AAPS Files Motion to Compel Discovery in AAPS v. Clinton
On June 22, 1993, the US Court of Appeals for the District of Columbia Circuit (the ``D.C.
Circuit'') handed down its decision in AAPS v. Clinton, remanding the case for further proceedings on the
issue of whether the ``interdepartmental working group'' (IWG), or any or all of its ``cluster groups'' or
``subgroups'' constitute federal advisory committees as defined in the Federal Advisory Committee Act, 5
U.S.C. App. Sections 1-14 (``FACA'').
In the lower court, AAPS had sought to take discovery on this issue, but the district court initially
refused this request and held that the IWG was not covered by FACA. On appeal, the D.C. Circuit
reversed this aspect of the district court's decision, writing that ``we believe further proceedings, including
expedited discovery, are necessary before the district court can confidently decide whether the working
groups is a FACA committee.''
The D.C. Circuit also set forth what it believed to be the relevant characteristics of a ``federal
The point, it seems to us, is that a group is a FACA advisory
committee when it is asked to render advice or recommendations as a
group, and not as a collection of individuals. The group's activities are
expected to, and appear to, benefit from the interaction among the
members both internally and externally...The whole, in other words, must
be greater than the sum of its parts.
Thus, an important factor in determining the presence of an advisory committee
becomes the formality and structure of the group...
The D.C. Circuit noted that ``[T]he record does not reflect where [the persons participating in the
IWG] came from nor does it show how many hours they work.'' While the government argued on appeal
that the IWG was composed only of ``special government employees'' and ``consultants,'' the D.C. Circuit
believed that such terms are alone irrelevant to determining whether a person is not a ``full-time officer or
employee of the federal government'' whose presence on the IWG would trigger the application of FACA.
On July 9, 1993, AAPS filed and served its First Set of Interrogatories and Second Set of Request for
Production of Documents seeking specific information on the structure, personnel, and purpose of the IWG.
Specifically, these discovery requests sought the names and addresses of all persons participating in the IWG
and any cluster group or subgroup thereof, their private or outside affiliations, their time records, travel
reimbursement records, payroll records, and conflict-of-interest forms.
Although the Defendants have provided lists of persons participating on the IWG, the response to
the discovery requests are replete with evasiveness and lack of candor. The Defendants have refused to
provide the time records, travel reimbursement records, and payroll records of all but 47 of the participants
whom they have identified, claiming such information to be irrelevant. Such information is, of course,
relevant to show a fixed membership and the formal structure of the group. The Defendants have also
refused to provide relevant documentation showing the number of meetings attended by individual
participants and the purpose of each meeting. Additionally, the Defendants have totally failed to produced
completed ethics forms required by the Ethics in Government Act.
Under Rule 37 of the Federal Rules of Civil Procedure, any party who is refused or denied an
answer to a relevant request for information may file a motion with the district court to obtain an order
compelling the party to answer the request. AAPS recently filed such a motion; oral argument will be held
in the weeks ahead. If AAPS prevails on the motion, it will be one step closer to proving that the IWG
must disclose its minutes and working papers to the public.
With the Clinton Administration planning to unveil its ``health-care reform'' agenda in the coming
weeks, exposure of the inner workings of the IWG will assist in the debate over the merits or fallacies of the
Although the appropriations necessary to keep the Selective Service alive and functioning were
deleted from the budget bill, Senator Barbara Mikulski's (D-MD) subcommittee of the Senate Appropriations
Committee has revived a proposal that would allocate $25 million to the Selective Service System beginning
The proposal must be approved by the Senate Appropriations Committee, the full Senate, and a
House conference. The process will probably move swiftly.
Pete Stark (D-CA), a member of House Ways and Means, called the Selective Service a ``phenomenal
waste of money.''
For a copy of the comments that AAPS submitted on this legislation, send a 9x12 self-addressed
envelope to 1601 N. Tucson Blvd. Suite 9, Tucson, AZ 85716 ($2.90 postage for return by priority mail,
$0.75 by first-class mail).
Control Through Medical Education: an Update
The AMA's view of its role in physician workforce ``planning'' is expounded in the Sept. 1, 1993
issue of JAMA:
``The AMA, with the largest and most accurate repository of information on GME [graduate medical
education]...stands ready to provide...policy makers with the policy-relevant analyses required...[for] physician
workforce planning'' (p. 1060). ``Goals could be subverted if residencies not approved for funding from the
payer pool are financed from other revenue sources....One approach would be to accredit only positions
funded from the payer pool. Students would accept unaccredited positions at their own risk because they
would be ineligible for...board certification'' (p. 1082).
``Licensure has been used successfully in other countries to limit the number of practicing
physicians'' (p. 1103).
``Convincing the medical education community that they must support workforce planning
recommendations that may negatively impact some sectors of the medical community will require skillful
consensus building....''(p. 1104).
``We need to teach [comprehensive, age-appropriate] health education like we teach math, every day
in our classrooms.''
Joycelyn Elders, MD, responses to Senators' questions Tucson, AZ
AAPS welcomes Ocala Eye Surgeons of Ocala, FL and Drs. James Abbenhaus of Yakima, WA; Mark
E. Anderson of Irvine, CA; John Bargren of Tacoma, WA; W. Ben Blackett of Tacoma, WA; Max W.
Brachvogel of Tacoma, WA; Todd M. Chapman of Charlotte, NC; Patricia A. Charochak of Puyallup, WA;
Peter M. Daloni of Sharon, PA; Devanand Anthony Dominique of Grand Forks, ND; Lee R. Dorey of
Tacoma, WA; Jay H. Ehly of Tacoma, WA; Judith T. Feigon of Houston, TX; Enrique J. Fernandez of
Bradenton, FL; Gloria W. Freundlich of Atlanta, GA; Albert F. Garib of Newport Beach, CA; Ronald E.
Harbut of Page, AZ; G. Gilbert Johnston of Tacoma, WA; Nathan Kaufman of Farmington Hills, MI; John
Kindzierski of Livingston, NJ; Robert W. Kuakle of Tacoma, WA; Bob Q. Lanier of Fort Worth, TX; Aaron
M. Levine of Houston, TX; Neville A. Lewis of Tacoma, WA; Ralph Litton of Reno, NV; Juvis Maes of
Aberdeen, WA; Leslie S. Malo of Tacoma, WA; George E. Maloof of San Francisco, CA; David T. Petty of
Chicago, IL; Joe Phipps of DeSoto, TX; Edward Rensimer of Houston, TX; Jeffrey Rutgard of La Jolla, CA;
Guadalupe Sanchez of St. Peters, MO; Elizabeth G. Sanford of Tacoma, WA; Joseph S. Schwartz of
Clearwater, FL; Bryan L. Smith of Venice, FL; Michael Steiner of Seattle, WA; Stanley Terman of Encinitas,
CA; and Dennis A. Wight of Tacoma, WA.
CLIAÄThe Inspections Begin
On August 1, the Georgia Dept. of Human Resources, acting as agent for HCFA, began inspecting
the office laboratories of dermatologists who had registered last year under the CLIA regulations. This first
inspection was touted as being ``educational,'' rather than punitive; presumably, subsequent inspections will
be the latter.
The most frequently cited deficiencies mentioned by the inspectors were: the failure of
dermatologists to document to temperatures of their refrigerators where the culture media for dermatophytes
is stored and the temperature of the room where the cultures are incubated (although these temperatures are
of no importance); failure to note the exact time to the nearest minute when a fungal culture was inoculated
(though it takes more than a week to grow); failure to perform a Gram-positive and Gram-negative control
for each and every Gram stain; failure to perform quality control testing (inoculation with a known pathogen
and contaminant) on every lot of culture medium, even though the manufacturer is required to do this;
failure to have a protocol for quality assurance (telling what action is to be taken if the medium fails the test);
failure to have a job description for all the ``positions'' in the laboratory even if all of them are filled by the
dermatologist personally; and failure to have proper laboratory requisition forms for ordering the tests.
Dermatologists were informed that the results of the inspection were a matter of public record,
accessible to ``any interested person'' on demand. Physicians were assured that the names of our patients
would not be made public. (Inspectors insisted on seeing actual lab records and patient charts if the
laboratory results were recorded directly on the chart.)
An informal poll of the Atlanta Dermatological Association last spring showed that 40% of the
membership had stopped all laboratory testing because of CLIA. The poll was taken before the onset of
Dermatologists were also informed that they would have to participate in at least four proficiency
testing ``events'' annually, beginning in 1994, for every individual test that they perform. Most programs
require the payment of $150 to $300 per test per year.
The major impetus for the promulgation of these regulations was inaccurate Pap smears, which are
virtually never read in a physician's office. HCFA has yet to develop a program for inspecting cytologic
It was particularly worrisome that the inspector wanted to record the names or Social Security
numbers of ``typical'' patients who had had laboratory testing. We refused to let this information leave our
offices, allowing only initials to be recorded.
The chilling effect of these inspections, along with the costs of the required licenses and proficiency
testing, will undoubtedly discourage any further development of in-office procedures with their advantages of
patient convenience, instantaneous reporting, and cost savings. (The screening culture for pathogenic fungi
costs $15 in the office and $42 in the commercial laboratory.)
Don Printz, MD Lilburn, GA
[The newsletter of the Missouri State Medical Association, June, 1993, reports that HHS has spent $100
million to get CLIA off the ground, but thus far has collected only $20 million in ``user fees.'']
Oct. 5. Board of Directors meeting
Oct. 6-9. 50th annual meeting, Menger Hotel, San Antonio, TX. For hotel reservations, call (800)345-
9285. To register, call AAPS at (800)635-1196.
Nov. 6-7. Medical Action Committee for Education, Philadelphia (see enclosure).
Oct. 12-15, 1994, 51st annual meeting, Atlanta.
Trimming His Sails?
Going into the final (?) stretch, the latest word is that President Clinton will reveal his Health Care
Plan on September 22. The most likely forum will be a special Joint Session of Congress. A comprehensive
bill is not likely to be sent up to the Hill at that time. Look for serious legislative action in the spring of
While the outlines of the emerging plan look substantially the same as reported here last month (see
AAPS News Legislative Supplement, Sept. 1993), Clinton's August 16 speech to the nation's governors
suggests that the White House is cutting back a bit. (The Gergen influence?) The Plan will still have phased-
in universal coverage, a standard benefits package, employer mandates and financing, and a system of
geographically based health alliances (purchasing cooperatives) managed by the several states. But there are
both subtle and important differences.
First, the subtle differences: 1. The phrase ``global budgets'' has been dropped for the nicer sounding
``spending caps.'' Call them ``expenditure targets.'' The plan is to cap spending in the Medicare and
Medicaid program, then extend the caps to private insurance premiums. The savingsÄexpected to be in the
billionsÄare to help cover the currently uninsured. 2. A straight employer-based payroll tax is apparently
``out'' because it would be a tough sell. Instead, there is to be an ``employer-based premium contribution,''
ranging from 3.5% of payroll for small firms up to 7.5% for large firms for the ``standard'' benefits package.
The maximum health insurance premium for the self-employed would be 9.5% of their earnings. Subsidies of
some sort are expected for small firms.
The important differences: 1. Instead of the states, the federal government will have the
responsibility to enforce the ``spending caps.'' 2. The exemption for big business is no longer on Hillary's
kitchen table due to the obvious political problem of trying to sell a double standard (and the high-pitched
objections of organized labor).
On the standard benefits package, the outlines are becoming clearer. Actually, two packages are
expected: a fee-for-service family package, with a $400 family deductible and a $200 deductible for individual
coverage, plus a 20% copayment for physician services. There will also be an HMO package with no
deductible and a 10% copayment on physician services. Employers will be expected to pay 80% of the
standard benefits package, and employees 20%. (Of course, as economists realize, health benefits are a one-to-
one trade-off with wages.)
To limit his vulnerability on the tax-and-spend issue, the President is now offering only a set of new
``sin'' taxes on alcohol and tobacco, with an annual yield of $15 billion.
Marching Off to the Gettysburg of Domestic Policy
With the start of the Fall Offensive, expect an all-out public relations blitz. The Democratic
National Committee and the National Health Care Campaign are sponsoring training sessions. Look for
concentrated grassroots efforts using phone banks, the mail, and even neighborhood street canvassing.
Former Ohio Governor Richard Celeste has been given field command.
In every congressional district in the country where it counts, congressional Democrats are being
organized by Congressman Vic Fazio (D-CA) who is preparing his colleagues for dealing with the media.
Members are advised to stress the ``drastic need for reform.'' Key allies are expected to be the AARP, the
National Council of Senior Citizens, local mental health associations, nurses organizations, members of the
Red Cross, the American Cancer Society, the ACP, and the AAFP.
The Clinton forces' lines of attack are crystal clear. If congressional Republicans are shocked by the
vigor of the White House offensive or thrown into confusion or find themselves on the defensive in the
coming public-relations blitz, they have no excuses. They will not be fighting on the comfortable turf of tax-
and-spend politics but on an issue where the congressional Democrats can and will make a powerful and
voter-friendly political appeal: ``security.'' The second major theme will be ``savings.'' The campaign will
promise to stop the skyrocketing costs that are allegedly ``crippling'' business and ``exploding our deficit.''
The third major theme will be ``simplicity''Äthe Clinton Plan promises to reduce the complexity of
insurance forms and claims processing and close the loopholes that effectively deny people coverage.
Capitol Hill insiders think that the Clinton team will capture the high ground of the national health-
care debate during the initial stages of the Blitz. The big question is whether he can maintain his
momentum. Arguing for his success are a few formidable advantages. 1. Whatever Clinton's weaknesses in
governing, he displays awesome skills campaigning outside of Washington. On this issue, he will be
switching into campaign mode. 2. The ``security'' issue (``we care, they don't'') has the potential to become
the ``wedge'' issue that brings blue-collar Democrats back into the fold.
However, there is a chance that the debate will ultimately turn on taxpayer cost rather than taxpayer
``security,'' and the cost issue is getting an early airing.
Early Skirmishes on Cost
In early skirmishing, the Clinton Administration is finding itself on defense. In a study for the
Health Care Leadership Council, a group of providers and insurers opposed to employer mandates, Lewin-
VHI, Washington's top number-crunchers, estimated that the net cost of the Clinton health-care proposal
would be $42.7 billion in the first year. The total cost of subsidizing insurance premiums for the uninsured
would be $75.4 billion, of which only $32.7 billion would be offset by ``savings'' (price caps and such) in
government programs such as Medicare and Medicaid. Lewin also estimated that the extra annual costs to
employers for covering their workers would be $24 billionÄmore if additional Administration proposals are
The Clinton Administration's response to the Lewin study has been to shoot at the messenger and
to attack the folks funding the study. According to a report in the August 20th Washington Post, White
House spokesman Robert Boorstin said that ``Lewin-VHI is an extremely reputable company that is
trafficking in ridiculous assumptions and drawing conclusions about a program that hasn't been announced.''
The Administration's cost estimates are said to be lower, but none of the math has been released. In the
meantime, attacking Lewin-VHI, whose cost estimates are routinely used by congressional committees and
major corporations, is not the best way for the White House to enhance its credibility on Capitol Hill.
Playing defense again, the Administration is trying to put out another fire: the projected labor costs
of employer mandates. Like a witness being pressed by Perry Mason, the Administration is strongly denying
that the job loss due to employer mandates will be as high as claimed. But there is a dispute about what
their own estimates really show. Is it ``only'' a couple hundred thousand jobs? Or is it more?
Drs. June and David O'Neill, two professors from Baruch College in New York, have just
completed a comprehensive study for the Employment Policies Institute. The employer mandate, subject of
an August 20 story in the Wall Street Journal by Carlos Bonilla, translates directly into the
loss of 3.1 million jobs, of which 75% will be in the low-paying service industries. The most significant
increase in labor costs would be in restaurants and taverns, where an increase of 19.% would result in an
estimated loss of 828,000 jobs. In retailing, a 7.9% increase would destroy 726,000 jobs; in agriculture, a
15.6% increase would kill 194,000.
In addition, mandatory health care costs cut wages or at minimum reduce wage increases. As Bonilla
comments: ''A Blue Cross card won't pay the rent.''
Attacks by the Allies
In an August 10 article in the Wall Street Journal, Paul Ellwood, MD, complained
that Clinton forgets his health-care allies. The Clinton policy wonks ``never embraced'' the managed-
competition model that the President promoted during the campaign.
Ellwood described the White House Task Force and its working groups as ``exclusive, secretive,
compartmentalized, and unduly complex.'' To start with, the Task Force was given contradictory
instructions: employ the marketplace, while imposing government controls that weaken market forces.
Then participants were asked to consider only disconnected parts of the problem, with ``no mechanism for
assuring that the policy ideas were consistent with others or with experience.''
The New York Times, the national arbiter of what's politically fashionable and what's
not, published an August 18 editorial that is hardly good news for the White House. Describing the
President's remarks as ``maddeningly vague,'' the Times went on to lament the absence of
genuine competition and incentives in the Clinton scheme and ended on this remarkable note: ``Once
providers are forced to compete to survive, and consumers encouraged to make cost-conscious choices,
Washington can let the states figure out their own solutions.''
Senate Republicans: Inching Toward Surrender?
While Congressman Richard Armey (R-TX), the unofficial leader of seriously combative
Republicans, is regularly unleashing preemptive salvos against the emerging Clinton health-care plan, Senate
Minority Leader Robert Dole of Kansas stunned Capitol Hill conservatives by saying he could go for ``sin
taxes'' as a way to help finance health-care reform. While drawing a line in the sand against new payroll
taxes, Dole's early signals to the Clinton Administration are troubling to Senate and House conservatives
who want to go on the offense with a comprehensive and politically attractive plan of their own. Not only
that, Capitol Hill conservatives view Clinton in a seriously weakened political condition with progressively
lower reserves of political capital. (Popular support for the Budget Plan actually dropped after Clinton's
nationally televised speech. Phone calls to House and Senate offices were often running ten to one against
In the meantime, Dole has been encouraging Senator John Chafee (R-RI), the Chairman of the
Senate Republic Task Force on Health Care Reform, who is in favor of ``managed competition,'' whatever
that happens to mean at the moment. Like President Clinton, Chafee still doesn't have a bill.
In response to Clinton's August 16th speech to the National Governors Association, Chafee quickly
circulated a statement of ``consensus principles'' signed by 24 Senate colleagues. This outlines three major
goals: the maintenance of quality health care; the need for universality of ``coverage,'' and the need to restrain
medical costs. Beyond that, the chief recommendation is that health care purchasing cooperatives be set up
to promote bargaining between providers and consumers and employers.
This statement itself is evidence of the rift in Republican ranks. Leading Senate conservativesÄsuch
as Phil Gramm of Texas, Connie Mack of Florida, John McCain of Arizona, Dan Coats of Indiana, and Don
Nickles of OklahomaÄare all missing from the line-up. While Chafee's staff keeps denying that there is a
serious feud, it is well know that very basic policy divisions are emerging among Senate Republicans. The
key issue: How much personal freedom should consumers have in making medical decisions?
On two issues, there does seem to be almost universal agreement. Senate Republicans, as indicated in
a letter to President Clinton signed by 41 Senators, will oppose any employer mandate. Likewise, there will
be strong GOP opposition to any global budget or expenditure targets.
`` Health Care Security Plan'': a Lexicon
A 47-page briefing paper called ``Health Care Update,'' dated August, 1993, is being distributed to
congressional Democrats by the White House. The theme is: ``Health care that's always there.'' This piece
helps to clarify the Plan, if you read between the lines. Here are a few important definitions (some based on
the presentations at citizen forums now being held throughout the nation):
Allow, as in ``allow small businesses and consumers to band together in health
alliances'': to force
Ask to contribute: force to pay
Choose: to pick one of a few standardized Health Plans and then to pick a doctor who
is on their list
Community rating: ``Everyone who lives in the same area pays an equal amount for
health insurance. Instead of letting insurance companies make a lot of money off a small number of people,
they will make a little money off a lot of people'' (sic.).
Coverage: enrollment in a Plan (q.v.)
Emphasize, as in ``emphasize preventive care'': fund at the expense of something else,
usually sickness care
Health alliance: ``All members of the community are part of the Health Alliance.''
Plan (n.): a scheme to provide all the care that is available
Plan (v.): to ration, prevent, restrict, prohibit, or obstruct the delivery
of unplanned medical care
Prioritize: decide which patients receive care, based on three- to five-line descriptions
of their problems
Security: They can't cancel your coverage. [Neither can you.]
Universal access: the availability of selected care to all on the basis of politically
determined priority; in effect, restricted access or rationing