Comments on ONC and CMS Proposed Rules on Interoperability and Information Sharing

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Comments on CMS Interoperability and Patient Access Proposed Rule & 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program and Medicare and Medicaid Programs;

Dear Secretary Azar,

We appreciate the opportunity to comment on the recent Center for Medicare and Medicaid Services (RIN 0938-AT79/CMS-9115-P) and Office of National Coordinator (RIN 0955-AA01) proposals pertaining to increased federal involvement in the Health Information Technology being improperly pushed on patients and the medical professionals who care for them.

The Association of American Physicians & Surgeons (“AAPS”) is a national non-profit membership organization of physicians and surgeons who are mostly in small, independent practices. Founded in 1943, AAPS defends and promotes the practice of private, ethical medicine.  Our legal filings have been cited favorably by the U.S. Supreme Court and appellate state and federal courts, and by HHS when it promulgated the landmark Privacy Rule. 65 FR 82462, 82468 (Dec. 28, 2000).

There is no other way to put it; federally-run efforts to “support the adoption of health information technology and the promotion of nationwide health information exchange” have failed. Instead of moving forward with additional regulations that may serve to exacerbate instead of ameliorate the failures, it is time to end this experiment. While harming patients, it has cost taxpayers at least $35 billion, and is further diverting $13 billion per year into the pockets of those creating and selling flawed HIT.

AAPS has been a longstanding critic of EHRs designed for the benefit of bean counters and bureaucrats instead of for patients. Unfortunately, the facts overwhelmingly bear out the validity of our concern.

AAPS is far from the only one sounding the alarm.  For instance, in March of 2019 Fortune published a lengthy exposé of “a digital revolution gone wrong.”  “The system is an unholy mess,” write Erika Fry and Fred Schulte in their shocking look at how “instead of streamlining medicine, the government’s EHR initiative has created a host of largely unacknowledged patient safety risks.” Their investigation “found that alarming reports of patient deaths, serious injuries, and near misses—thousands of them—tied to software glitches, user errors, or other flaws have piled up, largely unseen, in various government-funded and private repositories.”

Moreover, patient privacy and the autonomy of medical decisions are at risk. As Twila Brase of the Citizens’ Council for Health Freedom, and award-winning author of Big Brother in the Exam Room,  puts it: “Every American needs to know to protect themselves: the EHR is a government-mandated exam room surveillance system and command and control system over medical decisions.”

Continuing this harmful experiment on patients, while moving forward with requirements that further open EHRs to an internet rife with entities seeking to examine, steal or otherwise misuse medical records, would be unethical and violates the principles of medical care guided by the Oath of Hippocrates. Therefore AAPS calls for the following:

  1. an immediate suspension of all federal penalties levied on medical professionals who refuse to risk patient care and privacy to dangerous ONC-certified Health Information Technology, as well as a suspension of payments to incentivize further adoption or ongoing implementation;
  2. a moratorium on federal rulemaking that further promotes the subjugation of patient care and privacy to ONC-certified EHR systems;
  3. granting patients full control over use of their individual medical records. This means a patient’s medical records or Electronic Health Information must not be shared electronically (or otherwise) without the patient’s knowledge and consent, except in very limited circumstances (e.g. in situations requiring emergency treatment). And patients should have control over whether their data is entered into electronic records systems that are susceptible to access by bad actors or anyone with whom the patient would not want to share private information.

Although we are calling for these emergency measures to protect patients, we emphasize that AAPS is not anti-technology. There are numerous examples of HIT solutions developed in the free market, which are being adopted without coercion or subsidy, proving to be in alignment with high-quality patient care and patient privacy. Atlas.MD, an EHR designed by and for Direct Primary Care physicians, is just one example.

Our requests outlined above reflect our position that continued implementation of federally subsidized and micromanaged HIT needs to end. Although we are calling for a moratorium on new federal rule making, we will make a few comments targeted to specific proposals in the pending rule:

1) Regarding the Section titled “Information Blocking and Patient Privacy Rights”:

The ONC proposed rule states, “actors should not be compelled to share EHI against patients’ wishes or without adequate safeguards.” And the rule proposes a related regulation:

§ 171.202(e) Respecting an individual’s request not to share information. In circumstances where not required or prohibited by law, an actor may choose not to provide access, exchange, or use of an individual’s electronic health information…

The improperly permissive language of HIPAA regulations that allow sharing of patient data without consent, is mirrored in the language of §171.202(e). This wording erects a facade of patient privacy protection, without actually granting meaningful control to the patient. In essence, under this provision, the patient may make a request for privacy, but approval of the request is, in the majority of circumstances, not within the control of the patient. 

The view that the sharing of patient data is largely not subject to the consent of the patient is pervasive throughout federal HIPAA regulations, and this flawed view is bleeding into related federal regulations, like the current ones under consideration.

2) Physician Compare Profiles and Information Blocking Attestations.

The CMS rule proposes that “Physician Compare” data made available on “public facing profile pages,” include physician answers to “prevention of information blocking attestation statements.” It appears to be the intent of CMS that physicians attesting that they are not participating in “prevention of information blocking” are lower quality physicians than physician who attest that they are participating in “prevention of information blocking.” These attestations also are proposed to play a role in whether a physician is deemed to be in compliance with MACRA’s “Promoting Interoperability” scoring category and thus eligible for incentives (or subject to penalties for not complying). To the contrary, it may be that physicians who refuse to comply are more aligned with the interests of patients than those who do.

3) The Inclusion of Price Information in Electronic Health Information.

In its proposed rule ONC states that the definition of Electronic Health Information “provides for an expansive set of EHI, which could include information on an individual’s health insurance eligibility and benefits, billing for health care services, and payment information for services to be provided or already provided, which may include price information.”

Further, the rule states that “ONC has a unique role in setting the stage for such future actions by establishing the framework to prevent the blocking of price information.”

AAPS supports price transparency in no uncertain terms. But, in our view, to suggest that federal regulation, in tandem with ONC-certified EHRs, will create transparency is a flawed premise and risks further delays in creating an environment that welcomes and demands meaningful transparency.

HHS should be asking a different question: “Why is transparency largely missing in American medicine?” It isn’t because of a lack of federal regulation, but due to decade upon decade of overregulation that impedes the functioning of a healthy marketplace where transparency would be demanded.  More regulation built on top of a failed $35 billion experiment would be an unwise path if transparency, lower prices, and higher quality are goals.

So while AAPS seeks and supports transparency, we are skeptical of solutions that do not address the root causes of the opaqueness and leery of attempts to manufacture transparency by fiat.

HHS should consider harmful consequences of relying on an EHR to provide “price information” to patients.  One that comes to mind is the possibility that insurers or health systems could leverage pricing information displayed through an EHR to further trap patients in network instead of meaningfully providing price information for all options. For instance, even if there are out-of-network options that might be less expensive or better suited to the patients’ needs, EHR-driven pricing “transparency” seems susceptible to being rigged in ways that make in-network options or in-network pricing appear to be superior, even if in reality they are not.

One need look no further than how Pharmacy Benefits Managers game drug pricing to maximize their revenue, at the expense of patients. Similarly, in-network prices for imaging or diagnostics are increasingly found to be higher than cash prices offered to uninsured patients. So if EHRs were designed to display only a patient’s insurer-contracted pricing, this would be transparency in name only.

Conversely, in markets  where physicians and facilities are operating outside of the constraints of third-party control, transparency is flourishing and patients are finding that high quality care is available at costs much lower than pricing available through their health plan. For example, the cash-based Surgery Center of Oklahoma, the ambulatory surgery centers following its lead, and the nearly one thousand Direct Primary Care practices serving patients across the United States are leading the patient-centered drive toward price transparency and true value-based care, where value is defined by patients, not committees of bureaucrats. One lesson of this is that when patients are put in the driver’s seat, they demand transparency, and physicians and facilities respond, or miss out on the opportunity to serve these patients.

In conclusion, it is past time to put patients’ interest first. Doing so means putting the brakes on further implementation of federally driven Health Information Technology that is degrading patient safety and privacy. Simple, innovative, HIT and transparency solutions are thriving in the growing private marketplaces dedicated to direct patient care. Wider implementation of such solutions would occur at a faster rate but for the crowding out of resources and patients by the behemoth of unwieldy, costly, and dangerous systems being pushed from DC. Return control to patients and medical professionals by unleashing American ingenuity. Innovation is fueled by freedom and extinguished by overregulation.

Sincerely,

Jane M. Orient, M.D.

Executive Director