Wednesday, July 22, 2009

Quality, HR 3200, and The Meaning of Life, Literally!

I have written about quality in health care a few weeks ago and have just published a White Paper on health care quality. In reading HR 3200 I see that they too have included quality. In fact the Bill is called:

H. R. 3200 ‘‘America’s Affordable Health Choices Act of 2009’’ "To provide affordable, quality health care for all Americans and reduce the growth in health care spending, and for other purposes."

Now as we have said before quality is truly in the eye of the beholder, in this case the patient. If one has prostate cancer, quality care is not lots of morphine and just letting it met to the bone. Quality is engaging the patient in the process of managing his disease. Each patient is different, each patient has a different world view. Some dread incontinence, some sexual dysfunction, some pain. Thus the treatment of a patient, quality treatment, is a personalized interaction between patient and physician.

In HR 3200 they introduce sections defining as best as a politician can the idea of quality. It starts as follows:

"H. R. 3200 ‘‘America’s Affordable Health Choices Act of 2009’’.

DIVISION B—MEDICARE AND MEDICAID IMPROVEMENTS

TITLE IV—QUALITY

Subtitle C—Quality Measurements

SEC. 1441. ESTABLISHMENT OF NATIONAL PRIORITIES FOR QUALITY IMPROVEMENT.

Title XI of the Social Security Act, as amended by section 1401(a), is further amended by adding at the end the following new part:

‘‘PART E—QUALITY IMPROVEMENT ‘‘ESTABLISHMENT OF NATIONAL PRIORITIES FOR PERFORMANCE IMPROVEMENT‘‘ SEC. 1191.

(a) ESTABLISHMENT OF NATIONAL PRIORITIES BY THE SECRETARY.—The Secretary shall establish and periodically update, not less frequently than triennially, national priorities for performance improvement.

‘‘(b) RECOMMENDATIONS FOR NATIONAL PRIORITIES.—In establishing and updating national priorities under subsection (a), the Secretary shall solicit and consider recommendations from multiple outside stakeholders.

‘‘(c) CONSIDERATIONS IN SETTING NATIONAL PRIORITIES.—With respect to such priorities, the Secretary shall ensure that priority is given to areas in the delivery of health care services in the United States that—

‘‘(1) contribute to a large burden of disease, including those that address the health care provided to patients with prevalent, high-cost chronic dis eases;

‘‘(2) have the greatest potential to decrease morbidity and mortality in this country, including those that are designed to eliminate harm to patients;

‘‘(3) have the greatest potential for improving the performance, affordability, and patient centeredness of health care, including those due to variations in care;

‘‘(4) address health disparities across groups and areas; and

‘‘(5) have the potential for rapid improvement due to existing evidence, standards of care or other reasons."

It then goes on to define quality as follows:

"‘‘(d) DEFINITIONS.—In this part:

‘‘(1) CONSENSUS-BASED ENTITY.—The term ‘consensus-based entity’ means an entity with a contract with the Secretary under section 1890. ‘

‘(2) QUALITY MEASURE.—The term ‘quality measure’ means a national consensus standard for measuring the performance and improvement of population health, or of institutional providers of services, physicians, and other health care practitioners in the delivery of health care services...."

This is a deadly definition of quality. It is akin to what the Brits have in their national system where they use the QALY approach to the rationing of health care. The QALY approach looks at a disease and looks at the average quality of life for a variety of treatments. For example we consider prostate cancer. There are three treatments; do nothing, prostatectomy, radiation therapy. Each of these has an outcome and has a patient result in quality of life measurements. Thus is we consider the quality measures some weighted average of pain, sexual dysfunction and incontinence, then we get a quality measure for each treatment for each period of time after diagnosis. We then obtain the average across the country and see that for example doing nothing may have the least impact, the patient has longer time with no sexual dysfunction and incontinence and they die faster so the time with pain is less. Then we assign a cost. Doing nothing is cheap, just lots of morphine if the Government even allows that. The Brits then rank each treatment by the $/QALY and permit the lowest cost treatment only! That means often doing nothing!

But what is wrong with this you may ask, for Congress has in effect placed this in the new Bill! What is wrong is that every patient is different and we are assuming the average. If you are average then you get the correct treatment. If you are not then you are mistreated.

Parsing the above definition is telling. Let us proceed:

1. "national consensus": this means an average across all and disregard to the individual. Medicine is a profession which deals with persons, individuals, and not large groups. Each person with prostate cancer is different. However the Congress drives this to an average. The Brit's QALY approach is just that, an average. God forbid if your disease is one sigma either way, the plan drives to the mean.

2. "performance and improvement of population health" This is NOT individual health, not individual quality, but the population as a whole, as an average. This takes the practice of Medicine and throws it out the door. Why take patient histories, just do a test, diagnose the disease, and use what is in column A. Why perhaps we do not need physicians, that good old obese GS 10 can handle it all on their own!

3. "or of institutional providers of services, physicians, and other health care practitioners" This again focuses on the delivery, and one suspects the costs of the delivery. If we make them all size 10. I remember the tale a fellow grad student told me at MIT. He lived on a Kibbutz and he was 6" 5" and had a size 14 shoe. The Kibbutz only had size 6 thru 10 shoes. He never got shoes because he was outside the range that was acceptable in the Kibbutz. Thus he move to the States where he could get shoes. In the HR 3200 plan it assumes that the delivery will be those size 6-10 shoes and God forbid if you have a 14 foot, You die!

The Bill then continues:

SEC. 1192. DEVELOPMENT OF NEW QUALITY MEASURES.

(a) AGREEMENTS WITH QUALIFIED ENTITIES.—

‘‘(1) IN GENERAL.—The Secretary shall enter into agreements with qualified entities to develop quality measures for the delivery of health care services in the United States.

‘‘(2) FORM OF AGREEMENTS.—The Secretary may carry out paragraph (1) by contract, grant, or otherwise.

‘‘(3) RECOMMENDATIONS OF CONSENSUS BASED ENTITY.—In carrying out this section, the Secretary shall—

‘‘(A) seek public input; and

‘‘(B) take into consideration recommendations of the consensus-based entity with a contract with the Secretary under section 1890(a).

‘‘(b) DETERMINATION OF AREAS WHERE QUALITY MEASURES ARE REQUIRED.

—Consistent with the national priorities established under this part and with the programs administered by the Centers for Medicare & Medicaid Services and in consultation with other relevant Federal agencies, the Secretary shall determine areas in which quality measures for assessing health care services in the United States are needed.

‘‘(c) DEVELOPMENT OF QUALITY MEASURES.—

‘‘(1) PATIENT-CENTERED AND POPULATION BASED MEASURES.—Quality measures developed under agreements under subsection (a) shall be designed—

‘‘(A) to assess outcomes and functional status of patients;

‘‘(B) to assess the continuity and coordination of care and care transitions for patients across providers and health care settings, including end of life care;

‘‘(C) to assess patient experience and patient engagement;

‘‘(D) to assess the safety, effectiveness, and timeliness of care;

‘‘(E) to assess health disparities including those associated with individual race, ethnicity, age, gender, place of residence or language;

‘‘(F) to assess the efficiency and resource use in the provision of care;..."

Finally the Bill defines the Stakeholders who will assist in the definitions. It states:

"SEC. 1443. MULTI-STAKEHOLDER PRE-RULEMAKING INPUT INTO SELECTION OF QUALITY MEASURES....

‘‘(6) MULTI-STAKEHOLDER GROUPS.—For purposes of this subsection, the term ‘multi-stakeholder groups’ means, with respect to a quality measure, a voluntary collaborative of organizations representing persons interested in or affected by the use of such quality measure, such as the following:

‘‘(A) Hospitals and other institutional providers.
‘‘(B) Physicians.
‘‘(C) Health care quality alliances.
‘‘(D) Nurses and other health care practitioners.
‘‘(E) Health plans.
‘‘(F) Patient advocates and consumer groups.
‘‘(G) Employers.
‘‘(H) Public and private purchasers of health care items and services.
‘‘(I) Labor organizations.
‘‘(J) Relevant departments or agencies of the United States.
‘‘(K) Biopharmaceutical companies and manufacturers of medical devices.
‘‘(L) Licensing, credentialing, and accrediting bodies."

Does anyone notice who is missing from this list? The patient. There should be one and only one advocacy group and that should and must be the patient. The patient along with their physician should decide. Not some gang from Washington or the south side of Chicago!

Who (what) is a patient advocacy group? It is some political organization whose sole purpose is its own continuation. They, the Government, have all of these "stakeholders", entities interested in lining their own nests and pockets, but the poor patient is left out in the cold. Remember this bill looks at the average patient, not even plus or minus one standard deviation. The arrogance of assembling this group of people is an insult to the American patients who as taxpayers are paying for this collections of lobbyists. This Bill is a full employment Bill for Lobbyists!

Finally the Bill advocates the use of these measures as follows:

"SEC. 1444. APPLICATION OF QUALITY MEASURES.

(a) INPATIENT HOSPITAL SERVICES.—Section 1886(b)(3)(B) of such Act (42 U.S.C. 1395ww(b)(3)(B)) is amended by adding at the end the following new clause:...

‘‘(x)..

(I) Subject to subclause (II), for purposes of reporting data on quality measures for inpatient hospital services furnished during fiscal year 2012 and each subsequent fiscal year, the quality measures specified under clause (viii) shall be measures selected by the Secretary from measures that have been endorsed by the entity with a contract with the Secretary under section 1890(a).

‘‘(II) In the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical quality measure has not been endorsed by the entity with a contract under section 1890(a), the Secretary may specify a measure that is not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary. The Secretary shall submit such a non-endorsed measure to the entity for consideration for endorsement. If the entity considers but does not endorse such a measure and if the Secretary does not phase-out use of such measure, the Secretary"

Finally we have the Secretary of HHS selecting the quality measures! Health care is now a fully political process!You cannot make this up. The poor patient is thrown onto the ash heap of politics and their health care is reduced to political whims!