Tag: medicare

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.