Thursday, October 28, 2010

The October HIT Standards Committee Meeting

by John Halamka, Life as a Healthcare CIO

This month's meeting focused on the planning for standards which will support meaningful use stage 2 and 3, as well a review of NHIN Direct and its future plans to provide simple transmission of data among stakeholders.

We began the meeting with Jamie Ferguson's Vocabulary Workgroup report.   He highlighted the work that has been done to reduce the intellectual property barriers which have slowed the creation of centralized, web-based resources containing all vocabularies, codesets, and mappings needed by eligible providers and hospitals to achieve meaningful use.  Several financial models have been considered, including federal government funding of vocabulary licensing fees and the establishment of a single administrative group to centrally collect a single fee from providers in return for providing them all the meaningful use vocabulary resources they need.    We discussed two related issues 1) identifying who pays licensing fees and we determined it should be those who generate data not those who receive it or manipulate it as a business associate of the data generator.  2) identifying the need for proprietary code set vendors to create free mappings to federally mandated standards.   For example, RxNorm includes proprietary medication codesets and the vendors of these codesets should offer free mappings from ALL their proprietary codes to RxNorm codes.

Next, Liz Johnson updated the group on the Implementation Workgroup activities.   She highlighted the need for hearings, to be held in December or January, on five topics - the role of RECS in attaining meaningful use, certification experiences, lessons learned from early adopters seeking meaningful use attestation in 2011, experience with performance/quality measures, and the status of health information exchanges.   I discussed two barriers to certification - the fact that the syndromic surveillance implementation guide in the Final Standards Rule is incorrect.   It was updated via an interim final rule  so that has been addressed.   Also that the NIST testing tools for e-prescribing transactions did not include the XML forms of NCPDP standards.   On October 24, NIST issued version 1.1 of those tools, addressing the issue.

Paul Tang and George Hripcsak then presented the guiding principles behind Stage 2 and 3 meaningful use.   Summarizing the key points
*Some aspects of stage 2 will be incremental changes to stage 1 (i.e. raising the thresholds)
*Some will be a stepping stone on the way to stage 3
*Stage 3 will likely including outcomes measures as well as process measures. 
*Stage 2 and 3 will likely require analysis of data across a community and not just within an institution, increasing the amount of HIE enablement to be demonstrated.
*Patient engagement in future stages will clarify methods to share data with patients - "access/download" which is real time on demand, "copy" which is a point in time summary of available information including specific use documents/datasets. 

Our discussion included the need to clarify the term "document".  Most people concurred that "document" meant a collection of data elements, in electronic form, capable of many reuses.   Ideally, the standards committee will suggest a common container for assembly of structured and unstructured information that does not require creating numerous standards for individual document types.

Arien Malec then updated the group on NHIN Direct.   The consensus of the Direct collaborators is to require secure email (SMTP/TLS/certificates) as the backbone but allow SOAP (XDR) or SMTP at the edges.  This means that senders and receivers can decide how to transmit/receive data (SMTP or SOAP) as long as they have a way to communicate with the SMTP backbone.   Finally, an exception was made for those senders and receivers who agree to use SOAP from point to point by previous agreement.  This approach enables existing vendor products which already support SOAP to continue to do so, while enabling innovative approaches using secure email.   Specifications will be finalized by next month and live implementations will be evaluated by the Standards Committee in March.

Doug Fridsma reviewed the current state of the Standards and Interoperability framework, noting that it now has a set of tools and processes to support health information exchange project development including use case writing, harmonization, implementation guide writing, reference implementation and testing.   Priorities will focus on Meaningful Use data exchanges and the Virtual Lifetime Electronic Record (VLER) project.   Much discussion followed about the best way to incorporate the HIT Policy Committee, the HIT Standards Committee, NHIN, and the Standards and Interoperability Framework into a more coordinated set of activities.   The Concept of Operations document which guides the Standards and Interoperability Framework is being updated to knit all these activities together and we will discuss that at our November meeting.

Tuesday, October 26, 2010

Health Reform 101

In Health Reform Hits Main Street, the Kaiser Family Foundation delivers a cartoon video overview of the health reform law. Narrated by Cokie Roberts of National Public Radio.

Tuesday, October 12, 2010

Accountable Care Organizations - "made simple"

by David Harlow, Health Care Law Blog
Don Berwick kicked off the day-long Accountable Care Organization (ACO) Workshop and Listening Session, co-hosted by the FTC, CMS and the OIG, with a short, stirring speech that touched on his Triple Aim for health care: better care for individuals, better health for populations and reduced per-capita costs.  He committed the government to interpreting applicable statutes "wisely, so as not to impede the development of ACOs."  That sums up the reason this workshop was so eagerly anticipated.  Health care providers are extremely eager to become ACOs - though the term has yet to be fully defined - yet are extremely concerned about the potential to have specific ACO arrangements identified as illegal by the FTC, the OIG or CMS because the arrangements violate antitrust law, Stark, anti-kickback or anti-fraud and abuse laws, or may be subject to civil monetary penalties.  The health reform legislation authorized these agencies to develop waiver programs and safe harbors in order to implement the ACO concept, and proposed rules doing so will have to be issued this fall in order to have these systems up and running next year, as called for by the law.  Berwick's commitment to make this as pain-free as possible was echoed by FTC Chairman Jon Leibowitz and HHS Inspector General Dan Levinson.  Check out the live-tweeting transcriptof the day's events. (Audio of the day's proceedings should be posted in the near future.)
So, this leaves just a few questions:
  • What is an ACO and why are they given special status under the law?
  • Why are waivers or safe harbors needed if ACOs are authorized by the Federal health reform law?
  • What waivers or safe harbors are likely to be proposed in the next month or so?
  • Will these waivers and safe harbors protect ACO activity where the payor is a commercial payor, rather than a federal health care program payor?
What is an ACO and why are they given special status under the law?
The health reform law, now known by its acronym PPACA or ACA (Patient Protection and Affordable Care Act, or simply Affordable Care Act), authorizes (among many other demo and pilot programs) the establishment of a shared savings program known as the ACO program, in Section 3022 (codified as Title XVIII, Section 1899). See CMS Shared Savings (ACO) FAQ for details.  At its core, the law requires that an ACO must:
1) Have a formal legal structure to receive and distribute shared savings
2) Have a sufficient number of primary care professionals for the number of assigned beneficiaries (to be 5,000 at a minimum)
3) Agree to participate in the program for not less than a 3-year period
4) Have sufficient information regarding participating ACO health care professionals as the Secretary determines necessary to support beneficiary assignment and for the determination of payments for shared savings.
5) Have a leadership and management structure that includes clinical and administrative systems
6) Have defined processes to (a) promote evidenced-based medicine, (b) report the necessary data to evaluate quality and cost measures (this could incorporate requirements of other programs, such as the Physician Quality Reporting Initiative (PQRI), Electronic Prescribing (eRx), and Electronic Health Records (EHR), and (c) coordinate care
7) Demonstrate it meets patient-centeredness criteria, as determined by the Secretary. 
The ACO provision in the ACA has garnered a disproportionate amount of attention, likely because of the opportunity for shared savings and the opportunity for hospitals to more closely ally their affiliated physicians.  However, the point was made time and again at the workshop that the goal of the program is to improve patient care and the patient experience -- without that guidepost at the core, the exercise won't work.
Aside from large IDS's seeking to use the ACO program as a means to protect and potentially grow market share and margin (after all, "no margin, no mission"), why would hospitals want to get involved?  Hospital reimbursement is on the line here: about 70% of costs -- and potential savings -- are on the hospital side of the equation, and much of the control over those costs lies with physicians.  If they are not already employed physicians, the sharing of savings means the hospital will be sharing with the physicians, and not vice versa.  Despite this apparent disincentive, past experience has shown that strong physician-led initiatives can bring hospitals into the fold.  Two examples: the Medicare Physician Group Practice Demonstration Project (an ACO precursor) and the Grand Junction, Colorado experience: a physician-led arrangement initially targeted by the FTC as a price-fixing scheme, eventually resolved through a settlement agreement, and now seen as a national model of collaboration, aligned incentives, cost-effectiveness, and quality improvement.
Why are waivers or safe harbors needed if ACOs are authorized by the Federal health reform law?
The general idea is to get providers across the continuum of care to band together, work on reducing costs and improving quality, continue to be paid on a fee-for-service basis by CMS, and then retrospectively look at system-wide savings (e.g., avoided readmissions) and share those savings around.  Sharing those savings around outside of an integrated delivery system raises a host of potential antitrust, fraud and abuse (anti-kickback), Stark and CMP issues, and the statute authorizes the development of waiver programs and safe harbors in order to make it all work.  It's really a square peg-round hole problem, because the policy basis for making illegal this sort of sharing is grounded on fee-for-service, retrospective reimbursement systems.  Prospective payment, particularly bundled payments for episodes of care, eliminates the potential for the harm these rules protect against (over-provision of care due to financial incentives), yet they are still on the books.  For example, we want physicians to share in the hospital savings experienced as a result of an avoided readmission which would not be eligible for separate reimbursement; this opportunity will incentivize them to work harder to prevent the readmission.  Under current rules, however, a payment by the hospital, directly or indirectly, to the physician, tied to that savings, is impermissible.
What waivers or safe harbors are likely to be proposed in the next month or so?
Federal officials at listening sessions are notoriously tight-lipped, so not much was said about what to expect, other than proposed regulations are expected to come out this fall.  However, all were keen to emphasize that they want to eliminate the regulatory impediments to ACOs, and welcome further comments from the public.
As a whole, the regulated community is eager to have greater certainty, in the form of new regulated guidance; however, some would prefer to simply be guided by what's out there already: advisory opinions, guidelines, regulations, etc., that lay out safe harbors.  For example, the joint DOJ-FTC healthcare antitrust guidelines provide that clinical integration -- even in the absence of full merger or acquisition, or direct employment of physicians by a hospital -- will keep providers out of antitrust hot water even iof they are collaborating in ways otherwise prohibited.  At the other end of the spectrum, some folks would prefer to have the federales get broad authority to issue blanket waivers without establishing super-specific criteria.
Establishing criteria for waivers or safe harbors will be somewhat difficult, because the definition of an ACO is a little slippery. The financial arrangement at its core can be simply a shared savings arrangement, but it might also veer into other territory: underwriting patient expenses such as transportation costs or home monitoring device costs, or the payment of a physician group's up-front capital expenses by a hospital in order to kick-start the process (all potentially illegal inducements under current law).
Many of the comments were directed at ensuring that a particular type of arrangement or organization does not escape the feds' notice, so that they can all be written into waiver or safe harbor language.   
Will these waivers and safe harbors protect ACO activity where the payor is a commercial payor, rather than a federal health care program payor?
The rules at issue are all Federal health program rules -- except for the FTC antitrust rules, which apply across the board. 
A number of forum participants suggested that a rule of reason analysis under the antitrust laws (rather than "per se" analysis) would be needed in order to address market power issues in each unique ACO situation.  It seems to me that such an approach would be throwing away the current opportunity to craft a set of guidelines focused not only on ACOs but on other provider arrangements likely to come down the pike under other ACA demo and pilot authority.  This opportunity should be seized by the other agencies as well -- not just the FTC. 
Final thoughts
Will providers actually come together to form ACOs?  The jury is still out.  There is certainly a lot of noise being made, but the long-term key from both a policy and business perspective is that the efforts of the provider organizations must be to make themselves more patient-centered.  Berwick's emphasis on this point was striking, and he illustrated it with an anecdote from his days of practicing as a pediatrician at Harvard Community Health Plan, where systems were in place to support a patient-clinician partnership at a very high level, suggesting that HCHP was an ACO long ago.  In current-day Massachusetts, Blue Cross Blue Shield of MA has rolled out its Alternative Quality Contract to  a quarter of its provider network; half of the docs involved are in small practices.  While it has taken some years for the AQC program -- another proto-ACO program -- to get off the ground, it is significant because it has allowed for the agglomeration of small practices into a larger whole for purposes of the contract, thus perhaps lighting the way for ACO participation by organizations other than IDS's.
So is this deja vu all over again? Have we stepped back in time a couple of decades to re-experience managed care failures of an earlier era?  Certainly, some rpoviders see the ACO structure as a way to increase market share, margin and bargaining power -- and it's a no-downside financial deal.  As noted above, it cannot be only that.  There are significant costs and potentially difficult negotiations ahead as providers across the continuum work with the regulators to hash out the final status of the ACO landscape, and then deal with integrating themselves into one or more ACOs with a laser focus on patient-centered care.  That focus should yield benefits up and down the line: for patients, providers and ultimate payors in both the public and private sectors.

Sunday, October 10, 2010

Returning to the Source to Help Achieve Patient Safety Goals

by David Blumenthal, ONC 
Two landmark reports by the Institute of Medicine (IOM) changed Americans’ perception of their health care system and launched today’s drive to improve the quality and safety of medical care in America. The reports were To Err Is Human, published in 1999, and Crossing the Quality Chasm, released in 2001. 
Both these reports highlighted the important potential role that health information technology (HIT) could play in improving health care quality and reducing medical errors. In fact, Recommendation #9 in Crossing the Quality Chasm called for “renewed national commitment to building an information infrastructure” and said: “This commitment should lead to the elimination of most handwritten clinical data by the end of the decade.”
The end of that decade is now just three months away, and not to mince words, we’re behind the ambitious schedule that the IOM report envisioned. Nonetheless, we have at last made the substantial commitment that was called for in the report.  
Last year in the HITECH Act, Congress and the President authorized $27 billion in Medicare and Medicaid incentive payments for providers who adopt and make meaningful use of certified electronic health records (EHRs). At the same time, the Act created $2 billion in new programs to support the transition to HIT-assisted care. And this summer, the regulatory framework was completed for Stage 1 of the Meaningful Use path toward an EHR-based future in health care.
With the engines of change now in place, it is time to bring closer focus to other key issues for achieving the full potential benefits of HIT. One of these is the issue of improving patient safety. 
We know, both in theory and practice, that HIT-assisted care can reduce errors and improve patient safety. In particular:  
  • Reliable access to complete personal health information is the foundation of safe and effective care. EHRs are inherently superior to paper in delivering such access.    
  • Even more uniquely, EHRs can use their computing power to automatically cross-check personal information and other sources. With such backup, clinicians can be automatically alerted when drugs or other treatments may be contraindicated because of allergies, potential drug interactions, or other factors.
At the same time, however, it would be na├»ve to suppose that HIT-assisted care can deliver its full patient safety benefits in a single stroke – or that HIT will not present its own safety issues. Clinicians need to become familiar with new EHR systems, which will take time. EHR systems themselves need to evolve and improve. We need to ensure that the “decision support” information they provide is accurate and personalized. Their interfaces need to grow in user-friendliness. Even safety alerts need to find the right medium and avoid producing “alert fatigue.”
These challenges can be met – and indeed, the very “fix-ability” of HIT-based care can be one of its primary safety benefits. HIT systems tend to record and expose patient safety problems when they occur, while paper-based care too often hides them. And EHRs are amendable to rapid, systemic correction of problems – while corrections in a non-systemic, paper-based clinic can take years to accomplish, even when they are identified.
How can we maximize patient safety through HIT-based care? What roles and actions by government, the private sector, and health care providers themselves can help achieve the full potential benefits that were sought in those seminal IOM reports?
As we address these questions, there is no better source of guidance than the IOM itself, building on the same expertise and convening power that produced its initial reports 10 years ago. For that reason, the Office of the National Coordinator for Health Information Technology has contracted with IOM for a follow-up one-year study. In this study, IOM will:  
  • Identify approaches to promote the safety-enhancing features of HIT while protecting patients from any safety problems associated with HIT and preventing HIT-related patient safety problems before they occur;
  • Identify approaches for surveillance and reporting activities to bring about rapid detection and correction of patient safety problems;
  • Address the potential roles of private sector entities such as accrediting and certification bodies as well as patient safety organizations and professional and trade associations; and
  • Examine existing authorities and potential roles for key federal agencies, including the Food and Drug Administration, the Agency for Healthcare Research and Quality, and the Centers for Medicare & Medicaid Services.
As this study is carried out, we will move where appropriate to improve surveillance, reporting, product safety, and clinician performance. But at the same time, we will anticipate a “deep dive” in knowledge synthesizing and a new round of productive recommendations from the IOM.
There is every reason to believe that HIT-assisted care will be transformative for American medicine, but no reason to think the change will be easy or instantaneous. We are returning to the IOM as a key partner in helping to refine the course that it first helped to chart a decade ago.

Tuesday, October 5, 2010

The Social Network and Epidemics

Can the social network predict the spread of epidemics?  Nicholas Christakis presents his compelling research on the early detection of epidemics (as compared to the early warning of Google Flu Trends).

Monday, October 4, 2010

Clarifying Certification

by John Halamka, Life as a Healthcare CIO

On Friday, CCHIT announced certification of 33 complete and modular EHRs.  Drummond Group announced 3 certifications.

Many folks are asking about the difference between complete EHR certification and modular EHR certification.

A complete EHR must perform the functions necessary to support all 25 meaningful use criteria - 15 from the core set and all 10 from the menu set.   A complete EHR must support the 3 core quality measures, the 3 alternate quality measures and at least 3 of the menu set quality measures.

Modular EHR components are certified for the functions they perform.  The user then mixes and matches components as needed to meet the core set and the 5 menu set items they have chosen.   Each function included in meaningful use attestation must be certified.   Thus, in 2011, you only need to acquire the modular EHR components for the 20 criteria you are planning to include in your meaningful use attestation.

If your existing vendor-based hospital information does not provide all the functions you need for meaningful use, then acquire the modules needed to fill the gaps.   Alternatively, you can do what I am doing and seek a site certification of the hospital rather than assemble certifications for the products you are using.

It's likely that many existing EHRs will achieve modular certification - having most but not all needed functionality.   It's perfectly reasonable to use your existing EHR for the majority of the functionality you need, then supplement it with a data warehouse or health information exchange to achieve all the certifications necessary.

I hope this clarifies the certification process.

There will be many interesting lessons learned in this first round of certification.

1.  As I've reported previously, the Syndromic Surveillance implementation guide in the Standards Final rule is incorrect.   However, until it is fixed, vendors must implement the wrong data exchange in order to be certified because that is what the NIST testing site specifies.

2.  Some vendors may opt to be modular EHRs now and evolve to become complete EHRs as data exchange issues are clarified.   

3.  Testing procedures are going to evolve in these early days of certification and that is going to be challenging for vendors to support.   For example, NIST currently offers an e-prescribing validation procedure for NCPDP e-Prescribing formats using EDI but not XML implementations.  The HIT Standards Committee and the Standards Final Rule did not limit the transaction to just the EDI type.   Thus, it's likely NIST will change their testing criteria to support both EDI and XML.

  In the end, it will fall to the purchaser to ensure their goals are aligned with vendor plans.     If purchasers are seeking modules to expand the capabilities of an existing EHR, that should be clear.   If purchasers want a complete EHR and their preferred vendor is currently a module,  purchasers should request an agreement that the vendor will offer a complete EHR in a set period of time.