OPM posts online the Inspector General’s semi-annual reports to Congress as well as the agency’s responses to these reports. If you are involved with the FEHB Program, this is always an important read.
The FDA has approved Merck’s cervical cancer vaccine Gardasil for girls and women aged 9 – 26. The vaccine is administered three times over six months at a price tag of $360. On June 29, the Centers for Disease Control will consider whether to mandate the vaccine for girls aged 11 – 12. (The vaccine needs to be administered before the person becomes sexually active and potentially exposed to the virus that causes the disease). As the father of two daughters, I am very pleased by this news.
A provision in the lengthy Medicare Modernization Act established a Citizen’s Health Care Working Group which is to make health care reform recommendations to Congress and the President. The Group just released its interim report recommending the Nation move to a universal health care financed by taxpayers by 2012. The Group is now accepting public comments on the report. I enjoyed reading the Galen Institute’s comments.
As their contribution to National Health Information Technology Week, Sen. Sam Brownback (R-KS) and Representative Paul Ryan (R-WI) are introducing in the Senate and the House of Representatives an Independent Health Record Bank Act. The IHRB — a concept created by Cerner Corp. — would be a non-profit organization, similar to a credit union, regulated by the Commerce Secretary that would receive health record “deposits” from its customers. The bank would receive fees from customers and from the researchers to whom it would sell health data with the customer’s permission.
What’s more, the Center for Studying Health System Change released a study on the change in physician use of information technology for five clinical activities over the past five years. According to the Center, “[t]he 2000-01 survey contains information on about 12,000 physicians and had a 59 percent response rate, and the 2004-05 survey includes information from more than 6,600 physicians and had a 52 percent response rate. “Between 2000-01 and 2004-05, the proportion of physicians reporting access to IT for each of the five clinical activities grew by at least 5 percentage points. Changes in the proportion of physicians with access to IT for each of the clinical activities between 2000-01 and 2004-05 are as follows:
I attended the National Health Information Technology (HIT) Day festivities held today at the Renaissance Washington hotel as part of a HIMSS summit conference. I heard four policymaker speeches.
The first speaker was Dr. Carolyn Clancy, the Director of HHS’s Agency for Healthcare Research and Quality (AHRQ). Dr. Clancy believes that health care information technology will power health care transformation by increasing efficient care delivery, improving patient safety, and empowering consumers. She identified the organizing principle as quality and she said that we must use health IT to build an evidence base to tell consumers, payers, and providers which health care services and supplies work and what does not work. This should create a stronger, more transparent health care market.
Former House Speaker Newt Gingrich , who now leads the Center for Health Transformation, emphasized the need to set the right health information technology standards the first time — standards that are market oriented, and will maximize innovation and adoption. Those standards should not be command driven but rather should be recognized to work in the real world by providing true interoperability.
Dr. David Brailer, vice chair of the American Health Information Community, informed the audience that HHS Secretary approved the AHIC workgroup breakthrough objectives on May 16 and that the ANSI Health Information Technology Standards Panel (HITSP) will create standards for these objectives by September 2006. Then it will be up to the federal agencies to use its procurement leverage and encourage rapid implementation of those standards by government contractors, thereby stimulating demand in the marketplace. Also in the late summer, the Certification Commission for Health Information Technology (CCHIT) will begin certifying HIT products. Business and technical processes must move together.
Dr. Mark McClellan, the Administrator of HHS’s Center for Medicare and Medicaid Services, reported that critical mass around health information technology is coming together. He mentioned a May 23 Mathematica study on how six types of HIT are improving hospital quality of care. He is noted the health care provider community’s argument that health plans not the providers will enjoy increased profitability from the improved quality created by health informaiton technology. He reported that CMS is working hard to pay more Medicare and Medicaid benefits for better quality of care and better outcomes. CMS has created several public-private quality alliances, such as AQA and the Medicare care management demonstration project, to create valid, consensus based quality measures. He also reported that by late summer 2006 HHS will issue final Stark Act regulations to encourage donation of health information technology.
The New York Times reports that five veterans’ groups including the Vietnam Veterans of America have filed a class action against Veterans Affair Secretary Nicholson in the U.S. District Court for the District of Columbia. The veterans’ lawsuit seeks the following relief:
Health plans, in accordance with the HIPAA transaction and code set standards, use the International Classification of Diseases, 9th Ed, Clinical Modification (ICD-9-CM) to code diagnoses and inpatient procedures. Rep. Nancy Johnson’s (R-CT) health information technology bill (HR 4157) would require health plans to implement the new ICD-10 code sets by October 1, 2009. This proposal has always struck me as very aggressive. Consequently, I was very pleased to read about AHIP’s recommendation — based on a detailed IBM study — to delay ICD-10 implementation until 2012. AHIP’s President explained that while AHIP’s health plan members support the eventual use of ICD-10,
“This massive effort of moving from 24,000 to 207,000 codes calls for all health care stakeholders to completely rework operations for claims processing, provider contracting, medical management, quality reporting, information technology, disease management, and other business and health care activities. Planning for an adequate implementation period will help provide a smooth transition to the new codes by allowing for pilot testing that will help minimize unintended consequences for consumers, physicians and other providers without unnecessarily increasing administrative costs.”
Let’s hope that common sense prevails as the Health subcommittee of the House Energy and Commerce Committee begins its markup of the bill on June 8.
I read with interest an op-ed in Saturday’s Wall Street Journal by the Cato Institute’s VP for Legal Affairs Roger Pilon applauding the D.C. Circuit’s opinion in the “little noticed” Abigail Alliance case (which I discussed in aMay 30 post). Mr. Pilon explains that
“If there is a fundamental right to refuse life-sustaining treatment, as the Supreme Court had found in 1990, there is, equally, a right to seek life-sustaining medication free from government interference. That’s hardly pulling a right “out of thin air,” as the Washington Post charged editorially in its defense of FDA bureaucrats. It is not the freewheeling stuff of Roe v. Wade, but rather the careful mining of Locke, Blackstone and Madison.”I don’t often find myself agreeing with the Washington Post editorial page, but I do on this issue.
My concern with the Abigail Alliance decision is a practical public health issue best framed by the National Breast Cancer Coalition in a September 3, 2003, letter to the FDA commenting on the Abigail Alliance’s petition:
“Public policy should discourage access to investigational drugs outside of clinical trials. Investigational treatments made available outside of clinical trials have the potential to undermine the clinical trials system. There is little incentive for a patient to participate in a clinical trial if she can obtain the investigational drug outside of the trial. This makes trial accrual difficult, and may significantly undermine the ability of the investigators to determine the efficacy and safety of the intervention. That was certainly the case with bone marrow transplant for breast cancer – because it was so widely available outside of clinical trials it was extremely difficult to accrue patients to trials, and it took many years longer than it should have to learn that the high-risk and expensive procedure provides no benefit to women with breast cancer. “Investigational treatments are by definition unproven; even the most promising data in earlier stages of trials often do not hold up. Further, there may be significant safety issues that do not emerge until well into a phase III trial. For example, the cardiotoxicity of Herceptin was not apparent in the phase II data, but emerged in the much larger phase III trial.”I cannot imagine how the district court on remand could not find this public health concern to be a compelling government interest.
In today’s Washington Post, Steve Barr reports on OPM’s legislative proposal to amend the FEHB Act to permit the Service Benefit Plan to offer a third option pairing a high deductible health plan with a health savings account. On a related note, the GAO recently released a report on consumer directed health plans (06-514) finding that enrollment in high deductible plans pairedwith a health savings account or a health reimbursement account grew from 3 million to between 5 and 6 million in 2005. This small but growing share of the market is driven principally by employer interest in controlling their health care expenses and in allowing employees a little skin in the game, as they say. The report indicates that a survey of large employers (over 1000 employees) that offered HSA options along side more traditional plans had 3% average enrollment in the HSA option (Report, p. 14). What’s more five states — Alabama, California, New Jersey, Pennsylvania, and Wisconsin — still do not allow state income tax deductions for HSA contributions (p. 23). The GAO concludes that further growth in consumer directed plans will depend on many factors, such as changes in laws such as these that diminish interest in these plans, employer savings with these plans, and favorable employee experience with these plans.