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Saturday, July 7, 2018

Teva’s decision to move North American HQ leaves other sites in jeopardy


Teva Pharmaceutical Industries Ltd. will relocate its U.S. headquarters into a planned New Jersey facility, the company confirmed on Thursday. The Israeli drugmaker (NYSE: TEVA), which currently hosts its U.S. headquarters in the Philadelphia area and a specialty pharmaceutical business in Overland Park, announced in December that it would cut 14,000 jobs and consolidate its seven U.S. locations into one main campus.
The planned headquarters at Parsippany-Troy Hills will involved expanding an existing Teva location to 350,000 square feet, the Philadelphia Business Journalreports. The New Jersey Economic Development Authority approved $40 million in performance-based tax credits over 10 years for the project, which is expected to bring in or create 800 positions.
In an email Friday, Teva said that it would continue to maintain a presence in Pennsylvania, but did not confirm any details about its Overland Park offices.
As for Teva’s future in the Kansas City area, the company began winnowing down its workforce in December. It cut 57 jobs from its Overland Park headquarters for Teva Neuroscience, which reported 388 employees in 2017.
A Florida-based health care company, AssistRx Inc., will take over a portion of its Overland Park offices and rebadge roughly 200 of Teva’s employees. In April, Teva confirmed it sold AssistRx its patient services and solutions segment, which provided on-call nurses and support for patients using Teva’s specialty products, such as treatments for multiple sclerosis and Parkinson’s disease.

Hospitals see $218B in federal payment cuts from 2010 to 2028


Cumulative reductions in federal payments to hospitals from 2010 to 2028 are estimated to reach $218.2 billion, according to a study commissioned by the Federation of American Hospitals and the American Hospital Association (AHA).
The study, conducted by economics consulting firm Dobson DaVanzo & Associates in Vienna, Virginia, examined how 11 pieces of legislation combined with regulatory changes by the Centers for Medicare and Medicaid Services (CMS) would affect cumulative federal payments to hospitals from 2010 through 2028. The reductions are beyond those enacted under the Affordable Care Act.
Overall, federal payments to hospitals will be reduced by $218.2 billion over the 18-year period, according to the report. The largest reduction is attributable to documentation and coding adjustments ($79.3 billion). Sequestration is expected to reduce Medicare hospital payments by an estimated $73.1 billion. Original Affordable Care Act reductions to the federal Medicaid Disproportionate Share Hospital allotments were further cut by $25.9 billion. Modification of the definition of off-campus hospital outpatient departments will cut hospital payments by $13.2 billion. Cuts to post-acute-care provider payments are estimated to reach $6.1 billion. New criteria for Medicare payments are expected to reduce long-term-care hospital payments by $5.9 billion, while extending Medicare’s hospital transfer policy to hospice will result in $5.5 billion in cuts. The impact of the bad debt reimbursement reduction for hospitals totals $5 billion, and clarification of the three-day payment window results in a $4.2 billion reduction.
“Continued cuts of this magnitude represent a troubling trend for hospitals and health systems as many struggle with declining reimbursements for services provided in and out of the hospital,” AHA president and CEO Rick Pollack said in a statement.

Dr Reddy’s bullish about better sales in Europe in FY19


Dr Reddys Laboratories today expressed hope of higher sales this year in Europe, a key market, as it has overcome some of the regulatory issues that had hit its performance in the last quarter of FY18.
The drug maker also said it wants to have a strong pipeline of difficult-to-manufacture complex formulations that address key therapeutic needs to counter the pricing pressures in the USA as it is difficult to predict how long these trends will last.
There was also a regulatory hiccup when the Federal Institute for Drugs and Medical Devices (BfArM) of Germany audited” Dr Reddy`s formulation unit 2 at Bachupally here, the company said in its latest annual report.
This resulted in the good manufacturing practices (GMP) compliance certificate not being renewed in August, 2017. Corrective work was immediately undertaken.
After a follow-up audit, the GMP non-compliance status was withdrawn in January, 2018. However, stoppage in sale to Europe for four months led to lesser revenues, it said.
“Thankfully, this is over, and we expect to increase sales in FY 2019, Dr Reddy`sChairman and Co-Chairman K Satish Reddy and G V Prasad respectively said in the report.
Prasad is also the CEO of the pharma company.
Having launched operations in France, Italy, Romania and Spain, the drug maker should be working on generating higher revenues from these countries, and to increase its market presence in Europe in the near future, they said.
The companys management has accepted several challenging goals for FY2019 which include better plant management, an unwavering focus on institutionalising best-in-class manufacturing and quality practices, the report said.
Bringing about greater efficiency in Research and Development and product development, and driving hard to perform better in sales in the USA, Europe, India and the emerging markets were also among the challenges, it said.
The total revenues of the company in FY18 was pegged at Rs 14,203 crore.
Though, Dr Reddys registered eight per cent growth in revenues form Europe to Rs 822 crore during last year, the Q4 of the Fy 18 revenues from the region declined by 17 per cent year-on-year.

Flint, Mich. water prosecutor amends charges against two state officials


Attorney General Bill Schuette’s special prosecutor in the Flint water crisis has added an extra involuntary manslaughter charge against Michigan Department of Health and Human Services Director Nick Lyon and tacked on a new misdemeanor charge.
Special prosecutor Todd Flood on Tuesday amended the criminal charges against the state health chief, adding a second involuntary manslaughter charge for the 2015 death of 83-year-old John Snyder of Flint.
Flood had previously charged Lyon for being criminally responsible for the December 2015 death of 85-year-old Robert Skidmore of Genesee Township, who contracted Legionnaires’ disease in June 2015 after being hospitalized at McLaren Hospital.
During Lyon’s 10-month-long preliminary exam, the state prosecutor called witnesses to testify about Snyder’s death and Lyon’s defense attorneys contested the facts surrounding the deaths of both men and pre-existing medical conditions they had.
“There’s no medical evidence that either of them died because of Legionnaires’ disease,” said John Bursch, a Grand Rapids attorney who is part of Lyon’s taxpayer-funded criminal defense team. “There’s no action or inaction of Mr. Lyon that caused them to be ill.”
The amended charges against Lyon, which includes a new misdemeanor charge of willful neglect of duty in office, were filed before the Fourth of July holiday as required by the Genesee County judge who is expected to decide by July 25 whether Lyon should stand trial for the Flint water-related deaths.
Closing arguments in the preliminary examination of Lyon are scheduled for Wednesday in Genesee County District Court in Flint.
Flood’s case hinges on convincing Judge David Goggins that the state health chief’s failure to alert the general public about the Legionnaires’ disease outbreak led to the deaths of the two elderly men.
On Thursday, Flood also filed amended charges against the state’s chief medical officer, Dr. Eden Wells, scaling back the scope of his original allegations that she tried to cover up the Legionnaires’ outbreak.
Flood’s amended complaint of a charge of involuntary manslaughter against Wells for Snyder’s death also clears up an impossible sequence of events that was contained in his original Oct. 9, 2017 complaint.
That document alleged Wells’ instruction to the county health department in December 2015 to withhold information from the public about the Legionnaires’ outbreak caused Snyder’s death on June 30, 2015.
A charge of obstruction of justice against Wells also drops Flood’s original allegations that she threatened to withhold funding from a team of researchers at Wayne State University who were studying the Legionnaires’ outbreak.
Wells’ preliminary examination has spanned 17 days in court since last October. Closing arguments in preliminary exam begin Aug. 6.
The amended charges filed Tuesday against Lyon are not considered new, as Flood informed his attorneys of them last year, Schuette spokeswoman Andrea Bitely said Friday.
The criminal prosecutions of Lyon, Wells and other officials at the state health department have generated nearly $5.3 million in legal bills as of June 22, according the department’s most recent data.
Gov. Rick Snyder has stood by Lyon and Wells as they’ve faced criminal charges and did not suspend them or other state employees in the health and environmental quality departments who have faced charges from Schuette for their roles in Flint’s lead-tainted water crisis.
Lyon’s legal bills from Willey & Chamberlain in Grand Rapids topped $1.35 million as of June 22, while Wells’ private attorneys at the Ann Arbor law firm Pear Sperling Eggan & Daniels have billed the state about $555,000.
Bursch’s Bursch Law has been paid about $50,000 to date, state records show.

U Tenn. Med Center admits drug addicted patients under strict conduct rules


Almost a year ago, the University of Tennessee Medical Center in Knoxville started requiring addicted patients admitted for medical treatment of drug-use associated infections to submit to tough new conduct rules.
They must agree to a search by security, turn over their clothing and all personal property, hand over their cellphone, not leave the hospital floor, and receive no visitors. If they won’t sign an agreement to follow those rules, they must leave.
UTMC leaders say the policy, approved by the board of governors and implemented last August, was necessary to keep patients and hospital staff safe, and support nurses and other staff who were feeling burned out in dealing with these often-challenging patients. They say the approach has improved staff attitudes toward these patients and led to better care.
The policy was inspired by a similar, though more flexible, program started four years ago at Providence Regional Medical Center in Everett, Wash. Vanderbilt University Medical Center in Nashville says it’s considering adopting a similar protocol.
Experts say they haven’t seen this tried elsewhere, but University of Tennessee officials say the extreme measures are necessary and have worked. “This is done first and foremost for patient safety,” said Dr. Jerry Epps, UTMC’s senior vice president and chief medical officer. “When patients are bringing in needles and drugs, and their friends are coming in with drugs, and they can shoot up in the bathroom and maybe kill themselves, I argue we’re doing our best to protect patients and team members from this dreadful problem.”
In the midst of the nation’s spiraling substance abuse epidemic, many hospitals around the country are struggling with how to handle the surging number of patients coming for treatment of medical problems associated with chronic drug use. There’s wide agreement that these patients sometimes bring a host of problems into the hospital—illicit drugs, unsavory associates, defiant attitudes, bad personal hygiene, crime, chaos and the threat of overdose deaths. Everyone is scrambling to figure out how to offer them the best care while protecting staff and other patients.

Too hard on addicts?

But UTMC’s policy, which experts say may be the strictest in the country, has sparked a sharp debate about its ethics and therapeutic effectiveness. A number of doctors who treat drug-addicted patients call it a harsh and counterproductive way to handle people with a chronic, relapsing illness.
“When COPD patients smoke, we don’t discharge them,” said Dr. Larry Graham, president of Mercy Health’s Behavioral Health Institute in Ohio. “We educate them, try to get buy-in and offer smoking substitutes. If we’re not creating no-visitor rules for those patients, we shouldn’t do it for patients with chemical dependencies.”
UTMC leaders admit that a significant number of patients have not responded well to the new policy, which some see as forced detox. About 42% of the 343 patients admitted since August for treatment of drug-use associated infections—including osteomyelitis, endocarditis, sepsis and soft-tissue infection—have left the hospital against medical advice before completing their antibiotic treatment.
“Previously the hospital was known as a place where you could get medications provided by the hospital as well as illicit drugs brought in by contacts,” Epps said. Now, “once (patients) realize they won’t have illicit drugs, they won’t stay.”
Even physicians opposed to UTMC’s approach acknowledge that these patients often pose tough challenges. “This is a super-frustrating area of clinical care and I can’t judge someone for taking a command-and-control approach,” said Dr. Timothy Lahey, an infectious disease specialist and ethicist at Dartmouth-Hitchcock Medical Center. “But I think it’s misguided.”
Lahey and others argue that there are more ethical and effective ways to handle these patients, through an individualized, multidisciplinary approach. “If patients feel they are being restricted, they may leave and relapse,” said Dr. David Kasick, who leads a team of consulting psychiatrists working with medical and surgical teams at Ohio State University Medical Center. “We try to work with them on being safe in the last restrictive way, not one-size-fits-all.”
Mercy’s Graham agreed. “If a patient or guest has brought in drugs and we’re aware of it, the team has to sit down with the patient and say, ‘This can’t keep going on because it puts everyone at risk. What do we need to do that would be helpful to you?’ I can’t say we never discharge a patient, but we haven’t had to do it very often.”
A key split between the two camps is over acceptance of addicted patients continuing to possess and use illicit drugs while receiving hospital treatment.
The UTMC approach requires patients to give up all illicit drugs during their hospital stay and rely on pain medications and withdrawal management drugs such as methadone and buprenorphine provided by the hospital. “If they choose not to accept the plan of care, they have to leave,” Epps said.
The alternative view is that addicted patients will find ways to continue using, and that it’s best to openly discuss that and partner with patients to reduce the chances of harm and increase the odds of successful medical treatment and recovery from addiction.
“If someone is addicted and determined to use, they will, and we can’t stop them,” Lahey said. “What we can do is be their ally and be there to help when they want help. If we become police or parental figures in their minds, it’s less likely they’ll reach out for help.”
Graham said it’s essential to educate staff to reduce biased and stigmatizing attitudes toward drug-addicted patients, which he thinks is what produces policies like UTMC’s.
Further complicating the handling of these patients is the difficulty of treating them for pain arising from drug-use associated infections, given their high tolerance for narcotics and the risk of their misusing those medications. UTMC and Providence Regional, for instance, administer pain meds in liquid form to prevent patients from hoarding tablets and using them to shoot up.
Another challenge is that the most effective way of administering intravenous antibiotic treatment for infections is through a peripherally inserted central catheter line. Clinicians worry that patients will inject illicit drugs through the line in a nonsterile way, risking new infections and overdose.
Thus, clinicians must decide whether to forgo use of a PICC line, or take precautions to reduce the risk of misuse of the line, particularly if patients leave before treatment is completed and antibiotic treatment must be continued on an outpatient basis. Providers can either put a lockbox on the PICC line or switch patients to oral antibiotics.

How they developed the approach

Epps said he first learned last year about the severe problems UTMC staffers were having with patients being treated for infections associated with drug use when he was developing a new clinical protocol for standardizing pain treatment.
He found out about the large amount of drugs and paraphernalia being confiscated by security, the verbal abuse staff endured, the drug deals taking place, and the lack of consistency in the plan of care for these patients. Some nurses were making moral judgments about those patients that were affecting their care. He feared nurses were feeling overwhelmed and would start leaving.
After multiple meetings with physicians, nurses, other clinical staff, security and administrators, Epps crafted a plan of care for patients to sign, modeled on a patient contract used by Providence Regional. The goal was to have everyone present a united front, so patients couldn’t play individual doctors and nurses against each other.
That care plan has been modified over time, for instance allowing patients to earn back certain privileges—such as being allowed to have a cellphone and leaving the hospital floor for an outdoor break—based on good behavior. The policy has been extended to drug-addicted patients who are admitted for reasons other than infections.
“It’s one of the best things we’ve done for our team members to help them become more empathetic,” said Janell Cecil, UTMC’s chief nursing officer. “They aren’t being berated and abused, and that has changed the attitude of everyone involved.”
“Nurses were ready to quit over this,” said Laura Harper, a UTMC nurse manager. “This plan of care has rejuvenated them. Now they don’t mind taking care of these patients.”
But Epps acknowledges that major challenges remain, particularly getting patients into addiction treatment after discharge. That’s a big problem in Tennessee, which hasn’t expanded Medicaid to low-income adults, making it harder to find a payment source for an extended course of residential medication-assisted treatment.
That contributed to UTMC’s 18% readmission rate for patients with drug-use associated infections since the new rules were implemented. One patient returned nine times. “The lack of addiction treatment resources is the most disheartening thing for our team members,” Epps said. “Only 10% of our patients are getting addiction treatment. That’s appalling.”
Some patients respond angrily when asked to sign the written plan of care, he said. They often leave as soon as they find out they can’t have visitors. Or they may stay only two or three days until their abscess is drained and they feel better, even though most patients need three to six weeks of IV antibiotic treatment to cure their infections.
“After the way I was treated tonight at UT, I will be contacting a medical malpractice attorney,” one patient wrote in an online review of her experience. “I am sick of being judged because of my history & will not stand for it any longer! … I will speak out for myself & all recovering addicts.”
Epps said he understands that people feel it’s harsh. “But we don’t force patients to participate in this plan of care,” he said. “They are fully involved, they have autonomy, and they can refuse it.”
Arthur Caplan, director of medical ethics at the NYU School of Medicine, said he could accept short-term restrictions on the autonomy of addicted patients if that increases success in treating this difficult population. Yet he doesn’t see it as an ethical way to treat patients outside of mental health settings.
Still, he views such a restrictive policy, which he hasn’t seen at any other acute-care institution, as a research program that should be evaluated based on treatment effectiveness. UTMC’s 42% rate of patients leaving against medical advice seems high to him. “If you come up with a very tough treatment policy, and only about half the people sign it or complete it, my hunch is it won’t take us to where we need to go with that population,” he said.
Martin Green, immediate past president of the International Association for Healthcare Security and Safety, said he’s seen similar approaches in mental health facilities but never in an acute-care hospital.
“I’m not saying it’s the wrong thing to do, but it’s a new one on me,” he said. “The patient is in a hospital, not a jail. It may be a violation of that person’s human rights.”
But success with these patients is iffy no matter what approach providers take.
UTMC’s Cecil cited as a success story a patient who received antibiotic treatment for a drug-use associated infection under the new conduct rules, got clean after leaving the hospital, and returned several times to visit and thank the nurses. “That makes it all worthwhile,” she said.
Asked whether this patient would agree to an interview, a hospital spokeswoman checked. “I have sad news to report,” she replied the next day. “We learned that he overdosed and passed away this spring.”

Billions in payments expected by insurers under Obamacare halted


The Trump administration on Saturday confirmed it is suspending billions of dollars in payments expected by insurers under the Affordable Care Act, saying the halt is necessary because of a federal judge’s ruling in a lawsuit over the program.
The ruling prevents the Centers for Medicare and Medicaid Services, which administers the program known as risk adjustment, from making further collections or payments, including amounts for the 2017 benefit year, until the litigation is resolved, the agency said.
The amount frozen for the 2017 benefit year is $10.4 billion, according to a statement from CMS. Those payments, which are drawn from insurers and go to other insurers, had been expected to go out this fall.
“We were disappointed by the court’s recent ruling. As a result of this litigation, billions of dollars in risk adjustment payments and collections are now on hold,” CMS Administrator Seema Verma said in the statement.

Docs Concerned on Receiving Unsolicited Genomic Results for Healthy Patients


A group of researchers led by the Electronic Medical Records and Genomics (eMERGE) Network at Vanderbilt University surveyed physicians for their perspectives on genomic test results they didn’t order, which the researchers termed “unsolicited genomics results” (UGRs). The investigators asked the doctors how such information has affected their clinical practices and patients, in order to understand clinicians’ worries and provide a more complete picture of how genomic screening could be used with real-time healthcare delivery.
In the study, which was published yesterday in Genetics in Medicine, the researchers interviewed primary care providers and non-geneticist specialists at four sites associated with eMERGE. First, the team asked questions that probed the doctors’ opinions about the forthcoming results from eMERGE III — a panel sequencing about 110 genes linked to treatable and preventable diseases — as well as general UGRs. The 25 clinicians then discussed how UGRs would affect actionability, impact on patients, healthcare workflows, the return-of-results process, and responsibility for results.
The researchers found that physicians prioritize the usefulness of UGRs and the need for clear, evidence-based paths for action, as well as clinical decision support. Many physicians were also concerned that they would not know how to respond to UGRs, which may potentially limit the results’ utility.
Physicians further identified possible benefits of UGRs, including targeted screening, earlier intervention, and establishing care with the appropriate specialists. In addition, some clinicians believe that UGRs could improve routine patient care, as the results could explain symptoms that they didn’t understand at first or missed during initial diagnosis.
However, clinicians also identified potential harms the UGRs may cause patients, including anxiety, false reassurance, and clinical disutility. The study’s participants noted that they could do little to fix psychological distress about diseases or conditions that patients might develop after learning about their genetic results. The physicians believed that UGRs could cause unnecessary interventions and joint risks, complications, and increased costs for patients.
The clinicians also worried about their own professional potential workflow issues as well, including responding to UGRs and unreimbursed time. Some thought that explaining UGRs to their patients would limit the time needed for other important procedures during a patient visits. The researchers also pointed out that doctors did not know if they would be reimbursed for professional time spent on interpreting UGRs.
In addition, a number of clinicians worried that their patients’ genetic information would disappear or be transferred improperly if they changed providers or health systems. According to the authors, physicians “expected a low threshold for referring to other providers when faced with UGRs due to personal lack of expertise and a sense that specialists would be better suited to respond to results.”
If they used UGRs, physicians argued for increased expectations for improved clinical decision support with the UGRs, and integrating the information with set plans to help patients before their medical appointments. They wanted the support to include information on prognosis, penetrance, and urgency, in addition to specific recommendations for screening, referrals, and the potential for testing relatives.
However, the physicians had different opinions regarding who held responsibility for replying to the UGRs. While certain providers did not believe they are responsible for that aspect because genetic testing existed outside their realm of medical knowledge, others emphasized that the process needed a clear transfer of responsibility to a treating physician.
In addition, the physicians did not know who should “own” the patients’ UGRs, especially those of patients visiting multiple specialists. At the same time, certain doctors acknowledged that once they found out about an individual’s results, they felt personally obligated to reach out to their patient regardless of who actually ordered the initial test.
Overall, the clinicians understood the eMERGE III project to be a “form of opportunistic medical screening, and they raised concerns that large panel-based risk testing lacked validation compared with familiar evidence-based screening practices,” the authors wrote.
The researchers acknowledged that at least three academic centers involved in the study were heavily invested in genomics, which limited general application to other healthcare settings where clinicians are likely even less prepared to deal with UGRs. In addition the small sample size did not allow the team to observe any underlying differences in perspectives among provider types.
In the future, the team said it will assess healthcare professionals’ actions and impressions in response to UGRs returned through eMERGE. In addition, the authors noted that future studies in eMERGE III will “focus on how the UGRs affect the health behaviors, subjective wellbeing, and health outcomes of tested individuals.”
The researchers believe that future strategic workflow of UGRs will eventually help allow physicians to expedite patient treatment.