Health IT for the 21st Century

Government Affairs Updates for the Health IT Industry

Friday, April 2, 2010

ONC plans certification well beyond electronic health records

While the majority of the ONC’s rulemaking proposal for the certification of meaningful use EHRs concerns the process of becoming a certifying entity, the 184-page document originally published March 2 is also a compelling look into the future.

Healthcare providers and health information technology leaders take note: according to the proposal, future plans for the specific certification of personal health records is repeatedly stated. Other passages speak to the existing proposal as a framework to certify “other networks designed for the electronic exchange of health information,” and in another passage, “other types of HIT.”

If that sounds overly ambitious given all that must occur for meaningful use stimulus funds to begin flowing next year (or even potentially this year for some state Medicaid incentives plans), the proposal’s foundations in transparency, competitiveness and a maturing of certification and accreditation should – and is meant to – instill faith in providers of ONC’s serious intent in the long-term establishment of a mutually beneficial health information network with population health squarely in mind.

Some assurance of a master plan, so to speak, can be found in the more detailed timelines of the new EHR certification plan as it corresponds to the stages of meaningful use detailed in the December 30 proposals of EHR standards by ONC, and of eligible professional capabilities by the Centers for Medicare and Medicaid Services (CMS).

The March 2 Notice of Proposed Rulemaking (NPRM) establishes a well-publicized temporary and then permanent certification structure, done to meet 2011 stimulus incentives and coincide with Stage 1 (and then Stage 2) meaningful use criteria.

The NPRM predicts that temporary certification largely overseen by ONC can begin this May or June, and be replaced by permanent certification led by the private sector by the first quarter of 2012. May or June could coincide with the final issuance of Stage 1 eligible professional and EHR meaningful use criteria, now that public comment ended March 15, while Stage 2 can begin when permanent certification takes over. That way private sector entities like the Certification Commission for Health Information Technology (CCHIT), the current gold standard in HIT certification, can know just what they are certifying for. And the proposal’s language concerning recertification following the temporary designation is not a repeat process, but an expansion in accordance with meaningful use stages.

And if all goes well, there’s reason to trust that the future certification of personal health records, “other types” and “other networks” can take hold.

To get there, permanent certification entities will be accredited, according to the new proposal, with oversight provided by the National Institute of Standards and Technology (NIST) and the National Voluntary Laboratory Accreditation Program (NVLAP). Likewise, the overall approach to the certification plans has been built by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). I know that sounds like a lot of layers of bureaucracy, but that is the world we are currently in. Speaking of CCHIT, the proposal notes that upon its publishing, only CCHIT has applied for and received “recognized certification body” status as outlined by the guidelines establishing the overall certification program, though the proposal clearly states ONC is seeking a competitive environment of varying temporary and permanent certification entities. (Public comment on the March 2 proposal allows 30 days for the temporary program, and 60 days for the permanent certification language.)

The proposal also estimates that meaningful use certification will remain with the current pricing range of $30,000 to $50,000, and also promises to disclose all eventual certification bodies – and the HIT systems ultimately certified – on HHS websites in another nod to transparency.

Finally, the proposal projects that even within 2010, 45 percent of the estimated 93 complete EHR systems currently available will be certified, followed by 40 percent in 2011 and the remaining 15 percent in 2012.

That is a framework we all hope can be met, all toward comprehensive EHR adoption the meaningful use program is meant to facilitate. At the same time, and while the plan for private sector certification is to be applauded, ongoing vigilance is necessary to ensure that the progress and innovation inherent in our industry does not become subject to over-regulation and truly embraces the private sector during future oversights this document also proposes.

By Justin T. Barnes


Justin Barnes is chairman of the Electronic Health Record Association and vice president of marketing, corporate development and government affairs at Greenway Medical Technologies, Inc.

Monday, March 22, 2010

U.S. House Passes Healthcare Reform Legislation ~ Health IT Well-Represented

Last night, the U.S. House of Representatives passed healthcare reform legislation with significant investment in more health IT - H.R. 3590, the Patient Protection and Affordable Health Care Act - on a vote 219-212. The Senate passed H.R. 3590 on December 24, 2009. President Obama is expected to sign this legislation into law (as early as this Tuesday).

Also last night, the House passed the Reconciliation Act of 2010, H.R. 4872, which makes changes to H.R. 3590. The Senate is expected to consider H.R. 4872 during the week of March 22nd. Senate Democrats will need a simple majority, 51 votes, to pass the legislation.

Below is an brief overview that should suffice most with health IT provisions bolded at the bottom.

Healthcare Reform Legislation, H.R. 3590 and H.R. 4872:

• Costs $938 billion over a decade
• Cuts the deficit by $143 billion in the first ten years (2010- 2019)
• Cuts the deficit by $1.2 trillion in the second ten years
• Estimated to reduce annual growth in Medicare expenditures by 1.4 percentage points per year
• Aims to expand health insurance coverage to 32 million Americans
• Aims to provide healthcare coverage to 94 percent of Americans
• Prohibits insurance companies from denying coverage to individuals with preexisting conditions (effective immediately for children and applies to all individuals beginning in 2014)
• Expands Medicaid to cover individuals with income less than133 percent of the federal poverty level, or $29, 327 for a family of four
• Closes the gap in prescription drug coverage
• Prohibits insurance companies from placing lifetime caps on coverage
• Requires health plans to allow young adults, up to age 26, to remain on their parents’ insurance policy
• Increases funding for Community Health Centers
• Provides financial assistance to states to aid in the establishment of offices of health insurance consumer assistance
• Establishes 50 health insurance exchanges, administered by states, through which, small businesses and individuals without employer sponsored insurance coverage could buy coverage
• Offers tax credits to small businesses to make employee coverage more affordable
• Eliminates co-payments for preventive services and exempts preventive services from deductibles under the Medicare program

Leverages health IT to improve the quality, cost, and access to healthcare. For example, the legislation:
o Supports programs to foster the reporting of quality measures through the use of health IT
o Directs the establishment of standards to facilitate the enrollment of individuals in health plans, as well as standards to enable the determination of an individual’s eligibility and financial responsibility for specific services prior to or at the point of care
o Establishes new programs that apply, among many things, health IT to test new, more effective healthcare delivery models
o Aims to increase the use of health IT in long-term care settings through financial assistance
o Directs the use of health IT in health risk assessments for Medicare beneficiaries
o Establishes incentive payments for health plans and providers that apply health IT in improving healthcare outcomes
o Supports the education and training of health IT among medical students

Public Policy Update for March

Congressional Affairs

Congress Votes on Healthcare Reform

Nothing finalized as I put this update together but Health Reform is expected to pass with 216 or 217 votes.

On Thursday afternoon, the reconciliation bill, HR 4872, was released by the House of Representatives. Because Congressional leaders promised 72 hours for review, a vote on the final package—that includes the Senate-passed bill, HR 3590, the Patient Protection and Affordable Care Act— was now scheduled for Sunday afternoon, March 21. The House needs 216 votes for passage. If approved by the House, the package would be considered in the Senate as early as next week, under a process that would require 51 votes for passage rather than the 60-vote threshold to break a filibuster. The reconciliation bill was released after the Congressional Budget Office released its preliminary analysis of the legislation, which puts a $940 billion price tag on the bill over 10 years, with a $138 billion deficit reduction over the same time period.

Groups both pro- and con- have been campaigning hard in Washington, DC this week. President Obama has been meeting one on one with undecided Democrats to urge them to vote yes. Several hundred Tea Party activists protested healthcare reform efforts outside Democratic Congressional offices on Tuesday. And more than 200 advocacy and healthcare organizations placed ads in Capitol Hill newspapers on Wednesday calling for lawmakers to pass the bill. The Washington Post has a graphic showing which way Members of Congress are leaning, and which Members are still undecided.

Governors are frustrated that they have not been able to contribute more to the healthcare reform process. “Polls have shown consistently that the American people are not happy with process,” said Governor Jim Douglas (R) of Vermont. “They want Republicans and Democrats to work together. There’s a clear difference between the level of cooperation in Congress and [among the] nation’s governors, who work with each other and steal good ideas and implement them, who have to balance budgets and get the job done in time.”

Clarification of Eligible Providers in a Hospital Setting Closer to Final Passage
HR 4213, the Tax Extenders Act, amends ARRA to exclude “outpatient” from the definition of hospital based eligible professionals and insert “emergency room setting.” This legislation removes the exclusion of hospital based outpatient physicians from receiving incentive payments. After passage in the Senate last week by a vote of 62-36, House and Senate leaders will work to iron out the differences between the Senate version and similar legislation that passed the House in late 2009.

The EHR language reads:
SEC. 219. EHR CLARIFICATION.

(a) QUALIFICATION FOR CLINIC-BASED PHYSICIANS.—

(1) MEDICARE.—Section 1848(o)(1)(C)(ii) of the
Social Security Act (42 U.S.C. 1395w–4(o)(1)(C)(ii)) is amended by striking ‘‘setting (whether inpatient or outpatient)’’ and inserting ‘‘inpatient or emergency room setting’’.

(2) MEDICAID.—Section 1903(t)(3)(D) of the Social Security Act (42 U.S.C. 1396b(t)(3)(D)) is amended by striking ‘‘setting (whether inpatient or outpatient)’’ and inserting ‘‘inpatient or emergency room setting’’.

(b) EFFECTIVE DATE.—The amendments made by subsection (a) shall be effective as if included in the enactment of the HITECH Act (included in the American Recovery and Reinvestment Act of 2009 (Public Law 111–5)).

(c) IMPLEMENTATION.—Notwithstanding any other provision of law, the Secretary may implement the amendments made by this section by program instruction or otherwise.

Public Policy Events:

National Health IT Week 2010 will take place June 14-18, 2010.

The Government Health IT Conference, “Innovation 2010, On the Threshold of Meaningful Use,” is scheduled for June 15-16, 2010, in Washington DC. Registration is now open. The deadline for Calls for Proposals is March 22, 2010.

The HIMSS 9th Annual Policy Summit will be held June 16-17, 2010, in Washington, DC. Registration is now open.
HHS Releases Additional HIE Funds to States
This week, HHS Secretary Kathleen Sebelius and National Coordinator for Health IT Dr. David Blumenthal announced that an additional $162 million in ARRA funds would be awarded to 16 states to assist them in facilitating “non-proprietary health information exchange that adheres to national standards.” Said Dr. Blumenthal, “Health information exchange will enable eligible healthcare providers to be deemed meaningful users of health IT and receive incentive payments under the Medicare and Medicaid electronic health record (EHR) incentive program.” According to HHS, every state and eligible territory has now been awarded funds under this program.

HIT Policy Committee Meets
The HIT Policy Committee met on Wednesday, March 17. The agenda included updates from the Workgroups and discussion with the HIT Standards Committee on continued efforts to synchronize policy and standards harmonization efforts. Of particular note was an update on the progress made by the Strategic Plan Workgroup on the Health IT Strategic Framework, which is on track to be delivered to ONC by Spring 2010 for publication in October 2010. In addition, the Certification/Adoption Workgroup provided a summary of their February 25 hearing on patient safety. The Workgroup is working through a series of recommendations for the HIT Policy Committee that will include an emphasis on patient engagement in identifying errors; provider training on reporting patient safety issues; the development of a national health IT reporting system to capture incidents and potential hazards with health IT, to include specific recommendations on certification criteria and software requirements for Stage 2 of meaningful use; and the creation of a toolkit for best safety practices. Audio of the meeting is available on the ONC website.

FCC Releases National Broadband Plan
The Federal Communications Commission has released the National Broadband Plan to ensure every American has “access to broadband capability.” On the Healthcare chapter, the Plan’s Executive Summary notes that “Broadband can help improve the quality and lower the cost of health care through health IT and improved data capture and use, which will enable clearer understanding of the most effective treatments and processes. To achieve these objectives, the plan has recommendations that will: help ensure health care providers have access to affordable broadband by transforming the FCC’s Rural Health Care Program; create incentives for adoption by expanding reimbursement for e-care; remove barriers to e-care by modernizing regulations like device approval, credentialing, privileging and licensing; and drive innovative applications and advanced analytics by ensuring patients have control over their health data and ensuring interoperability of data.”


ONC Launches NHIN Direct
The NHIN Direct project was recently launched by the Office of the National Coordinator for Health IT as the result of a recommendation made by the NHIN Workgroup of the HIT Policy Committee, to enable a secure health information exchange at a more local and less complex level than the Nationwide Health Information Network. “NHIN Direct is the set of standards, policies and services that enable simple, secure transport of health information between authorized care providers. NHIN Direct enables standards-based health information exchange in support of core Stage 1 Meaningful Use measures.” For example, NHIN Direct can be used by a primary care provider to send a referral or care summary to a local specialist. As part of the project, Arien Malec, Coordinator for the NHIN Direct project, is running an NHIN Direct blog and discussion board to engage stakeholders. For more information, please see NHIN Direct FAQ.

Upcoming Federal Events:

The HIT Standards Committee’s Vocabulary Task Force is holding a public meeting on March 23, 2010 in Washington, DC. The subject will be vocabulary subsets and value sets, particularly in the public sector.

The HIT Standards Committee is scheduled to meet on March 24, 2010, from 9:00 am – 3:00 pm.

On March 25, 2010 from 4:00 – 5:00 pm EDT, ONC and NIST will present an informational webinar on the recently released Certification Programs for HIT NPRM. The public comment period ends April 9 on the temporary certification program and May 10 on the permanent certification program.

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State Government Affairs

NCSL Tracks State HIT Legislation
The National Conference of State Legislatures has released the March issue of its Project HITCh newsletter (Health Information Technology Champions). In addition to stories about Federal Certification Processes and Grants, the newsletter notes that several states are considering “legislation to establish state coordinators for HIT, responding to the requirements in the HITECH Act. Some examples include Connecticut (HB 5354), Mississippi (HB 941), Pennsylvania (SB 8), and Wisconsin (HB 779). Some states are also creating their own funding initiatives. In Maine, the legislature is considering SB 675, which would create a $10 million bond issue to purchase software and equipment for providers in the state so they could utilize HIE. New Jersey is considering AB 1986, which would establish the Electronic Health Information Technology Fund, or e-HIT fund. The fund would provide revenue to carry out the state’s HIT plan by levying a 0.199% tax on all health insurance claims in the state.”

Thursday, March 11, 2010

ARRA and Beyond: How to Select a Stimulus-ready EHR for the Life of Your Practice and Your Patients

By Justin T. Barnes

Stated goals of the HITECH (Health Information Technology for Economic and Clinical Health) Act within ARRA (The American Recovery and Reinvestment Act of 2009) mirror those of physician practices: early detection, prevention, and management of chronic diseases, for example.

Additional goals seek to improve the coordination of care and information among hospitals, laboratories, and physician offices; improve healthcare quality, reduce medical errors, reduce health disparities, and advance the delivery of patient-centered medical care.

Getting there, specifically in terms of qualifying for Medicare or Medicaid, Regional Extension Center (REC), Health Information Exchange (HIE), broadband, and the many related programs together offering approximately $45 billion in incentive funds and grants combines the art of traditional medicine and the science of today’s healthcare delivery capabilities, as well as innovation.

Now that the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) have released meaningful use criteria—with the CMS proposed rule defining criteria for eligible professional providers, and the ONC interim final rule setting functionality standards for EHRs—the documents can provide a checklist for selecting the right EHR.

With the public comment phase of the original proposals coming to a close March 15, expect final regulations due later this spring or in early summer to subtract or limit some of the functionality criteria, and expand the definition of providers in hospital settings eligible for funding, all based on public comment to date. By regulatory definition, and again based on public comment, do not expect any expansion of the CMS or ONC list of functionality requirements. The more recent ONC issuance of meaningful use certification the first week of March - proposing a temporary and then final certification process - will help streamline an EHRs current certification status.

And overall there’s still time to qualify. For both the Medicare and Medicaid incentive pathways, the initial meaningful use year for non hospital-based eligible providers remains 2011, with respective funding continuing for 5- and 6-year cycles. And within the Medicare pathway, for example, the proposals state that eligible professionals must only achieve meaningful use reporting for 90 continuous days to qualify, meaning meaningful use reporting can begin as late as October, 2011. (Medicaid incentives can be subject to individual state plans in regards to timetables and is well worth checking.)

The major financial tenets of achieving incentive funds through the use of a certified EHR offering meaningful use functionality are well chronicled and unchanged: up to $44,000 through Medicare and up to $63,750 through Medicaid pathways, paid per eligible professional within a practice of any size.

Whether your practice is seeking a fully integrated, interoperable, and certified EHR/practice management (PM) solution or just searching for a companion certified EHR for an existing PM system, many independent evaluation and analysis tools focus on ARRA-driven meaningful use functionality standards, as well as a wealth of ROI calculators and case studies to draw from.

Throughout the closing months of 2009 and early 2010, tangible ARRA-supporting funding announcements and new legislation brought multiple reasons for confidence in the incentive package. For example, The Small Business Health Information Technology Financing Act (HR 3014) guarantees loans through SBA of up to $350,000 for small practices and $2 million for group practices to bridge EHR implementation costs until ARRA reimbursement kicks in (http://tinyurl.com/yle7x9l). HR 3014 has already passed the House of Representatives, and a companion bill has been introduced in the Senate.

Looking deeper into incentives pathways reveals additional opportunities. Practices within health professional shortage areas can qualify for an additional 10% of incentive funds (www.gao.gov/new.items/d0784.pdf). A total of $2.5 billion is available for the aforementioned utilization of broadband and telemedicine capabilities, and the REC program’s $598 million in funding targets practices of 1-10 providers (http://tinyurl.com/my736w).

Demystifying Meaningful Use
The proposed meaningful use criteria for the main ARRA incentive funds for certified EHR adoption is a two-part consideration. On one hand, your certified EHR must have the necessary functionality to support meaningful use. On the other, practices must show they are using the functionality in a meaningful way within proposed criteria to qualify for the appropriate incentives.

The overall meaningful use criteria is proposed in three phases over time, with only phase one required in the first meaningful use year. Phase one includes the ability of providers to collect data in electronic form, share key information with other providers and patients, and the ability to report quality measures.

For EHR software providers, functionality must allow integration or interoperability via standard exchange language (CCD or CCR) to share data. Electronic prescribing and computerized physician order entry (CPOE) are examples of the basic interoperable and meaningful functionalities to secure.

And of course, it’s smart to look ahead. Phases two and three of meaningful use coming after 2011 expand functionality to include disease management criteria and information exchange with government and public health agencies, when formulary checks, encounter progress notes, and automated lab results come into play. For example, an interoperable EHR should link clinical devices such as ECG or spirometry, or merge automated lab results into flow sheets on a system that maintains the values and integrity of the data for later retrieval.

The demystification comes into play when practices selecting an EHR find that 1) EHR software providers have been developing functionality and interoperability that adheres to previously known meaningful use criteria, and 2) that current certification has also been shaped to meaningful use standards.

Throughout your selection process, keep in mind that the CMS and ONC proposals do state that meaningful use is, “based on currently available technological capabilities and providers’ practice experience,” and that, “the standards adopted in the rules are consistent with current industry standards.”

Selecting an EHR
It is important for practices to select an internal search committee that is well represented by physician, nurse, administrative, and IT personnel. Next, spend time evaluating the goals and workflows of the practice. Are you adopting a certified EHR for just ARRA incentive reasons? Are you looking for improved efficiency within your practice? Are you seeking to improve quality or improve patient satisfaction? Maybe you would like to participate in clinical research? Community leadership? All of the above?

Other areas to think about and discuss with companies that offer certified EHRs (and hopefully ones you have heard great things about) include:
• Your specific requirements in accordance with your practice’s workflow, growth, and revenue targets, as well as future meaningful use requirements
• Your infrastructure. Does your existing PM system have the ability to interoperate with a separate certified her, or should you invest in just a combined EHR/PM system?
• Your practice size and scope. Do they call for implementing a client-server EHR, or an offsite (Internet-dependent), SaaS (Software as a Service) EHR
• EHR product demonstrations, site visits, and references from similar practices of your size and specialty.

Other independent evaluations that speak more to usability should be considered. Two large studies by the AAFP and Medscape were recently released and represent the feeling of thousands of EHR users on the actual usability of their system (http://tinyurl.com/y8rntb6). Another good reference of EHR solutions is found at www.klasresearch.com, where products are listed by practice size. KLAS ratings are based on a set of 25 key questions in the areas of sales and contracting, implementation and training, functionality and upgrades, service and support, and general scoring.

Other national organizations such as the Medical Group Management Association (www.mgma.com) and the HIMSS EHR Association (www.himssehra.org) offer EHR implementation tips, as do such compatible websites as www.ehrdecisions.com. When it comes to cost, don’t be afraid to negotiate with EHR software providers; discuss monthly payment and lease options, as well as IRS Code section 179 tax incentives, with them.

Finding Confidence in ARRA
It’s important to realize that the stimulus EHR adoption incentives are grounded in law, and not just regulation. ARRA funding and other recent developments, such as HR 3014, that support and fund EHR adoption beyond ARRA have inherent flexibility meant to ensure that practices do not fall outside of the guidelines. For example, Medicare reimbursement is not a fixed appropriation, but a fluid formula that keeps pace with the number of practices that are adopting EHRs and achieving meaningful use.

In late 2009, CMS notified all state Medicaid directors that CMS will reimburse at a 100% level the incentive payments that providers who achieve EHR meaningful use are due by state. Also, on December 9, CMS notified its first group of states (TX, GA, NY, ID, CA, and MT) that funds were also being deployed for statewide analysis and infrastructure needs for the planning of activities to administer incentive funds. Texas, for example, received $3.86 million toward that effort.

And earlier, on November 24, ONC announced an $80 million grants program to train a healthcare IT workforce in community colleges and other realms, with all of these steps pointing to concrete support of the ARRA program.

Practices can keep up with the details of ARRA and ongoing events through HHS websites (www.recovery.gov, www.hhs.gov/recovery) and via a new ONC blog titled Health IT Buzz (http://healthit.hhs.gov/blog/onc).

Many components of the HITECH Act were directly supported by the current presidential administration’s transition team when ARRA was created. That support is further encouragement that the legislation is being successfully implemented, and in a bit of serendipity, the incentive funding in its current language will begin arriving at practices the year of this administration’s re-election campaign, meaning national healthcare organizations invested in ARRA will be letting themselves be heard.

The certified EHR adoption and implementation process for your practice should be as time-consuming as it needs to be for you and your practice to achieve meaningful EHR use, but not intimidating. On your side is a wealth of EHR adoption precedent, evaluation and certification resources, ROI examinations, and growing oversight by federal institutions. Making the right selection can provide ROI far beyond the ARRA incentives and can include your practice in the blueprint for a national health information network (NHIN).

Justin T. Barnes is chairman of the Electronic Health Records Association, and is vice president of Marketing, Corporate Development and Government Affairs at Greenway Medical Technologies, Inc.

Monday, February 15, 2010

Millions Awarded in Grants Tied to EHR Functionality

The following are helpful resources regarding the over $750 million investment in HHS grant awards for meaningful use of health IT, of which $386 million will go to 40 states and qualified State Designated Entities (SDEs) to facilitate health information exchange (HIE) at the state level, while $375 million will go to an initial 32 non-profit organizations to support the development of regional extension centers (RECs).

Additional information about the state HIE and RECs may be found at http://HealthIT.HHS.gov/statehie and http://healthit.hhs.govextensionprogram

Information about other health IT programs funded through the American Recovery and Reinvestment Act of 2009 can be found here: http://HealthIT.HHS.gov

Information about Healthcare/High Growth Grants, and other DOL training programs is available at http://www.doleta.gov/.

For more information about the Recovery Act, please visit: www.hhs.gov/recovery , www.dol.gov/recovery and www.recovery.gov.

Monday, February 8, 2010

Finding Focus at HIMSS

Conferences like HIMSS can seem overwhelming with information overload. Certainly the opportunities and excitement surrounding the ARRA funding is center stage, and there are many outgrowths from it. One that I believe is involved but even supersedes it in importance and history is the issue of patient privacy and security. It’s on the minds of patients and providers, and we’ve seen it’s a concern when providers consider adapting to electronic health records. Going back to the establishment of HIPPA and looking where we are now with increasing online patient portals and the relationships with Microsoft HealthVault and other patient empowering tools is important. The HIMSS conference has privacy and security workshops in place, and over the years ONC’s Policy and Standards committees have created workgroups just on privacy and security. And we know ONC’s Interim Final Rule on meaningful use has asked the EHR community to offer guidance on privacy and security in public comment to the IFR. If we are truly going to have a national health information network and truly interoperable delivery, the privacy and security of patient records is an area where there must be proven best practices, and this year’s conference is a watershed opportunity for that.