Search This Blog

Saturday, May 12, 2018

Lab company Rennova is an unlikely buyer of CHS hospital

The planned purchase of an 85-bed hospital in Tennessee by lab testing company Rennova Health raises a lot of questions. Chief among them: What does a lab company that’s losing tens of millions want with an underperforming rural hospital that Community Health Systems is trying to sell?
West Palm Beach, Fla.-based Rennova recently reported in a Securities and Exchange Commission filing a $51 million net loss from continuing operations in 2017 and a $16 million operating loss on less than $5 million in revenue. The company ended the year with no cash on hand from continuing operations, and has been sued by landlords and contractors alleging unpaid bills, according to the SEC filings. Three former employees have sued the company in Palm Beach County court alleging unpaid wages.
CHS agreed to sell the 85-bed hospital, Tennova Healthcare-Jamestown, for $1 plus the amount of net working capital as of the effective closing time, minus its capitalized leases, according to the asset purchase agreement contained in the SEC filing between CHS and Rennova. The deal includes an associated physician practice, medical office building, outpatient facilities and ancillary services. The agreement lists the closing date as April 1, but that has since been pushed to the end of the month, Rennova CEO Seamus Lagan told Modern Healthcare in an interview.
There’s been a trend in recent years of lab companies buying or partnering with rural hospitals to gain greater reimbursement for lab services using the hospitals’ favorable payer contracts. The difference in price could be $2,000 per test.
Scott Phillips, managing director of the firm Healthcare Management Partners, which specializes in turnaround management for distressed hospitals and is in a joint data venture with Modern Healthcare, said while he does not know Rennova’s intent, the key players in this proposed deal—a struggling rural hospital and an out-of-state lab company—fit the profile of between eight and 10 such lab test billing arrangements he’s aware of elsewhere, including cases he’s personally worked on.
Lagan said that acquiring the hospital to alter lab reimbursements is “absolutely” not his intention in purchasing Tennova Healthcare-Jamestown. He added that he’s aware of the model, but said this is not one of them.
“That is not an area we have any interest in pursuing or looking at,” he said. “We see these hospitals as a good little business on their own with increasing the services that are required by the local community and absolutely without the need to get into any complicated or convoluted agreements with far-away companies.”

Community Health Systems’ role

CHS included Tennova Healthcare-Jamestown in its $25 million in goodwill impairments related to hospitals up for sale in its first-quarter earnings report released May 1, but a CHS spokeswoman said the company does not comment on pending divestitures beyond its official filings.
Typically when companies sell hospitals, the buyer is the one asking a lot of questions, such as what capital expenditures will be necessary and whether the price is fair, among other things, said Steve Valentine, vice president of strategy and advisory consulting for the healthcare consultancy Premier.
“I know it sounds harsh, but a seller, it’s not their responsibility to sell it to someone who necessarily will keep operations going, who will have the financial wherewithal to invest,” he said.
Rennova’s main revenue source over the past five years had been urine toxicology testing, but commercial insurers have dramatically cut back on reimbursements for such tests amid overtesting by some providers, Lagan said. He said Rennova was not one of those unscrupulous companies, but nonetheless saw a nearly 80% drop in its insured lab test volume last year compared with 2016. Rennova used to operate five labs, but now has only two, Lagan said.
Lagan described rural hospitals as “much more predictable” than drug testing. “We see hospitals as a more reliable revenue source, more consistent,” he said.
But data show rural hospitals are anything but predictable, having faced declining occupancy rates relative to their urban peers and dire financial situations in recent years. More than 80 rural hospitals have closed since 2010 and more than 670 are at risk of closing, according to the National Rural Health Association.
Tennova Healthcare-Jamestown saw a net loss from operations and in total each year from 2013 through 2016, the most recent year for which data is available. The hospital reported a loss of $2.5 million in 2016 on total patient revenue of $15.6 million, or a negative profit margin of 16.2%, according to Modern Healthcare Metrics, the joint venture with Healthcare Management Partners.
Tennova Healthcare-Jamestown ran an average daily census of 13 patients in its 85 beds last year, a roughly 15% occupancy rate, according to Phillips of Healthcare Management Partners. Phillips said he doesn’t know how a hospital like Tennova Healthcare-Jamestown, which does not have a critical-access hospital designation, can survive with such a low occupancy rate.
Another rural health expert, Brock Slabach, senior vice president of the National Rural Health Association, said, “I don’t know what the advantage would be—let’s put it that way—in this company wanting to take over this to hospital.”
Lagan said he believes Rennova can turn around the hospital’s financial performance, and even “make a little profit,” by giving the hospital the changes and investments it needs to thrive, including potentially upgrading equipment and providing additional services. CHS focuses more attention on their larger hospitals, not the ones they’re divesting, he said. “The focus that’s required, the management that’s required to make these smaller hospitals run efficiently and work well, they can get a much better return from that same effort being expended on a larger facility,” Lagan said.
CHS spokeswoman Tomi Galin wrote in an email that the hospital chain made a strategic decision to focus future investments in its Knoxville market, about 90 miles from Jamestown.
“We’ve announced significant plans and investments in Knoxville that we believe will best serve that community and help generate long-term success for our Tennova healthcare system,” she wrote.

Rennova’s struggles

Meanwhile, Rennova has had its own problems. Nasdaq delisted the struggling company in October because its equity balance fell below the $2.5 million minimum requirement for listing. The company currently trades on the OTCQB, a market designed for early stage and developing companies.
In Rennova’s 2017 financial report, an independent auditor questioned whether company can stay in operation.
“As shown in the accompanying consolidated financial statements, the company has significant net losses, cash flow deficiencies, negative working capital and accumulated deficit,” Green & Co wrote. “Those conditions raise substantial doubt about the company’s ability to continue as a going concern.”
In 2017, Rennova paid $21.4 million in interest expenses, while its current assets as of year-end were $3.4 million and its current liabilities totaled $24.9 million.
Rennova admitted in the same report that its weak accounting procedures may not have documented all cash disbursements. “Based on these material weaknesses in internal control over financial reporting, management concluded the company did not maintain effective internal control over financial reporting as of December 31, 2017,” the company wrote.
Elsewhere in the filing, Rennova wrote that management, “does not expect that the company’s disclosure controls and internal controls will prevent all error and fraud.”
Last August, Rennova opened its first hospital, the Big South Fork Medical Center in Oneida, Tenn., which the company bought out of bankruptcy for $1 million. The company reported generating $1.8 million in net revenue last year from the hospital, which Lagan said does not perform toxicology testing in its lab. The company announced in January it signed an agreement with CHS to buy its hospital in Jamestown, less than 40 miles away.
Lagan said buying a second hospital nearby will create synergies. Rennova plans to refer patients from the smaller Oneida hospital to the larger one in Jamestown, Lagan said.
Lagan said Rennova’s stockholders voted Wednesday in favor of giving the company the ability to issue up to 3 billion shares, up from 500 million. But he said the company does not currently plan to issue the shares.
He said Rennova has a number of financing options it can use to buy the hospital, including cash, debt or debt financing.
There’s not a robust market of buyers for small, rural hospitals, so hospitals are eager to seek alternatives, including lab companies, said Michael Lane, managing director with the healthcare strategic advisory firm Hammond Hanlon Camp in Chicago.
“There is just no value in those rural hospitals,” he said.

Window of Opportunity to Lower Diabetes Risk?

Obese adults who shed pounds and dropped down to a non-obese body-mass index (BMI) before hitting middle age dramatically reduced their risk for diabetes, according to a retrospective cohort study.
These individuals lowered their risk by nearly 70% (hazard ratio 0.33; 95% CI 0.14-0.76) compared with those who were obese as young adults and stayed that way in middle age, researchers led by Andrew Stokes, PhD, of the Boston University School of Public Health, reported in Diabetes Care.
Not surprisingly, that kind of weight loss was difficult to achieve, and only 1.1% of the more than 21,000 study participants managed to do it. Gaining weight and becoming obese by middle age was much more common (14.6%). In addition, approximately 5% of participants were obese both as young and middle-aged adults, the researchers said.
Even individuals with a normal BMI as young adults but who then became obese by middle age had a lower diabetes risk compared with those who were obese both as younger and older adults (HR 0.70; 95% CI 0.57-0.87), the study found.
“A large percentage of the observed diabetes cases could have been averted with effective intervention and prevention efforts in young adulthood,” Stokes and colleagues said. They estimated that if all of the obese younger adults had dropped to a non-obese BMI (<30) before middle age, 9.1% of incident diabetes cases could have been prevented. If all adults in the study had maintained a normal weight throughout the study period, 64% of cases (95% CI 59%-68%) could have been prevented.
“This study demonstrates there is a window of opportunity between early adulthood and middle age to largely prevent one of the most serious consequences of obesity,” study co-author Robin Scamuffa, MS, director of clinical affairs at Ethicon in Cincinnati, said in a news release from the company, which helped support the research. “Obesity is a preventable cause of diabetes, and higher awareness of the long-term risks of obesity is needed, particularly among younger people.”
“Younger Americans are at a high risk for developing diabetes later in life if they are unable to prevent or overcome obesity,” added Stokes, also in the news release. “The findings from this study underscore the importance of population-level approaches to the prevention and treatment of obesity and diabetes across the life course of individuals.”
The researchers analyzed data on 21,554 adults from the National Health and Nutrition Examination Survey (NHANES) in 1988-1994 and 1999-2014. The mean age at baseline was 44, and half the participants were women. The majority (79%) were white, 9% were black, 8.5% were Hispanic, and 3.5% were other races and ethnicities.
Participants underwent a physical exam and completed a survey, and were asked to recall their weight at age 25 and to self-report a diagnosis of diabetes. The mean BMI at age 25 was 23.6, and at the end of follow-up, was 27.8. The incidence of diabetes ranged from 5% for those who were not obese at any time to more than 20% for those who were obese both as young and middle-aged adults.
Participants were categorized into four weight-change groups:
  • those who were never obese
  • those who lost weight and went from obese to non-obese
  • those who gained weight and became obese
  • those who were always obese.
The researchers used Cox proportional hazard models to examine the relationship between weight change and diabetes incidence over 10 years of follow-up.
One limitation of the study, the authors noted, was its reliance on self-reported weight: “Although prior studies have shown self-reported weight is a strongly correlated predictor of actual weight, our use of historic self-report likely introduced error.” In addition, the analysis did not adjust for diet or physical activity because recall data on these variables were not collected — “The results may thus partly reflect the effects of physical activity and dietary factors over the life course.”
Nevertheless, Stokes et al said, “the findings from a national sample underscore the importance of developing policies and programs that reduce the prevalence of obesity.”
The study was funded by the National Institutes of Health and Johnson & Johnson.
Stokes reported research funding from Johnson & Johnson; Scamuffa and two other co-authors are employees of Ethicon, a Johnson & Johnson company, and two other co-authors are employees of Johnson & Johnson.

Hepatitis B Impedes Rheumatoid Arthritis Treatment

Patients with rheumatoid arthritis (RA) who also had hepatitis B virus (HBV) infection had worse structural and clinical outcomes, Chinese researchers reported.
Among a group of 32 RA patients with HBV infection, significantly more had radiographic progression at 1 year compared with uninfected RA patients (53% versus 17%, P<0.001), according to Dong-Hui Zheng, MD, and colleagues from Sun Yat-Sen University in Guangzhou.
In addition, the proportion achieving the therapeutic target of Disease Activity Scores in 28 joints at month 6 was significantly lower among HBV-infected patients (53% versus 82%, P=0.003), the team reported online in Arthritis Research & Therapy.
The precise etiology of RA remains uncertain, although genetic disposition clearly plays a role, and environmental triggers, including infections, also have been proposed as contributory factors.
Infection with HBV has been reported to occur more often among patients with RA compared with the general population and has been associated with various extrahepatic manifestations, including polyarthritis and polyarteritis nodosa. In a few reported cases, patients with HBV who fulfilled the American College of Rheumatology (ACR) criteria for RA had their arthritic symptoms resolve following anti-HBV treatment.
Therefore, to explore the potential influence of HBV infection on RA disease course and treatment, the researchers conducted a retrospective study of RA patients seen from 2012 to 2016 at Sun Yat-Sen Memorial Hospital who had at least a year of follow-up. Those who were HBV surface antigen positive for more than 6 months were matched with four uninfected RA controls.
Clinical data were acquired during study visits at months 1, 3, 6, and 12, and all patients were treated according to ACR/European League Against Rheumatism (EULAR) recommendations for RA. In the HBV group, serologic markers and HBV DNA levels were measured at baseline and every 1 to 3 months, and antiviral prophylaxis with entecavir or tenofovir was encouraged prior to RA treatment. Radiographic assessments of the hands and wrists were performed at baseline and month 12.
A total of 84% of the included patients were women, mean age was 49, and mean disease duration was 3 years. Almost three-quarters were positive for both rheumatoid factor and anti-cyclic citrullinated peptide antibodies, and 75% to 78% in both groups already had bony erosions present at baseline.
Treatment differences between the HBV and non-HBV groups included more patients with HBV receiving sulfasalazine and hydroxychloroquine and fewer receiving leflunomide (16% versus 84%, P<0.001). In addition, cumulative dosages of leflunomide and methotrexate were lower in the HBV group — agents whose use has been contraindicated in ACR guidelines for patients with HBV infection and abnormal liver function.
Cumulative dosages of sulfasalazine, hydroxychloroquine, and cyclosporin A were higher in the HBV group, and almost all patients in both groups had received combinations of disease-modifying antirheumatic drugs (DMARDs). A total of 19% of the HBV group and 30% of the non-HBV group received biologic agents along with conventional DMARDs. Similar numbers of patients in the two groups used glucocorticoids, and the cumulative doses also were similar.
Fewer than half of the HBV group received antiviral prophylaxis; this was because of economic factors, the authors noted.
At month 6, fewer patients in the HBV group had achieved 20% improvements on ACR criteria (56% versus 81%, P=0.013) and also 50% improvements (47% versus 70%, P=0.029). Good or moderate EULAR responses were reported in smaller numbers of HBV patients at both months 3 (75% versus 91%, P=0.038) and 12 (69% versus 91%, P=0.004).
In an effort to identify risk factors for radiographic progression at 1 year, the researchers then conducted logistic regression analyses. On a univariate analysis that controlled for baseline characteristics and medications used, significant associations were seen for HBV status, baseline radiographic scores, and higher cumulative glucocorticoid doses, while on bivariate analysis that also controlled for baseline radiographic scores and cumulative glucocorticoid doses, HBV positivity was still a significant predictor of progression.
On a multivariate analysis that then adjusted for all factors, HBV positivity was independently associated with radiographic progression (OR 2.403, 95% CI 1.218-4.743, P=0.011). Similarly, HBV positivity also independently predicted failure to achieve the therapeutic clinical target at 6 months in a multivariate model (OR 2.617, 95% CI 1.140-6.007, P=0.023), but methotrexate use and cumulative doses, which were lower in the HBV group, also showed significant associations with failure to reach the therapeutic target at 6 months.
The researchers noted that the worse outcomes seen in the HBV group probably reflect both the infection itself and the differences in treatment regimens, particularly the lower use of methotrexate. “In light of the pros and cons, it is indeed difficult to find a balance during RA treatment.”
With regard to safety, one-third of patients in the HBV group had virus reactivation, but HBV DNA levels and aminotransferases normalized after treatment adjustments and antiviral therapy.
“HBV infection may play a deleterious role in radiographic and clinical outcomes among patients with RA, and HBV reactivation should be paid close attention to during immunosuppressive therapy,” the researchers concluded.
A limitation of the study, they noted, was its observational design in a single-center setting.
The study was funded by the National Natural Science Foundation of China, the Guangdong Natural Science Foundation, the Guangdong Medical Scientific Research Foundation, and the Key Program of Young Teachers Foundation of Sun Yat-sen University.
The authors reported having no competing interests.

Ligand Upcoming Investor Conferences

Ligand Pharmaceuticals Inc. (NASDAQ: LGND) announces that company executives are scheduled to participate in the following upcoming investor conferences:
• Berenberg Conference USA in Tarrytown, New York. Presentation takes place on Thursday, May 24, 2018 at 11:45 a.m. Eastern time (8:45 a.m. Pacific time). Matt Korenberg, CFO will attend for Ligand.
• 15th Annual Craig-Hallum Institutional Investor Conference in Minneapolis. Conference takes place on Wednesday, May 30, 2018 with one-on-one meetings only. John Higgins, CEO, Matt Foehr, COO and Matt Korenberg, CFO will attend for Ligand.
• Jefferies Healthcare Conference in New York City. Presentation takes place on Wednesday, June 6, 2018 at 8:00 a.m. Eastern time (5:00 a.m. Pacific time). Matt Korenberg, CFO will attend for Ligand.
A live webcast of the Jefferies conference presentation will be available on Ligand’s website at www.ligand.com. A replay of the presentations will be archived on the website for 30 days.

Anti-obesity effects of melatonin

Researchers have already demonstrated the anti-obesity effects of melatonin and its use in obesity control, but the current study has uncovered the specific molecular mechanism that is triggered by chronic administration of the hormone.
As reported in the Journal of Pineal Research, researchers from the University of Granada, University Hospital La Paz (Madrid) and the University of Texas investigated the effects of melatonin by administering the hormone to a group of diabetic fatty rats.
They found that the hormone tackles obesity on two levels. Firstly, melatonin increased the amount of brown adipose tissue (BAT), “good fat” that uses energy rather than storing it.
In turn, this decreased the amount of dangerous white visceral fat in the abdominal region of the animals. The hormone was also found to have a positive impact on thermogenesis, the process the body uses to burn calories and produce heat.
According to study author Professor Ahmad Agil Abdalla (University of Granada), these effects were observed in the rats, irrespective of other factors such as diet and physical exertion.
However, he suggests that in humans, melatonin treatment should be used as a complementary approach to weight loss, alongside reduced calorie intake and physical activity.
He also advises that people exercise in cold environments, since cold temperatures trigger thermogenesis, resulting in increased calorie expenditure.
The findings have important implications, given the dramatic impact obesity is currently having on public health and the estimated 3 million deaths it causes annually.
The highest obesity rates in the world are seen in the United states where more than 30% of the population is obese and in the Persian Gulf region, where 31 to 35% of the population is obese. Obesity is also steadily rising in Spain, where the rate is now 27%.
Abdalla and team are now conducting clinical trials involving melatonin agonists. They hope to eventually explore the potential applications of melatonin as a therapy for human obesity.

Friday, May 11, 2018

Heart Botox Injections Durably Protect from Arrhythmia in Pilot Trial

Injections of botulinum toxin (Botox) into the major epicardial fat pads during coronary bypass was associated with persistent protection from atrial tachyarrhythmias, according to 3-year follow-up of a pilot trial.
The cumulative incidence of these arrhythmias off antiarrhythmic medication was 23% with the 50-units/mL per fat pad injections versus 50% with saline placebo injections at 3 years (HR 0.36, 95% CI 0.14-0.88), Alexander Romanov, MD, PhD, of the National Medical Research Center in Novosibirsk, Russia, reported here at the Heart Rhythm Society meeting.
Secondary outcomes also showed fewer hospitalizations due to arrhythmia recurrence (7% versus 33%, P=0.02) and significantly lower atrial fibrillation (AFib) burden on implantable cardiac monitoring, along with a trend for less antiarrhythmic drug use (20% versus 50%).
These findings add to the previously reported advantage at 30 days and 1 year in the 60-patient randomized trial, although a separate, somewhat larger trial showed a nonsignificant 11% lower absolute risk of Afib at 1 week after cardiac surgery with similar injections of botulinum toxin.
“Because the favorable reduction of Afib outlasted the anticipated botulinum toxin effects on autonomic nervous system activity, this may represent a form of ‘autonomic reverse remodeling,'” Romanov suggested.
Botulinum toxin temporarily blocks release of acetylcholine stored in synaptic vesicles, which is important in post-ganglionic neurons found in large numbers in the nerve-rich fatty “pads” of tissue outside the heart, he explained.
Botulinum toxin can be viewed as a neuromodulator, Romanov added at a press conference. “The beauty of this let’s say treatment [is] that we are not destroying anything. We just temporarily block and reset the autonomic nervous system.”
“I don’t know if people realize how powerful this is,” session moderator Andrea Russo, MD, of Cooper University Hospital in Moorestown, NJ, commented at the press conference. “Looking at the duration of hospitalization and just the comorbidity of having atrial fibrillation and the cost to healthcare systems throughout the world … This could be really a great thing.”
The co-moderator, Andrew Krahn, MD, of the University of British Columbia in Vancouver, cautioned that the findings are “not conclusive, but are extremely interesting,” because the biology of how botulinum toxin could have effects beyond the time it wears off is not well understood.
The study included only patients with guideline-criteria indications for elective coronary artery bypass grafting and a preoperative history of paroxysmal atrial fibrillation. Due to the small sample size, as well as the lack of data on atrial fibrillation burden before the procedure, the results will need validation, Romanov acknowledged.
Such a study is planned to start later this year with a placebo arm and two different dose arms of botulinum toxin in around 300 patients getting coronary or valve surgery, he said.
Romanov reported relationships with Medtronic, Boston Scientific, Biosense Webster, Spectrum Dynamics, and EP Dynamics.

UnitedHealth: Bundled payments saved $18B, with major drops in readmissions

UnitedHealth’s value-based payments for spinal surgeries, as well as hip and knee replacements, have shown both major growth and major savings.
The Minnesota-based insurer announced on May 9 that it expanded its bundled payment program to 37 markets from 28 and netted $18 billion in savings from 115 employers in the program since 2016.
Under the program, the insurer pays providers for a defined episode of care under a single fee instead of per procedure, giving providers more incentive to focus on outcomes and costs. UnitedHealth said participating employers saved an average of $18,000 per surgery, while individuals saved more than $3,000.
“The initial results and nationwide expansion demonstrate the value of this program to healthcare providers, employers, and their employees, helping to improve health outcomes and make care more affordable for more people,” Sam Ho, M.D., chief medical officer of UnitedHealthcare, said in a statement.
The insurer said its bundled payments also led to improved patient outcomes. The program reduced hospitals readmissions by 22% and complications by 17% for joint replacement surgeries, while hospital readmissions for spine surgeries fell by 10% and complications dropped by 3.4%.

Insurers have lately been boosting their bundled payment portfolio as the healthcare sector continues to shift more toward value. Last month, Humana said it was expanding its Medicare Advantage bundled payment model for hip and knee replacements to seven additional states.
At the same time, the Centers for Medicare & Medicaid Services has received some flak for not issuing enough aggressive value-payment models. The agency rolled back mandatory bundled payment models last year before replacing them with a voluntary program months later.