FEHBlog

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.