U.S. judge dismisses concussions lawsuits against World Wrestling

A federal judge has dismissed lawsuits by dozens of former professional wrestlers who accused World Wrestling Entertainment Inc of failing to protect them from concussions and other head trauma, including chronic traumatic encephalopathy (CTE).

Many claims filed on behalf of 53 wrestlers like Joseph “Road Warrior Animal” Laurinaitis and Jimmy “Superfly” Snuka were brought too late and some were frivolous, U.S. District Judge Vanessa Bryant in Hartford, Connecticut, ruled on Monday.

Bryant also found no basis to suggest the defendants, including WWE Chief Executive Officer Vince McMahon, knew of any link between wrestling and CTE before 2007, which was after most of the plaintiffs had retired.

“The court is also unwilling to find that the diagnosis of one wrestler with CTE is sufficient to imbue WWE with actual awareness of a probable link between wrestling and CTE,” Bryant added.

WWE shares rose 2.3 percent to $89.74 on Tuesday.

CTE is a neurodegenerative disease often caused by repeated trauma to the head, and cannot be diagnosed before death.

A large part of Bryant’s 40-page decision focused on the plaintiffs’ lawyer Konstantine Kyros, who the judge said “persistently” ignored her orders and caused a “considerable waste” of time and resources over 3-1/2 years of litigation.

“The opinions expressed about my strong advocacy are inaccurate, bizarre and unworthy of the court,” Kyros said in an email on Tuesday, adding that Bryant should have let the case go to a jury. “We trust the wrestlers’ claims will be better received in the appeals courts,” he added.

Jerry McDevitt, a partner at K&L Gates representing Stamford, Connecticut-based WWE, welcomed the ruling.

“It was a thoughtful decision,” he said in an interview. “The WWE did not engage in misconduct, and had educated wrestlers about the risks.”

Laurinaitis has experienced memory loss, dizzy spells and sleep apnea, according to an amended complaint filed last November, while Snuka had CTE, dementia and Alzheimer’s disease when he died in January 2017 at age 73.

The cases are McCullough et al v World Wrestling Entertainment Inc, U.S. District Court, District of Connecticut, No. 15-01074; and Laurinaitis et al v World Wrestling Entertainment Inc et al in the same court, No. 16-01209.

https://www.reuters.com/article/us-wwe-lawsuit/u-s-judge-dismisses-concussions-lawsuits-against-world-wrestling-idUSKCN1LY2JZ

Zealand Pharma A/S (ZEAL) PT Raised to $29 at Needham

Needham & Company analyst Alan Carr raised the price target on Zealand Pharma A/S (NASDAQ: ZEAL) to $29.00 (from $26.00) .

https://www.streetinsider.com/Analyst+Comments/Zealand+Pharma+AS+%28ZEAL%29+PT+Raised+to+%2429+at+Needham+%26+Company/14620615.html

AI test detects early signs of dementia

A pioneering artificial intelligence (AI) computer test can help detect whether individuals are in the early stages of dementia.

Through a series of questions with an interactive on-screen avatar, a computer programme designed by researchers from Osaka University and Nara Institute of Science and Technology, can discern whether responses given by individuals indicate cognitive problems.

The team behind the research was seeking simple alternatives to the medical imaging used by hospitals to pick up the disease, particularly as rates of the illness soar.

They also wanted to lower the chance of people becoming used to being asked the same set of questions by doctors determining whether someone is showing signs of dementia.

Through algorithms, the programme assesses gaze, delay in responses, intonation, the percentage of verbs and nouns used, voice articulation and recall. It also asks fixed and random questions.

These algorithms were based on features of speech, language, and faces from recorded dialogues with elderly participants, some of whom had been diagnosed with dementia plus other, healthy individuals.

Thanks to artificial intelligence that allows machines to learn without being programmed, computers were able to distinguish individuals with dementia from healthy controls at a rate of 90% via six questions. Each question took two to three minutes.

Senior author Takashi Kudo said: “If this technology is further developed, it will become possible to know whether or not an elderly individual is in the early stages of dementia through conversations with computer avatars at home on a daily basis.

“It will encourage them to seek medical help, leading to early diagnosis.”

The need for early intervention is pressing, as someone worldwide develops dementia every three seconds. Alzheimer’s Disease International, which looks at the global incidence of dementia – which is an umbrella term for a group of symptoms – estimates that around 50 million people had the condition in 2017.

This number is expected to escalate dramatically, reaching 75 million in 2030 and 131.5 million in 2050. Research has shown that most people living with dementia have not been formally diagnosed, underlining the need for simpler, more accessible ways to ascertain whether someone is affected.

It is also important to note that dementia is not a natural aspect of ageing. The Alzheimer’s Society states that 40,000 people under 65 in the UK have dementia. While there is no cure, treatments can help patients to lead active lives and manage their symptoms.

https://pharmaphorum.com/news/ai-test-detects-early-signs-of-dementia/

How Surgery Partners plans to grow

On Sept. 4, Surgery Partners Executive Vice President and CFO Tom Cowey participated in the Wells Fargo Securities 2018 Healthcare Conference in Boston, addressing several questions about the company’s growth strategy and where he sees the best opportunities for the future.

Here are eight key takeaways from the discussion:

1. There are still plenty of opportunities to acquire new centers, with around 5,500 Medicare-certified ASCs in the U.S. as of 2016. Surgery Partners is affiliated with around 175 ASCs and surgical hospitals. “There is a tremendous amount of white space and there are really small individual facilities that are operating out there that present a great opportunity for the roll-up strategy,” said Mr. Cowey.

2. Despite consolidation in the industry, Surgery Partners is poised to remain independent. Over the past few years, Surgical Care Affiliates, United Surgical Partners International and AmSurg have merged or been acquired by larger entities. Surgery Partners remains independent.

“As it relates to what we are seeing from other providers and payers, our independence is a real asset right now,” Mr. Cowey said. “We can work with a provider in a larger system in a particular geography to help them manage a facility differently or bring different doctors to bear or do things a little bit differently than they might have thought of.”

3. Payer partnerships are slow to develop. Surgery Partners is in discussion with payers about potential ASC partnerships. “They like to think about doing a pilot program and then think about expanding that pilot, and then bringing that pilot to the region,” said Mr. Cowey. “I’m used to what that model is, but we also have a very clear view on what the goal posts are there to try to make [the partnership] attractive…We can help a payer direct care to our facilities to achieve higher savings at the same quality and we’re having some of those conversations now, whether it’s about simple bundles or potentially even co-investing with us alongside physician partners to think about freestanding ASCs.”

4. Surgery Partners more than doubled the size of the physician recruiting team, and it paid off. The company reported more physicians recruited in the first half of the year than over the same time period in 2017, and the new physicians are bringing high acuity cases to Surgery Partners’ ASCs.

“We are thinking about whether or not it makes sense to expand the team further to get more productivity,” said Mr. Cowey. “But even if you look at the team that has ramped up to get more sales over the course of this month, as you look at the pure number of doctors recruited, they recruited slightly more doctors in the first half of the year than the first half of last year. The productivity in terms of the doctors is okay but not great, but where you really see the benefit is in the cases those doctors produce”

5. After evaluating its GPO contract, Surgery Partners changed vendors. “We selected a vendor and we have a new contract that went into place this quarter and we expect those savings to ramp up as we train the field this quarter on what SKUs they need to get the maximized savings and we have an action plan for training that is happening at each facility,” said Mr. Cowey. “We will get the full benefit of that in 2019.”

6. Surgery Partners is in the middle of transitioning all facilities to a single clearinghouse to streamline operations. “That will provide us with some benefits and understanding of what some of the causes are for some payments getting denied so we can attack those processes across the entire organization,” said Mr. Cowey. “While in theory, we had the opportunity to do that by having the same vendors and consolidating those reports, having it in one place allows for easier and quicker analytics.”

7. The company aims to complete $80 million to $100 million in mergers and acquisitions by the end of the year; during the first half of the year, Surgery Partners completed $50 million in M&A. “At some point, we need to think about what our capacity is to do these deals and what we need to think about [is] the cash flows generated by our business for the remainder of the year,” said Mr. Cowey. “If I had more capacity, would I do more deals? As I think about the leverage ratio and how I want to manage it, I think I need to grow into my leverage more than I think people are going to see me deploy capital to actively deleveraging…If we keep the deals small enough, the integration risk should be low, especially as we standardize a lot more of these systems and processes.”

8. The company is looking to expand in certain geographies and specialties to maximize investment.While Mr. Cowey wouldn’t divulge which geographies Surgery Partners may jump into next, he did discuss the company’s focus on growing its musculoskeletal services.

Prior to his joining the team, Surgery Partners was examining operating room time as its scarcest asset; the team calculated how each procedure contributed to the margin of what the center makes per minute. Procedures that are done in a short amount of time typically had finite margins, whereas the potential for reimbursement was larger with larger orthopedic procedures that take longer in the OR.

“What we found is that from a dollars on the contribution margin perspective on per minute of OR time, the [orthopedic surgeries with implants] are actually the most profitable things we can do,” he said. “We talk about the implantables; we talk about the hips and knees and the shoulders and joints. Those are the most profitable things we do per minute of our most scarce resource. And so as we think about what we’re investing in from an M&A standpoint and where we’re targeting from a physician recruiting standpoint, this is where we are going.”

https://www.beckersasc.com/asc-transactions-and-valuation-issues/how-surgery-partners-plans-to-grow-in-the-next-year-8-key-points-on-strategy.html

ProQR Therapeutics initiated at Evercore ISI

ProQR Therapeutics initiated with an Outperform at Evercore ISI. Evercore ISI analyst Josh Schimmer initiated ProQR Therapeutics with an Outperform rating and $35 price target. The analyst believes the company’s recent clinical data for QR-110 for treatment of LCA-10 has transformed the outlook for the company, helping to “establish proof of concept for the lead program, it also helps de-risk the company’s broader platform.”
https://thefly.com/landingPageNews.php?id=2792279

Jazz Pharmaceuticals launch of Vyxeos in EU may produce upside, say BMO Capital

BMO Capital analyst Gary Nachman kept his Outperform rating and $206 price target on Jazz Pharmaceuticals after its webcast today to discuss the recent approval of Vyxeos for acute myeloid leukemia in Europe. The analyst notes that the regulatory action could be a “source of upside” given that the size of high-risk AML market in the region is the same as that of the U.S. Nachman expects Vyxeos to remain a “key long-term growth driver” for the company.
https://thefly.com/landingPageNews.php?id=2792307

CMS to Scale Back Med History & Physical Assessment Rules

Physicians and other clinicians in ambulatory surgical centers may soon have more discretion over when to conduct comprehensive medical histories and physical assessments (H&Ps), if proposed changes to the Medicare Conditions of Participation and Conditions for Coverage are implemented.

In new draft regulations issued by the Centers for Medicare & Medicaid Services (CMS) concerning minimum quality and safety standards that U.S. hospitals must meet to participate in Medicare and Medicaid, the agency suggested dropping the requirement for physicians and other clinicians to complete a comprehensive H&P for each patient within 30 days of a scheduled surgery.

The agency also proposed mandating that each ambulatory surgical center define and put to use its own policies for identifying patients who should receive H&Ps prior to surgery, as noted in an agency fact sheet.

These efforts build on President Trump’s executive order in January 2017 aimed at reducing regulations in government as a means of reining in costs.

“We all know that at times regulations can get in the way of innovation and can actually drive up costs, and the rising costs of our healthcare system are simply unsustainable,” said CMS Administrator Seema Verma, who announced the proposed rule during a press briefing at MedStar Washington Hospital Center here on Monday.

CMS estimates the draft rule would result in $1.12 billion in annual savings, in addition to the agency’s “Patients Over Paperwork” initiative, which the agency projects will achieve $5.2 billion in total savings from 2018-2021 and save 53 million total “burden hours” in that same period.

The Patients over Paperwork initiative, launched last October, seeks to reduce the burden of administrative regulations while lowering costs and improving care for patients.

As part of this effort, the agency conducted 21 site visits and dozens of listening sessions with clinicians around the country. CMS staff also spent months combing through regulations old and new and considered 2,800 comments in response to a series of requests for information, seeking ways to reduce provider burden and improve patient care.

“CMS listened and what we heard was that not only were many of our regulations not contributing to improving patient health outcomes, or improving quality of care or patient safety, but instead many of them were actually having a negative effect: keeping patients from the care that they need,” Verma said.

As a result of the Patients Over Paperwork initiative, 55% of all “burden topics” have been resolved or are being addressed and 16% are still under consideration, with the remaining 29% referred to other agencies, an agency fact sheet noted.

In keeping with the theme of reducing provider burden, the proposed rule, in addition to giving providers greater leeway around patient histories in ambulatory surgical centers, also suggests scrapping a requirement for Community Mental Health Centers to update client comprehensive assessments every 30 days, with some exceptions; eliminating requirements for transplant centers to re-submit data related to clinical experience and outcomes; and allowing multi-hospital systems to establish a “unified infection control program” and other integrated programs aimed at measuring performance improvement.

The rule would also allow more discretion to hospitals around when an autopsy is required to be performed. “CMS believes it is appropriate to defer to State requirements in this area and that this change will allow facilities to make better use of limited resource,” an agency fact sheet noted.

One issue the new rule aims to correct are the unintended consequences of current regulations around kidney transplant.

Stakeholders in the transplant community and research have suggested that current regulations have “resulted in transplant programs potentially avoiding performing transplant procedures on certain patients and many organs going unused,” the proposed rule notes.

“Therefore, we propose to remove the requirements … that require transplant centers to submit clinical experience, outcomes, and other data in order to obtain Medicare re-approval,” and to make other necessary changes to other regulations related to donor rights and to the Special Procedures for Approval and Re-Approval of Organ Transplant Centers.

The draft rule also suggested that outpatient providers conduct emergency preparedness testing exercises once annually instead of twice, allow inpatient providers to conduct one of their two annual tests as simulations, workshops, or in some alternative form, and clarifies requirements around when nonphysicians are allowed document “progress notes” for patients being treated in psychiatric hospitals.

Two issues that were not tackled by the agency in this rule but are key targets for stakeholders are modernizing the Stark Law on physician self-referral — which providers say is outdated and hinders implementation of alternative payment models — and reducing prior authorization requirements.

With regard to the Stark Law, Verma said that the agency only recently closed its request for information and is reviewing comments. CMS plans to announce changes “hopefully, this year,” she said.

As for prior authorization, Verma could not offer a specific timeline for any changes, but said that the agency was discussing the matter internally.

In July, CMS proposed changes to evaluation and management codes, which the agency suggested would also reduce physicians’ administrative burden, but those met with tepid enthusiasm from the physician community.

https://www.medpagetoday.com/publichealthpolicy/medicare/75162