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Friday, March 15, 2019

Two-thirds of Medicare recipients lack dental coverage

Lack of routine dental care can result in complications and high-cost emergency department visits. Yet almost two-thirds of Medicare recipients, 37 million people, don’t have dental coverage, according to a recent report from the Kaiser Family Foundation (KFF).
As a result of not having coverage, 49% of those surveyed said they had not been to the dentist in the past year. And for those that did see a dentist, 19% spent more than $1,000 out of pocket.
Specifically by demographic, 71% of black Medicare recipients, 65% of Hispanic Medicare recipients, 70% of low-income enrollees and 59% of those living in rural areas did not have a dental visit over the past year.
“We were surprised that 49% of all people on Medicare did not see a dentist in the past year, even knowing that nearly two-thirds of all people on Medicare have no dental coverage, but we were stunned how high the numbers were for black and Hispanic beneficiaries, and what that means for their oral health care,” Meredith Freed, a policy analyst for KFF’s Program on Medicare Policy, told FierceHealthcare.
The survey also spotlighted the strong connection between oral health and overall health. More than 6 in 10 of those surveyed who reported themselves in fair or poor health did not go to the dentist in the past year, compared with 37% who said they were in excellent or very good health.

In addition, 62% of people under the age of 65 but with a disability went without a dental visit in the past year.
Cost was the big driver for avoiding care. Overall, 10% of those surveyed did not get dental care because of the cost. Other reasons for not going included fear, inconvenient location or time for an appointment. And for the older demographic, hurdles include transportation challenges, lack of professionals, and health literacy issues. In fact, transportation disproportionately affects older adults and those living in rural areas with low incomes.
In 2016, the average out-of-pocket dental care cost was $469. With half of Medicare beneficiaries living on less than $26,200 per year, out-of-pocket costs can be significant. Only 11% of those surveyed used dental services without any out-of-pocket costs.
Plus, of adults 65 and over, 15% have no natural teeth. Even higher, almost one in three of those with incomes below 100% of the federal poverty level have no natural teeth. And not having any natural teeth correlates with many health conditions including lack of nutrition and periodontal disease. As a result, more than 2 million visits to the emergency department per year are for people with an oral health complication.
So what is the holdup? Freed says that dentists originally resisted the idea of being included in Medicare and subject to a fee schedule. But today, the biggest stumbling block is the potential cost of adding dental coverage to Medicare, and the potential implications for federal spending and beneficiary premiums.
“Medicare benefits have evolved fairly slowly over the years,” Freed said. “The last big benefit improvement was for prescription drug coverage, and that happened in 2006—40 years after the program was implemented.”
Since its establishment in 1965, Medicare has almost totally excluded coverage for dental services. In 2016, about 10.2 million beneficiaries (18%) had access to some dental coverage through Medicare Advantage.
Other options for coverage include Medicaid programs. Among those with dual eligibility, 88% lived in a state where they were eligible for some dental benefits from Medicaid. But about one-tenth of dual eligibles, 800,000 people, resided in the six states that provided no dental coverage through Medicaid in 2016: Alabama, Delaware, Maryland, Tennessee, Texas and Virginia.
Dental coverage is also available from private insurers. In 2016, about 4.5 million Medicare beneficiaries received dental coverage through private plans.
Currently, the government is considering a broad array of ideas to get Medicare recipients dental coverage. For example, some are advocating for CMS to cover oral health, and others have considered a separate benefit, similar to Part D, as its own premium. In addition, a benefit could be created exclusively for low-income beneficiaries under Medicare or Medicaid.
“Thus far, the Congressional Budget Office has not estimated the cost of adding a dental benefit to Medicare. Given the significant health risks associated with poor oral care and the costs and consequences of untreated dental needs, identifying potential solutions to improve the oral health status of the Medicare population remains a challenge,” the report concludes.

New enzyme boosts ‘CRISPR toolbox’ for disease detection

CRISPR is often associated with gene editing and the Cas9 enzyme—commonly referred to as its “scissors”—but the technology could also prove useful in diagnosing disease. Mammoth Biosciences is working on a platform that can detect any biomarker containing DNA or RNA using different enzymes: Cas12 and Cas13. Now, the company is adding to its “CRISPR toolbox” by licensing a new CRISPR enzyme, Cas14, from the University of California, Berkeley.
Mammoth launched last April with technology licensed from the lab of CRISPR pioneer Jennifer Doudna, Ph.D., at Berkeley. Its goal is to create a point-of-care diagnostic tool that can detect multiple diseases for use in hospitals and at home.
So why does it need so many enzymes?
Each CRISPR Cas protein offers different strengths in various applications because of factors like speed, precision, and cost, the company’s founders believe. Adding Cas14 to its arsenal allows Mammoth to target single-stranded DNA, as well as double-stranded DNA (Cas12) and single-stranded RNA (Cas13).
Mammoth CEO Trevor Martin thinks of DNA and RNA as the languages of CRISPR and single-stranded or double-stranded DNA and RNA as different dialects. Being able to speak multiple dialects of different languages allows Mammoth to target many different kinds of disease. The company thinks Cas14 could be particularly useful in infectious disease, oncology and genetic mutations.
“Where this comes in useful in diagnostics is that we have different biomarkers for different things,” Martin told FierceBiotechResearch. “Let’s say you want to genotype someone to see what their risk is for some type of cancer, then you’d want to look at double-stranded DNA. If you’re looking at someone’s immune response, or some sort of pathogen, such as malaria, then you probably want to look at RNA… You might even have other things like DNA viruses; in that case, you might want to look at single-stranded DNA.”
Cas enzymes are not monolithic; each Cas system has its variants. And certain variants may be able to go where others can’t. Take existing CRISPR-Cas9 systems. Most of them have sequence restrictions that limit the number of sites on the genome they can target. This is because these systems need a a “protospacer adjacent motif (PAM) sequence” to recognize a particular target on DNA for cutting. Without that sequence, no editing can occur. But last October, a team at the Massachusetts Institute of Technology discovered a new Cas9 enzyme that overcomes this issue and can target more than half of the locations on the genome.
As for Cas14, Martin sees much potential in what “seems to be a very diverse array of proteins within it,” he said. What’s more, it looks like Cas14 targets single-stranded DNA without class 2 sequence restrictions, according to a Science study authored by a Berkeley team that includes Mammoth’s cofounders. Like the new Cas9 variant discovered at MIT, Cas14 doesn’t need PAM to target sequences either, Martin said.
Since launch, Mammoth has grown the team “substantially” and started multiple partnerships, though Martin couldn’t disclose any names or disease targets yet. He did say that the company has been looking at areas where this technology could make a large impact, such as infectious diseases and “areas in which you need to know a very accurate result quickly and affordably.”
At the moment, the company is building out its diagnostic systems. A CRISPR-based tool could take various forms, from high-volume screens that live in hospital labs to point-of-care tests in a box.
But “the ultimate vision” is to have an at-home test “similar in use and accessibility as a pregnancy test,” Martin said.
When asked if Mammoth would continue looking for new CRISPR systems, Martin said the company is focusing on “characterizing” the systems it already has, but that it wouldn’t ignore brand-new systems. After all, Cas9 was around for a little while before Cas12 and its peers were discovered, he said.

Gilead’s Descovy gets its PrEP data, but can it stand up to Truvada generics?

Gilead Sciences has the data it’ll need to start transitioning patients taking Truvada for PrEP over to Descovy, a drug with a longer patient life. But once Truvada generics hit, it might be a different story.
The Big Biotech recently touted noninferiority data showing that Descovy had matched Truvada when it came to preventing HIV infection. Numerically speaking, Descovy beat out its predecessor, though its seven HIV cases to Truvada’s 15 came out to a difference that wasn’t statistically significant.
The “numerical Descovy benefit” was “likely driven by noncompliance and enrollment errors,” Leerink Partners’ Geoffrey Porges wrote in a note to clients.
Still, the result “sets the stage for Gilead to actively transition the >$2 billion in current PrEP revenue for Truvada to Descovy,” he said, adding that investors would likely expect most of that revenue haul to head Descovy’s way before Truvada’s September 2021 patent expiration.

But while “the trial results will provide Gilead with marketing ammunition” to switch scripts over to Descovy, the differences between the two products “remain modest, and it is difficult to tell how much of the transition will stick” after Truvada generics hit, Porges noted.
In the study, Descovy did come out significantly ahead of Truvada on the safety side, though Porges described its bone and kidney benefits as “small.” Still, the difference may convince physicians and patients to use the medicine; people are taking PrEP therapy longer than originally expected, increasing the importance of metabolic safety.
Payers, on the other hand? For them, Descovy may be a tougher pill to swallow. “At this stage paying about $18,000 per year for a 1% difference in Bone Mineral Density and a 2-4 mL/min difference in renal function might challenge the generosity of post-2020 government and private payers,” Porges wrote.

As Gilead gears up for the Truvada-to-Descovy transition, it’s also pouring money into PrEP awareness. The company “actually put a significant amount of additional funding” behind Truvada for PrEP this year, commercial chief Laura Hamill said on Gilead’s fourth-quarter earnings call, and it brought two DTC campaigns to the airwaves in 2018 to build buzz.
Gilead is counting on HIV to bring in big sales as the company finds its footing elsewhere. Hep C revenues have flagged in recent years, prompting the company to dive into oncology with its Kite buy. But CAR-T drug Yescarta has hardly been an instant success; on the contrary, it’s been slow to get off the ground, as has fellow CAR-T therapy and archrival Kymriah from Novartis.

HCA Acquires Majority Ownership Position in Galen College of Nursing

HCA Healthcare (NYSE: HCA), one of the nation’s leading healthcare providers, and Galen College of Nursing, one of the largest educators of nurses in the U.S., today announced that HCA Healthcare will become the majority owner of the parent company of Galen.
The innovative new strategic partnership brings together two of the top nursing organizations in the country in order to increase access to nursing education and provide career development opportunities in nursing to improve patient care.
With 94,000 registered nurses, HCA Healthcare is one of the largest employers of nurses in the country, with nurses holding positions from bedside caregivers in a variety of healthcare settings to leadership positions throughout the organization. This new partnership is a continuation of HCA Healthcare’s focus on nurses and nursing excellence, which has resulted in a positive impact on clinical outcomes, patient experience, efficiency of care, and nurse engagement.

Thursday, March 14, 2019

FDA allows marketing of new device to help treat carbon monoxide poisoning

The U.S. Food and Drug Administration today allowed marketing of a new device, ClearMate, intended to be used in an emergency room setting to help treat patients suffering from carbon monoxide poisoning. The FDA granted marketing authorization of ClearMate to Thornhill Research, Inc. The device uses a novel method for quickly removing carbon monoxide from the body by increasing a patient’s rate of breathing.

“Carbon monoxide poisoning is a serious issue, affecting thousands of people each year,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices in the FDA’s Center for Devices and Radiological Health. “While the current standard treatment of administering 100 percent oxygen through a mask can be done anywhere, hyperbaric treatment, which is necessary for severe carbon monoxide poisoning, is less accessible because there are only 60 medical centers with hyperbaric units in the entire U.S. Moreover, those medical facilities are seldom in rural areas, so treatment in those areas could be delayed considerably due to transport time. Today’s marketing authorization provides patients with access to a simple, yet lifesaving device that may minimize the delay of getting vital treatment, especially in severe cases of carbon monoxide poisoning.”
Carbon monoxide is a colorless, odorless gas that is extremely poisonous and can kill within minutes. In the U.S. each year, nearly 500 people die while as many as 20,000 visit emergency rooms for unintended exposure to carbon monoxide, primarily from poorly-maintained heating systems, or gas stoves or gas-powered generators used for heat or power during storms. The most common symptoms of carbon monoxide poisoning are headache, dizziness, weakness, upset stomach, vomiting, chest pain and confusion. Carbon monoxide poisoning occurs when carbon monoxide attaches to the hemoglobin in the blood exactly where oxygen is supposed to attach, reducing the amount of oxygen carried to the brain and other tissues.
The standard form of treatment for carbon monoxide poisoning is to have the patient breathe 100 percent oxygen through a mask. In severe cases, a hyperbaric chamber may be used, which delivers oxygen under higher than normal pressure.
ClearMate—a device consisting of a gas mixer, valves, meters, breathing circuits, an oxygen reservoir, a mask and hoses—works by speeding up the elimination of carbon monoxide from the body. It delivers both 100 percent oxygen to the patient, as well as a mixture of oxygen and carbon dioxide, causing the patient to breathe faster. The increased breathing accelerates the rate at which the carbon monoxide leaves the patient’s body, allowing a normal amount of oxygen to attach to hemoglobin and be carried where it is needed throughout the body.
In authorizing marketing of ClearMate, the FDA reviewed data from multiple clinical studies, which tested the effectiveness of the device on 100 patients. The studies demonstrated the device was effective at eliminating carbon monoxide. The combination of oxygen and carbon dioxide in the ClearMate resulted in a faster elimination of carbon monoxide than treatment with 100 percent oxygen alone but was not faster than hyperbaric oxygen therapy.
Patients did not experience any device-related complications in the clinical studies of efficacy or in a separate study of the device’s safety.
ClearMate was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

New Insomnia Drug Appears Safe, Effective in Older Patients

Clinicians may soon have a new option for treating insomnia in older patients, new research suggests.
Subanalyses from the phase 3 SUNRISE-1 trial showed that lemborexant (Eisai Inc), an investigational dual orexin receptor antagonist being developed for the treatment of insomnia and irregular sleep-wake rhythm disorder, was both safe and effective in an older population — and was not different from placebo on postural stability.
The results suggest that this new agent may be a suitable treatment for patients aged 65 years and older with insomnia disorder, the investigators note.
“We showed that the drug was effective on the objective endpoints of the study, which included efficacy in helping patients with sleep onset and with sleep maintenance, and the drug was well tolerated,” study author Margaret Moline, PhD, executive director of clinical development of Eisai’s Neurological Business Group, told Medscape Medical News.
The findings were presented here at the American Association for Geriatric Psychiatry (AAGP) 2019 Annual Meeting.

Facilitates Sleep

Lemborexant inhibits orexin signaling by binding competitively to both orexin receptor subtypes (orexin receptor 1 and 2). In individuals with normal daily sleep-wake rhythms, orexin signaling is believed to promote periods of wakefulness; but in those with sleep-wake disorders, orexin signaling may not be functioning normally.
“Blocking the orexin signaling at bedtime is thought to dampen wakefulness so sleep can happen at the appropriate time,” said Moline.
Two pivotal phase 3 studies (SUNRISE-1 and SUNRISE-2) investigated lemborexant in patients with a history of subjective wake after sleep onset (WASO) of 60 or more minutes at least three times a week in the previous 4 weeks.
SUNSHINE-1 was a 1-month, multicenter randomized double-blind, placebo-controlled study. It incorporated both objective outcomes using polysomnography sleep studies and subjective outcomes using sleep diaries. It included over 1000 participants with insomnia disorder, defined as an Insomnia Severity Index score of 13 or more.
SUNRISE-2 was a 12-month study that subjectively assessed the ability to fall asleep and stay asleep based on patient self-reports — again using sleep diaries.
Both studies compared lemborexant with a placebo. SUNSHINE-1 also had an active comparator arm (6.25 mg of zolpidem tartrate extended release [ER]). Zolpidem targets a different neurotransmitter system than lemborexant and is a type-A GABA receptor agonist.
“These two drugs are from totally different classes of drugs,” said Moline. …

Doddering Doctors: Hospitals Take a Stab at Weeding Them Out

This is the first in a MedPage Today series on the controversial but growing trend among healthcare institutions to screen physicians of a certain age with cognitive and physical dexterity tests.
Interventional cardiologist Jerrold Glassman, MD, spent the first week of March schussing down Park City’s powdery slopes. He even braved black diamond runs, belying the fact that this July, he’ll be 69 years old.
“A 60-year-old today is not the 60-year-old of three decades ago,” he said proudly. “Skiing is my passion and I’m going back up tomorrow.”
He and his ski buddies, older physicians like himself, dodge moguls some 30 days a year. A new app tracks his stats, like altitude, speed and distance, and said he did 25 downhill miles that day.
Glassman has no plans to retire from the cath lab — or from skiing — anytime soon. But in coming weeks, medical executive committees for his 3,000-physician Scripps Health system in San Diego are expected to require screening for all physicians age 70 and older for cognitive impairment, among other things. It’s to be a condition for recredentialing every two years.
Doctors up for review will sit in a room alone, with no pencil or mobile aid, while they answer dozens of questions in the MicroCog, a computer-based test also used by the Air Force. The test scores thinking skills, such as the ability to solve simple math problems, count backwards from 100, or find similarities among shapes or pictures.
Following the computer test comes history, physical, and mental health screens that review issues like substance use and tests for hearing and vision. They fill out a form that asks about sleep patterns, continuing medical education, patient load, and typical hours at work. The entire process takes about three or four hours.
The policy is a major change for the system, acknowledged James LaBelle, MD, chief medical officer for Scripps Health. “About 150 physicians 70 or older are due to be recredentialed in 2019 and all would be subject to the policy,” he said. LaBelle did not respond when asked whether the two-year recredentialing cycle would subject a similar number to mandatory screening in 2020 — which would bring the total to about 10% of Scripps’ medical staff.
An undisclosed number of allied health professionals such as dentists and optometrists who seek status as a Scripps staff member are also covered by the policy, LaBelle said.
For most hospitals around the country, “this is pretty new. I do think Scripps is leading in trying to understand how to manage the aging physician,” he said, adding, “I hope it’s going to be easier than I think it’s going to be.”
Failing the MicroCog won’t automatically end a physician’s credentialing at Scripps. But it will flag him or her for further evaluation, perhaps prompting recommendations for more rigorous fitness-for-duty review lasting several days. Physicians who perform poorly there would see their ability to practice limited or revoked.
I hope it's going to be easier than I think it's going to be
Come to PAPA
For Scripps and many other organizations, the plan is for screening to be done by PAPA, the University of California, San Diego’s PACE Aging Physician Assessment program — said to be the largest to provide this service in the nation. (PACE is an acronym for Physician Assessment and Clinical Education.) Many other organizations perform various screenings in house, with or without cognitive computer tests, or are working on plans to contract with four other service providers.
Surgeons and interventionalists like Glassman will likely also undergo PAPA’s 15-minute dexterity screen — in which they must correctly place shaped pegs into grooves in a board.
Although leadership’s commitment to a uniform policy is set at Scripps, some details are still being worked out, like how the system’s peer review committees will repurpose those long-time senior physicians who fail the tests but can still provide value to the workforce. LaBelle suggested the exact process Scripps will adopt “is a moving target” that may change, but added, “I have no doubt we’re going to learn a lot over the next few years around how to do this right.”
PACE is a multiple-day testing program which began 22 years ago to assess doctors referred by the Medical Board of California after negligence or behavioral issues threatened their license. Of the 1,000 physicians referred to PACE, an undisclosed number had age-related cognitive impairment that resulted in colleagues’ concerns, but the physicians continued to practice because the complicated peer review process takes a long time, and doctors don’t want to report on each other.
“In all honesty, when we started PAPA, it was because we saw so many wonderful careers that ended in disgrace and tragedy,” said PACE/PAPA director David Bazzo, MD. “Time and time again, the message we heard was ‘Gosh, I wish I had known, or I wish I had stopped or retired one case sooner,’ maybe because of a cognitive issue or dexterity issue. The regret is there.”
Absent screening, procedures for dealing with accusations of physician impairment, can take years. For example, a California medical board filing indicated that concerns about one gastroenterologist with a tremor were expressed internally in 2015, including that he “had forgotten that he was on call … exhibited occasional forgetfulness and confusion and had shown up on at least two occasions at the wrong surgery center.” The medical board didn’t receive a complaint until January 2017, however, and another 15 months elapsed before his license was revoked.
David Bazzo, MD, director of UCSD's PACE program, with a pegboard used to test tactile skills and dexterity. Photo courtesy of Bazzo.
David Bazzo, MD, director of UCSD’s PACE program, with a pegboard used to test tactile skills and dexterity. Photo courtesy of Bazzo.
So it’s understandable that proactive screening is gaining traction. “I know it provokes a lot of anxiety, but in the end, it’s really around assessing how much deeper a doctor needs to be looked into, or doesn’t need to be looked into,” LaBelle said. It’s not a slam dunk that they would be sent packing — unless they refuse the tests, LaBelle said. “That’s a hard stop.”
Growth mode
With five PAPA contracts with healthcare organizations or medical groups now active and three more pending, Bazzo sees the demand for late career physician screening as a service line in growth mode. He gives talks about the process to hospitals and medical groups around the country, and estimates 10% of health systems now have some form of screening triggered only by a birthday, even if limited to certain departments. “It’s on the national radar,” he said.
Outside San Diego, other hospitals and health systems have also begun screening their senior clinicians, with or without the MicroCog. Among them are Stanford Hospital, Clinics in Palo Alto, and Eisenhower Medical Center in Rancho Mirage, California; Driscoll Children’s Hospital in Corpus Christi, Texas; and the University of Virginia Health System in Charlottesville. Many others have policies they declined to discuss with MedPage Today.
An American Medical Association report discussed at the November interim meeting noted that 300,752 physicians were 65 years or older in 2017, up from 241,641 in 2013, and 120,000 were “actively engaged in patient care,” up from 97,000. The literature is clear, an AMA report said, that cognitive and physical skills generally decline with age, and physicians are not excepted.
That report urged delegates to adopt principles to guide screening senior physicians for competency. “It is critical that physicians take the lead in developing standards … to head off a call for nationally implemented mandatory retirement ages or imposition of guidelines by others that are not evidenced based,” it said. The suggested guidelines failed to win approval but are being rewritten.
Clearly the issue is a touchy one at many organizations around the country, especially those with many clinicians who’ve long served as their hospitals’ elder statespeople and may serve on influential committees.
Asked if UCSD’s hospitals and clinics screened their senior physicians, a communications director replied, “UC San Diego Health is in discussion on a potential policy, however, it hasn’t established one because the science on the topic is unsettled.”
That prompted a strongly worded retort from William Perry, PhD, vice chair of the UCSD department of psychiatry and a PACE program psychologist.
Robust data
“The data is fairly robust in two domains,” regarding the impact of age on physician care, Perry told MedPage Today, emphasizing that the communications director’s message was patently incorrect. “Abilities decline after a certain age and, as one gets older, adverse outcomes increase,” he said, citing unpublished data from PACE and other studies. “There’s no denying it; as we get older a lot of our functions decline.”
Perry said that these days, he’s receiving calls every week from around the country wanting him to give talks. “Organizations in North Carolina and New Jersey are putting together policies. It’s not a question of if, it’s a question of when this will become standard,” he said.
“I’m struck by how much science has demonstrated a connection between aging and impaired physician practice,” said Richard Barton, an attorney who represents physicians, medical groups, and hospitals and helped author a paper on the topic in 2015 for a Sacramento-based physician wellness group. In San Diego alone, Barton knows of three organizations, including Rady Children’s Hospital and UCSD Medical Center, who are also working on late career screening policies due to concern that some older physicians are at higher risk for causing patients harm.
Glassman, who has practiced at 655-bed Scripps Mercy Hospital since 1979 and was chief of staff for four years, said most older Scripps physicians favor the idea. “It’s kind of mom and apple pie. How can you say a physician who is not competent should be allowed to practice?” The big question is, after a clinician fails, which follow-up tests correctly determine whether an experienced physician can still practice?
Jeff Sandler, MD, 71 (left), and Jerrold Glassman, MD, 68 (right). Photo courtesy of Glassman.
Jeff Sandler, MD, 71 (left), and Jerrold Glassman, MD, 68 (right). Photo courtesy of Glassman.
One of Glassman’s fellow skiers, Jeff Sandler, MD, a Scripps endocrinologist, will be 72 this June and supports the idea of screening doctors his age. “If you think you shouldn’t be screened, maybe you shouldn’t be practicing,” he said. “It sounds discriminatory, but we have to protect the public from bad actors.”
But the issue remains controversial because screening based solely on age smacks of illegal discrimination and the age cutoffs are inherently arbitrary.
Next: Now comes the pushback