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Volume 50, No. 8 August 1994

OIG TARGETS INNOVATERS

More than 125 US hospitals have been served with federal subpoenas demanding ten years of records related to cardiac devices. Subpoenas dated June 2 give the hospitals until July 1 to produce so much data that the ``IG will spend the rest of the century sorting the paper,'' according to Los Angeles attorney Margaret M. Manning. The investigation could lead to criminal prosecutions (BNA's Medicare Report 6/24/94).

The extremely broad subpoenas appear to be part of a ``fishing expedition'' for evidence of false claims or kickbacks.

According to a memorandum by John Steiner, assistant general counsel for the American Hospital Association, the IG ``may be attempting to prove that hospitalizations involving non-FDA approved devices and/or `off-label' use of FDA approved devices are not eligible for program payment for the entire hospitalization'' (ibid.)

According to Section 2301.1 of the Medicare Part B Carriers Manual, medical devices not approved for marketing by the FDA ``are considered investigational by Medicare and are not reasonable and necessary for the diagnosis or treatment of illness or injury.''

Recipients of subpoenas include a children's hospital in Minnesota; community and public hospitals in Florida; teaching hospitals in Pennsylvania and Michigan; three hospitals and a clinic in Phoenix, AZ; and a number of California hospitals, including UCLA and UC San Diego.

The custodian of records in a Michigan hospital was commanded to appear in the office of a Special Agent in the office of the OIG in Seattle, WA, at 10:00 a.m., two weeks after the subpoena was received by the medical center attorney, bringing with him with following:

1. A listing of all procedures performed from April 5, 1984, through March 31, 1994, involving devices that were not approved by the FDA for marketing, including the use of approved devices for non-FDA approved purposes....List to include ... names and addresses of manufacturers of any devices(s) used in such procedures; purchase price of the device(s); ... type of insurance or the insurance company billed, the procedure code billed, the DRG code billed, the amount billed, and the amount paid for each item or service.

2. A listing of any and all persons employed as the Director of the Cardiac Catheter Laboratory, Supervisor of the Electrophysiology Department, the cardiac nursing supervisor, the operating room nurse, or any other person responsible for preparing the charge slips....

3. All Internal/Institutional Review Board records relating to the procedures/devices....

5. [All drafts of patient consent forms];

6. [All correspondence and records related to the purchase or use of a variety of devices]....

7. List of all payments, gifts, stocks and stock options, discounts or reductions in price, services, or any other remuneration received from manufacturers of devices....

The devices include coronary and peripheral lasers, stents, cardiac valves, pacemakers, implantable cardiac defibrillators, equipment for cardiac radio frequency ablation and electrophysiology studies; angioplasty and guiding catheters and guide wires, valvuloplasty balloon catheters, and vascular grafts.

To comply with the subpoenas, hospitals will incur enormous costs. Employees will have to search warehouses for charge slips a decade old.

The probe is said to be ``another sign of the Clinton Administration's aggressive prosecution of health care fraud as part of its efforts to curtail the growth of medical expenditures,'' according to a report in the L.A. Times 6/21/94.

``They are looking for big sum recoveries,'' the article stated, quoting San Francisco attorney Paul DeMuro.

Newspaper accounts suggested some connection with the case of C.R. Bard, Inc., which pleaded guilty last year to criminal charges of selling devices not approved by the FDA and illegal testing of devices on human subjects.

However, procedures used at the University of Michigan combine approved catheters with approved energy sources, according to Adam Strickberger, MD, Associate Director of the Electrophysiology Laboratory. One innovative but thoroughly researched procedure targeted in the subpoena is catheter ablation for arrhythmias. This $10,000 out-patient procedure can replace a $60,000 open-heart procedure carrying a much higher mortality.

``Standard medical practice has been and currently is to use approved drugs and devices for unapproved purposes. Medicare and Medicaid have a long history of paying for these procedures,'' stated Dr. Strickberger.

``This investigation is a preview of what proposed `all- payer' federalized `anti-fraud' legislation could mean,'' stated Jane Orient, MD, Executive Director of AAPS. ``Any physician deviating from guidelines imposed by a National Health Board might be risking total financial destruction.''

In the name of ``protecting'' patients against ``investiga- tional'' (new, improved) treatment, the government is forcibly diverting millions of dollars from patient care into legal fees and administrative costs, even if physicians and institutions escape huge recoupments, fines, and prison terms.

First, the OIG targeted physicians who serve large Medicaid populations. (They are part of a ``subculture of medical delinquency,'' stated James Todd of the AMA.) Then, the FDA stormed the offices of unorthodox practitioners. (They are ``quacks,'' according to many physicians.) Now, invasive cardiologists are the villains. (Some cardiologists are reputedly willing to catheterize anything that has a heart.)

Will you be next? And who will be left to defend you?


The FDA on Unapproved Uses of Drugs

From a letter published in The Journal of Neurological and Orthopaedic Medicine and Surgery, October, 1988, signed by John F. Palmer, MD, on the letterhead of the Food and Drug Administration, Public Health Service, US Dept of HHS:

``The indications carried in a drug's package insert are those for which adequate and well-controlled studies...have been performed and considered by the FDA to demonstrate the safety and efficacy of the product. However, it is well known that physicians prescribe drugs for many indications not in the labeling....

``The FDA has stated, repeatedly, as a matter of policy that the use of an approved drug for indications or at dosage levels not included in its labeling is within the province of the practice of medicine. The FDA recognizes that the labeling of a marketed drug does not always contain all of the most current information available to physicians relating to the proper use of the drug in good medical practice. Advances in medical knowledge and practice inevitably precede labeling revision by the manufacturer and formal labeling approval by the FDA.

``It is recognized that good medical practice and patient interests require that a physician be free to use commercially available drugs according to his best knowledge and judgment....''

 

FDA Halts Research on CPR Device

A device modeled on a household plunger appears to offer the first chance in 30 years to improve the generally poor results in reviving victims of cardiac arrest. Ambulances in Austria are required to carry it. Researchers in the US are forbidden to study it in a pre-hospital setting.

Active compression-decompression (ACD) CPR has demonstrably improved cerebral circulation and oxygenation in pigs. In a controlled study in St. Paul, MN, 130 patients received either standard CPR or ACD-CPR administered by paramedics. Although the overall differences were not statistically significant (the sample size was very small), patients with a known down time of less than four minutes did considerably better with ACD-CPR: more than 80% had return of spontaneous circulation and 73% were admitted to the ICU, compared with 33% in the control group (P<.05).

Researchers planned to study 260 patients, a study size with an 80% probability of detecting a 200% improvement in survival. However, the study was halted by the FDA because the subjects (being unconscious) could not give informed consent. The rules do not permit an exception from this requirement because a standard although highly ineffective therapy exists.

For failure to comply with an FDA edict, an institution or Institutional Review Board may be disqualified and subjected to civil or criminal proceedings by the Department of Justice.

Studies may continue in hospital settings if patients give informed consent on admission. Meanwhile, patients who don't make it to the hospital might be sentenced to a preventable premature death by David Kessler, et al., of the FDA. About 400,000 Americans have a sudden cardiac death outside the hospital each year. If ACD-CPR could increase survival from 5% to 10%, 20,000 Americans each year will die because of this FDA regulation.

The device, the Ambu CardioPump, is manufactured by Ambu International of Copenhagen. It is equipped with a pressure gauge easily viewed by the operator.

(See JAMA 271:1405-1411 and 1445-1447, 5/11/94, and the Wall St J 5/11/94, p. B14.)

 

An Incredible Hypothetical Flying Machine

The editorial ``Ira's Little Lie'' (Wall St J 6/8/94) describes the legal attempts of AAPS to [reveal] the names of the participants of the Clinton Health Care Task Force. They extracted only the names of some second stringers such as the Robert Wood Johnson and the Henry J. Kaiser Foundations. The only purpose of the Clinton Health Task Force was to provide a birthing place for a socialist health plan, long conceived and carried to term, just as Clark Kent's earthly parents gave him earthly presence but had nothing to do with Superboy's conception and development.

Mark Twain could have left behind a futuristic manuscript about a mob of hundreds of people without any experience in flying who called a meeting to develop a new airplane. Eventually, Mark Twain would find a fool to board such a contraption on its maiden flight, never to be heard from again. The idea to develop a new health plan by a mob of one thousand is equally preposterous.

The real antecedents of the ``Clinton'' Health Plan were conceived in Europe over a century ago and have been fine-tuned for decades. There is an uncanny resemblance to the Kombinates and Kolchoses of the Soviet Union in the 1920s, which were all- inclusive huge state farms and factories that smothered the Soviet economy into oblivion....

Even Mark Twain would have conceded that a plane conceived by people without hands-on experience must undergo testing before flying.
Andre Minuth, M.D., Fresno, CA

 

The Elders Bully Pulpit

Many Democrats fear that Joycelyn Elders, MD, will hurt their chances for reelection because of her relentless attacks on Roman Catholics, Evangelical Protestants, and traditional family values. Rep. Scotty Baesler (D-KY), former mayor of Lexington, stated: ``My constituents aren't extremists...[but] when anyone begins attacking their views and institutions as Elders has done, they're going to react.''

Led by Rep. Cliff Stearns (R-FL), 86 Congressmen drafted a letter to Bill Clinton, asking for Elders's resignation. Nevertheless, Elders survived the recent shake-up in the White House. One interpretation is that ``leftist cultural warrior Elders'' really does represent the Clinton view (Human Events

7/8/94). Another is explained by Anne Sabloff of Americans for America:

``Every time that Elders makes a fool of herself, she also sends a subliminal message to the American people that all physicians are idiots, not to be counted on or trusted. The Clintons rely heavily on psychological methods to communicate and sway opinion.'' As evidence for this analysis, Sabloff cites the lack of complaints about Rush Limbaugh's heavy criticism of Elders.

  

``Roberge would be a good one to squash and set an example.''

Jay Clement, US Army Corps of Engineers, 7/27/87


HCFA Issues Regulations To Implement ``Anti-Dumping'' Statute

On June 22, 1994, the Health Care Financing Administration (HCFA) issued an interim final rule with comment period, implementing the provisions of the Emergency Medical Treatment and Active Labor Act, 43 U.S. C. Section 1395dd, also known as the Patient Dumping Statute. The regulations, which were initially proposed and published in 1988, were amended to reflect statutory changes enacted by Congress in 1989 and 1990. The regulations became effective July 22, 1994, with some small exceptions. Physicians and hospitals will need to reexamine their procedures for compliance.

The two most significant additions concern qualifications of medical personnel performing initial screening examinations and the required reporting of suspected violations.

The statute itself provides that hospitals must, within the capabilities of its emergency department, provide an ``appropriate'' medical screening examination to any individual who comes to the emergency department for examination or treatment. Numerous questions have arisen concerning what type of personnel are qualified to conduct the examination so that it would be deemed ``appropriate'' within the meaning of the statute.

The proposed regulations contain no specific requirements concerning education or credentials for individuals conducting emergency medical examinations. They state that the screening examination should be done by individuals determined to be qualified under the medical staff bylaws of the hospital.

Commenters had expressed concern that hospitals would have to amend their medical staff bylaws to be in compliance with the regulations. In the preamble to the new regulations, HCFA has made it clear that formal amendments to either the medical staff bylaws or the rules and regulations of hospitals must be made to ensure compliance:

It is important to require the hospital to determine formally what type of personnel is qualified to perform the initial medical screening examinations because such a formal determination will insure that the hospital's governing body recognizes the ``capability of the hospital'' and is properly accountable for this function. For this reason, we believe that the delegation should be set forth in a document that is approved by the governing body of the hospital, rather than merely allowing the medical director of the emergency department to make what may be informal delegations that could frequently change. If the rules and regulations are approved by the board of trustees or other governing body, we agree that these examinations may be set forth in the rules and regulations, instead of placing this information in the hospital bylaws.

Because most hospitals provide for rules and regulations to become effective without submission to the governing body, this HCFA response illustrates the necessity for formal changes to the bylaws. Physicians sitting on the bylaws committees of medical staffs should take note of this requirement.

The second major provision of the new regulations requires hospitals receiving transferred patients to report suspected violations of the statute or regulations to HCFA regional offices and state regulatory agencies within 72 hours of the patients' arrival at the facility. A receiving hospital which violates this requirement is, like the transferring hospital, subject to termination of Medicare and Medicaid participation and civil monetary penalties up to $50,000 for each violation.

One commenter stated that the term ``suspected'' is unduly vague. HCFA agreed that the term is vague and then stated that the requirement of reporting is imposed when a hospital ``has reason to believe that a violation has occurred.''

As to the 72-hour requirement, HCFA has refused to recognize that such time is insufficient to investigate a perceived transfer problem to determine whether the complex web of regulatory requirements are satisfied, despite HCFA's recognition that particular cases are very fact-specific.

HCFA has also refused to specify when a hospital is deemed to know about a potential violation through its personnel. Therefore, it is important for hospitals and their medical staffs to review their policies and have in place a ``chain of command,'' whereby the records of transferred patients can be reviewed if personnel have reservations regarding the transfer. The existence of an in-house mechanism will enable the hospital to demonstrate good faith attempts at compliance to state and federal licensure and regulatory agencies at the time of survey and in the event of an investigation.

If a hospital transfers a substantial number of patients to another facility due to the facility's specialized capabilities (e.g. a hospital without a burn unit transferring burn patients to a hospital that has a burn unit), the hospitals should strongly consider entering into cooperative agreements with one another regarding transfer procedures to be followed in all such cases. This will help to prevent HCFA from pitting one hospital against another if questions arise.

The interim final rule with comment period can be found at volume 59 of the Federal Register, pages 32086 to 32127, which is available at any US Government Depository Library.

 

Resolutions

To be considered at the 51st annual meeting, October 13-15, Resolutions must be received by September 13. Send to Resolutions Committee Chairman Don Printz, 354 Arcado Rd Suite 4, Lilburn, GA 30084.

 

Nominating Committee Report

Chairman James F. Coy, MD, presents the following slate of officers for elections to be held at the 51st annual meeting:

President: Lois Copeland of Hillsdale, NJ
President-Elect: Don Printz of Lilburn, GA
Secretary: W. Daniel Jordan of Atlanta, GA
Treasurer: R. Lowell Campbell of Corsicana, TX
Board of Directors: John Boyles, Jr., of Centerville, OH; Nino Camardese of Norwalk, OH; Donald Quinlan of Northbrook, IL; and Joseph Scherzer of Scottsdale, AZ.

Watch your mail for registration materials. The annual meeting will be held at the Ritz-Carlton Hotel in Atlanta.


Members' Page

Confiscation

If I were to describe government bureaucracy in one word, it would be confiscation. All taxes combined confiscate nearly half of my income. The bureaucracies that govern Medicare and Medicaid confiscate about 40% of my professional time. Medicare has confiscated my ability to make professional judgment about which treatment is best for a patient....and my right to order certain appliances to help patients-like elevated toilet seats (Medicare considers them to be a ``luxury item''). The state even attempts to confiscate my thought processes by forcing me to attend state-mandated ``health courses'' designed by bureaucrats. In 1991, I had to spend three hours attending a ``child abuse'' course. Today, I had to forfeit another three hours to attend a course on infection control pursuant to ``Chapter 786 of the Laws of 1992''....Much of the first hour was spent telling us what the penalties and fines would be if we did not attend the course ....The things taught in these courses were so basic that I was embarrassed to be sitting and listening to ``medical school 101'' material, [but if I don't] the state can take my license away....

Ravaging Research

The mere threat of a socialist-style health-care reform has already caused 44% of cancer research to be delayed or curtailed, according to a study released by the Biotechnology Industry Organization. Moreover, 62% of biotech companies will make further cuts if the Clinton Plan becomes law.

The White House responded in its usual fashion by trying to tell industry that they could have made it still worse.
Lawrence R. Huntoon, MD, Jamestown, NY

 

Secure, Affordable Care with Choice Is Possible

The awesome power of tax incentives has stripped most Americans of their medical care security, affordability, and choice. Fifty years ago, to further the war effort, the govern- ment allowed employees to exclude medical benefits from their taxes. When the ``free ride'' was abused, employers moved to ``managed care'' (rationing and cost controls), instead of recognizing the offending cause....

The ``hot potato'' in the managed care system is the risk- choice link. Whoever has the financial risk will need to restrict the choice of medical care and therefore will be perceived as the villain. When physicians and hospitals take on risk, they will be withholding the medical care. Then they will be vilified instead of insurance companies.

If the tax incentive were broken-as by making all medical care 100% deductible-many patients would choose to switch their money from benefits to wages and buy high-deductible medical insurance, which they (not their employers) would own. Medical care would then be secure because it would not be tied to employers. Prices would decrease because patients would value shop. Patients who pay their own way could have their choice of the best available care....
Bert A. Loftman, MD, Atlanta, GA

 

On Community Rating

[A family can be financially ruined by lack of automobile insurance, and may be priced out of the market due to unfortunate events, such as being rear-ended by a negligent driver.]

I would propose that a National Automobile Insurance Board be created...Employers should be mandated to provide 80% of the cost of automobile insurance....A community rating for automobile insurance should be instituted, ensuring that older and safer drivers pay more, so that the youth of this country can be given some relief from the hardship the cost of this insurance imposes on them.

Why should one sector of our society pay more for automobile insurance than any other? Why should we expect our youth to carry this burden? After all, their salaries and savings are significantly lower than their elder fellow citizens, and they graciously contribute to our Social Security fund, knowing it won't be there for them when their time comes.

Automobile insurance should be a right, shouldn't it?
Robert T. Woodburn, MD, New Buffalo, MI

 

Resolutions Passed in South Carolina

The May AAPS newsletter reached me in a timely fashion. I submitted Resolutions B and C as authored by Dr. Kenneth Christman to the Horry County Medical Society. They passed virtually unanimously and were submitted to the South Carolina Medical Association, where they passed-again with a virtually unanimous vote-on May 1, 1994.
Richard W. Young, MD, Myrtle Beach, SC

 

Are Physicians Responsible?

My practice is now 5% to 10% what it once was. I attribute my predicament to the fact that I never have accepted third party payment. I still believe it is detrimental to me and to my patients to accept it.

I am convinced that the problems with medicine started with the decision of physicians to accept third-party payments. In 1962, the AMA said it was unethical for physicians to accept third-party payments. In 1963, the AMA said it was ethical for physicians to accept third-party payments....

Medicine leads the way. If we socialize medicine, all of America will follow. After that, Western civilization fails, and dictatorship and slavery are the consequence. I hold physicians responsible for the decline of America.
James H. Peoples, MD, Kinston, NC


Legislative Alert

The Political Equivalent of Pickett's Charge?

If the national health-care debate is the Gettysburg of domestic policy, then the Clinton Administration's options are being reduced to the political equivalent of Pickett's Charge, where the outcome is to be decided by a final, desperate political gamble.

After months of internal gridlock, John Dingell, Chairman of the House Energy and Commerce Committee has announced surrender. He can't get a bill out of committee-certainly nothing that would satisfy the White House. The incredible revelation that even Big John can't deliver has been sinking in over at the Oval Office.

Just before the Fourth of July recess, the Administration suffered an awesome humiliation in the full House Ways and Means Committee when Congressman Bill Thomas (R-CA) offered the original Clinton Plan as a substitute bill and called for a recorded vote. Thomas had pulled this stunt before in the Stark Subcommittee. Gibbons was infuriated. The vote was 17 to 0, with all the Democrats on the Committee voting ``present.'' Not one Democrat voted for the President's bill. Jim McDermott's ``single payer'' option got 7 votes, and the Archer mild incremental Republican substitute was defeated in a straight party-line vote.

With the indictment of Chairman Dan Rostenkowski, the Chicago Powerhouse, the House Ways and Means Committee has a slender majority, if that, for reporting out anything that resembles the Clinton Plan. The slim 20-to-18 vote in favor of the Gibbons version does not bode well for favorable floor action. To make matters worse, the new chairman based his reform on the Stark alternative that even Rostenkowski once repudiated as ``too liberal.'' The key elements of the Gibbons Bill are as follows:

  • Universal coverage for all Americans and the establishment of a guaranteed government standardized benefits package, including abortion.
  • An employer mandate, with employers paying 80 percent and employees 20 percent of the cost of the standardized benefits package. (Small business would get subsidies for up to 50 percent of their costs.)
  • The creation of a Medicare Part C program to enroll the uninsured, the unemployed, welfare recipients, and all small firms with less than 100 people if the firms opted to buy into the government plan rather than private insurance.
  • Voluntary purchasing cooperatives for the uninsured and part-time workers.
  • New government subsidies for persons with incomes at or below 240 percent of the official poverty level.
  • Changes in the insurance rules to prevent any company from cancelling or excluding individuals.
  • Price controls. If spending in any state exceeded the ``target'' level (the annual increase in the gross domestic product), and the state did not take appropriate steps, the federal government would impose fee schedules (like the Relative Value Scale) on doctors, hospitals and other providers. Unless a special commission recommended otherwise, this system would go into effect automatically in 2001 AD.
  • Financing through cuts (``savings'') in Medicare and Medicaid, an increase in the cigarette tax from 24 to 69 cents a pack, an extension of Medicare taxes to state and local employees, and a 2 percent tax on insurance premiums.

Already, the Gibbons Plan is being recognized as the foundation of national health insurance. The Congressional Budget Office (CBO) estimates that by the year 2002, the new Part C program would grow to cover between 90 and 95 million people under the age of 65. Altogether, that means that 130 million people would be under the Medicare program.

In the Senate Finance Committee, the employer mandate lost a key test vote on June 30th. Moynihan then proposed his own hybrid, which ``aims'' at universal coverage; establishes voluntary regional alliances; and establishes a less generous standardized benefit package. But under the influence of the so- called ``Rump Group'' on Senate Finance, the specifics of the benefits package can be enhanced by the National Health Board. Bradley added an amendment that would tax insurance premiums, including the premiums of self-insured plans, at a level above the standard health plan.

Moynihan's amended bill passed out of the Senate Finance Committee on July 2, in the closing hours before the recess. Clinton is being handed a fait accompli; if he accepts it, it is a humiliating retreat from the absolute, veto-based threat of ``universal coverage.'' If he doesn't, the Administration and Congress are set for a titanic battle of wills. (What ``universal coverage'' means, in the context of the current debate, is anybody's guess.)

Congress is running out of time. In the week before the July 4th recess, the pace of legislative action picked up furiously. Hour by hour, Senators met and caucused on new versions of ``reform.'' Giving up on an earlier managed competition plan, Chafee (R-RI), Durenberger (R-MN), and Danforth (R-MO) (the Senate Finance ``Rump Group'') fostered yet another option, ``the Mainstream Coalition'' package. It ``assures universal coverage'' through a ``trigger mechanism.'' If 95 percent of all Americans do not have coverage by 2002 AD, then a special commission (a mechanism beloved of the managed competition folks) will send a recommendation to Congress, and the Congress must act on the recommendations. The bill contains all of the standard managed competition entities: ``Accountable Health Plans,'' ``Health Care Coverage Areas,'' and a comprehensive standardized government health package, developed by the Commission and submitted to Congress for approval.

Senator Dole (R-KS), who has been at various places during the debate, decided to get his team together and is asking them to gird for battle. Dole's efforts now are to make sure, despite the Rump Group's latest efforts, that Senate Republicans refrain from handing the Clinton's increasingly desperate and frustrated Congressional allies a victory by default or indecision. The details of the Dole Bill are sketchy, but Senate conservatives, led by Nickles of Oklahoma and Gramm of Texas, are signing off, and conservatives still entertain reservations and suggestions to fix various features of the hurriedly thrown together bill. By July 1, some 40 Republicans Senators had signed on to the Dole draft.

The old problems of cost may plague this measure too; for the bill sets up a means-tested subsidy program for low-income people and the cost estimates are sketchy. Moreover, the Dole plan seems to set up some sort of standardized benefit for the new subsidy plan, and there is no exclusion for abortion. That has some conservatives and pro-life groups upset. Dole's staff, namely Sheila Burke, will be working overtime trying to resolve the drafting issues.

Senator Robert Bennett of Utah is the first Senator to announce that if the Clinton Plan, or any version of it, should come to the Senate floor he will launch a filibuster and try to talk it to death. Bennett called the Clinton Plan ``poison'' for the country and is asking his fellow Senators to address the causes of the cost and access problems in the current system by reforming the tax treatment of health insurance.

Some Senate Republicans fear that their opposition to the Clinton Health Plan and variants will enable the Democrats to blame them for ``gridlock'' and use this charge against them in the 1994 elections. But Senator Paul Coverdell of Georgia, among others, wants to make the 1994 elections a national referendum on the Clinton Plan.

Public Opinion

Coverdell's political reasoning is good. The polls indicate that popular support for the specifics of the Clinton Plan continues to decline, as people ask a lot of detailed questions. A June CNN/USA Today survey shows that 50 percent of those polled now oppose the Clinton Plan, while 42 percent say they favor it. A US News and World Report poll shows that only 17 percent strongly approve of Clinton's handling of the health care issue, and 34 percent strongly disapprove. If health care doesn't pass this year, 44 percent say that it will be because the Congressional Democrats are trying to create ``another government bureaucracy'' that the American people do not trust; only 28 percent say that the Republicans ``don't care enough about guaranteeing health insurance to all Americans.'' An NBC ``Meet The Press'' poll says that 37 percent of the people believe that Congress should pass a bill this year, but 57 percent believe that they should further debate the issue.

Although 53 percent would vote against a Member of Congress who opposed ``major health-care reform,'' according to a Newsweek poll, the mood of Americans changes when considering the legislative details. For example, 74 percent of Americans now believe that the health reform will lead to rationing. More Americans believe that the Clintons' Plan would be bad for the country rather than good (37 percent vs 33 percent); 77 percent think that they would have to pay more for health care; 76 percent think they would lose choices; and 58 percent think that quality would decline.

The response of the Clinton Plan's supporters to recent developments in public opinion has been remarkable. Senator Jay Rockefeller (D-WV) made the notorious statement in the April 19, 1994, edition of the Parkersburg (West Virginia) News (carried by AP) that ``We 're going to push through health care reform regardless of the views of the American people.''

It is increasingly apparent, despite White House propaganda to the contrary, that the Clinton Plan's troubles are not with Republicans. Senator Diane Feinstein (D-CA) (see July supplement) is not alone in her misgivings. Senator Max Baucus of Montana, second ranking Democrat on the Senate Finance Committee and an original cosponsor of the Clinton Plan, has been telling constituents (who are not buying Hillary's health recipe) that even though he sponsored the Plan, he does not support it. Congresswoman Louise Slaughter, a Liberal Democrat from New York and an original cosponsor of the Clinton Plan in the House of Representatives is asking Hillary Clinton and the Democratic leadership in Congress to give her District (Rochester, New York), an exemption from the Clinton Plan. And in the deliberations on the House variant of the Clinton Plan in the House Education and Labor Committee, Congresswoman Patsy Mink, a liberal Democrat from Hawaii, actually won an exemption of the State of Hawaii from that Committee's version of the Clinton Plan. When Congressman Mike Castle (R-DE) offered an amendment that would permit the other 49 states to get a waiver from the terms of the Clinton Health Plan, it was defeated in Committee by a vote of 16 to 27. Why special treatment for Hawaii? Hawaii doesn't yet, even with an employer mandate, meet the stated Clinton Gold Standard of universal coverage-about 95 percent of the citizens are covered.

White House Offense Foiled

The Clinton Team has tried to take the initiative and to define the terms of the national debate. But on the complex subjects of financing, employer mandates, the structure of the regional alliances and the role of the federal bureaucracy, the Administration has found itself thrown back, defending its huge plan against increasingly effective counterattacks. The problem for the White House team is that the rhetoric and the reality are always something different, or, at the very least, the rhetoric is what some politely call a ``stretch.''

For example, the White House team insists that all Americans are being ``asked to contribute,'' but Americans are not being asked anything. They would be forced to take a pay cut. When the White House says that businesses will be eligible for an ``insurance premium discount,'' it does not mean something offered on the open market to stimulate demand, but rather a taxpayer-financed federal subsidy.

The latest gambit is a White House media blitz that claims that it wants to give Americans the same health care that Members of Congress enjoy. The ploy is angering Members of Congress, who see it as a cheap shot at Congress. It is also giving an opening to conservatives to expose yet another Clinton Administration propaganda effort. Unlike the Clinton Plan, the FEHBP is voluntary; there are neither employer nor employee mandates. Unlike the Clinton Plan, the FEHBP has no government standardized benefits package, no National Health Board, and no premiums caps or price controls.

Ira Magaziner still works like a super wonk into the wee hours of the morning. The Clinton team may make a frontal assault with a serious Clinton-style bill, maybe the Kennedy Bill or the House Education and Labor bill-and just go for it-51 Senate votes or bust. But the clock's ticking.

Changes in Consumer Choice

Senator Don Nickles (R-OK) and 24 cosponsors have decided to modify the original consumer choice bill (S 1743), deleting the individual mandate to purchase insurance and the deductible limits of $1000 for individuals and $2000 for families. The consumer choice approach enjoys the editorial endorsement of over 130 newspapers around the nation.

Congressman Tom Petri (R-WI) has introduced yet another variation on the increasingly popular tax credit approach, ``The Multiple Choice Health Care Act of 1993'' (HR 4469). The heart of the Petri bill is to end the federal tax exclusion for employer based insurance, now estimated to reach $92 billion in 1995, and replace it with a national system of tax credits and vouchers.