Government & Policy

After being abruptly placed on admin leave, Leo Scanlon opens up about his 150-day leave, “dirty politics,” and what it means for the future of the HCCIC cybersecurity initiative.

A roundup of big ideas from experts on interoperability, patient engagement, security, cloud computing, innovation, policy and more during HIMSS18.

The group says privacy can still be maintained while giving care providers secure access to relevant substance abuse data and calls on Congress to allow HHS to pursue patient ID strategies.

A report from research firm Kalorama Information named the top healthcare disruptors it anticipates happening between now and the year 2027 -- and the Trump Administration’s health policies in the U.S. took the top spot.   In Kalorama’s report, the market research firm noted that while healthcare is in a perpetual state of change, so are global socio-economic trends, which in turn are changing the way all industries operate. Kalorama’s top seven disruptors: Trump Administration: The firm pointed specifically to ongoing attempts to repeal and replace the Affordable Care Act, as well as health IT policies, and statements about drug pricing as factors that could trigger disruption. Brexit and its impact on European markets: Much the way Brexit has already sent a ripple throughout Europe, and with so many healthcare firms there, Brexit changes could potentially impact many markets, Kalorama said. Rising rates of disease diagnosis and treatment: With more patients globally being diagnosed with a wider range of diseases, not to mention lingering reimbursement and medical and drug supply issues, healthcare systems will be taxed with treating a growing number of people moving forward. Mergers and acquisitions: As happens in so many industries, the high rate of mergers will continue in healthcare as companies seek growth by acquisition, new technologies and expertise. Exactly how the industry consolidation will happen remains to be seen but hospitals executives should plan for more of it in the future. High and rising out-of-pocket spending on healthcare: There’s little debating that health expenses in the U.S. are out of control and the rising rates of out-of-pocket spending will only make that reality more unpredictable and, in turn, planning and forecasting more complex. Physician shortages: Whether it’s because of burnout, physician’s retiring or the wave of hospitals acquiring solo doctors and medical practices, the supply of clinicians appear to be threatened and that will challenge hospitals, particularly with projections of more patients in the system. The Gig Economy: The health care delivery and insurance systems will have little choice but to keep pace with the growing legions of job-to-job workers and adapt to meet their unique needs in the age of consumerism. "There are so many factors impacting markets right now that they need to be considered in a multivariate analysis," Bruce Carlson, publisher of Kalorama Information, said in a statement. Carlson added that Brexit and austerity in Europe, heavy M&A activity and the targeting of healthcare by Amazon and Apple add up to an "Era of Uncertainty." Twitter: @Bernie_HITN Email the writer: bernie.monegain@himssmedia.com

The agency named University of Pittsburgh Medical Center Chief Innovation Officer Rasu Shrestha to lead work mapping the electronic medical record to the FHIR APIs and create common data standards through industry partnerships.

The MyHealthEData Initiative, announced by CMS' Seema Verma at HIMSS18, is too light on detail to make much of a difference, said the former VP – who offered his own way forward.

The embattled VA secretary told a Congressional committee that the agency is working closely with the DoD to learn lessons for its own Cerner overhaul.

The C should stand for connected, not comprehensive, say tech, policy and clinical experts at the school's Center for Digital Health Innovation.

The Securities and Exchange Commission has charged Elizabeth Holmes, founder and CEO of scandal-ridden startup Theranos, with “massive fraud.” Along with former Theranos President Ramesh “Sunny” Balwani, Holmes has been charged with raising over $700 million from investors “through an elaborate, years-long fraud in which they exaggerated or made false statements about the company’s technology, business and financial performance.” SEC alleges that Theranos, Holmes and Balwani deceived investors by making it appear as if they’d “successfully developed a commercially-ready portable blood analyzer that could perform a full range of laboratory tests from a small sample of blood,” according to the filing. Not only did Holmes and Balwani make false statements to the media about their technology, they hosted misleading tech demonstrations and overstated “the extent of Theranos’ relationships with commercial partners and government entities, to whom they had also made misrepresentations.” Theranos was once seen as a promising clinical lab startup, even inking a deal with Practice Fusion in 2015. Holmes could be seen in major magazines and was widely considered a top innovator. But by March 2016, reports emerged over differing lab results from Quest and LabCorp that impacted patient care. And Wall Street Journal investigations over five years called into question the accuracy of Theranos’ tests. While the company said it was addressing those deficient lab results and suspending testing, SEC soon launched its own investigation into Theranos and a class action lawsuit was filed shortly after. By July, Congress was demanding answers from Holmes, including how she intended to remedy those flawed test results. Holmes settled with one of the startup’s largest investors Partner Fund Management in May 2017, giving away her shares to some of the “most significant shareholders” as part of the settlement. As for the SEC filing, Holmes has agreed to resolve the charges against her and the company, and, in addition to a $500,000 fine, Holmes will give up majority voting control over Theranos. Holmes has also been barred as serving as an officer or director of a public company for 10 years and must return the remaining 18.9 million shares she obtained during the fraud. Further, if Theranos is acquired or liquidated, Holmes can’t profit from her ownership until she returns the $750 million to investors and other shareholders. Holmes and Theranos did not admit or deny the SEC claims, according to officials. Balwani will face litigation by the SEC in federal district court in the Northern District of California. “The Theranos story is an important lesson for Silicon Valley,” Jina Choi, SEC San Francisco Regional Office director said in a statement. “Innovators who seek to revolutionize and disrupt an industry must tell investors the truth about what their technology can do today, not just what they hope it might do someday.” Steven Peikin, SEC Enforcement Division’s co-director added that “the charges make clear that there is no exemption from the anti-fraud provisions of the federal securities laws simply because a company is non-public, development-stage or the subject of exuberant media attention.”   DV.load("https://www.documentcloud.org/documents/4412203-Theranos-Holmes-Suit-2018.js", { responsive: true, container: "#DV-viewer-4412203-Theranos-Holmes-Suit-2018" }); Theranos Holmes Suit 2018 (PDF) Theranos Holmes Suit 2018 (Text) Twitter: @JessieFDavis Email the writer: jessica.davis@himssmedia.com

Michigan, like much of the rest of this country, is in the midst of an opioid crisis. The number of opioid prescriptions, individuals in substance use disorder programs and, worst of all, opioid-related drug overdose deaths have all increased from 2011 to 2015 in the state. Michigan has turned to health IT to try to accomplish two goals: prevent overprescribing and over-dispensing by health professionals, and improve patient care for individuals suffering from substance use disorders. “We are attempting to prevent overprescribing and over-dispensing in two ways,” said Kim Gaedeke, acting deputy director of the Department of Licensing and Regulatory Affairs for the State of Michigan. “First, equipping Michigan physicians and dispensers with real-time patient data to be viewed prior to prescribing and dispensing schedule 2-5 controlled substances and dissuading overprescribing through disciplinary and enforcement actions.” [Also: Senator proposes bill to incentivize states to share PDMP data with law enforcement] Michigan health officials selected specialized vendor Appriss Health for its substance use disorder system NarxCare. The vendor works with 46 states that are sharing PDMP data across state borders to inform physicians and pharmacists at the point of care of a patient’s Rx history to avoid overprescribing or those who are doctor shopping. NarxCare provides participating physicians and dispensers with an abundant amount of patient history and data to help determine the degree to which the patient is at risk for substance use disorder, Gaedeke added. This helps inform a health professional’s clinical diagnosis.   "In the past, it would take health professionals on average 5-10 minutes to pull up a patient report. The state has experienced a return on its investment with an annual savings of roughly $1 million in staff costs." Kim Gaedeke, State of Michigan “Additionally, we are able to use individual and statewide prescription and dispensing data to determine overprescribing and over-dispensing by health professionals,” she said. “The state uses this data to follow up with disciplinary actions against health professionals who are overprescribing or over-dispensing.” [Also: Joining opioid fight, North Carolina signs on to PDMP data sharing collective] The second way Michigan is attempting to prevent overprescribing and over-dispensing is through the system’s ability to determine the degree to which a patient is susceptible to substance use disorder and, if necessary, provide ways to help that patient. “The additional resources can be presented within the health professional’s clinical workflow,” Gaedeke said. “This assures that the patient immediately receives appropriate assistance during a visit. This technology has helped transform the traditional model of a Prescription Drug Monitoring Program to a more robust clinical, care management, analytical and prevention tool.” The NarxCare technology fits into the clinical workflow by being integrated into a physician’s electronic health record system or a pharmacist’s dispensation system. This direct integration of the systems allows for the physician or pharmacist to stay in the software, and if the same patient is also in the state’s PDMP, called MAPS for Michigan Automated Prescription System, the patient’s data in MAPS automatically appears in the health professional’s EHR or pharmacy dispensation system without requiring the practitioner to log in and out of two separate interfaces. “Once the provider clicks to view on the NarxCare report, the practitioner can see the full data set of the patient such as risk scores, Medical Morphine Equivalent, and history of schedule 2-5 controlled substances that have been prescribed and dispensed to the patient,” Gaedeke explained. “In addition, it includes any red flags such as whether the patient has gone to multiple doctors or pharmacies in a short period of time to obtain the same prescriptions, indicating possible substance use disorder or drug diversion.” Based on an interactive visualization of usage patterns to help identify potential risk factors, the physician or dispenser can determine the appropriate course of action for treatment, she said. Since implementing the Appriss Health technology in April 2017, Michigan has documented a decrease in the number of Michigan residents receiving an opioid prescription and decrease in the rate of doctor shopping by patients, she said. She added the state expects a drop in the total number of controlled substance prescriptions filled in Michigan from 2016 to 2017 once the data is tabulated and finalized. “Additionally, the improvement in technology has increased the number of health professionals using the new MAPS/NarxCare platform,” she explained. “The increase in the number of users further contributes to aggregated data that is collected and analyzed to better inform clinical diagnoses by individual health professionals and potential enforcement actions by our department.” The state’s Department of Licensing and Regulatory Affairs, where MAPS is housed, has also experienced overall efficiencies with the new system compared to the old system by instantly providing data in real time along with system reports in less than half a second for its users, she added. “In the past, it would take health professionals on average 5-10 minutes to pull up a patient report,” she said. “The state has experienced a return on its investment with an annual savings of roughly $1 million in staff costs. Prior to replacing the state-maintained system, the state went from 13.5 FTEs to now 4.25 FTEs.” And ultimately, Gaedeke said, with the innovations and efficiencies created with the new MAPS/NarxCare platform, the Department of Licensing and Regulatory Affairs has been able to better identify licensed health professionals who are overprescribing, over-dispensing and diverting drugs, which has allowed for improved regulatory actions and in many cases more swift action taken by the department and its licensing boards. “Technology plays a vital role in our fight against the opioid epidemic and substance use disorders in Michigan overall,” she said. “Technology allows health professionals to go beyond their individual instincts or preconceived notions by providing them with access to comprehensive real-time data with a single click in their existing electronic health records.” Twitter: @SiwickiHealthIT Email the writer: bill.siwicki@himssmedia.com