Mammography Bailout is Coming

"A Very Expensive Program"

In 1993 the United States government seized control of the mammography "industry" with the Mammography Quality Standards Act. Over the past week I have blogged about this catastrophic government takeover here and here and here.

MQSA was purportedly designed to "improve" quality in mammography; however, as we have seen, the people involved in enacting the law really did not have a good grasp on the medical issues involved; rather, they were fixated on a political and social agenda that would send a bigger message to the United States health care system, and the world.

As one analyst described The Act:

"the adoption of the MQSA...was a highly political decision that reflected the efforts of numerous advocates and legislators to remedy the historical failure of the medical establishment and regulatory structure to pay the proper amount of attention to issues affecting the health of the nation’s women."

Because the aim of the act was social and political, the unintended consequences included the possibility of actually harming the practice of mammography -- something which has come to pass. As previously noted by Kennedy's Tumor:

*The sensitivity and specificity of mammography remain unchanged 1993 vs 2009.

*Mammography today is no better at finding cancer than it was in 1993 ...AND

*STILL...a mammogram is an insensitive test for many women
*STILL...mammography remains the second most dangerous thing a doctor can do in all of medicine
*STILL...jury awards for missed cancers on mammograms represent the largest liability awards in all of medical practice.

And what changes has MSQA actually catalyzed?

*massive closing of women's centers
*physicians fleeing the field
*millions of dollars in costs
*destruction of business initiative
*blunting of technology that might actually produce better methods of finding and diagnosing cancer

The Economy of Failure

MQSA has devastated the practice of mammography. But what are the real dollar costs?
A lot of money. As quoted above, a Harvard law school analysis in 2003 listed the government appropriation for operation of MQSA its first year of full operation, 1994, at $10,000,000 followed by an additional $1,000,000 that were transferred from the Center for Disease Control for MQSA implementation.

The Congressional Budget Office has estimated that reauthorization of the MQSA program, in 2003, cost $12,000,000 that year and an additional $77,000,000 over the 2003-2007 period.

Of that amount, $52,000,000 is for program services not covered by user fees.

"User Fees" are the fees/taxes levied each year on the mammogram facilities which, for 2008, were $18,398,000.00. These fees do not reflect the cost each center incurs hiring personnel to assist with compliance; buying software to track, publish and compile the data requested; and pursuing ongoing continued medical education training courses as required by this onerous law.

And those user fees are plummeting (think credit default swaps), as centers close at the rate of 20 per month; meaning more government bailout money will be needed, only this time to support the continued depreciation of the practice of screening women for breast cancer-- caused directly by government intervention in health care.

Zero Gravity Mammography

When You Gotta Go...

There's a scene in 2001 a Space Odyssey, when Dr. David Bowman, the ship commander, has to use the most simple of devices, the crapper.

Unfortunately, poor Dr. Bowman is going to have to wait until he reads and deciphers the instructions for the Zero Gravity Toilet before he gets to go...

Posted below, are the Zero Gravity Toilet Instructions for Mammography-- provided by Congress as the Mammograpthy Quality Standards Act (MQSA)--just in case you thought I was exaggerating in my previous posts here and here, describing the only federal law that regulates a specific medical practice or procedure.

There are no such guidelines for brain surgery or giving chemotherapy to children or even pulling bullets out of mafia hit men in the ER; only mammography -- the most basic of all basic radiological exams -- warrants its own set of rules, assessments and penalties, provided by its own law.

Now, provided for your bathroom perusal, are the MQSA guidelines that every mammography center is compelled to abide by -- through the force of law. Think of what it costs to do this (and you'll begin to understand why women's centers are shutting down at the rate of 20 per month!)...then think about what the situation will be when we have laws for all the things we do in health care (called nationalized health care or single payor system).

Then even Ted Kennedy might be stymied!

MQSA Regulations Overview

Quality Standards

Personnel. Interpreting physicians, radiologic technologists, and medical physicists must meet initial and continuing requirements. Documentation of these requirements must be available for inspection.
Equipment. Only equipment designed specifically for mammography qualifies for certification.
Medical Records and Mammography Reports. Summary data written in lay terms must be sent directly to all patients as soon as possible. Mammography films and reports must be retained for at least 5 years and up to 10 years, and labeled according to Food and Drug Administration (FDA) regulation.
Quality Assurance. Quality control testing protocols must be used and maintained by each facility, including mammography equipment evaluations and an annual physics survey. Documentation of daily, weekly, quarterly, semiannual, and annual quality control tests must be retained for FDA inspections
Mammography Medical Outcomes Audit. An interpreting physician must annually review the medical outcomes audit data.
Consumer Complaint Mechanism. Facilities must establish a written and documented system for collecting consumer complaints.

Accreditation
Current Accreditation Bodies. American College of Radiology (ACR), Iowa, Arkansas, and Texas.
Responsibilities of Accreditation Bodies. Accreditation bodies must monitor facility compliance with quality standards, review clinical and phantom images from each facility at least once every 3 years, conduct annual onsite visits of at least 5 percent of the facilities it accredits, and maintain a consumer complaint system.
Accreditation Body Audit. FDA will evaluate the performance of each accreditation body annually.
Facility Accreditation. Facilities must submit verification that personnel, equipment, and practices conform to established quality standards to be eligible for accreditation.

Certification

Current Certification Bodies. FDA, Iowa, Illinois, and South Carolina.
Responsibilities of Certification Bodies. Certification bodies must issue Mammography Quality Standards Act (MQSA) certificates allowing accredited facilities to operate lawfully, and must perform annual inspections of each certified facility.

Facility Certification. Accredited facilities are eligible for certification. Certificates are valid for 3 years, and are renewable.

Inspections

General. Facilities must undergo annual inspections.

Inspectors. Facilities may be inspected by FDA inspectors, state or local agency inspectors under FDA contract, or inspectors from states that are certifying agencies. Federal facilities can be inspected only by FDA inspectors.

Inspector Audit. Annual assessment of state performance is carried out by FDA auditors.
Fees. The facility undergoing inspection is responsible for all inspection fees. As of October 1, 2003, a fee of $1,749 is charged for the first mammography unit inspected, and $204 for every unit thereafter. Follow-up inspection fees are $991.

Compliance and Enforcement

Levels of Noncompliance
Level 1: Failure to meet a key MQSA requirement that may seriously compromise mammography quality. The facility is given 15 days to respond with corrective actions.
Level 2: All critical MQSA requirements met, yet a significant mammography quality item overlooked. The facility is given 30 days to respond,
Level 3: A minor deviation from MQSA standards. The facility is given until next annual inspection to address the problem, although it is advised to correct it as soon as possible,

Enforcement/Sanctions/Other
FDA may impose one or more of the following sanctions:
Directed Plan of Correction, allowing facility to correct violations in a timely manner, while being monitored by FDA.
Patient and Physician Notification, requiring facilities to inform those that may be at risk due to unacceptable image quality or other conditions that could cause significant negative impact on patient health. Follow-up Inspection.
Certificate Revocation or Suspension.
Civil Money Penalties of up to $10,000 per examination or per violation per day may be applied to facilities performing mammography services without proper certification or for other significant violations.

Advisory Committee

Title. The establishment of a National Mammography Quality Assurance Advisory Committee (NMQAAC) was mandated by MQSA.
Members. FDA appoints members from the community of physicians, health professionals, consumer organizations, and industry representatives.
Responsibilities. The NMQAAC advises FDA on appropriate quality standards, assists in the development of sanctions, designs a method to investigate consumer complaints, reports on new developments in breast imaging, determines whether a shortage of health professionals exists, and measures the costs and benefits of MQSA compliance.

SOURCE: Mammography Quality Standards Act, 42 U.S.C. § 263b (2003). 21 C.F.R. § 900.1 (2003).

MQSA, MUSSOLINI, AND MAMMOGRAPHY

Making the Trains Run on Time

"...the Mammography Quality Standards Act... had little if any precedent in the history of medicine. Never before had the federal government claimed a role in the regulation of medical practice."
-NYTimes: June 27, 2002

As I said in my previous post:

PRIOR TO THE 1992 GOVERNMENT SEIZURE OF MAMMOGRAPHY WITH THE MQSA (FEDERAL MAMMOGRAPHY ACT):

1. Women’s imaging is booming – competition for business is brisk
2. Women’s centers are being built everywhere with parquet floors and vaulted ceilings, furnished with overstuffed chairs and couches providing a private, comfortable milieu
3. Medical device manufacturers are eagerly in the game, developing stereotactic minimally invasive biopsy machines; MRI of the breast and digital mammography are both rapidly being developed to advance sensitivity and specificity of diagnosis
4. Diagnostic Imaging residencies open a new subspecialty: Women’s Imaging. Interest among radiology residents is high

What is the Situation Today? What Did We get From Government Regulation?

1. Women's imaging centers are closing at the rate of about 20 per month--
2. The wait for screening mammograms is 6 months in many areas and in lower population areas or areas of high liability--there are no radiologists available to interpret mammograms--the tests are shipped out for remote interpretation
3. No one wants mammography business except large hospitals who are banking on the spin-off money from surgery and therapy for the 1 in 1000 screening patients with cancer-- in other words, the only businesses interested in doing mammography now are businesses hoping women have a cancer ...
4. Medical device manufacturers have fled the field. Stereotactic biopsy devices, MRI of the breast and Digital mammography are all dead in their first or second iterations--without profits, no one is buying new technology, which therefore remains fallow
5. Radiology residents eschew women's imaging and most fellowships go unfilled and without applicants--despite the fact that at least 30 million mammograms will be done each year in the U.S.

Did MQSA Improve Quality in Mammography?

In mammography, improvement should = greater number of cancers found in any given 100 mammograms in 2009 vs 1993.

No matter what the unintended consequences, if MQSA resulted in MORE cancers found per 100 screening mammograms, then the price of this"reform" might be worth what it cost.

Not With a Bang

The sensitivity and specificity of mammography remain unchanged 1993 vs 2009. This means that for every 100 mammograms the same number of cancers would be found today as would be found in 1992--before the government seized mammography with MQSA.

Despite millions of dollars spent in compliance
Despite hundreds of pages of federal regulation
Despite education and training mandates
Despite licensing requirements, yearly requalifications, and mandated QA

Despite all of this, mammography today is no better at finding cancer than it was in 1993

What MQSA has done is to standardize the procedure of taking a breast x-ray and the machinations of the women's mammography facility--akin to Mussolini making the trains run on time in Italy in the 1940's --without ever addressing or even understanding why mammograms cannot do any better after reforms than before!

They threw everything they had at mammography -- anecdotes, laws, regulations, Congressmen, feminists, actresses --everything they want to throw at health care today; but, because they started with bad assumptions and a faulty premise, all the rules and dogma and laws could not repair what they perceived as wrong.

And the main reason is because it was not broken. Just like the medicine and surgery of our health care system today. And after such reform, what knowledge?

STILL...a mammogram is an insensitive test for many women

STILL...mammography remains the second most dangerous thing a doctor can do in all of medicine

STILL...jury awards for missed cancers on mammograms represent the largest liability awards in all of medical practice.

Government takeover of mammography has not improved quality, has not reduced liability, and has not saved one life...
But it HAS

...Caused massive closing of women's centers
...Chased physicians from the field
...Cost hundreds of millions of dollars
...Destroyed business initiative
...Stymied technology that might actually produce better methods of finding and diagnosing cancer

Nowhere Train

Is this what we want in health care reform today? Reform the system, reform the process, address social grievances and perceived injustices while satisfying special interest groups and politicians? Because the system then faces the same fate as mammography.

You will reform insurance. You will reform distribution. You will address costs, but in the process, you will vitiate the services, chase away the best practitioners, and create a great a void where once the world's best health care resided.

You want the train to run on time but to be going nowhere?

...this is what the government will bring us.