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In Severe Pandemic, Officials Ponder Disconnecting Ventilators

Understanding the So-Called New York Protocol

By Sheri Fink

ProPublica NewsEmergency Sign

With scant public input, state and federal officials are pushing ahead with plans that — during a severe flu outbreak — would deny use of scarce ventilators by some patients to assure they would be available for patients judged to benefit the most from them. 

The plans have been drawn up to give doctors specific guidelines for extreme circumstances, and they include procedures under which patients who weren’t improving would be removed from life support with or without permission of the families. 

The plans are designed to go into effect if the U.S. were struck by a severe flu pandemic comparable to the 1918 outbreak that killed an estimated 50 million people worldwide. State and federal health officials have concluded that such a pandemic would sicken far more people needing ventilators than could be treated by the available supplies. 

VA Guidelines

Many of the draft guidelines, including those drawn up by the Veterans Health Administration, are based in part on a draft plan New York officials posted on a state web site two years ago and subsequently published in an academic journal. The New York protocol, which is still being finalized, also calls for hospitals to withhold ventilators from patients with serious chronic conditions such as kidney failure, cancers that have spread and have a poor prognosis, or “severe, irreversible neurological” conditions that are likely to be deadly. 

New York officials are studying possible legal grounds under which the governor could suspend a state law that bars doctors from removing patients from life support without the express consent of the patient or his or her authorized health agent. 

Medicare Payment

State and federal officials involved with drafting the plans say they have been disquieted by this summer’s uproar over whether Medicare should pay for end-of-life consultations with families. They acknowledged that the measures under discussion go far beyond anything the public understands about how hospitals might handle a severe pandemic. 

By every indication, state and federal officials expect to weather this year’s flu season without having to ration ventilators. That assumes that the H1N1 virus will not mutate into a more serious killer, the vaccines against it and the other seasonal flus will continue to prove effective, and any dramatic surges in the number of patients in need of ventilators will occur in different parts of the U.S. at different times. 

In recent months, New York officials have met three times with physicians, respiratory therapists and administrators to rehearse how their plan might play out in hospitals in a severe epidemic. In one of those “tabletop exercises,” participants suggested that the names of triage officers charged with making life and death choices among patients at each hospital should be kept secret. The secrecy would be needed, participants said in interviews, to avoid pressure and blame from colleagues caring for patients who were selected to be taken off life support. 

When they posted their plan on the web in coordination with a video conference in 2007, New York officials promised to solicit public input. Since then, they have consulted with medical and legal professionals and other experts, but few members of the general public, and the plan has remained unchanged. They declined to make the comments they have gathered immediately available for review, and those comments are not published on the Health Department’s Web site

In the initial proposal, officials called public review “an important component in fulfilling the ethical obligation to promote transparency and just guidelines.” 

The academic publication of the plan envisaged the use of focus groups to solicit comment from “a range of community members, including parents, older adults, people with disabilities, and communities of color.” Those have not been held. 

Beth Roxland, the current executive director of the New York State Task Force on Life and the Law, said the ethicists included in the state’s planning process focused largely on vulnerable populations. “Even if we didn’t have direct input from vulnerable populations,” she said, “their interests have been well accounted for.” Roxland said that public comment solicited when the ventilator plan was posted on the Health Department Web site was “sparse.” 

Dr. Guthrie Birkhead, Deputy Commissioner of the Office of Public Health for New York State said he wondered whether it was possible to get the public to accept the plans. “In the absence of an extreme emergency, I don’t know. How do you even engage them to explain it to them?” 

Even so, other states, hospital systems and the Veterans Health Administration—which has 153 medical centers across all states — have drafted protocols that are based in part on New York’s plan. The inclusion and exclusion criteria for access to ventilators, however, are different. For example, under the current drafts, a patient on dialysis would be considered for a ventilator in a VA hospital in New York during a severe pandemic, but not in another New York hospital that followed the State’s plan, which excludes dialysis patients. The VA’s exclusion criteria are looser because the patient population it is charged with serving is typically older and sicker than in other acute care hospitals. Different states, reflecting different values, have also established different criteria for who gets access to lifesaving resources. 

IOM Input

The Institute of Medicine, an independent national advisory body, is expected to release a report on Thursday morning, at the request of the U.S. Department of Health and Human Services, that will recommend broad guidelines to help guide planners crafting altered standards of care in emergencies. At an open meeting held to inform the report on Sept. 1, participants described successful public exercises related to allocating scarce resources in Utah and in a Centers for Disease Control and Prevention study conducted in Seattle. 

Questions about how hospitals would handle massive demand for life support equipment arose when New York state health department officials ran exercises based on a scenarios involving H5N1 avian influenza.

“They kept running out of ventilators,” said Dr. Tia Powell, director of the Montefiore-Einstein Center for Bioethics and former executive director of the New York State Task Force on Life and the Law, which was asked to address the problem. “They immediately recognized this is the worst thing we’ve ever imagined. What on earth are we going to do?” 

Officials calculated that 18,000 additional New Yorkers would require ventilators in the peak week of a flu outbreak as deadly as the 1918 pandemic. Only a thousand machines would be available, the officials estimated. The state’s acute care hospitals in 2005 had about 6000 ventilators, 85% of which were normally in use. A moderately severe pandemic would have resulted in a shortfall of 1256 ventilators, health officials found. 

In 2006, New York planners convened a group of experts in disaster medicine, bioethics and public policy to come up with a response. After months of discussion, the group produced the system for allocating ventilators. They first recommended a number of ways that hospitals could stretch supply, for example by canceling all elective surgeries during a severe pandemic. The state has also since purchased and stockpiled 1700 Pulmonetic Systems LTV 1200 ventilators (Cardinal Health Inc., NYSE) — enough to deal with a moderate pandemic but not one of 1918 scale. 

Officials realized those two measures alone would not be enough to meet demand in a worst-case scenario. Ventilators were costly, required highly trained operators, and used oxygen, which could be limited in a disaster. 

Ventilator Rationing

The group then drew up plans for rationing of ventilators. The goal, participants said, was to save as many lives as possible while adhering to an ethical framework. This represented a departure from the usual medical standard of care, which focuses on doing everything possible to save each individual life. Setting out guidelines in advance of a crisis was a way to avoid putting exhausted, stressed front line health professionals in the position of having to come up with criteria for making excruciating life and death decisions in the midst of a crisis, as many New Orleans health professionals had to do after Hurricane Katrina.

The group based its plans, in part, on a 2006 protocol developed by health officials in Ontario, Canada which relied on quantitative assessments of organ function to decide which patients would have preference for an intensive care unit bed. The tool, known as the Sequential Organ Failure Assessment (SOFA) score, is not designed to predict survival, and not validated for use in children, but the experts adopted it in light of the lack of an appropriate alternative triage system. 

This summer, New York officials brought the state’s plan to groups from several New York hospitals for the tabletop exercises. They met behind closed doors to assess how hospitals might implement the proposed measures if the H1N1 pandemic turned unexpectedly severe this fall. In the fictional scenario, paramedics were ordered not to place breathing tubes into patients until physicians “can assess whether they meet the criteria to be placed on a ventilator.’’ 

Problems were immediately apparent. Dr. Kenneth Prager, a professor of medicine and director of clinical ethics at Columbia University Medical Center, was concerned about the lack of awareness of the plan among the larger public and the majority of the medical community. Societal input “is totally absent,” he said and called for more outreach to the public. “Maybe society will say, ‘We don’t agree with your plan. You may think it’s ethically OK; we don’t.'” 

The Protocol

The protocol, he said, would also place a great burden on clinicians charged with selecting which patients would be removed from life support. Physicians were concerned doctors involved in the legitimate and painful selection processes might be inappropriately construed as “death squads.” “We facetiously dubbed them the ‘death squad’ or the ‘guys in the back room’,” Prager said. He envisioned family members breaking down and screaming when they found out their loved ones would be disconnected from ventilators. “It really is a nightmare.” 

Even so, he felt that the plan – and its effort to save the greatest number of patients – was ethically appropriate. “If we don’t use triage, people will die who would have otherwise been saved,” he said, because a number of ventilators are “being used to prolong the dying process of patients with virtually no chance of surviving.” 

Doctors at the exercises feared that they would be sued by angry patients if they followed the draft guidelines. “There’s absolutely no legal backing for physicians,” said Lauren Ferrante, a medical resident at Columbia University Medical Center. “Who’s to say we’re not going to get sued for malpractice?” 

New York State law forbids doctors from removing living patients from ventilators or other life support except in cases where the patient has clearly stated such wishes, for example in a living will, or through his or her legal health care agent. Other sources of liability could come from federal and state anti-discrimination laws or claims of denial of due process. 

New York officials said they were currently working out legal options for implementing the plans, such as gubernatorial emergency declarations or emergency legislation. 

“You can take something today that’s not necessarily active and overnight flip the switch and make it into something that has those teeth in it,” said Dr. Powell, who served on the committee that drafted the plan.

Dr. Powell cautioned that it is critically important to maintain flexibility in the guidelines. Any rationing measures taken in a disaster must be calibrated to need and severity. 

Guidelines can also promote investment in new technology, such as cheaper, easier to use ventilators that would make rationing less likely. Already at least one company, St. Louis-based Allied Healthcare Products, is marketing a line of ventilators specifically for use in disasters. 

Some states, including Louisiana and Indiana, have adopted laws that immunize health professionals against civil lawsuits for their work in disasters. Other states, including Colorado, have drawn up a series of relevant executive orders that could be applied to address these issues.

Assessment 

Dr. Carl Schultz, a professor of emergency medicine at the University of California at Irvine and co-editor of the forthcoming textbook, Koenig and Schultz’s Disaster Medicine (Cambridge University Press), is one of the few open critics of the establishment of altered standards of care for disasters. He says the idea “has both monetary and regulatory attractiveness” to governments and companies because it relieves them of having to strive to provide better care. “The problem with lowering the standard of care is where do you stop? How low do you go? If you don’t want to put any more resources in disaster response, you keep lowering the standard.” 

Federal officials disagree. “Our goal is always to provide the highest standard of care under the circumstances,” said RADM Ann Knebel, deputy director of preparedness and planning at the Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services. “If you don’t plan, then you are less likely to be able to reuse, reallocate and maximize the resources at your disposal, because you have people who’ve never thought about how they’d respond to those circumstances.”

Note: Sheri Fink is a reporter for the ProPublica news service, which first published this article.

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Whither Physician Self-Portfolio Management?

Do it Yourself Considerations

By Clifton N. McIntire, Jr.; CIMA, CFP®

By Lisa Ellen McIntire; CIMA, CFP®fp-book

In order to self create and monitor an investment portfolio for personal, office, or medical foundation use, the physician investor should ask him/herself three questions:

1. How much do I have invested?

2. How much did I make on my investments?

3. How much risk did I take to get that rate of return?

How Am I Doing?

Most doctors and health care professionals know how much money they have invested. If they don’t, they can add a few statements together to obtain a total. Few actually know the rate of return achieved during last year’s debacle, or so far this year in 2009. Everyone can get this number by simply subtracting the ending balance from the beginning balance and dividing the difference. But, few take the time to do it. Why? A typical response to the question is, “We were doing fine” -or- “We did terrible last year.”

But, ask how much risk is in the portfolio and help is needed. Nobel laureate Harry Markowitz, PhD said, “If you take more risk, you deserve more return.” Using standard deviation, he referred to the “variability of returns” –  in other words, how much the portfolio goes up and down, its volatility.

Your Own Portfolio

How, and even whether or not to create and manage your own portfolio, is what this brief post is about.

First, you must determine what to do with your investments. How much risk can be taken and what is the time frame? You must understand the concept of risk vs. reward and write an investment policy statement.

Next, the assets that will be used for investment must be selected. This involves asset allocation and mixing different styles of investment management to achieve the desired results, and is the point where you go it alone, or professional investment managers are selected.

Be sure to review expenses, like wrap accounts, service fees, AUMs, commissions and compare mutual funds with private money management.

Monitor

Once the initial portfolio is in place, the performance must be monitored to assure compliance with the investment policy.  Here’s where you consider 401k or 403(b) plans, pension plans, retirement accounts, as well as how to change doctor trustees or managers when necessary.

Assessment

Finally, consider the role of professional consultants. Now after all of this, if you still want to do it yourself rather than be a doctor, the entire process will be professionally illustrated. An actual physicians’ financial plan with investing portfolio was reviewed previously, along with the steps taken to improve returns and reduce risk.

Link: https://healthcarefinancials.wordpress.com/2009/09/03/evaluating-a-sample-physician-financial-plan-iii/

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Encrypt or De-identify PHI

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[By Darrell K. Pruitt; DDS]pruitt

The United States’ advancement in Healthcare Information Technology, which has the potential to lead to wonderful money-saving cures through research using trustworthy interoperable health records, is currently stopped cold by patient security problems that are only getting worse. Our lawmakers cannot get around the security obstacle without resorting to authoritarian means using CMS’s power to withhold providers’ discounted payments and threats of obscene fines from the HHS and the FTC. History shows that tyranny is not tolerated well in this part of the world. Lawmakers can get their butts voted smooth out of office in my neighborhood.

HITECH  

Here is something nobody mentions: Despite the current hope in a thick, political fantasy called HITECH, encryption of patients’ Protected Health Information [PHI] is a non-starter in the land of the free. Everyone knows that resourceful, cynical Americans will simply never trust encryption to protect their secrets, and will reliably withhold important information from their eMRs – one way or another. Doctors as well as patients can be expected to go out of their way to sabotage technology they fear. We all intuitively know this is true, don’t we? We aren’t so naïve to think all the players will happily play by the rules, are we? And I think we can all agree that an untrustworthy digital health record in an emergency room is worse than no patient information at all. Security is a grand problem with eMRs that started with HIPAA changes in 2003 that made eHRs so slippery. And the problem is clearly not being resolved. Not yet.

Public Lacks Trust 

Regardless of the campaign donations which follow him, there is nothing Newt Gingrich and his entrepreneurial friends in high places can do about the public’s lack of trust in encryption. It gets worse: Encryption hasn’t a chance of isolating PHI from dishonest employees in doctors’ offices, and slippery digital patient data can be moved soo easily. Everyone knows that as well, don’t they? It is estimated that two-thirds of the identities stolen in the nation are lifted from doctors’ offices. That’s us, Doc. HIPAA is not only irrelevant, it is an expensive distraction – it gives future ID theft victims a false sense of security.

HIPAA Approved 

De-identifying digital records is not mentioned in HITECH as a HIPAA-approved method of security. Yet it is the ONLY solution that promises to be even more secure than paper records. Because of heavy stakeholder stakes in hospital care, it will take longer for CEO-types to embrace patient-friendly de-identification. Other than identifiers such as names, social security numbers, birthdates, addresses and other items that have street value, NOBODY cares what is in a dental record. I actually think this opens a tremendous opportunity for someone courageous in the Texas Dental Association to discuss the feasibility of de-identification of dental records. Otherwise, instead of leading the nation in solving security problems, the TDA will look just as stupid as the ADA.

Encryption would also provide a dangerous false sense of security in eMRs – that is if it had a chance in the marketplace. But encryption will never go far because consumers simply won’t buy it. That is a marketplace fact that stoically optimistic HIT stakeholders are trying hard to avoid. They also know they are running out of time. Deadlines are quickly approaching for both HIPAA and the Red Flags Rule that providers are far from prepared for.

Former Attorney Speaks 

Bill Lappen, a former attorney and author of the ad I copied below, as well as a partner with his brother David in the de-identified health record venture says: “Since no identifying information is ever entered, a hacker can’t determine whose information is shown.”

So in addition to protecting one’s practice against dishonest or vindictive employees, de-identification of dental records would make hacking a dentist’s computer a complete waste of time, and hackers wouldn’t endanger dental patients and bankrupt dentists.

My Confidence 

I confidently tell you that soon, someone smart will come upon the unprecedented idea that the ultimate answer to our security problem in healthcare will be de-identification of medical records, not encryption. De-identification allows a compromise of privacy for only a miniscule percentage of physicians’ patients. We cannot allow that to stand in the way of better health for everyone else. Those special cases are so few that I am confident that they can be dealt with individually. We simply must move forward. I’ll have to retire some day. I may need help from Medicare.

Encryption gives us only danger and protects nobody but a thief with a key.

Assessment 

We’ve wasted enough time on HITECH and HIPAA, as well as CCHIT. It’s time to say no to stakeholders and pay attention to patients’ needs instead of those who would needlessly increase the cost of their care. Stimulus money attracts cockroaches.

In the name of Hippocrates, disregard the tainted HIPAA mandate. It is dangerous, and especially absurd in dentistry.

Link: http://www.theopenpress.com/index.php?a=press&id=58568

Life-Saving Patient Information can be Online, Anonymous and Usable

Published on: September 26th, 2009 12:19am

By: blappen

Los Angeles, CA (OPENPRESS) September 26, 2009 — Hospital Emergency Rooms need instant access to patient medical information. Allergic reactions and dangerous drug interactions can be deadly. Time is critical. Until now, privacy was a large concern. Two brothers, who have developed medical software over the past 15 years, think they have a simple first step towards moving patient information on to the internet.

“The ER doesn’t need to look up the information by patient name” said Bill Lappen, a former attorney. “We have implemented secure systems in the past, but no matter how secure we make the site, we have to assume that it will be hacked” added David Lappen, a computer design engineer from Stanford. “But providing instant access to life-saving information is too important to ignore”, he added. To protect patient privacy, their system does not know to whom the medical information belongs. Since the person’s identifying information is never on the system, it can’t be stolen. “By enabling anonymous entry, we have protected people’s privacy while allowing them to put their life-saving information in a place where it can be instantly accessed when needed”, added Bill Lappen.

www.AMCC.me is the public service website they created. It allows anyone to enter medical information anonymously. The site provides a random ID which the user carries in his/her wallet. For someone to see that user’s medical information, they merely enter the ID into the site. Unless the user has given them their ID, the information shown is meaningless. That same information, when associated with a patient, can save their life.

Since no identifying information is ever entered, a hacker can’t determine whose information is shown. “Secure patient-controlled Electronic Medical Records are now available on the internet” said David Lappen. A sample ID has been set up on the site to allow users to evaluate the concept before setting up their own free ID.

Contact:

Bill Lappen

Bill@AMCC.me

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Whither Health Information Technology – Seriously?

Is it Really About Quality Improvement?

By Staff ReportersSurgeons

Health information technology (HIT) allows comprehensive management of medical information and its secure exchange between health care consumers and providers. Broad use of HIT has the potential to improve health care quality, prevent medical errors, increase the efficiency of care provision and reduce unnecessary health care costs, increase administrative efficiencies, decrease paperwork, expand access to affordable care, and improve population health.

Improving Patient Care

  • Interoperable HIT can improve individual patient care in numerous ways, including:
  • Complete, accurate, and searchable health information, available at the point of diagnosis and care, allowing for more informed decision-making to enhance the quality and reliability of health care delivery.
  • More efficient and convenient delivery of care, without having to wait for the exchange of records or paperwork, and without requiring unnecessary or repetitive tests or procedures.
  • Earlier diagnosis and characterization of disease, with the potential to thereby improve outcomes and reduce costs.
  • Reductions in adverse events through an improved understanding of each patient’s particular medical history, potential for drug-drug interactions, or (eventually) enhanced understanding of a patient’s metabolism or even genetic profile and likelihood of a positive or potentially harmful response to a course of treatment.
  • Increased efficiencies related to administrative tasks, allowing for more interaction with and transfer of information to patients, caregivers, and clinical care coordinators and monitoring of patient care.

Assessment

Link: http://healthit.hhs.gov/portal/server.pt?open=512&objID=1327&parentname=CommunityPage&parentid=112&mode=2&in_hi_userid=11113&cached=true A Letter from David Blumenthal, MD.

Conclusion

And so, your thoughts and comments on this Medical Executive-Post are appreciated. Is HIT really about medical quality improvement? Is Dr. Dave Blumenthal correct? Feel free to review our top-left column, and top-right sidebar materials, links, URLs and related websites, too. Then, be sure to subscribe to the ME-P. It is fast, free and secure.

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Stockholder Suit Targets Troubled Mental Health Chain

Psychiatric Solutions, Inc

By Robin Fields, ProPublica – September 22, 2009 5:01 pm EDTCaduceus

Psychiatric Solutions Inc. the nation’s leading provider of inpatient mental health care is being sued by stockholders who claim the company issued “false and misleading statements” about troubles at one of its hospitals.

The Lawsuit

The lawsuit, filed Monday in U.S. District Court in Tennessee, alleges that PSI violated securities laws by downplaying problems at Riveredge Hospital near Chicago and waiting too long to tell shareholders how they had affected the company’s bottom line.

The Investigations

Investigations last year by the Chicago Tribune and ProPublica detailed violence, sexual abuse and neglect at PSI facilities from coast to coast, including Riveredge. In several instances, PSI facilities were cited for not reporting patient deaths and injuries as required, federal and state records showed. In response to the reports, the Justice Department opened an investigation and the Illinois Department of Children and Family Services froze admissions of foster children to Riveredge.

The Allegations

The lawsuit alleges that PSI’s statements – particularly those indicating the admissions hold would end soon and that other regulatory deficiencies had been fixed – inflated the company’s stock price, helping company leaders reap millions from insider sales. In early 2009, PSI announced that its 2008 results had fallen short of estimates. Its share price dropped about 35 percent on the news.

Assessment

Through a spokesman, PSI called the lawsuit “wholly without merit.” “We have at all times operated, and will continue to operate in full compliance with the rules and regulations of the Securities and Exchange Commission,” John Van Mol said in a written statement.

Note: Robin Fields is a reporter for the ProPublica news service, which first published this article.

Conclusion

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Understanding Expenses and Investment Portfolio Performance

A Direct Relationship

By Clifton N. McIntire, Jr.; CIMA, CFP®

By Lisa Ellen McIntire; CIMA, CFP®fp-book

Expenses can play an important role in portfolio performance. You don’t hear much about expense ratios in an up market, like early 2007. If your account was up +28 percent, whether the expense was 3 percent or 1 percent doesn’t seem to make much difference. But, let the market decline, like it did later on in October 2007 and we change our perspective. A 10 percent portfolio decline plus charges of 3 percent equals a 13 percent decline. Now we need a 15 percent increase net of fees just to get even.

The Four Cost Horsemen

Basically you have four cost areas:

  1. Custody—someone must hold the stocks and bonds, collect dividends and interest, prepare tax information for the government, issue monthly statements, and send checks.
  2. Commissions—orders must be executed, transfer securities into and out of your account, trades settled.
  3. Investment Decisions—the money manager must be paid.
  4. Monitoring Performance and Advice—usually an investment management analyst is engaged to provide this service; as well as write the investment policy statement and prepare the asset allocation study.

Portfolio Size

Naturally, size makes a difference. For a doctor’s stock account with a $200,000 total value, all of the above can be accomplished for annual fees between 2.00 and 3.00 percent. An account with $1,500,000 in total assets part bonds and part stocks would pay annual fees between 1.25 and 1.75 percent depending on the ratio of stocks and bonds. These are annual fees and are all-inclusive. Commissions, portfolio management fees, and statements check charges are all included. One quarter of the annual fee is charged every three months. Family related accounts are generally grouped for a quantity fee discount.

Assessment

Some financial consultants prefer to use mutual funds with smaller accounts. A charge of 1 percent per year for their service with a stated minimal fee is common practice. This does not include fees deducted from the account by the mutual fund (anywhere from .50 to 2.50 percent) or commissions paid by the fund managers for trade executions. 

Morningstar Report: Morningstar Expense Ratio Results

Conclusion

And so, your thoughts and comments on this Medical Executive-Post are appreciated. How much do you pay for this service? Feel free to review our top-left column, and top-right sidebar materials, links, URLs and related websites, too. Then, be sure to subscribe to the ME-P. It is fast, free and secure.

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