Recent Comparative Studies of Health Systems

As America continues to wrestle with the thorny thicket of health care reform, there are a number of recent reports chronicling and comparing approaches to health care and health reform in different countries that are worth a read.  For example:

• The Organisation for Economic Co-operation and Development recently released Health at a Glance 2011: OECD Indicators, which provides “comparable data on different aspects of the performance of health systems in OECD countries.” The U.S. spends 2 ½ times more than the OECD average health expenditure per capita (which amounted to 17.4% of GDP in 2009). (OECD explores why in a separate addendum, “Why is Health Spending in the United States So High”.) Yet, with the exception of cancer care and acute care in hospitals, it is not clear Americans are getting improved quality for the greater expenditures. As reported by CQ HealthBeat and by the Commonwealth Fund, “hospital services cost much more in the United States and pharmaceutical prices are much higher compared to other countries;” “there are fewer practicing physicians per 1,000 population, fewer doctor consultations and shorter hospital stays;” “more CT scans, knee replacements, and Caesarean sections;” and “comparatively high hospital admission rates for preventable conditions like asthma, diabetes and hypertension.”

• Strengthening Primary Care: Recent Reforms and Achievements in Australia, England, and the Netherlands, a recent report by Sharon Willcox, Geraint Lewis, and Jako Burgers of the Commonwealth Fund, evaluates efforts to improve access to, and the quality of, primary care in these countries– and suggests what the U.S. can learn from these initiatives. These countries have been focusing on three primary care reform strategies: promoting coordination of care, reforming primary care payment, and improving quality and access. As the abstract summarizes, “[q]uality improvement strategies include postgraduate training programs for family physicians, accreditation of general practitioner (GP) practices, and efforts to modify professional behaviors–for example, through clinical guideline development. Strategies for improving access include national performance targets, greater use of practice nurses, assured after-hours care, and medical advice telephone lines. All three countries have established midlevel primary care organizations both to coordinate primary care health services and to serve other functions, such as purchasing and population health planning. Better coordination of primary health care services is also the objective driving the use of patient enrollment in a single general practice. Payment reform is also a key element of English and Australian reforms, with both countries having introduced payment-for-quality initiatives. Dutch payment reform has stressed financial incentives for better management of chronic disease.”

• Bradford H. Gray, Thomas Bowden, Ib Johansen, and Sabine Koch, also of the Commonwealth Fund, review the extent of adoption of “meaningful use” (as defined in federal regulations) in three countries with extensive experience with electronic health records, Denmark, New Zealand, and Sweden in Electronic Health Records: An International Perspective on “Meaningful Use.” Although these European countries have high levels of EHR adoption, they have not reached 100% meaningful use, with the greatest weakness being in information provided to patients. The authors suggest that the U.S. could learn from these experiences the value of “providing economic incentives to encourage adoption and designating an organization to take responsibility for standardization and interoperability.”

• International Profiles of Health Care Systems: Australia, Canada, Denmark, England, France, Germany, Italy, Japan, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and the United States, edited by Sarah Thomson, Robin Osborn, David Squires, and Sarah Jane Reed and published by the Commonwealth Fund, provides an overview of the health systems in these countries– including “health insurance, public and private financing, health system organization, quality of care, health disparities, efficiency and integration, use of health information technology, use of evidence-based practice, cost containment, and recent reforms and innovations.”

• The Commonwealth Fund also recently released results of an international study of patients with complex care needs in eleven countries: Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, the United Kingdom, and the U.S. Although it identified significant care coordination issues, it found that “patients who have a medical home reported better coordination of care, fewer medical errors, and greater satisfaction with care than those without one.” In addition, the study also found “that patients in the United States are much more likely than those in 10 other high-income countries to forgo needed care because of costs and to struggle with medical debt.” 27% “were unable to pay or encountered serious problems paying medical bills in the past year, compared with between 1 percent and 14 percent of adults in the other countries,” and 42% did not see a doctor, fill a prescription, or receive recommended care. The authors conclude that “[t]he United States in particular has opportunities to learn from abroad-including the use of purchasing power to lower prices, payment innovations, and the use of information systems and care system redesign efforts that are under way in several countries.”

Of course, there are a variety of reasons the experiences in other countries may not take root in the United States.  But we still should be aware of these efforts and critically evaluate whether we might transplant any of them as seeds of reform here.

Reform Rodeo

Photo by David Monniaux

[Ed. Note: HRW welcomes back Jordan Cohen from his work in Washington at HHS this summer-- the place just wasn't the same without him]

Waste: The New York Times provides an overview of a new study detailing health care wastefulness — which the Times reports as being the first study to quantify the problem.

Berwick’s Pilots: Newly appointed Medicare director Donald Berwick is pushing for hundreds of new pilot programs that would seek to innovate the delivery of health care.

Prognostication: The Health Care Blog’s David Kibbe and Brian Klepper look beyond meaningful use and distill five future trends of patient health data and clinical health information technology.

Meaningful Use FAQs: For those with questions on meaningful use, John Halamka has created FAQs.

PPACA and Employees: Researchers at RAND have published a study predicting PPACA’s effect on workers’ health insurance coverage.

Medicaid Outside the Box: Health Affairs’ Michael O’Grady and Jennifer Baxendell Young have published a post that discusses new ideas for Medicaid financing.

Reform Rodeo: Latest News & Interviews; CER; the Constitution; HIT; Robotic Surgery

Photo by David Monniaux

1. News: Kaiser Health News keeps you up to date by rounding up various stories on the Dems’ latest down-to-the-wire push on health reform. Their coverage of Representative Dennis Kucinich’s (and other reluctant Dems’) endorsement of the bill is here.

2. Betting on Health Care: The New York Times asks health wonks for opinions on the chances of passing health reform. Respondents include Robert Reich, former secretary of labor Gail Wilensky, Project Hope; Paul Starr, professor of public policy;  James C. Capretta, Ethics and Public Policy Center; Karen Davenport, Center for American Progress; Jacob S. Hacker, political science professor.

3. Evidence-based Medicine: A group at the New England Journal of Medicine proposes 5 steps to advance one of the most promising–yet often ignored–means of reforming our health care system: comparative effectiveness research.

4. Deem and Pass: Jonathan Adler at the Volokh Conspiracy discusses the constitutionality of the “deem and pass.” Regardless of its constitutionality, Ezra Klein exposes some factual inaccuracies in recent reporting on the tactic.

5. The Blues: The Pittsburgh Post-Gazette alerts us to a lawsuit by Highmark Inc. against the Pennsylvania Department of Insurance, which claims that the Department exceeded its authority when challenging Highmark’s proposed merger with Independence Blue Cross.

6. Meaningful Use Partial Credit: John Halamka at Life As A Healthcare CIO discusses the aggressive thresholds for meaningful use that have been set in the most recent rules, and what the HIT Policy Committee is doing to assuage those concerns.

7. Wild Card: A new TED talk about the current state of robotic surgery. An article covering the topic can be found here.

An Overview of the New Federal Standards Governing Health Information Technology (Part 1)

Those hoping for health reform have recently had a bad stretch of luck. I am here to report that movement in the reform process is certain in one area: health information technology (HIT). It may not be the sexiest topic in health care, but as David Blumental, the director of the Office of the National Coordinator for Health Information Technology (ONC),  noted in his piece for the New England Journal of Medicine, “[i]nformation is the lifeblood of modern medicine. Health information technology (HIT) is destined to be its circulatory system.” The ONC recently released an interim final rule (IFR) for HIT standards. CMS released a notice of proposed rule making (NPRM) that describes how Electronic Health Records (EHRs) are to be put to “meaningful use.” The context of both of these rules is the incentive-based program that the federal government has created. The goal of this program is to spur the creation of a sustainable and interoperable nationwide network of EHRs.

As opposed to describing every detail of the ONC’s interim final rule, I think it would be more valuable to broadly discuss the general standards that the government has decided upon, and then describe those standards so that the reader has a general idea of what these standards are.

Two Tables are Primary Reference for Understanding the Rule

So what did the ONC determine? The easiest way to tease out the big picture is to refer to two tables (Table 1 and Table 2A) that are buried within the IFR.

The two tables have been extracted from the pdf for ease of reference. Table 1 can be found here (pdf). Table 2A can be found here (pdf).

Preview of Table 1 - Click Thumbnail Above to View All of Table 1

Preview of Table 2A - Click Thumbnail Above to View All of Table 2A

For the full IFR, it can be found here in pdf or here in html.

Using the tables to decode the IFR

Table 1 has three columns. The column on the left consists of the stage 1 meaningful use objectives that were issued by CMS and which serve to govern the purpose and capabilities of EHRs at a broad level. (For background on CMS’s proposed guidelines for meaningful use, see my earlier post here). The two columns on the right of Table 1 are the ONC’s certification criteria. These criteria have been created in order to support CMS’s meaningful use objectives. The middle column corresponds to the criteria for non-hospital providers–referred to as eligible professionals–such non-hospital-based physicians. The rightmost column corresponds to the criteria for hospitals (referred to as eligible hospitals). These two groups, eligible professionals and eligible hospitals, are eligible in the sense that they are eligible for reimbursement in exchange for the meaningful use of EHR technology.

Table 2 is the final piece of the puzzle, laying out the standards that the ONC has adopted. The standards are the nitty gritty details of the broader certification criteria that support the even broader meaningful use objectives.  Thus, we have a framework for our standards: start with the meaningful use objectives, establish certification criteria for these objectives, and then specify the standards that would allow for an objective determination of whether the criteria has been met.

With these tables in hand, it is possible to delve a bit deeper into the ONC’s vision of HIT.

Three Important Phrases: “Certified EHR Technology”, “Complete EHR”, and “EHR Module”

The regulations utilize the phrases “Certified EHR Technology”, “Complete EHR,” and “EHR Module” in an effort to implement flexible standards that can evolve as the standards continue to evolve. This idea of the rules evolving is a common theme, and it cannot be stressed enough that the ONC has gone through great pains in balancing the predictability of constrained EHR standards with the dynamism of the evolving standards landscape.

Terms

• Qualified EHR: an electronic record of health-related information on an individual that:
  • (A) Includes patient demographic and clinical health information, such as medical history and problem lists; and
  • (B) has the capacity:
    • (i) To provide clinical decision support;
    • (ii) to support physician order entry;
    • (iii) to capture and query information relevant to health care quality; and
    • (iv) to exchange electronic health information with, and integrate such information from, other sources.’
• Certified EHR Technology: A Complete EHR or a combination of EHR Modules, each of which:
  1. Meets the requirements included in the definition of a Qualified EHR; and
  2. has been tested and certified in accordance with the certification program established by the National Coordinator as having met all applicable certification criteria adopted by the Secretary.
• Complete EHR: EHR technology that has been developed to meet all applicable certification criteria adopted by the Secretary.
• EHR Module:  any service, component, or combination thereof that can meet the requirements of at least one certification criterion adopted by the Secretary. Examples:  Interface or other software program that provides the capability to exchange electronic health information; An open source software program that enables individuals online access to certain health information maintained by EHR technology; A clinical decision support rules engine; A software program used to submit public health information to public health authorities; and, A quality measure reporting service or software program.

In order to allow for flexibility, the ONC does not require that “Certified EHR technology” is a complete “turn key” system. Rather, the ONC allows for two different types of “Certified EHR Technology.” On the one hand you have “Complete EHRs” which are  “turn key” solutions in that a complete EHR meets the broad functional requirements of a qualified EHR and all of the  certification criteria listed in Table 1 (see link to Table 1 pdf above). On the other hand, “Certified EHR Technology” may also consist of a combination of modules, as long as the combination of modules meets the broad functional requirements of a “Qualified EHR,” and the modules together satisfy all of the certification criteria. Thus, physicians and hospitals retain flexibility in how they implement technology to achieve meaningful use.

The Adopted Standards

The ONC has grouped the standards into four groups:

1. Vocabulary Standards — The standardized nomenclatures and code sets used to describe clinical problems and procedures, medications and allergies.
2. Content Exchange Standards –  The standards used to share clinical information such as clinical summaries, prescriptions, and structured electronic documents.
3. Transport Standards — The standards used to establish a common, predictable, secure communication protocol between systems.
4. Privacy and Security Standards — Standards relating to authentication, access control, transmission security which relate to and span across all of the other types of standards.

Content Exchange Standards

Table 2A describes the first 2 categories. It is actually most helpful to initially discuss the second category: the content exchange standards. The content exchange standard can be thought of as the rules that constrain the shape and form of the data. In other words, it concerns how the data is structured. A standardization  of the structure is necessary so that different computer systems can predictably send and receive data that is organized in a predictable format. A rough analogy can be made to the Bluebook citation standards which specify the organization of legal citations. Regardless of the court reporter being used, all bluebook citations to federal court cases have the same basic organization (e.g. case name in italics, followed by the reporter, starting page, etc). Whereas a law school journal may only accept the Bluebook standard, the ONC has decided to allow for two standards:  Health Level Seven (HL7) Clinical Document Architecture (CDA) Release 2 (R2) Level 2 CCD or ASTM CCR.  Again, the ONC has sought flexibility in the initial stage of the certification process by allowing for multiple standards to be used. As noted in Table 2A, the ONC will eventually decide on one of these standards. It should be noted that if HL7 is picked, the ASTM standard can be “mapped” onto HL7 so that systems using ASTM can become interoperable with HL7-based systems.

The first standard is referred to as HL7 CDA R2 CCD. Though the name is intimidating, it is not very difficult to explain. HL7 is an international health care standards organization. The Clinical Data Architecture part of the name serves to identify that we are dealing with HL7’s standards regarding the organization of clinical documents that are sent and received electronically. It is necessary to specify CDA because HL7 has released other standards. The R2 refers to the fact that it is a second version of the standard. The CCD stands for Continuity of Care Document, and identifies that the standard deals with a constrained amount of health information–specifically, the information necessary to create a summary of a patient’s medical history.

Vocabulary Standards

To go back to the Bluebook analogy, the Bluebook must do more than specify the organization of the information in a citation. Additionally, it must specify the actual content that can be represented. For example,  the vocabulary of the reporter of a federal appeals case consists of F. or F.2d or F. 3d. Likewise, the vocabulary of EHRs must be standardized. The standards adopted for the vocabulary are listed in Table 2A.  There are a variety of different standards that have been adopted, including ICD-9, SNOMED, and LOINC. Some of these standards are in competition, and as Table 2A shows, the ONC’s position on competing standards will change in Stage 2 of Meaningful Use. For example, the vocabulary for medications will become more restrictive in Stage 2. However, some standards are not in competition, but are independent and describe wholly different aspects of medicine. For example, RxNorm describes medications but says nothing about laboratory test results, which is the domain of the LOINC vocabulary.

Hopefully the above discussion of the ONC’s adopted standards offers a foundation that allows for closer inspection of the IFR. The second part in this series will detail the two additional categories of standards, as well as other salient details of the IFR.

For additional information on the ONC’s rules, the following resources may be of interest:

The ONC’s most recent meeting, including mp3s of the meeting, can be found here.

General information about the ONC’s efforts with respect to the new standards can be found here.

Information about Clinical Data Architecture can be found here.

A solid overview of the new standards can be found here.

CMS and HHS Release New Proposed Rules Governing Health IT – Part 1: Overview of Proposed Rule on “Meaningful Use”

Issues surrounding the implementation of health information technology (HIT) have not garnered anywhere near the amount of attention as issues such as the public plan, the intersection of abortion and health insurance, pre-existing condition provisions, etc. There are a variety of reasons for this.

First, HIT is not as accessible as these other issues. Discussions of HIT often involve the heavy use of acronyms as well as technical jargon that can be intimidating and confusing. This will not likely change in the future. HIT will increase in complexity, especially as variegated computer systems used by providers and hospitals are to be linked together.

A second reason for the lack of coverage of HIT is that there have been few if any significant steps on the federal level towards implementing a national HIT system. As I will discuss below, this is beginning to change, and this change provides for an important New Year’s resolution that all of those interested in health policy should make: stay informed about the changes in the HIT landscape. To make this resolution easier, I will write a series of posts describing the changes.

One of the more recent changes occurred with the passing of the American Recovery and Reinvestment Act (ARRA), and more specifically, portions known as the Health Information Technology and Clinical Health Act (HITECH Act). The HITECH Act initiated, among other things, an incentive-driven paradigm for transforming our health information system. The general idea is that physicians and hospitals will be paid for using HIT. However, in order for this transformation to take place, guidelines must exist such that physicians, providers and vendors of HIT products understand how to operate within this new system.

On December 30^th 2009, CMS and the Office of the National Coordinator of Health and Human Services (ONC), released two rules. ONC released an interim final rule regarding the standards that will govern the Medicare and Medicaid incentive program. Additionally, CMS released their proposed rule on what is considered meaningful use.

The interim final rule regarding the standards can be found here.

The proposed rule regarding meaningful use can be found here.

Meaningful Use

CMS’s proposed rule on meaningful use is important because it defines how physicians and providers must implement HIT in order to qualify for CMS’s incentive payments for the use of such technology.  Much of the proposed rule is based on the HIT Policy Committee’s proposals on Meaningful Use, but comments had been solicited and incorporated from other committees, HIT vendors, and providers. The proposed rule states that incentive payments will begin in 2011, and that there will be two different payment methodologies: one for Medicare and one for Medicaid. Those receiving incentives must choose either the Medicaid or the Medicare plan. Furthermore, the rule states that hospitals and providers that are not meaningfully using HIT will have their payments from Medicare reduced, with the reductions taking effect in 2015.

The HITECH Act amended the Social Security Act, and in doing so, incorporated a broad definition of what constitutes a meaningful user of Electronic Health Records (EHR). Specifically for a provider to be a meaningful user they must:

1. Demonstrate use of certified EHR technology in a meaningful manner;
2. Demonstrate to the satisfaction of the Secretary that certified EHR technology is connected in a manner that provides for the electronic exchange of health information to improve the quality of health care such as promoting care coordination, in accordance with all laws and standards applicable to the exchange of information; and
3. Use its certified EHR technology, submits to the Secretary, in a form and manner specified by the Secretary, information on clinical quality measures and other measures specified by the Secretary.

The proposed rule is an extension of this definition, and aims to provide those EPs and hospitals with the proper information to become a meaningful user.

Specifically, the rule provides for two classes of providers to participate in the incentive system: eligible professionals (EPs) and hospitals.  EPs are defined as non-hospital-based physicians, who either receive reimbursement for services under the Medicare Fee-For-Service program (FFS) or have an employment or contractual relationship with a qualifying Medicare Advantage organization (MA); or healthcare professionals meeting other requirements. (See page 22 of PDF). Hospitals are defined as hospitals that either receive reimbursement for services under the Medicare FFS program or are affiliated with a qualifying MA organization as described in section 1853(m)(2) of the Act; critical access hospitals (CAHs); or acute care or children’s hospitals. (See page 22 of PDF).

Transitioning to the meaningful use of EHRs will be phased in, taking place in three stages. On page 40 of the proposed rule, CMS describes the stages as follows:

Stage 1 (beginning in 2011):  The Stage 1 meaningful use criteria focuses on electronically capturing health information in a coded format; using that information to track key clinical conditions and communicating that information for care coordination purposes (whether that information is structured or unstructured, but in structured format whenever feasible); consistent with other provisions of Medicare and Medicaid law, implementing clinical decision support tools to facilitate disease and medication management; and reporting clinical quality measures and public health information.

Stage 2: Stage 2 expands upon Stage 1 to use HIT for continuous quality improvement at the point of care and the exchange of information in the most structure format possible, such as the electronic transmission of orders entered using computerized provider order entry (CPOE) and the electronic transmission of diagnostic test results such as blood tests and nuclear imaging tests.

Stage 3: Stage 3 focuses on improving the quality, safety, and efficiency of health care, focusing on decision support for national high priority conditions, patient access to self-management tools, access to comprehensive patient data, and improving public health.

The proposed rule that was recently released only describes the specific criteria for Stage 1, with the criteria for Stage 2 and Stage 3 to be released at the end of 2011 and 2013 respectively. In terms of Stage 1 criteria, there is a hierarchy of organizational structure. At the broadest level there are “health outcome policy priorities.” Within each of these policy priorities there is a group of “care goals,” and associated with each group of care goals are the specific “objectives.” CMS has provided a very helpful table which breaks down the hierarchy, including the various objectives. I have extracted the table, which can be accessed here. However, for reference purposes, I have summarized the organization below, and provided the objectives for the first health policy priority. Note that there is a different list of objectives for hospitals, many of which are similar or identical.

The organization is as follows:

Health Outcome Policy Priority 1: Improving quality, safety, efficiency and reducing health disparities.

Health Outcome Policy Priority 2: Engaging patients and families in their healthcare

1. Care Goal 1: Provide patients and families with timely access to data, knowledge, and tools to make informed decisions.

Health Outcome Policy Priority 3: Improving care coordination

1. Care Goal 1: Exchange meaningful clinical information among professional health care team.

Interestingly, for CPOE, EPs are required to use CPOE for at least 80 percent of all orders whereas hospitals are only required to use CPOE for 10 percent of orders. Why such a discrepancy exists is presently unclear.

In terms of the requirement for reporting clinical quality measures (as described in the original definition of meaningful use in the HITECH Act), the proposed rule adopts different measurements for EPs and hospitals. For EPs, the proposed rule utilizes the quality measures endorsed by the National Quality Forum (NQF) including selected for the Physician Quality Reporting Initiative (PQRI) program that had previously been endorsed by the NQF. For hospitals, the measures are a combination of the NQF measures and those measures from the Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU).

Reporting of these clinical quality measures would be accomplished by one of three methods. The primary method would require EPs or hospitals to log onto a CMS-designated portal and upload the clinical quality data in a specific data structure (as defined by the ONC’s standards). Alternatively, data could be submitted through a Health Information Exchange(HIE)/Health Information Organization (HIO) depending on whether the Secretary can access that network. Another alternative is submission through registries dependent upon the development of the necessary capacity and infrastructure to do so using certified EHRs. See page 169 of the PDF for more details on the uploading process.

As discussed earlier on this blog, one aspect of the transition that remains to be addressed is whether the incentives provided to EPs and hospitals will be sufficient to encourage physicians to take on the initial outlays associated with EHRs. H.R. 3014 ,a bill to provide loans guarantees to solo and small group practices, has been passed by the House and is currently being reviewed by the Senate Committee on  Small Business and Entrepreneurship. Without such measures to spur the initial implementation of EHRs, the incentives or downward payment adjustments may not be sufficient to implement the bold plan set out by CMS.