Some Concerns with the EHR Incentive Program

There has been much discussion and debate on the use of electronic health records and whether they are capable of improving the quality of care. In the recent Stanford University study by researchers Max Romano and Randall Stafford, MD, PhD, there was not much indication of quality improvement. In another study from Britain they were likewise unable to find empirical evidence of quality and safety improvement. However, my conclusion, unlike the headlines which blared "EHR Systems Do Not Improve Quality," is that while the technology itself will not automatically improve quality or safety the "meaningful use" of this technology can and will improve clinical outcomes and the quality of care. My concerns on the EHR Incentive Programs are not centered on this debate, but rather on components of the legislation and regulations.

I'm trying to remain optimistic about these programs, but there are some issues that I would like to highlight as potential roadblocks to success. Unfortunately, many of these problems are written into the legislation and can not be fixed by future rulemaking, but will require Congress to act. And the amount of incentive payments are too low and will not cover the transition costs for providers that are still on paper, although hospitals and health systems that have already made significant investments in health IT will see some return on their investment. I'm not much concerned that HR 408 the Spending Reduction Act of 2011, which would defund the HITECH Act incentive program, will become law. However, I would like to see checks make it to providers before future stages of meaningful use become a political football.

There are potentially some serious difficulties that rural providers and small hospitals will have being able to fund these projects within their limited resources, considering that the incentive payments will barely, if at all, cover the costs of implementation. I fear that billions of taxpayer dollars will pass right through the hands of hospitals and physicians and go straight to the bottom line of health IT vendors. Healthcare providers could end up having a very hard time maintaining the meaningful use of their EHRs with a dwindling revenue stream. The CBO estimated in 2008 that EHR implementation costs for hospitals amount to approximately $14,500 per bed for implementation. Annual operating costs amount to $2,700 per bed per year. For physician groups, the CBO reported that total implementation costs for office-based EHRs ranged from $25,000 to $45,000 per physician, with annual operating, licensing, and maintenance costs ranging between $3,000 and $9,000 per physician. These figures are conservative at best and costs have certainly risen since then in any event. The costs will continue to increase due to market pressures and vendor workforce shortages.

There are also eligibility problems that some providers in a Rural Health Clinic (RHC) setting are facing. The HITECH Act created an EHR incentive payment for an Eligible Professional (EP) under Medicare based on the allowed charges for covered professional services furnished by the EP. Only services billed under the Part B physician fee schedule meet the HITECH Act definition of "covered professional services." This means services provided in an RHC would not be included in the calculation for the Medicare EHR incentive. These providers may still qualify under their states Medicaid requirements, but only EPs who meet the 30 percent threshold for "needy individuals" as defined in statute and other program requirements will qualify for payments. This section of the law will cause some providers in rural and underserved settings to be unable to participate in the program at all.

This same section of the legislation also precludes Medicare Advantage providers from participating directly in the program since they do not bill Part B. Under the Medicare Advantage EHR Incentive Program, payments are made only to Medicare Advantage organizations that are licensed as HMOs, or in the same manner as HMOs, by a state. It seems that the legislation was crafted with particular lobbying interests at the table, and while no bill is perfect the HITECH Act was rushed through rather quickly and mistakes were made which are unlikely to be addressed in the current political environment.

Another group that is left out are Physician Assistants (PA)s, unless they are working in a RHC led by a PA. There are many PAs working in settings that will disqualify them from participating in the incentive program and this already having an effect on recruitment strategies. Why would a practice hire a PA who is ineligible instead of a Nurse Practitioner who is eligible? This can also create difficulty and confusion for EHR adoption strategy by clinics attempting to create a patient-centered medical home. The wise use of mid-level practitioners can be an important key to success. Addressing the primary care physician shortage is not helped by this provision in the legislation.

Finally, the Medicaid program is being approached in a wide variety of ways by the states, and some may be trying to use the incentive program as a policy lever to accomplish other goals. I am concerned that in some states the roll out of the incentive program may have lost sight of the economic stimulus side of the equation. Money continues to be poured into government run programs like the State Cooperative Agreements for health information exchange and the Regional Extension Centers to help with adoption, but few of these dollars are making it into the private sector. I like the "adopt, implement or upgrade to certified EHR technology (AIU)" provision in the Medicaid EHR Incentive Program. This will enable some to springboard to future stages of meaningful use. If this were expanded then perhaps there would not be so many rural providers and critical access hospitals left at the station...


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Enabling Personalized Medicine through Health Information Technology

On January 28, 2011 the Center for Technology Innovation at Brookings hosted a policy discussion focused on the challenges of enabling personalized medicine, as well as the policy and operational changes that would facilitate connectivity, integration, reimbursement reform and secondary analysis of information. Vice President and Director of Governance Studies Darrell West presented key findings and recommendations from his paper Enabling Personalized Medicine through Health Information Technology about the public policy actions needed to ensure that health information technology facilitates the adoption of personalized medicine in the U.S. healthcare system. David Brailer, chairman of Health Evolution Partners and the first National Health Information Technology Coordinator during the Bush administration, delivered the keynote address. Afterwards speakers took questions from the audience. The podcast is below:



"With federal officials pursuing the goal of a personal human genome map under $1,000 in five years (White House, 2010), it is possible to envision a future where treatments are tailored to individuals’ genetic structures, prescriptions are analyzed in advance for likely effectiveness, and researchers study clinical data in real-time to learn what works," said Mr. West in the Executive Summary of the report.

"Implementation of these regimens creates a situation where treatments are better targeted, health systems save money by identifying therapies not likely to be effective for particular people, and researchers have a better understanding of comparative effectiveness," he adds, citing the PCAST Report.

The summary goes on to say, "Interoperability represents a major challenge because of the difficulty of integrating data from different sources. If researchers and healthcare providers are not able to exchange information, it raises the cost of health care and makes it difficult to learn in real-time. A considerable amount of medical information is collected, but too little of it is integrated or put into data bases that are usable for research or public health purposes."

The report identifies three revolutions and how they affect healthcare:

1. The Medical Delivery Revolution: New Actors and New Relationships
A shift from a hierarchical delivery system to one that features greater transparency, collaboration, and patient involvement with more more empowered relationship between primary care doctors and their patients.
2. The Digital Revolution and Ways to Convert Data into Knowledge
An explosion of digital resources available over the Internet for patients as well as physicians.
3. Genomics and the Impact on Medical Care
The work of the Human Genome Project and further research has established links between gene structures, human illnesses, treatment effectiveness, and adverse effects.

The report goes on to identify policy challenges and provides recommendations including new approaches to privacy and access control. This is an excellent paper and I recommend studying it carefully.


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Multiple chronic conditions, not age, main driver of health system use by seniors

Study identifies gaps in primary health care for seniors with multiple chronic conditions

Seniors and the Health Care System: What Is the Impact of Multiple Chronic Conditions?

The number of health care services seniors use is determined more by the number of chronic conditions they have than by their age, according to a new study from the Canadian Institute for Health Information (CIHI). The study found that older seniors (85 and older) with no chronic conditions made less than half the number of health care visits as younger seniors (65 to 74) with three or more chronic conditions, such as diabetes, hypertension and heart disease.

CIHI’s study Seniors and the Health Care System: What Is the Impact of Multiple Chronic Conditions? examines how seniors not living in institutions access health services and what kind of care they receive. According to the study, three out of four Canadians age 65 and older reported having at least one chronic condition, while one in four seniors reported having three or more.

Among the study’s key findings:

• The 24% of seniors who reported living with three or more chronic conditions were responsible for 40% of health care use among Canadian seniors.
• Seniors with three or more chronic conditions reported using three times as many health care services as Canadians age 65 and older with no chronic conditions. Those with three or more chronic conditions also reported more than twice the rate of visits to a family doctor as seniors with only one chronic condition.
• Similar patterns of health care use existed among adults age 45 to 64; those with three or more chronic conditions made six times as many health care visits as those with no reported conditions.
• Seniors with three or more chronic conditions made three times as many visits to emergency departments as seniors with no reported chronic conditions.

“Our study shows that the presence of chronic conditions has a much higher impact on our health care resources than age alone. And with rates of diabetes and hypertension on the rise in Canada, the prevalence and resulting economic burden of these conditions is expected to increase as the population ages,” explains Jeremy Veillard, Vice President of Research and Analysis at CIHI. “However, while the risk of developing chronic conditions increases with age, good primary care plays a strong role in managing them and even possibly delaying or preventing their onset.”

CIHI’s study findings are based on the 2008 Canadian Survey of Experiences With Primary Health Care, conducted by Statistics Canada and funded by CIHI and the Health Council of Canada, which surveyed adults not living in institutions or remote areas. The 11 common chronic conditions included in the study are arthritis, asthma, cancer, chronic pain, depression, diabetes, emphysema or chronic obstructive pulmonary disease, heart disease, high blood pressure, mood disorders other than depression and stroke.

The study found that Canadian seniors with three or more chronic conditions reported taking an average of six prescription drugs regularly, twice as many as seniors with only one chronic condition. Seniors with chronic conditions regularly taking at least five prescription medications were more than twice as likely to experience a side effect requiring medical attention (13%) as those taking only one or two prescription medications (6%). Yet less than half of seniors with chronic conditions reported that their doctor reviewed their medications (48%) and explained potential side effects (47%) at least some of the time.

“Seniors who are taking a large number of drugs face not only the risk of side effects from negative drug interactions but also the possibility of not taking their medications as directed,” says Dr. Bill Hogg, Research Director of the C. T. Lamont Primary Healthcare Research Centre at the Élisabeth Bruyère Research Institute at the University of Ottawa. “Strategies to reduce the number of medications a senior is prescribed, when possible, can result in better compliance with medication regimens and lead to a better quality of life.”

Reducing gaps in preventive care could lead to fewer health care visits

While the majority of seniors reported having a family physician, only two out of five (42%) reported that at least some time in the past year they had talked with a health professional about what they could do to improve their health or prevent illness (including quitting smoking, increasing exercise or limiting alcohol consumption). The results were similar for tomorrow’s seniors, as only 45% of adults between the age of 45 and 64 spoke with their health care provider about things they could do to improve their health.

“As Canada’s population ages, it is natural to assume that the prevalence of chronic conditions will increase,” says Greg Webster, CIHI’s Director of Primary Health Care. “Efforts to better understand the relationship between the management of chronic conditions and health care use can lead to better preventive care, which will result in healthier seniors and reduced costs to the system.”

via cihi.ca

Information Exchange Workgroup Provider Directory Task Force 1-24-11

The Information Exchange Workgroup Provider Directory Task Force met on January 24, 2011 and continued their discussion on Individual Level Provider Directories. The webinar is below:

The Public’s Health Care Agenda for the 112th Congress

VIEW WEBCAST HERE

Though the public remains divided on health reform overall, opposition to the new law ticked upward in January as Republicans ramped up efforts to repeal it, according to a new survey conducted by researchers from the Kaiser Family Foundation and the Harvard School of Public Health.

The survey also showed that there is no groundswell of public support for overturning the law, that many individual components of the legislation remain popular across the political spectrum and that a majority of Americans oppose the idea of lawmakers using the appropriations process to defund or slow down implementation of the law.

The survey, fielded in the weeks prior to the House repeal vote, was conducted at a time of substantial change in the political landscape in Washington, as Republicans take control of the House and politicians of both major parties attempt to respond to public concerns over the rising federal budget deficit. While most Americans in the survey say they prefer spending cuts over new taxes as the main way to reduce the deficit, there is little public consensus about where to achieve meaningful savings and a majority opposes any spending reductions in two of the nation’s largest entitlement programs, Medicare and Social Security. Nearly half of Americans oppose any cuts in another major entitlement program, Medicaid. Large majorities oppose major reductions in all three programs.

"Budget experts say that the budget deficit cannot be tackled without taking on Social Security, Medicare and Medicaid spending, or by raising taxes," said Kaiser President and CEO Drew Altman. "But the American people do not believe this at all. There is a huge gap in basic beliefs and understandings of the problem and what it takes to solve it."

Mixed Views on Repeal, While A Majority Opposes Cutting Off Funding

The share of Americans with unfavorable views of the health reform law rose to 50 percent this month, up from 41 percent in December, while the share holding favorable views remained largely unchanged at 41 percent. Increasing opposition among independents drove much of the change. Fifty-seven percent of independents had an unfavorable view of the law in January, up sharply from 41 percent in December, suggesting that GOP messages about the need to repeal the law resonated with independents during this time period.

The public also is divided on what should happen next.  About as many people want to expand the law or keep it as it is (28% and 19%, respectively) as want to repeal and replace the law or simply just repeal it (23% and 20%).  Now that the repeal vote in the House is over, Republicans are expected to turn to efforts to defund and slow down implementation of the law through the appropriations process and other means. Yet the survey finds that most Americans (62%) disapprove of such a strategy.  Most Republicans (57%) favor defunding health reform in the absence of repeal, but most independents are opposed (62%) along with a large majority Democrats (84%).  Even among those who don’t like the law and want to see it repealed, about four in ten say they disapprove of cutting off funding.

"The public is frustrated with politics as usual, and may be saying that defunding a law is not how government should work," said Mollyann Brodie, senior vice president and director of the Foundation’s Public Opinion and Survey Research group.


The public’s concerns about the law are varied, and tend to vary by party affiliation.  More than half of Americans, including 81 percent of Republicans and 57 percent of independents, believe it will entail too much government involvement in the health care system.  Yet most Democrats, 58 percent, think it will lead to about the right amount of government involvement.  Also, despite the Congressional Budget Office’s findings to the contrary, 60 percent of Americans think the law will boost the deficit over the next decade -- a view common even among supporters of the law.

Component Parts of Health Reform Remain Popular
Despite such concerns, many of the law’s component parts remain popular.  Substantial majorities of Americans say they favor many of its provisions such as gradually closing the coverage gap known as the Medicare doughnut hole (85%), providing subsidies for low- and moderate-income Americans to buy health insurance (79%), establishing a voluntary insurance program known as the CLASS Act to help pay for long-term care services (76%) and expanding the Medicaid program (67%). Some provisions are less popular, including requirements that all but the smallest employers offer health insurance to their workers or pay a penalty (51% oppose this) and, most controversially, that nearly all Americans obtain health coverage or face a fine (76% oppose).

The survey shows, however, that public opinion about this last provision is somewhat malleable.  Told that without the requirement, insurance companies would still be allowed to deny coverage to people who are sick, unfavorable views fall from 76 percent to 47 percent.  On the other side, opposition rises to 85 percent when Americans are told that the requirement could mean that some people would have to buy health insurance they find too expensive or don’t want.

Most Want To Reduce The Deficit But Not With Big Cuts in Medicare, Social Security or Medicaid
About two in three Americans say they are "very concerned" about the federal budget deficit, including more than seven in ten Republicans and independents and fewer than half of Democrats.  There is a similar partisan divide over when Congress should tackle the problem, with most independents (61%) and Republicans (70%) saying lawmakers should act
quickly to reduce the deficit and most Democrats (61%) preferring to wait until the economy gets better.

Most Americans -- including majorities of Republicans and independents (76% and 59%) and a plurality of Democrats (39%) -- prefer spending cuts over tax increases as the main way to reduce the deficit.  But finding spending cuts the public will accept will be difficult for lawmakers.  Of the 12 areas of spending cited in the poll, the only one in which a majority of Americans say they are willing to support "major reductions" is the relatively small amount devoted to foreign aid. In addition, about four in ten would back major reductions in funding for the war in Afghanistan and in salaries and benefits for federal workers.

In contrast, a majority of Americans said they would support no spending reductions in Social Security (64%) and Medicare (56%), two entitlement programs that together account for about a third of all federal spending.  Nor do they want to see any reduction in spending for public education (63%).  Nearly half say the same thing about Medicaid (47%). Very small percentages of Americans support the "major reductions" that some believe are necessary in programs such as Social Security (8%), Medicare(8%) and Medicaid (13%), the survey found. 

This is true even among Republicans, just 18 percent of whom support major reductions to
Medicaid and 10 percent of whom support major reductions to Medicare and Social Security.
"The upcoming battle lines are clear," said Robert Blendon, professor of health policy and political analysis at the Harvard School of Public Health.  "One side will argue we need across the board cuts in domestic spending to quickly reduce the deficit, the other that popular health care programs should not be cut even if the deficit is not reduced.  Which side will win is not clear."



Even among Republicans, who are more likely than Democrats and independents to back spending cuts, majorities say they would not support any reductions in Social Security (59%) and public education (53%). Moreover, 52 percent of Republicans want no reductions in funding for national defense, another major area of federal spending and one in which independents and Democrats would support some cuts.  When it comes to funding for expanding insurance coverage under the health reform law, 44 percent of Republicans say they would support major reductions while almost as many Democrats (38%) want to see no reductions.

The public’s reluctance to touch Medicare, Social Security and, when it comes to big cuts, also Medicaid may stem from the benefits, direct and otherwise, that people believe they confer on their families.  More than three-quarters of Americans rated Medicare as either "very important" (55%) or "somewhat important" (22%) to their families, while nearly six in ten said the same thing about Medicaid (39% "very important," 20% "somewhat important").  Sixty-eight percent of Americans say the country’s budgetary problems can be addressed without trimming Medicare spending at all.

Methodology
This Kaiser Family Foundation/Harvard School of Public Health survey,The Public’s Health Care Agenda for the 112th Congress, was designed and analyzed by public opinion researchers at the Kaiser Family Foundation led by Mollyann Brodie, Ph.D., including Claudia Deane, Liz Hamel, Sarah Cho, Bianca DiJulio, and Theresa Boston and by Professor Robert Blendon, Sc.D. and John Benson at the Harvard School of Public Health.  The survey was conducted January 4 through January 14, 2011, among a nationally representative random sample of 1,502 adults ages 18 and older.  Telephone interviews conducted by landline (1,000) and cell phone (502, including 203 who had no landline telephone) were carried out in English and Spanish by Social Science Research Solutions. The margin of sampling error is plus or minus 3 percentage points.  For results based on other subgroups, the margin of sampling error may be higher.

The full question wording, results, charts and a brief on the poll can be viewed online.

via kff.org

Stage 2 Meaningful Use Request for Comments

The Health Information Technology Policy Committee, which advises the Department of Health and Human Services, is seeking comments through Feb. 25 on an initial set of proposed requirements for stage 2 meaningful use of electronic health records. The committee plans to hold public hearings this spring, and to issue final recommendations to HHS this summer for consideration in rulemaking. We should all plan to submit comments on the proposed stage 2 requirements currently under consideration. This will give ample opportunity for broad stakeholder input into the process before the proposed rule and final rule are published. Comments can be submitted here on regulations.gov. Below is information on the request for comment from the Meaningful Use Workgroup Regarding Meaningful Use Stage 2 [PDF]

HIT Policy Committee:

Meaningful Use Workgroup Request for Comments Regarding Meaningful Use Stage 2

I. Background

The Health Information Technology Policy Committee (HITPC) is a federal advisory committee that advises the U.S. Department of Health and Human Services (HHS) on federal HIT policy issues, including how to define the ―meaningful use‖ (MU) of electronic health records (EHRs) for the purposes of the Medicare and Medicaid EHR incentive programs. The HITECH portion of the American Recovery and Reinvestment Act (ARRA) of 2009 specifically mandated that incentives should be given to Medicare and Medicaid providers not for EHR adoption but for ―meaningful use‖ of EHRs. In July of 2010, HHS released that program’s final rule, thus defining stage 1 MU and strongly signaling that the bar for what constitutes MU would be raised in subsequent stages in order to improve advanced care processes and health outcomes.

The HITPC held six public hearings in 2010 including testimony from several dozen stakeholders and received additional dozens of public comments via its blog. All of this input helped to inform its many hours of public deliberations regarding the future vision of MU (e.g., stage 3) as well as the interim stepping stone of stage 2 MU that will set expectations for 2013 and 2014.

The HITPC has developed a preliminary set of recommendations specifically designed to solicit additional public feedback. The goal of sending out this request for comment (RFC) early is threefold.

1. Provide some signal to the industry of potential new EHR functionalities that the HITPC may recommend to help the industry get a head start on developing new functionalities.
2. Extend the public discussion of future stage MU definitions through a more formal public comment process well in advance of its formal final stage 2 recommendations to be issued in the summer of 2011.
3. Request input on specific questions.

Following analysis of the comments received through the approximately 45-day public comment period, the HITPC intends to revisit these recommendations in its public meetings in the spring of 2011. At that time, the HITPC will be able to review public comments in the context of the early feedback from providers on experience with stage 1 MU. That input will come through many vehicles: the Medicare program, the Medicaid program (both federal and state constituencies), the HIT regional extension program, and other sources. Note, this RFC solely represents the preliminary thinking of the HITPC and its Meaningful Use Workgroup.

Structure and Relevant Concurrent HITPC Activities

The HITPC has created a matrix of objectives and measures that it is considering for its recommendations to HHS. These objectives are organized into four of the five health outcome priorities that formed the stage 1 MU organizing structure. The HITPC approached its task of developing proposed stage 2 objectives by first developing a longer-term vision for MU and then determining what an appropriate stage 2 stepping stone is to get there. For this reason, the matrix includes possible stage 3 objectives, but they are only included in the matrix in order to provide context for the Stage 2 recommendations. Therefore, for the purpose of this Request for Comments, the HITPC is primarily interested in comments on the proposed Stage 2 objectives at this time.

The HITPC has a concurrent activity that is developing Stage 2 and 3 recommendations for the fifth health outcome priority — ensure adequate privacy and security protections for personal health information. The HITPC and its Privacy & Security Tiger Team will subsequently release recommendations for this domain.

In addition, the HITPC has a Quality Measures (QM) Workgroup that is concurrently developing a framework for the evolution of clinical quality measures to be electronically reported as part of Stages 2 and 3 MU. The HITPC recently collected public input through a request for comment on a set of proposed measure concepts, and it will provide more guidance on its measure development priorities in the near future following synthesis and analysis of those public comments. Other recommendations about information exchange are being developed by the HITPC’s Information Exchange Workgroup.

Proposed MU Objectives and Measures for Stages 2 and 3

Meaningful Use: Stage 1 Final Rule and Proposed Objectives for Stages 2 and 3
Improving Quality, Safety, Efficiency & Reducing Health Disparities
Stage 1 Final Rule		Proposed Stage 2		Proposed Stage 3	Comments
CPOE for medication orders (30%)		CPOE (by licensed professional) for at least 1 medication,  and 1 lab or radiology order for 60% of unique patients who have at least 1 such order (order does not have to be transmitted electronically)		CPOE (by licensed professional) for at least 1 medication, and 1 lab or radiology order on 80% of patients who have at least 1 such order (order does not have to be transmitted electronically)
Drug-drug/drug-allergy interaction checks		Employ drug-drug interaction checking and drug allergy checking on appropriate evidence-based interactions		Employ drug-drug interaction checking, drug allergy checking, drug age checking (medications in the elderly), drug dose checking (e.g., pediatric dosing, chemotherapy dosing), drug lab checking, and drug condition checking (including pregnancy and lactation)  on appropriate evidence-based interactions	Reporting of drug interaction checks to be defined by  quality measures workgroup
E-prescribing (eRx) (EP) (40%)		50% of orders (outpatient and hospital discharge) transmitted as eRx		80% of orders (outpatient and hospital discharge) transmitted as eRx	If receiving pharmacy cannot accept eRx, automatically generating electronic fax to pharmacy OK
Record demographics (50%)		80% of patients have demographics recorded and can use them to produce stratified quality reports		90% of patients have demographics recorded (including IOM categoriesi) and can use them to produce stratified quality reports
Report CQM electronically	Continue as per Quality Measures Workgroup and CMS		Continue as per Quality Measures Workgroup and CMS			The HIT Policy Committee’s Quality Measures Workgroup issued a request for comment in December; new measures will be considered after review of public comments
Maintain problem list (80%)	Continue Stage 1		80% problem lists are up-to-date			Expect to drive list to be up-to-date by making it part of patient visit summary and care plans
Maintain active med list (80%)	Continue Stage 1		80% medication lists are up-to-date			Expect to drive list to be up-to-date via medication reconciliation
Maintain active medication allergy list (80%)	Continue Stage 1		80% medication allergy lists are up-to-date			Expect to drive the list to be up-to-date by making it part of visit summary
Record vital signs (50%)	80% of unique patients have vital signs recorded		80% of unique patients have vital signs recorded
Record smoking status (50%)	80% of unique patients have smoking status recorded		90% of unique patients have smoking status recorded
Implement 1 CDS rule	Use CDS to improve performance on high-priority health conditions. Establish CDS attributes for purposes of certification: 1. Authenticated (source cited); 2. Credible, evidence-based; 3. Patient-context sensitive; 4. Invokes relevant knowledge; 5. Timely; 6. Efficient workflow; 7. Integrated with EHR; 8. Presented to the appropriate party who can take action		Use CDS to improve performance on high-priority health conditions. Establish CDS attributes for purposes of certification: 1. Authenticated (source cited); 2. Credible, evidence-based; 3. Patient-context sensitive; 4. Invokes relevant knowledge; 5. Timely; 6. Efficient workflow; 7. Integrated with EHR; 8. Presented to the appropriate party who can take action
Implement drug formulary checks*	Move current measure to core		80% of medication orders are checked against relevant formularies			What is the availability of formularies for eligible professionals?
Record existence of advance directives (EH) (50%)*		Make core requirement. For EP and EH: 50% of patients >=65 years old have recorded in EHR the result of an advance directive discussion and the directive itself if it exists		For EP and EH: 90% of patients >=65 years old have recorded in EHR the result of an advance directive discussion and the directive itself if it exists	Potential issues include: state statutes; challenges in outpatient settings; age; privacy; specialists; needs to be accessible and certifiable; need to define a standard
Incorporate lab results as structured data (40%)*		Move current measure to core, but only where results are available		90% of lab results electronically ordered by EHR are stored as structured data in the EHR and are reconciled with structured lab orders, where results and structured orders available
Generate patient lists for specific conditions*		Make core requirement. Generate patient lists for multiple patient-specific parameters		Patient lists are used to manage patients for high-priority health conditions
Send patient reminders (20%)*		Make core requirement.		20% of active patients who prefer to receive reminders electronically receive preventive or follow-up reminders	How should ―active patient‖ be defined?
(NEW)		30% of visits have at least one electronic EP note		90% of visits have at least one electronic EP note	Can be scanned, narrative, structured, etc.
(NEW)		30% of EH patient days have at least one electronic note by a physician, NP, or PA		80% of EH patient days have at least one electronic note by a physician, NP, or PA	Can be scanned, narrative, structured, etc.
(NEW)		30% of EH medication orders automatically tracked via electronic medication administration recording		80% of EH inpatient medication orders are automatically tracked via electronic medication administration recording
Engage Patients and Families in Their Care
Stage 1 Final Rule		Proposed Stage 2		Proposed Stage 3	Comments
Provide electronic copy of health information, upon request (50%)		Continue Stage 1		90% of patients have timely access to copy of health information from electronic health record, upon request	Only applies to information already stored in the EHR
Provide electronic copy of discharge instructions (EH) at discharge (50%)		Electronic discharge instructions for hospitals (which are given as the patient is leaving the hospital) are offered to at least 80% of patients (patients may elect to receive only a printed copy of the instructions)		Electronic discharge instructions for hospitals (which are given as the patient is leaving the hospital) are offered to at least 90% of patients in the common primary languages (patients may elect to receive only a printed copy of the instructions)	Electronic discharge instructions should include a statement of the patient’s condition, discharge medications, activities and diet, follow-up appointments, pending tests that require follow up, referrals, scheduled tests  [we invite comments on the elements listed above]
EHR-enabled patient-specific educational resources (10%)		Continue Stage 1		20% offered patient-specific educational resources online in the common primary languages
(NEW for EH)		80% of patients offered the ability to view and download via a web-based portal, within 36 hours of discharge, relevant information contained in the record about EH inpatient encounters. Data are available in human-readable and structured forms (HITSC to define).		80% of patients offered the ability to view and download via a web-based portal, within 36 hours of discharge, relevant information contained in the record about EH inpatient encounters. Data are available in human readable and structured forms (HITSC to define).	Inpatient summaries include: hospitalization admit and discharge date and location; reason for hospitalization; providers; problem list; medication lists; medication allergies; procedures; immunizations; vital signs at discharge; diagnostic test results (when available); discharge instructions; care transitions summary and plan; discharge summary (when available); gender, race, ethnicity, date of birth; preferred language; advance directives; smoking status. [we invite comments on the elements listed above]
Provide clinical summaries for each office visit (EP) (50%)		Patients have the ability to view and download relevant information about a clinical encounter within 24 hours of the encounter. Follow-up tests that are linked to encounter orders but not ready during the encounter should be included in future summaries of that encounter, within 4 days of becoming available. Data are available in human-readable and structured forms (HITSC to define)		Patients have the ability to view and download relevant information about a clinical encounter within 24 hours of the encounter. Follow-up tests that are linked to encounter orders but not ready during the encounter should be included in future summaries of that encounter, within 4 days of becoming available. Data are available in human readable and structured forms (HITSC to define)	The following encounter data are included (where relevant): encounter date and location; reasons for encounter; provider; problem list;medication list; medication allergies; procedures; immunizations; vital signs; diagnostic test results; clinical instructions; orders: future appointment requests, referrals, scheduled tests; gender, race, ethnicity, date of birth; preferred language; advance directives; smoking status. [we invite comments on the elements listed above]
		demand) relevant information contained in the longitudinal record, which has been updated within 4 days of the information being available to the practice. Patient should be able to filter or organize information by date, encounter, etc. Data are available in human-readable and structured forms (HITSC to define).		demand) relevant information contained in the longitudinal record, which has been updated within 4 days of the information being available to the practice. Patient should be able to filter or organize information by date, encounter, etc. Data are available in human readable and structured forms (HITSC to define).	locations; reasons for encounters; providers; problem list; medication list; medication allergies; procedures; immunizations; vital signs; diagnostic test results; clinical instructions; orders; longitudinal care plan;gender, race, ethnicity, date of birth; preferred language; advance directives; smoking status. [we invite comments on the elements listed above]
This objective sets the measures for ―Provide timely electronic access (EP)‖ and for ―Provide clinical summaries for each office visit (EP)‖		EPs: 20% of patients use a web-based portaliii to access their information (for an encounter or for the longitudinal record) at least once. Exclusions: patients without ability to access the Internet		EPs: 30% of patients use a web-based portaliii to access their information (for an encounter or for the longitudinal record) at least once. Exclusions: patients without ability to access the Internet
(NEW)		EPs: online secure patient messaging is in use		EPs: online secure patient messaging is in use
(NEW)		Patient preferences for communication medium recorded for 20% of patients		Patient preferences for communication medium recorded for 80% of patients	How should ―communication medium‖ be delineated?
				Offer electronic self-management tools to patients with high priority health conditions	We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3 objective
				EHRs have capability to exchange data with	We are seeking comment on what
PHRs using standards-based health data exchange				steps will be needed in stage 2 to achieve this proposed stage 3objective
				Patients offered capability to report experience of care measures online	We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective
				Offer capability to upload and incorporate patient-generated data (e.g., electronically collected patient survey data, biometric home monitoring data, patient suggestions of corrections to errors in the record) into EHRs and clinician workflow	We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective
Improve Care Coordination
Stage 1 Final Rule		Proposed Stage 2		Proposed Stage 3	Comments
Perform test of HIE		Connect to at least three external providers in ―primary referral network‖ (but outside delivery system that uses the same EHR) or establish an ongoing bidirectional connection to at least one health information exchange		Connect to at least 30% of external providers in ―primary referral network‖ or establish an ongoing bidirectional connection to at least one health information exchange	Successful HIE will require development and use of infrastructure like entity-level provider directories (ELPD)
Perform medication reconciliation (50%)*		Medication reconciliation conducted at 80% of care transitions by receiving provider (transitions from another setting of care, or from another provider of care, or the provider believes it is relevant)		Medication reconciliation conducted at 90% of care transitions by receiving provider
Provide summary of care record (50%)*		Move to Core		Summary care record provided electronically for 80% of transitions and referrals
(NEW)		List of care team members (including PCP) available for 10% of patients in EHR		List of care team members (including the PCP) available for 50% of patients via electronic exchange
(NEW)		Record a longitudinal care plan for 20% of patients with high-priority health conditions		Longitudinal care plan available for electronic exchange for 50% of patients with high-priority health conditions	What elements should be included in a longitudinal care plan including: care team members; diagnoses; medications; allergies;goals of care; other elements?
Improve Population and Public Health
Stage 1 Final Rule		Proposed Stage 2		Proposed Stage 3	Comments
Submit immunization data*		EH and EP: Mandatory test. Some immunizations are submitted on an ongoing basis to Immunization Information System (IIS), if accepted and as required by law		EH and EP: Mandatory test. Immunizations are submitted to IIS, if accepted and as required by law. During well child/adult visits, providers review IIS records via their EHR.	Stage 2 implies at least some data is submitted to IIS. EH and EP may choose not, for example, to send data through IIS to different states in Stage 2. The goal is to eventually review IIS-generated recommendations
Submit reportable lab data*		EH: move Stage 1 to core  EP: lab reporting menu. For EPs, ensure that reportable lab results and conditions are submitted to public health agencies either directly or through their performing labs (if accepted and as required by law).		Mandatory test. EH: submit reportable lab results and reportable conditions if accepted and as required by law. Include complete contact information (e.g., patient address, phone and municipality) in 30% (EH) of reports. EP: ensure that reportable lab results and reportable conditions are submitted to public health agencies either directly or through performing labs (if accepted and as required by law)
Submit syndromic surveillance data*		Move to core.		Mandatory test; submit if accepted
				Public Health Button for EH and EP: Mandatory test and submit if accepted. Submit notifiable conditions using a reportable public-health submission button. EHR can receive and present public health alerts or follow up requests.	We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective
				Patient-generated data submitted to public health agencies	We are seeking comment on what steps will be needed in stage 2 to achieve this proposed stage 3objective
Ensure Adequate Privacy and Security Protections for Personal Health Information
Stage 1 Final Rule		Proposed Stage 2		Proposed Stage 3	Comments
Conduct security review analysis & correct deficiencies					Additional privacy and security objectives under consideration via the HIT Policy Committee’s Privacy & Security Tiger Team

* menu option for Stage 1

Additional Specific Questions for Public Comment
The Health Information Technology Policy Committee welcomes public comment on all proposed objectives and their associated definitions. In addition, the Committee seeks specific input on the following additional questions.

1. How can electronic progress notes be defined in order to have adequate specificity?
2. For patient/family access to personal health information, what standards should exist regarding accessibility for people with disabilities (e.g., interoperability with assistive technologies to support those with hearing, visual, speech, or mobile impairments)?
3. What strategies should be used to ensure that barriers to patient access – whether secondary to limited internet access, low health literacy and/or disability – are appropriately addressed?
4. What are providers’ and hospitals’ experiences with incorporating patient-reported data (e.g., data self-entered into PHRs, electronically collected patient survey data, home monitoring of biometric data, patient suggestions of corrections to errors in the record) into EHRs?
5. For future stages of meaningful use assessment, should CMS provide an alternative way to achieve meaningful use based on demonstration of high performance on clinical quality measures (e.g., can either satisfy utilization measures for recording allergies, conducting CPOE, drug-drug interaction checking, etc, or demonstrate low rates of adverse drug events)?
6. Should Stage 2 allow for a group reporting option to allow group practices to demonstrate meaningful use at the group level for all EPs in that group?
7. In stage 1, as an optional menu objective, the presence of an advance directive should be recorded for over 50% of patients 65 years of age or older. We propose making this objective required and to include the results of the advance-directive discussion, if available. We invite public comment on this proposal, or to offer suggestions for alternative criteria in this area.
8. What are the reasonable elements that should make up a care plan, clinical summary, and discharge summary?
9. What additional meaningful-use criteria could be applied to stimulate robust information exchange?
10. There are some new objectives being considered for stage 3 where there is no precursor objective being proposed for stage 2 in the current matrix. We invite suggestions on appropriate stage 2 objectives that would be meaningful stepping-stone criteria for the new stage 3 objectives.

E. Evidence Base/Rationale for Proposed New Objectives

The HITPC identified proposed new objectives because of their potential impact on the five health outcome priorities to be achieved through the meaningful use of EHRs. Some of the relevant evidence to these proposed objectives is reflected below.

Patient and Family Engagement

In a randomized control trial assessing the efficacy of a home-based computer system in providing information and decision support as well as expert and other patient contacts to patients with HIV, findings were significant for improved quality of life indicators such as cognitive function, social support and participation in their health care, and also for decreased time spent during ambulatory visits, fewer phone calls to providers, and decreased number and length of hospitalizations.

Qualitative data analysis of provider impressions of a patient centered CDSS (Patient Assessment, Care and Education) designed to increase identification and treatment of chemotherapy related symptoms affirmed the increased awareness of underreported symptoms and additional benefits such as better communication with patients.

A retrospective cross-sectional study analyzing the adoption of and patient satisfaction with a PHR reported 25% of patients registered with PHR and reported over 90% satisfaction with the PHR, with greatest satisfaction with test results, medication refills, and secure messaging.

A CDSS electronic checklist specifically aimed to improve delivery of evidence based discharge instructions for patients with heart failure (HF) or acute myocardial infarction (AMI) was evaluated to be effective in increasing delivery of discharge instructions (from 37.2% pre-intervention to 93.0% post-intervention). In addition, prescription of ACEI or ARB in patients with HF and AMI improved to 96.7% from 80.7% and to 100% from 88.1%, respectively.

An interventional study assessing the effect of patient messaging reminding patients of screening, diagnostic and monitoring tests in accordance with evidence based guidelines found an increase in adherence to clinical recommendations by 12.5% (p < 0.001).

A randomized control trial of 246 patients who were newly diagnosed with breast cancer assessed the effect of a home-based computer system with information, decision-making and emotional support. The study found that patients in the intervention group were significantly more competent in seeking information, more comfortable participating in care, and more confident in their interactions with physicians at two months post intervention and had better social support and information competence at five months post intervention. Furthermore, the relative benefits in the intervention group were greater for patients in underserved populations.

Quality and Safety

A randomized control trial evaluating effect of CDSS alerting physicians to order venous thromboembolism (VTE) prophylaxis showed the intervention resulted in 41% decreased risk for VTE at 90 days.

Using CDS to alert physicians and pharmacists to 8 critical drug interactions resulted in 31% decrease in dispensed drugs known to have adverse interactions.

A prospective analysis of an antimicrobial surveillance system using evidence based guidelines in a children’s hospital showed successful identification of prescribing errors allowing for early intervention.

Analysis of a CDS system intervention aimed at improving asthma documentation and management in the emergency department found that asthma severity, asthma precipitants, ICU admission history and smoking status were recorded significantly more often with the CDSS. Additionally, 76% of patients received a discharge asthma plan compared with 16% before the intervention.

A prospective cohort study assessed efficacy of CDSS in identifying patients with acute lung injury (ALI) compared to physician diagnosis alone. This study is significant because early treatment of ALI is critical to overall prognosis. The CDSS had a sensitivity of 96.3% and specificity of 89.4% whereas physician diagnosis was 26.5% sensitive and 99.5% specific. Although the CDSS was less specific, physician diagnosis alone missed 239 cases while the CDSS missed 12.

A survey of ambulatory care providers assessed attitudes toward CPOE and e-prescribing systems and found that the majority reported improved quality of care and efficiency, prevention of medical errors, and increased patient satisfaction as advantages to the system. More than one third reported that in the last month they had avoided a medication error because of system alerts In addition, slightly less than half reported better counseling of adverse effects and improved monitoring. (Despite this only 47% reported satisfaction with the system. Complaints included alerts regarding medications discontinued, alert fatigue, and alerts inappropriately identifying drug interactions.)

Implementation of a web-based laboratory information system to treat multi-drug resistant tuberculosis patients in Peru greatly improved timely access to lab results and user satisfaction. The system was expanded to other institutions based on its success to serve a network for over 3.1 million patients. The system is at relatively low cost amounting to 1% of National Peruvian Tuberculosis annual budget.

Population Health

Population based surveillance system in a large multicenter primary care network identified patients overdue for mammography screening. The interventional study showed that providers successfully contacted 63% of over 3,000 patients at risk.

A computer based smoking cessation program designed after extensive review of the literature on the barriers associated with such a program, was found to be effective, inexpensive and required little time or skill from staff. The program was continued following the conclusion of the study because of the satisfaction rates from providers and patients.

Study showed feasibility and reliability of EHR based chronic kidney disease (CKD) registry composed of 57,276 patients in accurately relaying demographics and most comorbidities when compared to individual EHR chart review (κ >0.80). Study concluded such a registry has the potential to improve quality of care in this patient population and contribute to the development of a national CKD surveillance project.

Care Coordination

A study assessing the effect of a medication reconciliation program in an ambulatory oncology clinic found at least one error in 81% of all patients’ medication lists. In the group that received the intervention, 90% of incorrect medication lists were corrected, while only 2% were corrected in the control group (p < 0.001).

2007 cross-sectional survey of US home health and hospice agencies found 33% increase in use of EHRs since 2000. The agencies used available EHR functionalities in general, including telemedicine and information sharing..

Efficiency

Antibiotic approval system guiding use of 28 restricted antibiotics improved appropriate use of antibiotics and led to increased susceptibility of S. aureus to methicillin and of pseudomonas to several antibiotics. Patients with gram negative bacteremia did not suffer increased adverse outcomes as a result.

An interventional study (n=2200) compared RBC transfusions in critically ill patients before and after evidence based CDS intervention significant decrease in number of RBC transfusions per patient and percentage of patients transfused (p = 0.045 and p = 0.01 respectively) and net savings of almost $60,000 (n=1100 patients).