H1N1 Influenza - Conflicting Concerns Unclear Plans

Ten days ago, I spent several hours at an excellent Santa Clara County Public Health Department Emergency Medical Services for Medical Volunteers for Disaster Response. I won't tell you about my snazzy new federally-compliant government identification card or about the uniforms we're going to get. What I will tell you is the tone of concern that permeated the discussion of the Swine Flu pandemic. We were told that medical personnel who actually take care of patients will be high priority recipients of the H1N1 vaccine (two injections to a series - approximately 5 weeks to full immunity). Pregnant women, school children, and young people up to age 24 (perhaps to age 30) will also lead the list of those targeted for the vaccine series, along with migrant workers.  Significant plans for non-hospital care of influenza patients in staffed centers for those who are sick (but not critical) are in the works, where they will be able to receive hydration and respiratory therapy.  I asked whether the Medical Volunteers would receive the vaccine, since we would potentially be the staff for the centers and would need two injections and five weeks to build protective immunity, but was informed that no decision had yet been reached on that issue. We talked about Tamiflu and learned that when the commercial doses run out, there will be reserves of public health reserves to draw upon (but asked my self whether the influenza will be Tamiflu resistant by that time). The public will be advised not to go to their physicians' offices or hospital emergency departments for routine influenza care, but to be in contact with health care providers for illness that has life-threatening characteristics (high fever, dehydration, severe shortness of breath).

Incidentally the H1N1 vaccine, in my county, will be made available to the usual medical provider sources, but public announcements of vaccine availability and administration will be limited.

To my surprise, Thomas Frieden, head of the CDC provided a more reassuring picture concerning the severity of the expected US epidemic in an interview today (CDC-Frieden: or Click on Title Above for Linkage).

My suggestion to high risk people is that they contact their health care providers about the availability of the H1N1 vaccine from them.  While children in schools, young adults in colleges, and pregnant females are likely to have ready access to the vaccine, I don't know what the picture will be for those now healthy age 30 - 65 individuals.  When plans solidify, I will pass the information on to you

New HHS Rule

HHS Issues Rule Requiring Individuals Be Notified of Breaches of Their Health Information

August 19, 2009

As required by the Health Information Technology for Economic and Clinical Health (HITECH) Act passed as part of American Recovery and Reinvestment Act of 2009 (ARRA), the U.S. Department of Health and Human Services (HHS) issued “breach notification” regulations today requiring health care providers and other HIPAA covered entities to notify affected individuals following a breach of unsecured protected health information.

The regulations require covered entities to promptly notify affected individuals, the Secretary of HHS, and in some cases, the media, of a breach. Smaller breaches may be reported to the Secretary on an annual basis. The regulations also require business associates of covered entities to notify the covered entity of breaches at or by the business associate. The regulations were developed after considering public comment received in response to an April 2009 request for information and after close consultation with the Federal Trade Commission (FTC), which has issued companion breach notification regulations that apply to vendors of personal health records and certain others not covered by HIPAA.

To determine when information is “unsecured” and notification is required by the HHS and FTC rules, HHS is also issuing in the same document as the regulation an update to its guidance specifying encryption and destruction as the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals. Entities subject to the HHS and FTC regulations that secure health information as specified by the guidance through encryption or destruction are relieved from having to notify in the event of a breach of such information. This guidance will be updated annually.

The HHS interim final regulations are effective 30 days after publication in the Federal Register and include a 60-day public comment period. For more information, visit the OCR web site.


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They Are Not Wishing You Well

In the world of politics, as in the Mideast, nothing is what it seems. The best example is the rejection of a federal health system and the support for a system of health cooperatives by some denizens of the depths of Washington politics.

I estimate that a federal health system option would be a rousing success, putting pressure on health insurers, hospitals, health systems and others to rein-in excessive costs and to focus resources on the people who really count - patients. Health cooperatives, in limited areas, have demonstrated that they can do a good job. But in dealing with nationwide insurers, nationally organized health care providers, national or statewide health care and hospital systems, and other vendors of care, the cooperative model holds no promise of success and will represent, what insurers, hospital systems, health systems and others described above want - an impotent isolated series of cooperatives, which hold no competitive threat, or fail miserably.

Alternatively, the health cooperative system might allow health care redlining which results in areas with adverse health statistics to be abandoned by health insurers with the patients shunted to health cooperatives which cannot afford the sudden mass of very sick people shifted to their rolls. If insurers are forbidden to underwrite, that will not prevent them from choosing not to do business in a particular area or with a particular employer or group of employers.

The call for the cooperatives in Congress is not a call for cooperatives to succeed, it is means of torpedoing a federal health system option. It is a means for insurers to remain insulated from real competition, to allow health care systems to roll merrily on building grandiose suburban facilities as monuments to their executives and donors, to allow certain physicians to order unnecessary tests and provide unnecessary procedures, to cause health care costs to inflate, and to otherwise generate the fiction that these Congressional spokespersons, lobbyists and other interests have the public's good at heart, when that is not the case. They have their own campaign funds and political supporters interests at heart. After all, they get their care through the federal employee system and that's just not good enough for the rest of America.

FDA - Investigational Drug Rules Updated

The American Society of Hematology has notified me that the FDA's Dr. Richard Pazdur has issued a statement concerning "Expanded Access to Investigational Drugs for Treatment Use" and "Charging for Investigational Drugs." These are two significant new rules.

Links follow (for cut and paste use).

http://edocket.access.gpo.gov/2009/pdf/E9-19004.pdf and
http://edocket.access.gpo.gov/2009/pdf/E9-19005.pdf.

Touch Those Out Of Touch

As a board certified hematologist, my career often involved caring for patients whom I knew were soon going to die. Some of these patients were pregnant and in their twenties, many were middle-aged men and women, and some were older folks. They were professionals, religious leaders, politicians, business people, and workers and they represented all religions and all walks of life. Talking with patients about their prognoses was painful for me, as a doctor, and of course difficult for my patients. But even more difficult was imminent death in someone who had not considered or planned for that eventuality and who was surrounded by a family which was unprepared for, and often unwilling to accept, the possibility of a loved-one's death.

I serve on a multidisciplinary biomedical ethics committee which acts as a consultant to hospital medical staff members, patients, their families and others, often in matters of life and death. Our committee makes non-binding recommendations to patients and, more often, their families which affect life, death, quality of life, living arrangements, touch on religious preferences, and sometimes involve the appropriateness of proposed or rejected medical treatment. Although we are experienced and professional, it is sad to have us - as strangers to affected patients and their families - suggest resolution of situations which should have been resolved by those most involved - primarily patients, and when appropriate, their families.

My understanding is that payment by the federal government for end-of-life planning counseling services has been dropped, at the urging of a small group of Senators and politically-connected pressure groups. These services can provide peace of mind to those who are not yet patients, patients and patients' families, as well as practical solutions to individual problems. Planning is best done by the person whose life experiences give him or her the right to make his or her own life and death decisions.

I suggest that my readers contact the organizations listed below to express their wishes and expectations concerning this issue. Send your own message or forward this blog. But don't stand by silent, because when the time comes, no one may speak for you and you might not have your own plan.

Republican National Committee - - - www.gop.com
Republican Congressional Committee - www.nrcc.org
Republican Senatorial Committee - - - www.nrsc.org
Democratic National Committee - - - www.democrats.org
Democratic Congressional Committee - - - www.dccc.org
Democratic Senatorial Campaign Committee - - - www.dscc.org/home

Health Insurers' Wish Lists

Like children, hoping for a rewarding visit from Santa Claus in December, Health Insurers have their own wishes, waiting to be granted. While kids want Santa to come with a full sack of goodies, the insurers might want (and have already negotiated for) an empty sack from Congress and President Obama. Read on -

1. No weakening of anti-trust protection of insurers for the their activities constituting the "business of insurance."

2. No meddling by the federal government in the salaries and bonuses of health insurance company executives and their key staff.

3. No action by the federal government which might draw major employers away from traditional health care insurers to an insurance pool or public plan.

4. No interference by the federal government with health insurers' drug distributing subsidiaries ability to extract rebates, discounts and other incentives from pharmaceutical companies, as well as providers of other health care goods and services, and not pass them on to patients and employers.

5. No entry by the federal government into administration of health plan enrollments and premium collection and distribution which would cut into health insurers' profitable administrative overhead revenues.

6. No extension of federal fraud and abuse laws to the products, services and arrangements provided by insurers, their subsidiaries and contracting parties.

7. No national standard uniform contract for health care insurers with patients, employers and other similarly interested parties.

8. No single payer system.

9. No federal requirement of freedom of access by all health insurers to all physicians, nurses, hospitals and other organization which provide health care services (see #11).

11. No American standard of enforceable performance by health insurers for the services and products they sell to employers and patients, and no weakening of the ERISA protection of insurers against private lawsuits by injured patients and their families.

12. No restriction on the ability of health care insurers to purchase networks of providers and facilities who will then provide services only to each owner-insurers' clientele.

13. No unionization of health care professionals, such as physicians.

14. No interference with the system by which 50 states regulate insurers.

15. No restriction on commercial "free speech" by health insurers.

10. (Inadvert. omitted - added 8/17/09) - No requirement that the insurance companies be required to provide high-technology prostheses.

It Wasn't The Government Saying Goodbye Too Soon

I recall one of our Thursday lunches, to which the physician organizer invited representatives of a local hospice to talk about hospices and specifically about their hospice's services to patients and their families. It was an informative interesting talk, enlivened by a lot of questions from doctors. But the really interesting conversation came after the hospice people left.

Several cancer specialists angrily complained about a local hospital. These physicians found that immediately upon a patient's diagnosis of cancer, someone in the hospital (perhaps social services?) arranged for a prompt hospice consult before a cancer specialist could review the case with the patient, his or her family, the patient's primary physician, pathologists, radiologists, and other experts. Patients and their families were having "the crepe" hung for them, with the gloomiest possible prognosis. The cancer specialists said that patients were being whisked out of the hospital, consigned to hospice care, when they could have been treated palliatively (even during hospice care), to relieve pain and suffering and perhaps to prolong life, or could have explored the possibility of an effort at curative treatment.

Now, this wasn't the government convening a "let's shorten your life" committee. The physicians felt this was an apparent hospital policy.

Before we again shake our fingers at Senators and Representatives, and accuse our government of rushing people off to die to save money, let's think about other actors: insurers, hospitals and institutions which - if there are no ethical safeguards - could be advantaged by hastening the process of dying.