Volume 63, No. 3 March 2007
“HANDS OFF OUR KIDS”
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effect and in full force until modified, amended, rescinded, or
superseded by me or by a succeeding governor.”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.
[N]ot a single large-scale information
technology project instituted by the
government has worked. The National Health
Service has spent $60 billion on a unified
information technology system, no part of
which actually functions. Projects routinely
get cancelled after $400-$500 million has
been spent on them. Modernization in
Britain’s public sector means delay and
inefficiency procured at colossal
expense.
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
