TransEnterix (TRXC+1.2%) has agreed to sell certain AutoLap image-based laparoscope positioning system assets to British Virgin Islands-domiciled healthcare investor Great Belief International Limited (GBIL).
Under the terms of the deal, TRXC will retain of the broader intellectual property (IP) portfolio acquired from Medical Surgical Technologies in October 2018 while it will ink a cross-license agreement with GBIL for access to the AutoLap IP it sold. GBIL, in turn, will have a non-exclusive license to the additional AutoLap IP that it did not buy.
GBIL will pay the company $5M by the end of the month and $12M by November 30. It will also acquire $30M of TRXC common stock at $2 per share.
GBIL acquired the company’s SurgiBot in December 2017 for $29M.
The FDA has tentatively approved Mylan N.V.’s (MYL-3.3%) generic version of Bristol-Myers Squibb’s (BMY-0.1%) blood thinner Eliquis (apixaban).
Tentative approval means that MYL’s marketing application met the requirements for approval, but patent issues need to be resolved before full approval is granted.
A pair of startling new reports from the U.S. Department of Health and Human Services Office of Inspector General paints a troubling picture of America’s hospice system — with serious deficiencies in some cases and a lack of action from the federal government to remedy them.
According to the reports, released Tuesday, 87% of hospices that were surveyed over a five-year period that participated in Medicare had a deficiency, which means that they failed to meet one or more Medicare requirements to provide adequate care. And most of the hospices with a deficiency had multiple deficiencies.
Deficiencies can involve anything from poor care planning to serious deficiencies such as improperly vetting staff and inadequate quality control. According to the reports, 20% of hospices surveyed had serious deficiencies (when “a hospice violates one or more standards and the hospice’s capacity to furnish adequate care is substantially limited or adversely affects the health and safety of patients”) — a number that quadrupled from 2012 to 2015 and then decreased slightly in 2016.
To conduct the survey, nearly all of the more than 4,500 hospices that provided care to Medicare beneficiaries were contacted (90 percent of U.S. hospices are certified by Medicare). Of the 300 hospices across the country were identified as poor performers (those with serious deficiencies), the report discovered that some had a history of serious deficiencies and complaints. One-third of hospices had complaints filed against them and for almost half of these hospices, the complaints were severe.
“They key takeaway is that when hospices do not fulfill their obligations, there can be real human costs and the Centers for Medicare and Medicaid Services [CMS] needs to hold hospices accountable,” said Nancy Harrison, the deputy regional inspector general. CMS is part of the Department of Health and Human Services.
The reports laid out 12 examples of when patients were harmed due to their hospice care. In one instance, a hospice patient developed maggots around his feeding tube insertion site. In another, hospice staff failed to recognize and report signs and symptoms of possible sexual assault of a beneficiary. And in a third case, a patient who needed to receive 24-hour respiratory care got no treatment for two months.
“In order to ensure quality care and protect the health and safety of patients, CMS needs to follow through when it does identify problems,” Harrison said.
CMS released a statement to ABC News and said that they are “laser-focused on improving its oversight of healthcare facilities.”
“CMS has zero tolerance for abuse and mistreatment of any patient, and CMS requires that every Medicare-certified hospice meet basic federal health and safety standards to keep patients safe,” a CMS spokesperson said.
One of the problems the report identified was a lack of accountability. None of the hospices associated with the 12 cases in the reports faced serious consequences from CMS for causing harm. Harrison said that there should be more intermediate remedies such as monetary penalties and staff discipline to help address the issues.
“Other than termination, CMS does not have the tools to hold hospices accountable,” Harrison said.
What’s especially troubling to Harrison is that there is no way for patients to look up the performance record of a hospice prior to entering its care.
“You can go onto Hospice Compare and find a hospice provider near your home, but you cannot see how well that hospice performs,” Harrison said. “Hospice Compare tells you nothing about deficiencies nor does it give you the number complaints against the hospice.”
According to the reports, the top four poor-performing states are Texas, California, Missouri and South Carolina.
The OIG listed a series of recommendations for CMS to adopt to improve its quality of care including making all of its deficiency and complaint data public, increasing oversight of hospices with a history of serious deficiencies and strengthening requirements for hospices to report abuse, neglect and other harm.
“There are a lot of great hospices out there,” Harrison said. “There are a lot of highly skilled professionals who are dedicated to helping people leave this life with comfort and dignity, and the public should know about them. Families should be able to find them. It shouldn’t be secret.”
CMS said that they are currently working on making hospice quality information easier for consumers to find and understand on the Hospice Compare website.
NuVasive (NASDAQ:NUVA) commences the commercial launch of its Pulse integrated technology platform designed to help surgeons adopt more efficient less disruptive surgical techniques across all spine procedures.
The company says it engineered Pulse to improve workflow, reduce procedure variability and increase procedure reproducibility.
Mylan N.V. (MYL-5.2%) slips on below-average volume on the heels of a Bloomberg report that patients and pharmacists are still scrambling to obtain emergency allergic reaction treatment EPiPen (epinephrine injection), in short supply for over a year now.
Consumers are also having difficulties procuring alternatives (i.e., Sandoz’s Symjepi, licensed from Adamis Pharmaceuticals (ADMP+0.3%)) due to uneven distribution, apparent lack of familiarity with new products and the reluctance of insurers to pay for similar treatments.
Teva Pharmaceutical Industries (TEVA-3.9%) is supposed to launch its generic version in the U.S. by year-end.
CVS Health (NYSE: CVS) today announced that MinuteClinic, the company’s retail medical clinic, has rolled out its virtual visit offering in eight additional states. People with minor illnesses and injuries, skin conditions and other wellness needs can now seek care through MinuteClinic Video Visits, a telehealth offering, in the states of Arkansas, Connecticut, Hawaii, Indiana, Minnesota, Missouri, Oklahoma and Texas. MinuteClinic Video Visits provide patients with access to care 24 hours a day, seven days a week from their mobile device or computer.
A CVS Health study found that 95 percent of patients who opted to receive a telehealth visit during the pilot phase of the program, were highly satisfied with the quality of care they received.1 In the same study, 95 percent of patients were also satisfied with the convenience of using the telehealth service and the overall telehealth experience. Since MinuteClinic Video Visits launched in August 2018, thousands of Video Visits have been conducted in 18 states and Washington, DC, with more than half taking place outside of traditional clinic hours.
Working collaboratively with Teladoc (NYSE: TDOC), the global leader in virtual care, and leveraging Teladoc’s technology platform, patients can receive care via a MinuteClinic Video Visit, initiated through their computer or mobile device, including through the CVS Pharmacy app. Patients who opt to seek care through a fully customized MinuteClinic Video Visit experience the same high-quality, evidence-based care they receive at traditional MinuteClinic locations inside select CVS Pharmacy and Target stores.
Video visits can be used to provide care for patients ages two years and older who are seeking treatment for a minor illness, minor injury, or a skin condition. Each patient will complete a health questionnaire and be matched to a board-certified health care provider licensed in their state, who will review the completed questionnaire with the patient’s medical history, and proceed with the video-enabled visit.
