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This is the last installment in a three-part series that asks why we need both an insurance industry and an ACO industry. We are now stuck with the worst of all possible worlds – an inefficient insurance industry layered on top of an inefficient ACO industry.
I noted in Part I of this series that ACOs’ inability to cut costs explains why 90 percent of Medicare ACOs refuse to accept anything resembling insurance risk. In Part II I discussed ACO proponents’ expectation that many ACOs would accept full insurance risk, and I described the Medicare Payment Advisory Commission’s (MedPAC’s) reaction to ACOs’ inability to cut costs and their unwillingness to accept insurance risk. We saw that MedPAC attempted to design a plan called “premium support” that would generate competition between Medicare ACOs, Medicare Advantage plans, and the traditional Medicare fee-for-service program, and, after four years of trying (and even after dropping the FFS program from the project), gave up.
In this last installment I review a nearly identical attempt by Minnesota’s Medicaid program to set Medicaid ACOs and HMOs on a level playing field. I will close with a prediction of where the ACO industry is headed.
Minnesota mimics Obamacare and MedPAC
Within a few weeks after President Obama signed the Affordable Care Act, Minnesota’s then-governor Tim Pawlenty signed a bill containing ACO provisions lifted almost verbatim from the ACA.  These provisions required Minnesota’s Department of Human Services (DHS) to implement an ACO program within the state’s Medicaid program.  The legislation referred to ACOs as Integrated Health Partnerships (IHPs) (although DHS referred to them as ACOs in its communications with the federal government). DHS started the IHP program in 2013. Today 24 hospital-clinic and clinic-clinic groups participate. The smaller IHPs bear only upside risk, the larger ones bear both up- and downside risk. Nearly all of the state’s large hospital-clinic chains (Mayo, Fairview, Allina, HealthPartners, Essentia) have set up IHPs.
But unlike Congress and CMS, which inserted ACOs inside the Medicare fee-for-service program (not the Medicare Advantage program), Minnesota’s legislature inserted the new IHP program inside the Medicaid HMO program. Minnesota’s legislature long ago gave DHS the authority to turn Minnesota’s non-disabled Medicaid enrollees over to HMOs; DHS completed that process in the late 1990s.  Thus, when the legislature decided in 2010 to mimic Obamacare and insert ACOs in Minnesota’s Medicaid program, that program, unlike Medicare, consisted of a dominant HMO program and a smaller FFS program serving primarily the disabled (80 percent of Minnesota Medicaid dollars flow through the HMOs).
Inserting the IHP program into the smaller FFS program was not a realistic option in 2010. The legislature’s only options were (a) to replace the HMOs with IHPs, or (b) to insert the IHPs inside the HMO program. The latter option made no sense, but the former option was never debated. The former option would have required the Minnesota legislature and Governor Pawlenty to ask, Why do we need ACOs/IHPs in addition to HMOs? But asking that obvious question never crossed the minds of the ACO proponents at either the federal or the Minnesota level. And so the legislature chose option b – IHPs were inserted into the HMO portion of the Medicaid program.
The result of that irrational decision is that the IHP experiment in Minnesota is an even bigger mess than the ACO experiment within Medicare. Minnesota’s IHPs are enrolling people who are already enrolled in an HMO. How in the world do we answer the question, “What is it that IHPs do that HMOs don’t do?” if the IHPs and the HMOs are enrolling the same people? Get this: DHS even funnels the IHPs’ portion of the alleged savings back to the HMOs and leaves it to the HMOs to pass the money on to the appropriate IHPs. 
DHS has attempted to deal with this dilemma with a proposal that resembles MedPAC’s premium support proposal. DHS proposes to disentangle the IHPs from the HMOs and harmonize the payment methods for IHPs and HMOs (that is, set the two sectors on a level playing field); it identifies numerous complex issues that would need resolution; and it offers very few details about how DHS thinks those issues could be solved. To add to the complexity, DHS limited the proposed experiment to the seven-county Twin Cities metro area. DHS published this proposal, which it called “Next Generation IHP,” in the form of a Request for Comment (RFC) last November.
The separation of the IHPs from the HMOs is the most fundamental change proposed by the RFC. DHS proposes to do that with two new requirements: “Primary care exclusivity” (primary care doctors would have to choose between contracting with one IHP or with one or more HMOs); and gatekeeping (Medicaid enrollees would have to enroll with one primary care doctor). With the IHPs thus disentangled from the HMOs, DHS would then subject the IHPs to a method of payment very similar to the one DHS now uses to calculate per-enrollee payments to the HMOs.  These reforms, plus oodles of allegedly accurate quality information for Medicaid enrollees that would allegedly enable smart “shopping,” would in turn trigger real competition. And real competition – not competition on who can avoid sick patients – would, at long last, determine which HMOs and ACOs are the most efficient.
Request for blowback
DHS’s Request for Comment elicited a cacophony of criticism. Seventy-four people, representing all sectors of the health care system, posted comments covering multiple issues and filling up more than 400 pages. The vast majority of the comments were either critical or made suggestions that DHS couldn’t accept without radically altering its proposal. The commenters directed most of their criticism at DHS’s “primary care exclusivity” rule, and the fact that DHS cannot risk-adjust payments accurately enough to prevent providers who treat sicker patients from underpayment. Commenters saw the “primary care exclusivity” rule as disruptive and expensive (because it would require DHS to spend a lot of money educating Medicaid beneficiaries on the necessity of picking not just one HMO or IHP, but one primary care doctor as well). The vagueness and complexity of the RFC also drew criticism.
The four HMOs that now insure Medicaid patients in the Twin Cities area, and the providers who treat sicker patients, were the most critical of DHS’s proposal. The HMOs claimed they were already doing whatever it is the IHPs do and there was, therefore, no need to disentangle IHPs from the HMOs and force doctors to choose between the IHP and HMO sectors. Safety-net providers, notably clinics that specialize in addiction and mental health services, criticized DHS for proposing a payment system that will require accurate risk adjustment when accurate risk adjustment does not exist. They argued crude risk adjustment would harm the poor and the sick, both directly by underpaying the providers who treat them, and indirectly by encouraging HMOs and IHPs to exclude them from their networks. Motivated in large part by concern about bearing insurance risk in a world where accurate risk adjustment doesn’t exist, nearly all the IHPs as well as their sympathizers (the Minnesota Hospital Association, for example) urged DHS to be “flexible” and to let each IHP negotiate every important feature of its contract, including how many people it would enroll, the size and composition of its network, the services it would offer, and the level of risk it would bear. In other words, they wanted DHS to make the vacuous, aspirational definition of “IHP” even more useless.
Here is an example of a comment expressing doubt that DHS will be able to prevent the HMOs (described as MCOs in the comment, short for “managed care organizations”) from avoiding their share of the sick and the poor. The comment was posted by the Federally Qualified Health Center Urban Health Network (FUHN), a coalition of ten Federally Qualified Health Care Centers. “We are concerned that MCO’s will be reluctant to enroll all MA [Medicaid] patients due to the possibility that their patient risk profile will be riskier…. In effect, an MCO could manipulate their … patient risk by carefully choosing primary care providers who likely have a more favorable patient population.”
Here is an example of a comment calling for the further watering down of the flabby definition of “IHP.” It was posted by Allina, a large hospital-clinic chain that participated in the Medicare Pioneer ACO program and now participates in the IHP program. “We need flexibility in determining network structure and network adequacy criteria…. We recommend that IHPs have a great degree of flexibility in meeting the challenges of caring for the whole population and assuming increased risk. It is appropriate for DHS to require IHPs to describe their plans … to measure and report their progress. However, it would be better to allow each IHP to develop its own plans.”
The preceding brief summary of the reaction to DHS’s RFC reveals only a fraction of the doubts expressed by those who reacted to the vague and extremely complex RFC. DHS seemed to get the message. In its February 20 reply to the 74 comments, DHS announced it was abandoning “primary care exclusivity,” which is tantamount to saying it was giving up on separating the IHPs from the four HMOs, the most fundamental “reform” proposed in the RFC.  Obviously, the entire proposal is dead if “primary care exclusivity” is off the table. But DHS denied that. They said they intend to implement the proposal and “will continue information gathering … through the summer of 2018.” I don’t know what good more information gathering will do.
Lessons from MedPAC’s and DHS’s adventures in leveling the playing field
It’s clear now that the efforts by MedPAC and Minnesota’s DHS to determine whether ACO magic is superior to HMO/MA-plan magic have failed. This is not to say MedPAC won’t some day tinker again with the premium support fantasy, or that DHS won’t make some minor changes to the current Minnesota IHP program and bestow the name “Next Generation IHPs” on the IHPs that conform to the changes. It does mean MedPAC and DHS have demonstrated what should have been obvious from the beginning: Real competition (as opposed to a race to the bottom) on a level playing field between ACOs and HMOs and/or a FFS program is not possible, and that in turn means we can’t expect competition to answer the question, Do we really need both an ACO and a managed-care-plan program within Medicare and Medicaid? And if ACOs refuse to take on full insurance risk, we won’t see competition settle this issue in the private sector either.
So now what? Will inefficient ACO programs bumble along indefinitely alongside inefficient insurance industry programs within Medicare and Medicaid? That is the most likely scenario for the near term. And as long as Medicare and Medicaid funnel dollars into ACOs, private-sector payers will probably do likewise. The reason this is the most likely outcome is that evidence doesn’t matter in health policy. Our “thought leaders” and policy-makers behave more like a herd than a crowd of individuals thinking for themselves. The overpayment of Medicare Advantage plans and their predecessors for almost a half-century illustrates the problem. Since 1980, dozens, possibly hundreds, of studies have demonstrated that the insertion of HMOs (and later insurers of all stripes) into Medicare raised Medicare’s costs. But those studies have had little effect. The MA program sails along on auto-pilot.
The same will be true of the Medicare and Medicaid ACO programs for years to come. DHS’s refusal to commission an independent study of the IHP program, and the Minnesota legislature’s disinterest in making them do so, illustrates the power of ACO/IHP ideology. On several occasions over the last four years DHS has proclaimed via press release that the IHPs are saving enormous sums of money (which flies in the face of the evidence on Medicare ACOs), but despite requests from me and others asking for documentation, DHS refuses to produce it.  DHS’s behavior is reinforced by the managed care echo chamber. For example, the Center for Health Care Strategies, founded with money from one of the country’s earliest proponents of HMOs, the Robert Wood Johnson Foundation , periodically repeats DHS’s undocumented claims as if they were gospel (see Exhibit 6 page 6 )
I do, however, see a few straws in the wind that could eventually lead to the abandonment of the ACO experiment. A small but growing number of health policy researchers are beginning to acknowledge that excessive prices, not overuse of medical services, is the primary reason US health care costs are double those of the rest of the industrialized world. If price is the primary problem, not excessive volume, ACOs are not the solution. Negotiating a uniform set of fees and prices, as Medicare does for its FFS program, is the solution. The ACO, like the HMO before it, was supposed to lower costs by lowering the volume of services, particularly hospital services, not their prices.
Let us all do our part to encourage a shift in focus from volume to price. To the extent that we do attempt to reduce volume, we should employ specific services for specific categories of the chronically ill, not structures like ACOs and managed care plans that attempt to apply their crude quantity-cutting tactics to entire populations.
 Minnesota’s legislature copied directly from the Affordable Care Act. For reasons about which I can only speculate, Minnesota’s Legislature renamed ACOs “Integrated Health Partnerships” (IHPs). My speculation is this: Then-governor Tim Pawlenty didn’t want it known he was a fan of anything endorsed by the ACA (see this article on Pawlenty’s surreptitious endorsement of ACOs), and to conceal what he was doing he ordered his colleagues in the legislature to use the IHP label. Just a guess.
The Minnesota legislature lifted ACO language almost word for word from the ACA. You can see the plagiarism in side-by-side comparisons of the language in the ACA and Minnesota law that defines who can start ACOs. The ACO language appears in Section 3022 of the ACA; the IHP language appears in Minnesota Statutes Section 256B.0755.
[T]he following groups of providers of services and suppliers which have established a mechanism for shared governance are eligible to participate as ACOs under the program under this section:
(A) ACO professionals in group practice arrangements. (B) Networks of individual practices of ACO professionals. (C) Partnerships or joint venture arrangements between hospitals and ACO professionals. (D) Hospitals employing ACO professionals. (E) Such other groups of providers of services and suppliers as the Secretary determines appropriate.
(d) An integrated health partnership may be formed by the following groups of providers of services and suppliers if they have established a mechanism for shared governance:
(1) professionals in group practice arrangements;
(2) networks of individual practices of professionals;
(3) partnerships or joint venture arrangements between hospitals and health care professionals;
(4) hospitals employing professionals; and
(5) other groups of providers of services and suppliers as the commissioner determines appropriate.
 The 2010 Minnesota legislation authorizing DHS to create ACOs within Medicaid also authorized creating them within MinnesotaCare, a program for low-income people who make too much money to qualify for Medicaid. For the sake of simplicity, I refer throughout this article only to Medicaid.
 Minnesota requires insurance companies to qualify as “health maintenance organizations” if they want to participate in Medicaid. Currently four HMOs participate. They are Blue Plus (a subsidiary of Blue Cross Blue Shield), HealthPartners, Medica and UCare (an HMO started by the University of Minnesota in 1984 to protect its hospital and clinics from loss of patients to the older HMOs). Three “county-based purchasing coalitions” and one county (Itasca) also enroll Medicaid recipients in county-run plans.
 Minnesota’s DHS claims that all 21 IHPs are saving money, an achievement that stands in stark contrast to the miserable performance of the Medicare ACOs. But how would anyone know IHPs are saving money if HMOs and IHPs are working their magic at the same time on the same people? The immense overlap between the IHP “attributees” and the HMO enrollees makes it virtually impossible to answer that question. The small size of most of the IHPs (two of them have fewer than 1,000 “attributees”) constitutes an even more insurmountable obstacle to accurate measurement of the effects of those IHPs. If DHS has come up with a method of disentangling the effects of HMO magic from IHP magic, and for measuring accurately the performance of tiny IHPs, they haven’t published it. In fact, over the five years the IHP program has been in operation, DHS has never published a study of the IHP program that would allow anyone to divine what it is the IHPs are doing that the HMOs weren’t already doing and, if they are doing something different, what effect it’s having. In September 2017, RTI International published a study of several state Medicaid programs. They reported that DHS claims savings for the Minnesota IHPs, and then noted “these results have not been confirmed by an independent evaluation.” (p. 58)
 DHS proposes to subject IHPs to a combination of two-sided risk and partial capitation, while the HMOs would continue to be paid full capitation, aka premiums.
 Here is how DHS expressed its abandonment of the “primary care exclusivity” in its “Overview of community feedback….” “DHS is not proposing primary care exclusivity as a goal in itself and we are open to other mechanisms to address these historical issues and make the model functional and viable.” (p. 4)
Last week, House Representatives failed to pass “Right to Try” (RTT) legislation, a bill that purported to help terminally ill patients access experimental medications. Opponents of this legislation, including these authors, have long argued that RTT does nothing to bring potentially life-saving medications to patients who are in dire need and, potentially, puts desperate individuals at risk. With the bill’s failure, Republican leaders should rewrite the draft legislation in a collaborative fashion, taking input from the FDA, the biopharmaceutical industry, patients, patient advocates, and bioethicists who are experts in the field of pre-approval access, working to craft legislation that will actually bring help to patients in need.
The failed RTT bill was fraught with errors, poorly written, and lacked any concrete action to give access to potentially life-saving treatments for terminally ill patients outside of clinical trials. Currently, thirty-eight states, representing 83% of the population in the USA, have already signed Right to Try bills into law. These bills align with the model legislation crafted by libertarian think tank, The Goldwater Institute. Promoted as providing “immediate access to the medical treatments” for terminally ill patients, the cruel reality with Right to Try legislation is that it will not grant patients the immediate access to treatments they desperately need – and it never has. Although over 270 million Americans are currently living within the boundaries governed with Right to Try laws, there continues to be no evidence of a patient ever receiving a life-saving medication under Right to Try legislations that they otherwise wouldn’t have received under the FDA’s current Expanded Access Program. The legislation simply doesn’t work, and it never will, for numerous reasons.
First and foremost, RTT does not obligate pharmaceutical companies to make their investigational drugs available to patients. While RTT states that it gives patients the “right to ask” for this access, this is a right that they have had for over 30 years through the FDA’s Expanded Access Program. Second, Goldwater falsely claims that companies are afraid of the FDA, which is why they don’t provide drug under the FDA program. No ethical biopharmaceutical company would be more apt to provide their experimental medicine outside of clinical trials under RTT because that proposed pathway cuts the FDA out of the oversite of potential adverse events. In truth, these companies bear all of the risk for making such products available at an early stage, and have every right to be cautious about how and when they make their products available to the patients in need. Including FDA oversight in such a process is necessary and, indeed, welcomed by industry as they work to meet the needs of both current and future patients in need.
As members of NYU’s Working Group on Compassionate Use and Pre-Approval Access, we have been trying to address the true barriers patients face when trying to gain access to potentially life-saving drugs. We have been steadfast opponents of this legislation since its inception, writing journal articles, op-eds, presenting at conferences and testifying at Congressional Hearings designed to seek feedback on the proposed legislation. We have advanced solutions that would address the barriers that exist for patients and address the concerns that pharmaceutical companies grapple with when they are asked to make their investigational drugs available at an early stage.
Our group, consisting of bioethicists, patient advocates, physicians, academics, pharmaceutical CEOs and former officials at the FDA, believe the FDA’s current expanded access program works but can be improved to further enhance pathways to make potentially life-saving drugs available for dying patients. We strongly believe the FDA’s role in expanded access is to ensure treatment safety, which helps to protect both current and future patients in need. To help pharmaceutical companies feel more comfortable providing their early-stage drugs to patients, the FDA should issue clear and specific information about what – if any – consequences the company will face if there is an unexpected or severe adverse event related to their product. In addition, the FDA should develop and implement a plan to address fears and misperceptions about expanded access for all stakeholders – industry, advocacy organizations, patients, doctors, and the public.
Lawmakers have spent a lot of time and effort promoting RTT legislation publicly while admitting behind the scenes that they know the law will have little or no effect on providing dying patients with the help they deserve. We strongly believe that lawmakers could have the broad and immediate impact they seek for patients by facilitating FDA partnerships with industry, academia, and healthcare and advocacy organizations to better inform all stakeholders on the expanded access process, including relevant reporting requirements. At the same time, lawmakers should empower the FDA to work with industry to see if real world evidence from expanded access can serve to advance drug development and supplement clinical trial data.
It is important to recognize that a key reason for the decision not to make an experimental medicine available under expanded access is that they may not know enough about the compound’s safety or efficacy, and unforeseen issues could threaten their drug development timeline due to FDA or Wall Street concerns and derail their ultimate ability to make the experimental medicine available to future patients. These concerns are a very real barrier for patients getting the access they need. It’s imperative that we make expanded access more appealing to big and small pharma and biotech companies alike. For some companies, particularly small ones, who may be unable to provide experimental drugs – even if they wish to – due to expense, legislators and industry must work together to make this financially feasible.
Finally, we believe clinical trials are the safest, most common, and most valuable way for patients to get access to experimental drugs. Legislators must promote awareness of, access to, and equity in, trials to better support all stakeholders help patients get the access they need in an expeditious fashion.
The Goldwater Institute and other proponents of RTT have promoted this failed legislation as a law that “helps patients get immediate access to the medical treatments they need before it’s too late,” and have characterised Right to Try as legislation that “restores life-saving hope back to those who’ve lost it.” While this utopian vision of access to medications is laudable, it’s misleading, unrealistic and simply does not work. If lawmakers truly want to help patients find hope, they should immediately take action, collaborate with the experts in the field who deal with pre-approval access on a daily basis, and draft and pass legislation that will truly address the root causes of the barriers dying patients face while seeking access to potentially life-saving drugs. Our diverse working group stands ready to help make that happen.
Kenneth I. Moch is CEO of Cognition Therapeutics, a company developing new medicines for Alzheimer’s disease, and has been the co-founder or CEO of five companies developing therapies for life-threatening diseases.
Andrew McFadyen is executive director of the Isaac Foundation, a non-profit organization that provides support for patients and families impacted by rare and life-threatening diseases, including gaining access to pre-approved and potentially life-saving treatments.
Arthur Caplan, Ph.D. is a professor and founding head of the Division of Bioethics at New York University Langone Medical Center.
All three authors are members of the NYU Langone Health Working Group on Compassionate Use and Pre-approval Access (CUPA).
Jessica DaMassa asks me about PBMs, Amazon Prime for Medicaid, Patents and more–all in 2 minutes — Oh, and if you want to sponsor this and reach a bunch of people here & on Linkedin, let us know! — Matthew Holt
Take the example of a middle-aged woman undergoing chemotherapy for breast cancer. Month after month she receives a bill for $16,000. This purchases a monthly infusion of one chemotherapeutic agent. Much of the bill is paid by her insurance, but her personal checking account will cough up about $1000 per month until she pays down her deductible.
The invoice, however, is an illusion. The amount is not the actual number of dollars required to pay for services and materials rendered. Most of the money is diverted in accordance with contractual agreements between the hospital and various agents, brokers, and insurers. The total transfer of those dollars is known but not readily accessible to any who was not privy to the negotiations. The $1000 co-pay is a tithe with totally obscure added value to be paid no matter how painfully.
Few of us know the direct cost of any medical intervention. The term “cost” is the money needed to produce a service. For example, the cost of a single chest-x-ray is amazingly cheap, just a few dollars. The materials are inexpensive, the x-ray machine can spit out exam after exam, and one person can service a multitude of patients, making the unit cost a bargain. The cost of many a test is so low that it could be given away without wobbling a hospital’s budget.
Researchers have evaluated the true costs of some classes of medications, before marketing, distribution and middle-man charges are added. The cost to provide a pharmaceutical pale in comparison to what we pay. Parsing spread sheets in search of cost is very challenging. We do know that however the billing is construed, Americans pay far more for the same service than do residents of similarly resource-advantaged countries. Determining cost should not be so onerous that reproducible numbers are elusive. We suspect that few business leaders want us to know. The markups might astound if not infuriate us.
Markups from true cost are communicated as “charges”. Because charges are not costs, one person’s $16,000 charge may not be another’s. Charges are subject to differences in local markets, negotiating expertise; availability of insurance programs in a local area, and myriad other influences. Because charges are inaccurate proxies for true cost, charges are a misleading measure of patient care. This realization is the flaw in all the efforts and finger-pointing that surrounds debates over the costliness of healthcare in America. We misconstrue the “buck”, and, worse, do we know which “bang”, if any, we are purchasing?
Undaunted by the inaccuracies in the measures of cost of care, econometricians’ turn to cost-effectiveness analyses (CEA) as a means to make sense of the senseless. CEA explores whether expenditure for one intervention is as likely to result in a particular outcome as the same expenditure for another intervention. If not, one can calculate the cost/per added outcome. For example, if the outcome is a difference in longevity, a CEA may reveal the cost per year of a life saved. If there isn’t a difference in outcomes between two interventions, paying more for one would be folly. But if there is a difference, one cannot simply assume that the less costly intervention is the better choice.
To better understand CEA, consider this question; “What addition to standard care is costlier: a heart transplant or enteric-coated aspirin?” Students usually scoff and say, heart transplant, of course. But the answer is not so obvious. The question forces one to assume that there is no alternative to heart transplant since the standard of care has already been prescribed. Without the transplant death will ensue. The heart transplant will engender costs and charges in excess of doing nothing, but it has a potential for benefit. There will be a CEA ratio to ponder.
Enteric-coated aspirin provides no marginal benefit over regular aspirin; so even a penny more for enteric-coated aspirin would create a CEA ratio of infinity. Offering enteric-coated aspirin as an alternative to regular aspirin would not be cost-effective. Alas, such a violation is common. It occurs whenever we order tests that yield redundant information or continue treatments with long-term potential for a disease likely to be lethal in the short-term.
That’s why CEA offers little insight into the $16,000 bill this patient received, let alone the fraction that was consumed in the deductible. Any attempt at an explanation is thwarted; 1) determining the true costs of care is never easy and often not possible, 2) whether codified from Electronic Health Records or not, charges are a sorry representation of cost, and 3) using CEA to audit the healthcare system does not limit higher expense care. Furthermore, the notion of “how much is too much” exemplified by the heart transplant versus aspirin question is where CEA breaks down even further. If a CEA finds added benefit of one intervention over another, there must be a point when the marginal cost is too much for the marginal benefit.
But, what is this amount? We don’t know, and there is no consensus. In a review of 109 CEA studies, about 50% of the time, the higher expense strategy was chosen. The range of CEA ratios for those interventions were from $400 to $166,000 per added benefit. For interventions that cost between $60,000 to $166,000, calculations of added value lead to highly variable results, biased toward CEAs sponsored by industry. Without a defined “threshold” of how much is too much for a given added benefit, CEA becomes merely a smokescreen, which obscures debates on what matters most to patients and the practitioners treating them: the magnitude of benefit and the risk for harm.
We are purposely being diverted from what we should be doing in healthcare by debating dollars. The margin of benefit and harm of compared options for care should dominate discussions. In addition, who decides the value of a benefit and harm should be the patient, not the healthcare system. In our view, the more we explain benefits, the more people will tell us what the interventions should cost.
Struggling to break free from Obamacare oppression, Idaho is offering low-cost health plans that achieve this goal by avoiding covering anyone who’s been sick in the past and skimping on coverage for any diseases that might make you sick in the future. These strategies are, inconveniently, explicitly banned by the Affordable Care Act.
Fortunately, I have a solution perfect for Idaho and other GOPers eager to emulate Idaho’s example. My plan covers young and old, sick and healthy, fitness buff and couch potato, all for the same incredibly low price. No one, and no illness, is excluded.
Welcome to the Placebo HMO, dedicated to serving every American who fervently believes you don’t need real health insurance.
We’re a faith-based plan that offers empathetic, sincere and personalized advice from a broad range of highly skilled actors pretending to be doctors. Whether it’s a “seen everything” veteran like Tom Hanks or Meryl Streep in The Post or a bright-eyed idealist like Emma Stone and Ryan Gosling in La La Land, we provide unparalleled freedom of provider choice that plans dependent on actual doctors cannot match.
At Placebo HMO, we’re committed to consumerism. Your beliefs, whatever they may be, always come first, since we want you to have a doctor you can trust. So, for instance, you might choose our popular “Dr. Cooper” model, available not only in male and female versions (“Bob” or “Betty” Cooper) and a variety of ages, but also in a choice of religions (Protestant, Catholic or Mormon) and races (black or white). We also offer “Dr. Garcia,” “Dr. Gu,” “Dr. Gandhi” or “Dr. Greenberg.” Not all selections are available in all states; e.g., our Idaho plan, for example, does not include “Dr. Mohammed.”
You choose who to see (or avoid). Whatever your choice, you need never worry that your faith will be shaken by an upsetting political opinion. Each of our “doctors” has been specially trained to enthusiastically agree with whatever President Trump may have said that day.
The way our plan works is simple. If you feel ill, you don’t have to take off work or find a sitter for the kids while you trundle down to a crowded waiting room filled with God-knows-what contagious disease. Instead, just dial our toll-free number or FaceTime or Skype us, and you can talk directly to your “family doctor.” If you believe you need a “specialist,” no problem! Unlike real HMOs, we don’t require a burdensome referral.
Our “doctors” are not distracted by computerized medical records or calls from the hospital, so they can focus only on you — your symptoms, your concerns, your medical history, your life. For patients who believe their doctor should be a true partner, we offer shared decision-making: working together, our “doctor” and you can Google your symptoms.
Most of all, our doctors truly listen — unlike actual doctors, they won’t be interrupting you after 18 seconds to tell you what to do — and they truly care. To demonstrate their concern our “doctors” will gladly write you a prescription for a placebo drug. It will either be a brand name (which we’ll tell you ordinarily costs $150 a pill because of its powerful ingredients) or generic (which we’ll tell you ordinarily costs $1.50 a pill, but works just as well).
There are no co-pays, no deductibles and no paperwork. Best of all, our plan costs just two dollars a day — exactly the price of a daily Powerball lottery ticket. You gotta believe!
Can a placebo really help you? Of course it can. It’s been shown, for instance, that placebos can offer powerful pain relief — putting the Placebo HMO on the leading edge of solving our nation’s opioid crisis. No less an authority than the Harvard Health Letter concluded that “the placebo effect may be an integral part of good medical care,” which suggests that the Placebo HMO might have been named the Harvard HMO! (Just kidding, Harvard.)
In sum, the Placebo HMO provides everything that Obamacare opponents have been agitating for: Freedom of choice. Patient-centered consumerism. Respect for local preferences. Affordability rooted in the power of faith.
And, if you get really sick, we give you directions to the nearest hospital emergency room.
Huge news hit today as Theranos, its Chairman and CEO Elizabeth Holmes and its former President and COO Ramesh “Sunny” Balwani were charged with “elaborate, years-long fraud” by the Securities and Exchange Commission. The litany of supposed violations of the Securities Act of 1933 and the Securities Exchange Act of 1934 are almost as dizzying as the detailed factual allegations of repeated, willful fraud perpetuated by Holmes and Balwani on investors who likely should have known better.
Reviewing the SEC complaint against Holmes, it’s stunning to see the extent to which Holmes and Balwani were able to pull the wool over investors’ eyes. The highlights of the SEC allegations include:
In 2010, even knowing that Theranos’ miniLab product was not commercially ready, Holmes and Balwani pursued partnerships bringing the product to “Patient Service Centers” at a major pharmacy chain (Walgreens) and a national grocery chain (Safeway).
Holmes directly told pharmacy executives that Theranos could conducts hundreds blood tests through a fingerstick in under an hour for a much lower cost than other competing project even though the technology had not been finalized.
Holmes also told Walgreens that its analyzer was already deployed on military helicopters when no such relationship existed.
In 2013, just prior to Theranos’ launch at Walgreens, Theranos realized its miniLab product would not be ready so it substituted an earlier production – one that could only be used to perform immunochemistries, for patient testing. They never told their partners about this issue, in fact denying any such issues, and instead used modified third-party technology.
Even though Theranos failed to use its own technology, it presented itself to the media and investors as having achieved a technological breakthrough using its own proprietary technology.
In late 2013, Theranos was struggling with only $30 million in cash and short-term securities – which it promised to burn through in a few months.
In 2014, Holmes convinced the board to create a new, separate class of shares (“Class B Shares”) which had super-voting power and could only be given to Holmes. Thus, after a stock split and fundraising round, Holmes owned only just over half of the company’s shares but retained over 99 percent of its voting power.
Between 2013 and 2015, Holmes, Balwani and Theranos raised over $700 million from two rounds of financing with investors relying on the false and misleading statements by Holmes, Balwani and Theranos.
While courting investors, Holmes not only made false or misleading statements about Theranos’ technology and its usage of it but also about:
Historical contracts with the U.S. Department of Defense to convince investors of their supposed track record of success.
The relationship between Theranos and Walgreens and Safeway, which were presented as thriving when they were actually stalled.
Whether or not Theranos required FDA approval of its technology.
Theranos’ existing and projected revenues.
The breadth and scope of these lies is stunning. And such fraud would likely bring cries for criminal sanction in other fields, in the Valley, the overwhelming attitude to potential Department of Justice (DOJ) criminal charges accompanying SEC sanctions appears to be one of “who cares”.
In 2016, Thomas Lee, then of the San Francisco Chronicle actually accused federal prosecutors at the DOJ for “grandstanding” when they announced their criminal probe of Theranos’ practices, independent of the SEC.
His argument? That “[f]ederal prosecutors rarely investigate securities fraud at privately held startups, if ever” due to the high bar for putting someone behind bars and that the “supposed victims” should have known better. He distinguished between ordinary people and sophisticated venture capital firms that should have known better.
Some of what Lee says is true. White collar criminals rarely face criminal investigations and charges for defrauding corporate investors. Sympathy is hard to come by for VCs who fail to do the due diligence to see through an amateurish con pulled by a neophyte founder and a President and COO shrouded in mystery. And the DOJ does have limited resources in tackling such a complex and unusual case.
But crucially, Lee is wrong on who is hurt by Theranos’ actions and downfall. Not only were actual consumers defrauded by Theranos’ dubious tests but there is also likely to be downstream costs downloaded onto consumers by Walgreens and Safeway for their failed foray with Theranos.
And that’s the problem.
With healthcare costs running amuck, investments in shiny technology offered by charlatans represent a rapidly cumulating waste of resources and time and less money for other, worthier initiatives. Instead of focusing on how Theranos’ treatment deviates from the U.S. government’s traditional complacency on fraud, perhaps its time to recognize a special responsibility among those companies purporting to operate in the healthcare technology sector should act with a higher ethical standard.
Make no mistake. While Theranos was particularly brazen in its approach to massive fraud, the truth is that the current lax environment in terms of criminal sanctions may have allowed another Theranos to fester. Fraud costs society and when fraud affects funds earmarked for innovation in healthcare, it specifically hurts the sector. So maybe it’s time to throw the book at Theranos and those trading in fraudulent science – and make sure it hurts.
Jason Chung is the Law & Technology Editor at The Health Care Blog. He also writes on the intersection of health, technology and sports as the senior researcher and attorney at NYU Sports and Society, a think tank dedicated to the study of sports and social issues.
Elizabeth Holmes, the founder and chief executive of the controversial company Theranos, has been charged with an “elaborate, years-long fraud” by the Securities and Exchange Commission. The SEC alleges that Holmes and former company president Ramesh “Sunny” Balwani deceived investors into believing that its key product — a portable blood analyzer —was capable of using drops of blood to do the kinds of workups that now require much more blood—up to ten milliters per test. Holmes fooled many people including the Theranos board of board of directors, high-powered investors and high ranking members of the military including General James Mattis, a huge fan, who left the Theranos board to become President Trump’s Secretary of Defense.
Things don’t look good for the Theranos leadership in terms of the SEC charges. The company already saw a three-year partnership with Walgreen’s collapse leaving many customers wondering if they had been deceived. The technology, which Holmes and her company touted as disruptive and revolutionary, never worked. So what happened to permit so much enthusiasm and money to be spent on a useless technology?
First, the company never published on its technology. The promise of small volume blood testing sounded great and indeed is great for many reasons not the least of which a lot less misery for patients who need to get a lot of painful blood drawn for tests. But no publication, no data driven presentations at professional society meetings, a lack of transparency turned Theranos into an 8 billion dollar Dutch tulip bubble.
Blathering on about disruption may sell well in Silicon Valley software start-ups and with the titans of change at angel investment firms but it does not fly in health care. Coming up with an app to order food delivery is not the same as proving you have a reliable tool for accurately testing blood or for that matter genes, brains or excretion. Medical devices need to work with amazing reliability and there are government regulatory hurdles appropriately in place to insure they do. A clever PowerPoint and a lot of buzzwords is not what innovation needs to be in health care.
Too much of a good thing is bad. Too much of a good thing that rests on hype, hand-waving and wishful thinking combined with greed is worthless. Let Theranos be a warning—pure disruption is not the best way to go in health care.
Your address to HIMSS acknowledges many of the problems with Healthcare IT, highlighting lack of interoperability, lack of data exchange, and lack of cybersecurity, and suggesting some regulations that could be eliminated. This is a welcome realization of some of EHR’s more obvious limitations and problems. However, most of your recommendations for improvement of health IT are insufficient, unproven, or have been repeatedly shown to fail.
We applaud your acknowledgement of: 1. The frustration (and often rage) of many clinicians when using the current EHRs’ clunky and inefficient user interfaces; 2. Patients’ frustration and alienation when doctors spend much time entering data into the EHRs rather than listening to them; 3. The need for better cybersecurity; 4. Benefits of increased patient access to their data; and 5.Healthcare systems’ refusal to share patient data with others clinicians (data hoarding).
We are also delighted for your strong support for the Sync for Science program.
However, your solutions to these problems are faulty or have already failed—and thus we are obliged to explain why and how they fail:
Belief in the magic of value-based care as a cure for excessive spending
Claim that “open APIs” (defined in next sentence) will solve the problems of lack of interoperability. Here, APIs refer to software programs that try to translate different forms and formats of information into a single commonly understood item.
Belief that a patient’s personal data store or personal EHR, called “MyHealthEData,” will help solve the problems of patient care.
Confusing patients with customers. We train doctors to make diagnoses, order and interpret tests, and help patients make profoundly complex decisions. Healthcare decisions are not like buying a toaster.
Attributing so many of the problems of EHRs to the regulations created in 2009, the “Meaningful Use” rules. ting so many of the problems of EHRs to the regulations created in 2009, the “Meaningful Use” rules. In fact, meta-analyses of EHRs—both before the Meaningful Use rules, and after–fail to find they reduce costs, mortality, or morbidity.
We briefly consider each in turn.
Value-based care: Value based care makes total sense in theory—that we should only pay for outcomes and needed care. Unfortunately, the best studies show these bonuses and penalties to physicians don’t work. Often these are seen as insulting incentives for work they already do. Repeated studies also show that Accountable Care Organizations and many of the pay-for-performance plans are likewise unsuccessful. Tiny savings are overshadowed by huge delivery system implementation costs. Perhaps worse, they harm patients by avoiding care for the sick who drag down clinicians’ performance and “health measures.”
Part of the problem is that it is not possible to adequately adjust quality measures for doctors who care for more poor and sick patients. Other factors matter to health, like language, rurality, frailty, abuse, and hospital resources, to name a few. How many of these factors are in insurance company or CMS claims databases? “Risk adjustment” is a phony promise.
APIs as solution for lack of interoperability: These APIs—in this case, software programs that attempt to translate different forms and formats of information into a single term–can be useful. But they can’t overcome the lack of data standards allowed by the ONC in the past years. EHRs have the same “measure” defined in 40 different ways. For example, one EHR records blood pressure as 120/80, another as “labile” or “under control” or “stable” or “left foot” or “seated, post injection.” Faith in EHRs was so all encompassing that the federal government refused to require data standards. Without data standards, APIs often become failed workarounds that can’t possibly overcome the differences in the way the data are recorded. Often those differing measures appear in the same EHR. 
Belief in “MyHealthEData” to provide personal efficacy, address lack of interoperability, and improved transparency: Providing more information from EHRs to patients and their caregivers is a reasonable concept but won’t work as a solution to healthcare’s ills or as a national policy. Those of us who have been working on this for several decades are aware of the problems you may not have considered:
1. A patient’s several EHR “portals” contain massive amounts of contradictory and confusing information. Do you think the average patient will understand an increase in BUN (Blood Urea Nitrogen) from 9.2 to 9.8 mg/dL? Moreover many test results only make sense in relation to other test results and/or over a timeline. Can patients do that?
2. The operating instructions will be incomprehensible to many patients, especially poor and sick ones.
3. They will drop their cell phones with their MyHealthEData” and lose all the information.
4. They will have acute medical events, such as a stroke, and will be unconscious, failing to bring the device in the ambulance.
4. Substituting patients for hospitals as the responsible parties for patient safety multiplies the potential problems a thousand fold.
5. Even now, most medication lists include drugs that are dangerous or lethal in combination, or have not been used for years, or are duplicative and lead to double or triple dosages.
3) There is no such thing as an innocuous medical test result, e.g., a test result saying one does not have STDs may be both comforting and disconcerting to a patient’s family.
Last, you must be aware that MyHealthEData will be disastrous for the people who need it most: the sick, the disabled, the elderly, the poorly educated, those with less informed caregivers. Those of us who work with such systems call them ideal for the “worried well,” and generally useless for the rest of the population. We can only shift some of the responsibility for patient safety on patients.
Confusion of Patients as Customers: Under ideal conditions, customers can make considered judgements about the purchase of products and services. This is seldom the case in healthcare. If one had a heart attack while carrying a Wi-Fi enabled laptop, one could direct the ambulance to the best facility based on sophisticated statistical analysis. Of course, that’s absurd. What would actually happen is the patient would be struggling to stay alive and would go where the ambulance took her. More generally, patients go where their insurance companies send them, where their doctors have connections, and where their family members can visit. Even more important, while many people can evaluate the benefits of, say toaster “A” vs. toaster “B,” few can understand the relative or absolute value of differing medical treatments or medications. We notice that in your deeply poignant story of your husband’s illness, you did not pick the medical center that saved him–which happened to be where one of the authors of this document (RK) coincidently works.
Attributing so many of the problems of EHRs to the regulations enacted in 2009, the “meaningful use” regulations:You are right that some of the meaningful use regulation are annoying. As you say, doctors complain, and research confirms, EHRs increase the work and time needed for patient care and seldom increases safety or reduces costs. But the dysfunctions of “meaningful use” regulations pale in comparison to the pains inflected by the documentation requirements of insurance companies and CMS. Worse, private insurance companies are incentivized to deny payment, and thus encourage the worst abuses of copy and paste plus meaningless but legible gobbledygook in the EHR. Another source of clinician frustration–the lack of EHR usability–is probably a worse and separate problem. Here, again, the government refused to institute minimum standards, resulting in bizarre differences among EHRs and confusing displays of patient information. These lack of regulations and uniformity are a major patient safety danger. When we get into a new car we assume the brake is on the left and the gas is on the right. Such uniformity does not exist with EHRs.
You mention that the federal government initially spent $30 billion to support EHRs. That’s a pittance compared to what hospitals, clinics, physician practices and nursing homes are obliged to spend: a sum that far exceeds two trillion dollars.Moreover, the VA and the DoD are about to spend an additional $14 billion on EHRs.
Ms. Verma, with the complexities of healthcare and healthcare IT, one is reminded of Mencken’s line: “for every complex problem there is an answer that is clear, simple, and wrong.” Yes, there are solutions, but they are neither buzzwords, nor simple, nor apps, nor the removal of a few regulations. They require an honest appraisal of our technologies, our policies, and our resources. If CMS is willing to undertake such a journey, there are researchers who would join you. 2
We agree wholeheartedly with you that almost 20% of the GDP for medical care is too much to pay when so many other industrialized countries are getting much more health for half the cost. But, too many of your proposed “solutions” have repeatedly failed tests in situ. Blaming EHR problems on regulations is ironic because so many of their failings result from the government’s refusal to accept regulations that would have established common data terms and acceptable user interfaces. Faith in APIs is premature and not supported by evidence. Value-based care sounds great, but objective scholarship finds consistent failure in real-world settings, even patient harm because unhealthy patients are avoided. Belief that patients are customers is only occasionally true; most of the time it’s a fake metaphor used to fool regulators and those with only primitive economic understanding.
Healthcare policy is littered with buzzwords and blind faith that should have been subjected to rigorous testing before spending billions or trillions. Blind hope in technology or in naïve economic theory is unworthy of Americans’ health and pocketbooks. There are scientific methods to evaluate and guide healthcare policy. Given the vast sums and the lives at risk, we commit to careful analysis before we waste trillions of more dollars and endanger the health of millions.
1. Smith SW, Koppel R. J Am Med Inform Assoc doi:10.1136/amiajnl-2012-001419
2. Ross Koppel, “Great Promises of Healthcare Information Technology Deliver Less,” chapter in C.A. Weaver et al. (eds.), Healthcare Information Management Systems: Cases, Strategies, and Solutions, Springer International Publishing, Switzerland 2016
Ross Koppel, PhD, FACMI (University of Pennsylvania) and Stephen Soumerai ScD (Harvard)
Ross Koppel PhD, FACMI is at the University of Pennsylvania where he is a Senior Fellow at Wharton’s Leonard Davis Institute of Healthcare Economics, at Penn’s Center for Public Health Initiatives and at Penn’s Dept. of Biostatistics, Epidemiology and Informatics. He is also adjunct Professor of Sociology at Penn. email@example.com
Stephen Soumerai, ScD is Professor of Population Medicine at Harvard Medical School and Founding and Former Director of the Division of Health Policy and Insurance Research firstname.lastname@example.org
As rare disease patient advocates, we work with terminally ill patients on a daily basis. A new version of the ‘Right to Try’ bill, which purports to help terminally ill patients access experimental medication, is set to be voted on in the House on Tuesday. While we understand the appeal of Right to Try, we also know it will do more harm than good. It is our duty to patients in need to urge Congress to reject Right to Try.
Thirty-eight states, representing 83% of the population in the USA, have signed Right to Try bills into law. These bills align with the model legislation crafted by libertarian think tank, The Goldwater Institute. Promoted as providing “immediate access to the medical treatments” for terminally ill patients outside of clinical trials, the cruel reality with Right to Try legislation is that it will not grant patients the immediate access to treatments they desperately need – and it never has.
Looking past the myths that Right to Try proponents state ad nauseam, and looking past this legislation’s potential to create an unequal access to medication, the simple fact is: although over 270million Americans are currently living within the boundaries governed with Right to Try laws – providing them with, as Goldwater claims, “immediate access to medical treatments they need” – there continues to be no concrete evidence of a patient ever receiving a life-saving medication under Right to Try legislations that they otherwise wouldn’t have received under the current Expanded Access Program.
Tomorrow’s vote on a newly crafted Right to Try bill from House Energy and Commerce Committee Chairman Greg Walden (R-Ore.) is more limited than Senator Ron Johnson’s earlier iterations, yet remains little more than a feel-good bill that will do nothing to change the landscape with respect to access to life-saving medications for patients in dire need. In essence, the landscape for access to medications for dying patients does not change tomorrow if a Federal Right to Try law is passed. Very clearly, those patients in dire need of help today will wake up tomorrow needing access to the same life-saving treatments, and feel the same despair when they are not given the access they need through Right to Try.
Why? For starters, nothing in the legislation obliges pharmaceutical companies to provide their experimental products to dying patients. Sure, patients have the right to ask for drugs – but they’ve always had that right under the FDA Expanded Access Program. Without this obligation, drug developers will have the same hesitation to provide their investigational agents under RTT than they do under the current FDA program, thereby leaving patients in the same position they were before the passage of RTT laws as they will be after – desperate and fighting for access.
Another flaw in this legislation is the assumption that drug developers don’t provide their products at an early stage due to their fear of reporting adverse events to the FDA, and the belief that such reports could have a negative impact on the future approval of their drug. In reality, all ethical pharmaceutical companies that we know want FDA oversight of their program as they seek to create safe and efficacious products in the fastest way possible. These companies bear all of the risk for making such products available at an early stage, and have every right to be cautious about how and when they make their products available to the patients in need. Including FDA oversight in such a process is necessary and, indeed, welcomed by industry as they work to meet the needs of both current and future patients in need.
We are not alone in this view, which is echoed by rare disease advocates around the nation, including the National Organization for Rare Diseases (NORD), who agree: “these bills would likely do more harm than good” and that “removing FDA from this process is not likely to facilitate increased access to investigational therapies.” The Association of Clinical Research Organizations (ACRO), meanwhile, released a policy statement opposing Right to Try as “deeply flawed,” while The American Society of Clinical Oncology (ASCO), which supports many terminally ill patients, likewise denounces Right to Try as “ineffective and potentially harmful to patients.”
So, if RTT isn’t the answer for our patients, what is? In short – broader collaboration between drug developers, the FDA, patient advocates, and patients to enhance the FDA’s Expanded Access Program would be the most effective way to bring more immediate access to life-saving drugs for patients in need. Protecting our clinical trials process while using “real world evidence” through an enhanced Expanded Access pathway is possible, and will certainly help remove the barriers that patients face as they seek access to the drugs they need.
Lawmakers should be spending their time helping make that collaboration happen because that is how we are going to save our dying patients. Patient advocates, ethicists, and industry agree: there are ways to structure successful Right to Try laws. We all, lawmakers included, must focus on those and not spin our wheels promoting or passing legislation like Right to Try that looks good, and feels good, but will do nothing for those in need. If we do, we are doing a disservice to a large and very vulnerable group of patients now and in the future, and the hope and help these patients have been waiting for will never arrive.
There is one way the Trump HHS and VA can thread the needle between provider economic self-interest and burdensome regulation and it’s based on Federal health IT policy.
This past week has seen a number of high-profile announcements from the Trump HHS including Secretary Azar and CMS Administrator Verma about patient empowerment and enhanced transparency as a strategy to breathe life into healthcare reform. Meanwhile, VA Secretary Shulkin is under immense pressure to make their privatized Cerner EHR interoperable.
It’s pretty clear that the Trump HHS wants to do something about the frustrating and ineffective health IT policies that led to the 21st Century Cures Act information blocking provisions and that they’re hoping to leverage the $1 Trillion of federal spending in healthcare as an alternative to heavy-handed regulation. This is all good but what can they actually do?
Most of Secretary Azar’s talk is about disruption:
“In fact, it will require some degree of federal intervention — perhaps even an uncomfortable degree. That may sound surprising coming from an administration that deeply believes in the power of markets and competition. But the status quo is far from a competitive free market in the economic sense of the term, and healthcare is such a complex system, that facilitating a competitive, value-based marketplace is going to be disruptive to existing actors.”
And most of Administrator Verma’s talk is about patient control as essential to disruption:
“To this end, the administration is launching the MyHealthEData Initiative. MyHealthEData is a government-wide initiative that will break down the barriers that contribute to preventing patients from being able to access and control their medical records.”
Patient control can, and should, be mandated through regulation such as TEFCA but it might work even better if CMS and VA used their purchasing power in the market for health services and health IT. Medicare and Medicaid can set an example for how patients can direct access to their specific benefits to patient-centered service providers that will provide decision support and other services. The VA can set an example in how their new Cerner EHR implements patient-directed exchange as the foundation of interoperability with Department of Defense as well as private-sector providers of services to our veterans. The Federal health system does not need regulation, just discipline.
But there’s also one piece of regulatory temptation that HHS and our federal health system must avoid and it’s evident in this confusing quote from Administrator Verma’s speech:
“In addition, to help beneficiaries make good decisions about whom they share their data with; CMS will require that App Developers go through an approval process based on industry best practices before they are granted access to beneficiary data.”
An “app approval process” is regulation by a different name and must be shunned by the Trump HHS. Who would decide to approve an app or not? Why should electronic access to patient data be subject to censorship when paper-based access through the typical “Release of Information” form allowed patients to send data directly from the hospital to *anywhere*?
HHS and the VA must not be allowed to censor a patient’s decision to share our own medical data. The bureaucracy required to approve the patient’s choice does not exist today and does not need to be created tomorrow. This one issue was central to the 2016 API Task Force Recommendations and the discussions around this isssue dominated the debate prior to acceptance by the predecessor of today’s HHS technology advisory group (HITAC).
Patient control over the FHIR interfaces being implemented by Medicare Blue Button 2.0 and VA’s Cerner EHR must truly be under patient control if we’re to avoid burdensome regulation. It might be as simple as that.
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