Robust exchange of health information is absolutely critical to improving health care quality and lowering costs. In the last few months, government leaders at the US Department of Health and Human Services (HHS) have advanced ambitious policies to make interoperability a reality. Overall, this is a great thing. However, there are places where DC regulators need help from the frontlines to understand what will really work.
As California’s largest nonprofit health data network, Manifest MedEx has submitted comments and met with policymakers several times over the last few months to discuss these policies. We’ve weighed in with Administrator Seema Verma and National Coordinator Dr. Don Rucker. We’ve shared the progress and concerns of our network of over 400 California health organizations including hospitals, health plans, nurses, physicians and public health teams.
With the comment periods now closed, here’s a high-level look at what lies ahead:
CMS is leading on interoperability (good). Big new proposals from the Centers for Medicare and Medicaid Services (CMS) will set tough parameters for sharing health information. With a good prognosis to roll out in final form around HIMSS 2020, we’re excited to see requirements that health plans give patients access to their claims records via a standard set of APIs, so patients can connect their data to apps of their choosing. In addition, hospitals will be required to send admit, discharge, transfer (ADT) notifications on patients to community providers, a massive move to make transitions from hospital to home safe and seamless for patients across the country. Studies show that readmissions to the hospital are reduced as much as 20% when patients are seen by a doctor within the first week after a hospitalization. Often the blocker is not knowing a patient was discharged. CMS is putting some serious muscle behind getting information moving and is using their leverage as a payer to create new economic reasons to share. We love it.
notion that hospitals can reduce readmissions, and that punishing them for
“excess” readmissions will get them to do that, became conventional wisdom
during the 2000s on the basis of very little evidence. The Medicare Payment
Advisory Commission (MedPAC) urged Congress to enact the Hospital Readmissions
Reduction Program (HRRP) beginning in 2007, and in 2010 Congress did so. State
Medicaid programs and private insurers quickly adopted similar programs.
The rapid adoption of readmission-penalty programs without evidence confirming they can work has created widespread concern that these programs are inducing hospitals to increase utilization of emergency rooms and observation units to reduce readmissions within 30 days of discharge (the measure adopted by the Centers for Medicare and Medicaid Services [CMS] in its final rule on the HRRP), and this in turn may be harming sicker patients. Determining whether hospitals are gaming the HRRP and other readmission-penalty schemes by diverting patients to ERs and observation units (and perhaps by other means) should be a high priority for policy-makers. 
Part I of this series I proposed to address the question of whether hospitals
are gaming the HRRP by asking (a) does research exist describing methods by
which hospitals can reduce readmissions under the HRRP and, in the event the
answer is yes, (b) does that research demonstrate that those methods cost no
more than hospitals save. If the answer to the first question is no, that would
lend credence to the argument that the HRRP and other readmission-penalty
schemes are contributing to rising rates of emergency visits and observation
stays. If the answer to second question is also no, that would lend even more
credence to the argument that hospitals are gaming the HRRP.
In Part I, I noted that proponents of readmission penalties, including MedPAC and the Yale New Haven Health Services Corporation (hereafter the “Yale group”), have claimed or implied that hospitals have no excuse for not reducing readmission rates because research has already revealed numerous methods of reducing readmissions without gaming. I also noted many experts disagree, and quoted a 2019 statement by the Agency for Healthcare Research and Quality that “there is no consensus” on what it is hospitals are supposed to do to reduce readmissions.
this article, I review the research MedPAC cited in its June 2007 report to
Congress, the report that the authors of the Affordable Care Act (ACA) cited in
Section 3025 (the section that instructed CMS to establish the HRRP). In Part
III of this series I will review the studies cited by the Yale group in their
2011 report to CMS recommending the algorithm by which CMS calculates “excess”
readmissions under the HRRP. We will see that the research these two groups
relied upon did not justify support for the HRRP, and did not describe
interventions hospitals could use to reduce readmissions as the HRRP defines
“readmission.” The few studies cited by these groups that did describe an
intervention that could reduce readmissions:
Office of the National Coordinator (ONC) and the Centers for Medicare and
Medicaid (CMS) have proposed final rules on
interoperability, data blocking, and other activities as part of implementing
the 21st Century Cures Act. In this series, we will explore ideas
behind the rules, why they are necessary and the expected impact. Given that
these are complex and controversial topics are open to interpretation, we
invite readers to respond
with their own ideas, corrections and opinions.
Interventions to Address Market Failures
Many of the rules proposed
by CMS and ONC are evidence-based interventions aimed at critical problems that
market forces have failed to address. One example of market failure is the long-standing inability for health care
providers and insurance companies to find a way to exchange patient data. Each
has critical data the other needs and would benefit from sharing. And, as CMS
noted, health plans are in a “unique position to provide enrollees a complete
picture of their clams and encounter data.” Despite that, technical and
financial issues, as well as a general air of distrust from decades of haggling
over reimbursement, have prevented robust data exchange. Remarkably, this happens
in integrated delivery systems which, in theory, provide tight alignment between
payers and providers in a unified organization.
With so much attention
focused on requirements for health IT companies like EHR vendors and providers,
it is easy to miss the huge impact that the new rules is likely to have for
payers. But make no mistake, if implemented as proposed, these rules will have
a profound impact on the patient’s ability to gather and direct the use of
their personal health information (PHI). They will also lead to reduced
fragmentation and more complete data sets for payers and providers alike.
Overview of Proposed CMS Rules on Information
Sharing and Interoperability
The proposed CMS rules
affect payers, providers, and patients stating that they:
Require payers to make
patient health information available electronically through a standardized,
open application programming interface (API)
Promote data exchange
between payers and participation in health information exchange networks
Require payers to provide
additional resources on EHR, privacy, and security
Require providers to comply
with new electronic notification requirements
Require states to better
coordinate care for Medicare-Medicaid dually eligible beneficiaries by
submitting buy-in data to CMS daily
Publicly disclose when
providers inappropriately restrict the flow of information to other health care providers and payers
The 2016 21st Century CURES Act is the law. It is built around two phrases: “information blocking” and “without special effort” that give the administration tremendous power to regulate anti-competitive behavior in the health information sector. The resulting draft regulation, February’s Notice of Proposed Rulemaking (NPRM) is a breakthrough attempt to bend the healthcare cost curve through patient empowerment and competition. It could be the last best chance to avoid a $6 Trillion, 20% of GDP future without introducing strict price controls.
This post highlights patient-directed access as the essential pro-competition aspect of the NPRM which allows the patient’s data to follow the patient to any service, any physician, any caregiver, anywhere in the country or in the world.
The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have proposed final rules on interoperability, data blocking and other activities as part of implementing the 21st Century Cures Act. In this series, we will explore ideas behind the rules, why they are necessary and the expected impact. Given that these are complex and controversial topics open to interpretation, we invite readers to respond with their own ideas, corrections and opinions.
When it comes to sharing health data, the intent of the 21st Century Cures Act is clear: patients and clinicians should have access to data without special effort or excessive cost. To make this a reality, the act addresses three major areas: technical architecture, data sets and behaviors. Part two of our series looked at how APIs address technical issues while part three covered the new data requirements. In this article, we delve into information blocking. A companion podcast interview with ONC expert Michael Lipinski provides an even deeper dive into this complex topic.
Blocking Comes in Many Forms
The Public Health Services Act (PHSA) broadly defines information blocking as a practice that is “likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.” The overarching assumption is information will be shared though the Act does authorize the Secretary to identify reasonable and necessary exceptions.
The proposed rules focus on “technical requirements as well as the actions and practices of health IT developers in implementing the certified API.” Information blocking can come in a variety of forms. It can be direct and obvious (“No you can’t have this data ever!”) or indirect and subtle (“Sure, you can have the data, but it will cost you $$$ and we won’t be able to get to your request for at least 12 months.”). The proposed rules are designed to address both. This passage illustrates some of the concerns:
“Health IT developers are in a
unique position to block the export and portability of data for use in
competing systems or applications, or to charge rents for access to the basic
technical information needed to facilitate the conversion or migration of data
for these purposes.”
The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have proposed final rules on interoperability, data blocking and other activities as part of implementing the 21st Century Cures Act. In this series, we will explore the ideas behind the rules, why they are necessary and the expected impact. Given that these are complex and controversial topics open to interpretation, we invite readers to respond with their own ideas, corrections and opinions. In part three of this series, we look at how the new USCDI draft helps foster innovation.
The U.S. Core Data for Interoperability
(USCDI) draft is a step forward toward expanding the 21st Century
Cures Act. The Cures Act was helpful in moving the needle for interoperability
and defining data blocking. The latest draft of the USCDI is meant to further specify
what data should be shared freely.
In this article, we’ll look at the data added
to the Common Clinical Data Set (CCDS) used for ONC certification. We’ll walk
through the proposed plan to add more data over time. And we’ll explore why
this is a step in the right direction toward increased data sharing.
The bulk of the datasets in the USCDI comes
from the Common Clinical Data Set (CCDS), which was last updated in 2015. The
new USCDI draft adds two types of data:
Clinical notes: both structured
and unstructured. EHRs store these notes differently, but both are important
and helpful in data analysis.
Provenance: an audit trail of the data, showing where it
came from. It is metadata, or information about the data, that shows who
created it and when.
The Fast Healthcare Interoperability Resources (FHIR) have created standards around APIs used to access health care data. APIs developed under the FHIR standard aligns with the USCDI to meet the proposed certification rules. The USCDI draft recommends using a FHIR compliant API to access the data.
The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have published proposed final rules on interoperability and data blocking as part of implementing the 21st Century Cures act. In this series we will explore the ideas behind the rules, why they are necessary and the expected impact. Given that these are complex, controversial topics, and open to interpretation, we invite readers to respond with their own ideas, corrections, and opinions.
Health IT 1.0, the basic digitalization of health care, succeeded in getting health care to stop using pens and start using keyboards. Now, Health IT 2.0 is emerging and will build on this foundation by providing better, more diverse applications. Health care is following the example set by the rest of the modern digital economy and starting to leverage existing monolithic applications like electronic health records (EHRs) to create platforms that support a robust application ecosystem. Think “App Store” for healthcare and you can see where we are headed.
This is why interoperability and data blocking are two of the biggest issues in health IT today. Interoperability – the ability of applications to connect to the health IT ecosystem, exchange data and collaborate – is a key driver of the pace and breadth of innovation. Free flowing, rich clinical data sets are essential to building powerful, user-friendly applications. Making it easy to install or switch applications reduces the cost of deployment and fosters healthy competition. Conversely, when data exchange is restricted (data blocking) or integration is difficult, innovation is stifled.
Given the importance of health IT in enabling the larger transformation of our health system, the stakes could hardly be higher. Congress recognized this when it passed the 21st Century Cures Act in 2016. Title IV of the act contains specific provisions designed to “advance interoperability and support the access, exchange, and use of electronic health information; and address occurrences of information blocking”. In February 2019, ONC and CMS simultaneously published proposed rules to implement these provisions.
A Trump administration regulation issued just hours before the partial federal shutdown offers quiet hope for civility in government.
What happened, on its face, was simple: an update of the rules governing a particular Medicare program. In today’s dyspeptic political climate, however, what didn’t happen along the way was truly remarkable – and may even offer some lessons for surviving the roller-coaster year ahead.
A regulatory process directly connected to Obamacare and billions in federal spending played out with ideological rhetoric completely absent. And while there were fervid objections to the draft rule from those affected, the final version reflected something that used to be commonplace: compromise.
Think of it as Survivor being replaced by Mr. Smith Goes to Washington. Or, perhaps, a small opening in the wall of partisan conflict.
More on that in a moment. First, let’s briefly examine the specifics.
On the morning of December 21, I opened my copy of the New York Times to find an op-ed that said almost exactly what I had said in a two-part article The Health Care Blog posted two weeks earlier. The op-ed criticized the Hospital Readmissions Reduction Program (HRRP), one of dozens of “value-based payment” programs imposed on the Medicare fee-for-service program by the Affordable Care Act. The HRRP punishes hospitals if their rate of readmissions within 30 days following discharge exceeds the national average. The subtitle of the op-ed was, “A well-intentioned program created by the Affordable Care Act may have led to patient deaths.”
The first half of the op-ed made three points: (1) The HRRP appears to have reduced readmissions by raising the rate of observation stays and visits to emergency rooms; (2) the penalties imposed by the Centers for Medicare and Medicaid Services (CMS) for “excessive readmissions” have fallen disproportionately on “safety net hospitals with limited resources”; and (3) “there is growing evidence that … death rates may be rising.”
That’s exactly what I said in articles published here on December 6 and December 7. In Part I, I described the cavalier manner in which the Medicare Payment Advisory Committee (MedPAC) endorsed the HRRP in its June 2007 report to Congress. In Part II, I criticized the methodology MedPAC used to defend the HRRP in its June 2018 report to Congress, and I compared that report to an excellent study of the HRRP published in JAMA Cardiology by Ankur Gupta et al. which suggested the HRRP is raising mortality rates. In its June 2018 report, MedPAC had claimed the HRRP has reduced the rate at which patients targeted by the HRRP were readmitted within 30 days after discharge without increasing mortality. Gupta et al., on the other hand, found that for one group of targeted patients – those with congestive heart failure (CHF) – mortality went up as 30-day readmissions went down.
Republicans and Democrats are seen as poles apart on health policy, and the recent election campaign magnified those differences. But in one area—private-sector competition among healthcare providers—there seems to be a fair amount of overlap. This is evident from a close reading of recent remarks by Health and Human Services Secretary Alex Azar and a 2017 paper from the Brookings Institution.
Azar spoke on December 3 at the American Enterprise Institute (AEI), the conservative counterpart to the liberal-leaning Brookings think tank. Referring to a new Trump Administration report on how to reduce healthcare spending through “choice and competition,” Azar said that the government can’t just try to make insurance more affordable while neglecting the underlying costs of care. “Healthcare reform should rely, to the extent possible, on competition within the private sector,” he said.
This is pretty close to the view expressed in the Brookings paper, written by Martin Gaynor, Farzad Mostashari, and Paul B. Ginsburg. “Ensuring that markets function efficiently is central to an effective health system that provides high quality, accessible, and affordable care,” the authors stated. They then proposed a “competition policy” that would require a wide range of actions by the federal and state governments.