenny said. Policies often require documentation of the patient’s financial or asset verification whenever charity care is provided. That doesn’t always happen in practice, however, especially when it’s abundantly clear to a staff member—perhaps a patient accounts employee—that a patient is indigent and eligible for discounted or free care.
“Hospitals just need to be very aware that what’s in their policies will count,” Kenny said, “and to the extent they 
haven’t revisited those policies, in light of recent changes, they absolutely should.”
Beginning Oct. 1, hospitals will be required to submit patient-level data along with their uncompensated-care numbers under the CMS’ final inpatient rule. The rule requires hospitals to send records for each patient encounter that contributed to the uncompensated care amount reported on their S-10 worksheets. Currently, hospitals submit the total numbers, but not the patient-level data.
Chad Krcil, a senior manager in Crowe’s Medicare reimbursement and compliance unit, said he doesn’t think this will be overly burdensome for hospitals, as they are supposed to have that supplemental information ready in case of an audit.
Not everyone agrees. RSM’s Green said he believes those requirements will place a significant burden on hospitals, many of which simply add up the charity care write-offs listed in their ledgers to report charity care levels, rather than combing through patient data.
That’s what happens at Citizens Memorial Hospital. Wolters said he knows the patient-level records are out there, he just doesn’t collect them for every cost report. To comply with the new requirement, he’ll likely develop a separate reporting system to collect charity-care records. Wolters said the process could get “pretty cumbersome” for hospitals if the CMS asks for information that’s not routinely collected in their write-off reports.
The CMS hasn’t released a standard financial assistance policy template for hospitals to follow, and industry experts said the agency isn’t likely to do so, as each facility has different degrees of charitable giving and patient populations.
“It’s not like some other policies out there where the CMS can get very prescriptive about what needs to be done,” Kenny said, “and sometimes providers can find that a little frustrating. They would like a little bit more guidance.”
Uncompensated-care data that hospitals submitted from fiscal 2014 and 2015 originally showed dramatic swings, so the CMS issued clearer instructions and last year allowed hospitals to resubmit data for those years. More than half of hospitals resubmitted their data, which was due in January, Green said.
The CMS did not say whether it will let hospitals resubmit their uncompensated-care data for determining payments in fiscal 2020 and beyond.
Uncompensated-care DSH payments historically have been calculated under a formula that uses Medicaid patient days, which was a boon to hospitals in states that expanded Medicaid. The new methodology will gradually shift the benefit to hospitals in states that did not expand Medicaid, as they’re likely treating higher proportions of patients who would qualify for charity care or bad debt, and thus would see higher levels of uncompensated care.
“Is your state participating in the ACA? If they are, then it might be harmful to you from an uncompensated-care payment perspective,” Jonathan Skaggs, senior manager with healthcare consulting and accounting firm PYA, said of the new DSH payment methodology.

CDC: Coal Workers With Black Lung Disease Are Dying Earlier


Coal workers who died of black lung disease in recent years lost more years of life relative to their life expectancies than workers dying of the occupational disorder just a few decades ago, the CDC reports.
The study findings, published in Morbidity and Mortality Weekly Report, are consistent with a reported increase in a particularly aggressive type of black lung disease known as progressive massive fibrosis, or PMF.
In February of this year, the CDC’s National Institute for Occupational Safety and Health (NIOSH) reported the largest cluster of PMF ever, with close to 600 cases identified at three medical clinics in southwestern Virginia between 2013 and early 2018. Clusters of the disease have also been identified in Kentucky and West Virginia coal regions.
Last May, the U.S. Department of Labor reported that 4,679 cases of PMF have been diagnosedamong coal miners since 1970, with half of those cases occurring after 2000.
The resurgence of black lung disease among coal miners, starting in the mid-1990s, has been blamed, in part, on changes in mining practices. This includes longer shifts, increased surface mining and mining of narrower, lower-grade coal beds, which create more silica dust. Silica is much more toxic to the lungs than coal dust.
In the newly published analysis, NIOSH researchers identified black lung deaths among coal workers from 1999 to 2016, and calculated years of potential life lost to life expectancy overall (YPLL) and years of potential life lost before the age of 65 years (YPLL65).
The overall number of coal workers dying of black lung disease, known medically as coal-workers’ pneumoconiosis (CWP), decreased steadily from 1999 to 2016 — a high of 409 workers in 1999 to a low of 112 in 2016.
But during this period, the mean years of potential life lost to life expectancy increased by 55.6%, from 8.1 years of life lost to 12.6 years per decedent. This increase was mostly observed in the years 2003 to 2016.
The researchers noted that the decline in the age-adjusted CWP death rate might be explained, in part, by the decline in employment in the mining industry.
The YPLL65 per decedent ages 25 to 64 increased sharply at first — from 4.3 in 2002 to 8.9 in 2005 — before then gradually decreasing to 6.5 in 2016. Highest mean YYPLs65 per decedent were 7.2 in 2000, 9.6 in 2004, and 9.3 in 2008.
“The growing gap between each decedent’s actual age at death from CWP and his or her life expectancy corroborates recent reports of increasing prevalence and severity of CWP and of rapid disease progression among coal miners,” the researchers wrote.
In a 2014 report, CDC researchers reported an 8.6-fold increase in the prevalence of PMF from an annual average of 0.37% in the mid-to-late 1990s to 3.23% between 2008 and 2012 among miners in Kentucky, Virginia, and West Virginia participating in the Coal Workers’ Health Surveillance Program.
“The sharp increase in YYPLs65 was worrisome because it very likely reflected the increased prevalence we have observed in progressive massive fibrosis,” NIOSH researcher Jacek Mazurek, MD, PhD, told MedPage Today.
“We believe this finding is consistent with these earlier reports,” he said. “Miners are dying earlier than would be expected and the gap is growing.”
In 2014, the federal government decreased allowable exposures to respirable coal mine dust, made changes in dust monitoring, and directed NIOSH to expand medical monitoring for coal mine dust lung diseases.
CDC monitors miner health under the Coal Workers’ Health Surveillance Program, established in 1969.
Mazurek said the reported PMF clusters and mortality data highlight the importance of continuing to closely monitoring miner health during their working years and in the years after they leave the mines.
It also underscores the importance of programs addressing primary exposure prevention, secondary prevention through early disease detection, and appropriate medical care of patients with coal workers’ pneumoconiosis, the researchers concluded.
The researchers reported no relevant relationships with industry related to this study.
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Janssen, Bayer to close South Korean plants due to limited demand


Another drugmaker will close up manufacturing in South Korea. Janssen Korea will shutter its Hyangnam plant in Hwaseong, South Korea, by 2021, laying off an undetermined number of workers.
According to a Janssen Korea spokesperson cited by The Korea Times, the closure is a strategic decision made over limited needs for solid-dosage drugs.
“Our manufacturing network for solid dosage forms was found to have significant excess capacity, and our future pipeline is unlikely to drive significant volume upside for the solids, due to an ongoing shift of production to cancer drugs and immune booster injections,” the spokesperson told the Korean newspaper.
A Johnson & Johnson spokeswoman confirmed the closure to FiercePharma, saying that the company reached the conclusion after a review of existing and future global manufacturing capabilities.
“This decision was not made lightly, and Johnson & Johnson remains committed to the Korean market, with further investment planned for the company’s Incheon facility and through its local partnership to produce innovative beauty products in Cheongju for the global market,” said the spokeswoman.
It is not yet clear how many staffers will be affected, but the J&J spokeswoman said the company will provide them with resources, support and opportunities for ongoing employment during the next three and half years.
The Janssen announcement follows one by Bayer, which in May said it would close a plant in Anseong that manufactures contrast media, according to Business Korea. It now intends to stop operations at the plant by the end of the year as it seeks a buyer.

Bayer has been selling off assets to fund its Monsanto acquisition. It has just agreed to sell its prescription dermatology unit to Denmark’s Leo Pharma.
A declining Korean market and hence an increasing payroll burden was cited as a reason for the closure. “We have no reason to maintain our plants in every country, because of the global tendency of establishing integrated logistics centers,” a Bayer Korea spokeswoman said, as quoted by The Korea Times.
This is at least the second plant Bayer has closed in the country, following the shutdown of its Namyangju plant in 1999. After that, Novartis, Eli Lilly, Pfizer, Roche, Boehringer Ingelheim and Merck & Co. followed suit, and over 16 plants run by multinational pharma companies have been closed in South Korea over the past two decades, according to Business Korea’s tally.
In contrast to global pharmas’ retreat from Korea, some local drug manufacturers are expanding. For example, buoyed by the increasing global need for biologics, CDMO giant Samsung BioLogics is in the process of completing a third, $740 million biologics plant in Incheon, and a fourth one could be on the horizon should drugs by major clients Roche and Biogen pass clinical tests.

PerkinElmer Q2 Revenues Jump 29 Percent, Beat Analyst Estimates


PerkinElmer reported after the close of the market on Wednesday that its second quarter revenues grew 29 percent year over year as the company beat analyst estimates on the top and bottom lines.
For the three months ended July 1, 2018, PerkinElmer reported revenues of $703.4 million compared to $547.0 million a year ago and topping the Wall Street expectation of $693.0 million. Organic revenue growth was 10 percent year over year.
Revenues from the company’s diagnostics business grew 66 percent on a reported basis to $272.7 million from $163.8 million in the year-ago period. Diagnostics revenues increased 10 percent on an organic basis.
Revenues from the discovery and analytical solutions (DAS) business grew 12 percent on a reported basis to $430.6 million from $383.1 million in Q2 2017. On an organic basis, DAS revenues increased 10 percent.
On a conference call with analysts following the release of the earnings, PerkinElmer Chairman and CEO Robert Friel said the company is tailoring its portfolio to more attractive end markets and investing in innovative new products and services.
In the DAS business, he noted, “we are experiencing strong customer uptake of both our new imaging and analytical instrumentation, as well as solutions spanning informatics and service in both the pharma and applied markets.”
And as for the diagnostics business, he added, the company’s two major focus areas this year have been to identify key technology synergies with Euroimmun, which PerkinElmer acquired about a year ago, while maintaining its historical growth rate. “In our core diagnostic businesses, we are strengthening our respective franchises in reproductive health and genomics by expanding our detection capabilities, product and service offerings, and continuing to build out our presence in emerging markets,” Friel said.
Friel also said that the Euroimmun business grew in the mid-teens through the first half of the year, and that PerkinElmer is ahead of schedule in its plans to integrate the two companies’ product lines. Further, Euroimmun and Tulip, the privately held Indian diagnostics firm that PerkinElmer acquired two years ago, have been working together to develop new tests for infectious diseases, specifically for arboviruses in emerging markets.
He added that the firm’s relatively new genomic testing business continues to see “very good uptake,” and that it grew well in excess of 100 percent, though that started from a low base. The firm plans to continue providing confirmatory testing, and expanding its partnerships with pharma and biotech companies to treat rare diseases. “We’ll probably put in another five NovaSeqs in September to handle what we expect to be the significant volume uptake here,” Friel said.
Importantly, Friel noted that PerkinElmer has submitted its Vanadis NIPT diagnostic system for CE marking in Europe. “The reaction from prospective customers who were briefed on the system was very positive, and we expect to receive CE-IVD approval very soon,” he said, adding, “We’ve effectively already identified 10 labs that will be getting the systems throughout the remaining part of 2018. And then, as we sort of ramp up production, we’ll look to expand that across Europe, initially, and then ultimately, probably not until 2020, we’ll look to expand into other geographic regions.”
When asked about the firm’s perfomance in China, Friel noted that PerkinElmer continues to do well in the country, and still sees it as a strong growth opportunity. But there are potential headwinds, given the US government’s recent policy of levying tariffs against China, he added. Currently, that headwind is probably $1 million or less, Friel said, which could be absorbed in productivity or pricing.
“That’s mostly coming from products produced in China and used in our supply chain. When you look at the other way, right now there’s virtually no diagnostic product that comes from the US into China,” he said. “On the DAS side, we think there is probably $75 million to $80 million of product that goes from US into China. And we’ve looked at our ability to move that production. Some of it we can move relatively quickly, others probably would take us six to nine months, and we’re starting to put some contingency plans in place that would allow us to do that.”
PerkinElmer hasn’t put any plans into motion, he added, but those plans could be effectuated quickly if they’re needed.
PerkinElmer reported a Q2 net income of $64.1 million, or $.57 per share, down from $204.1 million, or $1.84 per share in the year-ago period. On an adjusted basis, earnings per share was $.91, besting analysts’ consensus estimate for EPS of $.86.
The company’s Q2 R&D costs rose 40 percent to $47.2 million from $33.6 million, while its SG&A spending shot up 37 percent to $204.9 million from $149.9 million a year ago. PerkinElmer also reported a loss of $610,000 from discontinued operations and dispositions in the recently completed quarter compared to a gain of $141.3 million a year ago.
PerkinElmer ended the quarter with $163.4 million in cash and cash equivalents.
The company said that based on the strong quarter it is raising its full-year 2018 guidance for EPS from continuing operations to $2.39 from a previous forecast of $2.25. On an adjusted basis, the company raised full-year EPS guidance to $3.65 from previous guidance of $3.60. Analysts expect full-year EPS of $3.61.
On the conference call, PerkinElmer CFO James Mock said that the company is expecting third quarter reported revenues of $675 million, and adjusted earnings per share of $.92. Analysts are expecting revenues of $687.5 million and earnings of $.92 per share for Q3.

Exact Sciences Q2 Revenues Up 78 Percent


Exact Sciences reported after the close of the market on Wednesday that its second quarter revenues rose 78 percent year over year, thanks to a 59 percent increase in testing volumes for its Cologuard noninvasive colon cancer screening test.
For the three months ended June 30, the molecular diagnostics company reported revenues of $102.9 million, up from $57.6 million in Q2 2017. But the results missed analysts’ average estimate of $104.7 million.
The firm completed about 215,000 Cologuard tests during the quarter and said that more than 10,000 healthcare providers ordered their first Cologuard during Q2 2018. Nearly 121,000 clinicians have ordered Cologuard since the test was launched. The average recognized revenue per test during Q2 was $479, Exact added. The company had guided for test volumes of 220,000 to 230,000 in Q2 after reporting its first quarter earnings.
“We are excited about the continued growth of our physician ordering base, as well as their increasing Cologuard utilization, which led to a record quarter for revenue, volume, and gross profit,” Exact Chairman and CEO Kevin Conroy said in a statement. “We are optimistic about the company’s future, including the opportunity to expand Cologuard’s label to reach even more people in the 45 to 49 age group, given the American Cancer Society’s recent guideline update.”
On a conference call with analysts following the release of the earnings, Exact CFO Jeff Elliott noted that one reason the company didn’t hit its expected guidance for test volumes in Q2 was that it didn’t see the full increase in orders it expected during June. He also said that fewer patients than expected returned their Cologuard kits to the company later in the quarter. However, Elliott also noted that the compliance rate for Cologuard is at 68 percent, which is significantly higher than other testing modalities for colon cancer, such as colonoscopy.
Conroy confirmed that the test volumes were tracking in the middle to the upper end of the firm’s expected range for most of the quarter, but that the unexpected drop in patients returning kits did have an impact on final test volumes for the quarter. He added that although Exact estimates that about 90 percent of patients currently have access to Cologuard with no out-of-pocket costs, some patients may be unwilling to pay potential out-of-pocket cost for the test if it wasn’t covered by their insurance company. This leads to a small number of patients not returning their kits.
However, he also noted that Exact signed a coverage deal for Cologuard with Anthem Blue Cross Blue Shield in Indiana, Ohio, Kentucky, Missouri, and Wisconsin during Q2, and that the company is continuing to sign coverage deals with other insurers. As this continues, he added, the problem of patients having to pay for the test out of pocket will be ameliorated, which could also have a positive impact on the rate of kit returns. Conroy also said the company is concentrating its sales reps on prescribing physicians with the highest potential for reorders.
Further, Conroy said, moving the screening age for colon cancer to 45 means an additional 21 million people in the US need to be screened. The company is working to expand Cologuard’s label to include the 45 to 49 age group. Responses to a survey of 500 people in this age group that Exact conducted shows they’re more comfortable with taking an at-home stool test, he added.
He also noted that the company is still making investments in TV ads. It has rolled out a new 60-second ad, and plans to unveil new ads in the fall to reach a greater number of consumers through digital and social media. “The investments we’re making in sales and marketing are aimed toward achieving our 40 percent long-term market share goal,” Conroy said.
The firm’s net loss for Q2 widened to $36.4 million, or $.30 per share, from $30.8 million, or $.27 per share, a year earlier. Analysts had expected a loss per share of $.33 for Q2.
Exact’s Q2 R&D costs rose 52 percent to $14.7 million from $9.7 million in the year-ago period, and its SG&A expenses rose 53 percent to $94.0 million from $61.3 million in Q2 2017. Elliott noted on the call that the higher R&D costs are due to expenses for new test development, and that the higher SG&A expenses are due to hiring of new sales reps.
The company ended the quarter with $225.7 million in cash and cash equivalents and $996.5 million in marketable securities.
Exact said it continues to anticipate revenues of $420 million to $430 million for full-year 2018. Analysts are expecting 2018 revenues of $435.8 million. On the call, Elliott reaffirmed the company’s previous guidance for 2018 Cologuard test volumes of 900,000 to 920,000, but noted that it expects to finish near the low end of that range.
Conroy also said that the company is making progress on its test for liver cancer, which Exact sees as an unmet market opportunity worth as much as a $1.5 billion. The firm has conducted two case-control studies of the test, each showing 95 percent sensitivity. One study showed the test had 97 percent specificity and the other showed 93 percent specificity. It is a substantial improvement over current options, Conroy said, adding that Exact is currently enrolling patients in a third, larger study to further validate and finalize the test’s design.
In notes to investors on Thursday, analysts said that while Exact did miss its test volume projections for the quarter, its overall business strategy is solid, and the sell-off in its stock following its earnings release could serve as an attractive entry point for people looking to invest in the shares.
“Based on our conversation with management post the call, we come away thinking that its surprise Q2 miss on volumes marks a temporary dislocation. We believe the Q3 guide is readily beatable, and we think there are enough drivers to enable the company to exceed the low end of its 2018 volume guidance,”Canaccord Genuity’s Mark Massaro wrote. He called the after-hours dip in the company’s stock “overblown,” and added that he believes Exact has the management and sales force in place to correct “what appears to be a transitory issue.”
William Blair’s Brian Weinstein concurred, noting that while the miss on test volumes is “frustrating,” Exact’s growth is not stalled. “The opportunity remains vast and remains barely penetrated, market access is at a record level… and reorder volume from patients who took the test three years ago has just begun to trickle in,” he said.
Overall, Weinstein added, nothing he saw in Exact’s Q2 earnings has dissuaded him from the thesis that the company has long-term growth potential. “We would use what seems to be setting up to be a meaningful valuation correction to move into what we still see as an important long-term growth stock,” he wrote.

Women with common ovary condition often feel medical system failed them


Many women with polycystic ovary syndrome feel they’ve been let down by a health care system that takes years to diagnose their condition, a new survey suggests.
Researchers found that women with polycystic ovary syndrome, or PCOS, a common condition characterized by metabolic and fertility problems, were more likely than others to distrust their primary care physician’s judgment and to feel that they weren’t getting enough social support from health care providers.
“I would hope that women with polycystic ovary syndrome will find it encouraging that there’s a growing acknowledgement that they are dissatisfied with their medical experience,” said study coauthor Marla Lujan of Cornell University. “What hasn’t been recognized is how important a role social support plays. If you trust your health care providers and enjoy your interactions with them, you’re more likely to go back.”
Though it’s estimated that anywhere from 7 to 20 percent of reproductive age women suffer from PCOS, women often see many doctors over many years before they get a diagnosis. Part of the problem is that there isn’t a single, simple test for PCOS.
That means the diagnosis is based on symptoms.
Women are diagnosed with the condition if they have two out of three hallmark symptoms: irregular periods or no menses at all; clinical evidence of high levels of male hormones, which can lead to increased acne and hair growth in places such as the chin, upper lip and sideburns; and a large number of follicles on the ovaries that show up as small bumps on ultrasound.
Another contributor to delayed diagnoses may be primary care physicians’ lack of familiarity with the condition, not to mention the latest information on it, said Dr. Andrea Dunaif, chief of endocrinology, diabetes, and bone diseases for the Mount Sinai Health System and the Icahn School of Medicine in New York City.
The name, which is really a misnomer, doesn’t help, Dunaif said. The bumps on the ovaries aren’t cysts and the condition has symptoms that go far beyond the reproductive system, she explained.
PCOS has also been linked to increased risks for diabetes, obesity and heart disease.
As reported in the Journal of the Endocrine Society, Lujan’s team surveyed 322 U.S., 134 diagnosed with PCOS and 198 without the condition. While women with PCOS believed their primary care physician was well qualified to treat general health issues, they had less confidence in their doctor’s knowledge of PCOS.
Women with PCOS also reported having arguments with their primary care physicians and feeling an overall lack of emotional support and empathy.
That doesn’t surprise Dunaif. “When they go to their primary care physicians, particularly if it’s not a gynecologist, the physician often isn’t going to be educated about what they have,” Dunaif said. “And so, the physician is going to think the patient’s complaints about irregular periods and difficulties losing weight don’t make sense.”
That leads to the women’s complaints being discounted, Dunaif said. “And they’re not getting the answers they need,” she added. “Typically the patient I see has become very frustrated.”
The internet has been a boon to patients with PCOS, Dunaif said. “They get online and figure it out and then tell their physicians,” she said. “When they say they argue with their physicians, I think the arguments are based on the fact that they have become more knowledgeable than their physicians in this area.”
Dunaif has a piece of advice for primary care physicians. “Menses are a vital sign,” she said. “You should be asking women what their menstrual history is. It can be a sign that there is an endocrine disorder that needs to be diagnosed.”
SOURCE: bit.ly/2n843w7 Journal of the Endocrine Society, online August 1, 2018