A Guide to Accountable Care Organizations, and Their Role in the Senate’s Health Reform Bill

The accountable care organization has been a model for health care reform, yet its modest success has been limited to a handful of health care systems across the country. However, the accountable care organization model has recently taken on far greater significance since being introduced as one of Medicare’s pilot programs in the Senate’s health reform bill.

The phrase is attributed to Dr. Elliot Fisher of Dartmouth Medical School.  Dr. Fisher has led the Dartmouth Atlas Project — a project that has, for the last 30 years, painstakingly documented the variation in care across the United States. (Click here for an interactive map of some of the Dartmouth Atlas results). The Dartmouth Atlas has focused on both the quality of health care as well as its cost. More importantly, they have reported on the relationship between the two, and their findings are nothing short of an indictment of our current paradigm.

Specifically, their findings illustrate that there exists wide variations in the cost of care across the country, and profoundly, that the regions that spend more per patient do not necessarily obtain better outcomes. So what to do? Dr. Fisher believes he has found at least part of the answer: the Accountable Care Organization, known as an “ACO”.

What is an ACO, and How Does it Differ from Other Payment Reforms?

In his paper “Creating Accountable Care Organizations: The Extended Hospital Medical Staff,” Dr. Fisher acknowledges that the term ACO “grew out of an exchange between he and Dr. Glenn Hackbarth at a MedPAC meeting in November of 2006″. (Fisher, 2006 n. 7). Dr. Fisher’s purpose in writing the aforementioned paper was to help identify the proper “locus for shared accountability” for a patient’s health care. HMO’s and other health insurers are obvious candidates, but as Dr. Fisher notes, HMOs only comprise a small percentage of the current market, and health plans in general have focused on negotiating favorable prices within relatively open networks of providers. (Fisher, 2006, p. 45).  The “medical home” (also referred to as a Patient Centered Medical Home or PCMH) is another candidate, but is taken out of the running by Dr. Fisher because of the untested nature of medical homes, and their requirement of new payment mechanisms. (Id.).

Dr. Fisher notes that a better option already exists: “virtual” organizations consisting of the various physicians that are associated with local acute care hospitals. As Dr. Fisher notes, these physicians are either directly affiliated with such hospitals through their inpatient work, or through the care patterns of the patients they serve.  Dr. Fisher refers to these multi-speciality group practices that are bunched around local hospitals as an “extended hospital medical staff.” He argues that improving quality and lowering cost should be realized by fostering greater accountability on the part of this “extended medical staff.”

In a recent Urban Institute paper on ACOs by Kelly Devers and Robert Berenson (pdf summary here, full pdf here), the authors point to three essential characteristics of ACOs:

1. The ability to provide, and manage with patients, the continuum of care across different institutional settings, including at least ambulatory and inpatient hospital care and possibly post acute care;
2. The capability of prospectively planning budgets and resource needs; and
3. Sufficient size to support comprehensive, valid, and reliable performance measurement. (Berenson, p. 2.).

In exchange for investing in this reformed health care provider structure, the ACO members will  share in the savings that results from their cooperation and coordination. Thus, ACOs can–theoretically–act as a reform tool by incentivizing more efficient and effective care. This would help to combat the current perverse incentives of overutilization and overbuilding of health care facilities and technology.

In 2007, Dartmouth’s Institute for Health Policy and Clinical Practice headed by Dr. Fisher and Dr. James Weinstein, teamed up with the Brookings Institution’s Mark McClellan to create The Brookings-Dartmouth ACO Learning Network. The ACO Learning Network will serve as a support tool for providers looking to transition to the ACO framework. In the “Overview” section of their site (available as a pdf here), the Brookings-Dartmouth team provide a useful chart comparing the ACO model to other payment reform models such as “bundled payments,” “medical homes” and capitation. Click the image below to enlarge.

Various Extant Structures Utilized

Since Dr. Fisher’s introduction of the ACO concept, the idea has continued to be refined. In their 2007 paper “Accountable Care Systems For Comprehensive Health,” Dr. Stephen Shortell and Dr. Lawrence Casalino envision a broad range of ACOs in addition to the “extended medical staff” originally described by Dr. Fisher. Drs. Shortell and Casalino identify extant organizational structures that could be leveraged to create ACOs, including the Multi-speciality Group Practice (MSGP), the Hospital Medical Staff Organization (HMSO), the Physician-Hospital Organization (PHO), the Interdependent Physician Organization (IPO), and the Health Plan Provider Organization or Network (HPPO/HPPN). (Shortell et al., 2007, p. 10). Below is a table from their paper that organizes the different ACO models while comparing their capabilities. Click the image below to Enlarge.

ACOs In Practice

Building on the Physician Group Practice (PGP) demonstration project that rewarded the provision of quality care with a share of the savings, the Brookings-Dartmouth group propose a “voluntary and incremental” ACO program. (Fisher et al., 2009, p. 2).  The ACO would have to be a legal organization that can receive shared savings, and would have to incorporate primary care physicians who solely practice under the ACO. (Id.). Furthermore, the Brookings-Dartmouth group believes there would have to be at least 5,000 beneficiaries in the ACO for it to be viable. The ACO would provide CMS with a list of their providers willing to participate in the ACO. As discussed above, the beneficiaries would be determined by, among other things, the patterns of patient referrals in the region. However, beneficiaries would not be “locked in” to a given provider. (Fisher et al., 2009, p. 4). The ACO would receive savings if their risk-adjusted, per beneficiary spending levels were below their benchmark. Id.

An Ultra-Simplified Example

A hypothetical independent practice association (IPA) teams up with a community hospital to create an ACO. Medicare determines a benchmark, that is, what it will cost to treat the average beneficiary in that geographic area per year–let’s say $10,000. The physicians submit their traditional claims to Medicare under the RBRVS system while the hospital submits its typical DRG-base claim. Thus, the traditional fee-for-service system remains in place. At the end of the year, Medicare determines if the ACO has provided care for less than $10,000. If they have, the ACO is entitled to share in the cost savings, and the savings are divided among the providers and hospital. Though simple in theory, ACOs become more difficult when attempting to construct payment models that will distribute the savings of the ACO to the individual providers. Shortell provides another helpful chart that lays out some of the options; Click on the image to enlarge.

Criticism of the ACO Model

The strongest criticism that I am aware of is from Dr. Jeff Goldsmith PhD, president of Public Health Services at the University of Virginia. In his Health Affairs article entitled “The Accountable Care Organization: Not Ready for Prime Time,” Dr. Goldsmith recalls previous attempts to at implementing payment reform models based on shared risk:

The problem with this movie is that we’ve actually seen it before, and it was a colossal and expensive failure. During the 1990s, many hospitals and physicians believed that the Clinton health reforms would force them into capitated contracts with health plans. . . . Risk-bearing physician/hospital organizations and hospital-sponsored preferred provider organizations (PPOs) sprang up all over the country. . . . Some of these hospital/physician efforts actually succeeded and survive today. . . . However, these were outliers in an expensive failure.  Employers and patients preferred open panels managed by health insurers to closed panels managed by providers. Billions of dollars were lost.. . . Many of the practice acquisitions were reversed, as hospital systems sought to rein in their expenses and adjust to an open-panel world dominated by point-of-service style health plans

However, the 1990s left behind an expensive legacy:  highly concentrated local provider markets….There were numerous reasons for the 1990s collapse of at-risk hospital/physician partnerships, besides the failure to find willing buyers of their services. These efforts lacked infrastructure, experienced management, as well as reliable and timely cost information to support cost management. They assumed global risk but paid for care on a fee basis, just as Fisher and colleagues propose.  But these hospital-sponsored organizations could neither redistribute income nor exclude their high-cost providers (who inconveniently generate most hospital profits).

Some things have clearly changed in the ensuing decade. . . . A rapidly increasing percentage of physicians, particularly primary care physicians, are now hospital employees.  A larger percentage of the physician community receives hospital subsidies for call coverage. Many of these subsidies are, in fact, extorted from the hospital by specialists in scarce supply, destined to become scarcer.  An entire generation of 80-hour-a-week baby-boomer physicians are retiring and being replaced by younger physicians who want to work 30 hours a week.  You are not going to see a lot of these younger physicians in utilization review committee meetings after hours; they are going to be at their kids’ soccer practices.

What hasn’t changed is the fragmentation of care, the huge disparities in income and political power inside physician communities, and also the level of suspicion that physicians have of their now much more powerful local hospitals.  There is also, sadly, a thundering absence of collegiality – in my view, the central precondition of assuming risk and managing care. This absence is palpable in suburbs and even more pronounced in many “lifestyle dominated” resort communities in the sunbelt.. . .They are “collections” of physicians, not communities.

The hospitals in these areas appear formidable:  they have beautiful campuses,  prestigious boards, and deep financial reserves. . . . But these hospitals have been picked clean of vital outpatient services by their medical “communities.”

….Entire disciplines have disappeared from hospitals: ophthalmology, cosmetic surgery, gastroenterology, urology. Even community-based internists and family practitioners have stopped coming to the hospital; their patients are cared for by hospitalists who work full time inside the hospital.

The result of our previous attempts at ACO-like integrated care, Dr. Goldsmith points out, is that…

. . . .while the hospital has become more involved in subsidizing physician practice, physician communities have drawn away from the hospital and function increasingly independently on a day-to-day basis. Wennberg’s own data show that something like 40% of physicians no longer have any Medicare hospital-related fee income. So squashing hospitals and physicians back together into economic interdependence in a joint hospital/physician economic pool makes no real-world sense.

Dr. Goldsmith goes on to note that there have been some successful ACOs, but that they haven’t been “virtual” in the sense that Dr. Fisher points out, rather, they are

. . . real organizations with P+Ls, medical directors, and management infrastructure. Prominent examples in my home region include Carilion Health System in Roanoke and the Bon Secours Health System in Richmond. Voluntary ACO arrangements, with Medicare and with private insurers, may find enthusiastic partnerships with many of these hospital-sponsored physician groups. . . .

The Senate Bill

In defense of the Brookings-Dartmouth model, the group has gone on record in favor of voluntary ACOs. To Dr. Goldsmith’s relief, the Senate’s health reform plan incorporates ACOs on a voluntary pilot program basis. You can read their rebuttal to Dr. Goldsmith here.  Section 3022 of the Senate bill — which amends Title XVIII of the Social Security Act (42 U.S.C. 1395) — introduces ACOs under the name “Medicare Shared Savings Program. (View a pdf of the extracted ACO part of Senate bill here).

The Senate’s plan is remarkably similar to the Brookings-Dartmouth model. Under the Senate’s plan, ACOs will be eligible to receive a percentage of the cost savings that they have realized under the traditional fee-for-service Medicare system. The requirements are set forth in section (B)(2). Furthermore, the ACO shall enter into a 3 year agreement with HHS whereby the ACO must agree to contain at least 5,000 Medicare beneficiaries, while being prevented from engaging in risk selection. The ACO must define processes to promote evidence-based medicine and patient engagement, report on quality and cost measures, and coordinate care, such as through the use of telehealth or other remote patient monitoring tools. The ACO must also demonstrate to HHS that it meets the yet-to-be defined criteria for “patient-centeredness”.

Whether ACOs will succeed is impossible to determine with certainty. The panopticon that would be ACO management looking over the shoulders of physicians may be enough to turn off many physicians. Nevertheless, as even Dr. Goldsmith acknowledges, some ACOs have thrived. Moreover, the voluntary ACOs in the Senate’s bill represent a measured approach towards reforming our system without a wholesale transformation. As Dr. Atul Gawande describes in a lesser-cited pre-”Cost Conundrum” article, the most sound approach is often “path-dependent,”  that is, it builds on what already exists. As Dr. Gawande notes:

. . .accepting the path-dependent nature of our health-care system—recognizing that we had better build on what we’ve got—doesn’t mean that we have to curtail our ambitions. The overarching goal of health-care reform is to establish a system that has three basic attributes. It should leave no one uncovered—medical debt must disappear as a cause of personal bankruptcy in America. It should no longer be an economic catastrophe for employers. And it should hold doctors, nurses, hospitals, drug and device companies, and insurers collectively responsible for making care better, safer, and less costly. . .

Whether the shared savings will entice physicians on a large scale is uncertain.  What is certain is that our current fragmented system incentivizes providers to offer neither cost-effective nor coordinated care. Though it is unlikely that physicians and hospitals will flock to ACOs from the start, the vision of ACOs conceived of by the Dartmouth-Group and described in the Senate bill may nevertheless prove itself a useful tool in a larger arsenal of approaches meant to salvage our unsustainable health care system. In other words, the Senate’s approach could provide a path-dependent solution toward the collective responsibility and better outcomes that Dr. Gawande mentions. And as described in the Senate bill, physicians and hospitals will not be offered a new path, but rather a resurfaced path that would retain fee-for-service, while providing a safer and smoother ride for the patient.

Reform Rodeo

1. The Final Push: Kaiser Health News compiles the latest news stories detailing the final push that is underway by Democrats and the White House to try and pass their comprehensive health reform plan.

2. Rep. Paul Ryan: Ezra Klein interviews Republican Rep. Paul Ryan of Wisconsin; the two discuss the economic impact of the Democrats’ health reform plan.

3. Abortion: Tim Jost does a yeoman’s job of laying out the differences between the House and Senate bills regarding abortion funding.

4. Health Summit Redux: Ewe Reinhardt discusses the lessons learned from the Health Summit.

5. Health IT: John Halamka covers the new HITECH-related NPRM that HHS recently released. The newest NPRM deals with the process of certifying EHR systems under the CMS’s incentive-based framework for meaningful EHR use.

6. Health IT Review: For those trying to catch up on health IT developments, Computerworld has a critical yet thorough account of the high speed push towards EHR adoption.

7. Isn’t That Nice:  A feel good story about the The Oracle of Omaha  and Dr. Atul Gawande.

High-Risk Pools: a Precarious Pillar of Republican Reform

At the Health Summit last week we were able to more fully observe the Republican vision for reforming health care. A constant idea that the Republican leadership came back to was the concept of “high risk pools.” But what are high risk pools, and what potential do they have to lower costs?

High-risk pools are state-run programs that provide insurance for those who suffer from pre-existing conditions or have some other issue that makes them “medically uninsurable.”  They are often utilized by those in limbo who were previously covered by an employer’s group coverage, but for whatever reason are now relegated to the veritable disaster that is the individual market. Currently, 34 states have high-risk pools, with the combined number of insured from those pools at 200,000. (See Kaiser Family Foundation, State High Risk Pools: An Overview). As noted by Kaiser, coverage is typically at 125% to 200% of the standard market rate for health insurance.  In some states, the high-risk pool insurance costs as much as $14,000 per year. Thirty states offering high-risk pool coverage have waiting periods before pre-existing medical conditions can be covered.

Edmund Haislmaier of the Heritage Foundation has provided a succinct and helpful discussion of the relationship between high-risk pools and the related concept of “reinsurance.”  Haislmaier breaks down these risk-transfer tools into two groups: “inclusionary” and “exclusionary” risk-transfer mechanisms:

The “exclusionary” mechanisms segregate high-risk individuals from the low-risk population, subsidizing them in a separate pool. The “inclusionary” mechanisms keep high-risk individuals in the same pool as everyone else but seek to redistribute and/or subsidize their more expensive claims.

A common exclusionary mechanism is a state-run “high-risk pool” for the individual health insurance market. The pool offers coverage to people who have been refused coverage in the individual market due to poor health status. Although coverage carries high premiums, the premiums are not enough to cover the cost of claims by enrollees. To make up the difference, lawmakers use a mix of assessments on private insurers and public subsidies. In some states, the losses are funded entirely out of assessments on insurers and, thus, ultimately included in the premiums paid by everyone with health insurance coverage. In other states, the losses are funded primarily out of general revenue appropriations and, thus, are ultimately born by all the state’s taxpayers. Still other states use a mix of both funding sources.

Inclusionary risk transfer mechanisms operate on essentially the same principle, except that high-cost individuals are not given separate coverage. Instead, some portion of their claims is pooled and then proportionately redistributed among the carriers in the market. As with high-risk pools, public subsidies may also be used to offset some of the cost of claims. This type of mechanism is often called, somewhat inaccurately, a “reinsurance pool.” A more precise termed is “risk-transfer pool.”

Notably, Haislmaier recognizes that high-risk pools offer little help when it comes to the true goal of health reform: reducing costs:

Regardless of design, risk transfer mechanisms only shift or redistribute costs among funding sources. Specifically, risk transfer mechanisms offer ways to more equitably redistribute the costs of a small number of expensive cases or individuals across a broader population. While these features enable health insurance markets to function more smoothly, they are not a solution for controlling health care costs in general.

This is noteworthy coming from the Heritage Foundation. However, to be sure, high-risk pools are not peculiar to Republican health reform proposals. Both the House and the Senate bills provide for high-risk pools. The follow table is from The Kaiser Foundation’s paper “High-risk Pools: An Overview”:

The important row of the above table is “Timeline.” Whereas the House and Senate bills utilize high-risk pools as a temporary measure to provide insurance to those with pre-existing conditions before the exchanges take shape, the Republican proposal would implement risk transfer mechanisms as the primary means by which individuals with pre-existing conditions can obtain coverage. For those purchasing on the individual market, the Republican proposal would provide federal funding for state-run high-risk pools. Reinsurance mechanisms would operate in the small group market.

This is in contrast to both the House and Senate proposal which both prohibit the insurance exchanges  from denying coverage because of an applicant’s pre-existing condition–thus negating the need for high-risk pools.  Instead of subsidizing high-risk pools that would segregate the sick from the healthy, the individual mandate in the Democrats’ bill would ensure that the costs of high-risk and currently sick individuals would be spread throughout the exchange.

As Haislmaier noted, it is unclear how risk transfer mechanisms would lower health care costs. For example, whereas exchanges would increase competition by making the purchase of health insurance more accessible, high-risk pools and reinsurance would not alter the current maze that is the individual insurance market.   It is somewhat remarkable that the Republicans opt for high-risk pools instead of a proscription against pre-existing condition preclusions, especially given the public disdain for pre-existing condition preclusions. But the Republicans have little choice. Since they are wholly opposed to the individual mandate, insurers and states running high-risk pools under the Republican plan would not have healthy individuals paying into the system to offset the cost of sick insureds.

Reform Rodeo! The Summit, Speed Dating, and More.

1. Summit!: Fretting about how to get your dose of tomorrow’s “summit”? Don’t worry, CSPAN has got you covered for the Health Care Summit that is kicking off at 10am.

2. Managed Care Meltdown?: Joe Paduda at Managed Care Matters points out that the Anthem rate increases have shown an inability for private insurers to control costs.  What Paduda is missing in his piece is advice to private health insurers about how to manage costs without another “managed care backlash” like we had in the 1990s.

3. The Cost Conundrum’s Conundrum, or Just a Canard?: Maggie Mahar has a beef with the New York Times’ channeling of Dr. Bach’s New England Journal of Medicine article, where Dr. Bach criticized the  Dartmouth Atlas researchers’ methodology by claiming that they failed to risk adjust. Dr. Atul Gawande also believes the criticism is misplaced.

4. Health Care and Reconciliation are BFFs: NPR reports on a somewhat cozy relationship between reconciliation and previous health care initiatives.

5. What do speed dating and OB/GYN docs have in common? Kevin MD discusses how hospitals are utilizing speed dating techniques to match obstetricians with potential patients.

6. HIT, Yeah You Know Me: Dr. John Halamka with a slew of handouts from the HIT Policy Committee’s recent meeting, as well as notes from a recent meeting of the HIT Standards Commitee.

Google Buzz & Your Digital Health Doppelganger

At this point, it is fair to say that everyone has either heard or read about how Google’s latest foray into social networking, Google Buzz, has gotten off to a bumpy start due to privacy concerns. We can only speculate as to why Google failed to appreciate Buzz’s underwhelming privacy protections. Maybe Google was aware of the privacy issues but felt that they were outweighed by the “turn key” social network that would automatically be created by leveraging the user’s own Gmail contact list. Alternatively, Google may have simply not appreciated the privacy issues. Whether Buzz’s threats to privacy justified the immense firestorm that has occurred is besides the point. Regardless of whether the privacy issues are justified or not, as consumers utilize social networking tools to a greater degree, they are becoming more aware of the potential privacy problems, and are becoming more vocal when they disapprove.

One of the more troubling aspects of Google Buzz was that  it automatically created a network of users in your Buzz social network based on the addresses you emailed most in Gmail. Buzz would then automatically start following those contacts. The issue was compounded by the fact that Google made the list of people you were following on Buzz public by default. This automatic follow-and-tell-the-world approach that piggybacked off of Gmail users’ contact list has since been tweaked. Currently, a user joining Buzz is offered suggestions of who to follow, and those whom they choose to follow are not broadcast for the world to see.

A hypothetical within the health care setting may serve to illustrate why this approach was problematic, and will also illustrate why social networking may have profound implications for our “digital health doppelganger.” Under the initial iteration of Buzz, physicians using Buzz who were following the Buzz feeds of their patients would, simply by using the service, make the names of who they were following public to all their other followers.  In other words, a patient could see the names of all the individuals that their physician was following, including any who happen to be patients.  This situation could be disastrous both personally and economically if the individual was being treated by a physician specializing in schizophrenia or HIV/AIDS–diseases that have, for whatever reason, become highly stigmatized and prone to various discriminatory responses. It is therefore clear that myriad privacy and confidentiality issues arise, including questions of whether such information would be considered protected health information under HIPAA. That the disclosure of fiduciary relationships is troublesome is nothing unique to health care: in the legal profession, the mere existence of an  attorney-client relationship can be considered privileged information.

But back to Health IT, an area where  our digital health doppelganger is progressing through its adolescence in a landscape of social networks, electronic health records, and a highly fragmented health care delivery system. A number of general areas of concern arise. Including:

1) the online storage of our personal sensitive health information (e.g. in EHR and PHR databases, and Law Enforcement and “Fusion Centers”).

2) current modes of interfacing with our online health data (e.g. access viz. home computer, mobile phone, kiosks).

3) future modes of interfacing with our online health data (e.g. increasing mobile use, RFID, Smartcards, video playback of encounters).

4) how others will access and use our online health data (e.g. Primary care physician accessing our PHR, Site-wide access by Accountable Care Organizations, targeted advertising in PHRs based on the content found within the PHR service or services it can connect to).

5) how we will interact with the health data of others (e.g. PatientsLikeMe.com, increasing meta-analysis of health data available through future nationwide interoperable EHR systems).

6) how our increasingly digitized health care persona will exist alongside our professional and social personas.

Google and  Microsoft offer immensely useful services, but which concomitantly force us to more deeply analyze these issues, particularly the last issue, which both feeds back, and is affected by, each of the other issues. More than any other company, Google has sought to integrate their products to make communication and organization as seamless as possible. For example, The to-do list in Google Tasks is, not surprisingly, symbiotic with Google Calendar, while the latter service interfaces with Gmail by scanning the content of a user’s email for the tell tale signs of future events, and and offering to add a calendar entry.  For those of you not using Google, the right portion of the picture below illustrates how Google recognizes the contents of the email message, and asks the Gmail user if she wants to add the event to their Google Calendar.

The simple example above makes it easy to imagine similar features being offered in PHRs like Google Health and Microsoft HealthVault–PHRs that are provided by entities that either offer social networking tools alongside their PHRs, or who plan to somehow utilize outside data that is available through other means.  As consumers, we must determine how precocious we want our online health persona to be. It must be noted that there is nothing intrinsically wrong with this integration, and such integration certainly offers many benefits to providing better information to patients and physicians.

However, both Google and Microsoft are unique in that they are introducing personal health records to their users who have already ceded to them an extraordinary amount of highly personal information.  This raises interesting questions that will test our willingness to integrate our social network with our health identity. For example, how should Google Wave–Google’s new hybrid email/chat service–be interfaced with Google Health? Furthermore, what status will a physician-patient conversation thread on Google Wave or Google Buzz be provided? Is it more like a health record or a phone conversation? Would it be acceptable for Google Health to utilize health related information that it recognizes within your Gmail messages? Even though Google has refrained from displaying targeted ads within Google Health, would the reverse be acceptable, whereby Gmail advertisements are determined based on Google Health data?  Would it be inappropriate for Google Health to utilize information about your newly diagnosed diseases  to connect you to health-related social networks such PatientsLikeMe?

Users are likely to forget about Google Buzz’s initial oversights, especially in the short-attention span sphere that is the Internet. This is okay, so long as changes are made to appropriately address such glaring issues. We must, however, ensure that we tackle the much more difficult question of what limits to place on the subtle, yet no less powerful, forces that are altering the breadth of our increasingly digitized and integrated online persona.  For many of us, the personality of our digital health doppelganger is taking shape on our screens and our smartphones. Are we going to like what we see? And perhaps more importantly, will others?

Reform Rodeo

1. Principle or Posturing (or both)? –Kaiser Health News discusses the sudden plea from certain Senators for a reintroduction of the public plan into the Senate’s bill.

2. Starting From Scratch? — The Hill highlights polling indicating that many Americans favor scrapping the health bill and starting over, an option that President Obama has repeatedly said is not an option.

2a. Presidential Preemption? — Interestingly, the New York Times details the possibility of Obama posting his own health reform bill on the Internet ahead of the much-hyped health care summit. Could Obama use his “new” bill as evidence of a “fresh start” to appease Republicans?

3. Back to Basics — Maggie Mahar details the longstanding debate about whether health insurance actually saves lives.

4. Scoop on Standards — Dr. John Halamka, a physician who serves as CIO of Beth Israel Hospital and Chairman of the Health Information Technology Standards Panel (HITSP) at the ANSI, shares his thoughts on the vocabulary standards that will come to be the Esperanto of HIT.

5. HIT Funding — On Febuary 12th, the first $1 billion of federal funding for HIT promised under the HITECH Act was made available, with $10.6 million going to Massachusetts for the creation of a health information exchange.

6. Health Reform “Casualty”: The New York Times reported that former Congressman-turned head of PhRMA Billy Tauzin is resigning.  Betting on the passage of health reform, Tauzin offered billions in concessions to the White House in exchange for, among other things, favorable patent exclusivity periods for pricey biologics.

7. Health 2.0 — The Health Care Blog reports on the purchase of online pain management company ReliefInSite.com by PatientsLikeMe.com–the popular patient web site which claims to be the  “leading online community for patients with life-changing diseases.” Don’t be to surprised to see further growth of similar “Health 2.0″ websites that seek to take advantage of the increasing digitization of health care delivery and research.

8. The Science Behind Reform — Stephen Novella at Science-Based Medicine revisits the question of the effectiveness of colonoscopies.

Things You Wanted to Know About the New HIT Standards But Were Too Afraid to Ask

In a previous post I discussed the interim final rule (IFR) that was recently promulgated by the Office of the National Coordinator for Health Information Technology (ONC).  The previous post discussed two of the four categories of standards in the IFR. This post will look at the final two categories. In order to appreciate the purpose of the final two standards, it is worth recapitulating the basic framework upon which the IFR is based.

The ONC’s framework for the standards is to first start with the meaningful use objectives. From the broad objectives of meaningful use, the ONC establishes certification criteria for these objectives. Based on the certification criteria, the ONC has adopted standards that would allow for an objective determination of whether the criteria has been met.

An example will help: One of the meaningful use objectives is “the capability to exchange key clinical information among providers of care and patient authorized entities electronically.”  To achieve this objective, “Certified EHRs” will have to meet the following criteria: “[The EHR system must] electronically receive a patient summary record, from other providers and organizations including, at a minimum, diagnostic test results, problem list, medication list, immunizations, and procedures and upon receipt of a patient summary record formatted in an alternative standard specified in Table 2A row 1, displaying it in human readable format.”

In order to guide EHR vendors (and purchasers) in fulfilling the above criteria–and likewise the larger meaningful use objective–the ONC has adopted a number of standards that EHRs must utilize in order to be certified. These standards fall into 4 general categories.

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.

My previous post provided a general overview of the first two standards, the first of which specifies the language of “EHR speak,” while the second specifies standards giving that EHR vocabulary a predictable organization so as to ensure that different EHR systems can interpret the data.

In the previous post I used the analogy of the Bluebook style of citation to explain the content exchange standard and vocabulary standard. As you can see, the following two citations share the same basic organization (e.g. case name in italics, followed by the reporter volume number, name of the reporter, starting page of case, etc).

Wilson v. Mar. Overseas Corp., 150 F.3d 1 (1st Cir. 1998)

Orange County Agric. Soc’y, Inc. v. Comm’r, 893 F.2d 529 (2d Cir. 1990).

The content exchange standard is analogous to the order of the different elements of the citation. Regardless of the case, all Bluebook citations to federal court of appeals cases have this same basic organization. The part that changes is the vocabulary. As you can see in the cases above, two different reporters (publishers) have been used: F.3d and F.2d.  There are still only limited options for the vocabulary of court reporters.  Likewise, even though the organization of a patient’s record will remain constant, it will obviously consist of different terms depending on, among other things, the patient’s diagnosis and test results. The possible terms within the chart are determined by the vocabulary standards.

Essentially, the signifier and syntax standards are meant to save us from constructing a costly high-tech Tower of Babel. A sign (word, letter, number, symbol) displayed in a particular way must have an agreed to and discernible meaning.

With these two standards in mind, a brief overview of the latter two standards is possible.

Transport Standards

Though the data is sitting on server A in a structured format–governed by the content exchange and vocabulary standards discussed above–there is more that needs to occur for the data to be useful. For example, Computer A must “know” how to send a request for that data in a way that Computer B can understand. Likewise, Computer B must “know” how to respond to Computer A’s request, i.e., how to structure the response it will give to Computer A. This is where the third category of “transport standards” becomes important.

Luckily for us, one of the transport standards (SOAP) adopted by the ONC is the same standard used by LexisNexis. This allows us to continue our analogy.

When I log onto LexisNexis, I have the opportunity to enter a citation. The citation must be entered in the same basic order that the Bluebook citation provides. Therefore, utilizing the first case cited above, I would type in:

150 F.3d 1

The name of the parties in the case is not necessary since only one case occurs at a given page (page 1) of a reporter’s (F.3d) volume (150). If I submit that citation and Lexis recognizes it, Lexis will then display the case. The beautiful thing about Lexis (and Westlaw) is that the case data, like the citations, has a specified organization–analogous to the organization specified by content exchange standards. One discrete element common to all Lexis cases is a field listing the parties’ counsel. Let’s say that I am an iPhone application developer and I want to create a simple application that would allow a user with a Lexis account to type in a citation like the one above, and in response the program would output the opposing counsel field (as opposed to the whole case). My application would need to know how to trigger Lexis’s server to go and find that information in the database. Likewise, the Lexis database must know how to package and send that data back to the client application. Thus, the fact that Lexis organizes data like citations and counsel into organized fields with specific vocabulary is not sufficient. Rather, there must be a standard governing the requests of specific information, as well as how that information should be formatted and transmitted. This is the role of the “transport standards.”

The ONC adopted two alternative standards–the SOAP standard and the REST standard–to govern requests and responses between client and server computers. As stated above, the SOAP standard is used by Lexis (and other Internet sites) to allow other applications and services to be able to interact with it. That Lexis uses the same standard as that adopted in the HIT interim final rule helps to illustrate the broad nature of  transport standards. Unlike the content exchange and vocabulary standards that are unique to the practice of health care, the transport standards ensure that services wishing to interact with a server have an agreed upon framework by which to accomplish the interaction.  As becomes obvious from this discussion, ensuring the proper implementation of the transport standards is critical to meeting the meaningful use objective described earlier that dealt with exchanging clinical information among providers. Additionally, having a specified standard for requesting and receiving the data is crucial for personal health record (PHR) services that seek to interface with the databases of health care providers in order to retrieve and display certain information to the consumer of the PHR.

Privacy and Security Standards

The fourth group of standards deals with privacy and security, and for the most part, this part of the IFR is straightforward. The reason for the straightforwardness is that the ONC has decided to model their privacy and security criteria off of HIPAA’s Privacy and Security Rules. Therefore, there are no real surprises. With that said, the HITECH Act does direct the various HIT committees as well as the ONC to look at capabilities beyond those specified in the HIPAA Security Rule. Thus, even though the IFR does not change the privacy and security landscape in any major way, there is no promise that things won’t change in the future.

Specifically,  the ONC has adopted standards for certain aspects of HIPAA but not others. For example, standards have been adopted for the encryption of data, but not for “access control” measures that are used to prevent unauthorized access at computer terminals connected to EHR systems. The ONC’s rationale is that the methods of regulating access are evolving at a rapid pace, whereas there are industry best practices available for encrypting information. As a result, the ONC requires all certified EHR systems to be capable of encrypting their data. This is somewhat remarkable given that HIPAA and HITECH do not require all entities to use encryption. The ONC believes that this capability will spur the use of encryption by making it available to all consumers of certified EHR systems. Furthermore, the implementation of encryption by HIPAA covered entities is important because it acts as a safe harbor, relieving them of the responsibility of having to report a data breach.

As Table 2B shows, the ONC distinguishes between the general encryption of stored data on the one hand and the encryption of transmitted data on the other hand. Please click on the thumbnail below to enlarge the table.

The ONC has stated numerous times that the IFR in no way changes the responsibilities of covered entities or business associates under HIPAA (and HITECH). Rather, it solely concerns the capabilities of certified EHR systems.

Reform Rodeo

1a. Health Reform Post-Brown: Kaiser Health News Staff Writer Jenny Gold discusses the Democrats’ seemingly new strategy of focusing on repealing health insurers’ antitrust exemption.

2. Bending the Curve, Success Story: Maggie Mahar over at Health Beat has a wonderful overview of  Maryland’s successful approach to reducing health care costs.

3. Comparative Effectiveness: Dr. Nortin Hadler offers a forceful and nuanced view on the role of comparative effectiveness research.

4. Medicare and Technology: The New England Journal of Medicine has an interesting piece on how Medicare determines which health-related technologies to reimburse.

5. Quack Attack: Over at Science-based Medicine, Dr. Steven Novella covers the retraction of Andrew Wakefield’s 1998 article that claimed to link autism with the mumps-measles-rubella (MMR) vaccine.

6. Neuro News: The New York Times reports on how new studies may question some bedside techniques used to diagnosis the degree of brain activity in severely brain-injured patients.

7. Bonus: For those interested in more health-related links, Joe Paduda at Managed Care Matters hosts the current Health Wonk Review

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).

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.

Reform Rodeo

1a. Massachusetts: A blog post by Harold Pollock can be found here, discussing why 47 health policy experts have sent a letter urging the House to pass the Senate’s bill in the wake of Scott Brown’s upset victory.

1b. Interesting Poll of Brown Voters: As MoveOn.org’s poll reveals: “Nearly half (49%) of Obama voters who voted for Brown support the Senate health care bill or think it does not go far enough.”

2. Health Care Economics: David Herszenhorn at the New York Times discusses William J. Baumol’s theory of cost disease, and why it should give us pause in expecting too much from health care reform.

3. Health IT: Adrian Gropper M.D. describes the advantages of the OAuth system of linking electronic health record systems.

4. The Science Behind Reform: The NEJM has a short editorial describing the findings of a recent study that underscore the importance of lowering salt consumption; findings that associate reduced salt intake with public health benefits on the level of smoking cessation and weight reduction.

5. Individual Mandate Constitutionality Redux: At the O’Neill Institute, Mark Hall responds to the Constitutional argument that the individual mandate is unconstitutional because it regulates inactivity as opposed to activity.

6. Visualizing Health Care: Comments on  a National Geographic piece apparently spurred National Geographic to discuss why they chose the plot on the top instead of the plot on the bottom.

Click the images below to enlarge:

An Overview of Exchanges under the House and Senate Bill

On January 8th, 2010, the Alliance for Health Reform and The Commonwealth Fund  co-sponsored and moderated a panel discussion on the health insurance exchanges that are being proposed in both the House and the Senate health reform bills. The panel consisted of Washington and Lee professor Timothy Jost, John Kingsdale of the Massachusetts Commonwealth Health Insurance Connector Authority, and Philip Vogel of the Connecticut Business and Industry Association (CBIA), which runs the non-profit CBIA Health Connections, a health insurance exchange for the state of Connecticut.

The co-sponsors have uploaded all of the event’s materials, including a webcast of the entire event, as well as all of the powerpoint slides and papers. All of this information can be found here.

Professor Jost and the Commonwealth fund created detailed charts comparing the differences between the two bills. Below is a reproduction of Professor Jost’s chart, which can be viewed by clicking on the thumbnails.

Both the House and the Senate bills would create new health insurance exchanges that would help consumers and employers navigate the purchase of health insurance. Though the common thread of a regulated marketplace runs through both bills, all three panelists noted the stark difference in the vision and implementation of the exchanges under the respective bills.

Below are some of the key distinctions between the two bills.

The House Bill — Public Option with Opt-Out Possibility

The House’s bill, H.R. 3962 (click here for entire pdf) provides for a federal exchange that would essentially eliminate the individual marketplace for health insurance going forward. A public plan would be offered that would reimburse providers at negotiated rates between those of Medicare and commercial rates. The applicable section of the House’s bill is Title III, entitled Health Insurance Exchange and Related Provisions.

Title III of the House Bill would create the Health Choices Administration with a Commissioner who would oversee the exchange. Citing Section 301 and 308 of the Bill, Professor Jost notes on page 17 of his paper:

The exchange operates at the national level, established within a new Health Choices Administration. The Commissioner of the HCA can, however, permit individual states or groups of states to administer an exchange within their territory in place of the national exchange if specific requirements are met, subject to revocation if the state ceases to meet the requirements of the bill. Even if the HCA delegates exchange authority to a state, the Commissioner retains enforcement authority and can further specify functions retained by the Commissioner and not delegated.

Thus, the House’s bill would create an exchange system that is fairly centralized and regulated, but with added flexibility. If the states fail to implement their own exchange then HHS will implement an exchange for them. Only those policies considered “grandfathered” could be sold outside of the exchange, and such “grandfathering” can only occur in the individual market. (See Section 202). Insurance offered inside the exchange would fit into one of four tiers: basic, enhanced, premium, and premium plus. (See Section 303). These tiers would correspond to different actuarial values of the plans. Subsidies would be provided on a sliding scale that is determined by the purchaser’s income.

The House bill would also limit the medical loss ratio of plans offered in the exchanges to 85 percent, largely prohibit the rescission of contracts, eliminate lifetime coverage limits, eliminate pre-existing condition exclusions, as well as require guaranteed issue and renewal of plans. Variations in premiums based on the age of the insured could only vary by a maximum of 2:1.

Not all of the panelists agreed with every provision. For example, Mr. Vogel took issue with the dependence on the medical loss ratio in regulating the market, instead arguing for a greater reliance on the “claim dollar” as a guide post.

Whether offered inside the exchange or grandfathered, all plans must meet certain requirements in terms of essential benefits, which would be determined by HHS, and would be based on the recommendation of the Health Benefits Advisory Committee–a public/private hybrid entity.

• Click here to jump to section 223 outlining the Health Benefits Advisory Committee

These benefits would include hospitalization, outpatient care, prescriptions drugs, equipment, and a host of other benefits.

• Click here to jump to the section 222 which details the essential benefits.

The House bill would also impose rules regarding the transparency of the plans offered in the exchange by requiring certain information about the plans to be disclosed.

The Senate Approach — No Public Option; Multistate Substitute Would Exist

For whatever reason, the Senate crafted a more complicated framework of exchanges.

A crucial point of divergence from the House bill is the Senate bill’s lack of a federally financed public plan offered through the exchange. However, as discussed below, part of the Senate plan attempts to act as a substitute. Another area of divergence is that existing individual and group plans may continue alongside newly created exchanges, in addition to any grandfathered plans. This is in stark distinction to the House bill that would eliminate some existing policies. Though as noted, the House bill would allow for some grandfathering.

The Senate’s exchange framework is based on section 1001 of the bill which provides that HHS will, with the help of the National Association of Insurance Commissioners (NAIC), craft standards regarding the minimum benefits and other aspects of the plans sold through the various exchanges.

In terms of the Senate’s framework for exchanges, it is as follows. The Senate bill will allow for a number of exchanges that would exist on variety of different governmental levels. Whereas the House bill envisions a more federal exchange system, the Senate bill would instead allow for state-based exchanges, multistate exchanges (i.e. regional), or substate exchanges.

• Click here for a pdf version of Senate bill, as passed.

State-based Exchanges
For the individual and the small group markets, the Senate bill would require each state to create a American Health Benefit Exchange for individual purchasers of insurance, and a Small Business Health Options Program (SHOP) for small businesses purchasers. HHS would regulate these exchanges (See section 1321(a)(1)). These exchanges would be governed by regulations promulgated by HHS, unless the states adopt alternative standards that the HHS finds acceptable.

The state may combine the individual market exchanges with the small business (SHOP) exchanges. Additionally, states have the flexibility to establish regional exchanges or smaller subsidiary exchanges that target specific geographic areas within the state. (See Section 1311(f)). If the states do not create a system of either separate exchanges for individuals and small business, or some combination, HHS will establish an exchange or utilize a non-profit insurer to fill the void. See 1321(c).

The multistate exchanges are important, as they may mollify those who have been touting the idea of interstate health insurance offerings as a panacea for the woes of U.S. health insurance.

Regardless of how any states’ exchange(s) plays out, many of the important provisions of the Senate’s bill such as certain minimum benefits, the ban on lifetime or annual dollar limits, the ban on rescission, and medical loss ratio requirements would apply across the landscape of exchanges.

State Opt-Out Possible
Under the Senate bill, the states would be eligible in 2017 to opt-out of the federal requirements listed above if they can demonstrate that they are providing affordable coverage that is at least as affordable and comprehensive as the Bill requires. Alternatively, the state may be allowed to create a “public health plan” for those under 200% of the federal poverty level. Under this arrangement, the federal government would compensate the state for 95 percent of what would have been provided through premium tax credits as well as cost-sharing reduction payments. (See Section 1331).

Multistate plans: A Compromise?
One major amendment passed on December 24th was section 1334 which amended section 1333 which dealt with multistate exchanges. Under section 1334, The Office of Personnel Management (OPM)–the agency that governs the federal employees health benefit program (FEHB)–will enter into contracts with insurance carriers to offer at least 2 multistate plans through each exchange in each state. (See 1334(a)(1)). These plans will cover the individual and small group market. At least one of those plans must be a non-profit insurance plan, and must be in accordance with the general standards set forth for health insurance plans.

Though there would be a minimum level of benefits and protections required for all plans, the States would be entitled to offer multistate plans with more substantial benefits. However the state will have to defray the costs of the additional benefits.

Unlike the House bill which eliminates the state-based individual market, the Senate bill envisions exchanges that would co-exist with both the individual and small-group markets, and operate under the same rules. Though the Senate bill allows for flexibility, the subsidies provided by the federal government could only apply to insurance plans sold through the exchange.

One of the most important and controversial sections of the amended Senate bill is section 1334(a)(4), which specifies that, in administering the multistate plan, OPM will have the same bargaining power as they currently have for plans offered in the FEHB. Thus, OPM would be able to negotiate for a specified medical loss ratio and profit margin, as well as specified premium rates and any other terms in the “interest of the enrollees.” The goal is for these plans to be offered nationwide. Whether the OPM-run exchange will succeed is obviously yet to be determined, but some like Professor Timothy Jost are worried that the Senate’s plan to allow some plans to operate outside of the exchange complicates the federal government’s job in risk adjustment.

Reform Rodeo

1. Big Pharma: The pharmaceutical industry is threatening to reverse their support of the health care reform legislation if the bill calls for a reduction in the number of years that a company’s biologics are protected from generics.

2. The Caddy Conundrum: NPR reports that organized labor appears to be on board with taxing Cadillac plans, with some movement in their favor regarding the thresholds triggering the tax.

3.  Health Insurance Exchanges: The Commonwealth Fund and the Alliance for health reform moderated a discussion on health insurance exchanges. Fantastic materials that outline the House and Senate plans can be found at the bottom of this page, which includes the extraordinary paper which Professor Timothy Jost presented.

4. Health Reform Discussions: The Health Care Blog has rounded up many of the discussions on health care reform.

5.  Play-or-Pay Problems: The NEJM has a thorough analysis of the “play-or-pay” provisions in health reform legislation, and the problems that may arise.

6. Multimedia: Atul Gawande chats with Charlie Rose on January 5th about health care, as well as Gawande’s new book “Checklist Manifesto”.

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.

Care Goals: 1. Provide access to comprehensive patient health data for patient’s healthcare team 2. Use evidence-based order sets and computerized provider order entry (CPOE) 3. Apply clinical decision support at the point of care 4. Generate lists of patients who need care and use them to reach out+ to those patients. 5. Report information for quality improvement and public reporting.

Objectives for Eligible Professionals (EPs): 1. Use Computerized Physician Order Entry (CPOE) 2. Implement drug-drug, drug-allergy, drug-formulary checks. 3. Maintain an up-to-date problem list of current and active diagnoses based on ICD-9-CM or SNOMED CT®. 4. Generate and transmit permissible prescriptions electronically (eRx). 5. Maintain active medication list. 6. Maintain active medication allergy list. 7. Record demographics 8. Record and chart changes in the following vital signs 9. Record smoking status for patients 13 years old or older. 10. Incorporate clinical lab-test results into EHR as structured data. 11. Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, and outreach. 12. Report ambulatory quality measures to CMS (or, for EPs seeking the Medicaid incentive payment, the States) 13. Send reminders to patients per patient preference for preventive/follow-up care. 14. Implement five clinical decision support rules relevant to specialty or high clinical priority, including for diagnostic test ordering, along with the ability to track compliance with those rules. 15. Check insurance eligibility electronically from public and private payers. 16. Submit claims electronically to public and private payers.

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.

Reform Rodeo

1. Getting Up to Speed: Kaiser Health News breaks down where reform currently stands now that the Senate has passed their version of the Bill.
2. Multimedia Perspective: A thorough and well-done interactive timeline of U.S. Health Care Reform helps to provide some much-needed context. Clicking on the event gives a synopsis as well as a link to an NEJM piece on the event from that era.
3. No Snow(e) in Sight: Sam Stein notes how Olympia Snowe–a Senator who not long ago garnered the attention of all health reform followers–rationalized her “Nay” by questioning the Bill’s constitutionality.
   1. Speaking of the constitutionality of the Senate’s bill: As we have noted on this site earlier, questions of constitutionality pervade the dialogue. For those whose interest has been piqued, bloggers at the Volokh Conspiracy have penned a number of pieces on the issue, here, here, and here.
4. Senate Bill’s impact on health insurance companies: Bob Laszewski discusses the Bill’s impact on insurance company–channeling the skepticism of non-profit Harvard Pilgrim’s CEO Bruce Bullen.
5. Impending Car Crash?: Michael Goozner reiterates his view that the tax on “Cadillac” plans is the biggest issue facing health reform.
6. In case you missed it (an oldie but goodie): A Health Reform Watch article on the impact of lobbyists included in the Wikepedia entries for “Health Care Reform, United States” and “Health Insurance.” Which, now that a bill has passed in the Senate, begs the question: do you think those lobbyists might be in line for a bonus?

Reform Rodeo

1. Kaiser Health News rounds up today’s editorials on health reform.

2. The New York Times reports that the CBO’s latest report finds that the Senate’s health bill will not increase premiums for the majority of Americans.

3. David Leonhardt describes how the Senate’s bill may offer more cost-cutting options than it is typically given credit.

4. John Iglehart offers his perspective on the the process that has allowed the Senate’s health reform bill to proceed to floor debate.

5. The Hastings Center has a thorough piece on the controversy surrounding the U.S. Preventitive Services Task Force’s decision to alter the recommended guidelines for mammography.

6. In case you missed it: Associate Dean Kathleen Boozang in The Health Care Blog regarding the Center for Health & Pharmaceutical Law & Policy’s latest White Paper: “Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight.”

7. In case you missed it again: Professor John V. Jacobi in the New Jersey Law Journal on “Genetic Discrimination and the Future of Health Insurance.” (First posted here on HRW).

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