ONC Sells Successes of Health IT Adoption to Congress in Annual Report

The ONC released its second annual report on the adoption of health IT this past June.  The report provides a snapshot of the nation's efforts and continuing barriers to health IT adoption.  Although EHRs have been lambasted lately by Congress, the report primarily covers the ongoing big "wins" for health IT adoption: increased participation in the Medicare and Medicaid EHR Incentive Programs ("Meaningful Use") in 2012, increased adoption of EHR technology among physicians and hospitals and increased rRx, and various federal and state HIE and HIT efforts. 

For example, CMS is more than happy to report that over half of the nation's eligible professionals have received payments through Meaningful Use as of April 2013, with about 80% of eligible hospitals receiving incentive payments as well. Among the 50 States, only 8 do not have mechanisms broadly available statewide for directed exchange, whether fully implemented or in pilot phases, of which New Jersey is one of. And 36 states have query-based exchange available either statewide or through at least certain regions.   

The report also highlights the variety of programs, pilots and regulatory efforts undertaken by CMS and ONC, among others, and the success these have had since the passage of the HITECH Act. However, ONC acknowledges the barriers that remain for health IT, particularly interoperability, and remains committed to developing flexible, modular standards and policies for the interaction and exchange of information among various types of systems. 

To help support interoperability, the State HIE Program recently released a set of online training modules for providers, supporting the roll-out of Meaningful Use Stage 2 set to kickoff this October for eligible hospitals, and January 2014 for eligible providers. The Standards and Interoperability ("S&I") Framework continues to work with stakeholders in the vendor and provider communities to identify barriers and their solutions to achieving national interoperability.  And the public/private partnership through the national eHealth Exchange (formerly the Nationwide Health Information Network or NwHIN) continues as ONC's "incubator of innovation" in HIE. 

Additional efforts highlighted by ONC include:

  • improving consumer and provider confidence and trust in health IT and HIE;
  • engaging consumers in their ehealth and identifying solutions for consumers to better control and direct the flow of their information through HIE;
  • gathering data through various public forums and surveys on privacy and security concerns for safeguarding health information in health IT;
  • development of interactive tools for providers to assess mobile device security as well as general security tools for safeguarding electronic PHI and EHRs, and minimizing breaches;
  • identifying strategies for improving coordination and integration of behavioral health providers into broader health IT efforts, including launching an interstate Direct behavioral health pilot; and
  • identifying stragegies for improving coordination and integration of long-term and post-acute care providers into broader health IT efforts.

For the entire snapshot of the nation's health IT status, read the full report with its easy-to-read charts and graphs.  You may be surprised at how much ONC has been involved with and that has happened in the evolution of health IT and HIE.  

Is NwHIN going from "Free" to "For Fee"?

Notable news late last week included ONC Coordinator Dr. Fazad Mostashari publishing a blog post stating that ONC has decided NOT to pursue promulgating regulations to govern the NwHIN. The decision was made in part after his OfficeNot Free.png considered comments to the RFI it released in the early summer seeking public input on a potential regulatory approach for the NwHIN and its participants, including the possibility of requiring accreditation and certification to validate organizations seeking to participate in the NwHIN.  Mostashari explains in his post that many RFI responders expressed concern that issuing new regulations to set governance standards for the NwHIN could actually slow the development of trusted exchange. In light of this, Mostashari indicates that his Office has decided to allow the HIE and HIT markets to continue evolving organically, at least for now. 

The NwHIN website currently posts a list of 27 organizations that are already approved NwHIN Participants. Other organizations seeking to become a NwHIN Participant have to "on board" to the Exchange by following the (painfully detailed) process on the NwHIN website, which you can review here

But buyer beware...   

While current NwHIN Participants may have "on boarded" and be using the NwHIN for free, it looks like subscription and/or use fees for the NwHIN are coming soon .....

On August 20th, the HealtheWay Exchange Transition Update was published, which summarizes some of the "transitions" to expect with regard to the NwHIN.  To start, it's helpful to know that HealtheWay is the nonprofit organization now chartered to support the NwHIN Exchange. The entity's Articles of Amendment and Restatement of the Articles of Incorporation were recently filed in the Commonwealth of Virginia and made effective July 30, 2012. Bylaws for HealtheWay are posted there as well. The Update notes a list of changes to how the NwHIN will be operating, including:

  • Currently, NwHIN Exchange is an ONC initiative, but as of October 2012 it will transition to the public-private initiative called the eHealth Exchange;
  • Currently, NwHIN operations are supported and funded by ONC, but going forward, operations will be supported and funded by HealtheWay;
  • Currently, all services are provided to NwHIN Participants for free, but very soon Participants are going to be asked to pay for the NwHIN's services being supported through HealtheWay.

It is probably not a huge surprise that, going forward, Participants will be charged fees to connect through the NwHIN Exchange because "free" is not a viable model for financial sustainability. However, it will be interesting to see how organizations respond and whether paying fees to utilize the NwHIN was something that such organizations, and States for that matter, have factored in to their HIE models.

In light of all this, it is important for organizations, providers and even State governments looking to join the NwHIN to have a solid understanding of how the DURSA works, especially with regard to how "material terms" can be changed (i.e., like imposing new fees), and how a Participant can terminate its participation with the NwHIN if it cannot meet (or does not agree with) a material change.  

If NwHIN Participants are going to be charged fees to use the NwHIN Exchange, then organizations should be considering this as part of their evaluation of whether the NwHIN Exchange is the best solution to meet its organization's primary needs.  Organizations will also want to evaluate whether the NwHIN delivers sufficient value in exchange for the fee that they will be charging (an amount which we don't yet know). In addition, the integration and on-boarding process is extremely time-consuming and resource intensive, and so organizations will not necessarily want to "go through" this process with two different HIE vendor solutions. Finally, for those that were expecting to connect to the NwHIN for "free", they should update their plan (and budgets) to reflect the transition of the NwHIN Exchange to a "for fee" model.

To review the provisions of the DURSA that pertain to "changes" to material terms, click "Continue Reading".


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The ACA SCOTUS Decision in Plain English

As we all know from the "media drama" as some might call the countless media coverage, news articles, blogs and other posts, the Supreme Court of the United States ("SCOTUS") upheld the Patient Protection and Affordable Care Act ("ACA") on June 28th, 2012.  Although four questions were before the Court, it focused primarily on one--the challenge to the individual mandate to purchase insurance by 2014 or pay a "penalty". 

In an opinion closing in on almost 200 pages, the Court found, 5-4, that the individual mandate penalty was constitutional.  Although the government's Commerce Clause argument was rejected, Chief Justice Roberts bought one of its alternative arguments: that the individual mandate penalty was the functional equivalent of a "tax."  However, the Court rejected the penalty which would have been imposed on states that refused to expand coverage under their Medicaid programs. Although granting higher funds for Medicaid expansion is permissible, withdrawal of all Medicaid funds to those states that do not would not be. 

For those of you who have not and will not have the time to plow through and digest the lengthy opinion, here are some of the best "plain english" explanations of the Court's decision as well as some interesting commentary:

But for those of you with a spare weekend or a day on the beach, or those of you who may simply miss law school, break out your Kindle and a glass of wine or margarita to read the opinion and the dissents.  You can download the full opinion here, National Federation of Independent Business v. Sebelius, from the SCOTUS website.

ACO Rule Keeps HIE Consent "On the Fence"

When DHHS published its Proposed ACO Rule in April 2011 and then the Final ACO Rule in November 2011 (I’ll refer to them as the “ACO Rules”), discussions focused predominately on issues such as who is “qualified” to participate, what the required governaConsent on the Fence.pngnce structure should be, what methodology will be used to assign Medicare beneficiaries, and what the payment models will be.  However, as I digested the ACO Rules, my reading deliberately slowed down as I zeroed in on the not unremarkable language and comments CMS included with regard to sharing individually identifiable health information in the ACO context.

Among other things, the ACO Rules would authorize key data sharing between CMS and an ACO.  In particular, four categories of data could potentially be shared:

  • Aggregated Data
  • Personal Identifiers
  • Personally Identifiable Claims Data
  • Prescription Claims Data

In the Preamble to the Proposed Rule, CMS emphasized the importance of sharing these forms of data in order provide more complete information for the services provided or coordinated for the ACO beneficiary populations, better achieve improvements in the quality of care and gain a better understanding of the population served while lowering the growth in health care costs. Notably, while the ACO Rules would permit Medicare beneficiaries to “opt-out” of certain data sharing, other data would be shared without the patient’s consent.  Moreover, it is clear that CMS deliberately chose to proceed with an opt-out approach, given its concerns regarding beneficiary participation and ACO Participant administrative burdens.  In the Preamble to the ACO Rules, it noted that:

An opt-out approach is used successfully in most systems of electronic exchange of information because it is significantly less burdensome on consumers and providers while still providing an opportunity for caregivers to engage with patients to promote trust and permitting patients to exercise control over their data.”  See 76 Fed Reg. 19560 (2011). 

Although some of the information that CMS proposes for “sharing” will be de-identified, other information will be identifiable. For example, limited beneficiary data (i.e., name, DOB, gender, insurance claim number) would be made available at the beginning of the first performance year and in connection with quarterly aggregated data reports.  Other data proposed to be shared could potentially include: (Medicare Part A & B) procedure codes; diagnosis codes; beneficiary IDs; DOB; geneder; date of dealth; claim ID; dates of service; provider/supplier ID; claim payment type; (Medicare Part D) beneficiary ID; prescriber ID; drug service date; drug product ID; if the drug is on the formulary. 

CMS acknowledges in the ACO Rules that there could be privacy concerns with sharing identifiable information, but nevertheless takes the position that the HIPAA Privacy Rule permits disclosure for purposes of sharing Medicare Part A and Part B claims data with ACOs participating in the Shared Savings Program.  The agency also specifically notes that the disclosures of claims data would be permitted as “health care operations”.  Under HIPAA, a covered entity may disclose PHI to another covered entity for the recipient’s health care operations if they both have or had a relationship with the individual, the records pertain to that relationship, and the records will be used for a health care operation function meeting one of the first two paragraphs in the definition of health care operation under HIPAA. 

Yet, although CMS explicitly states that it has the authority to share Medicare Claims Data without patient consent, the agency also notes that it “nonetheless believe(s) that beneficiaries should be notified of, and have meaningful control over who, has access to their personal health information for purposes of the Shared Savings Program.”  See 76 FR 19559; See also 76 FR 67849.  Therefore, while patients would not be able to opt-out of having de-identified aggregated data reports or limited identifiers shared with the ACOs, CMS will allow patients to opt-out of having claims data shared with the ACOs. 

Over the past year, privacy, patient consent and HIE opt-in/opt-out continues to be debated (sometimes painfully).  The debate continues essentially because certain stakeholders hold different and strong views on if, when and at what point affirmative patient consent is required (under current law) or should be required (through promulgation of new rules).  As a result, some HIE collaboratives have required affirmative patient consent before any data is shared. Similarly, Recommendations from the ONC Tiger Team include, in part, that consent should be obtained before any information is shared with third parties, including Business Associates and HIOs(except where sharing is directed exchange (provider-to-provider), or between providers participating in an OHCA (as as side note, query if ACOs might qualify as OHCAs? probably...at least in some cases)).  Others have determined that the value of networked electronic HIE – i.e., healthcare quality improvement and cost reduction – is most efficiently realized when certain data is readily shared without prior authorization or consent, in accordance with HIPAA's exceptions, as a presumed default.  Now with CMS throwing its views on consent & opt-in/opt-out into the ring, at least with respect to ACO's data-sharing with Medicare, I'm sure many are anxious to see if the forthcoming HITECH Final Rule and NHIN Governance Rule will offer clear standards for the current HIE consent conundrum, or continue to precariously balance this issue on the fence....... I know I personally can't wait to see.

HHS Announces Proposed Rules for Health Insurance Exchanges

In a Press Release posted yesterday, the U.S. Department of Health and Human Services (HHS) proposed a framework to assist states in building Affordable Insurance Exchanges, state-based competitive marketplaces where individuals and small businesses will be able to purchase affordable private health insurance and have the same insurance choices as members of Congress. The Press Release states, in part:

Starting in 2014, Insurance Exchanges will make it easy for individuals and small businesses to compare health plans, get answers to questions, find out if they are eligible for tax credits for private insurance or health programs like the Children’s Health Insurance Program (CHIP), and enroll in a health plan that meets their needs.

“Exchanges offer Americans competition, choice, and clout,” said HHS Secretary Kathleen Sebelius. “Insurance companies will compete for business on a transparent, level playing field, driving down costs; and Exchanges will give individuals and small businesses the same purchasing power as big businesses and a choice of plans to fit their needs.”

HHS indicates that the announcement is designed to help support and guide states in their efforts to implement Insurance Exchanges. HHS proposed new rules offering states guidance and options on how to structure their Exchanges in two key areas:

  • Setting standards for establishing Exchanges, setting up a Small Business Health Options Program (SHOP), performing the basic functions of an Exchange, and certifying health plans for participation in the Exchange, and;
  • Ensuring premium stability for plans and enrollees in the Exchange, especially in the early years as new people come in to Exchanges to shop for health insurance.

These proposed rules set minimum standards for Insurance Exchanges, give states the flexibility they need to design Exchanges that best fit their unique insurance markets, and are consistent with steps states have already taken to move forward with Exchanges.

To reduce duplication of effort and the administrative burden on the states, HHS also announced that the federal government will partner with states to make Insurance Exchange development and operations more efficient. States can choose to develop an Insurance Exchange in partnership with the federal government or develop these systems themselves. This provides states more flexibility to focus their resources on designing the right Insurance Exchanges for their local insurance markets.

Click below for a copy of the HHS's proposed rules for Insurance exchanges:

For a great summary of these new rules, click "Continue Reading" below.

For additional general information, check out www.healthcare.gov/exchanges.

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ONC Announces Launch of "Direct Project" Pilots

In a Press Release posted today, February 2nd, ONC announced that providers and public health agencies in Minnesota and Rhode Island began this month exchanging health information using specifications developed by the Direct Project, which is described as an "open government" initiative that calls on cooperative efforts by organizations in the health care and information technology sectors. The ONC Press Release notes that other Direct Project pilot programs will also be launched soon in New York, Connecticut, Tennessee, Texas, Oklahoma and California. The story is also covered today by the New York Times in Steve Lohr's article "U.S. Tries Open-Source Model for Health Data Systems".

The ONC Press Release notes that Direct Project is intended to give health care providers early access to an easy-to-use, internet-based tool that can replace mail and fax transmissions of patient data with secure and efficient electronic health information exchange.  It was designed as part of President Obama’s ‘open government’ initiative to drive rapid innovation, and last year is said to have brought together some 200 participants from more than 60 companies and other organizations. Volunteers worked together to assemble consensus standards that support secure exchange of basic clinical information and public health data. Now, pilot testing of information exchange based on Direct Project specifications is being carried out this year with the aim toward formal adoption of the standards by 2012.

ONC states that information exchange supported by Direct Project specifications address core needs, including standardized exchange of laboratory results; physician-to-physician transfers of summary patient records; transmission of data from physicians to hospitals for patient admission; transmission of hospital discharge data back to physicians; and transmission of information to public health agencies. The Press Release also notes

[t]hat in addition to representing most-needed information transfers for clinicians and hospitals, these information exchange capabilities will also support providers in meeting 'meaningful use' objectives established last year by HHS, and will thus support providers in qualifying for Medicare and Medicaid incentive payments in their use of electronic health records.

If you would like more information about Direct Project, or have questions such as:

  • How does direct exchange fit into the big picture?
  • How is direct exchange different than HIE initiatives?
  • Does direct exchange support or supplant State HIE initiatives?
  • What is the security model for Direct Project?
  • Who issues Digital Certificates for users?
  • What are the limitations of the Direct Project model?

Then, check out the following links for excellent information:



ACOs - Progressive HIEs, or Clinical Integration Déjà vu?

During my (long) flight back from the Southwest yesterday, an article in the Wall Street Journal caught my eye.  It was entitled "Embracing Incentives for Efficient Health Care" and prompted me to think about similarities between the recent HIE movement and the clinical integration movement in the 1990s. 

The article states that hospitals and doctors around the country are beginning to create new entities that aim to provide more efficient health care.  For instance, Tucson Medical Center in Arizona is forming a company that the hospital will own jointly with local physicians’ practices, which, in turn, will aim to sign contracts with insurers and Medicare to earn financial rewards if it reduces health care spending. This type of entity is referred to as an “accountable care organization” or “ACO” – a concept created by the Patient Protection and Affordable Care Act (PPACA) of 2010 – and they are indeed taking hold everywhere, including in New Jersey.

The WSJ article points out that Medicare’s traditional payment structure inherently incentivizes providers to order more tests and services because reimbursement is tied to volume. By comparison, under the PPACA the government intends to reward ACOs that can demonstrate reductions in Medicare costs across a group of patients, which should be achieved by the ACO-participants coordinating care and utilizing other methods (e.g., technology; patient care coordinators) to manage care for a certain patient group. Through future regulations, the Centers for Medicare & Medicaid Services (CMS) must implement the ACO option no later than the following new year (January 1, 2012).

However, the article also notes concerns are being raised that larger hospital-doctor coalitions could use their market clout to negotiate higher fees from private payors.  Karen Ignagni, chief executive of America’s Health Insurance Plans, an insurance trade group, is quoted in the Wall Street Journal article as stating "If ACOs are a recipe for more consolidation and price increases, that will take us in the wrong direction . . ."  But, CMS Deputy Administrator, Jonathan Blum's response is that CMS "wants the program to create incentives, both clinical incentives and payment incentives, that encourage providers to provide better and more low-cost care" and that his agency (CMS) is "working to ensure that [its] payment rules don’t produce unintended consequences for private payors.” 

To some extent, ACOs invoke a bit of déjà vu . . . 

In the 1990s, clinical integration was all the rage, as hospitals worked to acquire physician practices and create multi-entity systems.  However, even when clinical integration was successful, financial integration remained a formidable obstacle, and in most cases independent doctors were not able to integrate financially because health insurance plans were not willing to contract with independent doctors in this way.  Moreover, “messenger models”, global capitation and percent of premiums did not prove to be particularly effective solutions, as evidenced by the collapse of several health care systems attempting to create such integrated delivery networks. 

So, some may ask whether ACOs are destined to a similar eventual demise?  While some pilot ACO initiatives have produced mixed results, others, including ones in New Jersey, show promise of cost-savings and improved health care delivery, at least for certain patient populations.  In addition, with the feds pressing HIEs to operate with transparency and accountability, as well as engage in quality reporting using standardized measures, and to adopt new certified technologies supporting integration (e.g., the interoperability requirement), there will likely be more trust and "a common interest" among providers and, so ACOs may be better poised for success today than in the past.  

Even so, providers looking to form an HIE with future ACO-potential must ask and answer many vital questions with this prospective goal in mind, including, among other things: What corporate form should the HIE take?  What will be the governance and oversight structure? How will/can patients' data be used and disclosed through the ACO in compliance with federal and state privacy laws? In addition, once the PPACA rules are released, the HIE must be able to adapt to meet ACO-specific regulatory requirements.  Finally, and perhaps most importantly, an HIE or ACO that is looking to negotiate fees with potential payors must proceed with caution. Any network of otherwise competitive providers that are not adequately integrated to pass muster under the FTC's approved approaches may be engaging in collusive bargaining under the FTC's rules.  To review the FTC's advisory opinions where health care providers were found adequately integrated for purposes of antitrust analysis, visit the FTC's website for health care advisory opinions

For a select copy of 3 FTC's advisory opinions regarding integration of providers, click "Read More" below.  I also recommend reading an interesting interview with former CMS administrator, Mark McClellan, during which he answers the following questions:

  • What are some of the factors critical to successfully implementing an ACO?
  • How does the ACO model fit in context with other major reforms, like bundled payment, global and episode-based payment reforms, and the medical home model?
  • Long-term, which form of payment will work most effectively with the ACO model— shared fee-for-service savings, partial capitation, or some other form of global payment?
  • Are provider organizations "ready" to function as an ACO in areas such as governance, physician relationships, coordination, health information technology (HIT), and performance measurement?
  • ACOs have been discussed mostly in terms of hospitals and physicians. Does the ACO model hold promise for other combinations of health care providers?

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