The US Department of Justice announced on 27 February that it reached a $145 million settlement with Practice Fusion on what DOJ termed “kickbacks from a major opioid company in exchange for utilizing its EHR software to influence physician prescribing of opioid pain medications”. Allscripts, which now owns Practice Fusion, will be paying out penalties of $25.4 million in criminal fines, $113.4 million to the Federal Government, and up to $5.2 million to individual states, as well as forfeiting criminal proceeds of nearly $1 million from the ‘kickback’. The specific charges relate to two felony charges related to the Anti-Kickback Statute (AKS) and for conspiring with its opioid company client to violate the AKS.
The opioid company is widely believed to be Purdue Pharmaceutical, manufacturers of Oxycontin, according to HISTalk. The high dudgeon generated in the DOJ press release is related to opioid prescriptions and physician usage which are and remain highly controversial. Apparently, Purdue wasn’t the only pharma company that benefited from this type of influence.
In this Editor’s analysis, ‘kickbacks’ is a legalism to prosecute under the AKC what marketers would term a sponsorship deal. Practice Fusion was from inception advertiser supported. What is different here from pop-up screen adverts is that Practice Fusion created sponsorship packages in which not only advertising was featured, but also clinical support decision (CDS) alerts were created, aimed at increasing prescription sales of companies’ products. In addition, Practice Fusion allowed companies to participate in the design of the CDS software. These sponsorships took place between 2014 and 2019. None of this is unusual in AdLand in general, but in pharma and healthcare which play by far stricter rules about marketing programs, this goes against the expectation (and regulation) that an EHR is unbiased.
Allscripts had ‘leaked’ this back in August on their Q2 investor call. Buried in the DOJ release after the opioid ire is the settlement of Practice Fusion’s violations of Office of the National Coordinator for Health Information Technology (ONC) regulations concerning the voluntary health IT certification program, and the Centers for Medicare & Medicaid Services (CMS) regulations around EHR incentive programs, presumably Meaningful Use certifications and payments. This was the origin of the earlier announcement of a $145 million settlement on Allscripts’ Q2 2019 investor call, which in retrospect strikes this Editor as a nice try at minimizing far more serious charges. [TTA 14 August] CDS favoring opioid prescription is far more disturbing.
It does seem that Allscripts bought itself a bargain basement of trouble with Practice Fusion. Mobihealthnews, TechCrunch.
If you hate your EHR, think it’s swallowing your information, adding hours to your day, and if you don’t watch it, you’ll make an error, you’re not a Luddite. You’re right. An exhaustive investigation by Fortune and Kaiser Health News (KHN) concludes that it’s ‘an unholy mess’. In fact, even if you are not a physician or clinical staff, it will make you wonder what was going on the collective brains of the digerati, Newt Gingrich, Barack Obama–and the US government–in thinking that EHRs would actually “cut red tape, prevent medical mistakes, and help save billions of dollars each year,” committing $36 billion to pursuing the ‘shovel-ready’ HITECH stimulus in the depths of the 2008-9 recession. Perhaps the shovel should have been used on a body part. Now if only those billions went towards an interoperable, useful, and national system rather than a money giveaway–which even Farzad Mostashari, then ONC deputy director and later director, now admits was “utterly infeasible to get to in a short time frame.” (Mr. Mostashari is now head of Aledade, counseling those mostly independent practices which lined up–hungry or terrified–for meaningful use EHR subsidies on how they can continue to survive.) Even the vendors were a bit queasy, but nothing was stopping HITECH. (Your Editor was an observer of the struggle.)
Now that we have been living with them for over a decade, EHRs have been found culpable of:
- Soaring error rates, especially in medication and lab results
- Increasing patient safety risks in lack of pass-through of critical information
- Corporate secrecy, enforced by system non-disclosures, around failures
- Lack of real interoperability–even with regional HIEs, which only exchange parts of records
- Incomplete information
- A very real cognitive burden on doctors–an Annals of Family Medicine study calculated that an average of 5.9 hours of a primary care doctor’s 11.4 hour working day was spent on the EHR
- Alert fatigue
- Note bloat
- Plain old difficulty or unsuitability (ask any psychiatrist or neurologist)
- A main cause of doctor burnout, depression, and fatigue–right up to high suicide rates, estimated at one US physician per day
- Lack of patient contact (why the scribes are making a good living)
- All those dropdowns and windows? Great until you click on the wrong one and find yourself making a mistake or in the wrong record.
Not even the head of the Centers for Medicare and Medicaid Services is immune. Seema Verma’s husband, a physician, collapsed in the Indianapolis airport. She couldn’t collect his records without great difficulty and piecing together. When he was discharged, he received a few papers and a CD-ROM containing some medical images, but without key medical records.
A long read for lunch or the weekend. Death by a Thousand Clicks: Where Electronic Health Records Went Wrong. Also the accompanying essay by Clifton Leaf.
[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2015/11/upside-down-duck.jpg” thumb_width=”150″ /]For years now, your Editors have championed integration of data and system interoperability
–search on these terms and you’ll find a wealth of articles and views. This Editor also included how data is integrated in patient records as the Fifth Big Question (FBQ)
[TTA 8 Aug 13
]. Many digital health companies, not just startups, have failed at the data integration (and security) tasks, whether with EHRs, hubs, billing and practice management systems or with other devices. (Let us not forget that the initial impetus for Continua
back in 2007, the US state/regional HIXs and for HL7
now, was to have common data and interchange standards.)
So there’s no real element of surprise here by John Sung Kim’s pleading in TechCrunch re ‘integrating into legacy systems’ and the troubles his own startup DoctorBase encountered in what he tactfully puts ‘political and technical hurdles’ encountered. But then the velvet gloves come off about EHRs and their less-than-scrupulous idea of ‘partnerships’. (more…)
This week’s priceless quote:
“A lot of the response was, ‘We live in a cornfield in the middle of Minnesota,’” he said. “’Who wants to hurt us? Who can even find us here?’”–Jim Nelms, Mayo Clinic’s first chief information security officer,
We know where you are and what you do! The precarious state of healthcare data security at facilities and with insurers, plus increased external threats from hacking has been getting noticed by Congress–when you see it in POLITICO, you know finally it’s made it into the Rotunda. It was over the horizon late last summer with the FBI alert and legislators in high dudgeon over the Community Health Systems China hack [TTA 22 Aug 14]. It’s a roof that leaks, that costs a lot to fix, doesn’t have immediate benefit (cost avoidance never does) but when it does leak it’s disastrous.
This article rounds up much of what these pages have pointed out for several years, including the Ponemon Institute/IBM study from earlier this week, the Chinese/Russian connections behind Big Hacks not only for selling data, but also IP [TTA 26 Aug 14] and how decidedly easy it is to hack devices and equipment [TTA 10 May 14]. Acknowledgement that healthcare data security is about 20 years behind finance and defense deserves a ‘hooray!’, but when you realize that on average only 3 percent of HIT spend is on security when it should be a minimum of 10 percent (HIMSS) or higher…yet the choice may be better security or uncompensated patient care particularly in rural areas, what will it be for many healthcare organizations?
The article also doesn’t go far enough in the devil’s dilemma–that the Federal Government with Medicare, HITECH, meaningful use, rural telehealth and programs like Medicare Shared Savings demand more and more data tracking, sharing and response mechanisms, stretching HIT 15 ways from sundown. At the cutely named Health Datapalooza presently going on in Washington DC, data sharing is It for Quality Care, or else. Yet the costs to smaller healthcare providers to prevent that ER readmission scenario through new care models such as PCMHs and ACOs is stunning. And the consequences may be more consolidated, less available healthcare. We are already seeing merger rumors in the insurer area and scaledowns/shutdowns/buyouts of community health organizations including smaller hospitals and clinics. Also iHealthBeat.
DARPA to the rescue? The folks who brought you the Internet may develop a solution, but it won’t be tomorrow or even the day after. The Brandeis Program is a several stage project over 4.5 years to determine how “to enable information systems that would allow individuals, enterprises and U.S. government agencies to keep personal and/or proprietary information private.” It discards the current methodology of filtering data (de-identification) or trusting third-parties to secure. Armed With Science FedBizOpps has the broad agency announcement in addition to vendor solicitation information.
The report issued today by the influential Robert Wood Johnson Foundation (RWJF), ‘Data for Health: Learning What Works’ advocates a fresh approach to health data through greater education on the value/importance of sharing PHI, improved security and privacy safeguards and investing in community data infrastructure. If the above quote and the first two items sound contradictory, perhaps they are, but current ‘strict’ privacy regulations (that’s you, HIPAA), data siloing and the current state of the art in security aren’t stemming Hackermania (or sheer bad data hygiene and security procedures). Based on three key themes, the RWJF is recommending a suite of actions (see below) to build what they term a ‘Culture of Health. All of which, from the 10,000 foot view, seem achievable. The need–and importantly, the perception of need–to integrate the rising quantity of data from all these devices, pry it out of its silos (elaborated upon earlier this week in ‘Set that disease data free!), analyze it and make it meaningful plus shareable to people and their doctors/clinicians keeps building. (‘Meaningful’ here is not to be confused with the HITECH Act’s Meaningful Use.)
But who will take the lead? Who will do the work? Will the HIT structure, infrastructure and very importantly, the legal framework follow? We wonder if there is enough demand and bandwidth in the current challenged system. Release. RWJF ‘Data for Health’ page with links to study PDF, executive summary which adds details to the recommendations below, more.[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2015/04/Data-For-Health-Advisory-Committee-RWJF.png” thumb_width=”400″ /]
In 2009, the US Congress enacted the HITECH Act, as part of a much broader recovery measure (ARRA or ‘the stimulus’), authorizing the Department of Health and Human Services (HHS) to spend up to $35 billion to expand health IT and create a network of interoperable EHRs. Key to this goal of interoperability and seamless sharing of patient information among healthcare providers was achieving stages of ‘meaningful use’ (MU) with these EHRs in practice, to achieve the oft-cited ‘Triple Aim‘ of improved population health, better individual care, delivered at lower per capita cost. Financial incentives through Medicaid and Medicare EHR programs were delivered through multiple stages of MU benchmarks for hospitals and practices in implementing EHRs, information exchange, e-prescribing, converting patient records, security, patient communication and access (PHRs).
Five years on, $28 billion of that $35 billion has been spent–and real progress towards interoperability remains off in the distance. This Editor has previously noted the boomlet in workarounds for patient records like Syapse and OpenNotes. Yet even the progress made with state data exchanges (e.g. New York’s SHIN-NY) has come at a high cost–an estimated $500 million, yet only 25 percent are financially stable, according to a RAND December 2014 study. (more…)
[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2013/08/blue-blazes.jpg” thumb_width=”150″ /]Neil Versel in his personal blog Meaningful HIT News notes meaningful lapses in accuracy and good communications taste from two reputable companies targeted to US medical professionals. DrChrono is a mobile ambulatory EHR tweeting about ‘cashing in’ on the HITECH Act–the program that rewards practices for achieving stages of Meaningful Use with EHRs. Sermo is a physician social networking platform that has staged a contest called ‘The Pro Football Injury Challenge’ where one will go ‘head-to-head’ with other doctors in ‘making predictions about how injuries will affect pro athletes this season.’ This Editor felt in her comments below the article that this promotion’s communication crossed the line into, on the usual two-second read, a message that it is OK to ‘play for glory’ and win prizes out of players’ real pain, injury and career disaster–a misbegotten effort to gamify real-world medical situations ostensibly for learning. Yes, both have sound messages at the core, but how they were communicated…regrettable. Both DrChrono and Sermo are nominated for ‘Blue Blazes’ because, to paraphrase Neil, ‘what are their marketers thinking?’ What do you think? And this Editor would be more than open to comments from representatives of these two companies. DrChrono and Sermo, what are you thinking?
Editor’s Update: Sermo has provided an important response and clarification blazingly fast in their blog here. (more…)
[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2013/07/doctor_pulling_hair.jpg” thumb_width=”150″ /]Will this doctor be able to replace his hair?
Confirming EHR misery for doctors, this article in Healthcare Technology Online
gives more details on the Black Book Rankings
’ 2013 State of the Ambulatory EHR Market
report that we presented back in February
when early findings were released. Out of their 17,000 users from solo practitioners to 100+ doctor practices, 31 percent of respondents were dissatisfied enough with their EHR to consider making a change with 18% seeking to change systems within the next year. Poor usability led the reasons why. But there’s 84 percent plus queasiness about vendor viability, reasonable when there are 600+ vendors and a number have already gone out of business leaving their practices stranded. The basics aren’t enough–must-haves are support for mobile devices (80 percent), data sharing and integration (83 percent) and patient portal (58 percent). And it has to be Web-based/SaaS based (70 percent). One detail: confirmation of the anecdotal ‘we jumped too fast to get the Meaningful Use money’. #EHRbacklash, indeed.
ATA 2013’s final ‘industry executive session’, presented at the late hour when most attendees are daydreaming about a comfy chair and a solid drink, tackled one of the thornier underlying questions beleaguering health tech: return on investment (ROI). Providers want hard numbers, but even that definition is…indefinite. Is it data? Is it outcomes? Is it savings? Is it reduction in spending? For two systems or populations, it can be reducing 30-day same cause readmissions for one provider or improved outcomes in home care for another, and the results are not analogous nor even cause-and-effect. As Eric Wicklund from mHIMSS put it, “that’s the challenge, and it was the primary focus of this year’s ATA conference. The pilots are gone, the possibilities and proposals are old. It’s time to target the telemedicine and mHealth programs that are working and to explain why they are…” As GlobalMed’s Roger Downey less delicately put it, “It’s like pinning Jell-O to a wall”–but getting specific as to what should be done in the market helps. Not quite as blithe as the headline. ROI? To some of the industry’s top vendors, that’s just three letters.
Of course, EHR implementation continues to be the Rodney Dangerfield of health tech, with HITECH Act ‘Meaningful Use’ interoperability goals and patient platforms only spottily achieved despite years of generous past, present and future incentive payments. Yet one ATA presenter seriously advocated the addition of telehealth/telemedicine to MU standards, recommended that Health and Human Services become the authority and to add panels for Federal standards and policy in telemedicine as there are for health IT. Adding telehealth and telemedicine to the MU scramble will surely speed implementation ;-) (See above) Why not MU for telemedicine? (HealthcareITNews)