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Thursday, November 8, 2018

CMS floats new network-adequacy requirements for Medicaid managed care


The Trump administration wants to give states more freedom to states overseeing Medicaid managed care and shift network-adequacy standards.
On Thursday, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule (PDF) that updates a 2016 regulation, giving states more control over setting rates for capitated payments and providing a three-year transition period for pass-through payments to shift providers from fee-for-service to managed care.
Under Medicaid managed care, states contract with insurers to administer coverage. The program makes up a huge chunk of overall Medicare spending with more than two-thirds of beneficiaries enrolled in managed care in 2016.

Perhaps the biggest shift is a proposal to reform state network-adequacy standards by replacing the current time and distance standards with “a more flexible requirement that states set a quantitative minimum access standard for specified health care providers” including long-term care.
Those quantitative standards could include minimum provider-to-enrollee ratios, maximum travel time or distance to providers, a minimum percentage of providers accepting new patients or maximum wait times for an appointment.
CMS would also allow states to include access to telehealth providers and create their own definition of what qualifies as a “specialist” in determining network-adequacy standards.

“Today’s action fulfills one of my earliest commitments to reset and restore the federal-state relationship, while at the same time modernizing the program to deliver better outcomes for the people we serve,” CMS Administrator Seema Verma said in a statement.
Additionally, the proposed rule would strengthen program integrity by preventing states from retroactively changing risk-sharing mechanisms to boost federal reimbursement. The Government Accountability Office has previously said CMS needs to do a better job of auditing state managed care contracts that represented half of all Medicaid expenditures in 2017.
Verma has also said her agency will begin targeted audits of Medicaid managed care plans “to ensure that provider claims for actual health care spending matches what the health plans are reporting financially.”

Star drug in Mallinckrodt’s $1.2B Sucampo buyout flops in pivotal trial


Some of the insiders at Mallinckrodt $MNK may be wondering today why they paid $1.2 billion for Sucampo just 10 months ago. One of the two late-stage drugs they bagged in the deal has failed the registration study for often fatal cases of Niemann-Pick type C.
Billed as a relatively economical approach to building their late-stage pipeline, Mallinckrodt — which was drummed out of PhRMA after becoming a punching bag for critics due to its pricing strategy — told investors Tuesday that VTS-270 flopped in the registration study.

“In our recently completed registration trial, the product did not show a statistically significant separation from placebo,” noted Steven Romano, the company’s chief scientific officer.
But they are not writing it off. At least not yet.
Though their drug failed to outpace the placebo, Mallinckrodt says that they also didn’t see the expected decline in patients in the placebo group, giving them hope that there’s still something here worth keeping alive. That may be a lengthy stretch, but Romano insists they could salvage this one yet.
At a meeting in August, the FDA indicated to us that their view on the potential approvability of VTS-270 will be based on the totality of data, not a single study or endpoint. And in the coming months we will continue to work with the primary investigators and the FDA to clarify a potential path forward.
We understand the importance of pursuing this potential treatment for Niemann-Pick type C and based on our current assessment of the safety data, at this time, we believe continued treatment with VTS-270 in the ongoing open label portion of the trial is acceptable. Patients, their families, and our patient group partners should know that we remain deeply committed to this work.
The drug — a unique mixture of 2-hydroxypropyl-ß- cyclodextrins (HPßCD), which registered positive data from a tiny study with 14 patients — was originally from Vtesse, which Sucampo acquired in its $200 million buyout earlier in 2017.
The company’s shares nevertheless popped up about 10% by the end of the day, a reflection of investors’ appreciation for their Q3 numbers, which exceeded expectations.

Voyager hit as FDA reverses on accelerated filing for gene therapy


The FDA appears to have lost its appetite for an accelerated marketing application that could pave the way to an early OK for Voyager’s lead gene therapy. The company announced after the market closed Wednesday that the agency’s view has shifted dramatically.
After tantalizing investors in July with its claim that FDA officials said in a Type C exchange that they were open to a filing based on the safety and efficacy seen in a Phase II study for VY-AADC in Parkinson’s disease, the new word is that regulators are now viewing the mid-stage study as a necessary preliminary step to a pivotal trial. In an addendum that arrived in late October, the biotech said, the FDA now says that “although the data from the Phase II trial may support the safety and efficacy of VY-AADC and could be considered in the BLA review, the FDA currently considers the Phase II trial as an early phase exploratory study.”
Voyager’s stock $VYGR took a 12% dive in after-market trading.
But it gets worse when you plumb the company’s SEC filing on its latest 10K. The biotech says it decided to skip a formal sit-down with regulators in a Type C meeting after they got the initial written responses on the timeline from the FDA. But along with the note on their current view regarding Phase II’s exploratory status, the company adds:
Consistent with this statement, the FDA further informed us that it has significant concerns regarding the ability of the Phase 2 trial by itself to provide substantial evidence of safety and effectiveness and that the FDA generally requires at least two adequate and well-controlled clinical trials to provide substantial evidence of effectiveness for submission of a marketing application
Their gene therapy is designed to dispatch the AADC gene directly into neurons of the putamen where dopamine receptors are located, enabling the neurons to express the AADC enzyme and convert levodopa into dopamine to better control symptoms of the disease.
In an update on their Phase Ib trial, the biotech separately noted that they picked their Phase II dose after seeing results for the two highest dose cohorts in their study, which included a small group of 10 patients.
This combined analysis demonstrated an increase from baseline in good ON time of 2.4 hours per day at 12 months, the timepoint for the primary endpoint in the Phase 2 trial, and 2.6 hours per day at 18 months, the latest timepoint measured for both cohorts. Of the combined ten patients in Cohorts 2 and 3, seven patients would be eligible for the Phase 2 trial based on limits in severity of dyskinesia and minimum OFF time at baseline. For these seven patients, the Phase 2 trial relevant group, the improvements in good ON time were 2.8 hours at 12 months and 2.5 hours at 18 months. These results were achieved with clinically meaningful and sustained reductions in daily oral levodopa and related medications.

Profiling Mass Shooters: What We Know (and Don’t)


Below is a transcript of a quick reaction to the most recent shooting in Pittsburgh:
As America mourns for the victims of the Pittsburgh synagogue shooting, it might be comforting at least to know what is the mental health profile of a mass shooter. What can we look for? Recent studies, however, suggest that if we were to suddenly eradicate bipolar disorders, schizophrenia, and major depression, violence would be reduced by only between 2% and 19%. In fact, those with severe mental illness are much more likely to be the victims rather than the perpetrators of violent crime.
In one study where psychiatrists made predictions about which inpatients in mental health units were likely to commit violence within the next year, their predictions were a little better than the flip of a coin, just about 50-50. In other words, when it comes to our deepest questions, the ones about the origins of evil and violence, the explanations of science may offer no advantage over the constellations of religion and spirituality.
For MedPage Today, I am Morgan Campbell.
Comments:
— Russell Copelan
Firstly, the standard of care is not prediction, but rather reasonable anticipation or foreseeability of dangerous behavior. Secondly, “severe mental illness” is not limited to acute illness, such as decompensating schizophrenia or major depressive illness. Long term absence of psychological health, as defined in paranoid and antisocial personality disorder phenotypes, is deeply ingrained, tending to be chronic, and generally refractory to treatment. It is here that social, and clinical, indices of suspicion must remain high.
— jamie fields
There seems to be a correlation between domestic/relationship violence and mass shooting. Has this been studied?
— Bailey Lee
“Recent studies, however, suggest that if we were to suddenly eradicate bipolar disorders, schizophrenia, and major depression, violence would be reduced by only between 2% and 19%.” and “In one study where psychiatrists made predictions about which inpatients in mental health units were likely to commit violence within the next year, their predictions were a little better than the flip of a coin, just about 50-50.”
There’s part of the problem right there. IF educated people can’t tell the difference between 2%-19% and 50%, then there’s no hope for any solution.
Here’s a better question: Mass shooters get all the attention but gang violence and domestic violence kills multiple times more people than mass shootings. Go to where the money is (Willie Sutton ) and try to solve those crimes at the same time if not first.
— M Elward
There is a disconnect between the title and the content. It is true that we cannot well predict “violence” in many cases. That is different than prevention or profiling of potential “mass shooters.” What seems to be clearly true is that certain mental health issues predominate in mass shooters. Mass shooting and general violence are sad but in some ways significantly separate issues, in terms of prevention.
— Russell Copelan
All good points. Important to remember that “prediction”, whether five year survival following DX of CHF, or predatory violence, attenuates with time “within the next year.” Also, “If educated people . . .”; According to the Council on Behavioral Health, 1.CMS discontinued emergency psychiatry training many years ago, so whose training the trainers?; 2. A significant percentage of psychiatrists no longer accept insurance or see the most severely ill; and 3.Fifty-five percent of U.S. states have a severe shortage of general psychiatrists, 95 percent a severe shortage of child psychiatrists. To paraphrase Yogi Berra, “It has gotten late early.”
— Andrew Johnstone
While I applaud the goal of intervention by trying to predict who might be at risk of such a crime, the parallels if the person were an arsonist instead of a shooter might give us pause.
If periodically arsonists set fire to high-rise buildings, would we ONLY focus on either trying to analyze the personalities of currently known psychiatric patients, or all depressed individuals, or would we ONLY focus on trying to figure out which brand of matches or lighters they used, and try to somehow restrict the sale of those…?
No – we would ALSO be sure that the buildings that were potential targets of such activity were equipped with proper fire-detection and fire-stopping equipment, and that the occupants knew how to use those things. We would make sure each floor had working smoke detectors, sprinkler systems, fire extinguishers, and operate on the principle that intervention DURING the event may be necessary, given the likelihood that our prior-restraint interventions are likely to fail.
But when it comes to atrocities carried out with firearms, we completely ignore the idea of intervening DURING the event, and base our ‘rational’ discussion of stopping a violent criminal via trained and armed personnel, much less ‘ordinary citizens’ with concealed-carry licenses, on our vast experience as physicians with firearms – either watching movies, working in Emergency Rooms, or serving in the military, NONE of which help us make decisions advising public policy on concealed carry licensees being prohibited in certain areas.
That is no more logical than prohibiting fire extinguishers in high-rise buildings for fear that irresponsible individuals might misuse them and hurt other people.
‘Gun-Free Zones’ contribute to the problem, and we need to address that…!

Concussion Serum Biomarkers Miss the Mark in Sports


Blood-based biomarkers need further work to produce reliable assessments of sport-related concussions, according a large prospective analysis of college athletes.
Variability in serum biomarkers suggested inherent sensitivity and specificity limitations at baseline, reported Breton Asken, MS, of the University of Florida in Gainesville, and co-authors in Neurology.
“Our data show that cutoffs for normal or elevated biomarkers may differ based on factors like sex and race, but we don’t yet know if there’s a specific concentration that reliably signals a problem regardless of what’s considered normal for a given subgroup,” Asken told MedPage Today.
“Concussion is a clinical diagnosis based on symptoms, while blood biomarkers capture a physiologic state,” he added. “It is no surprise these do not always align.”
No biomarker for concussion currently exists and diagnosis depends on clinical history, physical examination, and clinical acumen, noted Erin Bigler, PhD, of Brigham Young University, in Provo, Utah, and Ellen Deibert, MD, of Drexel University College of Medicine in York, Pennsylvania, in an accompanying editorial.
“Limitations in diagnostic precision, especially for the mildest of traumatic brain injuries, have plagued the field from its inception,” and have led to varying opinions about sport-related concussion reflected in current guidelines and statements from the American Academy of Neurology and the 5th International Conference on Concussion in Sport, they added.
In the three-part BASICS (Biomarkers Assessed in Collegiate Student-Athletes) study, Asken and colleagues looked at levels of beta-amyloid peptide 42, total tau, S100 calcium binding protein B (S100B), ubiquitin carboxy-terminal hydrolyzing enzyme L1 (UCH-L1), glial fibrillary acidic protein, microtubule associated protein 2, and 29,39-cyclic-nucleotide 3′-phosphodiesterase (CNPase). It followed student athletes over time to look for changes at both the group and individual level.
In the first part of BASICS, an analysis of 415 healthy college athletes who played football, basketball, lacrosse, or soccer showed strong variability in S100B and UCH-L1 concentrations at baseline: men had higher levels than women, and black athletes had higher levels than white athletes. In the second part of BASICS, biomarkers in these same 415 athletes showed no consistent association with concussion history, or cumulative exposure to collision sports.
The third part of BASICS studied 29 college athletes who had sport-related concussions during the study and found that 67% had elevated levels of S100B after a concussion compared with baseline; that number rose to 88% when blood samples were collected within 4 hours of concussion.
When researchers compared blood samples of 36 athletes who had concussion within 4 hours with those of 86 athletes who did not have concussion, they saw that 75% of concussed athletes had higher levels of total tau, 81% had higher levels of beta-amyloid peptide 42, and 88% had higher levels of S100B than the median levels of non-concussed athletes. Neither absolute serum biomarker concentrations nor changes from baseline correlated with clinical outcomes, including symptom severity, sport-related concussion test scores, or duration of clinical recovery.
“The takeaway from this, at least in sport-related concussion, is that a serum biomarker may detect injury, yet not relate in meaningful ways to current motor, neurobehavioral, and neurocognitive outcome measures,” observed Bigler and Deibert. While this research “does provide Class III evidence that some serum biomarkers are elevated or higher than controls after sport-related concussion, their diagnostic accuracy depends on which reference group method is used and time post-injury,” they added.
The concussions studied in BASICS were sport-related only and did not require emergency department care, Asken and colleagues noted. Unmeasured factors also may have influenced the serum concentrations of biomarkers in athletes.
The study was supported by the Head Health Initiative (a collaboration between General Electric and the National Football League), Banyan Biomarkers Inc., and the U.S. Army Medical Research and Material Command. The University of Florida has a financial stake in Banyan Biomarkers, which conducted the biomarker analyses.
Researchers reported relationships with Banyan Biomarkers, Amgen, Cognition Therapeutics, Acumen, Biogen, Florida High Tech Corridor Matching Funds Program, and the NCAA-DoD CARE Consortium.
Editorialists reported relationships with the National Academy of Neuropsychology and the Army Medical Research and Material Command.

Pain in Osteoarthritis: Cause or Effect?


Higher baseline pain scores among individuals with knee osteoarthritis (OA) were associated with worse structural damage over time, an analysis of data from the Osteoarthritis Initiative showed.
Among patients who had no radiographic evidence of OA at baseline, higher scores on the Western Ontario and McMaster Universities (WOMAC) OA pain index were associated with an increased incidence of radiographic disease over 4 years (OR 1.07, 95% CI 1.01-1.13, P=0.02), according to Yuanyuan Wang, PhD, of Monash University in Melbourne, Australia, and colleagues.
And for those who already had radiographic OA at baseline, higher baseline WOMAC pain scores were associated with increased progression of the radiographic changes (OR 1.07, 95% CI 1.03-1.10, P<0.001), the researchers reported online in Arthritis Research & Therapy.
Evidence has been accumulating supporting the concept that joint health depends on an interplay between structures including cartilage, muscle, and bone, and that pain can have an adverse effect on these structures through inflammation and interference with mobility.
“Thus, it is plausible that knee pain not only is a consequence of structural deterioration in OA but also contributes to structural progression. Clarifying this is important because if this is the case, targeting the factors related to knee pain may offer a potential strategy for slowing disease progression of OA,” Wang and colleagues wrote.
Previous studies examining the potential influence of pain on OA progression have had mixed and inconclusive results, possibly because of differences in study populations, definitions, and assessment of symptoms, and duration of follow-up.
The Osteoarthritis Initiative, which is sponsored by the National Institutes of Health, is a large observational cohort that includes almost 5,000 individuals with knee OA or at risk for the disorder. This database offered a useful resource for analyzing the effects of pain on structural progression, the researchers noted.
The primary structural changes associated with OA are cartilage volume loss, which is assessed with magnetic resonance imaging, and the incidence and progression of radiographic knee changes on the Kellgren-Lawrence grading system.
Symptomatic OA was defined as a WOMAC pain score of 5 or higher. Patients with scores below 5 at both baseline and at 1 year were classified as having no pain, those who had scores above 5 at either baseline or at 1 year were classified as having fluctuating pain, and those with scores above 5 at both time points were classified as having persistent pain.
The analysis included 2,120 individuals classified as having non-radiographic OA, in that their baseline Kellgren-Lawrence grade was 0 or 1, or 2,249 with radiographic OA with grades 2 to 4. Mean ages were 60 in the non-radiographic group and 63 in the radiographic group, and 58% of both groups were women.
In the non-radiographic group, higher baseline pain scores were associated with a greater loss in cartilage volume in the medial compartment (regression coefficient 0.04%, 95% CI 0.02-0.06) and lateral compartment (0.04%, 95% CI 0.02-0.06) after adjustment for age, sex, body mass index, and Kellgren-Lawrence grade.
Similarly, in the radiographic group, a higher baseline pain score was associated with worse cartilage loss in the medial (regression coefficient 0.04%, 95% CI 0.02-0.07) and lateral (0.05%, 95% CI 0.03-0.07) compartments.
In the non-radiographic group, the annual rate of cartilage loss after adjustment for age, sex, body mass index, and Kellgren-Lawrence grade was 0.63% through 4 years of follow-up for those with no knee pain, 0.81% for those with fluctuating pain, and 0.93% for those with persistent pain (P for trend = 0.003). Fluctuating knee pain also was associated with the development of radiographic OA (OR 1.62, 95% CI 1.04-2.54, P for trend = 0.03).
For the radiographic group, the annual rates of cartilage loss were 1.26%, 1,47%, and 1.60% in those with no pain, fluctuating pain, and persistent pain, respectively (P for trend = 0.01). Persistent knee pain was associated with greater progression of radiographic damage (OR 1.82, 95% CI 1.28-2.60, P for trend = 0.001).
“These data suggest that knee pain is an important predictive factor for the deterioration of knee structural outcomes and highlight the significant adverse impact of persistent knee pain on knee structures,” Wang and colleagues stated.
“This study suggests that controlling knee pain early in the disease course as well as over time by targeting the underlying mechanisms may be important for preserving knee structure and reducing the burden of knee OA,” they concluded.
Among the mechanisms contributing to pain and structural changes are inflammatory hyperalgesia, genetic factors, and central mechanisms in the brain influencing fear and aversive conditioning, the researchers noted.
A limitation of the study, they said, was the lack of adjustment for medications.
The Osteoarthritis Initiative is a public-private partnership funded by the National Institutes of Health, Merck, Novartis, GlaxoSmithKline, and Pfizer.
Three of the co-authors reported financial ties with ArthroLab.
  • Reviewed by Dori F. Zaleznik, MD Associate Clinical Professor of Medicine (Retired), Harvard Medical School, Boston and Dorothy Caputo, MA, BSN, RN, Nurse Planner

NuVasive receives FDA 510(k) clearance for COHERE Porous PEEK implant


NuVasive announced it has received 510(k) clearance from the U.S. FDA for use of its COHERE Porous PEEK implant in eXtreme Lateral Interbody Fusion surgical spine procedures. COHERE XLIF is expected to launch commercially in the U.S. in second quarter 2019.
https://thefly.com/landingPageNews.php?id=2821089