JPMorgan analyst Robert Marcus downgraded Inogen to Neutral from Overweight and cut his price target for the shares to $72 from $175.
Wednesday, May 8, 2019
Genentech to Present New OCREVUS (Ocrelizumab) Data on MS
- New analyses show the effect of OCREVUS on reducing the risk of disability progression is associated with exposure and lower B-cell levels
- Long-term data in RMS and PPMS show that earlier treatment with OCREVUS significantly reduced the risk of permanent disability progression
- Over 100,000 people have been treated with OCREVUS globally, in clinical trial and real-world settings; data presented at the AAN Annual Meeting highlights a consistent and favorable benefit-risk profile
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new OCREVUS® (ocrelizumab) data in relapsing and primary progressive multiple sclerosis (MS) were presented at the 71st American Academy of Neurology (AAN) Annual Meeting from May 4-10 in Philadelphia, Pennsylvania. New analyses on OCREVUS show its effect on reducing the risk of disability progression is associated with higher exposure to the medicine and lower B-cell levels, and show the positive impact of OCREVUS in significantly reducing disability progression.
Tuesday, May 7, 2019
Insurers, providers question CMS push for cross-border plans
Insurers and healthcare providers warned the CMS that federal regulations aren’t the reason insurers steer clear of selling plans across state lines.
The CMS issued a request for information in March on how to eliminate barriers on insurers’ ability to sell cross-border plans, reviving an idea that was a pillar of President Donald Trump’s 2016 campaign. The agency also asked whether Farm Bureau insurance plans or short-term, limited duration plans could help facilitate the sale of individual market plans.
Currently there are four states—Georgia, Maine, Oklahoma and Wyoming—that have laws that allow such sales, but they have middling results.
The main insurance lobby America’s Health Insurance Plans also noted that states can already allow the sale of plans to other states via Section 1333 of the Affordable Care Act, which allows one or more states to create a healthcare compact to sell plans.
“Section 1333 does not include any requirements that impede selling insurance across state lines,” the group said in comments. “The main challenges states face in operationalizing cross-border individual market insurance sales would be the same in any framework. Additional federal action that is outside the option to create compacts under section 1333 would only compound those challenges.”
However, healthcare providers and patient advocates also question if selling across lines would even lower premiums.
“Issuers are unlikely to be able to construct provider networks that will support competitive premiums. Network development is expensive and issuers with no presence in a market into which they would like to expand will have little bargaining power with local providers,” said Trinity Health, a Catholic healthcare system that operates 99 hospitals across 22 states, in its comments.
If an insurer cannot secure competitive reimbursement rates from the market, they will raise premiums to recoup those costs, Trinity said.
Providers and some state regulators were also worried about the impact on coverage of pre-existing conditions if insurers can sell cross-border plans.
“Some insurers will migrate to the states with the least stringent coverage requirements,” Pennsylvania Insurance Commissioner Jessica Altman said. “Coupled with a marketing strategy to aggressively target the healthiest individuals, this will skew the market adversely against less healthy individuals.”
Other providers had major concerns about whether short-term and Farm Bureau association health plans should be sold. Both types of plans are cheaper than ACA exchange plans because they do not cover as many benefits or cover pre-existing conditions.
“Many states have adopted regulations restricting access, duration and renewability to short-term, limited duration plans,” the American Academy of Family Physicians said. “Allowing states to sell these types of policies across state lines would preempt state authority, erode consumer protections.”
The plans could also raise logistical issues, including which state would be responsible for oversight.
“Quite simply, my department would not have jurisdiction to require an issuer of an out-of-state policy to comply with the consumer protections in Pennsylvania (or any other state’s) laws,” Altman said.
340B cuts ruled unlawful; industry stakeholders applaud decision
A federal judge reaffirmed his view that the cuts by HHS to the discount drug program are unlawful.
KEY TAKEAWAYS
In a joint statement, three hospital plaintiffs urged HHS to follow the judge’s directive.
340B Health added their approval in a statement, asking the agency to “act quickly.”
A status report regarding HHS’ progress remedying the situation must be submitted to U.S. District Court Judge Rudolph Contreras by August 5.
U.S. District Court Judge Rudolph Contreras again ruled Monday evening that the 340B drug reimbursement rate that Health and Human Services set in the 2019 Outpatient Prospective Payment System (OPPS) rule is unlawful, a decision that earned praise from various industry stakeholders.
Five months after first vacating the 22% cut in 340B payments that HHS Secretary Alex Azar proposed late last year, Contreras reiterated that the cuts were implemented “in contravention of the Medicare Act’s plain text.”
Medicare Part B will sell prescription drugs to hospitals participating in the program at the average selling price plus 6%, well above the average selling price minus 22.5% as HHS had proposed.
“The Court also concludes that, despite the fatal flaw in the agency’s rate adjustments, vacating HHS’ 2018 and 2019 rules is not the best course of action, given the havoc vacatur may wreck on Medicare’s administration,” Contreras wrote in the 22-page ruling.
HHS will have “first crack” at crafting appropriate remedies for the two rules, according to the ruling.
On Tuesday, three hospital plaintiffs applauded the ruling as a positive development for the embattled federal program, which has been deemed wasteful and rife with abuse by critics who demand additional oversight and accountability.
“America’s 340B hospitals are pleased with the District Court’s decision and urge HHS to follow the judge’s directive to promptly resolve the harm caused by its unlawful cuts to Medicare reimbursement for certain 340B hospitals,” the American Hospital Association, Association of American Medical Colleges, and America’s Essential Hospitals said in a joint statement. “The ruling reaffirmed that the 2018 cuts were unlawful and extended that ruling to the 2019 cuts. Owing to the complexity of the Medicare program, the judge gave HHS first crack at fashioning a remedy for its unlawful actions. He also asked for a report from HHS on its progress on or before August 5, 2019. We urge HHS to promptly comply with the judge’s ruling and restore to 340B hospitals all funds that have been unlawfully withheld.”
HHS has not issued a statement regarding Monday’s ruling and did not respond to a request for comment by time of publication.
The December ruling by Contreras did have a material impact on nonprofit hospitals, according to Moody’s Investor Service, which determined in early January that the reversion of the cuts would lead to improved operating performance.
340B Health, an advocacy group for the federal program, also issued a statement Tuesday afternoon applauding Contreras’ ruling.
“On behalf of the nearly 1,400 hospitals we represent that participate in 340B, we are pleased that the court has, once again, found that HHS exceeded its statutory authority by cutting what Medicare pays for outpatient drugs delivered to their patients,” Maureen Testoni, CEO of 340B Health, said in a statement. “The cuts made in 2018 and again in 2019 have reduced hospitals’ ability to care for those in need. The sooner this policy is reversed, the better hospitals will be able to serve the needs of patients with low incomes and those in rural communities. HHS must act quickly, as any further delay will only harm patients and the hospitals they rely on for care.”
Nearly 2,500 hospitals currently participate in the 340B Drug Pricing Program, which was created in 1992 to assist safety-net and low-income providers purchase prescription drugs.
A status report regarding HHS’ progress remedying the situation must be submitted to Judge Contreras by August 5.
Net income falls $30M for DaVita in difficult Q1
The Denver-based dialysis company slid in several important financial metrics to start 2019.
KEY TAKEAWAYS
DaVita Inc. produced a net income of $149 million in Q1 2019, down $30 million year-over-year
The company did produce total revenues of $2.7 billion during the quarter, though those were also down just over $100 million compared to Q1 2018.
The dialysis provider also saw its cash flows reduced across the board, with a negative free cash flow from continuing operations of $52 million.
DaVita Inc. produced a net income of $149 million in Q1 2019, down $30 million year-over-year, according to the company’s latest earnings report released Tuesday afternoon.
The company did produce total revenues of $2.7 billion during the quarter, though those were also down just over $100 million compared to Q1 2018.
Most notably, DaVita’s operating and adjusted income fell from $411 million this time last year to $341 million and $382 million in Q1, respectively.
The dialysis provider also saw its cash flows reduced across the board, with a negative free cash flow from continuing operations of $52 million.
This was particularly pronounced after DaVita recorded $112 million in the same category during the last quarter.
As was the case in Q4 2018, focus remains on the still-pending sale of DaVita Medical Group to OptumHealth, a subsidiary of UnitedHealth Group.
In mid-December, United reduced its purchase price from $4.9 billion to $4.4 billion, citing “underlying business performance” as well as a desire to further advance the deal through its regulatory phases as reasons for the move.
There are no mentions of the transactions in either DaVita’s filing with the Securities and Exchange Commission of earnings report press release.
DaVita’s incoming CEO Javier J. Rodriguez, who will replace longtime CEO Kent Thiry effective June 1, will likely be in charge of completing the deal that was first announced in late 2017. Rodriguez is well-versed on the company’s dialysis business, taking over as CEO of DaVita Kidney Care in 2014.
Per day dialysis treatments were a lone bright spot for DaVita, increasing by 2.9% year-over-year.
As it did following DaVita’s Q4 2018 earnings report, the company’s stock price dropped in after hours trading by more than 2%.
ADDITIONAL DAVITA Q1 EARNINGS REPORT HIGHLIGHTS:
- Looking ahead, DaVita projects adjusted consolidated operating income in a range between $1.5 billion and $1.6 billion for the rest of 2019.
- During Q1, DaVita opened 27 new dialysis centers, acquired two new centers, and closed three in the U.S.
- Overseas, DaVita acquired two international dialysis centers.
Nevada Genomic Health Survey Goes Statewide
The Healthy Nevada Project, a first-of-its-kind, community-based population health study combining genetic, clinical, environmental and social data, is expanding enrollment to Las Vegas. The Project aspires not only to offer genetic testing to every Nevadan interested in learning more about their health and genetic profile but ultimately, to develop and expand the Project for communities across the United States to drive positive health outcomes nationwide.
Adding 25,000 Study Volunteers in Southern NevadaThe Healthy Nevada Project is announcing a statewide expansion – opening 25,000 testing slots in Las Vegas in a collaboration with University Medical Center of Southern Nevada (UMC), which serves as the host-site for Las Vegas.
With UMC welcoming the study to southern Nevada, the Healthy Nevada Project will offer no-cost genetic testing through a simple spit sample to 25,000 study volunteers. Study volunteers will take Helix’s clinical-grade DNA saliva test and will receive their ancestry and traits, at no cost, through the My Healthy Nevada Traits app. Participants will then be given a chance to answer a follow-up health survey from Renown Institute for Health Innovation (Renown IHI), and upon survey completion, will be entered to win an iPhone.
In addition, study participants can agree to be notified about genetic test results that could impact their health, and which could be used to improve their medical care. This return of clinical results, plus genetic counseling and other genetic services as appropriate, will be provided by Genome Medical, the leading network of clinical genetics specialists.
“This is an incredible opportunity to learn more about our genetics and improve health throughout the Silver State,” said Mason VanHouweling, CEO of UMC. “In support of UMC’s commitment to promoting innovation in health care and building a better future for our home state, we embrace the opportunity to collaborate with Renown Health while hosting the Healthy Nevada Project in southern Nevada.”
Healthy Nevada Project’s Evolution & Ongoing ExpansionWith more than 35,000 study participants enrolled in just over two years, the Healthy Nevada Project has become the fastest-enrolling genetic study in the country. The Project was created by Renown IHI – a collaboration between Reno, Nev.-based not-for-profit health network, Renown Health, and the world leader in environmental data, Desert Research Institute (DRI). Leveraging Renown’s forward-thinking approach to community health care and DRI’s data analytics and environmental expertise, Renown IHI has grown its capabilities to lead a larger, more complex research study of significance that will analyze and model public health risks in Nevada and serve as a national model for future population health studies working to improve overall health through clinical care integration.
During the Project’s pilot launch in September 2016, more than 10,000 community members signed up for DNA testing in just 48 hours. In March 2018, phase two offered full genomic sequencing through a simple spit test from partner, Helix, to northern Nevadans. In October 2018, the Project announced the return of clinical results for study participants, notifying them of their risk for CDC Tier 1 conditions including familial hypercholesterolemia, BRCA positive 1 and 2, and Lynch syndrome, a precursor to colon cancer. These conditions affect more than one percent of the population and are inherited, so they impact family members as well. Now, the Project announced its next phase – expanding enrollment to 25,000 people in southern Nevada through a collaboration with UMC.
Serving as a National ModelThis expansion to Las Vegas truly makes this the “Healthy Nevada Project” with a statewide impact making Nevada the only state in the U.S. to offer such a program.
“Nevada was ripe to advance population health goals because, sadly, our state ranks near the bottom in health outcomes. The Healthy Nevada Project is working to change that,” said Anthony Slonim, M.D., DrPH, FACHE, president and CEO of Renown Health and president of Renown IHI. “Our researchers are working on a number of clinical programs and scientific studies to determine why in Washoe County, the county in which Renown Health is located, Nevada’s age-adjusted death rates for heart disease, cancer and chronic lower respiratory disease are 33 percent higher than the national rate. Imagine if we can gather more data like this on a national scale and use it to change the future of health and health care? That is what the Healthy USA Project is looking to do in the years to come.”
“The Healthy Nevada Project is committed to providing study participants clinically actionable data that will help improve their health,” said Joseph Grzymski, Ph.D., associate research professor at DRI, principal investigator of the Healthy Nevada Project and chief scientific officer for Renown Health. “We are providing this information at the individual level so study volunteers can make lifesaving changes to reduce their risk. We’re also doing it on the community level to develop leading-edge research on health determinants for entire neighborhoods, states and eventually, the country.”
Expanding to Become the Healthy USA ProjectThe accelerated speed of the Project is made possible thanks to the ever-decreasing cost of sequencing. Today, Helix is able to sequence an entire exome – which allows reporting on most actionable genomic knowledge – for a fraction of what it would have cost just 10 years ago. Additionally, advances in digital health mean Helix and Project researchers can capture unprecedented amounts of health data digitally, making significant contributions to advancing precision health. The partnership has managed to remove the traditional barriers of population health studies, including the difficulty in recruiting participants, establishing quality high-throughput lab systems and scaling interpretation and return of results. This development will be key as other health systems around the country join the Project.
“We are thrilled to see the constant, fast-paced evolution of this Project with Renown IHI,” said Justin Kao, Co-Founder and SVP, Business Development and Partnerships, of Helix. “In less than a year, we have sequenced the DNA of thousands of study participants and are now preparing to offer this incredible study in other states. Combining environmental, clinical, social and genetic data allows us to discover risk factors within communities and help people take action to live longer, healthier lives. That’s what makes the next step of the Healthy USA Project so exciting for all of us.”
Teladoc CEO: Our mental health revenues are growing over 50% per year
In an interview on CNBC’s Mad Money, Teladoc CEO Jason Gorevic said: We’re global, a quarter of our business is outside the U.S… I feel pretty good about our prospects… We have 26M covered lives in the U.S… More than half of people who need mental care don’t get it… I think the government is getting behind Telecare.
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