Reform Rodeo: A Sick Wellpoint; Performance; EHRs; and More

1. Really?: Reuters released an exclusive story about Wellpoint’s recent push to rescind contracts for those suffering from breast cancer.

2. Specialists: The New England Journal of Medicine has a piece on the role of specialists in performance-incentive programs.

3. EeeeekHR: In the New York Times, Pauline Chen describes her experiences as a physician attempting to come to grips with the unforeseen changes that EHR-based health care delivery has introduced into the doctor-patient relationship.

4. Myths of Health Reform: On The Health Care Blog, Maggie Mahar discusses the myths of health reform, including the belief that the reform measure was a hand out to industry.

4. When Skepticism Becomes Quackery: Steven Novella at Science-Based Medicine calls attention to the often hyperbolic demonization of the pharmaceutical industry.

5. That’s Just Your Opinion: Kaiser Health News gathers the latest opinions and editorials about health care, including pieces about children’s health care, RomneyCare, and the nursing shortage.

6. Resources: For those studying PPACA, George Washington University has released, among other things, a thorough provision-by-provision comparison of PPACA and subsequent reconciliation.

Reform Rodeo

1. Duff Wilson of the New York Times discusses the lack of transparency with respect to industry’s payments to doctors.

2. John Halamka gives a nice overview of the various PPACA initiatives–including pilot programs–that involve HIT.

3. A group of lawyers discuss the impact that the recent Supreme Court decision in Citizens United could have on health care.

4. Matthew Holt at The Health Care Blog describes a new poll conducted about PHRs, and some of the results are surprising.

5. Health Affairs has a nice summary of a round table discussion on reforming CMS in the era of Don Berwick.

6. Jason Shafrin of the Health Care Economist gives an overview of a new paper by Basu and Philipson that question some of the common assumptions of the economics of comparative effectiveness research.

Recording of Sam Maizel’s Discussion of Distressed Hospitals

A noted expert in the restructuring of health care business debts, both in and out of court, Sam Maizel treated Seton Hall to a one hour crash course on the fiscal crisis encountered by many of America’s hospitals. The significant financial hurdles that the hospital industry is facing has made the bankruptcy process that many hospitals encounter one of the fastest growing fields in health law.

Mr. Maizel has represented the federal government as a trial attorney in the U.S. Department of Justice’s Commercial Litigation Branch. He also served in the JAG Corps in Operation Desert Shield and Desert Storm after serving in the 101^st Airborne Division and the 3^rd US Infantry Regiment. Mr. Maizel now practices in Los Angeles for  Pachulski Stang Ziehl & Jones LLP.

You can download Mr. Maizel’s talk here, or alternatively, you can stream it to your browser by clicking “Play” below:

Recording of Professors Tim Greaney, John Jacobi, Frank Pasquale, and Sidney Watson Discussing Health Reform

On Friday, April 9th, Seton Hall was treated to an expert round table discussion on the new health reform measures.

Visiting professor Tim Greaney, as well as Seton Hall’s John Jacobi and Frank Pasquale, joined Professor Sidney Watson from Saint Louis University School of Law, to discuss the historic health care legislation to a packed crowd.  Dean Kathleen Boozang served as the moderator of the panel discussion.

Topics discussed included a general overview of the Patient Protection and Affordable Care Act (PPACA), a discussion of the statute’s affect on Medicaid and Medicare, and the constitutionality of the individual mandate.

The panelists also discussed the strategies that they believe are required to properly implement PPACA’s immediate reforms, as well as the statute’s long term goals.

For background on PPACA, the Kaiser Family Foundation has posted a summary of the statute discussed by the panelists.

A recording of the round table discussion can be downloaded in MP3 format here. Alternatively, the recording can be streamed to your browser by clicking on the Play button below.

Reform Rodeo: Medicaid; Self-insurance; EBM; Gene Patent Smackdown; eRx; Cool stuff

1. PPACA & Medicaid: Kaiser Health News’ Maggie Mertens discusses PPACA’s affect on Medicaid, specifically the legislation’s increase in Medicaid reimbursement.

2. PPACA & Self-Insurance: Professor Tim Jost breaks down how PPACA will influence self-insured plans.

3.  Doc vs Doc: Maggie Mahar profiles two feuding medical organizations: The Association of American Physicians and Surgeons, and the newer National Physicians Alliance.

4. Preventive Problems: The New York Times’ Duff Wilson reports on the brewing controversy of the FDA’s decision to permit broader marketing of AstraZeneca’s blockbuster statin Crestor.

5. On Evidence-based Surgery: David Gorski at Science-based Medicine has a tome-of-a-piece on surgery and evidence-based medicine.

6. Patent Pending: David Post at the Volokh Conspiracy discusses the recent ruling that invalidated (for now) the patenting of a gene thought to be associated with breast and ovarian cancer.

7. E-Prescribing: John Halamka discusses the trials and tribulations of e-prescribing controlled substances.

8. Just plain interesting:

a. Parkinson’s patients who can’t walk but can ride bikes. Wow.

b. Transcranial Magnetic Stimulation appears (at least in the lab) to influence moral decision making.

c. TED Talk: The Future of Medicine — Taking health care off the mainframe.

Health Reform, “Death Panels,” & Section 1182–What the Text Really Says

This post is a follow-up to my prior post on the Patient-Centered Outcomes Research Institute, a nonprofit corporation created by the Patient Protection and Affordable Care Act (the Health Reform Law), which will oversee comparative clinical effectiveness research–or, in Palin-ese, “the Death Panel.” The pertinent text of the law under which the Institute will operate appears below along with explanation in the plainest English available.

LIMITATIONS ON CERTAIN USES OF COMPARATIVE CLINICAL EFFECTIVENESS RESEARCH

Sec. 1182. (a) The Secretary may only use evidence and findings from research conducted under section 1181 to make a determination regarding coverage under title XVIII if such use is through an iterative and transparent process which includes public comment and considers the effect on subpopulations.

• TRANSLATION: Must be open and transparent and must consider effect on particular groups, but can use research to make determinations regarding coverage

‘(b) Nothing in section 1181 shall be construed as–

‘(1) superceding or modifying the coverage of items or services under title XVIII that the Secretary determines are reasonable and necessary under section 1862(l)(1); or

‘(2) authorizing the Secretary to deny coverage of items or services under such title solely on the basis of comparative clinical effectiveness research.

• TRANSLATION: Coverage cannot be based solely on CER

‘(c)(1) The Secretary shall not use evidence or findings from comparative clinical effectiveness research conducted under section 1181 in determining coverage, reimbursement, or incentive programs under title XVIII in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill.

• TRANSLATION: CER cannot be used to assign a  lesser value to extending the life of the elderly, disabled or terminally ill (as compared to the younger and healthier) in regard to treatment. Health care dollars cannot be allocated first (or exclusively) to young and relatively healthy individuals under the rationale that extending the lives of the younger and healthier is, by definition, more valuable. The issue is further explored in 1182(e), discussed below. 1182(e) further limits the use of such valuations with regard to the Quality Adjusted Life Year.

‘(c)(2) Paragraph (1) shall not be construed as preventing the Secretary from using evidence or findings from such comparative clinical effectiveness research in determining coverage, reimbursement, or incentive programs under title XVIII based upon a comparison of  the difference in the effectiveness of alternative treatments in extending an individual’s life due to the individual’s age, disability, or terminal illness.

• TRANSLATION: When evaluating treatments to extend an individual’s life, CER can be used to determine whether Medicare will cover one  treatment rather than an alternative. Specifically, an individual’s age, disability, or terminal illness can be a factor in deciding which treatment will be covered, reimbursed and/or incentivized.  For example an elderly person with severe coronary artery disease may have two treatment options: surgery (e.g. revascularization) or drug therapy. Both of these treatments would theoretically extend the life of the patient by reducing the odds of a heart attack or stroke. However (hypothetically) CER data may demonstrate that an individual of advanced age lives longer on average if they opt for drug therapy. In such a circumstance, this section provides that CER data may take into account the individual’s age, disability and terminal illness when comparing two alternative treatments. It may also be the case that CER data shows that individuals with certain disabilities are less likely to respond to surgery or to different treatment, possibly due to immobility, or even impending death. Again, these facts can be taken into account in the CER calculus.

‘(d)(1) The Secretary shall not use evidence or findings from comparative clinical effectiveness research conducted under section 1181 in determining coverage, reimbursement, or incentive programs under title XVIII in a manner that precludes, or with the intent to discourage, an individual from choosing a health care treatment based on how the individual values the tradeoff between extending the length of their life and the risk of disability.

• TRANSLATION: The Secretary cannot use CER to deny or try to persuade a patient from choosing a treatment that may prolong their life but leave them severely disabled. Alternatively, the Secretary cannot prevent a patient from choosing a treatment which may improve the quality of their life, as opposed to an alternative treatment which may extend the length of life.

‘(2)(A) Paragraph (1) shall not be construed to–

‘(i) limit the application of differential copayments under title XVIII based on factors such as cost or type of service; or

• TRANSLATION: The extant differential copayment guidelines are unaffected. 

‘(ii) prevent the Secretary from using evidence or findings from such comparative clinical effectiveness research in determining coverage, reimbursement, or incentive programs under such title based upon a comparison of the difference in the effectiveness of alternative health care treatments in extending an individual’s life due to that individual’s age, disability, or terminal illness.

• TRANSLATION: See 1182(c)(2) discussed above.

‘(3) Nothing in the provisions of, or amendments made by the Patient Protection and Affordable Care Act, shall be construed to limit comparative clinical effectiveness research or any other research, evaluation, or dissemination of information concerning the likelihood that a health care treatment will result in disability.

• TRANSLATION: This section is straightforward. The Institute can compare various treatments and determine which is more likely to result in a disability, and disseminate those findings.

‘(e) The Patient-Centered Outcomes Research Institute established under section 1181(b)(1) shall not develop or employ a dollars-per-quality adjusted life year (or similar measure that discounts the value of a life because of an individual’s disability) as a threshold to establish what type of health care is cost effective or recommended. The Secretary shall not utilize such an adjusted life year (or such a similar measure) as a threshold to determine coverage, reimbursement, or incentive programs under title XVIII.’

• WHAT IS A QALY?: The Quality-Adjusted Life Year (QALY) is defined by the NIH as:
  • (1) A unit of measure of utility which combine life years gained as a result of health interventions/health care programs with a judgment about the quality of these life years.
    (2) A common measure of health improvement used in cost-utility analysis, it measures life expectancy adjusted for quality of life. (See NIH’s Health Economics Information Resources, Glossary, at http://www.nlm.nih.gov/nichsr/edu/healthecon/glossary.html#QALY)
• The goal of the QALY is to ensure that healthcare resources are allocated in a manner which is most beneficial. Because healthcare resources are scarce, however, the $/QALY looks to allocate those resources economically. The QALY ipso facto discounts the value of life due to a disability. This is because the QALY works by assigning different states of health along a continuum, with perfect health being 1 and death being 0. The QALY is interested in whether different treatments provide more QALYs, In other words, QALYs are interested in whether one treatment provides more years at a better state of health (i.e., closer to 1) than another treatment. See M. Weinstein, Spending Health Care Dollars Wisely: Can Cost-Effectiveness Analysis Help? (2005)

• TRANSLATION: The Institute cannot utilize a $/QALY ( or a similar measure) as a threshold to establish what treatment is cost-effective, recommended or incentivized. (It is, however, noteworthy that in describing “similar measure,” both “age” and “terminal illness” are not expressly excluded as prohibited criteria in the development of a metric, as they are throughout the text of other portions of the provision).

• Note: 1182(c)(2) does allow for a disability to be taken into account when comparing various treatments for an individual. That section must be distinguished from the current section (1182(e)), where the upshot is that the dollar valued QALY cannot be a benchmark by which to allocate resources. If we are only determining which of two resources to a given individual shall be reimbursed, then the individual’s disability may be taken into account, i.e., treatment effectiveness under the individual’s circumstances  is a metric for which CER may be utilized; however, dollar value of life quality is not a permitted metric or criteria for treatment.

Comparative Effectiveness Research Under Health Reform, “The Institute”

“Bend the cost curve” has been the mantra of many students of health care reform. The Dartmouth Health Atlas has shown that up to 1/3 of care may be unnecessary. But how do we find out what care is unnecessary? One tool that holds promise is comparative effectiveness research.   Now that health reform has been signed into law, there is greater certainty as to the future of comparative effectiveness research (CER). The Stimulus bill had already allocated $1.1 billion dollars to investigate CER. The newest health reform law continues to build on that start. So what about HR 3590, also known as the Patient Protection and Affordable Care Act? Will they ration care? Pull the plug on your grandmother? Get between you and your doctor? To start answering these questions, I will provide a brief overview of CER under the new law, and describe the law’s vision for a new institute for CER research.

Part D of  H.R. 3509 is entitled “Comparative Clinical Effectiveness Research.” Section 1181 of  Part D defines CER as: “research evaluating and comparing health outcomes and the clinical effectiveness, risks, and benefits of 2 or more medical treatments, services, and items described in subparagraph (B).” Subparagraph B goes on to describe various services and goods associated with health care.

The Institute
Section (b) of 1181 is where the rubber hits the road. Under this this section, the law creates a nonprofit corporation to be called the “Patient-Centered Research Institute,” known as “the Institute,” which is neither an agency nor establishment of the United States. This is rather interesting, and I did not know that our federal government created such corporations, but I suppose it could be compared to a nonprofit Amtrak.

Funding
The Institute will be backed by a Trust Fund created by money transferred from the Medicare Part A and B trust fund. It will receive, for year 2013, an amount equal to 1$ multiplied by the number of individuals entitled to benefits of Medicare Part A or enrolled under Part B. For years 2014 through 2019 the multiplier is $2.

The Purpose and Duties of the Institute
The purpose of the Institute is stated as what amounts to the typical reason for CER: making better health care decisions based on the evidence.

The duties of the institute are listed as:

1. Identifying and adopting (by majority vote within the Institute) research priorities and establishing research project agenda
2. Carrying out research project agenda by doing
   1. Systematic reviews of previous (and future) research (often known as meta-analysis), and
   2. Primary research including randomized clinical trials. The primary research the Institute conducts can be subcontracted to other institutions, under certain constraints.
3. Data collection from various electronic sources like those at the Center for Medicare and Medicaid Services.
4. Appointing expert advisory panels for clinical trials
5. Supporting patient and consumer representatives
6. Establishing a methodology committee to study new ways to measure and conduct CER.
7. Providing a peer-review process for primary research conducted by the Institute. Notably, if the Institute subcontracts, they can use the peer-review process of the organization to which they contract with.
8. Release of research findings to clinicians, patients, and the general public. The Institute must also release an annual report.

Governing in the Institute
The Institute will be run by a Board of Governors. The breakdown of the Board of Governors is quite interesting, and possibly telling:

• The Director of the Agency for Healthcare Research and Quality
• The Director of the National Institute of Health
• 17 members appointed by the Comptroller General of the U.S. The 17 members must be composed of:
  • 3 members representing patients and health care consumers.
  • 5 members representing physicians and providers, including at least 1 surgeon, nurse, State-licensed integrative health care practitioner, and a representative of a hospital.
  • 3 members representing private payers, of whom at least 1 member shall represent health insurance issuers and at least 1 member shall represent employers who self-insure employee benefits.
  • 3 members representing pharmaceutical, device, and diagnostic manufacturers or developers.
  • 1 member representing quality improvement or independent health service researchers.
  • 2 members representing the Federal Government or the States, including at least 1 member representing a Federal health program or agency.

This very well may be one of the handouts that the Senate provided Big Pharma and device manufacturers to get them on board. Remember that CER may very well show that a drug that a company has invested hundreds of millions of dollars in turns out to be ineffective when compared to its competitor. Thus, it is not surprising, for the cynics among us, that the Board has at minimum 3 industry reps from pharma and devices while there is a minimum of only 1 doctor. You start to wonder why the AMA supported the bill if physicians are only guaranteed 1/17th of the positions. After all, it is undeniable that physicians will be interacting with the CER data more than anyone, and they have on the ground experience using CER and related decision aids like Clinical Practice Guidelines.

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

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.

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).  Read more

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.

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