Search This Blog

Wednesday, August 29, 2018

Perrigo postpones investor event

Perrigo (NASDAQ:PRGO) has postponed its investor event scheduled for September 25 during which its was planning to present its long-term consumer growth strategies and key initiatives in operations. A new date has yet to be chosen.

New Campus Sexual Misconduct Rules Protect The Accused and Colleges


In new proposed rules obtained by The New York Times and described in a detailed news report today, Education Secretary Betsy DeVos is proposing changes to federal policy on campus sexual misconduct that would boost the rights of students accused of rape and other forms of sexual assault and harassment. The policy would also relieve schools of liability in many cases while encouraging them to give more support to victims.
Under the Obama administration, victims’ rights groups argued that schools did not adequately protect the rights of the accused. In 2011, the Obama Education Department sent a letter, now known as the “Dear Colleague” letter, that addressed what administration officials saw as a failure to protect victims of campus sexual assault. The letter went to 4,600 institutions of higher learning and advised that in adjudications involving sexual misconduct allegations, schools should require the lowest possible burden of proof, a “preponderance of evidence” standard often described as just over a 50% likelihood of guilt.
feature story in The Atlantic magazine last year described how a female student at the University of Massachusetts at Amherst got high with a male student, voluntarily performed oral sex on him and then afterward felt she had been sexually assaulted. The woman filed charges with local police who dropped her case but the school took her allegations seriously, placed restrictions on the male student and then suspended him and barred him from living in campus housing. The male student wound up leaving UMass.
The new DeVos regulations would allow schools to choose their own evidentiary standard. They could stick with a preponderance of the evidence or use a higher standard like “clear and convincing.”
For the last year, under Education Department policy, schools have been allowed to use mediation to reach informal resolutions. The proposed rules would let both victims and accused perpetrators both request evidence from one another and to cross-examine one another, and it would give both access to evidence gathered during an investigation. The Obama administration saw mediation as inappropriate, even when the parties were in favor of it, and it believed that allowing the parties to question one another would be traumatic or intimidating.
The proposed rules also narrow the definition of sexual harassment to a new Supreme Court standard that says it means “unwelcome conduct on the basis of sex that is so severe, pervasive and objectively offensive that it denies a person access to the school’s education program or activity.” Under Obama, it was defined as “unwelcome conduct of a sexual nature” that includes “unwelcome sexual advances, requests for sexual favors, and other verbal, nonverbal, or physical conduct of a sexual nature.”
Accord to the Times’ account, the new rules also say institutions can only be held legally responsible for investigating formal complaints and responding to reports that school officials have “actual knowledge” of happening. A formal complaint is one made to “an official who has the authority to institute correcting measures,” the Times quotes the document as saying, as opposed to a complaint made to a residential advisor in a dormitory.
The proposed rules only hold schools responsible for investigating incidents that take place within their own programs or on their campuses, and not, for example, in an off-campus house where fraternity members live and party. The Obama administration required schools to investigate complaints involving students no matter where they took place.
The proposed DeVos rules would also change a standard that dates back to 2001, that a “school knows, or reasonably should know, about possible harassment.” College leaders have complained that standard was too broad and held them responsible for conduct they knew nothing about. Under the new rules, schools are in violation of the law only if their response to sexual harassment “is clearly unreasonable in light of known circumstances.”
The proposed rules are coming to light at a time when big schools like Ohio State University, the University of Southern California and Michigan State University are all coping with serious charges.  Members of faculty and staff at the three schools have been accused of failing to protect students from sexual misconduct by coaches and campus doctors, and school leaders are charged with covering up the misconduct.
An Education Department spokeswoman reached by the Times said that the proposed rules were “premature and speculative and therefore we have no comment.”

Health insurance tax return would increase out-of-pocket costs


  • The Affordable Care Act’s health insurance tax on payers will increase insurance costs and premiums if it’s brought back in 2020, according to a new report by Oliver Wyman commissioned by UnitedHealth Group.
  • Congress approved a one-year moratorium on the tax for 2019, but it is expected to return the following year. That would increase premiums by 2.2% each year and cost payers $16 billion for 2020 alone, Oliver Wyman said.
  • That added cost will be transferred to members and employers through higher costs and premiums, resulting in people dropping their coverage and creating a less stable risk pool.

The HIT charges payers and employers for fully-insured coverage. That includes plans in the exchanges, individual insurance, large and small group markets and insured public programs like Medicare Advantage and Medicaid managed care. The ACA included the tax as a way to help pay for the newly insured in Medicaid and subsidized exchange plans.
However, payers have railed against the tax, which they say gets passed onto consumers, who then pay higher premiums and out-of-pocket costs.
Oliver Wyman predicted that 142 million people could get whacked by the HIT.
The return of the tax will lead to an increase of $196 per person in the non-group market, $154 per single contract and $479 per family contract in the small group market. In the large group market, it will mean a $158 per single contract increase and $458 hike per family contract. The HIT will also increase Medicare Advantage plans by $241, which includes special needs plans and employer group waiver plans, and $157 for Medicaid managed care enrollees.
Payers and employers oppose the tax’s return. The National Federation of Independent Business Research Foundation said that the tax will cost between 152,000 and 286,000 jobs by 2023.
With the HIT’s return expected in 2020, a bipartisan effort on Capitol Hill is hoping to delay the tax for another two years. The Health Insurance Premium Reduction Act is currently in the House Subcommittee on Health. America’s Health Insurance Plans supports the bill.
However, suspending the HIT again means less money to help fund poor and lower-middle-class people’s insurance. For instance, Congress lost nearly $14 billion by suspending the tax in 2017. When Congress implemented the tax in 2014, the Congressional Budget Office estimated it would raise $142 billion over a decade.
If Congress decides to delay the HIT again, it will have to find money elsewhere or make cuts to other programs to help people with subsidized plans.

90% of Americans use digital health tools, survey shows


  • Consumers continue to embrace digital health tools, with 90% of respondents in a new Rock Health survey using at least one last year, up from 80% in 2016.
  • The greatest adoption is occurring around online health information (79% vs. 72%) and online provider reviews (58% vs. 51%). A slower uptick was seen in mobile tracking (24% vs. 22%), while wearables held steady at 24% and live video televisits slipped three percentage points to 19%.
  • But while 77% of people prefer in-person doctor visits to telehealth, most who used video visits were satisfied with the experience. Among those who paid for their virtual encounter, 91% said they were satisfied. That number dropped to 62% when someone else paid.

Likewise, while not everyone is jumping at the idea of wearables, those who use them report progress meeting personal health goals. The chief reasons people use wearables are to track physical activity, lose weight, improve sleep and manage stress.
The tools for doing so are proliferating, with mobile operating systems and various apps offering to track the information. Fitibit has been upping the ante, and recently launched a product line update that includes detection of blood oxygen levels, goal-based exercise modes and a sleep tracking beta.
Interestingly, while people with specific health challenges are more likely to track their health, only 11% do so via a digital app or online journal. For example, 54% of respondents said they track their medications, but just 11% do that digitally. More than a third reported tracking their weight, but only 20% used a digital app.
Among the nearly quarter of respondents who own a wearable or smartwatch, more than a quarter of those no longer use it. About 30% said they quit using their wearable because they had reached their goal, while 20% ditched the device as ineffective in achieving their aim.
Another curious finding: Though more than half of respondents report using online reviews to search for providers, only a “significant minority” actually act on those reviews. That may be welcome news to hospitals, payers and others who are alarmed at the proliferation of online rating sites and trying to take charge of the narrative. In a Binary Fountain survey, 95% of patient respondents said online reviews and ratings are “somewhat” or “very” reliable and three-fourths said the ratings had influenced which physician they chose to visit.
Younger consumers are particularly ready to use digital health tools, but they and others want assurances of data security and privacy. People were most confident (87%) sharing their data with a doctor. The comfort level dropped to 68% with a pharmacy and 60% for insurers. Tech companies came in last at just 24%.
Apple is trying to bridge that confidence gap by teaming up with hundreds of health systems, hospitals and providers to give iPhone users more control over their personal health information. The tech giant has also opened up its health records API with the hope of creating an “ecosystem of apps that use health record data to better manage medications, nutrition plans, diagnosed diseases and more.”

Doc Groups Unhappy With Medicare’s Proposed Payment Changes


The proposal by the Centers for Medicare & Medicaid Services (CMS) to pay physicians less for some Medicare patients’ complex office visits hasn’t gotten any more popular over time.
Under the proposed rule that CMS issued in mid-July, evaluation and management (E/M) reimbursement codes for Medicare would be streamlined by having “new, single blended payment rates for new and established patients for office/outpatient E/M level 2 through 5 visits and a series of add-on codes to reflect resources involved in furnishing primary care and non-procedural specialty generally recognized services,” the agency said in a fact sheet posted on its website.
CMS positioned this change as a paperwork reduction for doctors, noting that it included a “minimum documentation standard” for a level 2 visit “where Medicare would require information to support a level 2 CPT visit code for history, exam and/or medical decision-making in cases where practitioners choose to use the current framework, or, as proposed, medical decision-making to document E/M level 2 through 5 visits,” CMS said.
“In cases where practitioners choose to use time to document E/M visits, we propose to require practitioners to document the medical necessity of the visit and show the total amount of time spent by the billing practitioner face-to-face with the patient,” the fact sheet continued. Although physicians might want to include additional information for clinical or legal reasons, “we would only require documentation to support the medical necessity of the visit and associated with the current level 2 CPT visit code.”
The agency estimated that making these changes to E/M coding will save providers 51 hours per year, an amount that CMS Administrator Seema Verma said was “one of the most significant reductions in provider burden undertaken by any administration.”
Physician organizations and other healthcare groups did express appreciation for the agency’s efforts to cut the paperwork burden. “We are grateful for your efforts to simplify these requirements and reduce their associated red tape,” read a letter to Verma sent on Monday and signed by the American Medical Association (AMA), the American Academy of Family Physicians, the American College of Cardiology, and more than 160 other medical organizations.
But the groups weren’t happy with compressing the office visit payment categories. “We oppose the implementation of this proposal because it could hurt physicians and other healthcare professionals in specialties that treat the sickest patients, as well as those who provide comprehensive primary care, ultimately jeopardizing patients’ access to care,” the letter stated.
Another letter, sent to Verma on Tuesday by a group of more than 120 mostly neurology and rheumatology organizations, expressed similar sentiments. “The proposals to consolidate the billing codes for physician evaluation and management so as to pay the same amount for office visits regardless of the complexity of the patient would cut payments for visits that are currently reimbursed at higher levels than simple or routine office visits, penalizing doctors who treat sicker patients or patients with multiple conditions,” the letter said.
“It is important to note that even small estimated changes in reimbursement will be magnified after physicians or their employers cover overhead business expenses,” it continued. “Additionally, payments from newly proposed add-on codes, which have been put forward with the intention of protecting complex care by making up for severe cuts, would not be sufficient to ensure continued patient access, and moreover the application of new codes to some specialties and not others would effectively result in CMS picking winners and losers.”
There could be consequences for patients as well, the letter said. “To offset the reimbursement cut, some physicians may spend less time with their patients and limit each office visit to one or two problems, forcing patients to return for a second additional visit to address additional medical issues … We are also concerned that this proposal would incentivize physicians to cherry-pick healthy patients to avoid financial losses. It would also severely exacerbate physician shortages by discouraging young physicians from going into careers that provide complex care.”
But the group does propose a solution as well. “Given the negative impacts of this well-intentioned proposal, we ask that CMS not finalize this concept as proposed, and instead urge CMS to work with stakeholders to identify alternative approaches that would accomplish its goal of reducing paperwork and administrative burden without endangering patient access to care.”
Asked for a response, a CMS spokesman said in an email that the agency “has been extensively engaged in seeking input from the medical community on this proposed rule and we look forward to receiving and reviewing the comments.”
He said CMS has a long history of participating in stakeholder workgroups, including the AMA’s RBRVS Update Committee, which plays a major role in setting reimbursement rates under Medicare’s fee-for-service system.
Comments on the proposed rule are due by 5 p.m. on Sept. 10.

Amedisys makes minority equity investment in Medalogix


Amedisys announced it has made a minority equity investment in Medalogix, a Nashville based Home Health and Hospice predictive modeling and analytics company.

MediciNova announces publication of results of MS trial


MediciNova announced that the New England Journal of Medicine has published results of the SPRINT-MS Phase 2b trial of MN-166 in progressive multiple sclerosis, or MS. The trial included 28 enrolling clinical sites across the U.S. and was designed to evaluate the safety, tolerability and activity of MN-166 administered orally twice daily to subjects with primary progressive or secondary progressive multiple sclerosis. Qualifying subjects were randomly assigned 1:1 to inactive control or MN-166 administered at a dose of up to 100 mg/day. The progressive MS subjects were either untreated with long-term disease modifying therapy or continued on either glatiramer acetate or interferon beta treatment. Hence, randomization was controlled by two factors: therapy status and disease status. The primary objectives of the study were to evaluate the activity of ibudilast versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging analysis for whole brain atrophy using brain parenchymal fraction and evaluate the safety and tolerability of ibudilast versus placebo in subjects with PPMS or SPMS. Additional measures included disability, imaging analyses of brain and retinal tissue integrity, cortical atrophy, cognitive impairment, quality-of-life and neuropathic pain. Exploratory objectives included pharmacokinetic and biomarker analyses.