The healthcare industry in the U.S. is highly-regulated at the state and federal levels, and the balance between the two depends on what part of the industry you’re in. To illustrate—
Health insurers are overseen by state insurance regulators, but the Affordable Care Act added a new layer of federal oversight. The current tussle between HHS and the National Association of Insurance Commissioners over what constitutes an accessible network of providers is a case in point.
The 56,000 retail pharmacies are overseen by states, but drug manufacturers and distributors are overseen by the FDA and FTC, and the 3000 compounding pharmacies find themselves regulated by both.
Physicians are primarily self-regulated by their state licensing and disciplinary boards, but federal rules that require transparency (Physician Sunshine Act) about their performance and prescribe limitations in their business dealings (Stark rules) take precedent.
Rep. Mike Burgess (R-Texas) has released a draft bill entitled “ensuring interoperability of qualified electronic health records” in which interoperable (Electronic Health Records) EHRs are defined as those that do not block sending and receiving data to and from other EHRs and provide users with complete access to the captured medical data. The draft bill proposes that detailed methods to assess interoperability be defined by a “Charter Organization.” According to the draft bill, this Charter Organization shall consist of one member from each of the standard development organizations accredited by the American National Standards Institute and representatives that include healthcare providers, EHR vendors, and health insurers. To keep its certification after January 2018, an EHR vendor should comply with the definitions of the Charter Organization, publish API’s to enable data exchange with other EHRs and attest and demonstrate that it has not willfully interrupted data exchange with other EHRs. The draft bill suggests that the Inspector General of HHS shall have the authority to investigate both EHR vendors and medical providers with regards to claims that they have interrupted interoperability.
The proposed Charter Organization will not be successful.
Authors Thomas Lewis and Jeremy Wyatt worry that “apps” can lead to patient harm.
They posit that the likelihood of harm is mainly a function of 1) the nature of the mistakeitself (miscalculating a body mass index is far less problematic than miscalculating a drug dose) and 2) its severity (overdosing on a cupcake versus a narcotic). When you include other “inherent and external variables,” including the display, the user interface, network issues, information storage, informational complexity and the number of patients using it, the risks can grow from a simple case of developer embarrassment to catastrophic patient loss of life.
In response, they propose that app developers think about this “two dimensional app space” that relies on a risk assessment coupled to a staggered regulation model. That regulation can range from simple clinical self assessment to a more complex and formal approval process.
The headlines and their storylines that you’re not likely to read in 2015:
Physicians optimistic about their future. They’re wildly enthusiastic about the mandate to use electronic medical records to coordinate patient care more effectively, and see the shift away from volume to value as positive trend for the industry. Increased penalties about unnecessary care and report cards about their clinical performance are welcomed as physicians embrace transparency. NOT!
Facts: Trust in physicians remains high but has slipped in recent years. Their compensation remains high relative to overall population at 5.8:1, but physician discontent is palpable. And the visibility given their business dealings vis a vis the Physician Sunshine Act and Medicare Physician database is unwelcome and discomforting.
The Affordable Care Act repealed. Overcoming a President veto, the Senate and House approved repeal. The newly insured in Medicaid and health exchanges will be easily absorbed into the current insurance system so the ranks of the uninsured will not swell. NOT!Continue reading…
In the past few years, we’ve seen headline after headline marveling at the advancements of medical technology. From wearable tech and micro sensors to 3D printing and health-oriented apps, it’s evident that technology and medicine have merged into an industry that’s pushing healthcare to a new level.
Yet many in the health tech industry are also voicing concerns about government regulators and their standards for healthcare technology. Some have even gone as far as accusing the FDA of “stifling” the creativity of healthcare tech and hindering the value these devices and apps could bring to the public.
In early 2014, legislation was introduced in an attempt to redesign the regulatory framework for certain types of technologies and lessen the FDA’s control over this growing industry. But are the FDA’s standards and actions so bad?
I’m in the tech field myself, and while I’ve heard many arguments against the FDA’s regulations, I strongly feel that it’s completely within its rights as a regulatory agency to place limits on medical technology. The FDA’s standards are put in place to protect consumers and to correct disingenuous manufacturer claims — an alarmingly frequent trend in today’s digital world.
Health care providers and consumers are increasingly using mobile technology to exchange information. Many health IT providers readily acknowledge that some level of oversight is required to ensure patient safety and privacy protections, but many providers question whether the FDA is the right agency for the job and want to see the FDASIA recommendations.
Can the FDA, with its already limited resources and lengthy review cycles, regulate the fast-moving health IT industry? Should it? Health IT is fundamentally different from a medical device in many ways. For oversight purposes, the key differentiator between the two is the opportunity for clinical intervention in the use of health IT. Many medical devices interact directly with the patient (such as an infusion pump or pacemaker). Most health IT, on the other hand, merely provides information to clinicians, who ultimately make independent, experienced care decisions. Physicians are informed, but not controlled, by the information. This leads to a vast difference in the patient risk proposition and rigid regulatory oversight is not appropriate.
Advocates of a broad health IT oversight framework – which encompasses mobile health IT – are urging the FDA to delay release of its final guidance, particularly in light of a July 2012 Congressional mandate for the creation of a comprehensive oversight framework that avoids regulatory duplication.
But some mobile medical application developers are pressing the FDA to move forward immediately, believing its guidance will reduce the regulatory uncertainty that they believe is stifling innovation and investment in some aspects of mHealth.
I have been absent from the blogosphere for about two months. The fact is, there just isn’t all that much new to write about. Healthcare spending growth continues to moderate, but not by enough to stave off forecasts of doom for Medicare and Medicaid. Nor can employers begin to shift money from health benefits back into wages. But wheels are turning. Health networks are expanding as providers prepare to offer ACOs and/or increase their bargaining clout. A handful of states are poised to start up exchanges with the feds ready to take the reins in the laggard states. Aon/Hewitt is about ready to launch a private sector exchange. We will start to learn whether exchanges save or destroy private health insurance.
The Affordable Care Act has had many detractors but at least it has disrupted the status quo. We needed to see fundamental changes in how we pay for and deliver healthcare services and the ACA has delivered. But ACA has brought us a very particular set of changes. Time will tell if we have chosen the right path.
Even as the industry changes the way it does business, one critical aspect of change is missing. The faces are all the same. The same large systems that dominated the fee for service world seem poised to dominate the shared savings world, and the same insurers that dominated the traditional employer-based insurance market stand ready to dominate exchanges. Value might be created when old businesses play by new rules, but even more value is created when new players are free to enter and perhaps even break the rules.
Entry is the engine that drives economic progress. Entrants bring new technologies to manufacturing and new service models to sales. Threatened by entry, incumbents strive to innovate and improve customer service. This is as true in high tech industries as it is in the service economy. Research confirms that entry is ubiquitous – in a typical manufacturing industry, fully one third of established firms are replaced by entrants within five years. Though the data is not as readily available, turnover in the service sector is likely even higher.
Tomorrow the Presidential election process comes to an end and the advertising will finally stop. We’ll all be relieved. I especially look forward to a quiet dinner at home without robotic election-related calls.
What about healthcare IT? Will differences in the Obama and Romney platforms impact the momentum of Meaningful Use?
Here’s what I believe.
The Obama Healthcare IT platform builds on what we’ve created over the past few years. It will continue to leverage the federal advisory committees (Policy and Standards) to engage a wide array of stakeholders. It will persist the progression to Meaningful Use Stage 3 and possibly future stages. It will embrace certification now the temporary certification process has been replaced with a permanent one. It will support the initiatives of the Standards and Interoperability framework (S&I), although the end of stimulus funds from ARRA means that ONC will move some of the S&I initiatives to private/public partnerships. It will support the current leadership at ONC – Farzad and his delegates such as Steve Posnack, Doug Fridsma, and Judy Murphy.
The Romney Healthcare IT platform notes that Healthcare IT is an issue which has broad bipartisan support. No one argues that a foundation of healthcare IT implemented properly is essential for accountable care organizations. Quality, safety, and efficiency all benefit from the process enhancement afforded by healthcare IT. Michael Leavitt, former Secretary of HHS and chair of the American Health Information Community (AHIC) will lead the Romney transition team and Leavitt has years of experience with healthcare IT issues from the early days of ONC. As Governor of Massachusetts, Romney supported the early EHR rollout efforts of the Massachusetts eHealth Collaborative.
Doctors of my generation have experienced dramatic changes in the way we access the information we need to care for patients.
As a medical student 15 years ago, my “peripheral brain” consisted of fat textbooks sitting on office bookshelves or smaller, spiral-bound references stuffed into the bulging pockets of my lab coat. As a doctor-in-training, I replaced those bulky references with programs loaded onto PDAs. Today, smartphone apps allow health professionals at all levels to access the most up-to-date medical resources such as drug references, disease-risk calculators, and clinical guidelines—anytime, anywhere.
Lastly, apps can enable remote monitoring of high-risk patients and reduce the need for office visits. In a small study published in PLoS ONE, for example, researchers found that patients hospitalized for heart vessel blockages were able to complete “supervised” rehabilitation exercise sessions in their homes with a portable heart monitor and GPS receiver that transmitted real-time data to doctors via smartphone.
The Supreme Court’s decision upholding the ACA is deliciously ironic. The “individual mandate”–an idea promoted for everyone in the 90s and for Massachusettians (?) in the 2000s by the arm of the Republican party known as the Heritage Foundation–was found to be legal. But not as a mandate, instead as a tax.
Put aside for a minute the dreadful political contortions required to get this quasi-universal health insurance bill past Congress in the first place. Put aside the fact that the supposedly non-political Supreme Court hands down decisions time after time that are a pure reflection of the exceedingly public extreme political views of its justices. Put aside for a minute the fact that the ACA has undeniably kickstarted a round of changes in the health care delivery and insurance system that at least has the potential to lower costs and improve care, and that the luncay of politics meant we nearly lost that momentum.
Instead focus on what the Supremes have done. They’ve cut through decades of rhetoric about how we pay for health insurance and clarified it thus: we pay for health care via taxes–whether they are private taxes on employers and employees (and now individuals) or public ones on citizens.