Until now, most parents have accepted incremental government intrusions into family life and medical decision-making. But Governor Rick Perry of Texas crossed the line, igniting a firestorm of protest with Executive Order RP 56.

The Order states: "Rules. The Health and Human Services Executive Commissioner shall adopt rules that mandate the age appropriate vaccination of all female children for HPV [human papilloma virus] prior to admission to the sixth grade."

Although the Texas legislature was considering bills on this issue, the Governor decided to override its authority. Irrespective of legislative action, "this order shall remain in effect and in full force until modified, amended, rescinded, or superseded by me or by a succeeding governor."

Merck doubled its lobbying budget in Texas and has funneled money (Merck declines to say how much) through Women in Government. Gov. Perry has ties both to Merck and to this advocacy group of women legislators.

"Mandates can ease doctors' concerns about ordering the vaccine," said Renee Jenkins, president-elect of the American Academy of Pediatrics (AMNews 1/29/07). Many physicians have declined to take the financial risk of stocking the expensive vaccine ($360 wholesale for the 3-shot series), as parents don't want to pay. Gov. Perry has ordered Vaccines for Children and Medicaid to pay. Additionally, Texas law requires insurers to pay for all mandatory vaccines.

A nationwide mandate would mean $4 billion in annual revenue for Merck. Some have alleged that HPV stands for "help pay for Vioxx" litigation. Unlike with drugs taken voluntarily by sick patients, manufacturers are shielded from liability arising from government-mandated childhood vaccines.

The HPV vaccine (Gardasil) protects against four of about 100 strains of a virus that causes genital warts. At least one of these four has been found in about 70% of cervical cancers. In television ads, Merck has little girls skipping rope to the chant "one less, one less" "one less life affected by cervical cancer."

"Who would be against a cure for cancer?" asked Rep. Joan Brady (R-Richland), who introduced a bill mandating the vaccine for entry to seventh grade in South Carolina, one of at least 18 states considering a mandate.

Mandates are being pushed with unprecedented speed Ga- rdasil was approved by the FDA in June 2006 and "recommended" by the ACIP (Advisory Committee on Immunization Practices) for females aged 12 to 26 in January 2007.

Though Gov. Perry likens Gardasil to polio vaccine, HPV is sexually transmitted. And there is no mandate to vaccinate the persons who could transmit the infection to the girls: men of all ages a gross departure from usual public health policy.

Merck spokeswoman Janet Skidmore called cervical cancer the "second-leading cancer among women worldwide" [emphasis added]. But in the United States, cervical cancer does not even make the top 10, and causes less than 1% of cancer deaths. In 2003, there were about 3,700 U.S. deaths from cervical cancer, compared with 68,000 from lung cancer. The incidence of invasive cervical cancer declined from 10.2 to 8.5 per 100,000 U.S. women between 1998 and 2002. The rate is 50% higher for black women compared with whites, and 66% higher in Hispanics, possibly owing to differences in follow-up for abnormal Pap smears (MSNBC.com 2/4/07). Invasive disease is rare with screening and follow-up as recommended.

HPV vaccine is claimed to be "100% effective" against cancer, based on the finding that none of 755 vaccine recipients developed CIN 2-3 Pap smear abnormalities in 48 months (Obstet Gynecol 2006;107:4-5). Duration of immunity is unknown. The longest follow-up is less than 5 years.

Safety data is limited. Fewer than 2,000 girls under 12 have been studied. "Arthritis" of some type occurred in 9 of 11,813 Gardasil recipients, compared with 3 of 9,701 women receiving the adjuvants only. (There were many fewer adverse reactions when a saline placebo was used.) It is possible that the vaccine imposes a 1 in 1,000 risk of autoimmune arthritis on little girls to "save" them from a 1 in 10,000 risk of invasive cervical cancer at age 40 the latter almost completely preventable by sexual abstinence or annual Pap smears.

Outraged parents and grandparents brought their children to an AAPS press conference in Dallas to demand that Gov. Perry rescind his Order. They are not mollified by the provision that the health department will "modify the current process in order to allow parents to submit a request for a conscientious objection affidavit form via the Internet."

"Parents should not have to get permission from the state to make informed consent medical decisions for their own children," writes Dawn Richardson, of PROVE (Parents Requesting Open Vaccine Education). Moreover, she states that the process of opting out is a "bureaucratic nightmare."

The new "Hands Off Our Kids" coalition organized by AAPS sent a letter to Gov. Perry urging him to rescind the Order, return vaccine policy to elected representatives, and allocate no taxpayer funds toward the HPV vaccine or make full disclosure of all financial interests, meetings, and negotiations that led up to the Order. The more than 60 signatories included the American Academy of Environmental Medicine; Rep. Ron Paul (R-TX); former Rep. Bob Barr; 16 Texas physicians; a number of parents and grandparents; and a broad coalition of advocacy groups.

The Order violates parental rights and privacy, overreaches executive powers, imposes an unjustified tax burden, and violates sunshine in government, states the letter.

"Take a good look at her, Governor" said one Texas mother, holding her little girl up for the camera. "You'll use her as your guinea pig over my dead body."

National Licensure?

Beneath the radar screen of most state licensure boards and medical organizations, the Federation of State Medical Boards (FSMB) is participating in summits on ways to hold all physicians accountable for meeting standards of "competence" now that experts have agreed on a draft definition of that term.

The Mutual Insurance Company of Arizona (MICA), the malpractice carrier for the majority of Arizona physicians, is concerned about increased liability. The "guidance" from Good Medical Practice USA is derived from a document published in the UK 10 years ago. Perhaps not coincidentally, the medical defense unit that insures British physicians is now technically bankrupt because of a rapid escalation in malpractice claims.

The "core competencies" in the book generally use term "must." For example, we must "adhere to national peer reviewed, evidence-based guidelines or document a persuasive case for deviating from them." And we must document "our own evaluation of the care we provide" and "perform practice-based improvement activities using a systematic methodology." We must "use information technology to manage information." At the same time, we must "utilize healthcare resources parsimoniously." We're also responsible for reporting on others: we must "protect patients from risk of harm posed by another colleague's conduct, performance or health."

The goal is evidently specialty-specific licensure with periodic, compulsory re-certification. A virtual portfolio will be collected on all physicians from medical school onward, including information from their patient records.

Sponsors include AARP, AMA, Blue Cross/Blue Shield Association, and the Robert Wood Johnson Foundation.

According to MICA's CEO, James F. Carland, III, M.D., the proposed plan makes the Clinton Health Security Act look simple. It will require a huge investment in computers.

See www.innovationlabs.com/summit. Click on "Summit IV" and then on "draft of the Good Medical Practice document" to download the Jan 10, 2007, version. Ask what your medical society is doing about this.

Britain Leads the Way

The Commonwealth Fund says that 89% of primary-care physicians in the UK use electronic medical records, compared to only 28% in the U.S. Is the government the entity to lead the health-information-technology revolution? Frank Timmins sends this link to a commentary by Theodore Dalrymple: www.city-journal.org.

Dalrymple concludes that "nothing works in the omnicompetent state." The intellectual, moral, and economic corruption of the British public service has a "profoundly catalytic" relationship to the degeneration of the national character. An epigram from deputy prime minister John Pres-cott tells you everything about the British government that you need to know: "If you set up a school and it becomes a good school, the great danger is that everyone wants to go there."

NPI (National Provider Identifier) Updates

Philip Catalano, M.D., received this note from the Medical Staff Coordinator, Manatee Memorial Hospital, in response to his questioning the need for an NPI:

"My apologies for the delay in getting back to you. I have never been presented with this question before, so I consulted our corporate office. It is my understanding that the NPI numbers replace the UPIN numbers. It is also my understanding that if you expect to get paid for your services, you would need to present an NPI number to the payer and those entities that produce bills for your services...."

Dr. Catalano concluded that the issue is purely economic, and as he is paid by patients, he does not need an NPI.

This is a note from AAPS that Dr. Catalano shared with the hospital: "The NPI is required by law for physicians who file electronic claims or who file Medicare claims. Its purpose is `administrative simplification,' i.e. to do away with the need to have multiple other numbers. It is for expediting the filing of electronic claims, and possibly to help detect fraud. It may be counterproductive for the latter purpose; at least one doctor's number has already been stolen and used to open store-front Medicare billing scams....

"Physicians who have opted out of Medicare and who do not file electronic claims are not legally required to have an NPI, nor does it serve any purpose for them. It potentially exposes them to the risk of identity theft. I am not aware of any government requirement that any private entity needs to have an NPI on file for physicians who serve on the medical staff or order procedures or laboratory tests, unless an electronic or Medicare claim is filed to obtain reimbursement for that doctor's work...."

AAPS General Counsel Andrew Schlafly writes: "The NPI is not required until May 2007, and there is talk of extending that deadline. We do not know how much pressure insurers, labs, and hospitals may be able to exert on physicians to force them to obtain NPIs. I fear that NPIs will be required as a universal physician ID, and we may not be able to avoid this. But some AAPS physicians are determined to try."

"How Can They Do This to Me?"

From Dr. William Plested, former Chair, AMA Board of Trustees, advice AAPS has given for years: "With sham negotiations, automatic reductions in reimbursement, payment denials, silent PPOs and now P4P with public reporting, signing a contract with anyone seems to be terminally stupid."

AAPS Calendar

Mar 5. Dr. William Summers, Arizona chapter, Tucson, AZ.
Jun 8-9. Thrive, Not Just Survive VI, and Board of Directors meeting, Milwaukee, WI.
Oct 10-13. 64th annual meeting, Cherry Hill, NJ.

Wal-Mart Law Violates ERISA, Court Rules

In a 2-1 ruling, the Maryland Fourth Circuit Court of Appeals upheld a challenge to the Maryland law that required nongovernment employers with more than 10,000 employees (Wal-Mart being the only example) to either spend 8% of payroll on health benefits, or pay the difference in taxes. The lower court had ruled that the law is preempted by the 1974 Employee Retirement Income Security Act, or ERISA.

The ruling "threatens to derail health-care legislation known as fair share that is under consideration in states across the country" (New York Times 1/29/07).

The special accommodation Wal-Mart would have had to make for Maryland employees was "precisely the sort of regulatory balkanization that Congress sought to avoid by enacting ERISA's preemption provision," wrote Judge Paul V. Niemeyer (Washington Post 1/18/07).

"ERISA is the barrier to creating the health care system the left wants," writes Linda Gorman of the Independence Institute. "If the public isn't educated about the benefits of ERISA, given time, ERISA will be toast."

Dr. Rottschaefer Sentenced to Five Years

After being denied a new trial, which he had requested on the basis that prosecution testimony about providing sexual favors was perjured, Dr. Bernard Rottschaefer was sentenced to 5 years imprisonment (AAPS News, Oct, Nov 2006). He also must forfeit his medical license and medical office building, and pay a fine of $12,500 and a special assessment of $15,300.

In imposing sentence, Judge Lancaster ignored the evidence of perjury and lectured on the seriousness of the offense of trading sex for drugs. In opposing a new trial, prosecutor Mary Beth Buchanan had argued that the sex allegations were not controlling in obtaining the verdict.

Dr. Rottschaefer warns of the hazards of prescribing Schedule IV substances. The 153 counts included 65 instances of prescribing alprazolam (Xanax) in a patient with the diagnosis of anxiety disorder and panic attacks.

Sham Peer Review Is State Action, AAPS Argues

In an amicus brief filed in December, AAPS asks the U.S. Court of Appeals for the Third Circuit to reverse a decision against Steven H. Untracht, M.D., Ph.D. (Untracht v. Fikri, docket no. 06- 4221). After a sham peer review, Dr. Untracht was entered into the National Practitioner Data Bank (NPDB).

The U.S. District Court for the Western District of Pennsylvania refused to address the core of the case: the unreasonableness of the hospital's action against Dr. Untracht. Though accepting riskier patients, Dr. Untracht, an exemplary surgeon, had better mortality and complication rates than his competitors. Despite the risk of retaliation, six physicians offered to testify in his behalf but the hospital refused to hear their testimony. AAPS General Counsel Andrew Schlafly argues that the procedures used to destroy Dr. Untracht were illegal, anticompetitive acts. "Peer review is inherently `concerted action' within the meaning of Section 1 of the Sherman Antitrust Act."

In denying relief, the lower court found a lack of state action. AAPS argues that the operation of the NPDB, "which operates as a blacklist,...implicates full power of the state." The "symbiotic relationship" test for state action is met when "entities are given the special authority to ruin physicians through use of a federal data base."

AAPS asks the Court to remand the case to determine whether the hospital had complied with the due process requirements of the Health Care Quality Improvement Act.

"Without meaningful judicial review of sham peer review, the hospital industry will remain in the dark ages replete with archaic techniques, rampant errors, incompetence, wrongdoing and cover-ups."

Challenging Subpoena Avoids HIPAA Violation

The U.S. District Court for the Southern District of Texas ruled that a clerk of a court is not a "judicial officer," and that Corpus Christi Medical Center Bay Area properly challenged a subpoena to hand over a medical record. Otherwise it would have been in violation of HIPAA although the law doesn't define "judicial officer." In general it means someone who can make decisions in an official capacity, such as a judge or magistrate. Some state laws are more specific (HIPAA Compliance Alert 4/10/06).

Who's Guilty of HIPAA Violation?

In June 2005, the U.S. Dept. of Justice announced that covered entities that knowingly obtain or disclose protected health information can face fines up to $250,000 and up to 10 years imprisonment. It "clarified" that the penalties applied to the entity but not to its employees. Individuals could face other penalties for identity theft, but that would require that the entity itself be indicted. In the three criminal cases prosecuted so far, however, no action was taken against the employer (AM News 10/16/06). Three employees have pleaded guilty. In the only HIPAA case that has gone to trial, Fernando Ferrer, Jr., of Naples, FL, was convicted of a HIPAA violation, identity theft, and computer fraud. The theft led to the submission of $7 million in fraudulent Medicare claims (USDOJ press release 1/24/07). His employer, the Cleveland Clinic, was not indicted. It probably has "a really good HIPAA compliance plan," and (unlike for doctors who prescribe pain medicine) "there are some good faith defenses if it is established that [an entity] didn't know what an employee was doing" (AM News, op. cit.)

Tip of the Month: Medicare carriers may have some rights to see records of their beneficiaries. But a patient who sees an opted-out physician is self-paying for the services. What right does a carrier have to demand a copy of a physician's private contract? Physicians who receive requests from carriers to see their private contracts should first inquire whether patient consent has been obtained. In at least one case, a carrier's demand to see a physician's private contract was successfully rejected because the patient did not consent.

Employees Must Be Told to Seek, Report Fraud

Under the Deficit Reduction Act, Medicaid providers receiving more than $5 million annually must inform employees and contractors in writing about their compliance program, protection from retribution if they file a whistleblower case, and potential rewards. Any physician contracted with such an entity is also affected, as it must require its contractors to adopt its rules; compliance with multiple sets of contradictory policies may be needed (MCA 1/8,22/07).

Correspondence

Clinton on ClintonCare. On the campaign trail, Hillary Clinton said she learned a lot in 1993 and 1994 and intends to turn the debacle on healthcare reform from a liability into an asset. In Iowa, Clinton "said she does not believe that the political will yet exists for a government-run, universal health- care system. Instead, she says the best way to begin moving toward health care coverage for everyone is to guarantee it for children" (Des Moines Register 1/29/07). Asked for a show of hands, her Iowa audience "overwhelmingly favored moving toward a Medicare-like system for all Americans" rather than employer-based or individually purchased insurance (Wash Post 1/29/07). The game plan put out by "the experts" running the Congressional Research Service is apparently based on a Medicare model providing coverage to the young and to the old, and gradually expanding the ages of coverage.
Lawrence R. Huntoon, M.D., Ph.D., Lake View, NY

If You're Fat, She'll "Deal with" You. Clinton told Iowans she got an insurance company to give permission for a child to get a "desperately needed" operation. "But, you know, happy as I was to be able to take care of him, I thought, `What a sad commentary that you have to go to a Senator of the United States to get the treatment you need for your child.' We're gonna change that. We're gonna have universal health care. We're gonna deal with obesity and with diabetes."
David Hogberg, The American Spectator

And If You Smoke... Thanks to Overlawyered.com, I found the latest use for clinical practice guidelines malpractice suits against physicians and hospitals who fail to "deal with tobacco use." (http://tc.bmj.com/cgi/content/abstract/15/6/447). I want to know when they are going to deny care to mountain climbers, another group addicted to a risky activity. At least the smokers don't burden the rest of us because they more than pay for their activities. The climbers cost a bundle.
Linda Gorman, Independence Institute, Golden, CO

Dealing with "Disparity." Medicare is analogous to government-run schools. Pretty soon doctors will be told to move to a different hospital to serve the special needs of disadvantaged populations, just as happened to teachers here. We could end up bussing white and rich patients to poor, black neighborhoods to foster "diversity."
David McKalip, M.D., St. Petersburg, FL

Waiting Required. I wrote to a British physician, Dr. Gordon Caldwell, to ask whether I had misunderstood his letter on New Guidance from the UK Prime Minister (Lancet 2006;368: 2124). I hadn't. Dr. Caldwell writes that for years, consultants were told to see patients as soon as possible when referred by a family doctor. But now they are paid by the Primary Care Trust commissioner only if the patient has been made to wait 8 weeks. "Daft?" he asks.
Elizabeth Kamenar, M.D., Mountaintop, PA

NICE. The June 2006 issue of AAPS News had a squib about the British National Health Service's National Institute for Clinical Excellence. It rang a remote bell. I found it. In the novel That Hideous Strength, C.S. Lewis's arch-evil organization used the same acronym for the National Institute of Coordinated Experiments. The overlap of the 1946 and 2006 versions in mission, methodology, and malevolence cannot be coincidental. Some British wag did this on purpose.
Hilton P. Terrell, M.D., Florence, SC

How "Health Care" Is Different. The automobile industry went from zero to more than 20% of the GDP, and nobody complained. Money circulated. Jobs were created. Products got better. Wealth accumulated. The difference is that individuals bought cars with their own money instead of demanding that employers or government buy for them.
Thomas LaGrelius, M.D., Torrance, CA

The New American Way. The tide to adopt socialized medical care/insurance is moving through the states. Similar tides have included light rail, convention centers, and subsidized sports stadiums. Once enough localities fall for the economic planning hokum and build these monuments to stupidity, those that don't are considered backwards and rush to follow suit. I am preparing for the damage by cutting my income to lower my tax bracket; protecting my family's economic security; and trying to take as much as I can and pay as little as I can, just as everyone else does, instead of working to help society as I have done all my life. I am proof that government spending and tax policies change behavior in ways that harm society by encouraging people to be less productive.
Craig Cantoni, Scottsdale, AZ

Mandates v. Incentives. Once you have a mandate, say to buy insurance, you can forget about the incentives because you no longer have to persuade people. Once the mandate is imposed, the government gets to define what is mandated, who may offer it, and how much they may charge. Any company that wants to offer an innovative product in Massachusetts will first have to get the blessing of the Connector. That means it must first become politically connected before it can ever connect with the marketplace: lobbyists, PACs, maybe bribes.
Greg Scandlen, Consumers for Health Care Choices