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A Case for Accountability

Bill Bysinger, writing for Healthleaders.com, March 13, 2002, says he is "amazed that most of the response to articles I write about change in healthcare comes from vendors who are trying to tell me their latest 'XYZ software or service' will make what I say happen." And, he continues that he has "finally come to the realization that it is not technology, HIPAA, ehealth, or any other single factor that will make healthcare better, only healthcare itself and those who participate in it are capable of making it better."

Mr. Bysinger advocates for medical informatics-- "the rapidly developing scientific field that deals with the storage, retrieval, and optimal use of biomedical information, data, and knowledge for problem solving and decision making." [Shortliffe et al. Medical Informatics: Computer Applications in Healthcare. Addison Wesley, 1990]. He suggests that payers "Get out of the float process and pay on time."

He makes a passionate plea for change and lists practitioners as its number one customer. See "The time for change is now: A revolutionary approach to healthcare" by Bill Bysinger, for Healthleaders.com, Millennium Healthcare News section.

For further information, please visit Guidelines/Standards of Care for Quality Management. You might want to also review the Case for Accountability on Discussion Forum (Postings)

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"N.Y. case raises question of health plan accountability; The plan says it made a coverage decision. Physicians say it was a medical decision and the plan, and its medical director, should bear responsibility."

"The AMA's Litigation Center and the Medical Society of the State of New York have filed a friend-of-the-court brief in a case against a health plan, Vytra Healthcare, that is now before the 2nd U.S. Circuit Court of Appeals. In it, the physician groups say the New York-based plan should have to answer for going against a physician's recommendation." According to Donald J. Palmisano, MD, AMA Secretary-Treasurer, the health care profession needs to be brought "back to where we ought to be… . [where the] physician and patient relationship will be one where the physician and patient discuss the treatment options and the patient rejects or accepts the treatment." [The American Medical News, Government & Medicine Section, March 11th, 2002].

This very point is the proximate reason why hospitalists have been a successful addition to the medical armamentarium to the point where patient acceptance and doctor lifestyle impact are overwhelmingly supportive of these programs.

The successes of hospitalist programs can be compared to the failure of "micromanagement" in the same context.

· In hospitalist programs, physicians work with primary care or referring physicians as peers to manage hospitalized patients. This has been so well accepted that it is now rare for a hospitalist program director to have to decide whether all patients who belong to a given medical group's practice or a health plan should be admitted and managed during the hospital episode exclusively by a hospitalist.

· In "micromanagement," nurses apply criteria to whatever can be gleaned from the medical chart. This is done telephonically or onsite. They report their "findings" to a medical director, who by definition and by law is not the treating physician. If the reviewed service or venue does not meet criteria or does not seem appropriate to the medical director, that care is "carved out" or denied. The patient and treating physicians are told they have the right to appeal, after the fact. As one can imagine, this can be very upsetting to patients and treating physicians alike, and it comes at a most inopportune time-when the patient or their physician are in need.

You may send me an E-mail: fitdoc@sprintmail.com to request a complete Policy and Procedure for a Hospitalist program, complete with medical management problems and solutions, anticipatory guidance and a 2 page, 2-sided brochure

Re: Weight Loss Drugs, I need to repeat the obvious: one looses weight if one burns more than they take in as calories-regardless of the source of the calories and regardless of the type of exercise, be it formal or just moving more each day.

Now, here is something about the pill approach by Bruce Japsen, a Chicago Tribune staff reporter who writes in a piece entitled: "Diet drugs failing to pull weight; But Abbott, others stick to their goal", February 26, 2002, New York (paraphrased). Remember American Home Products Corp.'s fen-phen pill combination that proved disastrous when it was linked to heart damage? (Over the last two years, they have had to take $13 billion in charges to compensate former users and their families.)

Nevertheless, while Abbott's Meridia (a potential a genomic solution) and Roche AG's Xenical (that blocks the absorption of fat) have not lived up to expectations as they afford only modest weight loss and realized under a $billion in worldwide sales, now Abbott and Millennium Pharmaceuticals Inc. (Mass., USA) have a new offering-MLN4760, targeted for a market estimated to be worth more than $30 billion annually. It is derived from the human genome and it works by blocking carboxypeptidase, an enzyme that may play a role in regulating fat metabolism (meaning it causes a net burning as opposed to storing fat).

"'No drug exists today that brings people to an ideal body weight,' said Dr. Samuel Klein, director for the Center for Human Nutrition at the Washington University School of Medicine in St. Louis. 'Everybody is looking for medications because it's hard to change lifestyles to eat right and exercise more.'"

"Still, analysts caution about too much excitement over MLN4760 because it could be five to seven years before the genomic drug has even completed human trials. Given the fen-phen debacle, drug companies expect the U.S. Food and Drug Administration to be especially cautious." Nevertheless, other drug companies are joining the foray: Genset S.A. (Paris), Bayer AG (Germany), and CuraGen Corp., CT, USA).

Also, Abbott now appears to be moving away from direct-to-consumer advertising to market Meridia direct-to-doctors (primary-care physicians and endocrinologists) intending that "obesity will be treated more as a medical problem than as a cosmetic or lifestyle issue. The Meridia campaign was launched by BASF AG's Knoll Pharmaceuticals unit, which Abbott bought last year for $6.9 billion… . [S]ales had been flat until the company began 'medicalizing the drug,' said Dr. Jeffrey Leiden, president and chief operating officer of Abbott's pharmaceuticals group." He added that "Even modest weight loss reduces medical risk … .If you lose 5 percent of your body weight ... medical treatment really makes a difference," he said.

Hollywood takes on health insurance
" The day before the movie opened, the American Assn. of Health Plans began running full-page ads in Washington, D.C., and Hollywood newspapers declaring that 'the fictional character John Q. has the wrong answer for America's health care cost crisis.'"

"It seems the film has struck a raw nerve with managed care executives, who learned four years ago with the release of "As Good As It Gets," that slamming their industry can play very well with movie-goers. In that film, actress Helen Hunt called HMOs a string of obscenities, and movie audiences cheered with gusto, revealing a groundswell of anti-HMO sentiment."

Now, in another election year, another film contains a troubling message about America's health care system, however, "[T]his time the message is that not just HMOs but the entire system is in need of reform. The question remains whether the film will spur action in Washington." (See Myrle Croasdale, AMNews, Feb. 25, 2002)

"What about other widely pushed tests? Some are controversial. For instance, studies are mixed on just who benefits from prostate cancer screening since there's no good way to tell if men have a type of tumor that needs immediate therapy or not.... For now, the Task Force advises men to discuss this one with their doctors. For bone-crippling osteoporosis, doctors argue over just which bone test to use, much less who needs it when. But if the doctor is counseling women about proper weight, nutrition and exercise, ``you're already treating the problem''.... Specialty groups urged screening for diabetes as early as age 30 plus a list of other tests to catch such ailments as thyroid or kidney disease." Reference: HealthLeaders 2.20.02

I want to offer a silver lining for most kids who get colds from day-care
A long-held theory among some pediatricians is that early exposure to common viruses that cause upper respiratory tract infections (URIs), while inconvenient, confer some immunity for later.

In a study, referenced below, children in large (more than 6 kids) day-care centers had nearly twice the colds at age 2 years as those cared for at home, but at age 6-11 years, they had about 1/3 fewer colds. However, this immunity advantage disappeared by age 13 years.

February, 2002's Archives of Pediatrics and Adolescent Medicine

Jeff: Do you have a copy of the Satisfaction Survey that you wrote to evaluate HMO's with? I believe it was directed toward physicians but perhaps it was employers. If you could send an electronic copy, I am interested in proposing to _ _ _ that we seek feed-back from employees on their interactions with our carriers as a means to make HMO's more accountable for their actions. I just went through a nightmare situation with U_____ Health Plan over payment for a mammography, and I ran into two other women at work who had had the same thing happen to them. How does the employer know what they are getting for their money? -MAK

Response: No, the Satisfaction Instrument was part of my Master's Thesis: "A Comparison of Prepaid Health Care and Socialized Medicine in Terms of Patient Satisfaction." However, I worked on something for you. Please click Anatomy of a Denial

ChemoBrain--"One survivor used this term in the context of: "I can't keep my head straight." At the time, I did not think chemo-brain was real; I thought they imagined they suffered an injury to their brain... .

Response: There is only imperfect statistical evidence that exercise improves therapeutic outcomes. Without question, it is vital for the quality of life and for handlng the bio-psycho-social stress of the disease. Furthermore, in my experience, psycho-social support may decrease the real or perceived need link for outpatient services.

We were at dinner, and I reacted poorly to my friend's returned habit; I stated, unabashedly that this was no Faustian bargain--I declared that smoking is worse for your health than obesity. Well, was I wrong?

In a study reported in the Associated Press, March 12, 2002 (Washington): "Obesity Increases Health Costs More Than Smoking," it stated: "Obese Americans spend more for health care and medications than smokers, largely because the extra weight causes the same jump in chronic health problems as does 20 years of aging." Nevertheless, I was also partially correct: "While tobacco is still the nation's chief cause of preventable deaths, the surgeon general warned in December that obesity was running a close second."

Economist, Roland Sturm of the Rand Corporation previously had contributed the following notion to the literature: "Obesity is highly prevalent and associated with at least as much morbidity as are poverty, smoking and problem drinking." [Sturm R, Wells KB. "Does obesity contribute as much to morbidity as poverty or smoking?" Public Health 2001 May;115(3):229-35]. In the March, 2002 volume of Health Affairs, using two national health surveys, he has estimated that inpatient and outpatient health services by the obese are greater than by tobacco users.

• When it comes to long-term health problems, being obese is worse with 36% increased health care costs and 77% increased medication costs. Smoking was 21% and 30%, respectively.
• Obesity contributed to a decline in quality of life at nearly four time the rate of smoking or alcohol abuse
• Only by aging two-decades (going from age 30 years to 50 years) brought similar health effects and costs.
• But, tobacco users may die sooner, largely because lung cancer can kill more quickly than some common obesity-linked diseases.
  

R. Sturm. Health Affairs, March, 2002 as reported in the Associated Press, March 12, 2002 (Washington, DC).

There's a new wrinkle in the old question of why smokers' faces are prematurely lined. See this Intelihealth article

Bush and Public Health
"With vacancies already at the NIH and the FDA, the Surgeon General's departure has many health advocacy groups concerned." Dr. Satcher's articulating scientifically-based health policy analysis gained the admiration of advocates while placing himself at odds with some Bush administration policies, like gun control and teenage sex. For instance, he questioned if programs that stress sexual abstinence for teens actually delay sexual activity. Do you agree?

'I Don't Know' Is What Your Doctor Is Sometimes Saying
By Robert H. Shmerling, M.D. Beth Israel Deaconess Medical Center, Jan. 23, 2002, InteliHealth Health Focus article

"My infant had a croup spell and he's only 3 month's old. I heard that if they wheeze in infancy, they'll have asthma, later. Is that true?"
Response: Here's a recent piece on the subject of Wheezing Worries
jgk 1.25.02

Oh, My Aching Back "Dr. K; my back has gone out. I'm better now, but what can I do to prevent this from happening again?"

Costs and Value

Policy Cost-Effectiveness
"In general, policy cost-effectiveness is always less attractive than treatment cost-effectiveness. Consequently trying to improve the uptake of underused cost-effective care or reduce the overuse of new and expensive treatments may not always make economic sense." This article presents a method for calculating policy cost-effectiveness of educational outreach by community pharmacists to influence physician prescribing in England.

From a 1997 and 1998 trial (England):
 1) Angiotensin-converting enzyme (ACE) inhibitors are underused in the care of patients with heart failure.
   a) Economic Message: Patients with heart failure not treated with an ACE inhibitor are denied a cost-effective treatment valued at $2156 per life-year gained. Costings, originally conducted in pounds sterling, have been converted to US dollars (£1 = $1.50) for ease of exposition."
 2) Newer classes of antidepressants have achieved widespread first-line use without demonstrating added value.
   a) Economic Message: Every patient with depression treated first-line with a selective serotonin reuptake inhibitor (SSRI) instead of a tricyclic antidepressant costs an additional $75 per episode without demonstrable clinical benefit."

For a robust estimate of the "cost and impact of alternative methods of behavioral change, and understanding of the local organization of health care," click here.
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From: Mason J, Freemantle, N, Nazareth I, et al. When Is It Cost-effective to Change the Behavior of Health Professionals? JAMA. 2001;286:2988-2992.

Disease Management costs vary greatly depending on such things as the medical condition, the stage at which it presents, risk-shifting (e.g., disease management carve-out programs), cost-sharing arrangements (e.g., co-pays and deductables, population demographics, access to care, etc. So, don't quote me, but some numbers bantied about indicate a per member per month cost of $300 for CHF, $110 for COPD, $70 for asthma, $35 for high risk pregnancy and $20 for diabetes.
Example: The Economic Burden of Pneumonia or the opportunity of Beta-Blockers Post-op to reduce morbidity and mortality.

When is it worthwhile to change provider behavior?

Press Release (1.2.02): 35.5% Reduction in Heart Attack Incidence even while reducing invasive procedures per Bob Mosby of QMed, Inc. (804) 359-5054, a disease-state management firm and CHA Health. Information received via Managed Care Magazine's DMFORUM

Osteoporosis 12.28.2001 7:10 A.M.
Jeff, I would love to get your views/ experience /recommendations on the diagnosis/screening / treatment of osteoporosis.. Let's narrow it down to peri/post menopausal women first .. thanks...would also be interested in your wife's views [Kaplan's wife's a 10-year breast cancer surviver and patient advocate.
H.K (California, Radiologist/Nuclear Medicine).

Reply: Great question - In response, I put a piece out on the Guidelines page including a nationally recognized protocol.

"Those who continue to believe an old adage--health care is recession proof--have little understanding of health care in America today; unfortunately, health care professionals are not insulated from this naive view, either. Yes, people get sick and injured in good economic times and bad - but the need for medical care is not linked solely to demand. The reality is that access to and demand for medical care is inexorably linked to economics - the ability to pay. If this were not so, then the 43 million uninsured Americans would be a non-issue.

Analysis of past recessions shows a pattern of predictable behavior and response to worsening economic times by patients, employers and health plans.

Employers: Health benefits in this country are driven by the employer. A recession, an increase in unemployment rates, strengthens the employers' hand, not in negotiating better pricing from payors, but in forcing employees to accept higher cost sharing of health premiums and accepting reductions in benefits. As one HR executive has said, "Nothing like a spike in unemployment to take the arrogance out of a workforce." Full employment meant that employers competed to find and keep a workforce, increasing company cost in wages and benefits. Recession - be thankful you have a job, and by the way your health benefits are going to, 1 - cost you more or, 2 - be curtailed

Health Plans: Driven by fear of reduced enrollment, resulting from layoffs and company closings, health plans press for higher rates. This is not the time to "buy" market share. Market share based on lower prices in a recession is temporary growth, and makes increases when the economy improves harder as employers tend to shop around more when they have money. Employers grumble, but pass the costs down to employees, so they willingly share the pain.

Knowing that a recession reduces the pool of the insured, and a general understanding that cost pressures decline, payors resist demands for rate increases by hospitals and physicians. What physician wants to further reduce their patient base as insured (paying) patients are lost to unemployment and no benefits? As other cost pressures decrease, from fuel to supplies, plans see this as added justification to constrain fee increases. No one expects to pay more in a recession. Historically, recessions have been the time of the greatest increase in health plans profit margins.

Medicare: For the first time in many years, the benefits of a recession, lower fuel costs, rents, and other pressures on costs have worked into the formula for calculating the Medicare conversion factor (the rate multiplied by the RVUs to get the fee per CPT). With more than 50% of insurance plans fees tied to current year Medicare, some health plans are predicting a windfall. (Most health business is tied to a specific base year). The reduction this year is an average of 5.4%, netting to 4.8% with added procedure coverage. Note: there are significant variations among specialties.

Patients: Prior to job loss, reduced demand for medical care. No one wants to be out of the office when they decide who to layoff. Disposable income is hoarded, reducing elective (non-covered) services, plastics and infertility for example. Once laid off, a spike in demand for covered services before benefits end. After benefits end, self-care, delay, and worry.

Any thought that COBRA, the ability purchase health benefits on your own, will be the norm, assuring continued insured coverage is denial of the reality that insurance premiums can run upwards of $1,000 per month for a family. This with unemployment benefits of may be $500 a month.

For those with insurance, the higher out of pocket costs, higher deductibles, and other cost sharing, will restrain patient use, ask for out patient over inpatient, and seek out providers that take their health benefits, without cost sharing. Less interest in POS benefits with 20% co-pays. And selection of more restrictive benefit packages to lessen the out-of-pocket costs and premium cost sharing. (Example, growth of Oxford's Liberty Plan--coverage with more restrictions)

Things To Do and Consider
1. Be sure to re-verify insurance coverage and benefit levels - they may have changed between visits. Did the patient move from a POS to a HMO with required referrals?
2. Collect co-pays and deductibles up front when ever possible. Swipe a credit card and hold it as assurance against lack of coverage.
3. Review your billing processes. Watch your receivables. Become less tolerant if you have not heard from a health plan. You want the denial as promptly as possible so you re-bill, appeal or seek collection from the patient. Have a signed statement for individual patient financial responsibility. Reviews of physician billing practice indicate that 11-20% of revenue is lost by bad billing practices, including late filing. Expect plans to tighten their requirements. Reconsider your billing company and arrange for a collection process that is appropriate
4. Consider your mix of revenue sources. Now might be the time to add contracts to be in a position to attract patients that continue to have insurance coverage.

Reproduced with permission of the author, Robert Goff, Executive Director, University Physicians' Network, NYC

Pay Negotiations-The Empowered Physician
Editorial: "Medicare pay cut: Contact your lawmakers now Physicians should let their legislators know now that they need relief from Medicare's outlandish payment update." This appeared in the American Medical News, an AMA Publication, December 3, 2001. On December 17, 2001, they posted "Information; the Physician's Ally In Securing Equitable Pay." This piece makes a business case for measurement of variation and for proper incentives.

Blended Payment Methods in Physician Organizations Under Managed Care James C. Robinson JAMA. 1999;282:1258-1263

Dr. Kaplan, do you think patients' interests are placed first?

"A decade ago, the American Board of Internal Medicine (ABIM) began a campaign to shore up physicians' 'special place in society.' Citing eroding professional standards inside medical schools and out, ABIM published a number of reports and guidelines defining and encouraging professionalism. The movement spread as other groups expressed similar distress, coalescing 2 years ago as a project driven by the ABIM Foundation, the American College of Physicians–American Society of Internal Medicine Foundation, and the European Federation of Internal Medicine. The first fruits of the project have arrived as a charter outlining the ideals 'to which all medical professionals can and should aspire.' The charter is scheduled for widespread dissemination early next year [in 2002].

Physician Charter of Professionalism
Fundamental Principles
* Primacy of patient welfare. Altruism contributes to the trust central to doctor-patient relationships. Market forces, societal pressures, and administrative exigencies must not compromise this principle.
* Patient autonomy. Physicians must be honest with patients and empower them to make informed decisions about treatment.
* Social justice. Physicians should work actively to eliminate discrimination in health care whether based on race, gender, socioeconomic status, ethnicity, religion, or any other social category.

A Set of Commitments
* Professional competence. Physicians must be committed to lifelong learning. The profession, as a whole, must strive to see that all of its members are competent.
* Honesty with patients. Physicians must ensure that patients are completely and honestly informed before consenting to a treatment; they must be empowered to decide about the course of therapy. Physicians should also acknowledge that medical errors that injure patients sometimes occur. If a patient is injured through error, he or she should be informed promptly, since failure to do so seriously compromises patient and societal trust.
* Patient confidentiality. Fulfilling the commitment to confidentiality is more pressing now than ever before, given the widespread use of electronic information systems for compiling patient data.
* Maintaining appropriate relations with patients. Physicians should never exploit patients for any sexual advantage, personal financial gain, or other private purpose.
* Improving quality of care. This commitment entails not only maintaining clinical competence, but working collaboratively with other professionals to reduce medical error, increase patient safety, minimize overuse of health care resources, and optimize the outcomes of care.
* Improving access to care. Physicians must individually and collectively strive to reduce barriers to equitable health care.
* Just distribution of finite resources. Physicians should be committed to working with other physicians, hospitals, and payers to develop guidelines for cost-effective care. The physician's professional responsibility for appropriate allocation of resources requires scrupulous avoidance of superfluous tests and procedures.
* Scientific knowledge. Physicians have a duty to uphold scientific standards, to promote research, and to create new knowledge and ensure its appropriate use.
* Maintaining trust by managing conflicts of interest. Physicians have an obligation to recognize, disclose to the general public, and address conflicts of interest. Relationships between industry and opinion leaders should be disclosed.
* Professional responsibilities. Physicians are expected to participate in the process of self-regulation, including remediation and discipline of members who have failed to meet professional standards.

Annals of Internal Medicine's Harold Sox, MD, Discusses Physician Charter of Professionalism (JAMA. 2001;286:3065-3066)
© 2001 American Medical Association. All rights reserved.

Guest Editorial
Thinking of Dropping Health Plans and Trying to Gain by becoming an "Out-of-Network" Physician?
--FIRST, READ THIS--
I am often asked what are the implications of dropping a health plan, such as Blanket-y-Blank insurer (payer, HMO, etc.), and accepting the reimbursements of "out-of-network" (OON) benefits that sometimes are greater than par reimbursement?

The decision to participate or not is an individual one. I can make no recommendations, but before you make a move, you should consider not only reimbursement, but also the potential impact on your referral sources and your patients.

Not all payors offer OON benefits as part of their products. Within each health plan some patients have such coverage and some don't. It is also not uncommon for an employer to motivate employee choice by increasing cost-sharing of health benefits when premiums increase to the disadvantage of the patient in choosing out-of-network coverage.

For those plans that offer products with such benefits and for patients that have it, the financial impact is mostly on the patient. Deductibles and co-insurance apply. The deductibles can run up to several thousand dollars in some plans and co-insurance payments can be 20-30% of the allowable fee level. The patient is 100% responsible for the amount over the allowable fee level. Importantly, hospitalization coverage may be limited or restricted. Some plans will not provide coverage for admission by a non-par, for non-emergencies, while others impose significant deductibles and co-insurance.

Patients without OON benefits or with a high out-of-pocket cost to use such benefits could be lost from the practice. Depending on the individual's disposable income, they may be motivated to choose other physicians to avoid these costs.

If the reimbursements to the physicians are higher for out-of-network benefits, some physicians have suggested that they "write-off" the co-insurance. (If you were to agree to accept only what the insurance reimburses, you could loose your entire fee to the deductible).

Sounds good, but it's not legal. There are insurance fraud implications as the plan has a liability based on a percentage of the bill. For example, if the plan covers 80% of a $1,000 fee, and you waive the $200 co-insurance, the plan is liable for 80% of $800. You and the patient have perpetrated insurance fraud. Financial need may dictate the allow ability of a write-down or write-off, but routinely raises the specter of fraud. Furthermore, writing off Medicare co-pays, except in cases of documental financial hardship, is a "hot button" for HCFA/CMS auditors.

Robert Goff
12.11.2001

-----Original Message-----
From: Jeffrey Gene Kaplan, M.D., M.P.S.
Sent: Sunday, November 18, 2001 5:54 PM
To: Stan Mehr (Editor in Chief, Medicom International, Inc.)
Subject: RE: HIPAA and Access to Data for Research

In "Reintegration of Disease Management" (latest issue of Managed Care Interface, p. 8), you say: "Under HIPAA, patients must consent to the use their personal data, even in aggregate analysis." I would imagine this point of view comes from the regs. To paraphrase: Health care providers are required to obtain patient consent before sharing information for the purposes of treatment, payment, and/or health care operations, and patients can request restrictions on the uses and disclosures of such information.

While I admit that there may be a breech revealing even sanitized (i.e., it has been stripped of all personal identifiers) and aggregated data, that breech will not be material, so long as one cannot identify the patient. To preserve privacy means anonymity, and to have anonymity in this context, one needs enough data in the cohort or, importantly, in the subgroups of the published data, to hide the identity of the individual patient; one should not be able to figure out who the patient is even through correlational analysis and deduction. This breech might, however, be material with the obverse-if one can discover or infer who the patient is by examining the data.

So, my take on HIPPA [J. Kaplan. "Confidence in Confidentiality: The Role of the Privacy Officer" Managed Care Interface. October 2001; 4(10):71-75.] is different and, perhaps, more forgiving and rational. That is, to be in compliance with HIPAA does not suggest that all data aggregation and meta analyses, etc. must be constrained, bureaucratized, and, thereby made onerous. Moreover, in this context, if we use common sense and proper research practices, the protections patients need should be possible without having to obtain a waiver or place great burden on the health care system

For you reference, here are HIPAA's stipulated Waiver criteria:
(A) The use or disclosure of protected health information involves no more than minimal risk to the individuals;
(B) The alteration or waiver will not adversely affect the privacy rights and the welfare of the individuals;
(C) The research could not practicably be conducted without the … . waiver;
(D) The research could not practicably be conducted without access to and use of the protected health information;
(E) The privacy risks to individuals whose protected health information is to be used or disclosed are reasonable in relation to the anticipated benefits if any to the individuals, and the importance of the knowledge that may reasonably be expected to result from the research;
(F) There is an adequate plan to protect the identifiers from improper use and disclosure;
(G) There is an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law; and
(H) There are adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart." [HIPAA, Part 160; General Administrative Requirements § 164.512, Section (i)(2)]

I submit that the key points HIPAA makes about a health care organization's responsibilities in handling protected health information vis a vis research:
1) Determine if the health information is, in fact, the type that must be protected.
2) Compare your current procedures for disclosure of health information with the proposed privacy standards. For instance, does your organization account for all disclosures of protected health information for purposes other than treatment, payment, or healthcare operations? Are individuals allowed to inspect and copy their health information? Are reasonable fees charged for this? Is there a procedure in place to allow individuals to request amendments or corrections to their health information? Is there a mechanism for individuals to complain about possible violations of privacy? Do you have a designated privacy officer?
3) Evaluate the audit trails on your existing information flow; these must record every access (including read-only access) to patient information. That is, it is no longer sufficient to record only additions or deletions to electronic information. Can your information system help you analyze large amount of data flow and flag suspicious exceptions or patterns for further evaluation.
4) Your contracts must ensure that your business partners also protect the privacy of identifiable health information. Review/revise existing vendor contracts to assure HIPAA compliance.
Jeffrey Gene Kaplan, MD, MPS

Response from Medicom International:
Jeff: Thanks for your comments on my editorial. (I can't publish though; I have a firm policy against letters to the editor from members of the Editorial Board--it seems to our readers that we don't generate enough letters from our readers--which we don't!) . The point I was trying to make was that if an organization is to comply with the intent of HIPAA, it will have to obtain all patients' consents at the time of contemplating data use (as a practical and legal precaution). Therefore, whether or not the information ends up being de-identified before use, they will be covered. Regardless of whether the breech is material, health plan counsel will demand that releases are obtained; they would not be doing their jobs if they suggested otherwise.

Mammogram Debate--Breast Cancer Screening

"Major Study Reaffirms That Regular Mammograms Save Life" (sic). March 14, 2002. Does this, finally reestablish the value of routine mammography as a screening test in that it reduces breast cancer death rates by about 20%. [From Intelihealth]

Letter to the Editor
The New York Times; February 3, 2002

On behalf of 19 major cancer organizations, we are deeply concerned that ongoing discussion in the press about the value of screening mammography ("Uncertainty Over Mammograms," editorial, January 27) might discourage women from having appropriate examinations. Scientific debate on critical issues like this is common, but well-established guidelines must be followed unless there is compelling reason to alter them. Many analyses, including a new study published in The Lancet this week, have found that mammograms are life saving. Several other thorough reviews are under way. Because it is vital to consider all evidence and analyses in assessing the usefulness of mammography, we are planning to meet in February with other breast cancer experts-physicians, nurses, statisticians, epidemiologists, and patient advocates - representing prominent professional, government, and patient organizations. Until carefully thought-out recommendations based on all available information can be offered to the public, we strongly urge all women to follow the advice of their physicians and obtain mammograms per current guidelines.
LARRY NORTON, M.D. President of the American Society of Clinical Oncology.
New York, Jan. 31, 2002
This letter was co-signed by 19 organizations; their names are listed at www.nytimes.com.
American Cancer Society
American College of Obstetricians and Gynecologists
American College of Surgeons
American Society for Breast Disease
American Society of Clinical Oncology
American Society for Therapeutic Radiology and Oncology 800-962-7876 breastcancer.org 610.658.0734 Breast Cancer Research Foundation 646-497-2600 or toll-free 866-Find A Cure
Cancer Care
Cancer Research Foundation of America
Living Beyond Breast Cancer
National Alliance of Breast Cancer Organizations
National Medical Association
Oncology Nursing Society
Sisters Network, Inc.
Society of Gynecologic Oncologists
Society of Surgical Oncology
The Susan G. Komen Breast Cancer Foundation 800-I'm-Aware
Y-Me National Breast Cancer Organization
Musa Mayer mailto:musa@echonyc.com

It would be premature to abandon a screening tool that they, the Officials from the National Cancer Institute and the American Cancer Society believe saves the lives of many women.

"But the judgment rendered by the expert panel this week makes it imperative that both organizations re-examine the evidence closely and not simply go into a defensive crouch… . Mammography has been so strongly endorsed by the cancer establishment and has become such a significant source of revenue and patients for many hospitals and doctors that it may be difficult to excise without overwhelming evidence that it is dangerous. Officials at the National Cancer Institute are said to be reviewing the matter. The institute's new director, Dr. Andrew C. von Eschenbach, needs to make it a priority." The New York Times Co. January 27, 2002

"Expert Panel Cites Doubts on Mammogram's Worth" By Gina Kolata, Rockville, MD. (Jan. 23, 2002).

"The issue of whether women should have mammograms has been controversial for some time, and now an independent panel of experts on evidence-based medicine-the P.D.Q. Screening and Prevention Editorial Board, is raising doubts that mammograms prevent breast cancer deaths. Citing that seven large studies of mammography had serious methodological flaws, they have reversed their and the National Cancer Institute position of 1977 that the evidence showed that mammograms prevented breast cancer deaths starting at age 40. Indeed, the institute's Web site, www.cancer.gov, still says that women in their 40's and older should have the test and that it reduces the breast cancer death rate by as much as 30%."

"The researchers said none of the studies found that mammography prolonged life, and even when the studies were analyzed as a group, women who had the test lived no longer, dying of diseases other than breast cancer. The P.D.Q. board said it would like to see others take on a detailed and independent analysis of the mammography studies and that some of the data that might settle questions about the quality of the studies could be obtained with difficulty. However, the P.D.Q. board is emphasizing that mammograms may have drawbacks, at times leading to excessive tests and/or treatments (mammographies, biopsies, surgeries and the like) for tumors that would not have threatened a woman's life. The group agreed that doctors should respect a woman's informed decision."

Here's what my 'other half,' Marie, a breast cancer advocate, had said about Deductibles and Co-pays for Mammograms
January 27, 2002 Press Conference Statement

"My name is Marie A. Kaplan; I am a 10-year breast cancer survivor. In 1994, while living in Western New York, I began my career as an advocate for breast cancer research and treatment. I have volunteered throughout the State of New York and have met many women who cannot afford a mammogram; in some cases, they have even have asked me where they can get a free mammogram in their area as they are unwilling to choose their own health needs over their family's."

"Three-years ago, I spoke about the issue of women who cannot afford the co-pays and deductibles for screening mammography. Here I am, again, in a different venue wondering why we have not solved this outrageous inequity-the de facto creation of a financial barrier to a standard of care. It is known, for instance, that finding breast cancer early can allow breast-conserving therapy."

" As someone who has survived cancer, twice, I cannot help but follow the current guidelines to have this test; why cannot all women? It is time for the New York State Senate to pass the Women's Health and Wellness Act to get these financial barriers to care, eliminated. They've had four (4) opportunities to do so, and have not-we need Liz Kruger in the New York State Senate. I thank you for your consideration."

This web site began its discussion on this subject, earlier: Thursday, November 01, 2001

Subject: Jeff: I read the comment on screening mammograms with interest. I had read the info that less than 50-years of age showed poor outcome but more than 50-years showed a need for screening routinely...the big question and to really provide a service is if you downplay screening mammography, then what alternative do women have to be diagnosed at an early stage? I care because I'm one of those women who goes in yearly....no breast cancer in my family. .....Liked your website :) MAK

JK (Responding): The debate about the value of screening continues, and like the elevated PSA when screening for prostate cancer, one has to prove that early intervention helps. However, it is antithetical and almost callous to think otherwise (according to the theory of cognitive dissonance). It is logical that cancer be detected early, especially since therapies are in a constant state of evolution. Moreover, one cannot argue that if a breast cancer is found early, breast conserving therapy is more likely.

November 3,2001 Jeff: I went to see my doctor and my "white coat hypertension" kicked in. I told him that I monitor my B.P. at home and at the most, the systolic (upper reading) is 140. Nevertheless, he out me on an ACE inhibitor and I had tons of side effects. What am I supposed to do?

ANS: Larry: White Coat Hypertension is a real phenomenon and, if that is the correct diagnosis for you, by definition your B.P. is usually normal. It is also normal (per Dr. Hans Seyle, father of Stress Theory) for your B.P. to rise when stressed, at times. Why take a medication that you do not need? This is controversial. For example, in th December 10th issue of The Archives of Internal Medicine, a study by Dr. Anna Grandi and colleagues at the University of Insubria in Varese, Italy, found that though the changes found in white-coat patients weren't as significant as those in patients with true hypertension, they suggest some strain is being put on the heart. This may (and I only say MAY) increase the risk of developing cardiovascular disease, including heart attacks, down the road, according to Dr. Daniel W. Jones, hypertension director at the University of Mississippi Medical Center and an American Heart Association spokesman. [InteliHealth's AP Health News 12.11.01) While the study is not the first to link the condition with heart abnormalities, it is perhaps the most convincing, Jones said. "It's the strongest evidence that we have to date regarding office hypertension" and its risks, Jones said. "The evidence looks persuasive."

National Institutes of Health hypertension guidelines have no definitive recommendations for treating white-coat hypertension, leaving it up to doctors to decide whether to prescribe treatment, including medication. Therefore, the doctor may side with putting you on medicine or he may recommend lifestyle changes and care monitoring.

Please also take a look at "Stress Management for Patient and Physician" and articles on Anxiety Disorders

Disease Managing with less Disease Managers
November 4, 2001
Dear Dr. Kaplan:
I want to learn how to manage my chronic condition on my own.

Response: Take a look at Medicom International's publication

Also, from the the Disease Management Association of America (DMAA), here's a working definition of Disease Management

NOW, there is another problem with M_______l and I am really scared...My daughter took him to the doctor today for a regular check-up. It seems he has lost a little weight, his hands and feet were purple (*which usually happens when he's cold, but he had been inside for about an hour)...they want her to stop nursing, try to feed him more often and come in next week...and of course there is still the head concern...I think he looks short/almost stunted with a large head, but of course I didn't say anything to my daughter...he is crying much less, very alert, active, starting to turn over but I am scared...what does the doctor think, HONESTLY?

Response: On my web site, bcause of your question, I have placed a link on the "Links" page (Cick "Health Sites" to go to Growth Charts from the . With a little training, you can plot the growth, weight gain and head circumference changes that your pediatrician or family practice practitioner provides. Hands and feet getting blue is usually "acrocyanosis," a benign condition where the blood is shunted from the periphery (hands and feet) to the vital organs (brain - GI track)

October 22-26, 2001:

Forum on Perceived Unfair Payment Practices:

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Taxation Without Representation Examples

A) A member has been transferred and the HMO takes back 4 months of cap payments. In this example, the doctor closed their practice, duly notified their patients, even making arrangements for transfer of some records and other information. What does one do?

B) A member has no insurance card as it was their spouse's employer who changed their coverage. Nevertheless, they urgently need a service. They arrive on your doorstep. What is your responsibility?

C) In one case, it took months for the HMO to determine eligibility. All during this time, the doctor is expected to provide a service with no guarantee of payment. In fact, the doctor who gave me this example, said that the HMO finally gave them two (2) months of the six (6) months of Cap owed. How does one proceed to resolve the fairness issue?

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The Homeless (Referring the Concept of the "Medical Home")

A) A patient is "assigned" a doctor, or they simply appear, or they call for a service. They are very anxious, but also very confused about what type of health plan they have, its rules, and, especially problematic for the managed care organization, which doctors and facilities are in its provider network. How does one handle this 'crisis'?

B) The doctor's office is closed for Wednesday morning. The patient leaves a message on their answering machine to the effect that they are going to an emergency room to obtain a refill; they got into trouble smoking dope, taking recreational drugs and imbibing in alcohol, again. To make matters worse, the E.R., the patient threatens to go to is non-par (non-participating) and very expensive. You learn that what he really wants is an excuse to go back to work. After you count to 10, what can you do about this situation?

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Violation of a Laws of Pharmacoeconomics: Cost-Effectiveness (C:E)

A) The Worried Well: A patient is noted to be non-compliant with his psychotropic and anti-hypertensive medications. The anecdotal observation the doctor makes, however, is that, despite the expense, when patients are adherent, they suffer less anxiety, and this translates into less office visits and lower blood pressure. How can you get a win-win out of this?

B) The Ripple Effect ("When the balloon gets squeezed, it will inflates somewhere else.") In the psychotropic / anti-hypertensive scenario, above, the expensive drug used carefully and well means less visits to the ER. In fact, if one looks at the total episode of care (EOC), the drug costs are more than offset by the reduction of expensive services and hospitalizations. Nevertheless, the HMO raises questions about your (the doctor's) per member per month (PMPM) cost because they are looking only at the cost of the Rx, not the EOC. Is there a way to enlighten the HMO on behalf of all physicians in the same plight?

C) The Offset Effect: In a recent study, the not surprising finding was that by increasing the compliance with Beta blocker use in CHF, office visits went up, and the hospitalization rate went down. [Whellan DJ, Laura Gaulden L, Gattis, WA, et al. The Benefit of Implementing a Heart Failure Disease Management Program.Arch Int Med, October 8, 2001;161(18):2161-2276http://archinte.ama-assn.org/issues/v161n18/abs/ioi00685.html]. How can you make the same argument for other types of care--mental health, depression, renal disease, chronic pain syndrome, diabetes, etc.?

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Measurement by Proxy:

A) A doctor is judged, not by what they do or don't do, but rather what is documented. Medical records and claims-based data and information are at the disposal of the payer (insurance company, HMO) by contract. How can one protect themselves? What, exactly, needs to be done?

B) How does the payer know a patient has not had a PAP Smear, refused a colonoscopy, or prefer to use their old ophthalmologist (who is not in the Health Plan) to check their diabetes.

C) A patient has a borderline fasting blood sugar (FBS) after chewing on gum containing sugar, and subsequently gets labeled as having "Diabetes mellitus" by the Plan because they have had a glycosylated hemoglobin test, regardless of its results. How can you avoid lableing?

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Being Used

The doctor's office feels like it is being used when patients demand a referral, Rx or test and don't seem to care about the doctor's opinion on the matter. That is, the doctor's office gets the impression they are merely a conduit, an arranger when patients demand refills beyond their need (stocking up), when they want to see a non-par, but do not have or do not want to use (higher Out Of Pocket-OOP expenditures) or their Point Of Service (POS) Plan. For example:

A) The doctor refuses to authorize an MRI for a headache, an Rx for a cold, etc. How can the doctor's office keep from losing patients over such things?

B) The doctor's office has a policy that will not retro-auth (retrospectively authorize care), or retro-refer. How to you communicate this policy?

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Dual Choice; Single Responsibility

A) Leakage A member can go to an Ob-Gyn who, in turn can order a procedure at a non-contracted facility; the "leakage" statistic affects his or her profile and incentive. What can be done to prevent getting dinged for leakage?

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Return On Investment (ROI) - Is Managed Care worth the trouble?

A) Doctors are feeling that the extra work in doing chart review, being subject to criticism based upon imperfect data, and so forth is not worth the incentives promised by health plans. This is especially felt when they are having to deal with so many HMOs. Is there a way to handle this burden?

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Doctor Inconvenience: The doctor cannot charge for no-shows under the cap. Nor can she collect for extraordinary time spent in patient education, when managing the abusive or over-demanding patient, or the "Oh by the ways" Or can they?

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Balance Billing - In most HMO-Provider contracts, the member cannot be billed for contracted service, other than their co-pay or reinsurance.

A) An Ob-Gyn office charges the patient for contracted care because the HMO did not pay them. Why?--the Ob-Gyn billed the HMO late. The member calls thier doctor, calls the insurer, calls the state insurance department, and still gets a dunning notice, written by the Ob-Gyn's lawyer for payment. How can you fight such billing practices?