Practice management IT startup provides a method to preserve data from patients’ after-hrs calls

Among the overlooked pitfalls facing physicians is after-hrs calls. The data can take a backseat, queries can explore the shuffle or aren’t addressed inside a timely way, or even the on-call physician doesn’t have the patient’s chart during the time of the phone call. Another risk is the fact that potentially crucial information from that decision doesn’t get documented which could have serious implications in case of a malpractice suit.

MedXCom was created by a few physicians who lost a malpractice suit partly simply because they lacked the information from your after-hrs call. CEO Henry Kane spoken concerning the company’s method of record and instantly integrate these calls within an interview from MedXCom’s Hoboken, Nj offices.

Ironically, Kane originates from the medical negligence industry where he labored with large physician practices. He noted that most from the after-hour communication from patients is thru a live operator service. He observed these services are usually national or regional and frequently use antiquated technology.

Advertisement

With MedXCom’s approach, patients decide whether or not to leave a voicemail message for that office staff to become clarified the following working day, leave a non-urgent voicemail message for that provider, or interact with the doctor in those days.

When patients want to talk with the company after hrs, they’re recognized by their number, the application instantly delivers relevant personal health information using their Electronic health record, for example allergic reactions, the medication they’re on and last visit notes, Kane noted. The on-call physician can push a control button in order to save the conversation, as well as their publish-call notes, in to the Electronic health record.

Urgent calls are attached to the on-call provider instantly as the phone application displays the patient’s chart.  After the phone call, a hyperlink towards the phone call recording and then any publish call notes instantly flow into the patients EMR record being an encounter.

The prospective markets are practices that take lots of after-hour calls, particularly pediatrics, cardiology, Primary health care provider-GYN, and surgical practices.  The clients are also endorsed through the American Academy of Dental and Maxiofacial Surgeons.

Two kinds of partnerships are helping drive sales. Athenahealth and AdvancedMD are the initial major electronic health record vendors to work with MedXCom and Kane stated his clients are speaking to other people. Medical negligence insurers will also be important partners.

“Medical malpractice carriers told us ‘if you integrate with EHRs we’ll support it.’” NORCAL Group is a such group. It incentivizes physician practices to consider MedX by providing a ten percent discount to individuals which use it.

Although a lot of medical negligence insurance providers offer discounts as high as five percent to take a training course or utilizing a specific medical protocol, Kane claimed that MedXCom may be the first automated tool to garner this type of discount.

“I spent twenty years employed in medical negligence. We designed MedXCom after extensive conversations using the nation’s leading insurer. We requested them what features did they think would substantially reduce risk in after-hrs patient care.  They told us when we could record every after hour call after which fully integrate it in to the Electronic health record, it might be a no-brainer.”

The company has additionally added the opportunity to display data from the patient’s chart instantly, produced a method to enable HIPPA-compliant texting and integrates with 90 % from the live operator services in the united states. The explanation behind this move is to provide a choice for those who still want the private touch of the local operator having a value-added plan to sell full integration using the EHRs, Kane stated.

Up to now, the organization has 3,000 clinical users across 48 states, based on Kane. To date, the organization has guaranteed investment from angels and hasn’t yet required to approach institutional investors for funding, however that could change the coming year as the organization concentrates on scaling the company.

Photo: LDProd, Getty Images 

MedCity ENGAGE, October 23-24 in North Park, concentrates on the most recent strategies and innovations to boost patient engagement, care delivery and company wellness. Use code MCNTAG in order to save $50.

Beckman Coulter seeks to market BNP assays directly

MDBR Staff Author Printed 29 November 2017

Beckman Coulter stated that it’ll seek legal action to let it directly sell a natriuretic peptide assay that’s presently solely marketed by Quidel because of its recent agreement with Alere.

Quidel solely markets the assay, although it was created and made by Beckman Coulter.

The agreement permitted Quidel to build up, produce and offer BNP assay for detecting cardiac disease (heart failure)

Quidel stated it views Beckman’s claims as meritless and towards Beckman’s lengthy-standing technique of honoring the availability agreement using its previous partners Alere and Biosite during the last 14 years.

Lately, Quidel’s board of company directors rejected Beckman’s parent company Danaher’s offers to get the BNP assay business.

In October, Quidel purchased certain assets and legal rights from Alere, that have been offered included in Abbott’s purchase of Alere.

Underneath the supply agreement, which Alere purchased in Biosite and Quidel acquired from Alere, Quidel purports to Beckman certain proprietary antibodies(developed within license with Scios).

Beckman produces and sells the assays to Quidel, which sells the assays to customers to be used on Beckman analyzers.

Beckman Coulter noted it requested Diego courts in California to explain and enforce its legal rights to market a natriuretic peptide assay straight to its customers.


Image: Quidel has joined into commercial dispute with Quidel to market BNP straight to the shoppers. Photo: thanks to ponsulak / FreeDigitalPhotos.internet.

Drug discount program 340B reaches center of dialogue between CMS, lawmakers and hospitals

A 25-year-old federal drug discount program is continuing to grow just too large and questionable it faces a battle for survival as federal officials and lawmakers furiously debate the program’s achieve.

This program, referred to as 340B, requires pharmaceutical companies to provide steep discounts to hospitals and clinics that provide high volumes of low-earnings patients.

The Centers for Medicare & State medicaid programs Services struck a blow towards the program this month announcing your final rule to chop Medicare payments for hospitals signed up for this program by 28 percent, or about $1.6 billion. The American Hospital Association, the Association of yankee Medical Colleges, America’s Essential Hospitals yet others sued on November. 13, quarrelling the agency lacks the legal right to slash the instalments which the rule undermines the intent Congress had when designing this program.

Advertisement

Several federal reports recently in the Medicare advisory board, along with the Government Accountability Office and also the Office of Inspector General, have evaluated 340B’s explosive growth. About 40 % from the hospitals within the U.S. now buy drugs with the program, based on the 2015 GAO report.

Richard Sorian, from the hospital lobbying group 340B Health, stated that for many small, rural hospitals the funding cut “could really function as the distinction between remaining open and shutting.Inches

Northeast Ohio’s largest safety-internet hospital, MetroHealth System in Cleveland, stated it might see an $8 million decline in Medicare reimbursements.

In attempting to explain the significance of that funding, Dr. Benjamin Li, a MetroHealth cancer surgeon, stated when the 340B program would disappear “some in our cancer patients won’t be able to possess lifesaving care.”

In comparison, individuals supporting the cut, including drugmakers, reason that this program is continuing to grow beyond its original intent because hospitals have pocketed the discounts to pad profits — to not help indigent patients.

Stephen Ubl, president from the drug industry group PhRMA, stated this program “needs fundamental reform” which the most recent rule change is just a great initial step. His group, which has deep pockets and a marketing campaign geared at pinpointing the program’s flaws, lists changes that Congress and also the Trump administration could tackle. Individuals include restricting which hospitals ought to be qualified for 340B cost breaks and ensuring needy patients benefit when hospitals buy discounted drugs.

The next day a healthcare facility groups sued, Joe Grogan, director of health programs in the White-colored House’s Office of Management and Budget, known as 340B “really messed up,Inches based on Politico, and stated the Trump administration isn’t afraid to defend myself against this program. “We aren’t wimps.” Grogan brought a White-colored House task force last summer time that suggested scaling back this program.

The hospitals — frequently the greatest employers inside a congressional district — are prepared for any fight. The American Hospital Association launched an advertisingcampaign. And countless people of Congress signed a letter defending this program. On November. 14, two House lawmakers introduced a bill that would prevent CMS from applying the suggested rule.

Under 340B, named following the portion of the Public Health Service Act that authorizes it, qualified hospitals buy drugs for a cheap price in the pharmaceutical companies after which are reimbursed for individuals purchases from Medicare. The medicine is purchased underneath the Medicare Part B program, which provides coverage for costly chemotherapy along with other treatments inside a hospital, doctor’s office and clinics.

The hospitals earn money around the spread, utilizing it to enhance the financial stability from the hospital.

In comment letters to federal officials, a variety of hospitals from St. Cloud, Minn., to Kalamazoo, Mi., stated the brand new rule would cost them thousands and thousands of dollars.

Yet, even while concerns arise round the impact from the cuts along with a legal fight plays out, Congress has increased scrutiny from the program. The Home Energy and Commerce Committee held two hearings over yesteryear couple of several weeks, analyzing how hospitals use money made on 340B drugs. A vital question for lawmakers was just how much the patients benefited.

The brand new rule, based on CMS Administrator Seema Verma, addressed that concern — although not directly.

As the actual cost of medication won’t be lower underneath the rule, Verma stated beneficiaries helps you to save an believed $320 million annually on copayments. Medicare patients typically have the effect of a portion of coinsurance on their own prescriptions. The decreased Medicare reimbursement implies that an enrollee’s coinsurance could be lower at 340B hospitals because Medicare would pay hospitals less for that drug.

In a single example the administration provided, if Medicare reimburses a participating hospital $2,000 per month for a person drug, a beneficiary would save over $100 on their own out-of-pocket share.

Dr. Peter Bach, director from the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New You are able to, agreed.

“If Medicare cuts down on the reimbursement amount, which will directly reduce exactly what the patients pay,” Bach stated. “Patients might find affordable prices.Inches

Allan Coukell, senior director for health programs in the Pew Charitable Trusts, stated the modification in how Medicare spends its money might have broader, unintended effects for that healthcare system. Patients may change providers, seeking lower copays. Or, on the other hand, hospitals may drop from the program due to lower reimbursements.

“The lengthy-term impact of these a shift is unknown,” Coukell stated, adding that certain factor is for certain: Less hospitals taking part in this program simply “transfers the 340B revenue in the provider towards the manufacturer.”

The 340B program wasn’t always so questionable. The balance, signed by Republican President George H.W. Plant in 1992, had bipartisan support.

“Everyone loved this program. That is why Congress expanded it on three separate occasions,” remembered William von Oehsen, who helped lobby for that initial law and it is a founding father of a healthcare facility group 340BHealth. Most lately, this program was expanded underneath the Affordable Care Act this year.

“There never was any worry about its size until, essentially, pharma made the decision it’d become too large and began buying a pr and lobbying campaign to reform it,” von Oehsen stated, adding, “We just don’t have the cash they’ve, and it is type of discouraging.”

KHN’s coverage of prescription medication development, costs and prices is based on the Laura and John Arnold Foundation.

Photo: Ieremy, Getty Images 

Mass. State medicaid programs program seeks capacity to negotiate drug discounts, exclude meds with little value

Money pile and medicine pills representing medical expenses

Within the absence of new federal policies to tame break-the-bank drug prices, Massachusetts’ condition State medicaid programs program wishes to road-test a concept both radical and market-driven. It wants the ability to barter reduced prices for the drugs it purchases and also to exclude drugs with limited treatment value.

“This is really a serious demonstration proposal,” stated Sara Rosenbaum, any adverse health policy expert and professor at George Washington College. “They’re not merely using [this concept] being an excuse to chop State medicaid programs. They’re attempting to move toward efficiency.”

When the Department of Health insurance and Human Services approves the Bay State’s plan, others will probably take similar action. Based on the most recent federal data, State medicaid programs paying for prescription medications elevated about 25 % in 2014 and nearly 14 % in 2015.

Advertisement

Presently, condition State medicaid programs programs are needed to pay for just about all drugs which have received Fda approval, including multiple drugs from various manufacturers used for the similar purpose as well as in exactly the same category. As a swap, manufacturers must discount individuals drugs — typically with different set number of their email list cost, specified by federal law. The concept is Medicaid’s vulnerable beneficiaries get medications they require and also the condition doesn’t go bankrupt having to pay on their behalf.

As drug prices soar, states say, individuals fractional rebates no more suffice to defray the responsibility of rising costs.

Take, for example, the hepatitis C cures released recently. The cost tags are available in tens or perhaps thousands and thousands of dollars and — despite rebates — have cost State medicaid programs billions. In turn, some states attempted to restrict access, so just the sickest patients might get the drugs. Advocates filed suit in response and won in line with the argument that such limits violated Medicaid’s statutory drug benefit.

Condition officials contend the current State medicaid programs rebate system may encourage drug cost inflation, since a collection number of a greater cost yields a larger profit. Also, the legal requirement to pay for most prescriptions leaves little wiggle room to barter a much better cost.

So, Massachusetts really wants to go another route, requesting a federal exemption referred to as a Section 1115 waiver, which is supposed to let states test methods for improving State medicaid programs. It really wants to select which drugs it covers according to most beneficiaries’ medical needs and which medicines demonstrate the greatest rates of affordability.

It states it can negotiate better prices consequently, saving public dollars while keeping patients’ use of needed therapies.

The government Centers for Medicare & State medicaid programs Services, that will ultimately approve or reject Massachusetts’ proposal, doesn’t have deadline because of its decision. A Massachusetts spokeswoman stated officials are pushing to have an answer by year’s finish.

Already, though, the pitch is popping heads.

“This is completely something lots of other states are searching very carefully at,” stated Matt Salo, executive director from the National Association of State medicaid programs Company directors.

When the request qualifies, agreed Jane Horvath, a senior policy fellow in the National Academy for Condition Health Policy, other states would follow “in about 5 minutes.Inches

Critics worry this transformation might make it tougher for low-earnings individuals to get needed medications, without always supplying them an alternate. Previously decade, though, it is commonplace for those who have commercial insurance to possess limited drug choices — meaning only individuals medicines for auction on a plan’s formulary are covered.

The Pharmaceutical Research and Manufacturers of the usa (PhRMA), the drug industry’s trade group, has lodged its displeasure, saying this could limit consumer access and it is unnecessary on the top from the rebates State medicaid programs programs receive.

“The pharmaceutical industry includes a status to be litigious. This is an issue on their behalf,Inches stated Andy Schneider, a State medicaid programs expert at Georgetown College, who labored at CMS underneath the Federal government. If CMS approves the waiver, analysts stated, the may likely sue, though PhRMA wouldn’t discuss potential law suit.

But federal approval isn’t any sure factor.

On a single hands, the Trump administration has encouraged states to check changes that will run State medicaid programs a lot more like a personal insurance policy. Using that frame, Massachusetts’ approach appears may well fit. Though a proper strategy is not released, President Jesse Trump has said his administration promises to bring drug prices “way lower.”

However, analysts stated, CMS’ decision-making regarding waivers has shown unpredictable. The company declined to comment beyond confirming it had been reviewing Massachusetts’ request.

It’s obvious why states have an interest. Typically, between 25 and 30 % of condition budgets visit State medicaid programs, and program company directors across the nation identify rising drug costs as a significant cause of spending increases, based on a current survey by the Kaiser Family Foundation. (Kaiser Health News is definitely an editorially independent program from the foundation.)

In Massachusetts, State medicaid programs makes up about about 40 % from the state’s budget. Prescription-drug spending has previously seven years greater than bending — from about $917 million this year to around $1.94 billion this past year, based on figures supplied by the condition health department.When the waiver qualifies, the state’s State medicaid programs program would cover a minumum of one medication per therapeutic class — that’s, per specific medical need.

Additionally, it might have an appeals process that people obtain off-formulary drugs covered, if they’re medically necessary.

Number crunchers say it’s difficult to estimate what this could save. This will depend about how the condition negotiates, how industry responds and just what this program covers. The possibility outcome is significant, though.

“You’d need to be foolish to not think about this,Inches stated Ameet Sarpatwari, an epidemiologist and lawyer at Harvard School Of Medicine, who studies drug prices and related legislation.

But consumer groups be worried about Medicaid’s low-earnings beneficiaries, even while they acknowledge that rising drug pricing is unsupportable for condition budgets.

“The State medicaid programs population differs from the commercially insured — they’re more susceptible and also have a much more happening within their lives, and tend to be poorer. So that they have less sources to get the help and prescription medications they require,Inches stated Suzanne Curry, affiliate director of policy and government relations at Healthcare For Those, a Massachusetts-based advocacy group.

Although Massachusetts, a condition having a lengthy good reputation for innovation, has dedicated to ensuring patients get needed medicine, “you need to ask what’s going to real-world implementation appears like,Inches stated Benjamin Sommers, an affiliate professor of health policy and financial aspects at Harvard’s public health school. Appeals processes, he noted, could be burdensome or restrictive.

As well as if Massachusetts receives federal approval, still it couldn’t challenge the price of certain costly drugs which are the only real offering within their therapeutic class. For example, Spinraza, which treats the rare but debilitating disease of spine muscular atrophy, includes a cost tag of $750,000 to have an initial year of treatment. Without any therapeutic equivalent, it might still need to be covered.

But states are eager to break the rules in new ways and nonetheless they can. “We have experienced previously year … drugs which have almost bankrupted condition budgets,” Sarpatwari stated. “There will be numerous other states that’ll be thinking about after this lead.”

KHN’s coverage of prescription medication development, costs and prices is based on the Laura and John Arnold Foundation.

Kaiser Health News, a nonprofit health newsroom whose tales come in news outlets nationwide, is definitely an editorially independent area of the Kaiser Family Foundation.

Photo: gerenme, Getty Images

Statement from Broadcasting Board of Governors (BBG) Chief executive officer John F. Lansing Concerning the Russian Federation’s Media Law

WASHINGTON, November. 25, 2017 /PRNewswire-USNewswire/ — President Putin has signed legislation to which foreign media organizations could be considered “foreign agents.”  Russian officials have established that, under this law, much more limitations might be put on the BBG’s systems, including Radio Free Europe/Radio Liberty (RFE/RL) and Voice of the usa (VOA), as well as their services, such as the Moment television and digital network.

RFE/RL, VOA, and yet another systems of U.S. worldwide media will stay dedicated to our mission, stipulated by U.S. law, to supply accurate, objective, and comprehensive journalism along with other happy to our global audiences, including within the Spain.

We’ll study carefully all communications we might receive from Russian government bodies concerning our operations.  While we won’t speculate regarding the effect that any new steps through the Russian government may have on the newspaper work, any portrayal of these steps as reciprocity for U.S. actions seriously distorts reality.  Russian media, including RT and Sputnik, can be employed in the U . s . States and could be, and therefore are, transported by U.S. cable tv outlets and Radio stations.  However, U.S worldwide media, including VOA and RFE/RL, are banned from television and radio in Russia.

Additionally, our journalists on assignment are harassed by Russian government bodies and face extensive limitations on their own work.  RFE/RL contributor Mykola Semena lately was sentenced with a Russian court to have an article he authored, and contributor Stanislav Asayev has been held by Russia-backed separatists in Ukraine.  RFE/RL journalists were knocked lower and kicked during assignment in Russia’s southern area of Krasnodar in March, and VOA correspondent Daniel Schearf continues to be denied a visa to re-enter Russia. 

The BBG could be pleased when the current concentrate on reciprocity between Russian and American media ends by providing U.S. outlets – including U.S. worldwide media for example VOA and RFE/RL – exactly the same legal rights and possibilities in Russia that Russian systems have in the U . s . States.

CONTACT: Nasserie Carew, 202-203-4400, [email protected]

View original quite happy with multimedia:http://world wide web.prnewswire.com/news-releases/statement-from-broadcasting-board-of-governors-bbg-chief executive officer-john-f-lansing-regarding-the-russian-federations-media-law-300561594.html

SOURCE Broadcasting Board of Governors

Related Links

http://bbg.gov

Zenlayer Launches Zenlink For Connecting Clouds

La, November. 25, 2017 /PRNewswire/ — Whether your computer data traverses the world or between clouds, there’s a company and legal barrier. From the business perspective, different cloud providers have competing goals, therefore the collaboration of clouds is incompatible.

Governments also regulate the flow information for security and safety reasons. Consequently, many governments pay meticulous focus on how details are stored and disseminated. This enhances the barriers to entry for businesses attempting to expand to sensitive locations.

To beat the barriers to entry, Zenlayer launched a method to connect cloud servers and knowledge centers all over the world, which may be deployed within a few minutes. The brand new services are known as Zenlink and it is available these days to any or all cloud providers. 

Zenlayer enables companies for connecting clouds with various geographic locations in addition to different cloud providers. Zenlayer utilizes a dedicated link with reduce latency while increasing security between data centers. This preserves transfer reliability and enables pay-per-use.

Before Zenlink was introduced, companies would take days to provision their cloud infrastructure, which may incur heavy service charges to keep. Now companies can connect their clouds instantly and seamlessly with Zenlink.

To understand more about Zenlink, contact Oliver Leung at [email protected] to set up a personal meeting.

About Zenlayer

Zenlayer enables companies to rapidly deploy and manage their global infrastructure to enable them to globalize their business in a few minutes. Zenlayer provides hosting and software defined networking services, including bare metal servers, SD-WAN, and edge computing. Zenlayer began in 2014 and also have expanded to 77 data centers across six continents. Zenlayer is headquartered in La and Shanghai with offices in Singapore, Beijing, Shenzhen and Hong Kong. At Zenlayer, we feel in powering a much better connected world.

View original quite happy with multimedia:http://world wide web.prnewswire.com/news-releases/zenlayer-launches-zenlink-to-connect-clouds-300561580.html

SOURCE Zenlayer

Calif. fines Anthem $5M for neglecting to resolve consumer grievances in timely manner

California’s managed-care regulator announced Wednesday it’s fined insurance giant Anthem Blue Mix $5 million for frequently neglecting to resolve consumer grievances on time.

The condition Department of Managed Healthcare belittled Anthem, the nation’s second-largest health insurer, for systemic violations along with a lengthy good reputation for flouting what the law states regarding consumer complaints.

“Anthem Blue Cross’ failures to conform using the law surrounding grievance and appeals legal rights are lengthy-standing, ongoing and unacceptable,” stated Shelley Rouillard, director from the Department of Managed Healthcare. “Anthem knows this can be a huge problem, however they haven’t addressed it.”

Advertisement

Before latest action, California had already fined Anthem greater than $six million with each other for grievance-system violations since 2002.

The condition stated it identified 245 grievance-system violations in this latest analysis of consumer complaints at Anthem from 2013 to 2016.

Rouillard reported an example by which Anthem denied a posted claim to have an extensive surgical treatment, though it had issued prior approval for that operation. Twenty-two calls contesting the denial — placed through the patient, the patient’s spouse, the couple’s insurance agent and also the medical professional — unsuccessful to solve the complaint. It wasn’t before the patient searched for the aid of the managed-care agency, greater than six several weeks following the treatment, that Anthem compensated the claim.

Inside a statement, Anthem acknowledged there are several legitimate findings within the audit, however it strongly could not agree using the state’s assertion the troubles are “systemic and continuing.Inches The organization stated it’ll contest the fine.

“Anthem has had responsibility for errors previously and it has made significant alterations in our grievance and appeals process, in addition to investments in system enhancements,” the organization stated. “We remain dedicated to putting the requirements of our people first.”

Anthem Corporation., located in Indiana, sells Blue Mix policies in California and 13 other states.California is renowned for getting tough consumer protection laws and regulations on coverage of health as well as for assisting policyholders once they exhaust their appeals with insurers. In other actions, the condition has fined insurers for overstating the level of the physician systems as well as for denying patients timely use of mental health treatment.

Jamie Court, president of Consumer Watchdog, an advocacy group in Santa Monica, Calif., stated the regulatory reaction to these complaints varies by condition.  He designated New You are able to, Washington and Kansas as a few of the states with higher records of holding health insurers accountable.

“The real issue is when states don’t act there’s not really a great avenue for that consumer. It’s very difficult to bring law suit,Inches Court stated. “Anthem certainly needed a wake-up call. However this may also send a note with other insurers.”

Across the country, consumers still express their displeasure with health insurers over an array of issues, including denials for treatment, billing disputes and the possible lack of in-network doctors.

Verified complaints associated with health insurance accident coverage rose 12 % in 2016 when compared to previous year, totaling 53,680, based on data published by the nation’s Association of Insurance Commissioners. The information only includes occurrences by which condition regulators confirmed there is a breach or error through the insurer involved.

Court along with other advocates welcomed the functional fine in California and stated case the most recent illustration of Anthem’s failure to uphold fundamental consumer protections.

Overall, condition officials stated that calls to Anthem’s customer support department frequently brought to repeated transfers which the organization unsuccessful to follow-up with enrollees.

“If you consider the good reputation for Anthem and also the penalties assessed through the years, they’re certainly an outlier when compared with other health plans,” Rouillard stated.

“All the plans possess some difficulties with grievances, but nothing as far as there has been with Anthem.”

The managed-care department stated any adverse health plan’s grievance program is crucial, to ensure that consumers know they’ve the authority to pursue an independent medical review or file a complaint with regulators if they’re dissatisfied using the insurer’s decision. The grievance system will also help insurers identify systemic problems and improve customer support, condition officials stated.

The state’s independent medical review program enables consumers to obtain their situation heard by doctors who aren’t associated with their own health plan. The instances frequently arise when some insurance company denies a patient’s request treatment or perhaps a prescription medication.

In 2016, insurance provider denials were overturned in nearly 70 % of medical review cases and patients received the requested treatment, based on condition officials.

This publish continues to be updated. 

This story was created by Kaiser Health News, which publishes California Healthline, something of the California Healthcare Foundation.

Photo: zimmytws, Getty Images

Luminex Corporation Reports Third Quarter 2017 Financial Results

AUSTIN, Texas, Oct. 30, 2017 /PRNewswire/ — Luminex Corporation (Nasdaq: LMNX) today announced financial results for the third quarter of 2017.  Financial and operating highlights for the quarter include the following:

  • Consolidated revenue of $74.1 million, an increase of 4% compared to the third quarter 2016.
  • Assay revenue was $37.9 million for the quarter ended September 30, 2017, representing a 17% increase over assay revenue for the third quarter of 2016.
  • Total sample-to-answer molecular product revenue of $11.9 million; growth of 55% compared to $7.7 million in the third quarter of 2016.
  • Placed 60 sample-to-answer molecular systems under contract, bringing the total number of active customers to over 400.
  • 266 multiplexing analyzers were shipped during the quarter; a combination of MAGPIX® systems, LX systems, and FLEXMAP 3D® systems.
  • GAAP net income of $17.6 million, or $0.40 per diluted share. Non-GAAP net income of $10.7 million, or $0.25 per diluted share (see Non-GAAP reconciliation).
  • In September, Luminex agreed to continue to provide a major customer with our Cystic Fibrosis product portfolio through the end of 2019, with an option to extend beyond this time period.

“The tremendous momentum in our sample-to-answer molecular business drove the Company’s performance this quarter. Our VERIGENE and ARIES systems are experiencing excellent traction in the market resulting from a combination of factors, including their ease of use, a rapidly expanding FDA cleared test menu, differentiated pricing strategies, and a large, fully integrated sales and support team,” said Homi Shamir, President and Chief Executive Officer of Luminex.  “We remain enthusiastic about our diversified business model, our solid balance sheet, positive cash flow profile, and the significant future growth opportunities in both our Licensed Technologies Group and our molecular diagnostics business.”

REVENUE SUMMARY

(in thousands, except percentages) 

Three Months Ended

September 30,

Variance

2017

2016

($)

(%)

(unaudited)

System sales

$           9,903

$         10,494

$       (591)

-6%

Consumable sales

10,619

12,305

(1,686)

-14%

Royalty revenue

11,001

11,068

(67)

-1%

Assay revenue

37,917

32,443

5,474

17%

Service revenue

2,894

2,934

(40)

-1%

Other revenue

1,802

1,977

(175)

-9%

$         74,136

$         71,221

$     2,915

4%

Nine Months Ended

September 30,

Variance

2017

2016

($)

(%)

(unaudited)

System sales

$         28,309

$         27,805

$        504

2%

Consumable sales

39,314

37,489

1,825

5%

Royalty revenue

33,375

33,888

(513)

-2%

Assay revenue

113,077

85,367

27,710

32%

Service revenue

8,594

7,892

702

9%

Other revenue

5,703

5,927

(224)

-4%

$       228,372

$       198,368

$    30,004

15%

FINANCIAL OUTLOOK AND GUIDANCE

The Company reaffirms its guidance for the full year and expects fourth quarter 2017 revenue to be between $76 million to $78 million.

CONFERENCE CALL

Management will host a conference call at 3:30 p.m. CDT / 4:30 p.m. EDT, Monday, October 30, 2017 to discuss the operating highlights and financial results for the third quarter 2017 ended September 30, 2017. The conference call will be webcast live and may be accessed at Luminex Corporation’s website at http://www.luminexcorp.com.  Simply log on to the web at the address above, go to the Company section and access the Investor Relations link. Please go to the website at least 15 minutes prior to the call to register, download and install any necessary audio/video software. If you are unable to participate during the live webcast, the call will be archived for six months on the website using the ‘replay’ link.

Luminex develops, manufactures and markets proprietary biological testing technologies with applications throughout the life sciences industry. The Company’s xMAP® system is an open-architecture, multi-analyte technology platform that delivers fast, accurate and cost-effective bioassay results to markets as diverse as pharmaceutical drug discovery, clinical diagnostics and biomedical research, including the genomics and proteomics research markets. The Company’s xMAP technology is sold worldwide and is in use in leading research laboratories as well as major pharmaceutical, diagnostic and biotechnology companies.  Further information on Luminex or xMAP can be obtained on the Internet at http://www.luminexcorp.com.

Statements made in this release that express Luminex’s or management’s intentions, plans, beliefs, expectations or predictions of future events are forward-looking statements. Forward-looking statements in this release include statements regarding expected revenue and cost savings, projected 2017 performance, including revenue guidance, including the revenue contribution from our recently completed acquisition of Nanosphere, Inc. The words “believe,” “expect,” “intend,” “estimate,” “anticipate,” “will,” “could,” “should” and similar expressions are intended to further identify such forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995.  It is important to note that the Company’s actual results or performance could differ materially from those anticipated or projected in such forward-looking statements.  Factors that could cause Luminex’s actual results or performance to differ materially include risks and uncertainties relating to, among others, market demand and acceptance of Luminex’s products and technology in development, including ARIES®, Verigene®and NxTAG®products; dependence on strategic partners for development, commercialization and distribution of products; concentration of Luminex’s revenue in a limited number of direct customers and strategic partners, some of which may be experiencing decreased demand for their products utilizing or incorporating Luminex’s technology; budget or finance constraints in the current economic environment, or periodic variability in their purchasing patterns or practices as a result of material resource planning challenges; the timing of and process for regulatory approvals; the impact of the ongoing uncertainty in global finance markets and changes in governmental funding, including its effects on the capital spending policies of Luminex’s partners and end users and their ability to finance purchases of Luminex’s products; fluctuations in quarterly results due to a lengthy and unpredictable sales cycle; fluctuations in bulk purchases of consumables; fluctuations in product mix, and the seasonal nature of some of Luminex’s assay products; Luminex’s ability to obtain and enforce intellectual property protections on Luminex’s products and technologies; risks and uncertainties associated with implementing Luminex’s acquisition strategy, including Luminex’s ability to obtain financing; Luminex’s ability to integrate acquired companies or selected assets into Luminex’s consolidated business operations, and the ability to recognize the benefits of Luminex’s acquisitions; reliance on third party distributors for distribution of specific Luminex-developed and manufactured assay products; Luminex’s ability to scale manufacturing operations and manage operating expenses, gross margins and inventory levels; changes in principal members of Luminex’s management staff; potential shortages, or increases in costs, of components or other disruptions to Luminex’s manufacturing operations; competition and competitive technologies utilized by Luminex’s competitors; Luminex’s ability to successfully launch new products in a timely manner; Luminex’s increasing dependency on information technology to improve the effectiveness of Luminex’s operations and to monitor financial accuracy and efficiency; the implementation, including any modification, of Luminex’s strategic operating plans; the uncertainty regarding the outcome or expense of any litigation brought against or initiated by Luminex, risks relating to Luminex’s foreign operations, including fluctuations in exchange rates, tariffs, customs and other barriers to importing/exporting materials and products in a cost effective and timely manner; difficulties in accounts receivable collections; the burden of monitoring and complying with foreign and international laws and treaties; and the burden of complying with and change in international taxation policies, as well as the risks discussed under the heading “Risk Factors” in Luminex’s Reports on Forms 10-K and 10-Q, as filed with the Securities and Exchange Commission.  The forward-looking statements, including the financial guidance and 2017 outlook, contained herein represent the judgment of Luminex as of the date of this press release, and Luminex expressly disclaims any intent, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in Luminex’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

LUMINEX CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

September 30,

December 31,

2017

2016

(unaudited)

ASSETS

Current assets:

Cash and cash equivalents

$        110,911

$         93,452

Accounts receivable, net

36,432

32,365

Inventories, net

46,114

40,775

Prepaids and other

9,915

7,145

Total current assets

203,372

173,737

Property and equipment, net

57,686

57,375

Intangible assets, net

78,152

84,841

Deferred income taxes

45,943

42,497

Goodwill

85,481

85,481

Other

8,094

6,785

Total assets

$        478,728

$       450,716

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

$            7,813

$         12,276

Accrued liabilities

21,175

22,804

Deferred revenue

5,123

5,120

Total current liabilities

34,111

40,200

Deferred revenue

1,609

1,875

Other

4,828

4,962

Total liabilities

40,548

47,037

Stockholders’ equity:

Common stock

43

43

Additional paid-in capital

345,663

336,430

Accumulated other comprehensive loss

(817)

(1,692)

Retained earnings

93,291

68,898

Total stockholders’ equity

438,180

403,679

Total liabilities and stockholders’ equity

$        478,728

$       450,716

LUMINEX CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

Three Months Ended

Nine Months Ended

September 30,

September 30,

2017

2016

2017

2016

(unaudited)

(unaudited)

Revenue

$     74,136

$     71,221

$    228,372

$    198,368

Cost of revenue

28,317

25,556

79,706

62,976

Gross profit

45,819

45,665

148,666

135,392

Operating expenses:

Research and development

10,670

12,762

35,350

35,324

Selling, general and administrative

26,454

26,393

78,604

70,942

Amortization of acquired intangible assets

2,166

2,482

6,689

5,797

Total operating expenses

39,290

41,637

120,643

112,063

Income from operations

6,529

4,028

28,023

23,329

Other income, net

(1)

30

(6)

(1,395)

Income before income taxes

6,528

4,058

28,017

21,934

Income tax benefit (expense)

11,085

(1,307)

4,371

(4,760)

Net income

$     17,613

$       2,751

$     32,388

$     17,174

Net income attributable to common stock holders

Basic

$     17,299

$       2,751

$     31,789

$     17,174

Diluted

$     17,299

$       2,751

$     31,789

$     17,174

Net income per share attributable to common stock holders

Basic

$         0.40

$         0.06

$         0.74

$         0.40

Diluted

$         0.40

$         0.06

$         0.74

$         0.40

Weighted-average shares used in computing net income per share

Basic

43,164

42,683

43,110

42,522

Diluted

43,266

43,136

43,216

42,929

Dividends declared per share

$         0.06

$         0.18

LUMINEX CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

Three Months Ended

Nine Months Ended

September 30,

September 30,

2017

2016

2017

2016

(unaudited)

(unaudited)

Cash flows from operating activities:

Net income

$     17,613

$       2,751

$     32,388

$     17,174

Adjustments to reconcile net income to net cash provided by operating activities:

Depreciation and amortization

5,609

5,913

16,879

14,401

Stock-based compensation

3,829

3,526

8,577

8,181

Deferred income tax expense

(10,379)

1,540

(3,112)

4,471

Loss (gain) on sale or disposal of assets

417

87

417

128

Other

357

(799)

1,279

(870)

Changes in operating assets and liabilities:

Accounts receivable, net

(3,295)

(3,118)

(4,053)

3,555

Inventories, net

988

(2,125)

(5,316)

(6,165)

Other assets

(1,564)

(902)

(2,761)

(230)

Accounts payable

(2,163)

(1,674)

(4,532)

1,050

Accrued liabilities

2,273

(428)

(5,138)

(6,602)

Deferred revenue

81

112

(269)

733

Net cash provided by operating activities

13,766

4,883

34,359

35,826

Cash flows from investing activities:

Sales and maturities of available-for-sale securities

19,491

Purchase of property and equipment

(3,981)

(2,675)

(10,384)

(8,394)

Proceeds from sale of assets

1

42

1

45

Business acquisition consideration, net of cash acquired

(1,196)

(68,098)

Issuance of note receivable

(700)

(700)

Purchase of cost method investment

(500)

(1,000)

(500)

Acquired technology rights

(60)

(60)

(200)

Net cash used in investing activities

(4,740)

(4,329)

(12,143)

(57,656)

Cash flows from financing activities:

Payments on debt

(25,000)

Proceeds from issuance of common stock

1,005

1,799

3,234

3,561

Shares surrendered for tax withholding

(28)

(13)

(2,124)

(1,497)

Dividends

(2,645)

(5,281)

Net cash (used in) provided by financing activities

(1,668)

1,786

(4,171)

(22,936)

Effect of foreign currency exchange rate on cash

(152)

87

(586)

365

Change in cash and cash equivalents

7,206

2,427

17,459

(44,401)

Cash and cash equivalents, beginning of period

103,705

81,718

93,452

128,546

Cash and cash equivalents, end of period

$    110,911

$     84,145

$    110,911

$     84,145

LUMINEX CORPORATION

NON-GAAP RECONCILIATION

(in thousands)

Three Months Ended

Nine Months Ended

September 30,

September 30,

2017

2016

2017

2016

(unaudited)

(unaudited)

Income from operations

$       6,529

$       4,028

$     28,023

$     23,329

Stock-based compensation

3,829

3,526

8,577

8,181

Amortization of acquired intangible assets

2,166

2,482

6,689

5,797

Acquisition costs

479

2,487

Severance costs

243

126

901

940

Adjusted income from operations

$     12,767

$     10,641

$     44,190

$     40,734

Other income, net

(1)

30

(6)

(1,395)

Acquisition costs

1,500

Income tax expense

11,085

(1,307)

4,371

(4,760)

Income tax effect of above adjusting items

(761)

(305)

(2,053)

(721)

Income tax benefit from discrete tax items

(12,400)

(12,400)

Adjusted net income

$     10,690

$       9,059

$     34,102

$     35,358

Adjusted net income per share, basic

$         0.25

$         0.21

$         0.79

$         0.83

Shares used in computing adjusted net income per share, basic

43,164

42,683

43,110

42,522

Adjusted net income per share, diluted

$         0.25

$         0.21

$         0.79

$         0.82

Shares used in computing adjusted net income per share, diluted

43,266

43,136

43,216

42,929

The Company makes reference in this release to “non-GAAP net income” which excludes stock-based compensation expense, amortization of acquired intangible assets and the impact of costs associated with legal proceedings; some of which are unpredictable and can vary significantly from period to period; and certain other recurring and non-recurring expenses. The Company believes that excluding these items and their related tax effects from its financial results reflects operating results that are more indicative of the Company’s ongoing operating performance while improving comparability to prior periods, and, as such may provide investors with an enhanced understanding of the Company’s past financial performance and prospects for the future. In addition, the Company’s management uses such non-GAAP measures internally to evaluate and assess its core operations and to make ongoing operating decisions. This information is not intended to be considered in isolation or as a substitute for income from operations, net income, net income per share or expense information prepared in accordance with GAAP.

View original content with multimedia:http://www.prnewswire.com/news-releases/luminex-corporation-reports-third-quarter-2017-financial-results-300545678.html

SOURCE Luminex Corporation

Related Links

http://www.luminexcorp.com

The legal and regulatory landscape for digital health companies

Fredrikson & Byron attorneys Ryan Manley and Shaun Steinle have extensive experience dealing with digital health companies. They sitting lower in the MedCity INVEST conference in Minneapolis to go over legal techniques for evolving digital health business models and also the legal challenges facing digital, mobile and virtual medicine.

Q: So how exactly does the company plan for digital health vary from classical medtech and pharmacy?

Steinle: About about ten years ago, traditional medtech centered on the company or pharma prescriber. Only then do we saw a transition toward the medtech buyer, for example group purchasing, hospitals or insurance providers. With digital health, we’re visiting a transition to some patient-centric concentrate on the consumer along with a shift toward value-based healthcare.

Q: What are the unique legalities facing digital health companies?

Manley: Cybersecurity is very large, out of the box the way you obtain access to significant data. Many of the possibilities that are offered now weren’t available if this began.

Steinle: Typically, we’re patent-centered. With encoded or sealed devices, we’re on your journey to more trade secret protection. If a person look at and duplicate your device, you patent it. In case your system is locked and no-one can discern the safety code, you might not require a patent onto it. Patents are slower-moving too. Fraxel treatments evolves so rapidly, when you receive a patent issued, we’ve got the technology has managed to move on.

Q: So how exactly does the regulatory landscape for digital health companies vary from that for medical devices and pharma companies?

Manley: From your investor’s perspective, having your digital health product available on the market is simpler. They’re either not controlled or Food and drug administration is exercising enforcement discretion in controlling some things as medical devices.

Steinle: For approved devices, Food and drug administration is battling with thorny issues around artificial intelligence and machine learning. If your device comes with an approved code sequence and machine learning therefore the code adapts itself, does the organization need to submit a brand new application each time that occurs? Food and drug administration has had an operating, risk-based undertake it, as opposed to a rigid parameter to approving it. It’s new, so it’s difficult to say how it’s likely to evolve.

Q: May be the regulatory plan increasingly challenging for digital health companies? Why?

Steinle: It’s evolving and it is different. Firms that aren’t typically within the healthcare space are beginning to maneuver in it, like Google’s Verily healthcare initiative. They might hire the best individuals to manage regulatory issues, but others, because they turn to expand or are maybe upgrading-margin or entering the healthcare space, it normally won’t have a similar regulatory DNA. Food and drug administration and CMS are wrestling with start up business initiatives, and that’s developing a new dynamic.  It isn’t precisely the wild west, but it might be getting there.

Q: What are the effective partnerships within this market which are breaking lower a few of the traditional industry silos?

Manley: Payers and device companies and startups are looking for methods to share and evaluate data and improve quality. You will find partnerships that you simply couldn’t have imagined ten years ago, like pharma and providers focusing on lowering costs, and device makers and providers trying to lower costs to enhance outcomes. Should you look outdoors healthcare, information mill using the data they’ve on people, like travel data, to supplement the permanent medical record. Should you overlay this, it’s very significant and predictive.

Steinle: Healthcare today has twin holy grails: monetizing the information and creating individualized medicine. The information that individuals generate might be stacked to produce individualized care plans.  That’s what these businesses are actually going after.

Q: Exactly what do firms that are thinking about joint ventures with digital health companies have to know?

Steinle: I consider it poor the master of the ip or even the trade secrets. Who can access and may make use of the data? Who takes the regulatory risk for that traditional healthcare and also for data breaches? How exclusive is the fact that relationship? You will find numerous other details.

Q:  When do you consider the emerging digital companies will be ready for any strong market exit?

Steinle: You can observe lots of smaller sized secure-on acquisitions at this time. Information mill searching to include initiatives or healthcare companies. The standard players, such as the big medtech or pharmaceutical companies, will probably have plenty of competition within this space from more consumer-driven electronics firms that are searching to get involved with healthcare, from large insurance providers and payers that are looking to bridge into consumer services, and a few large healthcare systems, too, that are attempting to give a broader suite of services for his or her patients. I believe we’re likely to see lots of activity for smaller sized acquisitions now, which 3 to 5 years from now, you’ll most likely visit a pretty significant consolidation inside the industry.

MedCity ENGAGE, October 23-24 in North Park, concentrates on the most recent strategies and innovations to boost patient engagement, care delivery and company wellness. Use code MCNTAG in order to save $50.