Anger, Frustration and the Red Army

09/16/2009 04:10 PM |

What were the town hall meetings and tea parties all about? Healthcare reform? Sure. But the anger exhibited by our fellow citizens was clearly grounded in a much broader frustration over the continuing growth of government. The current debate over healthcare reform was a lightening rod -- and the results have been explosive.

And that's not surprising when you consider that healthcare reform, as positioned by the President and many senior members of Congress, would represent the biggest increase in the size and expense of government in our lifetime.

Many who favor such programs point to Great Britain and their National Health Service (the NHS) as a desirable model of single-payer delivery. But small government it ain't. Consider this: the NHS is the single largest employer in Great Britain. In fact, it's the world's fourth largest employer -- only the Chinese People's Liberation Army, Wal-Mart, and the Indian Railways directly employ more people.

Americans believe that the healthcare reform packages being considered by Congress would result in ever bigger government. They're right. Whether or not that's the right thing to do is another matter.
  Read More & Comment...

A Fat VAT?

09/15/2009 02:02 PM |

In May, I opined on giving Americans a tax deduction based on a healthy BMI (Body Mass Index). 

My article can be found here.

Yesterday, Brian Sullivan of Fox Business News blogged on a similar idea.  His blog can be found here.

Today, Brian and Degan McDowell and I discussed the idea on air.  My point is that, when it comes to healthcare reform, we seem to be discussing everything except diet and exercise ... and personal responsibility.

We talked about tax incentives (the "carrot") as well as the political time bomb of a fat VAT (the "stick").

All things considered -- a very timely conversation.

The complete video interview can be found here.

As Julia Child would say: "Bon Appetit!"
  Read More & Comment...

Passing the Buck on Personalized Medicine?

09/15/2009 02:25 AM |

  Read More & Comment...

Will ACORN Be a Health Exchange Navigator?

09/14/2009 09:40 PM |

Sure looks that way:

"Section 3105 of the Kennedy bill says American health Benefit Gateways would be created in every state, serving as a health insurance exchange. A "Navigators" program would award grants to public and private entities to "conduct public education; distribute fair and impartial information regarding health plans; [and] assist with enrollment and provide information that is culturally and linguistically appropriate for the population." The bill stipulates that both health insurance issuers and current independent insurance agents would be prohibited from participating in the Navigators program."

Read more here.

And here is what ACORN is already doing:

"Moving toward maximum eligible participation in federal and state benefits programs is one of ACORN’s key national priorities. ACORN will begin transitioning many of its offices to the Nets2Ladders screening platform (Nets2Ladders is also a key strategic partner with H&R Block). Nets2Ladders offers a powerful, automated benefits enrollment platform that will increase the efficiency and effectiveness of enrolling low-income families in federal and state benefits programs. This software integrates tax return and benefit information so that the information that is collected while filing the tax return is automatically updated into the benefits screening tools, reducing the amount of time needed to add a benefit screening component. Beginning in January 2008, ACORN will conduct benefits screening and enrollment in approximately 26 states, meaning that anyone visiting an ACORN Tax and Benefits Access Center in these states can also quickly be screened for up to 15 federal, state, and local assistance programs, including:

• Food Stamps

• Medicaid

• State Children’s Health

Insurance Program (SCHIP)

ACORN’s new screening platform will generate complete applications that are then printed out for clients, saving them countless hours of trouble and heartache and more importantly dramatically increasing their chances for actually qualifying for these important programs. By January 2010, all 50 states will be covered by the ACORN screening and enrollment platform"

Read more here

Will Congress ban ACORN and other politically-motivated groups from grabbing control of health care at the grass roots level with federal funding?

Exchanges we can believe in....
  Read More & Comment...

It's D-Lovely

09/11/2009 06:19 AM |

Health reform, that is. Or it could be.

President Obama's effots to sell lawmakers and the American public on the merits of his proposals have been hamstrung by his preference for a big-government solution to the nation’s healthcare woes. While it’s true that reform is needed, there’s no need to completely remake the health sector. Instead, the president should borrow from more hands-off reforms, like Medicare Part D, which have been both successful and popular in the past.

A recent survey revealed that 92 percent of beneficiaries were satisfied with their drug coverage in 2008. And, at last tally, Part D was costing about 30 percent less than initial budget projections. The program’s popularity as well as its cost-effectiveness can be attributed in large part to its use of the private-sector competition.

Part D allows Medicare participants to choose from a variety of government-subsidized yet privately-administered drug plans. Seniors get to choose from a number of plans and decide for themselves which one best suits them. Meanwhile, insurers must compete to offer high-quality plans at reasonable prices.

But does Part D really work? The numbers speak for themselves: in 2004 nearly one in four seniors lacked drug coverage. By 2006, when Part D took effect, that statistic dropped to seven percent.

Democratic lawmakers could use this success as a roadmap for expanding coverage while avoiding the kind of drastic government intervention that inspired such rancor in opponents of the public option.

In other words, create a program that allows insurers to compete to offer those 8-16 million chronically uninsured Americans the best plan. The government could then provide subsidies to make that plan even more affordable. This would by no means be easy to implement. But it wouldn’t be revolutionary either, since the policy’s basic framework has already proven to work well.

President Obama is in desperate need of fiscally responsible healthcare reform ideas. A Part D-like insurance program might be exactly what he’s looking for.

For more on this, see a new article in Reuters' "Great Debate" series here.


  Read More & Comment...

About President Obama's speech

09/10/2009 07:03 PM |

  Read More & Comment...

Boustany’s No Zany

09/10/2009 06:51 PM |

  Read More & Comment...

The "Character of Our Country"

09/10/2009 07:36 AM |

Last night the President summoned “the character of our country.”

But his attempt to create an atmosphere of bipartisan support evaporated with the turn of a single phrase:

“I will not stand by while the special interests use the same old tactics to keep things exactly the way they are. If you misrepresent what’s in the plan, we will call you out.”

Threats to those who honestly oppose his ideas?  Or does that also apply to those (such as Speaker Pelosi) who accused our fellow citizens of being “anti-American” for venting their honest frustrations at town hall meetings?

No question this speech was largely an exercise about reasserting the President’s leadership.  Did that happen?  Will, for example, Henry Waxman decide that he is now obligated to the agreements the President reached with, among others, PhRMA?  If Mr. Waxman remains unobligated, will the President “stand by” or will he “call him out.”

 “If you like your healthcare plan, you can keep it.”  But “your healthcare plan” could be more expensive – or your employer may cease to offer it at all. As the old Yiddish proverb goes, “A half-truth is a whole lie.”

And as far as the tax on “gold-plated” insurance policies, here’s what Robert Pear wrote in the New York Times, “Proponents say the idea … would encourage employers to buy cheaper, less generous coverage for employees, thereby reducing excessive use of medical services.”

“Excessive use?”  According to whom? And what does “gold-plated” mean? No details offered.

Pear continues, “But many House Democrats and labor union leaders have resisted those proposals, saying the tax would often be passed on to employers and to workers in the form of higher premiums” and “that could be seen as violating a campaign promise not to raise taxes on anyone making less than $250,000 a year."

The President’s for a “not for profit” public plan – but “We should remain open to other ideas that accomplish our ultimate goal.”  Translation:  “I’ll sign a bill without a public plan.” 

And the left cringes.

Welcome news that the President supports a yet-to-be written initiative to create pilot projects intended to curb medical malpractice lawsuits.  But who will co-pilot this idea in Congress.  That’ll be interesting to see -- or to see if it really happens.

Strangely lacking – a timeline, or even a call for one.

As Senator John McCain commented post-speech on the Larry King Show, “Facts are stubborn things.”

  Read More & Comment...

Technologically Challenged

09/09/2009 05:10 AM |

Is innovation the problem or the solution?  Well, it depends who you ask and what you’re talking about.  The issue at hand is the future of medical technology innovation and the question is – are we willing to trade tomorrow for today?  Or, put another way – are we willing to focus on short-term costs savings and jeopardize long-term patient outcomes?

Here’s what Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), had to say in response to the proposed $40 billion tax on medical devices and diagnostics that is included in a draft health care reform proposal from Senator Max Baucus, chairman of the Senate Finance Committee:
 
“This tax will raise the cost of care for all patients, especially those in greatest need of advanced treatments and diagnostics.  It is a form of double taxation, since a portion of the hundreds of billions in cuts aimed at our customers, including hospitals, nursing homes, and home health care agencies will be passed on to us.  Moreover, the tax will fall most heavily on the small and emerging companies that are the backbone of our industry, often driving development of cutting-edge treatments and cures, and are least able to pay new taxes.  Additionally, the fee imposed on clinical labs raises serious concerns in view of other cuts to payments for lab services.”
 
“While AdvaMed supports broad-based health care reform and has been working to achieve that important goal, we cannot support a proposal that unfairly singles out the medical technology industry for a tax on innovation on top of the billions in cuts that the industry would already have to absorb within the health care reform proposal.  We will continue to work with congressional leaders and the White House to further real health reform and to eliminate this counterproductive proposal from any reform package considered by the Congress.”

Real reform doesn't pay for itself by standing on the throat of innovation.

  Read More & Comment...

FDA Promoting Off-Label Use?

09/08/2009 08:08 AM |

From the Pink Sheet:

FDA may hold approval of supplemental indications to a higher standard of evidence than what can feasibly be obtained since the drugs are already available to treat patients in an off-label setting, FDA Office of Drug Oncology Products Director Richard Pazdur indicated at a Sept. 1 advisory committee meeting. Pazdur told the Oncology Drugs Advisory Committee not to consider the need to have Genzyme's Clolar (clofarabine) available to treat elderly acute myeloid leukemia patients in voting whether or not a randomized trial should be required prior to the drug's approval for the new indication.

ODAC was convinced that clofarabine is active in getting elderly AML patients into remission, but ultimately voted 9-3 that the additional trial did need to be conducted prior to its approval - regardless of the enormous disease and patient population challenges that have stood in the way of conducting such trials thus far. "This really is a level of evidence question that we're asking here," Pazdur said. "We're not asking 'can a randomized study be done,' 'would you like a randomized study to be done,' 'would it be nice if a randomized study were to be done.' The vote is: for a level of evidence for approval - cognizant that this does set precedence for other drugs - is a randomized study necessary in the proposed indication. Right now, availability is not an issue ... There are many ways of getting this drug [through] off-label use."

Hmm.

  Read More & Comment...

Sharp DARRTS

09/04/2009 03:56 PM |

Jenkins blamed the lapses on "long-standing limitations in staffing and information technology resources," saying that "competing workload priorities prevented us from the level of oversight and review of the entire portfolio of [postmarketing requirements] and [postmarketing commitments] that we would have desired …With new resources and congressional directives, FDA is committed to ensuring proper drafting and review of the entire portfolio going forward.”

Among the changes, each Center for Drug Evaluation and Research division now has a designated postmarketing study coordinator and a postmarketing study tracking coordinator.

In general, the deputy division director for safety - a position established under the agency's Safety First initiative - has assumed the postmarketing study coordinator job, and the safety regulatory manager will handle postmarketing study tracking. "These people as their full-time job are managing the safety and postmarketing study portfolio for their division," Jenkins said.

According to Jenkins, new policies and procedures are in place to "improve consistency in developing" postmarket requirements and commitments and lead to "better designed studies and trials with effective and realistic time frames for initial completion.” He added that other changes have been made to improved tracking and reviewing, including standardizing policies and procedures across CDER review divisions and offices.

A new postmarketing study database implemented at the end of July as part of the Document Archiving and Records Retention System (DARRTS) includes increased capacity for data capture, tracking and report generating.  Read More & Comment...

Giving the Finger -- A New Low

09/03/2009 05:06 PM |

According to the AP:

THOUSAND OAKS, Calif. — California authorities say a clash between opponents and supporters of health care reform ended with one man biting off another man's finger.

Ventura County Sheriff's Capt. Frank O'Hanlon says about 100 people demonstrating in favor of health care reforms rallied Wednesday night on a street corner. One protester walked across the street to confront about 25 counter-demonstrators.

O'Hanlon says the man got into an argument and fist fight, during which he bit off the left pinky of a 65-year-old man who opposed health care reform.

A hospital spokeswoman says the man lost half the finger, but doctors reattached it and he was sent home the same night.

She says he had Medicare.

O'Hanlon says the attacker fled but authorities have a good description.

  Read More & Comment...

Bextra Credit

09/03/2009 11:33 AM |

No doubt there will be much pontificating and punditry surrounding the Pfizer settlement.  That the matters at hand happened in the past and under different management will be largely ignored.  (And the fact that they did certainly doesn’t make any past malfeasance less serious.)  That being said, a few personal observations.

The people I know at Pfizer are honest and honestly dedicated to advancing both the business aims of their company and (even more importantly), the public health.  These are not mutually exclusive objectives. They are proud of what they do – and rightfully so.

Don’t give up the ship.

  Read More & Comment...

What's the Value of CER

09/02/2009 10:06 PM |

The latest contribution to our understanding of "what works" -- guaranteed to save money according to CER kool-aid drinkers -- from AHRQ:

Comparative Effectiveness of Lipid-Modifying Agents

"Due to these limitations in the available data, we present first our results based on the available evidence for the group requiring intensive lipid lowering when combination treatment is compared to a higher dose of a statin, and then provide a broader perspective using available data in all risk groups comparing combination therapy to any monotherapy statin dose."

Translation into humanspeak:  the less than 100 randomized trials we review only gave us a one-size fits all conclusion, which is lousy but we are going to give it to you anyway.

Media translation:  "Researchers analyzed 102 published studies on the topic and found no benefit of combination therapy at reducing the risk of death, heart attack, stroke, or the need for bypass surgery over using high doses of statins alone."

Statins May Perform Better as a Solo Act
Combination Therapy for Lowering Cholesterol Not Yet Proven to Be Superior to Statins Alone
By Jennifer Warner
WebMD Health News

Policy translation:  Gee, one pill -- especially the cheaper red bill -- is even cheaper than two pills.   So let's start everyone on the cheapest pill. 

Recommendation:

"Pragmatic trials are required in order to provide relevant guidance to practitioners and patients. In trials of this type, oversampling of populations of interest, including women, ethnic groups, elderly Americans, and persons with diabetes,would help define the relative applicability"

Humanspeak:  "We need to spend more money to come up with the same conclusions about needing more research years from now.  In the meantime we will tell the press that one cheap pill is just fine."

"...the benefits of additional therapies need to be clearly defined along with attendant risks and costs before advocating widespread use of combination treatment,” writes researcher Mukul Sharma, MD, MSc, of the Canadian Stroke Network in the Annals of Internal Medicine.

http://www.webmd.com/cholesterol-management/news/20090831/statins-may-perform-better-as-a-solo-act

So glad the $1.1 billion in CER money is being put to such good use....


  Read More & Comment...

Not so dynamite?

09/02/2009 12:35 PM |

Nobody said it was going to be easy.

Mixed news from the 2009 European Society of Cardiology Congress in Barcelona on a new post hoc sub-analysis of patients treated with Lipitor (atorvastatin calcium) in the five-year Treating to New Targets (TNT) study. For patients with established heart disease who were treated with a statin, 18 novel biomarkers including C-reactive protein (CRP) did not predict future cardiovascular events such as heart attack and stroke. By contrast, traditional lipid risk factors were strong predictors of cardiovascular events.

The 18 novel biomarkers were not predictive of risk for future cardiovascular events in patients with stable coronary heart disease already on statin therapy. Higher levels of LDL cholesterol and triglycerides and lower levels of HDL cholesterol, however, were each strongly and significantly predictive of risk for future events.

The complete report can be found here.

  Read More & Comment...

Δ House

09/01/2009 04:42 PM |

Consider value-based insurance design, and then consider Section 224 (c) of HR3200, "Encouraging the Use of High Value Services." The public health insurance option may modify cost sharing and payment rates to encourage the use of services that promote health and value."

The Pink Sheet points out a recent paper sponsored by the National Pharmaceutical Council as "adjust[ing] out-of-pocket costs based on an assessment of the clinical benefit value - not simply the cost - to a specific patient population." The overall goal is "getting more health out of every health care dollar."

And they continue:

“A shift to value-based insurance would provide some interesting opportunities for drug manufacturers to develop and present evidence of their products' value. A permanent comparative effectiveness research program, which is being considered as part of health care reform legislation, also could become an important source of information on value.”

It’s important to consider VBID in the broader conversation of clinical effectiveness and more specifically HTA modeling a la QALY – because that brings you into the direct path of VSLY – the value of a statistical life year.  According to Dr. Frank Lichtenberg of Columbia University, for a healthcare technology assessment scheme (such as the NICE model) to yield valid decisions in practice, it is necessary to have reliable estimates of:

ΔCOST
ΔQALY
and VSLY (Value of a Statistical Life Year)

and his main point is that the devil is in the details.

Lichtenberg believes that incorrect estimates of some or all of these key inputs are often used:

ΔCOST is frequently overestimated
ΔQALY and VSLY are frequently underestimated

And due to these estimation biases, health technologies that are truly cost-effective may often be rejected as cost-ineffective.

Per the recent debate over the utility of new cancer treatments, he makes a very interesting point -- that even though, over the past 30 years, the U.S. Mortality Age-Adjusted Rates for cancer have remained relatively constant -- (leading to such mainstream media headlines as Fortune Magazine's "Why have we made so little progress in the War on Cancer?” and NEJM articles like "The effect of new treatments for cancer on mortality has been largely disappointing” -- the often ignored reality is that 5-year relative survival rates, for all cancer sites, have increased from 50.1% in 1975 to 65.9% in 2000.

Lichtenberg cites two crucial studies, pointing out how health care economists must seriously reconsider the outdated estimates of a QALY:

Viscusi and Aldy: The value of a statistical life for prime-aged workers has a median value of about $7 million in the United States

Viscusi, W. Kip and Joseph E. Aldy, “The Value of a Statistical Life: A Critical Review of Market Estimates Throughout the World,” The Journal of Risk and Uncertainty, 27:1; 5–76, 2003.

and

Murphy and Topel: The value of a life year is $373,000.

Murphy, Kevin M., and Robert H. Topel, “The value of health and longevity,” Journal of Political Economy, 2006.

Attention must be paid. Hello Senator Baucus.  Read More & Comment...

The Myth of the Rising Uninsured

08/31/2009 05:25 PM |

One of the presumptions behind calls for wider access to health insurance is that over the last ten years more and more Americans have found themselves uninsured. But it turns out that this isn’t quite true. Sure, the number of uninsured Americans is higher now than it was a decade ago but the change has a lot to do with population growth. A far better measure is the percentage without insurance, which despite fluctuations, has not changed a lot since even the early 1990s. In fact, between 2006 and 2007, the last years for which there is good data, both the number and the percentage of Americans who are uninsured went down.

Uninsured Americans



And while obviously the recession that hit the US beginning last year has worsened the picture, a Gallup poll in June 2009 put the number currently uninsured at around 16 percent of adults. That is higher than in previous years, yes, but not shockingly or dangerously so. It also represents only those uninsured at one point in time and leaves out people under 18, who tend to have a higher rate of being insured, especially with the extension this year of programs like SCHIP.

I’m hardly going to argue that “only” 14-16 percent uninsured is a reason to leave the US health care system as is. However, both honesty and well-researched information have been lacking, on all sides, of the health care debate. The myth of the rising uninsured is yet another example of this.
  Read More & Comment...

Camp Counseling

08/31/2009 11:52 AM |

In Sunday's edition of the New York Times, Robert Pear reported that:

“Medicare beneficiaries would often have to pay higher premiums for prescription drug coverage, but many would see their total drug spending decline, so they would save money as a result of health legislation moving through the House, the Congressional Budget Office said in a recent report.”

The "but" is at the very end of the article:

“But, Mr. Elmendorf  said, the averages conceal the fact that beneficiaries would be affected in different ways.”

(That’s Doug Elmendorf, director of the CBO.)

And when you consider the, um, facts …

“Those who use a relatively small amount of prescription drugs would pay more in additional premiums than they would save, he said, while those who use a large amount of drugs would gain more from lower cost-sharing than they would pay in higher premiums.”

The CBO study was undertaken at the request of Representative Dave Camp (R, MI), the senior Republican on the House Ways and Means Committee.

Mr. Pear ends by reporting that, “The budget office did not estimate how many Medicare beneficiaries might see an increase in their spending for prescription drugs and drug coverage, and how many would see a reduction, under the House bill. Mr. Camp said “the vast majority of seniors” would pay more, and he said House Democrats should scrap their bill and “start over with open, bipartisan talks.”

The complete New York Times article can be found here.

What’s the problem with higher co-pays?  They reduce usage and compliance.  Great if you’re trying to save money in the short-term.  Not so great if you’re trying to enhance patient outcomes over the long-term.  Short-term-savings (a political objective) vs. long-term patient health (which is also much more cost-effective in the long-term).

Short-term (political) thinking delivers long-term (public health) problems.

According to a recent study by Wolters Kluwer Health, fewer Americans are filling their drug prescriptions. In the fourth quarter of 2008, U.S. patients neglected to fill 6.8 percent of on-patent prescriptions - a 22 percent increase compared to the first quarter of 2007. (On-patent prescriptions are those for which there is no generic alternative to the brand-name drug.)

Why?

Drug prices. It's not that the cost of prescription drugs is rising - it's patients' out-of-pocket costs, or co-pays. One of the reasons for this is that insurance companies, reluctant to foot the bill for brand-name medications, have been refusing to cover more brand-name prescriptions.

In the fourth quarter of 2008, in fact, health insurers denied coverage for 10.8 percent of brand-name drugs - a jump of 21 percent from the first quarter of 2007.

And it's not because the medicines themselves are becoming more expensive. Between 1998 and 2003, prescription drug costs increased by $22.48 per person. Meanwhile during that same period, the average health insurance premium went up by $104.62 per person.

When co-pays go up, more people see the need to abandon their prescription drug regimen. At least that's what a study from Oregon Health & Science University found. In 2003, researchers looked at what happened when a small $2 to $3 co-payment was introduced for Oregon Medicaid patients. After examining data on 117,000 patients, the researchers found that prescription drug use dropped by 17 percent.

As health care costs continue to rise, it's understandable that insurance companies (including the nation’s biggest payer – Uncle Sam) are looking to save money wherever possible. Passing off the cost of prescription drugs to patients, however, will only drive up overall costs while resulting in dramatically poorer health for more Americans.

  Read More & Comment...

The Week in Quotes

08/28/2009 09:01 PM |

“We’ve got to think about putting a lot of that off until the economy’s out of recession. There’s no reason we have to do it all now, but we do have to get started. And I think the place to start is cost, health delivery reform and insurance market reforms.”

  Read More & Comment...

Industry Support for CME

08/28/2009 08:56 PM |

  Read More & Comment...