Category: health

The website that cried wolf: World Net Daily and death panels

Today, the far right website, World Net Daily, is accusing the President of using the Food & Drug Administration drug approval process as a way to ration health care via “death panels.”  As evidence for the claim, this front page story by Greg Koprowski states that “new drug approvals declined dramatically last year” citing a drop in such drug approvals from 25 in 2009 to 21 in 2010.

Although website claims the article is “breaking news,” the other evidence offered is a quote from a July 27, 2010 letter to FDA official Dr. Richard Pazdur from Senator David Vitter (R-LA) writing in support of the anti-cancer drug Avastin.  The FDA recently made a recommendation to remove the breast cancer indication from the Avastin drug label. In the letter, Senator Vitter worries that the approval process may signal the beginning of treatment rationing.

I spoke with Sandy Walsh at the FDA who called the claim that the FDA was using cost as a measure of approval “absurd.” She also noted that recent approvals are in line with past years.  As a review of FDA data demonstrates, she is correct.  For perspective, here are numbers of new medicines approved by the FDA from 2000 to the 2010 estimate.

2010 – 21 (estimated)

2009 – 25

2008 – 24

2007 – 18

2006 – 22

2005 – 20

2004 – 36

2003 – 21

2002 – 17

2001 – 24

2000 – 27

Mr. Koprowski called the drop from 25 new drugs in 2009 to a “mere 21 new drugs in 2010” a dramatic decline. Not at all. An examination of the approvals over time tells a different story. Clearly, Obama’s FDA is keeping pace with the record of the Bush administration.

Regarding Avastin, the maker of the cancer fighting drug is appealing the decision but it is simply wrong to assume that the FDA decision was based on cost considerations. The FDA panel that voted 12-to-1 to recommended the action consisted of physicians and patient advocates. FDA spokesperson Erica Jefferson told me that “no political appointees were involved in the decision-making” adding that “most of the reviewers have been with the agency close to 15 years.” Moreover, the decision was endorsed by the National Breast Cancer Coalition, which said about the action, “We applaud the FDA for responding to the scientific evidence in the face of significant political and public pressure.”

By reading WND, one would never know the rest of the story. Selective reporting is just one reason to question crying wolves at WND. Enter the Medicare death panel scare.

In late December, World Net Daily published an article that said the Obama Administration was slipping death panels back into Medicare via a regulation defining patient-physician discussions of advance directive planning. Yesterday, the Obama administration rescinded that rule, in part because of the misinformation campaign waged by social conservatives.

Judie Brown of the American Life League was quoted as saying:

Nothing good can come of this,” said Judie Brown, the president of American Life League. “This will affect everybody’s parents and grandparents and preborn babies, and it will not affect anybody for the good.

She added ominously:

Congress must step up to cancel the regulation, Brown added. “If not, a death certificate is written for an awful lot of elderly people.”

Ratcheting up the rhetoric, Liberty Counsel’s Mat Staver told WND that the Medicare regulation was not just a death panel, but a “super death panel,” saying

When you have the government mandating this end-of-life counseling, they’re conscripting doctors to do end-of-life counseling on a massive scale. It will be the equivalent of a super death panel. Elderly patients will get confused and will end up signing documents without having a clue what they’re signing, and they will sign away care they might really want.

As I noted in a previous post, claims that the just rescinded Medicare regulation required doctors to persuade senior citizens to refuse care are just false. The new regulation was an extension of a definition of advance care planning which remains a part of the initial Medicare visit, a provision that was added by Congress in 2008. That bill was passed via override of a President Bush veto. The veto however, had nothing to do with end-of-life counseling, but rather concerns over cost. As far as I can find via search engines, there was no outcry from conservatives then over the end-of-life provision. No one cried death panels then.

As an administration official told me yesterday, Medicare does not prescribe any conversation between patients and physicians about end-of-life issues. Patients are free to use pro-life resources and advance directives to plan their end-of-life care. The only reason the definition was included was to alert physicians that these conversations are important. There is neither a separate reimbursement for advanced care planning now nor would there have been if the rule, rescinded yesterday, would have remained viable.

In the case of the advance care planning regulation, the scare tactics worked. The Obama administration backed off of a reasonable definition of advanced care planning, a practice that pro-life groups actually recommend to their constituents. However, hysteria and spin won out over good policy. In the case of FDA approvals, it is clear that there is no trend specific to this administration. At what point, do readers realize that those crying death panels are crying wolf?

Obama Administration rescinds voluntary advance care planning rule

Just about an hour ago, the Health and Human Services Department rescinded the Medicare rule on voluntary advance care planning that had been misrepresented as the return of “death panels” by some social conservatives. I will comment more on this story but for now here is a link to the Federal Register and relevant portions of the order.

II. Provisions of the Amendment

In the July 13, 2010 Federal Register (75 FR 40039), we published the proposed rule entitled “Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011.” In response to this publication, we received comments from health care providers, and others urging us to add voluntary advance care planning as a specified element of the definitions of both the “first annual wellness visit” and the “subsequent annual wellness visit.” The commenters stated that their recommendations were based upon a number of recent research studies, and the inclusion by the Medicare initial preventive physical examination (IPPE) provisions of a similar element in the existing IPPE benefit.

CMS agreed with the commenters that voluntary advance care planning should be added as a specified element in the definitions of both the “first annual wellness visit” and the “subsequent annual wellness visit” based on the evidence provided and the inclusion of a similar element in the IPPE benefit (also referred to as the Welcome to Medicare CMS-1503-F2 3 exam) since January 1, 2009, and incorporated it into the final rule.

It has since become apparent that we did not have an opportunity to consider prior to the issuance of the final rule the wide range of views on this subject held by a broad range of stakeholders (including members of Congress and those who were involved with this provision during the debate on the Affordable Care Act). Therefore, we are rescinding the provision of the final rule that includes voluntary advance care planning as a specified element of the annual wellness visits providing personalized prevention plan services, and returning to the policy that was proposed, which was limited to the elements specified in the Act. We are revising our regulation at §410.15(a) to remove voluntary advance care planning as a specified element from the definitions of “first annual wellness visit providing personalized prevention plan services” and “subsequent annual wellness visit providing personalized prevention plan services” and to remove the definition of “voluntary advance care planning.”

And the rule is now amended to read:

For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR part 410 as set forth below: 

PART 410–SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

1. The authority citation for part 410 continues to read as follows:

Authority (42 U.S.C. 1302, 1395m, 1395hh, and 1395ddd). Secs. 1102, 1834, 1871, and 1893 of the Social Security Act Subpart B–Medical and Other Health Services § 410.15 [Amended]

2. Section 410.15 is amended as follows:

A. In paragraph (a), in the definition of “First annual wellness visit providing personalized prevention plan services” removing paragraph (ix) and redesignating paragraph (x) as paragraph (ix).

B. In paragraph (a), in the definition of “Subsequent annual wellness visit providing personalized prevention plan services” removing paragraph (vii) and redesignating paragraph (viii) as paragraph (vii).

C. In paragraph (a), removing the definition of “voluntary advance care planning”.

Let me note here that in 2008, the same concept was included in the Medicare Improvements for Patients and Providers Act of 2008 and remains a part of Medicare regulations for the first visit by a Medicare enrollee to a physician. George Bush vetoed that bill in 2008 but not because of the end-of-life counseling was included in the bill. He did so because he was concerned that the bill was too costly. I have looked in various search engines for record of opposition to the end-of-life provisions by social conservatives at that time. I found none.

Administration reverses course on end-of-life care planning regulation

UPDATE: I just spoke with an Obama Administration official who said the new proposed rule would be published at 4:15pm today in the Federal Register. This will allow for comment. He also confirmed to me that the advance care planning provision remains in the initial Welcome to Medicare visit with a physician. That provision was included by via statute during the Bush Administration in 2008. In other words, all of the bluster from social conservatives is a bit late. The Administration official indicated that the rule had been removed in order to give the public opportunity to indicate their views on the issue. He noted the misrepresentation of the issue and the Administration did not want the political process to jeopardize the existing benefits.

….

Annual voluntary advance care planning, we hardly knew ya.

Last week, I defended a new Medicare regulation which would have added advance end-of-life care planning to the definition of what could take place during the new Annual Wellness Visits authorized by the Affordable Care Act (ACA), otherwise known as ObamaCare. Some conservatives demonized this rule as the return of “death panels” in an effort to frighten voters. I don’t know whether or not the public was frightened, but according to the New York Times, these false characterizations scared the administration so much that the rule is being deleted.

And this is sad because this is case where spin and misinformation won out over fact and good sense. The truth is the Medicare regulation did not create a new reimbursable benefit and did not bring back “death panels.” The regulation added one voluntary component to the annual wellness visit – a discussion of the patients’ wishes if they become unable to express themselves during illness or injury. Physicians were not going to be paid separately for this conversation; they will still do the annual wellness visit and focus on many other issues of prevention and health maintenance. And here is the kicker, physicians can still bring up advance care planning if they want to.

Social conservatives who ranted about government involvement in end-of-life decision either had not read the regulation or were  intentionally  misleading people. 

But now the administration without attribution has shifted course and it is quite unclear why. 

Since yesterday morning, I have been seeking answers from the HHS press office and will comment more  as I get more information.

Here is an AP piece on the matter…

Fact checking the death panel scare

One thing I have learned in the culture wars is to check the specifics of breathless claims from both left and right. So here is a claim from the Liberty Counsel that is making its way around the echo chamber:

Medicare Regulations Revive “Death Panels” of ObamaCare Bill

Is this true? Is Medicare about to unleash a panel of Dr. Deaths on the nation’s elderly? Not at all. This Wall Street Journal article has it about right, describing what Medicare is about to implement via their rule making process:

Advance care planning lays out the options and allows patients, in consultation with their providers and family members, to ensure that their future treatment is consistent with their wishes and moral values should they become too sick to decide for themselves.

To their credit, Liberty Counsel links to the Federal Register issue containing the new regulation, but unfortunately then misrepresents what it says. As noted by the WSJ, discussing advanced directives is something patients should do.

Called “voluntary advance care planning” in the Medicare regulation, this new rule allows physicians to be reimbursed for this consultation during the annual wellness visit, a service allowed by Medicare which covers all sorts of preventive care. The service is defined in the Federal Register:

Voluntary advance care planning means, for purposes of this section, verbal or written information regarding the following areas:

(i) An individual’s ability to prepare an advance directive in the case where an injury or illness causes the individual to be unable to make health care decisions.

(ii) Whether or not the physician is willing to follow the individual’s wishes as expressed in an advance directive. (p. 73406 & 73614).

No death panel there; just the patient, perhaps family, and the physician. Since the conversation is voluntary, a patient can avoid the whole thing. Physicians are allowed to provide written information about how to construct an advanced directive and what individual physicians will do under certain conditions. Physicians must provide informed consent to care and letting patients know what they will do is good practice. If a patient doesn’t like the approach of that doctor, then another doctor can be pursued. I like this approach much better than just waiting around for something to happen and then trying to figure out what the patient would have wanted.

These are important and necessary conversations, even though they can be emotionally difficult. The Federal Register cites studies which suggest that patients appreciate the opportunity to express their wishes and are not harmed by doing so.  

Back to the current flap. Where WSJ gets a little misty is when they let Sarah Palin and by extension other fear mongers off the hook a bit by saying that Palin really wants to talk about rationing of care when she writes about “death panels” (as she does here – note the title of the column).

Now I have a whole page on this blog devoted to debunking myths about Sarah Palin so I think it is fair to comment when she is stretching things. If you want to talk about rationing of care, then talk about rationing of care. Voluntarily discussing advanced directives with a personal physician is not a “death panel” nor is it of necessity rationing of care.

Lifenews.com is running a headline claiming that pro-life leaders want the new Congress to overturn the regulation. I am pro-life and I hope the new Congress does not overturn the regulation. I believe physicians should be reimbursed for bringing up the difficult topic and making adequate preparations for the inevitable. Conversations about end-of-life care will happen with or without the regulation. The question is: Will they happen with the patient’s wishes known or not?

UPDATE: Here are some Christian and pro-life groups which advocate advance directives. All the Medicare regulation does is include such planning in annual wellness visits if the patient agrees. Medicare patients could use any of these resources in conversation with their physicians.

Focus on the Family

Anglicans for Life

Physicians for Life 

National Right to Life

Aquinas Institute

Center for Bioethics and Human Dignity

This list was generated after about 5 minutes of searching. I suspect there are other groups with similar recommendations. There is nothing in the Medicare regulations which requires patients to accept a physician’s views if at odds with the patient’s views (although some state laws may allow a physician to ignore advanced directives). Nothing I can find in the Medicare regulation prohibits a patient from drawing on faith based resources to inform these conversations.

Added on Jan 3, 2011: I think it is important to note the voluntary element of these conversations from the Medicare regulations. Advanced care planning may be conducted at the initial Medicare visit and at the annual wellness visit, if the patient agrees. Here is how the Medicare regulation includes the procedure in these visits:

Voluntary advance care planning as that term is defined in this section upon agreement with the individual.

Health care reform: Who must buy insurance?

The Christian Science Monitor takes a simple stab at this question here.

But here’s a key thing to remember: There is a simple concept at the center of this rambling, Rube Goldbergian machine. Democratic healthcare reform would expand insurance coverage in America by requiring people to obtain it.

That’s right. The healthcare reform bill would mandate that most US citizens and legal residents purchase “minimal essential coverage” for themselves and their dependents. They can get this either through their employer, or, if their employer doesn’t offer health insurance, they can buy it through new marketplaces that will sell policies to individuals.

Those marketplaces would be called “exchanges.” We’ll talk more about them in a later story. (We’ll also cover subsidies for health insurance, when it all would take effect, how it would be paid for, and what it means for businesses.)

I feel sure that the requirement to purchase health insurance will be challenged in court. Forcing a purchase with the penalty of fines seems to compel associations which could give rise to constitutional challenges.  The forced purchases, however, are key to the provision which is attractive to most people: elimination of pre-existing conditions as a reason to refuse coverage.

Why is Congress doing this? It’s a pretty obvious way to expand coverage, for one thing. Also, it will help bring in a flood of new customers for health insurance firms, including healthy young people who might not need much healthcare.

For insurance firms, those new customers could balance out the losses they might incur if they can no longer deny coverage to people with preexisting conditions. (Yes, that’s another change the bill makes.)

And remember, many people will not be buying this coverage purely on their own. Uncle Sam will be helping them. The bookend to the individual mandate is federal subsidies for insurance purchases, which reach deep into the middle class. We’ll talk about those next.

In essence, you and I (via taxes) will be providing coverage for people who may not want it so that people who need coverage for serious conditions will have it. Insurers may still benefit by virtue of the millions of new subscribers. I suspect there will be severe fines for insurers who attempt to limit coverage or benefits. But I don’t know. And the lack of knowledge is what is politically troubling. There will be legislators who approve this bill over the weekend that have not read it.

According to the NY Times, key votes are still in play approaching a Sunday vote.