In April 2019, the Centers for Medicare & Medicaid Services (CMS) announced the Primary Cares Initiative, which is expected to reduce administrative burdens and improve patient care while decreasing health care costs. Learn more about the Primary Cares Initiative and its proposed value-based payment models in part one of this two-part blog series.
While the health care landscape has never been static,
rarely has it seen such radical changes as it has within recent decades. The
population of the United States continues to age, and the prevalence of chronic
conditions such as obesity, diabetes, heart disease, and anxiety or depression contribute
to a substantially increased demand for care. These factors are pushing a shift
from a provider-centric model toward more efficient outcome-based models that
put the patient at the center and heavily rely on primary care as the steward
of patient care.
Primary care is a vital resource in dealing with the many factors altering the health care landscape. A 2019 study published in JAMA Internal Medicine found that for every 10 additional primary care physicians (PCPs) per 100,000 people, patients saw a 51.5-day increased life expectancy.
To promote further adoption of primary care-based models, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) recently announced a set of payment models meant to further transform primary care through value-based options under the new Primary Cares Initiative. This voluntary initiative will test financial risk and payment arrangements for primary care physicians (PCPs) based on performance and efficiency, including five new payment models under two paths: Primary Care First (PCF) and Direct Contracting (DC). These models, slated to hit 20 states in 2020, seek to address the many difficulties in paying for, and incentivizing, valuable primary care within current payment models.
Super Bowl Week ended with the San Francisco 49ers and 161 U.S. hospitals having something in common.
Both were publicly penalized, both lost money as a result and both passionately believed the process was unfair. Unfortunately, it’s not easy to decide whether their objections were sensible or sour grapes and, in the case of hospitals, the real-life consequences are not a game.
The penalty that pained the 49ers occurred shortly before halftime of Super Bowl LIV, when offensive pass interference was called on tight end George Kittle. The call negated a big gain that might have enabled the 49ers to take the lead.
Replays showed that the referees – nicknamed “zebras” for their black-and-white striped shirts – were technically correct in their decision. Nonetheless, controversy erupted over whether given other possible penalties called or overlooked, this one deserved a yellow flag.
Hospitals call that kind of context “risk adjustment.” A few days before the Super Bowl, the Medicare program blew the whistle on a group of hospitals having high rates of infection and other patient injuries. The hospitals who are outliers in what are blandly labeled “hospital-acquired conditions” (HACs) suffer a cut of one percent in their Medicare payments over next fiscal year.
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.