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PRESIDENT’S MESSAGE Just Say No!
The Patient-Centered Medical Home (PCMH)
Alicia Abels, MD
George Meyer, MD
Balancing Patient Autonomy and Physician Responsibility
Using CURES to Monitor Prescription Drug Use
Mark Blum, MD, FAAHPM
John McCarthy, MD
EDITOR’S MESSAGE The Gestation of an SSVMedicine Blog
Our Life With the Pygmies
Scott Kellerman, MD
CONVERSATIONS Claire Pomeroy, MD: Vision and Values
David Gunn, MD
IN MEMORIAM Clifford W. Skinner Jr., MD
John Loofbourow, MD
Now Do We Have a Clear Conscience?
Shilpa Mathew, Esq.
The Drug Expiration Date: A Costly Illusion
Scott Sattler, MD
Plate Reform: A Call to Action!
Sarah Jones, MD
Cardiology: the Pulse of Evidence-based Medicine?
Nathan Hitzeman, MD
We welcome articles from our readers by email, facsimile or mail to the Editorial Committee at the address below. Authors will be able to review articles before publication. Letters may be published in a future issue; send emails to e.LetterSSV Medicine@gmail. com or to the author. All articles are copyrighted for publication in this magazine and on the Society’s web site. Contact the medical society for permission to reprint.
SSV Medicine is online at www.ssvms.org/magazine.asp This is another in a series of covers by Sacramento otolaryngologist Dr. David A. Evans. “One of my interests is night photography in unusual locations, such as this Mojave Desert junkyard. This old camper is made to look alive through the use of flashlights to light the headlights, as well as colored theatre gels and strobes to light the inside in a technique known as ‘light painting’.” The photo was taken around 11 p.m. in bright moonlight. The white streaks in the sky are moving clouds, blurred by the long exposure.
Volume 62/Number 3 Official publication of the Sierra Sacramento Valley Medical Society 5380 Elvas Avenue Sacramento, CA 95819 916.452.2671 916.452.2690 fax firstname.lastname@example.org
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MEDICINE Sierra Sacramento Valley Medicine, the official journal of the Sierra Sacramento Valley Medical Society, is a forum for discussion and debate of news, official policy and diverse opinions about professional practice issues and ideas, as well as information about members’ personal interests. 2011 Officers & Board of Directors Alicia Abels, MD President David Herbert, MD, President-Elect Stephen Melcher, MD, Immediate Past President District 1 District 5 Robert Kahle, MD, John Belko, MD Secretary Louise Glaser, MD District 2 Robert Madrigal, MD Jose Arevalo, MD David Naliboff, MD Steven Chen, MD Anthony Russell, MD Ann Gerhardt, MD District 6 District 3 J. Dale Smith, MD Bhaskara Reddy, MD, Treasurer District 4 Demetrios Simopoulos, MD 2011 CMA Delegation Delegates District 1 Jon Finkler, MD District 2 Lydia Wytrzes, MD District 3 Vacant District 4 Ron Foltz, MD District 5 Elisabeth Mathew, MD District 6 Marcia Gollober, MD At-Large Alicia Abels, MD Satya Chatterjee, MD Richard Gray, MD David Herbert, MD Richard Jones, MD Robert Kahle, MD Norman Label, MD Charles McDonnell, MD Janet O’Brien, MD Kuldip Sandhu, MD Boone Seto, MD Earl Washburn, MD
Alternate-Delegates District 1 Reinhart Hilzinger, MD District 2 Margaret Parsons, MD District 3 Katherine Gillogley, MD District 4 Demetrios Simopoulos, MD District 5 Anthony Russell, MD District 6 Karen Hopp, MD At-Large Robert Forster, MD Ulrich Hacker, MD Russell Jacoby, MD Maynard Johnston, MD Robert Madrigal, MD Rajan Merchant, MD Richard Pan, MD, Assemblyman Gerald Upcraft, MD Vacant Vacant Vacant Vacant
CMA Trustees 11th District Barbara Arnold, MD Richard Thorp, MD Solo/Small Group Practice Forum Lee Snook, Jr., MD Very Large Group Forum Paul Phinney, MD AMA Delegation Barbara Arnold, MD, Delegate Richard Thorp, MD, Alternate Editorial Committee John Loofbourow, MD, Chair George Meyer, MD Robert Forster, MD John Ostrich, MD Ann Gerhardt, MD Gerald Rogan, MD David Gunn, MD F. James Rybka, MD Nathan Hitzeman, MD Gilbert Wright, MD Albert Kahane, MD Robert LaPerriere, MD Lydia Wytrzes, MD John McCarthy, MD Managing Editor Webmaster Graphic Design
Ted Fourkas Melissa Darling Planet Kelly
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Advertising rates and information sent upon request. Acceptance of advertising in Sierra Sacramento Valley Medicine in no way constitutes approval or endorsement by the Sierra Sacramento Valley Medical Society of products or services advertised. Sierra Sacramento Valley Medicine and the Sierra Sacramento Valley Medical Society reserve the right to reject any advertising. Opinions expressed by authors are their own, and not necessarily those of Sierra Sacramento Valley Medicine or the Sierra Sacramento Valley Medical Society. Sierra Sacramento Valley Medicine reserves the right to edit all contributions for clarity and length, as well as to reject any material submitted. Not responsible for unsolicited manuscripts. ©2011 Sierra Sacramento Valley Medical Society Sierra Sacramento Valley Medicine (ISSN 0886 2826) is published bi-monthly by the Sierra Sacramento Valley Medical Society, 5380 Elvas Avenue, Sacramento, CA 95819. Subscriptions are $26.00 per year. Periodicals postage paid at Sacramento, CA. Correspondence should be addressed to Sierra Sacramento Valley Medicine, 5380 Elvas Avenue, Sacramento, CA 95819-2396. Telephone (916) 452-2671. Postmaster: Send address changes to Sierra Sacramento Valley Medicine, 5380 Elvas Avenue, Sacramento, CA 95819-2396.
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Just Say No! By Alicia Abels, MD This month there will be no President’s message. That is what I was fantasizing about this morning while trying to come up with some idea for a column this month. Those of you who do not know me have probably figured out by now that I’m not a visionary, or full of pithy thought or knowledge to inspire or motivate as some of my predecessors have been. Frankly, I’m a lot like most of you — trying to fulfill numerous obligations, having little time for rest or exercise lately and, well, just busy! Sometimes I just have to slow down and remind myself to take a breath. Being a bit of a controlling perfectionist as many doctors are, lately I am finding myself very frustrated at not being able to fulfill every task with the highest level of perfection that I’d like to. Years ago, probably at least 10 or so, I went to a talk given by a female physician. I can’t remember her name, or her specialty, but think she was a surgeon. She wasn’t from our area. Her message was simple and stuck with me. Give it up. You just have to let go of some things. I think her tag line was something like, “If it’s not worth doing half-assed, it’s not worth doing at all.” After the laughter came a wave of relief. Here was a successful woman physician out on the lecture circuit, talking to other physicians, who gave me permission to let some things go. It was an epiphany. After that, I no longer worried about little things like all the typos in my reports. I didn’t care if other docs thought I was illiterate, or who knows what. It didn’t really matter. Patient care did not suffer. No lightning bolt struck, no referrals were
lost — patients kept coming in. My friends still talked to me. This was just the tip of the iceberg as there were lots of other obligations that could be fulfilled without perfection — and again, nothing happened. Still, I have to keep reminding myself that it’s OK to let some things go. There’s a joke about a young woman who by all outward appearances seemed, well, less than intelligent. She was driving with her headphones on. Stopped by the highway patrolman, she pled her case, saying, “My doctor told me never to take these off or I would die.” Irritated, the patrolman told her to take off the headphones. She did. When the patrolman returned to the young lady’s car after checking her license and registration, he found her dead. Alarmed and curious, he picked up the headphones where he heard, “Breathe in… breathe out.” Sometimes we all need a little reminder to let things go and just breathe. This week I depart for the CMA’s Leadership Academy in the desert — one of the perks of being President of this Medical Society. Hopefully, there will be some visionaries who will inspire me to inspire you in future columns. Until then, have a wonderful spring.
Her message was simple and stuck with me. Give it up.
Is there a pattern here? The President’s Message in January: Let’s Talk About Sex The President’s Message in March: “What’s Next? Drugs and Rock-n-Roll?” The Message this issue: Just Say No! Your suggestions for the next issue are welcomed.
Comments or letters, which may be published in a future issue, should be sent to the author’s email or to e.LetterSSV Medicine@gmail. com.
Balancing Patient Autonomy and Physician Responsibility By Mark Blum, MD, FAAHPM
Comments or letters, which may be published in a future issue, should be sent to the author’s email or to e.LetterSSV Medicine@gmail. com.
The thoughtful essays in the January/ February 2011 edition of Sierra Sacramento Valley Medicine by Dr. Hitzeman, “Doesn’t Anyone Die In Their Sleep Anymore?” and by Dr. McCurdy, “Assault on Conscience,” raise provocative questions about our role as physicians in guiding patients and families/surrogate decision-makers as they try to cope with the end stages of incurable illness. Dr. Hitzeman accurately describes the frightening cost of end-of-life care in our country and offers useful suggestions for methods we might employ to try to stem this tide. I would like to add my recommendations for a major shift in how we care for these patients. We have observed a significant evolution (much like the swing of a pendulum) in the balance between medical autonomy and paternalism/maternalism. Fifty years ago, the concept of autonomy barely existed. The process of informed consent was not routine, as it is now. Most medical care decisions were made for patients by their physicians, often with little or no discussion of potential risks, benefits, or alternatives, nor with significant input from the patient or family. In recent years, this pendulum has shifted radically towards decision-making completely or largely by the patient or surrogates, especially near the end of life. In order to bring rationality back to decision-making at the end of life, we need to guide the pendulum back towards the middle to achieve a balance between autonomy and physician responsibility. This shift has occurred because the ethical principle of autonomy has attained a position of primacy over the other
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ethical principles of beneficence, non-malificence, and justice. Yet, in the philosophy of medical ethics, no one principle is supposed to carry more weight than any others; i.e., there is no ethical “trump card.” We, as physicians, are largely responsible for this state of affairs. By shifting decision making to patients or surrogates, we have abandoned our duty to our patients to provide treatments which are beneficial and not knowingly harmful. Instead, we ask untrained, non-professionals to weigh complex medical issues and make extremely difficult decisions. We exacerbate this problem by mistaking plan of care for goals of care. We should be asking patients or surrogates about their goals for their remaining life; i.e., “Do you want to live as long as possible, as comfortably as possible, or something in between?” Instead we ask, “Do you want CPR, tube feedings, hospitalization, etc.?” All too often, we see the bizarre plans of care which result from this method of communication such as “yes” to CPR but “no” to ICU care or, even more illogically, “yes” to chest compressions and defibrillation but “no” to intubation and mechanical ventilation or vice versa, thus artificially separating the C from the P of CPR. Even worse, we frequently ask surrogates what they want us to do for their loved ones rather than what the patients would want if they could speak for themselves. This strategy adds guilt to the already profound burdens on the shoulders of surrogate decision-makers. It should be our role as physicians to take the weight of such decisions to potentially limit
non-beneficial care on our professional shoulders rather than asking loving family members to add this to the already heavy burdens they bear when a loved one is approaching death. This odd state of affairs seems to occur primarily near the end of life. With much less momentous decisions, we generally have much less difficulty saying “no” to requests for illogical or non-beneficial care. I don’t know of any surgeon who would offer to perform an appendectomy for a patient with obvious indigestion just because the patient insists upon having the procedure. Neither does the internist offer anti-diabetic medicines to the patient who insists on insulin therapy after reading in a website that a fasting blood glucose of 100 mg/dl is abnormal and requires prompt treatment. Why then do we agree to attempt CPR on a patient dying of widespread cancer when we know the chance of a successful resuscitation approaches zero? Or why do we not say “no” when the family insists on instituting hemodialysis in their loved one in acute renal failure due to shock from multi-organ system failure with ARDS, DIC, sepsis, and heart failure? As Dr. Hitzeman points out in his essay, 30 percent of Medicare expenditures occur in the five percent of beneficiaries who die. Any of us who has ventured into an ICU in recent years knows that at least 1 out of 3 patients (and often many more) have illnesses from which they obviously will not recover to hospital discharge. Or, at best, they will be discharged to a skilled nursing facility in a severely debilitated state, only to return to the hospital in very short order and will never again live anything resembling an independent life. Continuing this practice completely ignores the ethical principle of justice (a fair allocation of finite medical and financial resources). What needs to be done? We need to know and communicate to our patients the best available information on prognosis (data-based when such data exist, as is the case for many end-stage illnesses) to assist in the decisionmaking process. This does not necessarily mean we have to say, “You have X number of days/
weeks/months to live,” but it also doesn’t mean we can say, “I really have no idea how long this process will take; it’s not in my hands.” Rather, we should give educated estimates such as, “It looks like a matter of days to a couple of weeks,” or, “The data (or my experience with patients like you) lead me to believe that it would be surprising if you were still alive six months from now.” We need to accept and educate our patients and their families that just adding more care and/or technology to an endstage illness will not prolong or improve quality of life; i.e., death is not optional. Finally, we need to accept and reassert our role as physicians, rather than simply ”providers” of information. We can make recommendations (with compassion and sensitivity) to our patients and families about the best options for care. We can return medical decision-making to physicians where it belongs and relieve the heavy burden of guilt placed on patients and families when we ask them to assume our responsibility for making difficult decisions. If we can start the process of bringing the pendulum of medical decision-making back towards the center, between total autonomy and total paternalism, then perhaps we won’t have to ask, as did Dr. Hitzeman, “Doesn’t anyone die in their sleep anymore?” email@example.com
Finally, we need to accept and reassert our role as physicians, rather than simply ”providers” of informa-
Dr. Blum is Medical Director, Bristol Hospice, Sacramento.
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The Gestation of an SSV Medicine Blog By John Loofbourow, MD I’d like to invite readers to an SSVMedicine blog, a new feature of our online magazine. When you run into an interesting link, blog, or site, please take a moment to email the address (URL) to e.LetterSSVMedicine@gmail.com. It will be considered for publication at our blog, www. ssvmedicine.wordpress.com. Among our relatively large membership, many will occasionally find blogs or links that could be enjoyed by others among us; we are a relatively large and diverse medical society, and should collectively discover far more items of interest than any one of us alone. As URLs or comments are offered by readers, they will be edited and added to the blog when they come in, rather than bimonthly as they would be in the hard copy magazine. This should make blog communication timely. URLs will be ”live” in the online edition. When reading the online magazine, open the blog link to read what colleagues have contributed there recently. While our in-hand print version retains its unique appeal, reader activity in our online version continues to grow steadily. I suggest that the printed issue and its online version are symbiotic; each delivers much that the other lacks. The portability, comforting solid feel, and look of a good print magazine cannot be duplicated online. Yet an online magazine offers almost instant connection in vivo to an electronic universe that is infinite and expanding ever more rapidly, like the known cosmos. SSVMedicine online issues are emailed to members, and are open access, available by browser to anyone, at www.SSVMS.org. The addition of a blog offers an opportunity for
more timely and convenient communication among our readers.1 To read a hard copy article, to then write and mail or fax a response, is not very appealing in a sound bite culture; while to respond to a posit, or to send an e.Letter is fast and convenient. Yet e.Letters and posit commentary, are stored for several weeks until publication. They are ideal for our print issues, but are only first steps on the road to an electronic magazine’s full potential, where moving forward requires ongoing, active involvement of members and readers, rather than merely editors; the push must be live, alive, and lateral rather than vertical. It must draw on the talent and diversity among all of us rather than an Aristotelian few. What I am attempting to describe here is simply an undefined life form. Whether that creature survives, or is even viable at all, or what it may grow to be is not clear. It’s up to readers to determine its future as it struggles to develop. Take a look at the following URLs**, contributed by the Editorial Committee and members, and posted at www.ssvmedicine.wordpress.com: • A fine graphic on average radiation exposure from different common sources. (via Dr. Barish-Wreden) http://www.scientificamerican.com/article. cfm?id=exposed-graphic-science&WT.mc_ id=SA_CAT_HLTH_20110517 • About universal high cost, low quality healthcare (Via Editors) http://scientopia.org/blogs/whitecoatunder ground/ • About fatuous, deceptive disclaimers in advertising. (via Editors) http://scienceblogs.com/whitecoatunder ground/2008/01/quack_miranda_warning.php May/June 2011
Comments or letters, which may be published in a future issue, should be sent to the author’s email or to e.LetterSSV Medicine@gmail. com. 7
• A commentary on narcotic prescribing (via Drs. Risley and McCarthy) http://www.theregister.co.uk/2011/05/12/broad band_equals_drug_abuse/ • About Turkey in the 1600s — Smallpox immunization, and women’s rights. http://millicentandcarlafran.wordpress. com/2011/03/27/lady-mary-wortley-montaguand-the-womens-coffee-house/ • The original blog that first clearly outlined Julian Asange’s Wikileaks position. Within minutes it was picked up by the world press, quoted, and attracted many thousands of “hits” within a few hours of posting. (This and the following blogs via John Loofbourow) http://zunguzungu.wordpress.com/2010/11/29/ julian-assange-and-the-computer-conspir acy-%E2%80%9Cto-destroy-this-invisiblegovernment%E2%80%9D/ • An essay by the same author, about a Washington Post article and chart depicting
the “worth” of various advanced degrees; “a chart is where knowledge goes to die.” http://zunguzungu.wordpress.com/2011/05/24/ education-and-the-path-to-riches/ http://thehappyhospitalist.blogspot.com/ (also at wordpress.) • From http://bestmastersinhealthcare.com/2010/ top-50-blogs-by-physicians/ list of most frequently visited physician blogs. Many of these blog sites are directed to the public. This one includes a stash of humorous medical signs, is addressed to hospital gnomes. http://thehappyhospitalist.blogspot.com/ This is a learning process, dear reader. If the links don’t work perfectly, please be patient. We will try to improve. firstname.lastname@example.org ** Some blogs are quite active; here you may need to scroll down to find this post. Please contribute to or visit the blog, and consider leaving a comment! 1 See the San Francisco Medical Society blog at http://sfmedical society.wordpress.com.
Your care makes all the difference. Roberta Reid, BloodSource employee, head-trauma survivor and grateful platelet recipient.
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For every patient, like Roberta, who gratefully receives the gift of blood — and another day to be with family and friends — there are countless medical professionals whose care and support make all the difference. Thank you for the care you give to every man, woman and child whose life depends on the precious gift of blood. Yes, you do save lives.
Now Do We Have a Clear Conscience? A new regulation leaves many unanswered questions about U.S. “Conscience Statutes.”
By Shilpa Mathew, Esq. Shilpa Mathew is an associate at the Law Office of Barbara A. Goode in San Francisco and a legal intern at the California Medical Association. She specializes in health law, and will be starting at UC Davis School of Medicine in the fall. ON DECEMBER 19, 2008, the U.S. Department of Health and Human Services (DHHS) issued a federal regulation entitled, “Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law.”1 Known as the “2008 Rule,” it was designed to interpret already existing federal healthcare conscience laws and offer more extensive protection to physicians and other healthcare workers who refuse to provide care they find objectionable on religious or moral grounds. This 2008 Rule was the subject of great controversy. Those in favor of the rule applauded its attempt to fortify conscience rights. Those opposed shuddered at its unclear and potentially overbroad scope. Shortly after being elected, President Obama announced he would overturn the 2008 Rule. After gathering extensive commentary from the public, DHHS issued a partially revised and partially rescinded version of the 2008 Rule on February 23, 2011.2 DHHS stated this version, the “2011 Rule,” was intended to support clear and strong conscience protections for healthcare providers, while minimizing the potential for harm from any ambiguity and confusion that may have
been caused by the 2008 Rule. The law went into effect on March 25, 2011, but will continue to develop as it is enforced. This article briefly explains the four federal healthcare “conscience statutes” that are in effect, the important changes the 2011 Rule made, and their implications.
Existing Conscience Laws Church Amendments3 These amendments were enacted to protect conscience rights of entities and individuals that object to performing or assisting in abortions or sterilization procedures if doing so would be contrary to their moral convictions or religious beliefs. This provision also extends protections to personnel decisions and prevents discrimination against any physician or other healthcare personnel in employment because the individual performed an abortion or sterilization, or refused to perform one because it was contrary to the individual’s religious beliefs or moral convictions.4 Weldon Amendment5 This law allows the federal government to withhold federal funding from any federal, state or local entity that discriminates against any institutional or individual health care entity6 for not providing, providing coverage of, paying for, or referring for abortions. 7 Public Health Service Act Section 2458 This law prohibits the federal government and any state or local government receiving federal financial support from discriminating
Comments or letters, which may be published in a future issue, should be sent to the author’s email or to e.LetterSSV Medicine@gmail. com.
against any health care entity on the basis that the entity refuses to undergo training in the performance of induced abortions, to require or provide such abortion training, to perform such abortions, or to provide referrals for such training or such abortions. The law also protects entities that refuse to make arrangements for such activities and those that attend a post-graduate physician training program or any other program of training in the health professions that does not perform induced abortions or require, provide, or refer for training in the performance of induced abortions, or make arrangements for the provision of such training.9 Patient Protection and Affordable Care Act10 This Act includes new healthcare provider conscience protections in the health insurance exchange program, and states that no qualified plan offered through an exchange may discriminate against any individual healthcare provider or healthcare facility because of its unwillingness to provide, provide coverage of, pay for, or refer for abortions.11
Revisions in the 2011 Rule
The 2008 Rule defined the terms used in the Conscience Statutes and how they would be applied, noted requirements and prohibitions of those statutes, and created an enforcement mechanism. It also required recipients and subrecipients of any DHHS funds to submit written certification that they would operate in compliance with the Conscience Statutes. The 2011 Rule confirmed that the Office for Civil Rights would be in charge of receiving complaints of discrimination and coercion based on the Conscience Statutes. However, it deleted all the definitions, applicability discussions, and the certification requirement. Instead of requiring providers to file independent paper certifications acknowledging protections in Conscience Statutes, the Office for Civil Rights will instead consolidate these written acknowledgments into federal funding grant paperwork.
…the 2008 trend that was widely seen as, for example, allowing pharmacists to refuse to fill prescriptions for the emergency contraceptive Plan B, allow-
fertility treatments to lesbians, and allowing hospital janitors to refuse to clean an operating room used for an abortion.
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Implications for Providers This new rule seeks to maintain only the long standing protections specifically mentioned in the Conscience Statutes, offering safeguards for providers not wanting to be involved with abortions or sterilizations in some context. In fact, DHHS’ comments on the 2011 Rule specifically stated that the term “abortion” in the Conscience Statutes does not include contraception. DHHS also emphasized that the Conscience Statutes were designed to protect providers from being forced to participate in medical procedures that violated their moral and religious beliefs, but were never intended to allow providers to refuse medical care to individuals engaged in behavior the providers found objectionable. It appears the 2011 Rule is attempting to counter the 2008 trend that was widely seen as, for example, allowing pharmacists to refuse to fill prescriptions for the emergency contraceptive Plan B, allowing doctors to refuse to provide fertility treatments to lesbians, and allowing hospital janitors to refuse to clean an operating room used for an abortion. Second, this rule sought to address access to medical care. The Attorney General of Connecticut had filed a lawsuit to block enforcement of the 2008 Rule, stating it jeopardized access to vital medical services such as emergency contraception and HIV/AIDS treatment by interfering with enforcement of state laws that provided for these services. Connecticut was joined by the attorneys general for Massachusetts, New Jersey, Rhode Island, Illinois, California, Oregon, and New York. DHHS agreed with these states’ concerns, and stated that the 2011 Rule sought to prevent any reduction in healthcare access. The lawsuit was dropped after the 2011 Rule was issued. Third, the rule reaffirmed a process for enforcement and emphasized the importance of outreach and education to improve knowledge of the Conscience Statutes. The Office for Civil Rights of DHHS will receive complaints, conduct investigations and enforce the Conscience Statutes in conjunction with the staff of DHHS.
Additionally, the Office for Civil Rights will work to educate healthcare providers about protections under the Conscience Statutes. Fourth, regarding informed consent, DHHS states in its comments on the 2011 Rule that the provider-patient relationship is best served by open communication of all conscience issues surrounding the provision of health care services. DHHS strongly encourages providers to provide patients with all information surrounding sensitive issues of health care. Thus, for example, instead of failing to inform about abortion as a viable treatment option, a doctor should tell a patient about that option and then tell the patient abortion is not offered at the doctor’s office in exercise of his or her conscience rights. Finally, the 2011 Rule sought to reduce any added costs to providers. Accordingly, instead of requiring providers to submit a written certification and taking on the administrative costs of collecting and maintaining such information, DHHS will now instead amend its grant documents to include an acknowledgement of compliance with the Conscience Statutes.
Questions Under the New Rule The 2011 Rule leaves some intriguing, unanswered questions. From the point of view of provider compliance, there may be some confusion as to how to follow the law. The federal government could have revised any potentially overbroad definitions and applications in the 2008 Rule. Instead, it deleted them and left application of the Conscience Statutes to individual investigations by federal agencies. This action fails to clarify what is objectionable and what is permissible. This is especially worrisome in the context of comparing state and federal laws.12 Federal regulations ordinarily preempt any conflicting state laws. Without explicit textual clarity and specific guidance on applicability, it is more difficult to determine if state and federal laws are in conflict. From a lawmaking standpoint, this seems to be a clear example of how cutting edge medical science and evolving societal definitions of
marriage, healthcare roles and cultural norms outpace the law. The Conscience Statutes are antiquated. Medical science has progressed way past abortions and sterilizations. Healthcare institutions now have several types of healthcare workers (not just physicians, nurses and support staff) looking to see how they fit into the regulatory framework. The healthcare industry is looking for clear guidance on these issues and the 2011 Rule does not provide clear, textual answers. Finally, from a theoretical standpoint, is a provider’s conscience truly protected with the 2011 Rule? What if, for example, a provider’s conscience dictates selective provision of fertility treatments? DHHS has failed to offer explicit law on this issue. Instead it has taken a “back-end” approach, stating this issue will be determined through independent investigations of federal agencies in response to complaints. Consequently, how the 2011 Rule will operate in actual practice will likely be determined through enforcement actions and subsequent litigation. email@example.com
The healthcare industry is looking for clear guidance on these issues and the 2011
1 Laws are created by statutes that originate from legislative bills. Regulations are standards adopted as rules by federal agencies to interpret, apply and enforce the laws. Both laws and regulations have the same effect. 2 See text of law at 45 C.F.R. 88.1 et seq. 3 See 42 U.S.C. 300a-7. 4 See http://www.hhs.gov/ocr/civilrights/faq/providerconsciencefaq. html. 5 See Pub.L.No. 111-117, 123 Stat 3034. 6 Note that the definition of “health care entity” under this Act also includes an individual physician or other health care professional, a hospital, a provider-sponsored organization, a health maintenance organization, a health insurance plan, or any other kind of health care facility, organization, or plan. 7 See http://www.hhs.gov/ocr/civilrights/faq/providerconsciencefaq. html. 8 See 42 U.S.C. 238n. 9 http://www.hhs.gov/ocr/civilrights/faq/providerconsciencefaq. html. 10 See Pub. L. No. 111-148 as amended by Pub. L. No. 111-152; See also Executive Order 13535. 11 http://www.hhs.gov/ocr/civilrights/faq/providerconsciencefaq.html 12 For example, consider this hypothetical scenario: A state law declares that physicians providing HIV/AIDS treatment must comply with state anti-discrimination laws and thus may not selectively decline HIV/AIDS treatment to certain individuals because of moral objection. Neither the Conscience Statutes nor the 2011 Rule contain textual guidance on this issue, so it makes it more difficult to assess whether this state law conflicts with federal law.
Rule does not provide clear, textual answers.
The Drug Expiration Date: A Costly Illusion By Scott Sattler, MD
This is the first of a two part series. The second will appear in our next issue. The article originally appeared as three essays in the Humboldt Del Norte Medical Society Bulletin, and has been edited and revised by the author. Recently I noticed that the label on my prescription carried a new warning. Somewhere along the way the old “Good Until” had been replaced by the much more ominous words, “Do Not Use After,” and it set me thinking. What’s with this drug expiration business anyway? Who determines the magic moment when a medication goes from being perfectly fine and dependable to being so potentially dangerous or useless that it needs to be discarded for reasons of health and safety? How are such determinations made? What does the phrase “drug expiration date” really signify? I called my friendly local pharmaceutical rep. He referred me to a fellow rep who gave me his company’s physician access line. I called and asked these questions, and was told that someone higher-up would get back to me. A while later I got a call from a woman who quickly informed me that our conversation would be recorded and asked if that was OK with me. When I assured her it was, she told me (as best as I can recall, for I didn’t record the conversation) that each pharmaceutical company is responsible for setting the date for each batch of medicine it produces, by order of the FDA. I was told the process involved proving that the drug would still be good on the date stamped on the batch. I asked whether it was good after that date as well, and she repeated that it was good on the date indicated. I asked if this date actu-
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ally defined the time when the drug had been shown to become unstable and/or unsafe, and she again affirmed that the drug was safe up to the time of its expiration date. At some point the conversation became more circuitous than I could follow, so I asked if she would kindly fax or email me the information I sought. To my surprise, she told me that she had been instructed very clearly by her supervisors that she was to send nothing to me in writing pertinent to this conversation. Our information exchange was to be absolutely verbal only. Since this was a pretty good conversation stopper, it was clear that I needed to look elsewhere. Thank God for Google.
The FDA Regulations In 1979 the FDA began to require that drug products bear an “expiration date” which was to be supported by appropriate stability data. But despite the use of the word “expire,” as in “die,” the FDA did not actually require drug manufacturers to determine how long a given medication remained safe and effective. Instead, it allowed companies to choose an arbitrary date and to perform tests demonstrating the drug’s safety and efficacy as of that selected date. Interestingly, the 1985 federal regulations recommended that “stability testing be performed initially, every three months for the first year, every six months for the second year, and annually thereafter. “However, more frequent testing near the end of the anticipated expiration date is likely to give better information about the actual stability of the finished product. Nonetheless, testing
annually is considered minimal for compliance with CGMPs [Current Good Manufacturing Practices].”1 I find it fascinating that this specific requirement for prolonged ongoing stability testing to determine a drug’s true expiration date no longer exists.2 Clearly the term “drug expiration date” has become a misrepresentation of reality, an obfuscating misnomer. What the FDA currently allows to pass for an “expiration” date is, in truth, a “good at least until” date.
The Wall Street Journal Weighs In On March 28, 2000, Laurie P. Cohen, a Pulitzer Prize winning investigative journalist working for the WSJ, published a feature story on just this subject.3 She reported that in 1985 the Air Force had become very concerned about the costs needed to destroy and replace their worldwide multimillion-dollar stockpile of medications every two to three years. They asked the FDA to check 58 different pharmaceuticals to determine which, if any, might be safely used beyond their expiration date. After testing, the FDA extended more than 80 percent of the 137 expired lots, by an average of 33 months. More than half of the drugs studied in 1985 were still safe and potent when they were retested yet again in 1992. Some remained stable for 15 years post expiration. They reportedly saved 59 times the cost of the drug testing in this first year alone by avoiding destruction of perfectly good medications.
The DOD-FDA Shelf Life Extension Program (SLEP) The Department of Defense was interested in these findings (it was holding over $1 billion in medication reserves) and invested nearly $3.9 million from 1993 through 1998 to do further stability testing on an expanded group of over 100 pharmaceuticals. During this fiveyear period it found that 88 percent of tested medications were clearly safe and effective far past their original expiration date and the DOD saved more than $263 million on drug replacement expenses. They named this program SLEP, the Shelf
Life Extension Program4, and it continues to this day. The FDA administers it for the Army, Navy, Air Force, Marines and Coast Guard. It probably contains the most extensive source of pharmaceutical stability data in the world. Unfortunately, full access to this huge database appears to be restricted to the military branches listed above. My research to date indicates that this restriction specifically excludes sharing data with the U.S. Public Health Service and, as you can see, the general public. Francis Flaherty, pharmacist and former director of this FDA testing program, concluded that expiration dates have essentially no bearing on whether or not a drug is usable for a longer period, and that the stated expiration date does not mean or even imply that a given drug will stop being effective or become harmful after that date. He went on to share his perception that “Manufacturers put expiration dates on for marketing, rather than scientific, reasons.” Flaherty retired from the FDA in 1999. The following are some specific SLEP findings that might be of interest. As you read them, understand that, according to the 1992 FDA SLEP director Flaherty, the outdate extensions SLEP authorizes are “intentionally conservative,” in that if SLEP extended an outdate by 36 months, it had concluded that the drug would be safe and effective (maintaining at least 90 percent of its labeled active ingredient without degrading into toxic substances) for at least 72 months. Tetracycline: In 1963 G.W. Frimpter et al reported in JAMA, (184:111) that outdated tetracycline degraded into a toxic substance, causing kidney damage and reversible Fanconi’s syndrome. This has been the only known study to purport that a prescription medication became toxic with age. Despite the fact that other studies failed to confirm this report, this allegation continues to mislead physicians and pharmacists. In fact, the current (2010) Merck Manual listing for tetracycline still contains this toxic information. To the contrary, SLEP found tetracycline to be quite stable. If stored correctly, it can be used safely for years beyond its stated expiration date.
More than half of the drugs studied in 1985 were still safe and potent when they were retested yet again in 1992. Some remained stable for 15 years post expiration.
Aspirin: Bayer gives a 2-3 year outdate label on its aspirin and states that it should be destroyed after that date. SLEP found that this product was good for at least four years from manufacture, and Dr. Jens Carstensen, professor emeritus of pharmacy at the University of Wisconsin, found that it was still stable after five years. The 2010 Merck Manual states that aspirin, too, becomes toxic beyond its stated expiration date. Acetylsalicylic acid (ASA) may break down into salicylic acid and acetic acid (the active ingredient in vinegar) after prolonged exposure to heat and humidity, but neither substance is toxic at these levels. Salicylic acid was actually a precursor of aspirin (ASA) and is still being used as an anti-inflammatory. Cipro: The DOD maintains a large stockpile of Cipro (Bayer) to deal with the threat of disseminated anthrax. It carries a three year outdate. SLEP was asked to evaluate Cipro stability and
found the tablets to safely maintain potency for at least 13 years after manufacture. Atropine injectable: Not a common household medication, this drug is used in hospitals and clinics worldwide to control secretions and cardiac arrhythmias. Itâ€™s also important in the treatment of nerve gas poisoning. The standard military outdate was for two years after manufacture. SLEP found it to be stable for 15 years after manufacture. Pralidoxime HCL autoinjector: This nerve gas antidote carried an initial shelf life of five years. SLEP found it to be safe and effective for 18 years. Diazepam autoinjector: This anti-seizure medication (Valium) carried an initial shelf life of four years. SLEP extended it to nine years. Doxycycline tablets: Its initial shelf life was two years. SLEP found it still safe and effective at seven years. The list goes on and on: Penicillin, Thorazine, Tagamet, Lasix, Dilantin, potassium iodide, captopril, cefoxitin, each had their outdates extended by SLEP investigators. Interesting, isnâ€™t it? firstname.lastname@example.org 1 Title 21 Code of Federal Regulations: (21CFR 11.166) 10/18/85 Stability Testing: Number 41, Section B-3: Test intervals 2 Title 21 Code of Federal Regulations: (21CFR 211.166) 04/2010 Stability Testing: Chapter I, Subchapter C 3 Cohen LP. Many medicines prove potent for years past their expiration dates. Wall Street Journal. March 28, 2000. http://www.terrierman.com/ antibiotics-WSJ.htm 4 Garamone J. Program extends drug shelf-life. American Forces Press Service. March 29, 2000
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Plate Reform: A Call to Action! By Sarah Jones, MD “One cannot think well, love well, sleep well, if one has not dined well.” — Virginia Woolf I invite you to come with me to the “banquet-eating table.” I wish to take you on a journey that will whet your appetite and make you carefully consider that age-old ritual of sharing meals. Along the way, I’ll introduce pearls learned from the “Healthy Kitchens, Healthy Lives” CME course I recently attended. That’s right. A CME event about eating! It is hosted each spring at the historic Culinary Institute of America’s (CIA) St. Helena campus in collaboration with Harvard Medical School. The banquet table is set. Crisp white linen cloth serves as the backdrop for such savory delights as pistachio dukkah with herb-grilled flatbread, Indian-spiced grilled chicken skewers, and Greek yogurt cucumber salad with toybox tomatoes. Locally grown vegetables are prepared with zesty spices, herbs and aromatics. Rich olive oil lemon cookies punctuate the meal. Mouths water, anticipating the feast. Our host reminds us that “the banquet is in the first bite.” We intend to savor every morsel. Arguably, our challenge as physicians, parents, partners, and party hosts is to define “dining well.” Inasmuch as the dining experience is both necessary and pleasurable, we face an obesity epidemic affecting millions of our youth and adults. We have witnessed its myriad devastating health effects. Is it possible to promote health while satisfying our own palates? How can we get our patients to appreciate the cornucopia of emotions associated with the epicurean experience?
We have all heard some version of the German proverb, “Man is what he eats.” Indeed. More and more research underscores the direct relationship between our diet and our health. And so isn’t it worth our while to be thoughtful, mindful, and intentional about how we nourish ourselves and our families? And how do we achieve this in the midst of demanding, chaotic lifestyles and schedules? Why the zeal? Much of what I learned at the CME event resonated with me as a family physician. I value prevention and promoting wellness through natural means. More compelling were the delectable, healthful dishes we enjoyed throughout the course. Take a glimpse at our breakfast offering: black bean omelets with cheddar cheese and avocado salsa verde, mixed citrus salad with mint and peanuts, and cottage cheese with tomatoes, arugula and extra virgin olive oil. Clearly, the food served was unlike any other food presented at a CME conference — no dense pastries with trans-saturated fat, overly sweet yogurt, or oil-laden muffins. Absent were the mid-morning or mid-afternoon reactive hypoglycemic “crashes.” Combining science and years of research presented by some of the “big names” in nutrition, together with the hands-on demonstrations by the CIA’s chefs, the four-day conference delivered its message loud and clear: It is possible to eat mindfully, healthfully, sustainably, and enjoyably across the age spectrum and amidst demanding schedules. Thought-provoking lectures were bolstered by live cooking demonstrations and kitchen workshops. Dr. Regina Benjamin, U.S. Surgeon
Comments or letters, which may be published in a future issue, should be sent to the author’s email or to e.LetterSSV Medicine@gmail. com. 15
General, joined us in the midst of Japan’s posttsunami nuclear crisis to endorse the message of healthy lifestyles underscored by healthy eating and regular physical activity. Engaging all the senses, visually, aromatically, audibly. Hearing the pop of onions “sweating,” tactilely. Handling heavy duty Viking knives in the CIA’s huge professional kitchen, and, of course, sampling too numerous to count dishes — I have never been so compelled to put into practice the tools I learned. I returned to my humble home with a mission — a mission for my own family of six, a mission to introduce healthy cooking techniques to my office staff and patients, and ultimately, a mission to develop a teaching kitchen for my community. Here are four simple “doable, delectable diet strategies” that I immediately put to task upon returning home and hope you might try, too: 1. Plan ahead. Yes, that’s right. Whether you’re planning for one, two, or ten, planning ahead makes all the difference…and more so if you need to accommodate special dietary needs or specific cultural or religious considerations. Savor the
time to consider your nourishment for the week ahead. We are born with one body. It is worth the effort to fuel that body efficiently and enjoyably. Readers may contact me for a simple meal planning worksheet. 2. Trim your plate. Use smaller plates — try 9-inch plates instead of 11-inch plates. Our eyes truly are often bigger than our stomachs. Fill up a smaller plate, take time to taste each bite, chew it well, and eat to satisfy hunger — not boredom or habit. 3. Reform your plate! Tantalize your palate by changing the composition of your food palette. An idea popularized by author Mollie Katzen (The Vegetable Dishes I Can’t Live Without; Moosewood Cookbook): Fill half of your plate with colorful vegetables and fruits, a quarter with lean protein (4 oz lean meat or protein) and the rest with a complex carbohydrate or whole grain. Complete your meal with a glass of water and perhaps a glass of wine. 4. Share at least one meal a day with someone else. Surround yourself with friends and loved ones, be thankful for the food you are about to
Pistachio Dukkah Ingredients Amounts pistachios, dry roasted, finely chopped 1 cup sesame seeds ½ cup coriander seeds ⅓ cup cumin, ground 2 tsp sea salt 2 tsp, or to taste sugar 1 tsp, or to taste black pepper, freshly ground 2 tsp, or to taste Method 1. Toast the sesame seeds and coriander seeds separately in a dry pan over moderate heat on a stove or in a preheated 400°F oven for 3 to 5 minutes, or until fragrant. 2. With a spice or coffee grinder, grind the coriander in short bursts until reasonably fine; add to a bowl along with the pistachios and sesame seeds. 3. Grind the cumin, salt, and sugar together until very fine; taste and adjust the seasonings. Store in an airtight container for up to 4 weeks. Recipe credit: John Ash, as presented at the Healthy Kitchens, Healthy Lives Conference. Presented at Plenary Session I and tasting reception on March 17, 2011.
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partake, and share the highlights of your day as you enjoy your meal. So, if questions like “What’s for dinner?” And, “What did you pack in my lunch?” send your head spinning, your blood pressure rising, or simply make you cringe, take heart. Two weeks after the conference, my children’s lunch boxes were transformed. Pistachios and dried fruit replaced bags of chips. We’ve started enjoying wild rice and farro, and I’ve introduced dukkah as a condiment. We’ve made a small garden and marvel at the inch-high sprouts that emerged a mere nine days after planting carrot, edamame, and tomato seeds. So far, so good! The time for action is now. Our mission is clear. Please join me — in your homes, in your offices, in your community — in promoting healthy eating habits as we fight the war on obesity, one bite at a time. I have included two recipes that I hope you’ll try, used with permis-
sion of the CIA. I welcome your ideas and comments. Bon appétit! email@example.com Dr. Peña’s Breakfast Shake (easily modifiable and affordable) Ingredients Amounts low-fat soy milk 1 cup (can use almond milk) blueberries, fresh or frozen ½ cup raspberries or strawberries ½ cup banana 1 ea. oatmeal, raw ¼ cup (optional) walnut halves 3 ea. protein powder 1 Tbsp. (optional) flaxseed 1 Tbsp. orange juice concentrate 1 tsp. (or squeezed lemon juice) Method 1. Combine all the ingredients in a blender. Add water (or ice) to achieve the desired consistency. Source: Dr. Heather Peña. Presented at Kitchen Sessions F-1, F-2, and F-3
Cardiology: the Pulse of Evidence-based Medicine? By Nathan Hitzeman, MD
As a family physician coordinating care, I get a unique perspective into all the different specialties. I know and respect many cardiologists who are excellent diagnosticians and technicians. I have enjoyed their Powerpoint lectures complete with the plaque progression slides and homage to Lance Armstrong. Heart disease is the leading cause of mortality in the US and the world, but its scourge has diminished in recent decades thanks to many advances in cardiac care — in particular blood pressure and lipid management. Indeed, much has changed since the days of FDR, whose painful progression of heart disease was so thoroughly documented without any tools to treat it!1 Unfortunately, as in many fields, technology and monetary incentive are outpacing common sense in cardiology. The New Yorker article, “The Cost Conundrum” by acclaimed writer/surgeon Atul Gawande, highlights some of the excesses of cardiology.2 He compared two counties in Texas with similar demographics: McAllen and El Paso. McAllen spends twice as much per Medicare patient as El Paso and is known as “the most expensive town in the most expensive country for health care in the world.” McAllen patients “received two to three times as many pacemakers, implantable defibrillators, cardiac bypass operations, carotid endarterectomies, and coronary artery stents” but ostensibly were no better off than patients in neighboring El Paso. As health care reform rolls out Accountable Care Organizations (ACOs) next year with the prospect of bundled payments for Medicare patients, cardiology may find itself squarely
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in the crosshairs of targeted health care costs. Following are some examples of how cardiology has strayed from evidence-based medicine and what we need to do to get it back on track. I hope this information will help your patients and family make informed decisions.
Stents These cute little lifesavers are hands-down ingenious and everyone seems to be getting them. Bare metal stents were too simple, though. The much more expensive drug-eluting stents promised to be far superior, and they do reduce rates of restenosis, but not as dramatically as first thought. In a large Swedish registry, patients who received bare metal stents were compared with those who received drug-eluting ones over a mean of 2.7 years.3 Surprisingly, drug-eluting stents did not reduce the incidence of death or myocardial infarction compared to bare-metal stents. The prevention of restenosis was modest: “39 patients would need to be treated with drug-eluting stents to prevent one case of restenosis [over one year].” Furthermore, not all patients with coronary artery disease need stenting. The COURAGE study showed that patients with stable angina who undergo elective percutaneous intervention (PCI) do not fare better in terms of death or myocardial infarction compared to those receiving optimal medical management.4 Although a small benefit in anginal burden was seen in the PCI group, it is dubious whether that is clinically significant or worth the risks and radiation of PCI. An editorialist to the COURAGE trial noted that “one third or more
of contemporary patients undergoing PCI are similar to the patients in the COURAGE trial.”5 Considering the sheer volume of PCIs done annually, that’s a whole lot of unnecessary procedures and fluoroscopic radiation exposure!
Plavix I have found Plavix ubiquitously prescribed and indefinitely continued in post-stent patients. Undoubtedly, this has boosted business for gastroenterologists who see these patients frequently for GI bleeds, but is this the best care for our patients? The evidence for using Plavix during acute coronary syndrome and for one month after stent is strong. It dramatically decreases acute thrombosis, especially in drug-eluting stents. However, recent evidence has emerged that Plavix offers no additional benefit beyond 12 months out from stent.6 Moreover, the benefits from months 1–12 are overstated. The CREDO study showed that patients randomized to 12 months of Plavix versus one month did not have statistically significant differences among the individual outcomes of death, MI, stroke, or target vessel revascularization.7 However, a 27 percent relative risk reduction was seen in the composite end point of death, MI, or stroke at one year (for an absolute risk reduction of only 3 percent, NNT = 33). The absolute risk reduction is much less compelling than the relative risk reduction, but it was not reported in the abstract. This leads me to my next gripe.
Composite Endpoints Cardiovascular studies are notorious for measuring benefits in terms of composite end points — that is, multiple outcomes lumped together to reach statistical significance. However, a recent BMJ study seriously questions the validity of composite end points as a valid measure of improved health outcomes.8 In this systematic review of prominent cardiovascular studies, authors Ferreira-Gonzalez et al state that “clinical trials, particularly in cardiology, often use composite end points to reduce
sample size requirements.... Use of composite end points appeals to clinical trialists because it increases event rates and statistical power.” However, here’s the rub given by the authors: “A claim that an intervention reduces a composite of cardiovascular mortality, myocardial infarction, and revascularization procedures is problematic if most events were revascularization procedures and treatment had a large effect on revascularization but not on death or infarction.” Think of it this way: it’s like saying, “Michael Jordan and I together scored 60 points in a basketball game.” Sounds great, but I didn’t do much of the scoring! In short, if the results are that earth-shaking, they should show more than just composite end point significance.
Patient Understanding Patients, and probably many clinicians, are clueless about the vagaries of this statistical buffing. Many patients think anything their cardiologist recommends is life-saving and absolutely necessary. In fact, some researchers looked at the perceived benefits of PCI for stable angina after the COURAGE results became known by conducting an interesting consenting study.9 In this study of 153 patients with stable angina, 53 of whom underwent elective PCI and received “informed consent,” 88 percent of patients surveyed after consenting believed that PCI would lower their risk for MI, and 82 percent believed that it would lower their risk for death. Cardiologists surveyed gave responses of 17 percent and 15 percent, respectively. Hence, this study calls for proceduralists to not only educate patients on the risks of a procedure, but also to adequately inform them on what they can realistically expect to gain from the procedure.
Think of it this way: it’s like saying, “Michael Jordan and I together scored 60 points in a basketball game.”
Implantable Cardiac Devices A number of my patients have sprouted pacemakers and implantable cardioverter-defibrillators (ICDs) on their chests. These devices started as intimidating brick-like devices and now are the size of small breath mint dispensers. They are remarkably good at keeping the
I’m sure most clinicians mean well, but someone
has to take responsibility for the cost incurred and the accumulated radiation exposure.
heart going as long as the patient comes in for regular tune-ups. Indeed, Arne Larsson, the world’s first implantable pacemaker recipient in 1958, ended up going through 26 different models and outlived his pacemaker inventor as well as the surgeon! However, who is a suitable candidate for a pacemaker? Should patients with dementia and poor quality of life get a pacemaker at the request of their families or at the prompting of their cardiologist, instead of allowing a natural death? Should a pacemaker be turned off at the request of a family if natural death is desired? Furthermore, ICDs are not always benign. Between 10–20 percent of patients will receive unneeded shocks over a 5-year period. Also, a recent review of the National Cardiovascular Data Registry-ICD Registry showed that 25,000 patients, or about a quarter of all ICD recepients over a 3-year period, did not meet evidencebased criteria for implantation.10
Few people realize that nuclear med scans and PCI each impart 15 mSv of radiation to a patient, the equivalent of hundreds of chest X-rays.11 When I think of patients, many with anxiety-induced chest pain, who present to the Emergency Department almost yearly for a “rule out” and get yet another nuclear medicine scan, I cringe at their accumulated radiation exposure. In a recent retrospective cohort study of 1,097 consecutive patients who underwent nuclear heart scanning at Columbia University, NY, some findings were striking.12 When two decades of prior medical records were reviewed for these scanned patients, 38 percent had received an accumulated dose of 121 mSv from all their heart scans. That’s more radiation than those in the Life Span Study of Japanese atomic bomb survivors, and I’ll bet you not one of those patients knew that.12 I’m sure most clinicians mean well, but someone has to take responsibility for the cost incurred and the accumulated radiation exposure. While reforming malpractice may alleviate the defensive medicine aspect of “rule out”
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work ups, convenience and a lack of regulatory oversight are major contributors, too.
CAC and Other Procedures Some cardiology groups are performing diagnostic procedures without supporting evidence of clinical validity or utility. A case in point is the coronary-artery calcium (CAC) score scan. In a recent review, these scans impart anywhere from 1 to 10 mSv of radiation, but no studies to date have shown improved outcomes from the information gained.13 In a local Channel 13 News segment on November 21, 2009, an evidence-based medicine champion at the UC Davis School of Medicine was interviewed, and he strongly cautioned against CAC scans. This was lost on the reporter who ended the segment by getting a free scan herself through a local cardiology group well known for promoting them. Her reason: high cholesterol in her family. Funny, then, that the American Heart Association (AHA) issued a statement, with expert consensus from the American College of Cardiology (ACC), that it is reasonable to consider CAC screening in asymptomatic persons identified as having intermediate risk of coronary events on the basis of an assessment of multiple risk factors.13 Well, with the epidemic of obesity and diabetes in our country, that includes just about everyone! And that leads me to my last gripe.
Consensus Guidelines Consensus guidelines are often looked upon as holy gospel. They are frequently invoked to define standard of care in medicolegal proceedings. But how appropriate is this when consensus guidelines do not align with evidence-based medicine? The ACC/AHA are among the biggest offenders. In a September 25, 2009 article in JAMA, the authors noted that only 11 percent of current 2,711 ACC/AHA recommendations are based on Level A evidence (multiple randomized trials, meta-analysis supported), and 48 percent (the most frequent recommendations) are based on only Level C evidence (expert
opinion, case studies).14 The authors conclude that “clinicians need to exercise caution when considering recommendations not supported by solid evidence.” The sheer volume of medical care in this country behooves us to better scrutinize practices of the esteemed and respected field of cardiology — as well as other fields of medicine. Improvements in longevity and decreased death from heart disease no doubt have drawn from advances in cardiology. But we may be reaching a point of diminished returns for patient health and a point of too many returns — financially — for the profession. firstname.lastname@example.org 1 Levy D and Brink S., A Change of Heart: FDR’s Death Shows How Much We’ve Learned About the Heart. U.S. News & World Report. Feb 6, 2005. health.usnews.com/usnews/health/ articles/050214/14heart.htm 2 Gawande, A. The Cost Conundrum: What a Texas Town Can Teach Us About Heath Care. The New Yorker. June 1, 2009.
www.newyorker.com/reporting/2009/06/01/090601fa_fact_ gawande 3 James, S et al. Long-term Safety and Efficacy of Drug-eluting Versus Bare-Metal Stents in Sweden. NEJM. 2009;360(19): 1933-45. 4 Boden, WE et al. Optimal Medical Therapy With or Without PCI for Stable Coronary Disease. NEJM. 2007;356:1503-16. 5 Peterson, ED and Rumsfeld JS. Finding the Courage to Reconsider Medical Therapy for Stable Angina. NEJM. 2008;357(7):751-3. 6 Park, SJ et al. Duration of Dual Antiplatelet Therapy After Implantation of Drug-eluting Stents. NEJM. 2010;362(15): 1374-82. 7 Steinhubl, SR et al. Early and Sustained Dual Oral Antiplatelet Therapy Following Percutaneous Coronary Intervention. JAMA. 2002;288(19):2411-20. 8 Ferreira-Gonzalez, I et al. Problems With Use of Composite End Points in Cardiovascular Trials: Systematic Review of Randomised Controlled Trials. BMJ. 2007;334:786-8. 9 Rothberg, MB et al. Patients’ and Cardiologists’ Perceptions of the Benefits of Percutaneous Coronary Intervention for Stable Coronary Disease. Ann Intern Med. 2010;153:307. 10 Al-Khatib, SM et al. Non-Evidence-based ICD Implantations in the United States. JAMA. 2011;305(1):43-49. 11 www.radiologyinfo.org/en/safety/index.cfm?pg=sfty_xray#3 12 Einstein et al. Multiple Testing, Cumulative Radiation Dose, and Clinical Indications in Patients Undergoing Myocardial Perfusion Imaging. JAMA. 2010;304(19):2137-2144. 13 Bonow, RO. Should Coronary Calcium Screening Be Used In Cardiovascular Prevention Strategies? NEJM. 2009;361:990-7. 14 Tricoci, P et al. Scientific Evidence Underlying the ACC/AHA Clinical Practice Guidelines. JAMA. 2009;301(8):831-42.
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Family Practice or Emergency Medicine Physician We are currently seeking a Family Practice or Emergency Medicine Physician with a minimum 5 years ED experience for a 20-bed Emergency Department in the Contra Costa Regional Medical Center (CCRMC, located in the City of Martinez. CCRMC sees 60,000 patients per year in its Emergency Department and Fast Track. Family Medicine residency program works very closely with the ED. We offer a very competitive salary, pension and benefits package. Please contact Dr. Brenda Reilly, Chief of Emergency Medicine, at Brenda.Reilly@hsd.cccounty.us, or at (925) 370-5691 for further information and to schedule an interview. EOE
w w w.cchealt h.org
The Patient-Centered Medical Home (PCMH) By George Meyer, MD
The Patient-Centered Medical Home concept was introduced in 1967 by the American Academy of Pediatrics (AAP), initially to provide a central location for a child’s medical record. In 2004, the American Academy of Family Physicians (AAFP) developed its model as the “medical home” and the American College of Physicians (ACP) developed its concept in 2006, the “advanced medical home.” In 2007, the ACP, AAFP, AAP and American Osteopathic Association (AOA) published Joint Principles of the Patient-Centered Medical Home, summarized below. It is based on the idea that the PCMH is a healthcare setting that facilitates a partnership between the patient, the personal physician and, perhaps, the patient’s family members. The Joint Principles outline the ideal home, a physician or health care group (physician directed) that oversees all aspects of the patient’s care, is available at all times (on call persons), and coordinates care. Each patient should have a personal physician trained in all aspects of primary care, including first contact, continuous, and comprehensive care. This person or organization generally is responsible for enhanced access to care, including arranging for the patient to be seen in an urgent manner, if necessary. Quality and safety are key aspects of this system. Evidence-based medicine principles guide decision-making where such information exists. Information technology (IT) is used when it can be helpful to the care. Using IT, physicians in the PCMH practice strive for continuous quality improvement through voluntary engagement in performance measurement and improvement.
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Patients are encouraged to participate in decision-making, and feedback programs are developed to ensure patient expectations are met. Practices go through a voluntary recognition process by an appropriate non-governmental entity to demonstrate that they have the capabilities to provide patient centered services consistent with the medical home model. The National Committee for Quality Assurance (NCQA), a private not-for-profit organization dedicated to improving health care quality, introduced its Physician Practice Connections–Patient-Centered Medical Home (PPC-PCMH), a physician practice recognition program. The NCQA program uses standards established by the AAFP, the AAP, the ACP and the AOA. Practices seeking PPC-PCMH recognition must complete a web-based survey and provide documentation that validates their responses. The NCQA evaluates the practice data, then documents and scores the practice using a point system. There are six PCMH 2011 standards, including six “must pass” elements, which can result in one of three levels of recognition. (See the scoring system on the next page.) The AAFP has produced Road to Recognition, a guide to simplify the process, which can be downloaded by members and purchased by nonmembers. The ACP has developed a medical home builder. For more information about the PCMH, contact the NCQA Customer Support at 888-275-7585 or go to the NCQA site at www. ncqa.org/tabid/631/default.aspx. email@example.com
NCQA PCMH 2011
6 Standards, 27 Elements, 149 Factors Points 20
1 Enhance Access and Continuity
A Access During Office Hours
B Access After Hours
C Electronic Access
E Medical Home Responsibilities
F Culturally and Linguistically Appropriate Services (CLAS)
G Practice Organization
2 Identify and Manage Patient Populations
A Patient Information
B Clinical Data
C Comprehensive Health Assessment
D Using Data for Population Management
3 Plan and Manage Care
B Identify High-Risk Patients
C Manage Care
D Manage Medications
E Electronic Prescribing
4 Provide Self-Care and Community Support
A Self-Care Process
B Referrals to Community Resources
5 Track and Coordinate Care
A Test Tracking and Follow-up
B Referral Tracking and Follow-up
C Coordinate with Facilities/Care Transitions
A Measures of Performance
B Patient/Family Feedback
C Implements Continuous Quality Improvement
D Demonstrates Continuous Quality Improvement
E Performance Reporting
F Report Data Externally
6 Measure and Improve Performance
A Implement Evidence-Based Guidelines
Standard and Element
149 6 MP Factors Elements
Using CURES to Monitor Prescription Drug Use By John McCarthy, MD California is one of many states with a Prescription Drug Monitoring Program called CURES (Controlled Substances Utilization Review and Evaluation System). It tracks prescriptions of all scheduled substances, including names and addresses of patients, prescribing physician, and pharmacies. This program offers us the opportunity to know the past year of prescription use history of any patient we treat. As an addiction specialist using methadone and buprenorphine to manage opiate addiction, I have found it helpful in identifying patterns of use that assist in the diagnosis of opiate addiction — at least in those where prescriptions are the source of the drugs. And it helps detect those few who continue overuse of prescription meds in spite of treatment. In our case, this usually involves benzodiazepine prescriptions. So the CURES program has become a regular part of our initial evaluation and on-going assessment. This program should also be incorporated into all practices with high risks for dealing with opiate and benzodiazepine addictions, such as primary and urgent care clinics, pain clinics, and ER Departments. That said, this information can be misused to just kick patients out of our offices and ERs. Our job as physicians is to screen, do a brief intervention, and refer for treatment. Addicts are patients in need of help, but first they must be diagnosed and non-judgmentally engaged in a discussion of treatment options. Showing a patient pattern of overuse of prescription drugs can be the first step in helping them to recover. The system is now close to real time, i.e., we can see very recent prescriptions. It is statewide,
and there are plans at the federal level for an integrated nationwide system. Once a physician registers in the system, a patient name and address will lead to a Patient Activity Report (PAR). Access to the system requires registering on the state Bureau of Narcotic Enforcement (BNE) website, and providing notarized physician or AHP credentials to BNE for review and approval. One of our UCD psychiatry residents rotating through Bi-Valley for addiction medicine training got a CURES report in the course of an assessment of anxiety in one of our patients. She discovered that the patient got 16 benzodiazepine prescriptions from 10 different doctors in a one-month period and was taking at least 10–15mg/day of Xanax and/or Klonopin. We got releases for the two doctors we knew to advise them of the situation, but most were ER docs and we haven’t figured out how to deal with ERs. We tried to start a controlled detox from benzos, but the patient left treatment and is no doubt still visiting ERs. Most of our CURES interventions have better outcomes. There is an epidemic of prescription drug abuse locally and nationally, and while doctors are not the primary source of all the pills out there (the cartels are dealing pills as an avenue to heroin), doctors in certain practice settings are constantly bombarded with requests for pain meds and benzodiazepines. CURES can help us in our efforts to provide appropriate medications for those who need them and appropriate diagnosis for those needing addiction treatment. firstname.lastname@example.org
Comments or letters, which may be published in a future issue, should be sent to the author’s email or to e.LetterSSV Medicine@gmail. com. 25
Our Life With the Pygmies By Scott Kellerman, MD
We lie awake in our one room hut before dawn, listening to the cacophony of sound emanating from the forest as the birds awake. The Bwindi Impenetrable Forest of South West Uganda contains over 350 species of birds and it seems that they are all chattering to each other at once. The Bwindi Forest is also home to over half of the world’s 650 mountain gorillas. The Batwa pygmies were once part of the vast ecological complex of the Bwindi forest. It was their home and their source of subsistence. When a national park was created to protect the gorillas, however, the pygmies were forced to leave and lost their homeland and their only known way of existing, as hunters and gatherers. The transition from a nomadic existence of picking fruits from the trees, hunting with poison tipped arrows and living in temporary shelters of leaves and branches, to a sedentary lifestyle of permanent houses and farming was disastrous. Our life in Africa seems a far cry from what we had previously experienced. We both had deep roots in New Orleans. My wife, Carol, was a graduate of Tulane, and I had earned an MD from Tulane Medicine and, subsequently, a Masters of Public Health and Tropical Medicine. After residency, we had worked for a few years in Nepal and then moved to California, made our home there and raised a family. We became absorbed in the activities of our two sons. Encouraging their athletic activities, we had to fill our only garage with baseball, ski and camping gear. Cars had to be parked outdoors. Our car shelter became a storage unit. In the course of 20 years of medical practice in California, we had also collected the trappings of the “good” American life — two homes, an office, a small hospital and several cars.
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We had enjoyed our time in Nepal and wanted to continue this service during our family summer vacations, which typically revolved around some form of outreach. Summer trips included starting a little league baseball team at an orphanage in Bolivia, working with the street kids of Brazil, building on a medical clinic in Katmandu, Nepal, constructing a hospital in Mexico or short term medical outreaches in Honduras and Nicaragua. One area of the world that we had not experienced was Africa. It had a myriad of diseases and Carol was frightened — and not without foundation. When I was in my masters program, I related to her the extraordinary lifecycles of parasites cycling through insect, crustacean or other mammals. What frightened her was their cycle in the human body. Early in our marriage, I had suggested we visit Africa as “all the most interesting diseases are there”; she was cradling our one-year-old child in her arms, and this solidified her resolve to avoid Africa. However, she had eagerly agreed to visit Central and South America. For 25 years, she had steadfastly refused an African working vacation until she heard about the plight of the Batwa pygmies. An organization with a medical outreach in developing countries, Episcopal Medical Missions Foundation, needed a volunteer to do a needs assessment of these pygmies. Since early childhood, Carol had been enthralled by National Geographic accounts of these diminutive forest dwellers. Here was an opportunity to meet them face-to-face — the only problem was that they lived in Africa. She agreed to accompany our youngest son and me to assess the plight of these pygmies. During a six-week visit, our survey revealed appalling statistics. The childhood mortality rate of the Batwa pygmy was 38 percent, twice
as high as the Ugandan average, itself one of the worst in the world. The pygmies were dying of malaria, dysentery, malnutrition and the usual complement of tropical diseases. Without intervention it was obvious that they would not survive for long. In contrast to their lives of desperation, the Bwindi forest was filled with myriads of exotic plant and animal life. Colors seemed brighter, the sunsets more vibrant and the animal life more abundant than we had ever experienced before: camping by rivers, as hippos fed around the tent at night; sitting on a roof rack of a vehicle to track tree-sitting lions, while elephants menacingly trumpeted our approaching vehicle. It seemed straight out of a novel. In spite of their desperate circumstances, the pygmies expressed a joy for life through their singing, dancing and laughter that was infectious. We found their needs so compelling and the continent so enticing that, when we returned to the U.S., I retired from my private medical practice and Carol from her counseling practice. We shed many of our possessions and prepared to return to Africa for an extended period of time. Since returning to Uganda in 2001, our outreach to the Batwa pygmies has stretched us in ways we never could have appreciated. Our initial approach was to spend a considerable time in a tent, camping around the Bwindi forest and learning the Batwa’s language, culture and tradition. We would conduct mobile medical clinics under the protection of spreading ficus trees and would see 300–500 patients daily. We would hang IV solutions from the branches of trees, securing them with vines, and drip Quinine into the veins of kids suffering from cerebral malaria. Surgery would be performed on mats laid on the open ground — we would always collect a crowd. In 2004, we constructed an outpatient unit and in 2005 a maternity unit to address the maternal mortality rate of 880 maternal deaths per 100,000 live births, and a maternal death for every 120 births. The hospital has continued to expand and now has 132 beds and a surgi-
cal theater; though it was recently rated the number one hospital in Uganda, it is obvious a hospital alone does not improve the health of a community. Malaria was a devastating illness at our hospital. In 2006, we were losing one or two children a week to malaria. As there were many local customs regarding malaria, we engaged our friends the “abafumu” (traditional healers/witchdoctors), along with the elders, in an education campaign. The vulnerable chil-
The Kellermans at the left, with the patriarch Jacobo and members of his family.
These Batwa warriors formerly used their spears to hunt in the nearby Bwindi Impenetrable Forest.
The large buildings are part of the hospital built to serve the Batwa population.
A gorilla living in the nearby Bwindi Impenetrable Forest.
dren and pregnant mothers were identified and 20,000 bed nets were subsequently distributed. Not one child has died in our institution in over the last 13 months, and the incidence of malaria has been reduced 90 percent. HIV/AIDS is a considerable burden in subSaharan Africa, with an estimated 25,000,000 cases. One focus of our hospital is preventing mother to child transmission of HIV. If a mother is HIV positive, approximately 35 percent of her children will have HIV; if untreated, 50 percent of those children will be dead by the age of 2.
By administering anti-retrovirals to the mother in the later stages of pregnancy and the early portion of breast feeding, and to the child in the first week of life, the transmission rate from mother to child can be reduced to less than 2 percent. To our great joy, we have found that HIV in childhood is a preventable illness. We have also introduced a training program for medical students from around the world, including Uganda. One U.S. student said about his time with the pygmies: â€œWords cannot adequately describe the experience I have had working with the pygmies in the southwest Uganda area. I can honestly say that it was one of the defining moments of my life to date. By sharing their hard work, ample laughter, and enthusiasm to learn, the pygmies showed me a purely genuine human character that warmed my heart. It was eye opening that those who seemed to have so little, actually had so much to give to me and gave it so freely. Their smiles and endless laughter are contagious and I learned that when one has nothing, he or she can still give love.â€? This echoes our sentiments completely. Although the challenges are great, we consider it a great privilege to serve here in Equatorial Africa. email@example.com
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Claire Pomeroy, MD: Vision and Values By David Gunn, MD This is the third of a 6-part series of interviews with deans of the UC Davis School of Medicine. Claire Pomeroy, MD, MBA, is the Chief Executive Officer of UC Davis Health System, UC Davis Vice Chancellor for Human Health Sciences and Dean of the School of Medicine; she is an expert in infectious diseases and a professor of internal medicine and microbiology and immunology. Dr. Pomeroy joined UC Davis in 2003, and was appointed vice chancellor and dean in 2005. She was initially interviewed last December and agreed to a February follow-up interview on pension litigation. David Gunn: I see this thread that the school started off with a primary care focus, then changed direction when the California state Legislature wasn’t able to keep tabs on the original arrangement, the faculty wanted more ”esteem,” and the Chancellor pressured Joe Silva to increase NIH funding to be equivalent to UCSF or Stanford. Would you like to comment? Claire Pomeroy: This school was created to improve the health of this region. At that time, a big hole was the number of primary care doctors. The evolution of the school is: what do we need to improve health outcomes? How do we make the people in our communities healthier? As you know, I’m very frustrated by our country in that we spend this huge amount of our GDP [17 percent] on health care and we’re ranked 49th. I think the reason that they created this school was to address those kinds of statistics and improve health. We need more primary doctors, more specialists, research to find better ways of doing
it, [be] more active in policy and advocacy; we need to do inter-professional, hence the reason for the nursing school. The goal hasn’t changed. The goal is to improve health. DG: How does that 40 percent [of students going into primary care] compare to how UC Davis did in the 1980s, for example? CP: I don’t have all the numbers in front of me. I know the country has set a bar of 50 percent, which is probably a good percentage. California as a state has decided it will pay for fewer medical students per capita as compared to almost every other state. Second, we as a country have not created health care systems that allow primary care doctors to be as fulfilled as they should be. We overload them with paperwork, we under-reimburse them, we don’t create good teams. I think the job for UC Davis is to prepare the students who want to go into primary care as best as we can. But we also have an obligation to change the system. DG: Hibbard Williams suggested that we should just take money away from the specialists and give it to the generalists. CP: Now you’re talking about national health care policy. DG: What’s your opinion on that? CP: My personal opinion is that we spend far too much on acute interventional hospitalcentered care and far too little on prevention and wellness. Far too much on end-of-life care in an ICU, and far too little on the underlying social determinants of health. The UC Davis Health System has the full range of opinions. We have a long list of things that are waiting for money, things that serve our community. People remember a time in health care when
I think there is a long list of things which people are turning to our health system to fix, and a limited pot of money to do that with. Those are really hard choices.
hospitals and medicine were making lots and lots of money. We’re no longer in that era. We have to communicate that more effectively to people. The demands on the health system’s budget are huge right now. I think the debt our medical students are graduating with right now is unacceptable. I think that academic health centers are providing huge amounts of uncompensated care, and that should be shared amongst all the providers in our communities. I think there is a long list of things which people are turning to our health system to fix, and a limited pot of money to do that with. Those are really hard choices. DG: Do the millions of dollars UC Davis receives from the NIH help to improve the bottom line? Why would increasing the NIH research dollars be a driving goal of the Chancellor? What benefit would the university have? CP: Getting a research award doesn’t give you any free money. Most of the national studies have suggested that it costs the system an additional 25 to 30 cents per research dollar you bring in. The reason to go out and get research grants in not to bring money into the system, it’s for the mission. [If it] were making a purely financial decision you might make a different conclusion. High impact research that advances the mission is why you do the research. DG: The MD/PhD program is not accepting applicants this year? Is it struggling? CP: We’re looking at the MD/PhD program; it’s very expensive. The question, is what is the goal? DG: To produce researchers? CP: That’s one of the goals. What’s the best way to get to physician scientists? The MD/PhD is a very important experiment from the NIH. Other people have argued that the most effective thing to do is to complete your medical training [and] do your research during your residency and fellowship years. That’s what I did. DG: [Dean C.J.] Tupper had a goal to improve health; he thought you had to make more GPs. Hibbard Williams and Joe Silva wanted to increase NIH funding, research and specialization focus. I hear you reframing that
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goal, to say that there are many paths to improving health. What are the top three paths you’re going after? CP: The three paths are first to educate the workforce to have the full spectrum of skill sets and opportunities. By that I mean from primary care to specialists to researchers to policy to public health to informatics: the full spectrum. The second would be innovation. We need to be the place where innovation happens. DG: Why do we need to be the place where innovation happens? CP: Academic health centers are where the greatest minds come, where we have the innovation and support. Students are drivers of innovation and new ideas. DG: So innovation leads to answers that improve health, that’s your connection. CP: That innovation needs to come from the full range of research, basic to translation to what we now call dissemination and implementation science. Discovering new ways to do things isn’t sufficient, it’s necessary to go out and disseminate them. We’re no longer an ivory tower to discover things for ourselves. The third thing is [that] we are really [an] important part of the clinical delivery system for this region. We provide essential clinic services (level 1 trauma, cancer center). And we play a critical role in the safety net. Our motivation is not profit or money making. That distinguishes us from other providers. DG: Have you read Atul Gawande’s book “Better”? CP: Yes. DG: He writes about how there are always great centers that know how to do something really well, but there’s a block that prevents hospitals from sharing that with each other; they don’t want to show the bad stuff, or share their advantages, etc. How do you get around that problem of learning from other hospitals? Or is that not a problem for you because you’re so good on the phone? CP: [laughs] It is really important to share best practices. The five UC health centers have something called UC Health, where we can share things like how to reduce wound infec-
tion rates. These are examples of people sharing their best practices. However, we’re a long ways from doing that nationally. Technology can help us share best practices — telemedicine can help us reduce geographic disparities by letting them know what’s the best treatment for HIV or diabetes. Ultimately the health care system in our country works against sharing, because it’s based on competition, percent market share. Kaiser, Sutter or Mercy — one of their jobs is to increase their market share. DG: What types of public policy steps are we going to take to change that? We’re right here in the state capital. What are you doing with the government? What are you doing to get students involved in MPH and public policy? From a student’s perspective, that doesn’t seem to be a major focus of the curriculum. CP: Public health is something the School of Medicine has been the sole supporter of — we’re working to get it funded and expanded. It’s been an ongoing goal, we’re thinking about a graduate program. We’ve successfully recruited [former state Health Director] Dr. Ken Kizer, who is going to be starting the Institute for Population Health Improvement. He’s the architect for many of the improvements in the VA system. We want to do more in policy. DG: Have you thought about how many more years you’ll be in this position? CP: [laughs] I do think about that. I feel very dedicated to this job, and I want to be effective. I get approached by a lot of headhunters, because I’m the senior dean among medical school deans in the University of California system — 6 years now I’ve been doing this job. I would like to stay as long as I stay inspired. DG: If you had to pick some qualities of a candidate who would succeed you, can you give me something other than euphemisms of ”sticking to a mission” and what not? CP: The one thing I would like to see is someone who recognizes that this is a pretty special place. I would want someone who would take risks. Commitment to our wonderful and diverse community, with cultural competence. The most effective leaders...it really comes down to core values. The rest will follow.
DG: What are your core values? CP: Mine focus on social justice and diversity. Innovation and excellence. The ability to be collaborative is important to me. For me, personally, what’s important is to work towards society being a more equitable place. That we feel a sense of responsibility for the vulnerable in our society. That we never let expediency keep us from doing the right thing. It’s important to remember how you make your decisions. DG: From what I understand, there was a period of time where the school was at a crossroads where some thought that UC Davis should go for more primary care physicians than specialists...have anything to say about that? CP: Yes, I think leadership is important, but I think it’s important to remember we’re an organization founded on the faculty as a whole. So, for me, I think the importance is making sure we listen carefully to [what] students think they need when they get here and what they say they needed when they leave, the faculty, and the public. What’s important for me is to not impose any ideas from the top. DG: So how do you as a leader change where an organization is going if you think it’s going in the wrong direction? If you’re listening to them...right? CP: That’s the ultimate question on leadership [laughs]. It’s a great question. There are a few ways you can try to change organizations. First, you can try and look at your own behavior, and role model behaviors you hope others will follow. If people see a disconnect, if they see you acting differently, they pick up on it. I hope you can share your ideas and inspire people. You can provide venues for people to come together — opportunities to express their voices. Yes, it’s absolutely true that you can provide resources to support things. You said this at the beginning — ultimately people have to embrace where the organization is going or it won’t go there. DG: Recently I heard that UC Davis students placed last on a national standardized clinical skills exam [the CPX exam]. In the context of producing more general clinicians, as opposed
For me, personally, what’s important is to work towards society being a more equitable place. That we feel a sense of responsibility for the vulnerable in our society. That we never let expediency keep us from doing the right thing.
I feel that the University made a commitment to the people that I hired, and my principle is that it’s important to keep our word to the people that we hired. When I make a commitment to someone, I keep those commit-
to researchers, I can’t help but see this result as evidence of what students are being trained to do. CP: I think physical exam skills, history taking, patient care skills in general, are sort of the essence of the art of being a physician. I was disappointed to see our performance at the bottom. I understand the other schools use your performance on the exam as part of your grade, whereas ours did not. So maybe we’re not comparing apples to apples — and I don’t want to downplay this [result]. But I’m a big supporter of Dr. Servis [Mark Servis, Associate Dean for Curriculum and Competency Development] and I think he’s paying attention to this. DG: Students have told me that you learn physical exam in the clinic. I had one excellent attending who every day said, ”come on, get in here, let’s do this exam.” But, if you don’t have that attending... So my suggestion was to put more people in the clinics, get more faculty and residents to teach. Yet I hear from residents who admit that they don’t know how to teach it, because they never learned how to do it either. CP: Two points on this. First, it is very clear that the LCME is driving us to ensure that the students don’t have a disproportionately hospital-based experience. They’re emphasizing more ambulatory care. The second is that we’re talking more about teaching residents how to teach. Why does anyone think that comes naturally? It’s just like any other skill. We do have to teach the teachers, then give the students the right experiences so they can learn. When I look back at my medical school training, I agree with you that I was not taught physical exam in a very supportive and thorough way. DG: I want to talk to you about the letter you signed that threatened legal action if the UC retirement pension cap was not lifted. Governor Brown, Chancellor Katehi and Chancellor Yudorf have come out against removing the cap, given the state’s financial trouble. I would like to read you a quote from
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a letter from the Sac Bee’s editorial board that sums up the emotional element. “Neither should some of them [UC executives] claim that lavish pensions are required to keep and recruit good people to UC. Good people don’t threaten lawsuits against a cash strapped state to enrich themselves.” How does that make you feel? CP: I never do anything for political expediency; the important thing is to do the right thing. I feel that the University made a commitment to the people that I hired, and my principle is that it’s important to keep our word to the people that we hired. When I make a commitment to someone, I keep those commitments. DG: So the reason you signed the letter was not so much over a concern for your own pension, so much as it was for the people you hired? CP: That is correct. DG: The State of California doesn’t have enough money to honor all of its commitments, let alone the commitments that were promised to folks who make a lot of money. How can the UC System justify paying people more money, when they already make more than almost everyone else? CP: Again, I think that when I make a commitment to someone, I keep my word to that commitment. People plan their lives on the offers that we make to them. DG: Sure, I read that theme throughout the letter — the retirement plan was the policy that was agreed on, etc. But to me that reductionist argument seems short-sighted. We don’t have the money, so whether we agreed to lift the pension cap or not is irrelevant. CP: And what the letter called for was finding out a way to meet our commitments in the current economic reality. I’m comfortable that this will get resolved through the appropriate personnel processes. DG: How does Governor [Jerry]Brown and Vice-Chancellor [Linda] Katehi’s statements in coming out against lifting this pension cap, how does that make you feel about your retirement? Are you worried about your retirement? CP: I’m not worried about my retirement. For me, that’s not what’s driving any of this.
Board Briefs April 11, 2011 The Board: Elected Ann Gerhardt, MD, to replace Michael Flaningam, MD, as Director, District 2. Dr. Flaningam completed his term December 31, 2010 and had agreed to continue to serve until a replacement was named. Reviewed information regarding SSVMS joining CMA’s Professional Employer Organization (TriNet) through an Administrative Services Operating Agreement, and authorized the Executive Committee to make the final decision after all agreements are finalized.
Approved the Membership Report For Active Membership — Scott W. Adams, MD; Gary M. Cederlind, DO; Katherine E. Eastham, MD; Joy Melnikow, MD; Trung L. Nguyen, DO; Humberto D. Temporini, MD; Roderick V. Vitangcol, MD For Reinstatement to Active Membership — Tracy M. Skolnick, DO For Resignation — Robert W. Derlet, MD; Evalyn Horowitz, MD; Edward J. K. Lee, MD (moved to New York); Connie Mitchell, MD; Grace K. Moi, MD.
Claire Pomeroy, MD continued from previous page My personal opinion is that we can accommodate different approaches going forward that accommodate the current economic reality. That doesn’t necessitate going back on our word to the people who are already here. It’s very important to have discussions about what’s the right thing to do going forward. DG: The man on the street looks at this thing and says, ”You’ve got to be kidding me, they’re already making $500,000, they work here for 30 years and they’re going to retire with $185,000. They don’t think that’s enough, they want $300,000.” They look at that and say that’s just greed — promises aside. There’s not a lot of sympathy out there for the semantics of, “You promised us this or that.” All of the news and commentary say those executives are up in the clouds. They don’t realize with what people are dealing with out here. What do you think about that? CP: I think that we see every day what
people are dealing with. I don’t think that this discussion has anything to do with the compassion people have with the patients that we serve in this community. I’m very open to defining a different approach going forward — then people know what they’re signing up for; that’s the honest and transparent and appropriate way to move forward. DG: Thank you for speaking with me about this. firstname.lastname@example.org REFERENCES http://gawande.com/better http://www.ucdmc.ucdavis.edu/welcome/ features/2010-2011/02/20110223_Ken_Kizer.html http://www.sacbee.com/2011/01/02/3290033/editorial-uc-executivesoffer.html#ixzz1CDQFJVZw http://www.sfgate.com/c/acrobat/2010/12/30/regents-12-10-execpensions.pdf http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2010/12/29/ MNDC1GUSCT.DTL&tsp=1
Meet the Applicants The following applications have been received by the Sierra Sacramento Valley Medical Society. Information pertinent to consideration of any applicant for membership should be communicated to the Society. — Robert A. Kahle, MD, Secretary
Adams, Scott W., Pediatric Hematology/Oncology, University of Michigan 1993, The Permanente Medical Group, 1600 Eureka Rd, Roseville 95661 (916) 784-4190
Currlin, Tuzdy L., Pediatrics, Univ Texas Health Science San Antonio 2007, The Permanente Medical Group, 2155 Iron Point Rd, Folsom 95630 (916) 817-5400
Nguyen, Trung L., Family Medicine, Chicago College of Osteopathic Medicine 2001, The Permanente Medical Group, 2345 Fair Oaks Blvd., Sacramento 95825 (916) 973-5243
Belko, Andrea E., Internal Medicine, St. Louis University 2006, The Permanente Medical Group, 6600 Bruceville Rd, Sacramento 95823 (916) 688-2106
DeSantis, Molly L., Pediatrics, UC Davis 2007, The Permanente Medical Group, 1955 Cowell Blvd., Davis 95616 (530) 757-5075
Reed, J. Brian, Ophthalmology/Vitreoretinal Diseases, Uniformed Services University 1990, Retinal Consultants Medical Group, 3939 J St #104, Sacramento 95819 (916) 454-4861
Caravelli, Rebekah H., Emergency Medicine, UC San Diego 2003, The Permanente Medical Group, 1600 Eureka Rd, Roseville 95661 (916) 784-5380 Cederlind, Gary M., Internal Medicine, WUHS College of Osteopathic 1986, The Permanente Medical Group, 10725 International Dr, Rancho Cordova 95670 (916) 631-3040 Choy, Jennifer H., Internal Medicine, University of Health Sciences, College of Osteopathic, Kansas City 1995, The Permanente Medical Group, 10725 International Dr, Rancho Cordova 95670 (916) 631-3040 Cooper, David M., Pediatrics, Medical College of Ohio 2005, The Permanente Medical Group, 1650 Response Rd, Sacramento 95815 (916) 614-4060
DiSibio, Guy L., Pathology, UC Los Angeles 2003, The Permanente Medical Group, 2025 Morse Ave, Sacramento 95825 (916) 973-7278 Eastham, Katherine E., Pediatrics, Tulane University 1997, The Permanente Medical Group, 1955 Cowell Blvd., Davis 95616 (530) 757-7057 Follette, David M., Cardiothoracic Surgery, UC Los Angeles 1973, 3941 J St #362, Sacramento 95819 (916) 452-1189 Kienle, George S., Family Medicine, WUHS, College of Osteopathic 2002, The Permanente Medical Group, 2155 Iron Point Rd, Folsom 95630 (916) 817-5200 Luig, Tiina, Family Medicine, Tartu Medical School, Estonia 1993, The Permanente Medical Group, 1001 Riverside Ave, Roseville 95678 (916) 784-4050
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Sierra Sacramento Valley Medicine
Sayegh, Antoine, Hematology/Oncology, Aleppo University, Syria 1979, The Permanente Medical Group, 1600 Eureka Rd, Roseville 95661 (916) 784-5626 Vitangcol, Roderick V., Family Medicine, UC Davis 1996, The Permanente Medical Group, 1650 Response Rd, Sacramento 95815 (916) 614-4040
A July 13 lecture on Healing Music Georges M. Halpern, MD, PhD will give the next lecture, Healing Music: Magic & Medicine, in the 2011 series presented by the Sierra Sacramento Valley Museum of Medical History. Although music serves no essential biological need, it is intrinsic to all cultures and can have surprising benefits. The speaker is Distinguished Professor of Pharmaceutical Sciences at The Hong Kong Polytechnic University and a member of the directorate of the State Key Laboratory in Modern Chinese Medicine and Molecular Pharmacology in Shenzhen, China. The lecture at SSVMS offices, 5380 Elvas Avenue, Sacramento, is free and open to the public. Reservations are requested to ensure adequate seating; please call (916) 452-2671.
Clifford W. Skinner, Jr., MD 1929 – 2011
Cliff and I first met in 1965 when he joined The Permanente Medical Group a few months after I did. He soon became the first Chief of Pediatrics, and I the first Chief of Ob-Gyn. Thus a friendship that would last over 30 years was born, based on a professional relationship of two closely allied specialties. As the years went by, we pursued parallel managerial and executive positions, while at the same time expanding our personal interactions by traveling with our wives to many parts of the world. Cliff became Sacramento’s first elected representative to Board of Directors of The Permanente Medical Group Board of Directors (TPMG). As the years went on, he was instrumental in the development of the Roseville, Davis, and Point West Medical Office Buildings, as well as the South Sacramento Medical Center. The Roseville facility then spun-off the current Roseville Medical Center. In 1984, Cliff succeeded me as Physician-in Chief of the original medical center on Morse Avenue. In addition, he was re-elected twice as Secretary to the Board of Directors, and then Chairman of the Board. He was also a member of the Board of Directors of this Medical Society. It is noteworthy to recall that, in addition to his executive/management roles, Cliff remained a practicing pediatrician (albeit part-time). After stepping down from those roles in 1994, he returned to full-time practice until his retirement in 1996. Cliff was born in Meadville, Pennsylvania, into a medical family. (His father and grandfather were both physicians.) He enjoyed
summer vacations at the family vacation retreat in Chatauqua, New York, where he became a proficient devotee of sailing and, as one would expect, won many races. Cliff was graduated from Alleghany College with a bachelor’s degree, and received his MD from Temple University College of Medicine in Philadelphia. He completed his internship at the Strong Memorial Hospital in Rochester, New York, where he met his wife, Patricia, who was a nurse there. He completed his pediatric residency in Denver at the University of Colorado, and then spent two years in the Air Force in Plattsburgh, New York, at Stewart Air Force Base. His next move was to Denver where he joined Clifford W. Skinner, Jr., MD a pediatric group, and from there he came to Sacramento to join The Permanente Medical Group. I recall that Cliff, with all of his many accomplishments was most proud of his three sons, Clifford III (Chip), Mark, and Roger. Some of his proudest and happiest moments were at the ceremonies where each of them attained the rank of Eagle Scout. Cliff died on January 31. In addition to his sons and their wives, he is survived by two brothers and four grandchildren. His wife, Patricia Norton Skinner, preceded him in death. Although in many ways a very private person, he had many friends and the respect of all who knew him. We are all the poorer with his passing, and I have lost a brother. — Albert J. Kahane, MD
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Are you a physician willing to donate a few hours of your time to mentor eager new medical students? The Willow Clinic, an affiliated UC Davis School of Medicine program, needs doctors like you. We’re recruiting friendly people with a desire to teach the next generation of physicians and to help the community. The clinic serves Sacramento’s homeless and is open every Saturday from 9 a.m. to 1 p.m. Volunteer physicians are welcome on a one-time only or rotating basis. For further information, contact: email@example.com.
Physician Needed for Geriatric Practice Sacramento, California Sutter SeniorCare is seeking a full time physician to provide care for a frail, elderly patient population. Sutter SeniorCare PACE is a Program for All-Inclusive Care for the elderly. This multidisciplinary model of care has been recognized as the most appropriate model of comprehensive care for the frail elderly population. The mission of this not-for profit organization is to keep frail older individuals safely residing in the community. In addition to the primary care clinic, PACE services include home health, Adult Day Healthcare, social services, and rehabilitation therapy. The physician will work in close cooperation with the PACE Medical Director. Responsibilities will include providing primary care to Sutter SeniorCare participants. Evaluation and management of medical conditions, with a strong emphasis on preventive care is our desired model of care. The physician will initiate referral to and follow-up with specialists when needed. Additional responsibilities include ensuring continuity of care when the patient enters an acute or sub-acute facility. Candidates must have an M.D. or D.O. degree as well as board certification or eligibility in Internal Medicine or Family Practice; and a license to practice medicine in California. Additional qualifications in Geriatric Medicine, and a strong knowledge base and experience working with frail elder patients are preferred. Experience working with family and caregivers a multidisciplinary team and providing care in community-based long-term care facilities are also desirable qualifications.
Membership Has Its Benefits!
Free and Discounted Programs for Medical Society/CMA Members Auto/Homeowners Discounted Insurance
Mercury Insurance Group 1.888.637.2431 or www.mercuryinsurance.com/cma
Car Rental / Avis or Hertz
Members-only coupon code is required 1.800.786.4262 / www.cmanet.org/benefits
Clinical Reference Guides
Epocrates discounted mobile/online products www.cmanet.org/benefits/epocrates_guides.asp
Conference Room Rentals
Medical Society 916.452.2671
CMA rewards credit card, Bank of America 1.866.598.4970
Office Supplies/Equipment – Staples, Inc. Save up to 80%
Members-only discount link www.cmanet.org/benefits
Healthcare Information Technology (HIT) www.cmanet.org/hit Resource Center HIPAA Compliance Toolkit
PrivaPlan Associates, Inc. 1.877.218.707 / www.privaplan.com
Insurance Life, Disability, Long Term Care Medical/Dental, Workers’ Comp, more...
Marsh Affinity Group Services 1.800.842.3761 www.marshaffinity.com/assoc/cma.html
Legal Services & CMA On-Call Documents
800.786.4262 / www.cmanet.org/member
Magazine Subscriptions 50% off subscriptions
Subscription Services, Inc. 1.800.289.6247 / www.buymags.com/cma
1.800.253.7880 / www.medicalert.org/cma
Merchant Services/Payroll Services/ Check Management
Heartland Payment Systems 1.866.941.1477 www.heartlandpaymentsystems.com
Practice Financing Reduced Loan Administration Fees
Members-only coupon code is required 1.800.786.4262 / www.cmanet.org/benefits
Reimbursement Helpline Assistance with contracting or reimbursement
Security Prescriptions Products
RX Security www.rxsecurity.com/cma.php
Travel Accident Insurance/Free
All SSVMS Members $100,000 Automatic Policy www.ssvms.org/about/downloads/ travel-accident-ins.pdf
Sutter SeniorCare is part of Sutter Health Sacramento Region. This is a salaried full time position with excellent benefits. For more information please contact Debbie Kreidler, Management Recruiter (916) 781-7538, email firstname.lastname@example.org, or apply online for this at checksutterfirst.org/ careers (Job #1104937). EOE.
Sierra Sacramento Valley Medicine
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Financial & Insurance Services Acme Financial Group* ®, mSFS** Jane Smith, cFP Steven R. Kaneski CA License # 0B36175 Kelly D. Kaneski Insurance License # 123456 Blaine K. Johnson CA LicensecA/AR # 0G27275 CA License # 0C47001 Samuel S. Goodyear CA License 123# 0G29812 Anytown Road River Park Drive # 202 New York, NY1425 10010 2999 Douglas Boulevard # 340 Sacramento CA 95815 P. 555-123-4567 F. 555-123-4567 Roseville CA 95661 P. 916.258.7339 F. 916.923.5752 email@example.com P. 877.772.4374 F. 916.783.8674 firstname.lastname@example.org * Independently owned and operated from New York Life and its affiliates. ** Agent, licensed to sell insurance through New York Life Insurance Company and may be licensed to sell insurance through various other independent unaffiliated companies.
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1 Cash value of a whole life insurance policy begins accumulating at the end of the first year. Cash value is accessible through policy loans, and generally does not equal premiums paid. Loans accrue interest and reduce the cash value and death benefit. 2 Dividends are not guaranteed. 3 Guarantee refers to the guaranteed cash value feature of a whole life insurance policy. Guarantees are dependent upon the claims paying ability of the issuer. ©2011 New York Life Insurance Company, 51 Madison Avenue, New York, NY 10010. In Oregon, the Whole Life policy form number is 208-50.27. SMRU 00425399 CV (Exp. 12/31/11)
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Our passion protects your practice
Sierra Sacramento Valley Medicine is the official journal of the Sierra Sacramento Valley Medical Society (SSVMS) and promotes the history,...
Published on May 14, 2011
Sierra Sacramento Valley Medicine is the official journal of the Sierra Sacramento Valley Medical Society (SSVMS) and promotes the history,...