OPM Legislative Proposal

Govexec.com (dated 5/30) and the Federal Times in this week's issue (p. 6) report that on May 23, OPM Director Linda Springer submitted to the House and Senate leadership a proposal to amend the FEHB Act to permit the Service Benefit Plan to offer a third option that pairs a high deductible health plan with a health savings account. NARFE has expressed its strong, unalterable opposition to this proposal. As far as I can tell, no bill implementing OPM's proposal has been introduced in the House or Senate yet.

Interesting DC Circuit opens Pandora's Box -- The Right to Self-Preservation

On May 2, the U.S. Court of Appeals for the District of Columbia issued a split opinion in Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, -- F.3d -- , No. 04-5350 (PDF copy). In this case, the Alliance, supported by the Washington Legal Foundation, sought access to post phase I trial investigational new drugs on behalf of mentally competent, terminally ill adults with no alternative government approved treatment options. Under the Food Drug and Cosmetic Act, drugs cannot be sold in interstate commerce without Food and Drug Administration (FDA) approval for marketing. 21 U.S.C. § 321(p)(1). The FDA approval process involves three phases of human testing -- phase I which is a safety test on 20-80 patients; phase II which is an efficacy test on up to several hundred patients, and phase III which is an expanded trial. These trials can take seven years, according to the opinion.

The Court in a majority opinion written by Judge Rogers and joined by Chief Judge Ginsburg held in reliance on Washington v. Glucksberg, 521 U.S. 702 (1997) that the due process clause of the Fifth Amendment to U.S. Constitution protects the right of terminally ill people to access investigational new drugs that have cleared initial safety testing at phase I of the trials when the patient's doctor holds the opinion that the drug is potentially life saving, even though its efficacy has not yet been proven. The Court found that the government has not blocked access to investigational new drugs for the greater part of our Nation's history. Analogizing to the Supreme Court's opinions in Cruzan v. Director, Missouri Department of Health, 497 U.S. 261 (1990)(holding than an individual has a due process right to refuse life sustaining treatment), as well as Roe v. Wade and Griswold v. Connecticut, the Court decided that "the key is the patient's right to make the decision about her life free from government interference." (Slip op., at 3).

The Court remanded the case to the district court for its decision on whether the FDA's
policy restricting access to investigational new drugs with certain compassionate exceptions is narrowly tailored to serve a compelling governmental interest." I learned in law school many years ago now that it is very difficult for the goverment to satisfy the compelling interest test (as opposed to the rational basis test which is applied when there is no fundamental substantive due process right at stake.)

I found Judge Griffith's dissenting opinion quite convincing. Judge Griffith believes that the Alliance should have taken its argument to Congress rather than the courts. He disagrees that there is a fundamental right to access investigational new drugs citing a long history of state and federal regulation of drugs. "Contrary to the tradition asserted by the majority, there is a tradition of courts rejected arguments that the Constitution provides an affirmative right of access to particular medical treatments prohibited by the Government" (Dissent at 19). The dissent raises a number of important health law questions presented by the majority opinion, e.g, "If a terminally ill patient has such a right, are patients with serious medical conditions [similarly entitled]; can a patient access any drug if she believe in consultation with a physician that it is potentially life saving?" (do you remember Laetrile) and here's a question from me -- if these investigational new drugs become widely available after phase I -- why would anyone participate in a phase II or III trial where some participants receive the drug and others receive a placebo? (Trials are ethical because there is no evidence that the investigational new drug is more effective than existing treatments or the placebo.)

The D.C. Circuit, in my view, has opened a real Pandora's box, and I trust that the FDA and the Justice Department are evaluating their rehearing/appeal options.

Memorial Day

On Memorial Day, we pay tribute to the soldiers, sailors, and airmen who have fallen in defense of the United States, our country, as well as those who now are in service. At 3 pm on May 29, I hope that everyone will observe the National Moment of Remembrance. In particular, I will remember my cousin Army Capt. Eric T. Paliwoda (left), 4th Infantry Division, West Point Class of 1997, who was killed in combat in Iraq on January 2, 2004. We will never forget.

Competing Prompt Payment Surveys

The latest salvos in the ongoing feud between the medical profession and health insurers were competing prompt payment studies published by Athena Health and the America's Health Insurance Plans (AHIP). The New York Times, reporting on the Athena Health study, trumpeted that "late payment of medical claims adds to the cost of health care." The article begins "Few things rankle a doctor more than an insurance company's saying it cannot find a claim for medical services. Particularly when there is even a signed return receipt to document delivery of the bill." The article then quotes a Pittsburg medical group CEO who, in 20th century fashion, has the green USPS return receipt for a large dollar claim.

Why didn't this group send the claim electronically (and why didn't the Times reporter ask that obvious questions)? As the AHIP study points out, health plans process electronic claims much more efficiently than paper claims, and all health plans have prepared to receive standard electronic claims as a result of the federal government's HIPAA mandates. This CEO only has herself to blame for any delay here. As Dr. David Kibbe remarked to the American Academy of Family Physicians, "If there's a silver lining to the HIPAA regulations, it's here. These standards can save your practice time and money." Now there's a valuable message for medical practices to apply. The Hatfield-McCoy feud eventually ended; maybe this one will too.

VA Security Breach Update

The Washington Post has been reporting daily about the massive Veterans Affairs (VA) Department security breach. As I mentioned in an earlier post this week, a laptop computer was stolen from a VA employee's home in Montgomery County, MD. The stolen property included a portable hard drive on which was stored the unencrypted personal demographic information on 26.5 million U.S. veterans, including Social Security numbers -- the largest theft of SSNs on record. The government has established a website to help affected veterans and their families.

On Friday, the Post reported that this employee routinely took home such demographic data. Today's article provides more details on the nature of the theft and the reporting timeline. The Post reports that "the employee 'assumed full responsibility, acknowledging he knew he should not have taken the data out of the office." The Post explores the disturbing reporting timeline -- the employee promptly reported the theft to his superiors and the Montgomery County Police, but the VA Secretary did not learn of the theft until May 16 and the public was not informed until May 22. Even the FBI was not brought in until late last week.

According to the Post, Sen. Susan Collins described the situation as baffling. I agree. While the employee has accepted responsibility, I cannot understand how the VA computer system evidently permitted that employee to download and externally store unencrypted personal data. At a May 25 hearing before the Senate Veterans Affairs Committee, the VA Inspector General reported security vulnerabilities related to the operating system, passwords, a lack of strong detection alerts and a need for better access controls -- all of which have existed at least since 2001. I trust that in view of this nightmare all IT security officials are now double checking their own systems' internal controls.

Travel Vaccinations

The Saturday edition of the Wall Street Journal (a wonderful addition to my reading) includes an article on vaccinations required for travel to exotic foreign locales (warning - subscription wall). The article recommends that a traveler check a U.S. Centers for Disease Control website for required or recommended vaccinations and then check out their health plan coverage for those immunizations (FEHB plans generally provide good vaccination coverage.) The article also provides consumer tips on how to negotiate vaccination charges with the provider, e.g., group discounts at nurse practitioner travel clinics. I googled travel clinics and found several in DC, which I guess is not surprising.

HIT Developments

Rep. Nancy Johnson’s (R-CT) House Ways and Means Health subcommittee endorsed her Health Information Technology Promotion Act, H.R. 4157, by an 8-5 vote yesterday. (Hat tip to my colleague Theresa Defino. This bill would enshrine in law various HHS HIT initiatives such as ONCHIT. It also would fast track transition to a new electronic claims format (X12 5010 837 – April 1 2009) and the ICD-10 diagnosis and hospital procedure coding system (October 1, 2009). I understand that these are expensive IT projects for health plans. The House leadership may be planning to have the House vote on this bill during the body's Health Week which reportedly begins June 18.

Sen. Ensign’s Commerce Committee will be holding an HIT acceleration hearing on June 21.

Take Your Vitamins?

In March, 2006, Wall Street Journal Tara Parker-Pope wrote a counter-intuitive article titled "The Case Against Vitamins." (I found a copy that is not behind the subscription wall.) She writes

"Over the past several years, studies that were expected to prove dramatic benefits from vitamin use have instead shown the opposite. Beta carotene was seen as a cancer fighter, but it appeared to promote lung cancer in a study of former smokers. Too much vitamin A, sometimes taken to boost the immune system, can increase a woman's risk for hip fracture. A study of whether vitamin E improved heart health showed higher rates of congestive heart failure among vitamin users. And there are growing concerns that antioxidants, long viewed as cancer fighters, may actually promote some cancer and interfere with treatments."

The Washington Post's health section featured an article titled "Multi Vitamins, Multi Questions" about a recent conclusion by "a federal panel that there's no evidence to recommend for or against these dietary supplements." The article is worth reading because it seeks to put the findings in context.

These articles remind me of a scene from Woody Allen's 1973 movie "Sleeper" in which Woody awakes from a Rip Van Winkle length nap to find that eating red meat and smoking are now endorsed by the American Medical Association.

When I was a senior in college many years ago, I took a course on the future of the world. It was very Malthusian -- warning of the coming population explosion. (My word, the 1970's were a very depressing time.) Thirty years provides one with perspective. I therefore enjoyed reading my friend Robert Samuelson's column in today's Washington Post titled "Behind the Birth Dearth." I commend it to you.

A Big Bowl of Wrong

Several news sources report, and the Veterans Affairs (VA) Department has confirmed, that an electronic data file containing the the names, birthdates, and Social Security Numbers of all living U.S. veterans (26.5 million in all) was stolen earlier this month from the home of VA analyst, who should not have taken the data from his office. Such major security breaches are not going to help the ongoing effort to create a national health information network.

Total Recall

I found a fascinating HIT article buried in the Metro section of today's Washington Post that minded me of the excellent Arnold Schwarzenegger movie from 1990 -- Total Recall.

Evidently a company called Verichip is selling an implantable chip carrying a 16 digit patient ID number. The chip is implanted in a person, usually someone suffering from dementia, in a particular place on the body. When patients arrive unconscious or with dementia at an emergency room with a Verichip scanner (according to this article three DC area ERs now have one), the facility will scan the patient for the chip. If the ER finds the chip, ER personnel will use the patient ID scanned from the chip to log into a Verichip web site where the patient's medical history is stored. Wow.

The sky is falling!!?

Former HHS Secretary Tommy Thompson is predicting that the U.S. health care system stressed by an aging population will collapse under its own weight by 2013. To avoid this outcome, he recommends increasing the cigarette tax by $1, somehow convincing Americans to eat less/better, and improving patient safety through health information technology.

Mark Your Calendars!

June 7 is National Health IT Day. I will celebrate the day by attending the keynote speeches by Former Speaker Newt Gingrich, Dr. David Brailer, and others.

June 13 is the date for the House Federal Agency and Workforce Organization Subcommittee's hearing on H.R. 4859, the Family Friendly Health Information Technology Act of 2006. The lead article in this week's issue of the Federal Times discusses this bill and OPM's HIT issues described in the 2007 benefit and rate proposal call letter.

Supreme Court musings

Yesterday, the U.S. Supreme Court unanimously handed the ERISA-governed health plan community a major victory. Chief Justice Roberts' opinion in Sereboff v. Mid Atlantic Medical Services, Inc., -- U.S. --, No. 05-260, now permits ERISA-governed plans to enforce in federal court equitable liens on judgments and settlements that are subject to the plan's contractual subrogation rights. I believe that this opinion undoes much of the damage to legitimate ERISA plan subrogation efforts created by the Supreme Court's 2002 opinion in Great-West Life & Annuity Ins. Co. v. Knudson, 534 U. S. 204.

If private sector ERISA plans can enforce their subrogation rights in federal court, why shouldn't the Court similarly rule in the McVeigh case (argued April 25) that FEHB plans have the same right, particularly when the funds which they recover are deposited in the U.S. Treasury. Sereboff adds support to my prediction that the Supreme Court will rule in Empire Blue Cross's favor in the McVeigh case (see April 26 post).

Senate Health Week Ends Anticlimatically

I am in rainy Madison Wisconsin, attending my daughter's graduation (ON WISCONSIN!) from the University of Wisconsin so I am a little delinquent in reporting that the Senate Health Week ended anticlimatically. On Thursday night, the Senate Republican majority was only able to round up 55 votes -- five short of the 60 votes needed to end the filibuster over Sen. Enzi's small business health care reform bill. I think that's no great surprise.

My family and I visited the Mustard Museum in nearby Mount Horeb, Wisconsin today. Much fun!

Bill Reflecting President's HSA Proposals is Introduced

On May 3, 2005, Rep. Eric Cantor (R-VA), the Chief Deputy Majority Whip in the House, introduced a bill (HR 5262) that embraces the Health Savings Account / High Deductible Health Plan improvements that President Bush proposed in the year's State of the Union address:

• Increasing HSA contribution limits to the plan's out-of-pocket maximum;

• Making premiums for HSA-compatible insurance tax-deductible;

• Providing a low-income tax credit the purchase of HSA-compatible insurance;

• Allowing employers to make greater HSA contributions for chronically ill employees;

• Allowing flexibility to coordinate HSAs with existing health coverage options like Flexible Spending Accounts (FSAs) and Health Reimbursement Arrangements (HRAs);

• Allowing early retirees to use HSA savings to pay for insurance coverage premiums;

• Providing an income tax credit equal to amount of payroll taxes paid on HSA-compatible insurance premiums;

• Providing an income tax credit equal to the amount of payroll taxes paid on HSA contributions, and

• Providing pre-tax treatment of health care expenses incurred under HSA-compatible health plans before an individual establishes an HSA.

The bill was referred to the House Ways and Means Committee whose chairman, Bill Thomas (R-CA) reportedly supports the bill. Rep. Cantor, who sits on that Committee, would like for the full House to vote on the bill during its Health Week scheduled for the week of June 18th. The stumbling block for this bill may be the Senate.

Are we really 12 years behind the rest of the world in HIT?

The Baltimore Sun reports today that "The United States lags "at least a dozen years" behind other industrialized countries in adopting electronic medical records, according to a study published yesterday in the journal Health Affairs" authored by Prof. Gerard F. Anderson, Johns Hopkins Bloomberg School of Public Health and others. The report faults the government and insurance companies for failing to fund the initiative. I have not read the report, but I wonder whether the authors considered the fact that health insurers have spent millions of dollars over the past decade to come into compliance with the HIPAA administrative simplification standards at Congress's direction?

Prof. Herbert presented an interesting price transparency report to Congress in March 2006. Here's a link to a PDF copy.

Senate Health Week Update III

The Senate majority leadership's push to pass the Enzi small business healthcare reform bill has stalled, according to the Washington Post, and the minority leadership may apply the coup de grace today. The President has endorsed this bill; the House has passed a substantially similar version (H.R. 525) last year, and business community strongly supports it. However, the Democrats, state insurance regulators, many insurance companies, and patient advocate groups oppose it.

Steven Pearlstein of the Washington Post had an interesting health care reform in yesterday's paper and held an online chat to discuss his article. In his article, he mentioned three "fresh ideas" for small business health care reform:

• A plan offered by Katherine Swartz of Harvard's School of Public Health to have the federal government provide specific stop loss insurance for claims over $50,000 (subject to 10% coinsurance) funded by a tax on premiums. "This would equalize premiums and reduce the incentive for insurers to 'cherry-pick' the healthiest employee groups."
• A plan offered by Michael Porter of Harvard Business School and Elizabeth Olmsted Teisberg of the University of Virginia's Darden School of Business to price fix all hospital and physican charges regardless of payor. "That would eliminate the massive cost-shifting that favors big employers and big insurance companies." (Of course the most massive cost shifting is done by the federal government's Medicare, Medicaid, and TRICARE program not these payors, and in my view, you can date the health care cost problem from the time when Medicare shifted to a prospective payment/DRG system for compensating inpatient hospital care in 1983. But it's always easier to blame the insurance companies.)
• The recently enacted Massachusetts state mandate requiring the purchase of health insurance.
  

If these were the freshest ideas that we've got, I would be worried.

Senate Health Week Update II

The Washington Post reports that the Senate minority leadership is now considering a filibuster of the majority's small business health insurance reform bill, S. 1955. The Senate majority is trying to line up support for a cloture vote. The President has expressed his support for the bill.

Unique Health Plan Identifier Update

As I mentioned in a recent post to this blog, the recent HHS unified agenda states that the proposed rulemaking for a HIPAA-mandated unique health plan identifier was withdrawn. This surprised me as I had understood that HHS was close to publishing a proposed rule, and there is no privacy issue associated with this identifier. With help from my colleague Theresa Defino, I have learned that HHS has gone back to the drawing board on the unique health plan identifier and the agency therefore described the proposed rule as withdrawn because HHS does not currently have an anticipated publication date for that proposed rule. But it is still in the regulatory pipeline.

Senate Health Week Update I

The U.S. Senate's Republican majority leadership is now holding a Health Week to consider health care related bills that the House passed last year in different forms. Yesterday, the Senate leadership failed to break a filibuster over a medical malpractice liability reform bill, S. 22. Today, the Senate is considering a small business health care reform bill, S. 1955. The Senate's Democrat minority leadership reportedly does not plan to filibuster this bill, but they would like an opportunity to hold a vote on their own small business reform bill, S. 2510, which would create a quasi-FEHBP for small businesses (under 100 employees) that OPM would administer. I'll keep you posted.

Price Transparency Survey

The Center for Affordable Health Insurance released the results of a Zogby nationwide poll which finds that 84% of Americans agree that hospitals, doctors, and pharmacies should post their prices for all goods and services and that 79% of Americans are likely to price shop for health care based on that information. The margin of error is plus or minus 2.9%.

More Docs without Managed Care Contracts

The Center for Studying Health System Change released a report yesterday stating that "After remaining stable since the mid-1990s, the proportion of U.S. physicians without any managed care contracts rose from 9.2 percent in 2000-01 to 11.5 percent in 2004-05.

"Compared with physicians with one or more managed care contracts, physicians without managed care contracts are more likely to have practiced for more than 20 years, work part time, lack board certification, practice solo or in two-physician groups, and live in the western United States, the study found."

Tip of the hat to my journalist friend Theresa Defino for pointing out this interesting study.

Price Transparency in the News

On May 1, 2006, President Bush spoke before the American Hospital Association (AHA) convention. He had the following comments on price transparency:

“My administration is working with the AHA and other health care associations to provide patients with reliable information about prices and quality on the most common medical procedures. And I want to thank the AHA board for adopting a resolution this week supporting transparency. I appreciate your leadership on this vital issue. (Applause.)

“We must work together to get patients the information they need so they can get the best quality care for the best price. If you're worried about increasing costs, it makes sense to have price options available for patients. That's what happens in a lot of our society; it should happen in health care, as well. By increasing transparency, the idea is to empower consumers to find value for their dollars and to help patients find better care and to help transform this system of ours to make sure America remains the leader in health care.

“Secretary Leavitt has met with leaders in the health care industry in 13 cities to encourage them to work with the Department of Health and Human Services to increase transparency in the marketplace. We're asking doctors and hospitals and other providers to post their walk-in prices to all patients.

I directed the Department of Health and Human Services to make data on Medicare's price and quality publicly available on the Internet. The first data will be available to all Americans by June 1st. We're also asking insurance companies to increase health care transparency by providing their negotiating prices and quality information to their enrollees. And the federal government will do the same.

“My administration will be requiring transparency from insurance plans participating in federal programs. Beginning this year, the Federal Employees Benefit Program and the military's Tricare system are asking contractors to begin providing price and quality information.

"Today, I'm asking for your help. Every hospital represented here should take action to make information on prices and quality available to all your patients. If everyone here cooperates in this endeavor we can increase transparency without the need for legislation from the United States Congress. By working together, transparency -- to increase transparency, we can help lower costs.”

Here’s a link to the AHA’s new price transparency policy. The AHA asks for federal standards on the presentation of pricing information and for insurers to provide an explanation of benefits before care is provided – an advance EOB. (I believe that easier said than done.) According to the AHA, Aetna is piloting an advance EOB in Cincinnati, OH. AHA also points out that the amount of pricing information that a consumer needs depends on their type of health care coverage.

Proactive

The Washington Post reports today the death of Yale University professor Albert Reiss Jr. who coined the managementspeak phrase "proactive."

Medco Settlement

Medco , a major prescription benefits manager, released its first quarter earnings today and in doing so it announced an agreement in principle on financial terms to settle the False Claims Act lawsuit pending against it in the U.S. District Court located in Philadelphia. The lawsuit relates to Medco's FEHB Program business.

Marketwatch.com reports that

"Medco said it's reached "an agreement in principle on financial terms" with the U.S. Attorney's office, with final disposition contingent on the parties striking what the company called a "corporate integrity agreement."

"These additional elements have not been agreed to by the participating entities and there can be no assurance that a mutually satisfactory agreement will be reached," Medco said, adding that it hasn't admitted to any wrongdoing under the settlement."

Medco's stock price is up 4.61% today on a strong earnings report and the settlement news.

Breaking News -- OPM announces supplemental dental and vision vendors

OPM just publicly releases the following information:

U.S. Office of Personnel Management has selected the companies that will offer supplemental dental and vision benefits under the new Federal Employee Dental and Vision Insurance Program which will begin December 31, 2006. Following a review of proposals, OPM has selected MetLife, GEHA, United Concordia, Aetna, GHI, CompBenefits, and Triple-S to offer dental benefits and Vision Services Plan, BCBS Vision, and Spectera to offer vision benefits.

Proposed USPS Rate Hike linked to FEHB premium increases by USPS

Earlier today, the USPS Board of Governors proposed to increase the price of a first class stamp from 39 cents to 42 cents in 2007. In its press release, the Board blamed the increase on rising fuel costs and on FEHB premiums: "Like other businesses, the Postal Service has also experienced significant growth in health benefit payments for more than 621,000 current employees and 445,000 retirees. In 2005 alone, these costs increased by $437 million, reaching a total of $6.6 billion." But that's only a 7.1% increase, which is pretty reasonable these days.

The Washington Post reports that Rep. Tom Davis (R-VA), who chairs the House Government Reform Committee, immediately criticized the decision in a press release "I am disappointed the Board of Governors did not see fit to wait until comprehensive postal reform legislation becomes law before making a decision on whether to seek rate increases," he said. "The bill that emerges from the House-Senate conference will most likely significantly alter the Postal Service's costs and may alter the process by which rate cases are decided." The proposal now goes to the Postal Rate Commission for review. Given Rep. Davis's reaction, I think that we can expect a Congressional hearing on this.

Medicare News

I am interested in the Medicare Program for FEHBlog purposes because there are hundreds of thousands of Medicare eligible enrollees in the FEHB Program. Generally, Federal employees who have had five years of FEHBP coverage immediately preceding retirement carry their FEHBP coverage into retirement with the full government contribution. Federal employees who retired after 1982 are eligible for Medicare Part A and can subscribe for Medicare Part B.

The Wall Street Journal (subscription required) reported on Tuesday that "Medicare beneficiaries will see a big jump in the premiums they pay for physician and other outpatient care, under the portion of the program known as Part B. Medicare officials said yesterday that premiums would increase next year by 11%, to $98.20 a month from $88.50, partly because of a surge in the volume and intensity of Part B services and a decision by Congress to override a reduction in physician payment that was scheduled to occur this year."

Also in 2007, the Medicare Modernization Act of 2003 requires CMS to means test Part B premiums. The baseline is the 75% subsidy for beneficiaries with a taxable income of $80,000 (single) or $160,000 (couple). Above those income levels the subsidy will decrease thereby raising the Part B premium as follows:

• 65% premium subsidy for beneficiaries between $80,000 & $100,000
• 50% premium subsidy for beneficiaries between $100,000 & $150,000
• 35% premium subsidy for beneficiaries between $150,000 & $200,000
• 20% premium subsidy for beneficiaries over $200,000

These increases will be phased over a five year period. The change is expected to affect only 3% of Medicare beneficiaries.

What's more according to the Journal and the Washington Post , the Medicare Trustees now are projecting that Part A Trust Fund will run out of money in 2018, which is "two years sooner than predicted a year ago and 12 years sooner than had been anticipated when President Bush first took office." This report has an immediate Congressional ramification according to the Wall Street Journal report:

"Under a requirement passed with the Medicare drug benefit, legislative action is supposed to occur if Medicare's trustees predict that, within the first seven years of their annual 75-year projections, general revenues fund more than 45% of total Medicare spending for two years in a row. Yesterday's report said that threshold would be reached in 2012. That means the trigger for action would occur in 2007 if projections hold. President Bush would be required to propose legislative changes, and Congress would have to give them fast-track consideration."

That will be an interesting development shortly before the next Presidential election.

HIPAA Standard Identifiers Update

The HHS semi-annual regulatory agenda published on April 24, 2006, informs us that HHS expects to release the final HIPAA electronic claims attachment standard (proposed Sept. 23, 2005, 70 Fed. Reg. 55,989) in September 2008 (No. 1035) and that HHS has withdrawn the rulemaking for the HIPAA standard health plan identifier (No. 1051). Previous agendas indicated that a proposed rule on the standard health plan identifier would be released in November 2005 (e.g., 70 Fed. Reg. 26,865). So we are down to two standard identifiers, employer and health care provider, from the four originally anticipated (employer, provider, health plan, and patient).

D.C. Bar HIT Overview

Yesterday, I attended a DC Bar Health Information Technology (HIT) Overview. The speakers were Mark Mantooth, an HHS attorney with the Office of the National Coordinator, Dr. Bill Braithwaite of the e-health Initiative, and Ben Butler, a partner with Crowell & Moring.

Mr. Mantooth reviewed the many HHS initiatives underway, and he described how the initiatives interact. Of particular interest to me was his discussion of the work of the American Health Information Community because the OPM Director sits on that FACA committee. The Community has four workgroups -- BioSurveillance, Chronic Care, Consumer Empowerment, and Electronic Health Records. The OPM Director is the co-chair of the Consumer Empowerment workgroup.

Each of the workgroups has established a "breakthough objective" upon which they are focusing their attention. All of the breakthroughs involve making recommendations to the Community so that within one year the objective can be achieved. The workgroups are preparing the recommendations now and draft letters to the HHS Secretary are posted on the website.

Bio-surveillance -- Essential ambulatory care and emergency department visit, utilization, and lab result data from electronically enabled health care delivery and public health systems can be transmitted in standardized and anonymized format to authorized public health agencies within 24 hours.

Chronic care -- Widespread use of secure messaging, as appropriate, is fostered as a means of communication between clinicians and patients about care delivery.

Consumer Empowerment -- A pre-populated, consumer-directed and secure electronic registration summary is made available to targeted populations and a widely available pre-populated medication history linked to the registration summary is deployed.

Electronic Health Records -- Standardized, widely available and secure solutions for accessing current and historical laboratory results and interpretations is deployed for clinical care by authorized parties.

Dr. Braithwaite spoke primarily about regional health information organizations (RHIOs which he wants to call RHINOs -- similar to Hippos with HIPPA) and the Connecting for Health Initiative. In April 2006, Connecting for Health, a Markle Foundation project, released a common framework for a national health information network. The framework would link frequently interacting health care providers into SNOs which would be connected into a national health information network using a SNO-Bridge and a Record Locator service. I am no technology expert but the framework clearly looks like a step in the right direction to me.

Dr. Braithwaite also mentioned a peer-reviewed study titled "Systematic Review: Impact of Health Information Technology on Quality, Efficiency, and Costs of Medical Care" to be published in the May 16, 2006 issue of the Annals of Internal Medicine. The study draws the following sobering conclusions:

"This review suggests several important future directions in the field. First, additional studies need to evaluate commercially developed systems in community settings, and additional funding for such work may be needed. Second, more information is needed regarding the organizational change, workflow redesign, human factors, and project management issues involved with realizing benefits from health information technology. Third, a high priority must be the development of uniform standards for the reporting of research on implementation of health information technology, similar to the Consolidated Standards of Reporting Trials (CONSORT) statements for randomized, controlled trials and the Quality of Reporting of Meta-analyses (QUORUM) statement for meta-analyses. Finally, additional work is needed on interoperability and consumer health technologies, such as the personal health record.

"The advantages of health information technology over paper records are readily discernible. However, without better information, stakeholders interested in promoting or considering adoption may not be able to determine what benefits to expect from health information technology use, how best to implement the system in order to maximize the value derived from their investment, or how to direct policy aimed at improving the quality and efficiency delivered by the health care sector as a whole."

Ben Butler provided the attendees with excellent guidance on various privacy/security and intellectual property issues.