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How We Got the Mandate: the Agencies Involved

or ... A Quick Tour with Alice
Through the Federal Regulatory Wonderland

How was HHS able to mandate coverage of contraception and abortion-inducing drugs? What was the regulatory path to this mandate? Here is a brief tour guide.

The Patient Protection and Affordable Care Act, Public Law 111–148 (warning: huge file!) (shortened as Affordable Care Act, but commonly called the “Obamacare Act”), grants vast powers and discretion to the Secretaries of the Treasury, Labor, and Health and Human Services (HHS). The words “the Secretary” appear some 3210 times in the Act, which is over 900 pages in the small print of the Federal Register. “The Secretary shall” [do or decide something] appears 1018 times, and a phrase such as “identified by The Secretary” or “as determined [or prescribed] by The Secretary” appears some 650 times.

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This “HHS Mandate” is only one of thousands of decisions these three cabinet secretaries are empowered to make under the Obamacare Act. It is one provision in the “Final Rules” issued February 10, 2012 by the Departments of Health and Human Services, Labor, and the Treasury. These rules implement Section 2713 of the Obamacare Act.

The most relevant part of this section reads as follows:

“ … a health insurance issuer offering group or individual health insurance coverage shall, at a minimum provide coverage for and shall not impose any cost sharing requirements for—
… such additional preventive care and screenings … as provided for in comprehensive guidelines supported by the Health Resources and Services Administration [HRSA] …

So we must visit HRSA. Have you ever heard of HRSA? This obscure little agency has six bureaus, 13 offices, and spends $7 billion a year. It is one tiny particle in the great cloud of bureaucracies that surrounds us today.

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But wait! It turns out that HRSA simply adopted the recommendations of the “Institute of Medicine.” What's that, you ask? It's a self-selected group of unaccountable poobahs (“new members of the organization are elected annually by current members”). “Their work is conducted by committees of volunteer scientists – leading national and international experts – who serve without compensation.” This may sound very noble, but it raises a red flag to a veteran of D.C. Why? Their decisions have great impact on the medical marketplace. Someone is paying these people and covering their expenses, so they represent entities that have a stake in their decisions. Why does this matter? The institutions for which these IOM members work, and their research projects, are largely funded, through grants from the industry. Look here. It took a special act of Congress to allow this arrangement.

Who are these public servants? Experts. Scientific experts. They know better than you what is good for you, whether you like it or not. Well, not necessarily good for you as an individual — a selfish, greedy individual. Rather, what is good for “society,” of which you are but an insignificant cog. Mark Levin describes them in his new book, Ameritopia:

The [tyrant] is served by an enthusiastic intelligentsia or “experts” professionally engaged in developing and spreading utopian fantasies ... Meanwhile, intellectuals are immune from the impracticability and consequences of their blueprints, for they rarely present themselves for public office ... They legislate without accountability...¹

The IOM Committee on Clinical Preventive Services for Women issued its “consensus report” on July 19, 2011. We can get an idea of the thinking that shaped this consensus by looking at some of the panelists. Many are not MDs, but rather sociologists or specialists in public health (administration). One panel member's bio boasts of her work:

… this program has successfully served … women and men, helping to avert approximately 200,000 pregnancies per year. For every dollar spent on the program, an estimated savings of $5.83 in medical and social costs is realized through the prevention of unintended pregnancies up to five years after birth^[2]

We'll take a close look at those cost-savings claims elsewhere, but for now simply note that the savings stem from preventing children. Children are expensive, at least while they are children. Preventing them does avoid costs. Of course, preventing children also prevents new adults. Even from a purely financial perspective, if one is to consider the costs of the first five years of raising a child … one must also consider what that child will produce after he grows up … and even the taxes he will pay. It is increasingly apparent that a major reason the Social Security system is in such imminent danger is that we have “prevented” so many children since 1973. Preventing children has, of course, other downsides as well. The financial or tax considerations may be the least important factors … but not according to the Obamacare Act.

It might also be noted that this focus on preventing healthcare costs raises troubling precedents. If preventing children avoids costs, what about preventing elderly people? A very large fraction of medical costs are for treating the elderly, after all. This question may not be entirely theoretical under the provisions of Obamacare. Various panels will determine criteria for who gets what types of care. Then there are the increasing calls from “bioethicists” for “post-natal abortion,” that is, killing infants born with disabilities — or who are simply an unwanted burden on the parents. This would be a return to pre-Christian practices in Rome and Greece, where the father decided whether a newborn was accepted or exposed to die on a hillside. It should not be surprising to find such practices advocated by post-Christian academics. Do we really want to start down this slippery slope?

Another panel member's bio reveals that she served as “a trainer and counselor for CHOICE.”^[3] The website of this Philadelphia “reproductive health care advocacy organization” contains the following notice:

Most of the other panel members' bios do not reveal their views on abortion, but I could find no trace of involvement in pro-life activity. When the consensus behind the “consensus report” was being formed, strong pro-abortion views were clearly at the table, but there is no evidence that the other side was represented.⁴ The resulting consensus was, in fact, to recommend requiring coverage of every “method and procedure” that FDA had approved. FDA, however, is not charged to evaluate moral questions or cost-benefit factors, but only whether a procedure is “safe and effective.”

The IOM panel also explicitly ruled out any cost-benefit considerations.⁵ In fact, Secretary Sebelius explicitly excluded this from their purview. Nor were cost-benefit considerations addressed anywhere else in the proceedings, in part because the administration claims there are no net costs.

The sole economist on the panel wrote a stunning dissent objecting to the manner in which this report was adopted without careful evaluation of the evidence or any consideration of costs. There was not even discussion of whether particular procedures or treatments might be less cost-effective than others. His dissent included these startling statements:⁶

Readers of the Report should be clear on the fact that the recommendations were made without high quality, systematic evidence of the preventive nature of the services considered. Put differently, evidence that use of the services in question leads to lower rates of disability or disease and increased rates of well-being is generally absent.

…the committee process for evaluation of the evidence lacked transparency and was largely subject to the preferences of the committee's composition. Troublingly, the process tended to result in a mix of objective and subjective determinations filtered through a lens of advocacy.

Put less politely, the report simply reflects the biases of the panel, which was dominated by advocates of abortion and unlimited spending on any and all contraceptive procedures. It's as if the contraception industry got to write the rules for how much and what sorts of contraception methods and procedures the insurance industry has to buy and provide free to their customers. In fact, that's essentially what happened.

After the IOM report appeared, it was adopted by HRSA and published as an "Amended Interim Final Rule" in less than two weeks, without further opportunity for public comment. Those IOM-generated, HRSA-approved 'comprehensive guidelines', include “All Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education and counseling for all women with reproductive capacity.” If we go to FDA to discover what all these approved methods and procedures might be, we will see that they include so-called “morning-after” pills, that is, abortion-inducing drugs: “Plan B, Plan B One-Step, Next Choice, Ella.”

Notice also that this FDA “fact sheet” avoids mentioning that these drugs induce abortions … that is not all FDA omits. [We are preparing a further analysis showing that, while FDA here tells some truth, it is not the “whole truth,” and that these are abortion-inducing drugs. Check back ‘soon.’]

Christopher C. Barnekov, PhD