Reform Rodeo

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

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

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

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

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

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

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

Mammography, Cervical Cytology Screens, and Rationing

The recent recommendations on mammography and cervical cytology screens by the US Preventive Services Task force and ACOG (American College of Obstetricians and Gynecologists), respectively, have added a new dimension to reform discussions.  Some are inclined to say “gotcha,” suggesting that the recommendations are evidence of a creeping denial of needed care that would follow governmental insinuation into health finance and benefits design.  Others see the reports as serendipitous irrelevancies, unconnected to reform discussions.  The truth is, not surprisingly, more complex.  The irony is that consumers will be more represented in health technology assessment in a public plan than they have been in private insurance.

It seems inevitable that any future health finance system will rely on evidence-based assessments of new (and old) technologies for both quality and cost purposes.  Our experience with the widespread use of affirmatively harmful (e.g., hormone-replacement therapy) and apparently useless treatments (e.g., knee arthroscopy for osteoarthritis) points to the possible risks of rapid  or uncritical adoption of new technologies.  As Sara Rosenbaum and others have pointed out,  (subscription required) we don’t want to confuse population data with individually-applied diagnostic and treatment judgment.   Both reports, to their credit, got this part right, and advised individual patients and physicians to assess each case in context, notwithstanding the general population-level guidance.  But evidence-based population data on the efficacy and comparative benefit of new and expensive interventions will be of enormous assistance in future treatment and funding decisions.

How should such health technology assessment be done, if not by expert panels?  As Bill Sage has observed, private health plans were opaque and inconsistent when they were in the technology assessment business.  (They have pretty much gotten out of that field, leaving cost control to others.)   One criticism of the mammography and cervical cytology reports has been that they should have included a more public process before issuing recommendations.  As the reports are merely advisory, it is not clear that post-publication comment doesn’t get the job done.  Where, as may be the case in the future, such expert analysis has instrumental effect, pre-implementation public process is essential.   Two guides for public health technology assessment advise as much.  The Institute of Medicine, in guidance issued earlier this year for comparative effectiveness analysis funded by the stimulus bill, observed that,

Clinicians and patients do not always consider the same factors when weighing the tradeoffs posed by important health care alternatives.  To ensure that the fruits of CER support consumers’ health care decision making, the CER Program should focus on the questions of patients as well as their health care providers.

Similarly, a health technology assessment guide created by the European Observatory on Health Systems in 2008 describes well-functioning technical assessment as consultative and transparent:

Social accountability permeates the whole knowledge production and is reflected not only in the interpretation and diffusion of results but also in the definition of the problem and the setting of research priorities.

We don’t want a health system — public or private — that is blind to either sound evidence-based technology assessment or the particular health needs of individual patients.  One advantage to a public system is that the assessment of technologies can and should include a robust public process.  We didn’t get that with private managed care.  The mammography and cervical cytology reports should call our attention to the opportunity for public process in decision making in publicly-funded coverage, and the need for close attention to the implementing regulatory processes if and when a bill is signed.

New Breast Cancer Screening Recommendations Cause Controversy

Rarely do medical recommendations or clinical guidelines receive such immediate and passionate attention as those released this month by the U.S. Preventive Services Task Force (USPSTF), an independent panel of doctors and scientists who make recommendations to the Department of Health & Human Services.  In a striking detour from prior recommendations by the Task Force and those of the American Cancer Society (ACS) that women over 40 receive a mammogram every one to two years, the Task Force now recommends:

• “against routine screening mammography in women aged 40 to 49 years”;
• “biennial screening mammography for women aged 50 to 74 years”;
• “against teaching breast self-examination (BSE)” (emphasis added).

In a radio interview on the new guidance, Dr. Bruce Calonge, chair of the Task Force, was asked about the USPSTF recommendation against routine screening for women in their 40’s and “the possibility that some women may die as a
result of not having routine mammograms.”  Calonge’s astonishing answer:

“what women really need to understand in that decade is that overall reduction in mortality, which is for all comers in that age group, only about 15%, because breast cancer is relatively rare in that age group, that benefit is really quite small…”

Although he claimed that cost analysis had no place in the Task Force’s recommendations, later, focusing on early detection generally, he repeated,

“I think one of the things that is important to say… that mammography’s benefit is only a 15% reduction in mortality.”

Kathleen Sebelius, HHS Secretary, has clarified that the federal policy on breast cancer screening has not changed, despite the Task Force’s recommendations.   In response to concerns that patients who seek mammograms before the age of 50 would not be covered by health insurance, Sebelius stated that she “would be very surprised if any private insurance company changed its mammography coverage decisions as a result of this action.”  Despite such assurances, if past experience is a guide insurance companies will use these criteria to determine coverage.

A number of professional and advocacy groups have responded to the Task Force’s November 16 recommendation.   The ACS continues to recommend annual screening using mammography and clinical breast examination for all women beginning at age 40.  The American College of Radiology issued a frankly titled statement, “USPSTF Mammography Recommendations Will Result in Countless Unnecessary Breast Cancer Deaths Each Year” and labeled the recommendations “cost cutting.”  And the American Congress of Obstetricians and Gynecologists continues to recommend a screening mammography every 1-2 years for women aged 40-49 years and every year for women 50 and over, as well as to recommend BSE.

So what would the task force’s mammography recommendations mean for patients?  The changes to the recommendations extend beyond the age at which they recommend beginning mammography screening.  For example, the 2002 USPSTF recommendations explained, “[t]he precise age at which the benefits from screening mammography justify the potential harms is a subjective judgment and should take into account patient preferences” (emphasis added).  The elimination of the term “preferences” and the focus on “patient context” and the “patient’s values regarding specific benefits and harms” indicates a move toward evidence-based medicine, whereby a patient’s inclinations and personality are taken less into consideration or play a less significant role in predicting outcomes.  In a November 17 New York Times article, the author asks,

Are you the sort for whom shivering in a paper gown, enduring discomfort and waiting a week for results is so unnerving that you are thrilled for a decade-long reprieve? Or are you that woman who gets an extra breast sonogram with your gynecologist even when it is not medically indicated? Do you trust scientists or prefer your own gut?

These concerns seem more like preferences than medically-supported decision-making factors.   The 2009 recommendations instruct that “the patient’s values regarding specific benefits and harms” be taken into account — but do not explain how far “patient context” be considered.  The recommendations do not apply to women with “known underlying genetic mutation or a history of chest radiation.”  Beyond these two exceptions, how will doctors and patients make individual decisions to start regular, biennial screening mammography?  The recommendations should be appreciated for confirming — to an extent — that the decision to begin regular screening mammography is individual.  The doctor and patient, in collaboration, should consider the patient’s risk tolerance, family history, and any other applicable factors.  Sebelius recommends that patients “[k]eep doing what you have been doing for years — talk to your doctor about your individual history, ask questions, and make the decision that is right for you.”  It is unclear how the Task Force’s recommendations could affect the decision to begin mammography in an educated and reasoned way.

The Task Force’s self-examination recommendation is also worrisome.  The USPSTF states that “there is moderate or high certainty that [BSE] has no net benefit or that the harms outweigh the benefits.”  However, discouraging the use of self-examination — a short, free, easy, and non-invasive process — might seem astonishing to many, particularly those who have known someone for whom a BSE has been the means by which breast cancer was first discovered.  Appreciating the concern about BSE leading to higher incidences of biopsies, additional screenings, and false-positive test results, with the increasing focus on disease prevention, this recommendation seems, at best, counter-intuitive, particularly when taking into account those who are uninsured and may not pursue other methods of breast cancer screening.