Wednesday, September 12, 2018
Hologic sees Q4 EPS at the low end of its previous view
On August 13, Hologic made a statement describing the decision by its Cynosure division to suspend marketing and distribution of its TempSure Vitalia handpieces and single-use probes, and to ask customers to return any Vitalia handpieces and unused probes they had purchased. Cynosure had launched the Vitalia handpiece and probe under an FDA 510k clearance and had been marketing the device for heating of vaginal tissue.”This decision was made in response to a public statement made by the FDA and letters it sent to Cynosure and other medical aesthetics companies expressing concerns regarding “vaginal rejuvenation” procedures using energy-based devices. Cynosure received such a letter relating to its MonaLisa Touch laser,” said the company. The company is now providing an update on the financial impact of its actions in advance of meetings with investors at the Morgan Stanley 16th Annual Global Healthcare Conference later this week.The company now expects Cynosure revenue in the current fourth quarter of fiscal 2018 to be approximately $15M less than previously forecast. However, Hologic is reaffirming its financial guidance provided on July 31.Hologic continues to expect revenue in the fiscal fourth quarter to be in the range of $800M- $815M. “Since refunds and rebates related to TempSure Vitalia will be recorded as reductions to revenue, which reduce operating income on a dollar-for-dollar basis, the company now expects earnings per share in the fiscal fourth quarter to be at the low end of its previous GAAP and non-GAAP guidance ranges.”
https://thefly.com/landingPageNews.php?id=2789657
Fitbit hit as Apple discusses health features of new Watch
Apple (AAPL), at its product event, has said that Apple Watch Series 4 received FDA clearance and is the first over-the-counter ECG product. As Apple’s event continues, shares of smartband and smartwatch maker Fitbit (FIT) are down about 3% to $5.77 per share.
https://thefly.com/landingPageNews.php?id=2789507
Behavioral Therapy Slows Decline in Mild Cognitive Impairment
A behavioral intervention appeared to slow cognitive and functional decline in older black individuals with mild cognitive impairment, a randomized clinical trial found.
Over a 2-year period, behavioral activation therapy — which helped patients set goals to increase cognitive, physical, and social activity — was associated with an 88% reduction in cognitive decline, compared with open-ended supportive therapy, reported Barry Rovner, MD, of Jefferson Hospital for Neuroscience in Philadelphia, and colleagues in JAMA Neurology.
“This is the first study to show that a behavioral treatment like this can prevent cognitive decline in people with mild cognitive impairment,” Rovner said in an interview with MedPage Today. “There are no drugs that do that. And, more importantly, this is something anybody can do.”
African Americans are a high-risk, understudied population with nearly twice the rate of dementia as whites, Rovner noted: “It’s a consequence of exposures during life. They are exposed to greater social adversities on average and have higher levels of medical risks for cognitive decline.”
Previous trials of behavioral interventions to prevent cognitive decline have had mixed results, he added. The FINGER trial found that a multi-domain lifestyle intervention improved or maintained cognitive scores among elderly people who were at risk for dementia. The MAPT trial showed no significant effect in cognitive decline with any of three treatment interventions over 3 years, although a secondary analysis showed benefits for participants who had high cardiovascular risk scores.
In the new trial, Rovner and co-authors studied 221 black patients with mild cognitive impairment, randomly assigning them to behavioral activation (experimental treatment) or supportive therapy (control). Participants enrolled from 2011 to 2014, and follow-up ended in December 2016. The average age of the group was about 76, and 79% were women.
Participants in the behavioral activation group used goal-setting and action plans to reinforce healthy activities. These action plans relied on visual cues, written schedules, step-by-step sequencing, and procedural memory to compensate for cognitive deficits. If patients didn’t meet self-defined goals, staff members helped break them down into smaller steps.
Supportive therapy controlled for the nonspecific effects of social interaction. It gave patients attention and helped them with personal expression about the experience of aging, memory loss, and disability, but did not include goal-setting strategies.
The trial was single-masked; participants were aware of their assigned treatments. Each therapy consisted of five in-home, 60-minute treatment sessions over 4 months, followed by six in-home, 60-minute maintenance sessions over 20 months. Staff members in the study all were African American.
The primary outcome was a decline of six or more recalled words on the total recall score of the Hopkins Verbal Learning Test–Revised, a 12-item word test. The secondary outcome was functional decline, measured by the University of California Performance-Based Skills Assessment.
Over 2 years, 69% of the behavioral activation group and 79% of the supportive therapy group completed the study. In the behavioral activation group, the 2-year incidence of memory decline was 1.2% (95% CI 0.2-6.4), compared with 9.3% (95% CI 5.30-16.4) in the supportive therapy group (RR 0.12; P=0.02).
Behavioral activation also was linked with stable everyday function, while supportive therapy was associated with decline (difference in slopes 2.71; 95% CI 0.12-5.30; P=0.04). The behavioral activation group also experienced fewer falls (13% versus 25%).
These findings are “intriguing and I would suggest a bigger study should be done,” said Ronald Petersen, MD, PhD, of the Mayo Clinic in Rochester, Minnesota, who was not involved in the study.
“The population studied is at higher risk for cognitive decline and this intervention appeared to work, although it was single-blinded and there was attrition,” he told MedPage Today. “Nevertheless, it is encouraging that behavioral interventions may be beneficial in these participants.”
The racial characteristics of the study and the motivation to enroll in a clinical trial limit whether the findings apply to other populations, the authors noted. Nonrandom attrition that was higher in men also may have skewed the results.
This study was supported by the National Institute on Aging. The authors reported no conflicts.
LAST UPDATED
Avoidable Sepsis Infections Rampant in Nursing Homes
Shana Dorsey first caught sight of the purplish wound on her father’s lower back as he lay in a suburban Chicago hospital bed a few weeks before his death.
Her father, Willie Jackson, had grimaced as nursing aides turned his frail body, exposing the deep skin ulcer, also known as a pressure sore or bedsore.
“That was truly the first time I saw how much pain my dad was in,” Dorsey said.
The staff at Lakeview Rehabilitation and Nursing Center, she said, never told her the seriousness of the pressure sore, which led to sepsis, a severe infection that can quickly turn deadly if not cared for properly. While a resident of Lakeview and another area nursing home, Jackson required several trips to hospitals for intravenous antibiotics and other sepsis care, including painful surgeries to cut away dead skin around the wound, court records show.
Dorsey is suing the nursing center for negligence and wrongful death in caring for her dad, who died at age 85 in March 2014. Citing medical privacy laws, Lakeview administrator Nichole Lockett declined to comment on Jackson’s care. In a court filing, the nursing home denied wrongdoing.
The case, pending in Cook County Circuit Court, is one of thousands across the country that allege enfeebled nursing home patients endured stressful, sometimes painful, hospital treatments for sepsis that many of the lawsuits claim never should have happened.
Year after year, nursing homes around the country have failed to prevent bedsores and other infections that can lead to sepsis, an investigation by Kaiser Health News and the Chicago Tribune has found.
No one tracks sepsis cases closely enough to know how many times these infections turn fatal.
However, a federal report has found that care related to sepsis was the most common reason given for transfers of nursing home residents to hospitals and noted that such cases ended in death “much more often” than hospitalizations for other conditions.
A special analysis conducted for KHN by Definitive Healthcare, a private healthcare data firm, also suggests that the toll — human and financial — from such cases is huge.
Examining data related to nursing home residents who were transferred to hospitals and later died, the firm found that 25,000 a year suffered from sepsis, among other conditions. Their treatment costs Medicare more than $2 billion annually, according to Medicare billings from 2012 through 2016 analyzed by Definitive Healthcare.
In Illinois, about 6,000 nursing home residents a year who were hospitalized had sepsis, and 1 in 5 didn’t survive, according to Definitive’s analysis.
“This is an enormous public health problem for the United States,” said Dr. Steven Simpson, a professor of medicine at the University of Kansas and a sepsis expert. “People don’t go to a nursing home so they can get sepsis and die. That is what is happening a lot.”
The costs of all that treatment are enormous. Court records show that Willie Jackson’s hospital stays toward the end of his life cost Medicare more than $414,000. Medicare pays Illinois hospitals more than $100 million a year for treatment of nursing home residents for sepsis, mostly from Chicago-area facilities, according to the Medicare claims analysis.
Sepsis is a bloodstream infection that can develop in bedridden patients with pneumonia, urinary tract infections and other conditions, such as pressure sores. Mindful of the dangers, patient safety groups consider late-stage pressure sores to be a “never” event because they largely can be prevented by turning immobile people every two hours and by taking other precautions. Federal regulations also require nursing homes to adopt strict infection-control standards to minimize harm.
Yet the failures that can produce sepsis persist and are widespread in America’s nursing homes, according to data on state inspections kept by the federal Centers for Medicare & Medicaid Services. Many of the lawsuits allege that bedsores and other common infections have caused serious harm or death. The outcome of these cases is not clear, because most are settled and the terms kept confidential.
Cook County, where the private legal community is known to take an aggressive approach to nursing homes, has more of these suits than any other metro area in the U.S., KHN and the Tribune found by reviewing court data.
State inspectors also cite thousands of homes nationally for shortcomings that have the potential to cause harm. Inspections data kept by CMS show that since 2015 94% of homes operating in Illinois have had at least one citation for conditions that increase the risk of infection. These citations include care related to bedsores, catheters, feeding tubes, and the home’s overall infection-control program.
“Little infections turn to big infections and kill people in nursing homes,” said William Dean, a Miami lawyer with more than two decades of experience suing nursing homes on behalf of patients and their families.
Much of the blame, regulators and patient advocates say, lies in poor staffing levels. Too few nurses or medical aides raises the risks of a range of safety problems, from falls to bedsores and infections that may progress to sepsis or an even more serious condition, septic shock, which causes blood pressure to plummet and organs to shut down.
Staffing levels for nurses and aides in Illinois nursing homes are among the lowest in the country. In the six-county Chicago area, 78% of the facilities’ staffing levels fall below the national average, according to government data analyzed by KHN.
Matt Hartman, executive director of the Illinois Health Care Association, which represents more than 500 nursing homes, acknowledged low staffing is a problem that diminishes the quality of nursing care.
Hartman blamed the state’s Medicaid payment rates for nursing homes — about $151 a day per patient on average — which he said is lower than most other states. Medicaid makes up about 70% of the revenue at many homes, he said.
Last October, CC Care LLC, an Illinois nursing home group that specializes in treating mentally ill patients on Medicaid, filed for bankruptcy, arguing that the state’s “financial troubles have been disastrous for all nursing homes.”
In a July court filing, CC Care creditors’ committee argued that the company couldn’t stay afloat relying on Illinois Medicaid payments, which it called “slow, erratic and significantly less than what we are due.”
Pat Comstock, executive director of the Health Care Council of Illinois, said nursing homes she represents “are operating in an increasingly difficult environment in Illinois, yet they continue to prioritize delivering the best care possible to residents in a safe and secure setting.”
A Festering Complaint
Shana Dorsey remembers her father as a quiet but friendly man. He worked as a uniformed bank security guard and picked up extra cash fixing neighbors’ cars in an empty lot adjacent to his West Side apartment building. He was a stickler for detail, who relished teaching his granddaughter the state capitals and was always ready to lend a hand to help his daughter, who now works for a Chicago property management firm.
But age and declining health caught up with the Army veteran, who by his early 80s began to exhibit signs of dementia and moved into an assisted living apartment.
Dorsey knew her dad needed more specialized care when she found him sitting in his favorite peach recliner in his apartment, unable to get up and incontinent.
He required more intense medical and personal care as his kidney disease worsened and he became more confused, medical records show. In his last 18 months of life, he cycled in and out of hospitals eight times for treatment of septic bedsores and other infections, according to court records.
The Chicago law firm representing Dorsey, Levin & Perconti, provided KHN and the Tribune with medical records and additional court filings that cover Jackson’s care.
Jackson had two pressure sores in late November 2012 when he was first admitted to Lakeview nursing center from the Jesse Brown VA Medical Center in Chicago, according to lawyers for his daughter.
These wounds healed, but in late September 2013, Jackson spiked a fever and had an infected sore in his lower back that exposed the bone, causing what Dorsey’s lawyers called “significant pain.”
The nursing home transferred Jackson to Presence St. Joseph Hospital in Chicago, where surgeons cut away the dead skin and administered antibiotics. At that time, the sore was as wide as a grapefruit and had “copious purulent drainage, foul smell and bleeding,” Dorsey’s lawyers argue. Tests confirmed sepsis, and the wound had grown so deep that it infected the sacral bone in his back, a condition known as osteomyelitis, the lawsuit said.
In November 2013, Dorsey moved her father to another nursing home. He required three more hospital visits before Dorsey made the difficult decision to place Jackson in hospice care. He died March 14, 2014, from “failure to thrive,” according to a death certificate.
In her suit, Dorsey, 39, argues that Lakeview nursing staff knew Jackson was at “high risk” for bedsores because of his declining health. Yet the home failed to take steps to prevent the injuries, such as turning and repositioning him every two hours, according to the suit. That didn’t happen about 140 times in August 2013 alone, Dorsey’s lawyers said.
“My father was like my best friend. Most people go to their mom to talk and tell all their secrets, and for me it was my dad,” Dorsey said in a November 2015 deposition.
While Lakeview declined to discuss Jackson’s treatment, it has denied negligence and argued in court filings that its actions were not to blame for Jackson’s death. Lockett, the home’s administrator, said the facility “strictly follows” all regulations to minimize the effects of skin breakdowns that can occur naturally with age.
“We are grateful for the daily opportunity to enhance the lives of seniors and other chronically ill populations in our community,” Lockett said in a statement.
Infection Control
Poor infection control ranks among the most common citations in nursing homes. Since 2015, inspectors have cited 72% of homes nationally for not having or following an infection-control program. In Illinois, that figure stands at 88% of homes.
Illinois falls below national norms for risks of pressure sores or failure to treat them properly in nursing homes. Inspectors have cited 37% of the nation’s nursing homes for this deficiency, compared with 60% in Illinois, according to CMS records. Only three states were cited more frequently.
Inspectors in November 2016 cited Alden Town Manor Rehabilitation and Health Care Center in Cicero, Ill., for neglect due to its care of an unnamed 83-year-old man with pressure ulcer sores that went untreated. Gangrene had set in by the time the staff sent him to the hospital, where surgeons ended up amputating his right leg above the knee, according to the inspectors’ report and citation. Alden Town Manor had no comment.
Dean, the Miami lawyer, said that nursing home staffs often miss early signs of infection, which can start with fever and elevated heart rate, altered mental status or not eating. When those symptoms occur, nurses should call a doctor and arrange to transfer the patient to a hospital, but that process often takes too long, he said.
“They don’t become septic on the ambulance ride over to the hospital,” Dean said.
There is little agreement over how much staff should be required in nursing homes. Federal regulations simply mandate that a registered nurse must be on duty eight hours per day, every day. In 2001, a federal government study recommended a daily minimum of 4.1 hours of total nursing time per resident, which includes registered nurses, licensed practical nurses and certified nursing assistants, often referred to as aides. That never became an industry standard or federal regulation, however.
Most states set requirements lower and face industry resistance to raising the bar. A California law requiring 3.5 hours per resident as of this July 1 is drawing intense criticism from the industry, for instance.
In addition, staffing can fluctuate, particularly over the weekends. A recent KHNinvestigation found that on some days, nursing home aides could be in charge of twice as many residents as normal.
At a minimum, Illinois requires 2.5 hours of direct care daily for residents. Yet federal nursing home payroll data show that at least 1 in 4 Chicago-area nursing home residents live in facilities that aren’t consistently providing that much care, KHN found.
Nationally, each aide is responsible for 10 residents on average; in the six-county Chicago area, the average is 13 residents per aide.
Federal officials have linked inadequate staffing to bedsores and other injuries, such as falls. If left unattended, even a small ulcer or sore can become septic, and once that happens, a patient’s life is in imminent danger.
In October 2014, Milwaukee-based Extendicare denied wrongdoing but paid $38 million to settle a federal False Claims Act lawsuit that accused it of not having enough staff on hand in 33 nursing homes in eight states, including Indiana, and failing to take steps to prevent bedsores or falls.
In other cases, federal officials have alleged that some nursing homes overmedicate residents — which can result in injuries such as falls from beds or wheelchairs and bedsores — rather than staff up to care for them properly.
In May 2015, owners of two nursing homes in Watsonville, Calif., agreed to pay $3.8 million to settle a whistleblower lawsuit alleging the homes persistently drugged patients, contributing to infections and pressure sores.
The suit alleged that an 86-year-old man who could barely move after receiving a shot of an anti-psychotic medication lost his appetite and spent most of the day in bed, “was not turned or repositioned and developed additional pressure ulcers.” He ran a 102-degree fever, but the staff failed to notify his doctor for three days, according to the suit.
Hospital doctors later diagnosed the man with sepsis and an infected pressure ulcer. The home did not admit wrongdoing and had no comment.
Personal injury lawyers and medical experts say that poor infection control often sends nursing home residents to hospitals for emergency treatment — and that the stress can hasten death.
Elderly people often “don’t have the ability to bounce back from an infection,” said Dr. Karin Molander, a California emergency room physician and board member of the Sepsis Alliance advocacy group.
That odyssey of multiple, stressful trips to the hospital is a common thread in negligence and wrongful death lawsuits involving sepsis or bedsores. KHN identified more than 8,000 suits filed nationwide from January 2010 to March of this year that allege injuries from failing to prevent or treat pressure sores and other serious infections.
Molander said serious bedsores indicate “someone is being ignored for an extended time period.”
“When we see patients like that we file [patient neglect] complaints with adult protective services,” she said.
Some of these cases led to million-dollar jury verdicts. In 2017, a Kentucky jury awarded $1.1 million to the family of a woman who suffered from bedsores and sepsis in a nursing home. In a second case last year, a jury awarded $1.8 million to a widow who alleged a Utah nursing home failed to turn her husband often enough to prevent bedsores, which led to his death.
Lawyers filed more than 1,400 of the cases from January 2010 to March of this year in Cook County Circuit Court, which tops all metro areas across the country in the KHNsample.
Nursing homes complain that garish billboards to solicit clients are a fixture in Chicago, where many attorney websites also boast of recent million-dollar verdicts from bedsore cases alone.
“We see an incredible amount of lawsuits out there,” said Hartman, of the Illinois nursing home association. “We feel we have a target on our backs.”
Trial lawyers counter that nursing homes often try to duck responsibility for poor care by creating complex corporate structures to limit their liability. Yet Hartman derided these suits as “cash cows” for law firms that can rack up six-figure legal fees as cases drag on. The nursing home industry supports tort reforms that would compensate injured persons but also bring a quicker resolution of claims, he said.
“That is something that needs to be fixed in Illinois,” Hartman said.
Avoidable Hospital Transfers
In September 2013, the Centers for Medicare & Medicaid Services said it was working to reduce avoidable transfers from nursing homes to hospitals. CMS had previously called these trips “expensive, disruptive and disorienting for frail elders and people with disabilities.”
The plans came in the wake of a critical 2013 Department of Health and Human Services audit that found Medicare had paid about $14 billion in 2011 for these transfers. Care related to sepsis cost Medicare more than the next three costliest conditions combined, according to the audit.
The auditors have not checked in to see if Medicare has since reduced those costs and have no plans to do so, a spokesman for the HHS Office of Inspector General said.
However, Definitive Healthcare’s analysis of billing data, modeled after the HHS audit, shows little change between 2012 and 2016, both in terms of deaths and costs.
Wendy Meltzer, executive director of Illinois Citizens for Better Care, said that hospital trips caused by treatment for sepsis can be “emotionally devastating” for confused elderly patients.
“It’s not a choice anybody makes. It’s horrible for people with dementia,” Meltzer said. “Some never recover from that. It’s a very real phenomenon and it’s cruel.”
Preventive Services Panel Reaffirms Ocular Prophylaxis for All Newborns
All newborns should receive ocular prophylaxis to prevent gonococcal ophthalmia neonatorum, according to the U.S. Preventive Services Task Force (USPSTF).
There is “convincing” evidence that ocular prophylaxis with 0.5% erythromycin ophthalmic ointment can prevent gonococcal ophthalmia neonatorum. The net benefit is “substantial,” and the practice is recommended for all newborns (“A” recommendation), reported the USPSTF, in a draft recommendation statement on their website.
This is consistent with the task force’s previous recommendations in 2011. The “reaffirmation process” was used to review the evidence, similar to the recent USPSTF recommendations for screening for syphilis infection in pregnant women.
But a newborn screening procedure generally considered standard of neonatal care may have taken on new relevance, in light of recent CDC data on the rising numbers of sexually transmitted infections (STI) in the U.S., particularly gonorrhea. The CDC reported last month that gonorrhea diagnoses were up by 76% since 2013, and increased by one fifth in young women.
Young women are at the highest risk of gonorrhea infection, with the risk peaking around age 19, but potentially that risk extends to all women of child-bearing age, task force member Alex Kemper, MD, told MedPage Today.
“We are particularly concerned about the increase in incidence of gonorrhea infection, because many women in high-risk populations do not receive prenatal care,” he said. “By recommending that all babies be treated, it takes care of the risk of [newborns] developing that infection.”
Kemper added that getting women into prenatal care is important to potentially screen for STIs, and for other USPSTF recommended screenings, such as folic acid supplementation during pregnancy.
Gonococcal ophthalmia neonatorum is caused by gonococcal infection and, in the absence of ocular prophylaxis, transmission rates from mother to newborn are 30% to 50%, the authors said. If untreated, the infection may cause “corneal scarring, ocular perforation and blindness.”
While erythromycin ophthalmic ointment is currently the only drug approved by the FDA for gonococcal ophthalmia neonatorum, screening for and treating gonococcal infection can be an additional preventive strategy, they stated.
“It’s important that people understand how common STIs are, and depending on where they live, that they have different ways to access care to get evaluated,” Kemper said.
The CDC, the World Health Organization, the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG) all recommend “universal topical prophylaxis to prevent gonococcal ophthalmia neonatorum,” with the AAP and ACOG recommending to screen all pregnant women at risk for gonorrhea or who “live in a high-prevalence area” at the first prenatal visit.
Despite the increasing prevalence of gonorrhea, incidence of gonococcal ophthalmia neonatorum is still very low, Kemper said, but it’s still important for clinicians to be “vigilant about its use.”
“It’s a rare infection, but we do a good job of treating it,” he noted.
The task force found no new data that changes its previous conclusion that there are no serious harms associated with topical ocular prophylaxis for gonococcal ophthalmia neonatorum, although one potential harm is the threat of antibiotic resistance to the treatment medication.
The authors noted that it is currently unknown whether Neisseria gonorrhoeae has developed resistance to erythromycin ointment in the U.S., but that further research into “safe and effective alternatives” may be needed.
Public comment on this new draft recommendation statement is currently being accepted through Oct. 9, 2018.
Provider Groups Hit Back at California’s Death Certificate Project
The Medical Board of California has been using death certificates in fatal overdose cases as a starting point to find clinicians who may be guilty of overprescribing. Hundreds of physicians and other providers have been told they were under investigation, but thus far, only 10 have been formally accused. In this report, physicians and their representatives have their say about the project.
Leaders in organized medicine in California and nationally are expressing horror over the state medical board’s “Death Certificate Project.”
“This is terrifying,” said Barbara McAneny, MD, president of the American Medical Association and an Albuquerque, N.M., oncologist. It “will only discourage doctors from taking care of patients with pain.”
McAneny noted that prescribing practices now deemed unacceptable came out of public policies years ago that “compelled doctors to treat pain more aggressively for the comfort of our patients.”
For example, payers have measured quality of care by whether their patients answered surveys saying their pain was well-controlled, or wasn’t. “We’re doing a lot of education to undo the damage” from those policies. She added that, in California, those efforts are working in a “more productive way” than through “a disciplinary process that sows fear in the medical community.”
Osteopathic Physicians and Surgeons of California president Richard Riemer, DO, said his organization applauds the effort to identify physicians who are grossly negligent and inappropriately prescribe. But he’s concerned the project will have unintended consequences, such as “the unjust targeting of physicians who provide care to the sickest amongst us.”
The methodology the licensing agency’s executive director described during the board’s enforcement meeting last year “raises a number of questions, he said. What is the definition of an ‘over-prescriber’?” Riemer asked. And are the years the agency targeted to examine first, 2012 and 2013, “representative of the current epidemic and trends, as deaths from prescription overdoses have declined in California?” Guidelines weren’t published until 2014, and prescribing has been scaled back a lot since then.
Deborah Burger, RN, co-president of the California Nurses Association and National Nurses United, said that investigating overdose deaths and tying that to the prescriber, does not necessarily show evidence of poor care. “One-off opioid deaths linked to a particular clinician do not show evidence of mis-prescribing.” Her group also believes the project will dissuade providers from treating chronic pain. Providers can’t control patients who obtain opioids from illegal or legal sources, or lethally mix them with over-the-counter medications.
The Medical Board of California (MBC) quietly launched the project 4 years ago, collecting some 2,700 opioid-related death certificates filed in 2012 and 2013. Since then, using the state’s CURES prescription drug monitoring database, the MBC has been linking the dead individuals with physicians who prescribed opioids for them within 3 years of the fatal overdoses.
It identified more than 500 providers — mostly allopathic physicians but also including osteopaths, nurse practitioners, and physician assistants — for follow-up, sending stern letters to most of them informing them of a “complaint” about their practices. The letters ordered the recipient to turn over the dead patient’s records or face citations and fines of up to $1,000 per day.
So far, the MBC has determined not to pursue action against just under half of the 450 allopathic physicians initially targeted. Ten physicians have been formally accused of wrongdoing while scores more remain under active investigation.
Medical board executive director Kimberly Kirchmeyer said she understands providers’ concerns and frustration. But the board is charged with investigating “any time there appears to be a violation of the Medical Practice Act and that’s how these were identified.” She added, “I hope individuals understand that by identifying a physician, and even by potentially educating them … that could potentially save patients in the future.”
But there are concerns that the agency is going much farther. In the case of a patient death, the board is looking at living patients for whom that provider also prescribed opioids, and asking them to authorize their doctor to turn over their medical records to the medical board, or else the records would be subpoenaed.
The board also intends to apply the same protocol to investigate prescribing clinicians whose patients end up in a hospital emergency department because of an overdose.
Given what McAneny and many individual physicians have said about the project, one might expect strong condemnation from the California Medical Association as well.
Not so.
CMA President Theodore M. Mazer, MD, a San Diego otolaryngologist, issued this statement:
“The CMA remains committed to continuing to work with the Medical Board of California on its disciplinary framework to improve effectiveness and prioritize patient safety, while protecting due process for physicians, including appropriate focus and scope of investigations and preserving the ability of physicians to provide appropriate treatment to patients.”
Sources have told MedPage Today that the organization is afraid of offending the California legislature, which is intent on doing something about the overdose problem. Although the state’s opioid fatality rates are among the lowest in the country, California’s large population means the absolute numbers are among the highest. Highly publicized celebrity deaths make the issue especially touchy.
But Encinitas family physician James Hay, MD, who served as CMA president in 2012 — he emphasized he no longer speaks for the organization — did not hold back. He called the effort “atrocious” and “a witch hunt” because of the 3-year lookback, “especially since a large majority of overdoses occur from mixing prescribed drugs, street-purchased drugs, and illicit drugs.”
Years ago, he said, “I was the liaison between the CMA and the medical board, so I have some insight. I know they’re under a lot of pressure because of this problem with opioid use and ODs, taking actions they think are necessary.”
But the project has put a lot of doctors in a terrible spot, Hay said. “They get a letter from the medical board, and the first thing they must do is call their lawyer. You’re automatically on notice, and it does create fear.” It is only months later that recipients learn whether or not the MBC will take further action.
With just 10 accusations filed after 4 years, “that’s a pretty poor yield, in my opinion,” Hay said.
He’s already seeing the impact on colleagues with pain medicine practices. Those specialists are seeing a surge in referrals from doctors who now want no part of opioid prescribing at all, he said. In his practice, he does what he can, “but when we’re not getting anywhere, we send them to pain medicine [specialists]. But they’ve gotten so overwhelmed, not just from us but everybody, they’re now sending patients back to us.”
Bioethicist Arthur Caplan, PhD, of NYU School of Medicine in New York City, also disagreed with the board’s strategy. Investigating based on an incident rather than a pattern “doesn’t seem like the best use of resources,” he said.
“It’s worth it to go back and check [the CURES database] to see what doctors did when someone died, but it should be done a little less punitively and it has to be quick.” It shouldn’t leave providers “in the lurch” for months and months. “That program sounds Draconian,” he said.
Instead, health agencies should spend more time chasing down sellers of the drugs, like the OxyContin company, Purdue. But nobody’s threatening them with jail.”
Julianne D’Angelo Fellmeth, an attorney with the Center for Public Interest Law, which monitors the state medical board and other professional licensing agencies, defended the project but said she has concerns about how it was rolled out.
She explained that California county coroners are required to report when an autopsy concludes a death was caused by physician gross negligence or incompetence, but “coroners apparently do not consider excessive prescription of narcotics” as that severe. The medical board had received only nine such reports in a 2-year period.
A bill that would have required reporting to the board when a death is due to a Schedule II, III, or IV drug passed 5 years ago, but was vetoed by the governor as an unfunded mandate. The Death Certificate Project was a way around that and one she supported.
With opioid deaths skyrocketing it seemed like a good approach.
Besides, doctors who are responsible, who keep detailed patient records, do adequate follow-up, confine prescribing to standard of care, and get aggressive histories and do physicals on their patients before prescribing “should not be ‘terrified’ about an MBC inquiry or investigation,” she said.
“The MBC needs this information so it can take preventive action to correct a physician’s prescribing practices, preferably before a lot more people die,” she said. “It is not going to get any complaints from the patient who is drug seeking and perfectly happy — until they die.”
That said, Fellmeth lamented the board’s use of the word “complaint” in most letters informing doctors they were under investigation, “when in fact there has been no complaint.” (Beginning this past May, the letters were reworded with a softer tone, though they still warned of fines and other sanctions for noncooperation with the inquiry.) And she doesn’t approve of the “lengthy time” before doctors not at fault are told they are off the hook.
Fellmeth blamed the delays on staffing shortages and turnover in the MBC. The board “needs to pay its investigators more in order to retain them, and it needs more investigators so their caseloads are not so huge,” she said.
FibroGen granted FDA Fast Track Designation for pulmonary fibrosis med
FibroGen announced that the U.S. FDA has granted Fast Track designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients with idiopathic pulmonary fibrosis. This follows review of the Phase 2 clinical data evaluating pamrevlumab in a placebo-controlled trial and represents recognition by the FDA that pamrevlumab has the potential to address an unmet medical need for this disease.
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