On a preliminary basis, Globus Medical (NYSE:GMED) expects Q4 and 2019 sales to be ~$211.0M (+8%) and ~$784.7M (+10%), respectively.
2020 guidance: Sales: $850M; non-GAAP EPS: $1.82.
Wednesday, January 8, 2020
Where Democrats Go Wrong On Pre-existing Conditions
This week, Senate Democrats are voting on a resolution to curtail the use of the Affordable Care Act’s Section 1332 waivers, which empower states to revamp their failing individual insurance markets. These waivers are a lifeline for states whose individual markets are on the verge of a death spiral. Yet Democrats claim they would put people with pre-existing conditions in jeopardy and are an attempt to “sabotage” Obamacare.
Here’s the problem.
If you have a decent income and have a chronic health condition, things have gotten worse, not better, for you under Obamacare.
For example, if you are single and earn $50,000 a year, you get no subsidy if you have to buy your insurance in the individual market. Yet under Obamacare, premiums have doubled nationwide. In some areas they have increased fivefold. Deductibles are three times what they are in a typical employer plan.
For family coverage, premiums in the range of $15,000 to $20,000 a year with $7,000 individual deductibles are not uncommon.
What about access to care? Across the country there has been a race to the bottom in the Obamacare exchanges. Narrow networks exclude the best doctors and the best hospitals almost everywhere.
Before the passage of the Affordable Care Act, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) required states to enact protections for people with health problems who transitioned from the group to the individual health insurance market.
Most states met this obligation by establishing risk pools. The insurance offered in these pools was typically a Blue Cross plan that allowed access to almost all doctors and facilities. The premium was often 25% higher than what healthy people paid. But never more than 50%.
Today, if you leave an employer plan and enter the individual market you will face higher premiums and less access to care than under the old system – whether you are healthy or sick.
Centene is a Medicaid contractor that now sells about one-fifth of all the Obamacare plans sold in the country. The insurance it offers looks very much like Medicaid managed care. Doctors and hospitals that are in Centene’s network must accept Medicaid fees. If a patient goes out of network, Centene doesn’t pay anything.
It has taken a few years for the market to settle down. But today almost every other insurer is following Centene’s lead. In Dallas, Texas, not a single plan offered in the individual market ill allow a patient to enter UT Southwestern Medical Center, arguably the best medical research facility in the world. MD Anderson Cancer Center in Houston also doesn’t take Obamacare patients. Ditto for many other centers of excellence across the country.
What Obamacare promised was something that looked like traditional Blue Cross insurance for an affordable price. What we got was Medicaid with a high deductible and an unaffordable price.
A lot of healthy people are going bare. In fact, most people in the individual market who don’t qualify for a subsidy are currently uninsured! But if you are sick and need medical care, that’s not an option.
Obamacare desperately needs reforming. Seven states have received Section 1332 waivers and in every case premiums came down because the states were allowed to offset expenses for the most costly enrollees. Next year, an additional five states will get waivers and premiums are expected to decrease in those states as well.
Yet Democrats in the Senate say they want to undo those reforms.
Much more needs to be done. Health plans need to be able to specialize – say in cancer care, diabetic care or heart disease. Plans should be able to ask heath questions at the time of enrollment to make sure the right plan gets connected with the right patient. And risk pool funds are needed to make sure that plans that attract patients with expensive-to-treat problems receive fair compensation.
The healthcare framework recently released by the Job Creators Network offers such a personalized approach to healthcare by giving patients more control over their healthcare choices through reforms such as expanded personal health management accounts and increased use of direct medical care.
We also already have a model for reform. It’s called Medicare Advantage (MA). Like Obamacare, it has an exchange. It has guaranteed issue and community rating. But unlike Obamacare, Medicare Advantage for the elderly and the disabled works and works well.
Instead of fighting the Trump Administration and state-level reformers and unduly alarming people with health problems, Democrats in Congress should work with their Republican colleagues to make changes that are long overdue.
FDA accepts Nabriva’s refiled Contepo application; shares up after hours
The FDA accepts for review Nabriva Therapeutics’ (NASDAQ:NBRV) resubmitted marketing application for Contepo (fosfomycin) for the treatment of complicated urinary tract infections. The agency’s action date is June 19.
The company received a CRL last year citing deficiencies at one of its contract manufacturers.
Shares up 8% after hours.
Applied Genetic Tech up after hours ahead of key update
Applied Genetic Technologies (NASDAQ:AGTC) perks up 6% after hours ahead of tomorrow’s announcement of preliminary six-month data from the expansion group in a Phase 1/2 clinical trial evaluating its recombinant adeno-associated virus vector rAAV2tYF-GRK1-RPGR in patients with X-linked retinitis pigmentosa caused by RPGR mutations.
The conference call will start at 8:00 am ET.
Hepion Pharma up after hours ahead of CRV431 update
Hepion Pharmaceuticals (NASDAQ:HEPA) is up 5% after hours ahead of a presentation of data from four nonclinical studies demonstrating that CRV431 improved liver fibrosis in animal and human tissue models.
Chief Scientific Officer Dr. Daren Ure will be announce the results at the NASH-TAG 2020 Conference in Park City, UT this week.
FDA OKs Merck’s Keytruda for treatment-resistant bladder cancer
The FDA approves Merck’s (NYSE:MRK) Keytruda (pembrolizumab) as monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy (bladder removal).
Regular Cannabis Use Linked to Cardiac Abnormalities
Regular recreational use of cannabis is associated with potentially adverse features of left ventricular size and subclinical impairment of left ventricular function, compared with rare or no cannabis use, an observational study concludes.
Previous use of recreational cannabis was not associated with such features, suggesting that any deleterious effects may not be permanent.
“These are early data which included a relatively small group of regular cannabis users, and the changes we detected were subtle,” lead author Mohammed Y. Khanji, MBBCh, PhD, William Harvey Research Institute, NIHR Barts Biomedical Center, Queen Mary University of London, and the Barts Heart Center, St Bartholomew’s Hospital, London, United Kingdom, told theheart.org | Medscape Cardiology.
“However, regular users of cannabis may wish to reduce their intake until further systematic research becomes available which will hopefully provide further insight on the long-term effects of recreational cannabis use,” Khanji said.
The study was published online December 21 as a letter in JACC: Cardiovascular Imaging.
However, at least one observer is not convinced. Steven E. Nissen, MD, Lewis and Patricia Dickey Chair in Cardiovascular Medicine and professor of medicine, Cleveland Clinic, Ohio, disagrees with the authors’ conclusion that healthcare professionals should caution patients on regular use of cannabis.
“This very brief manuscript describes a poorly controlled, observational study suggesting differences in cardiac structure and function in regular cannabis users. The findings are unreliable,” Nissen told theheart.org | Medscape Cardiology.
“There were only 47 regular users, and no amount of adjustment can correct for imbalances in the study groups. To conclude that healthcare professionals and policy makers may need to advise caution on regular recreational cannabis use is not warranted based upon these limited data,” he said.
However, addiction psychiatrist Thersilla Oberbarnscheidt, MD, University of Pittsburgh School of Medicine, Pennsylvania, warned that cannabis has not been properly studied and that regular use can have serious health side effects.
“It has been shown before that the frequent use of marijuana increased the risk of myocardial infarction and hypoxemia, but a direct pathological effect on the heart has not been shown until now,” Oberbarnscheidt told theheart.org | Medscape Cardiology.
“We need more studies to look at the organ toxicity of marijuana,” she said. “In the general population, marijuana is seen as natural and ‘harmless.’ As an addiction psychiatrist, I see many patients who smoke marijuana and are not aware of the toxic effects of that substance,” she said.
Khanji said he hopes his study stimulates further research on the cardiovascular health effects of regular cannabis use as well as discussions on the potential public health implications of recreational cannabis.
“Currently, little or no mention of cannabis exists in guidelines on cardiovascular risk assessments or related lifestyle advice guidelines,” he noted.
“Our study does have some limitations, including the fact that the study group were mainly Caucasians and we relied on self-reported cannabis usage, which may not be very accurate. The number of regular cannabis users in our study was relatively small. It’s also unclear whether the associations observed are due to cannabis use alone or other unmeasured confounding factors,” Khanji said.
Discussions of the potential impact of marijuana legalization on public health are hampered by gaps in evidence and variable quality of available data, he added.
Most Widely Produced and Consumed Recreational Drug
A lot has been published about the deleterious effects of smoking cigarettes, but relatively little is known about the effects of recreational cannabis use, the authors say.
“Our team has a clinical and research interest in the prevention of cardiovascular disease. Cannabis is one of the most widely produced and consumed recreational drugs in the world, with over 192 million global users, and so we felt it was important to determine the cardiovascular implication of cannabis use, particularly given the increasing legalization of recreational cannabis,” senior author Steffen E. Petersen, MD, PhD, professor of cardiovascular medicine, Barts Health NHS Trust, London, said in an interview.
To study the association between cannabis use and cardiac structure and function, the investigators analyzed cardiovascular MRI data from individuals who did not have cardiovascular disease and who were participants in the UK Biobank population study.
They then categorized self-reported cannabis use into following three categories:
- “rare/no,” meaning no use or less than monthly usage of cannabis;
- “previous regular,” defined as weekly or daily usage of cannabis up to 5 years prior to the interview; or
- “current regular,” defined as weekly or daily cannabis usage within 5 years of the interview.
The study included 3407 individuals. The average age was 62 years, and 55% were women. Of the participants, 47 individuals reported being current regular cannabis users, 105 said they were previous regular users, and 3255 said they were rare or nonusers.
Those who were current regular users were more likely to be younger, male, current tobacco smokers, and to have experienced greater levels of social deprivation compared to rare/never users and previous regular users. They were also less likely to be taking medications for hypertension, Khanji noted.
Regular cannabis use was associated with larger left ventricular size and early signs of impairment of heart function compared to rare/never cannabis users.
Compared with rare/never users, after controlling for age, sex, body mass index, systolic blood pressure, use of cholesterol medication, diabetes, smoking, and alcohol consumption, regular cannabis use was associated with the following:
- larger indexed left ventricular end-diastolic volume (+5.31 mL/m2; 95% confidence interval [CI], 1.4 – 9.3 mL/m2; P = .008);
- larger end-systolic volume (+3.3 mL/m2; 95% CI, 0.78 – 5.83 mL/m2; P = .010), and
- impaired global circumferential strain (–0.78; 95% CI, –1.47 to – 0.09; P = .026).
There were no differences between the groups with respect to left ventricular myocardial mass, ejection fraction, and stroke volume, nor for right ventricular, left atrial, and right atrial parameters.
Interestingly, parameters were similar for previous cannabis users and rare/no users. “This is encouraging and may suggest a dose response or that changes may be reversible after stopping use, as seen in cigarette smoking,” Khanji said.
These findings should be interpreted with caution; further research is required to understand the potential pathophysiology and dose-response effects of cannabis use, as well as the long-term implications of regular use on the cardiovascular system, the authors state.
“Health care professionals and policy makers may need to advise caution on regular recreational cannabis use until further systematic research is available,” they conclude.
They point out that cannabis use remains illegal in the United Kingdom, “creating additional barriers to reporting usage.”
Khanji, Oberbarnscheidt, and Nissen report no relevant financial relationships. Petersen reports a financial relationship with Circle Cardiovascular Imaging, Inc, Calgary, Canada, and Servier.
JACC Cardiovasc Imaging. Published online December 21, 2019. Full text
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