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Thursday, September 27, 2018

Medicare Advantage plans could be denying claims to boost profits: HHS


The HHS’ Office of Inspector General fears that Medicare Advantage plans could be denying needed medical services to maximize profits, according to a new report released Thursday.
When beneficiaries and providers appealed preauthorization and payment denials, Medicare Advantage organizations, or MAOs, overturned 75% of their own denials between 2014 and 2016. They overturned approximately 216,000 denials each year, HHS OIG said.
During the same period, independent review entities, which handle the second level of appeals for denials, overturned additional claims denials in favor of beneficiaries and providers.
“The high number of overturned denials raises concerns that some Medicare Advantage beneficiaries and providers were initially denied services and payments that should have been provided,” the HHS OIG said in the report. “MAOs may have an incentive to deny preauthorization of services for beneficiaries, and payments to providers, in order to increase profits.”

Beneficiaries and providers rarely used the appeals process. Over the two years studied, beneficiaries and providers appealed only 1% of denials.
Patient advocates have raised concerns that the appeals process can be confusing and overwhelming, particularly for critically ill beneficiaries. The HHS OIG noted that patients may either be going without needed services or paying for them out of pocket because of this.
HHS’ OIG said that some denials may stem from legitimate issues such as a plan determining that its original decision was incorrect, or they may have lacked necessary information to approve a claim, only to receive what they needed later.
Nevertheless, the HHS OIG wants the CMS to increase its oversight of Medicare Advantage plans to help ensure denials made by insurance companies are truly valid.
The agency should provide technical assistance, training, education and increased monitoring or enforcement actions for MAOs that exhibit higher denial rates. The CMS could impose civil money penalties if it finds claims are being denied for the wrong reasons or appeared to be motivated by profit, the watchdog said.
The CMS also could also require plans with repeated violations to hire independent auditors to perform program audits more frequently than the CMS is able to.
The CMS told the HHS OIG that it agreed that enhanced oversight of Medicare Advantage plans was needed, but it did not say what actions it will take to do so.
AHIP pushed back against the report highlighting the fact that MA plans approve the vast majority of prior authorization and payment requests they receive, according to Cathryn Donaldson, a spokeswoman for the trade association.
“It is also important to distinguish between patients getting needed care and providers receiving payment for services delivered, which the OIG reports in a combined fashion,”Donaldson said.
“A denial does not necessarily equate to patients not getting the care they need.”
In addition, researchers often rank Medicare Advantage plans higher in terms of quality of care provided compared to Medicare fee-for-service, according to John Rother, who heads the National Coalition on Healthcare, a group of insurers and employers,
“Many researchers actually fear the converse that the incentives in the fee for service sector promote over treatment due to financial considerations [by providers],” Rother said. “Over treatment often results in extra expenses but can also result in harm to the patient.”
Medicare Advantage enrollment has grown steadily over the past decade and shows no signs of slowing. About 21.4 million seniors are currently enrolled in Advantage plans, up 7.8% over last year, according to the latest data from the CMS. That represents about one-third of all Medicare beneficiaries.

Why Are STD Rates Soaring Nationwide


Hello. I’m Dr Arefa Cassoobhoy, a primary care internist, Medscape advisor, and senior medical director for WebMD. Welcome to Medscape Morning Report, our 1-minute news story for primary care.
The United States has the highest sexually transmitted disease (STD) rates in the industrialized world. After decades of watching rates decline, the incidence of three sexually transmitted infections hit an all-time high in 2017.
Chlamydia, gonorrhea, and syphilis combined were diagnosed in 200,000 more people in 2017 compared with 2016. Rates of syphilis, in particular, have doubled in the past 4 years. About half of these cases are in men who have sex with men. Another major concern is the rise in gonorrhea that is resistant to ceftriaxone.
These alarming trends point to a public health crisis. One reason for the increase is a lack of awareness. It can be an uncomfortable conversation. Patients rarely ask for STD testing or treatment. And providers often fail to take sexual histories or screen for STDs. The opioid crisis adds to the problem, as individuals trade sex for drugs, becoming infected.
When testing for chlamydia or gonorrhea, clinicians should ask patients if they have had anal-receptive intercourse. If so, a rectal culture should also be obtained, because genital testing alone will miss about 20% of STDs.
When treating gonorrhea, give a single injection of ceftriaxone, plus an oral dose of azithromycin, to prevent the development of resistance. For syphilis, screen any patient at elevated risk—including pregnant women—at the earliest opportunity, without waiting for symptoms.

What’s New in Cannabis Clinical Trials


There has been quite a lot of big news coming out involving cannabis as of late, with much of this news being in regard to clinical trials and government approvals.
All of these clinical trials are helping to further our knowledge of cannabis’s potential medical benefits and safety as a medication, and they are opening the way for more research to be done down the line as well. While many of these studies are still only in the beginning phases, others are already starting to show positive results.
Nebraska clinical trial shows promise
A two-year clinical trial on cannabidiol (CBD) oil in Nebraska has produced results showing that CBD can help treat the seizures caused by epilepsy.
The majority of the patients involved in the trial showed improvement with their epilepsy symptoms by taking CBD oil. All of the patients have a form of epilepsy that isn’t easily treated by normal methods, and so the results of this study show that CBD oil could potentially be a valuable treatment for more severe forms of epilepsy.
With that said, four of the patients did drop out of the trial because they began suffering from side effects such as sleepiness and lethargy. However, one of the researchers noted that the side effects could be improved by adjusting the dosage.
The medication that is being used for this clinical trial is Epidiolex, which is a solution containing CBD that was approved for medical use by the FDA back in June. This approval was specifically for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, which are both severe forms of epilepsy that are often resistant to normal epilepsy medication.
Cannabis as a treatment for essential tremor
A new clinical trial that will study cannabis’s safety and effects on essential tremor is slated to begin in early 2019 at University of California School of Medicine. This will be an innovative trial as cannabis has never before been studied for its effects on essential tremor. If it has positive results, then cannabis may serve as a safe alternative to the beta blockers and anticonvulsants that are used to treat essential tremor today.
The specific medication being tested in this study is an oral solution that contains CBD along with a low dose of tetrahydrocannabinol (THC), which is the primary psychoactive substance found in cannabis.
Tilray, a Canadian cannabis company, has received DEA approval to begin importing the marijuana that will be required for this clinical trial. This is a monumental decision by the DEA as this makes Tilray the first company to export legal marijuana to the US. Because of this news, Tilray’s stock has risen by 29% and has many predicting a bubble for the marijuana industry.
CBD for psychosis
A study being done in the United Kingdom has found that CBD oil may be effective in treating psychosis. This could prove to be an enormous discovery as a safe alternative to conventional antipsychotics has long been desired.
THC on its own is considered a risk factor for inducing psychosis. However, by its very nature, CBD counteracts the effects of THC and through this same mechanism, is able to help aid with psychosis.
According to the study’s findings, it only takes a single dose of CBD in order to decrease the amount of abnormal brain activity that causes the symptoms of psychosis, making it quick and easy to administer.
With the positive results from this study, the research team are now working towards starting a major clinical trial spanning multiple hospitals in order to research CBD’s effectiveness as an alternative to antipsychotics.
Cannabis to treat Huntington’s disease and multiple sclerosis
Some potentially good news for those who suffer from either Huntington’s disease or MS: MMJ International has filed two applications with the FDA to start clinical trials. These studies will test whether or not cannabis has an effect on Huntington’s disease and MS.
MMJ International also hopes to meet with the FDA soon to discuss the development of a new drug to treat these debilitating illnesses and to create a strategy for bringing this new medication to market faster.
Both Huntington’s disease and MS are neurodegenerative disorders that progress slowly and severely cripple those who suffer from them. Neither one currently has a known cure and there are few medications available to help treat them, making the outlook quite bleak.
In preliminary studies, CBD has shown to be neuroprotective, so the hope is that it may be able to help combat the degenerative effects of these disorders. If all goes well, then this could lead to a novel medication that will give some hope to those afflicted with Huntington’s disease and MS.

Medical office space gets tight

The swelling demand for healthcare services is undebatable. The age 65-and-older cohort will rise to just over 56
million by 2020, comprising 17% of the nation’s total population. This represents an annual growth rate of 3.5%,
which is approximately 14 times the rate of those aged 64 and younger.
As the senior age bracket grows, it will drive physician growth and subsequent need for medical office space.
Through 2019, expenditures on professional medical services is projected to grow 5.2% annually, compared to 4.3% historically. Those 65
and older will require more healthcare services, as this group visits doctors well above the rate of any other age group.
Given rising demand for healthcare services, current projections
estimate that just over 150,000 healthcare practitioners will be
added to the economy over the next two years.
The required space demanded by most practitioners ranges
from 1,000 square feet to 1,500 square feet, dependent on if they
are starting their own practice or adding additional practitioners
to their staff, per MedScape. Therefore, total demand for medical
office space across the U.S. could range from 150.5 million
square feet to 225.8 million square feet by 2019.
There is an estimated 110 million square feet of available medical
office space in existing and under-construction buildings in the
U.S. as of the second quarter of 2018. If all healthcare practitioners
added to the economy through 2019 aim to locate within medical
office space, absorption of this demand is impossible.
More specifically, when drilling down to the top 10 most populous
metros and several other select markets, for most areas the
ability to handle this increased demand is unlikely – even at the
low end of the projected range – without a major shift in how
people expect and receive healthcare. New York, Dallas/Fort Worth,
Atlanta, Denver, and Miami/Fort Lauderdale would be the most
challenging for practitioners wishing to locate within medical
office space.
However, medical practitioners could explore leasing space in
conventional office buildings, of which there is currently ample
space available, or accelerate the trend of repurposing empty
retail space for medical uses. In addition, the emergence of new
forms of healthcare, such as telemedicine, digital health, and
shared service centers, could suppress future demand to some
degree, depending on how quickly these new approaches are
adopted by the healthcare industry.

Autolus Therapeutics: UK biotech raises bumper $2 billion, despite Brexit blues


Britain’s biotechnology industry has raised a bumper 1.56 billion pounds in the first eight months of this year, surpassing the 1.2 billion reached in the whole of 2017, despite anxiety in the sector about the fallout from Brexit.

The increase has been fuelled by recent changes to venture capital tax incentives, according to UK BioIndustry Association (BIA) CEO Steve Bates, as well as global investor enthusiasm for drug discoveries emanating from biotech labs.
Data published by the BIA and Informa Pharma Intelligence on Friday showed venture capital accounted for 927 million pounds of this year’s tally, with initial public offerings (IPOs) adding 228 million and other public financings 408 million.
Big venture rounds included 115 million pounds raised for Orchard Therapeutics, which bought GlaxoSmithKline rare disease gene therapy drugs, while cell therapy specialist Autolus banked 132 million pounds in a Nasdaq IPO.
Britain’s decision to leave the European Union is a worry for the life sciences sector, given uncertainty about future medicines regulation and concerns over access to top scientific talent.
The growing threat of a “no-deal” Brexit has led to warnings about possible disruption to drug supplies, prompting the government to ask companies to build an additional six weeks of medicine stockpiles.

Lilly says FDA has approved new migraine drug Emgality


Eli Lilly and Company [s:lly] said late Thursday that the U.S. Food and Drug Administration has approved its drug Emgality for the preventive treatment of migraine in adults. Emgality is delivered via a once-a-month, self-administered, subcutaneous injection. Lilly said the drug, one of three in a new class of drugs recently approved for migraines, will be available to patients shortly after approval. Patients with commercial insurance will be candidates to receive Emgality for up to 12 months free as part of Lilly’s patient-support program, the company said. Lilly also said Emgality will be available for pickup at retail pharmacies. The drug maker said the efficacy and safety of Emgality was demonstrated in two Phase 3 clinical trials in patients with episodic migraine and one Phase 3 clinical trial in patients with chronic migraine.

Powell: ‘Our uniquely expensive healthcare’ system will catch up with us


The Federal Reserve may primarily deal with monetary policy and financial regulation, but Fed Chair Jerome Powell called out the U.S. healthcare system that’s contributing to a ballooning federal budget deficit during the Fed meeting press conference on Wednesday.
“It’s no secret: It’s been true for a long time that with our uniquely expensive healthcare delivery system and the aging of our population, we’ve been on an unsustainable fiscal path for a long time,” Powell said while answering a question by Yahoo Finance’s Myles Udland. “And there’s no hiding from it.”
Federal spending on health care (mostly Medicare and Medicaid) has risen from 14.4% of all federal outlays in 1990 to about 31% in 2018 — one of the main reasons the national debt is $21.5 trillion and growing. And the amount of money Americans spend on health care is likely to rise by about 5.5% per year for the next several years, according to government projections on health spending through 2026.
Federal Reserve Chairman Jerome Powell speaks during a news conference in Washington, Wednesday, Sept. 26, 2018. REUTERS/Al Drago
Comments like Powell’s are not something people at the Fed take lightly, as the agency has traditionally been careful to avoid overstepping its bounds. In his answer, Powell prefaced his comments on healthcare by noting that the Fed will continue to take this approach and “stay in [its] lane.”
“We don’t have responsibility for fiscal policy. But in the longer run, fiscal policy will have a significant effect on the economy,” said Powell. “So for that reason, my predecessors have commented on fiscal policy, but have commented at a high level, rather than get involved in particular measures.”
Powell has expressed concerns about unsustainable deficits before. At a symposium sponsored by the Federal Reserve Bank of Kansas City, the Chair expressed concernover the shrinking tax-base/larger-entitlement situation that comes from an aging population.
At Wednesday’s press conference, the Chair doubled down on these words and made a gentle recommendation to deal with the problem.
“In the end, we will have to face [the unsustainable path] and the sooner the better,” he said. “Also these are good times. This is the economy at nearly full employment. Interest rates are low — it’s a good time to be addressing these things. I just put that out there and leave it at that.”